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Thalidomide: Pediatric drug information

Thalidomide: Pediatric drug information
(For additional information see "Thalidomide: Drug information" and see "Thalidomide: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Pregnancy:

If thalidomide is taken during pregnancy, it may cause severe birth defects or embryo-fetal death. Thalidomide should never be used by females who are pregnant or who could become pregnant while taking thalidomide. Even a single dose (1 capsule [regardless of strength]) taken by a pregnant woman during pregnancy may cause severe birth defects.

Because of this toxicity and in an effort to make the chance of embryo-fetal exposure to thalidomide as negligible as possible, thalidomide is approved for marketing only through a special restricted distribution program: Thalomid REMS program, approved by the Food and Drug Administration. Information about Thalomid and the Thalomid REMS program is available at https://www.thalomidrems.com or by calling the REMS Call Center at 1-888-423-5436.

Thromboembolic events:

The use of thalidomide in multiple myeloma results in an increased risk of venous thromboembolism, such as deep venous thrombosis and pulmonary embolism. This risk increases significantly when thalidomide is used in combination with standard chemotherapeutic agents including dexamethasone. In 1 controlled trial, the rate of venous thromboembolism was 22.5% in patients receiving thalidomide in combination with dexamethasone compared with 4.9% in patients receiving dexamethasone alone (P = 0.002). Patients and physicians are advised to be observant for the signs and symptoms of thromboembolism. Instruct patients to seek medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. Consider thromboprophylaxis based on an assessment of individual patients' underlying risk factors.

Brand Names: US
  • Thalomid
Brand Names: Canada
  • Thalomid
Therapeutic Category
  • Angiogenesis Inhibitor;
  • Immunosuppressant Agent;
  • Tumor Necrosis Factor (TNF) Blocking Agent
Dosing: Pediatric
AIDS-related aphthous stomatitis

AIDS-related aphthous stomatitis: Limited data available: Adolescents ≥13 years: Oral: 200 mg once daily at bedtime for 4 weeks or sooner if resolution. May be increased to 200 mg twice daily if no improvement after 4 weeks. Dosing based on double-blind, placebo-controlled trial by AIDS Clinical Trials Group (n=57; age: ≥13 years) which showed 55% healing in treatment group vs 7% in placebo (Jacobson 1997).

Erythema nodosum leprosum, cutaneous

Erythema nodosum leprosum (ENL), cutaneous: Children ≥12 years and Adolescents: Oral:

Acute: Initial: 100 to 300 mg once daily at bedtime; continue until signs/symptoms subside (usually ~2 weeks), then taper off in 50 mg decrements every 2 to 4 weeks. For severe cases with moderate to severe neuritis, corticosteroids may be initiated with thalidomide (taper off and discontinue corticosteroids when neuritis improves).

Patients weighing <50 kg: Initiate at lower end of dosage range.

Severe cutaneous reaction or patients previously requiring high doses: May be initiated or increased to 400 mg/day at bedtime or in divided doses.

Maintenance (prevention/suppression, or with flares during tapering attempts): Maintain on the minimum dosage necessary to control the reaction; efforts to taper should be repeated every 3 to 6 months in decrements of 50 mg every 2 to 4 weeks.

Graft-versus-host disease, chronic, treatment

Graft-versus-host disease, chronic (refractory), treatment: Limited data available: Children ≥2 years and Adolescents: Oral: Initial: 3 to 6 mg/kg/day (maximum initial daily dose: 100 mg/day) at bedtime or in 2 to 4 divided doses before meals; may be adjusted at ≥2 week intervals based on patient response up to 12 mg/kg/day in 3 to 4 divided doses (maximum daily dose: 800 mg/day) (Browne 2000; Rovelli 1998; Wolff 2011); one trial used initial doses of 3 mg/kg/dose every 6 hours with dose adjustment to attain thalidomide concentration of ≥5 mcg/mL 2 hours postdose (Vogelsang 1992).

Inflammatory bowel disease, refractory

Inflammatory bowel disease, refractory: Limited data available: Note: Use reserved for patients who do not tolerate or have lost response to anti-tumor necrosis factor agents (ECCO/ESPGHAN [Ruemmele 2014]).

Weight-based dosing (ECCO/ESPGHAN [Ruemmele 2014]; Facchini 2001; Lazzerini 2007; Lazzerini 2013; Zheng 2011):

Children ≥2 years and Adolescents: Oral: 1.5 to 2.5 mg/kg/dose once daily, usually dosed in the evening; doses as high as 3 mg/kg/dose were described in a small case series. Maximum reported dose in clinical trials is 150 mg/day. Taper to lowest effective dose after remission is achieved.

Fixed dosing:

Adolescents: Oral: Initial: 50 mg once daily; if needed, may titrate dose in 50 mg increments to a maximum of 150 mg daily. Taper to lowest effective dose after remission is achieved. (ECCO/ESPGHAN [Ruemmele 2014]); Felipez 2012). Fixed initial dosing adjusted for patient weight has also been described in the literature; patients weighing <30 kg received 50 mg once daily, patients weighing 30 to 60 kg received 100 mg once daily, and patients weighing ≥60 kg received 150 mg once daily (Lazzerini 2013; Lazzerini 2015).

Dosing based on clinical trials and case reports. In the largest trial, pediatric patients with refractory Crohn disease received fixed thalidomide doses based on weight (n=28; mean age: 14 ± 3.5 years) or placebo (n=26; mean age: 15 ± 3 years); at 8 weeks, 46.4% of patients receiving thalidomide achieved clinical remission, compared to only 11.5% of those receiving placebo (Lazzerini 2013). In another randomized clinical trial, pediatric patients with severe, refractory ulcerative colitis received fixed thalidomide doses based on weight (n=12; mean age: 11.7 years) or placebo (n=11; mean age: 12.9 years). At 8 weeks, 83.3% of patients receiving thalidomide achieved clinical remission, compared to only 18.2% receiving placebo (Lazzerini 2015). In a retrospective study of severe refractory Crohn disease patients (n=12; ages: 8 to 19 years), thalidomide was initiated at 50 mg once daily and titrated by 50 mg increments to a maximum dose of 150 mg. Markers of disease severity significantly improved and long-term follow up found a lower rate of surgical resection from baseline (Felipez 2012).

Systemic juvenile idiopathic arthritis, refractory

Systemic juvenile idiopathic arthritis, refractory: Limited data available: Children ≥3 years and Adolescents: Oral: Initial: 2 mg/kg/day rounded to the nearest 50 mg dose; if necessary, may increase at 2-week intervals to 3 to 5 mg/kg/day. Dosing based on a multicenter, open-labeled prospective study (n=13, age: 3 to 23 years); 11 of 13 patients showed sustained response with adequate disease control (Lehman 2004).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing adjustment for toxicity:

ENL, cutaneous:

Children ≥12 years and Adolescents:

ANC ≤750/mm3: Withhold treatment if clinically appropriate.

Angioedema or anaphylaxis: Permanently discontinue therapy.

Constipation, oversedation: Temporarily withhold; consider a reduced dose upon restarting therapy.

Dermatologic reactions:

Grade 2 or 3 rash: Consider interruption or discontinuation of therapy.

Grade 4 rash, skin exfoliation, bullae, or any severe dermatologic reaction: Permanently discontinue therapy.

Grade 3 or 4 adverse reactions: Consider dose reduction, delay, or discontinuation (based on clinical judgment).

Peripheral neuropathy: The manufacturer recommends to temporarily withhold or continue with a reduced dose.

The following adjustments have also been recommended for adult patients with multiple myeloma (Richardson 2012):

Grade 1: Reduce dose by 50%.

Grade 2: Temporarily interrupt therapy; once resolved to ≤ grade 1, resume therapy with a 50% dosage reduction (if clinically appropriate).

Grade 3 or higher: Discontinue therapy.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling. Kidney impairment is not expected to alter drug exposure because <3.5% of dose is excreted as unchanged drug. In a study of 6 adult patients with end-stage renal disease on dialysis, although clearance was increased by dialysis, a supplemental dose was not needed (Eriksson 2003).

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling (has not been studied); however, thalidomide does not appear to undergo significant hepatic metabolism.

Dosing: Adult

(For additional information see "Thalidomide: Drug information")

AIDS-related aphthous stomatitis

AIDS-related aphthous stomatitis (off-label use): Oral: 200 mg once daily at bedtime for up to 8 weeks; if no response, then 200 mg twice daily for 4 weeks (Jacobson 1997).

Erythema nodosum leprosum, acute cutaneous

Erythema nodosum leprosum, acute cutaneous: Oral: Initial: 100 to 300 mg once daily at bedtime, continue until signs/symptoms subside (usually ~2 weeks), then taper off in 50 mg decrements every 2 to 4 weeks. For severe cases with moderate to severe neuritis, corticosteroids may be initiated with thalidomide (taper off and discontinue corticosteroids when neuritis improves).

Patients weighing <50 kg: Initiate at lower end of the dosing range.

Severe cutaneous reaction or patients previously requiring high doses: May be initiated at up to 400 mg once daily at bedtime or in divided doses.

Erythema nodosum leprosum, maintenance

Erythema nodosum leprosum, maintenance (prevention/suppression, or with flares during tapering attempts): Oral: Maintain on the minimum dosage necessary to control the reaction; efforts to taper off should be attempted every 3 to 6 months, in decrements of 50 mg every 2 to 4 weeks.

Graft-versus-host disease, chronic, treatment

Graft-versus-host disease, chronic (refractory), treatment (off-label, second-line use; optimum dose not determined): Oral: Initial: 100 mg once daily at bedtime, with dose escalation up to 400 mg daily in 3 to 4 divided doses (Wolff 2011) or Initial: 50 to 100 mg 3 times daily; maximum dose: 600 to 1,200 mg daily (Kulkarni 2003) or 200 mg 4 times daily (dose adjusted to goal thalidomide concentration of ≥5 mcg/mL 2 hours postdose) (Vogelsang 1992) or 100 to 300 mg 4 times daily (Parker 1995).

Multiple myeloma, newly diagnosed

Multiple myeloma, newly diagnosed: Oral: 200 mg once daily at bedtime (in combination with dexamethasone).

Multiple myeloma

Multiple myeloma (off-label dosing or combinations):

In combination with bortezomib and dexamethasone (off-label combination): Induction therapy: 100 mg once daily for the first 14 days, then 200 mg once daily for 3 (21-day) cycles (Cavo 2010) or 100 mg once daily for up to 8 (21-day) cycles (Kaufman 2010).

In combination with daratumumab, bortezomib, and dexamethasone (off-label combination): DVTd regimen (in newly diagnosed transplant-eligible patients): 100 mg once daily for up to 4 pretransplant induction cycles and 2 posttransplant consolidation cycles; each cycle is 28 days (Moreau 2019).

In combination with melphalan and prednisone (off-label combination): 200 to 400 mg once daily (Facon 2007) or 100 mg once daily (Palumbo 2008) or 50 to 100 mg once daily, depending on patient tolerance (Hulin 2009).

Multiple myeloma, maintenance (following autologous stem cell transplant; off-label use): Oral: 200 mg once daily starting 3 to 6 months after transplant; continue until disease progression or unacceptable toxicity (Brinker 2006) or 100 mg once daily starting 42 to 60 days following transplant; increase to 200 mg once daily after 2 weeks if tolerated; continue for up to 12 months (in combination with prednisolone) (Spencer 2009).

Multiple myeloma, salvage therapy: Initial: 200 mg once daily at bedtime; may increase daily dose by 200 mg every 2 weeks for 6 weeks (if tolerated) to a maximum of 800 mg once daily at bedtime (Singhal 1999) or 100 mg once daily (in combination with dexamethasone) (Palumbo 2001) or 200 mg once daily (in combination with bortezomib and dexamethasone) for 1 year (Garderet 2012) or 400 mg once daily at bedtime (in combination with dexamethasone, cisplatin, doxorubicin, cyclophosphamide and etoposide) (Lee 2003).

Systemic light chain amyloidosis

Systemic light chain amyloidosis (off-label use): Oral: 200 mg once daily (starting dose 50 to 100 mg once daily; titrate at 4-week intervals) in combination with cyclophosphamide and dexamethasone (Wechalekar 2007).

Waldenström macroglobulinemia

Waldenström macroglobulinemia (off-label use): Oral: ≤200 mg once daily for up to 52 weeks (in combination with rituximab) (Treon 2008).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

No dosage adjustment necessary for patients with renal impairment and on dialysis (per manufacturer). In a study of 6 patients with end-stage renal disease on dialysis, although clearance was increased by dialysis, a supplemental dose was not needed (Eriksson 2003).

Multiple myeloma: An evaluation of 29 newly diagnosed myeloma patients with renal failure (serum creatinine ≥2 mg/dL) treated with thalidomide and dexamethasone (some also received cyclophosphamide) found that toxicities and efficacy were similar to patients with normal renal function (Seol 2010). A study evaluating induction therapy with thalidomide and dexamethasone in 31 newly diagnosed myeloma patients with renal failure (CrCl <50 mL/minute), including 16 patients with severe renal impairment (CrCl <30 mL/minute) and 7 patients on chronic hemodialysis found that toxicities were similar to patients without renal impairment and that thalidomide and dexamethasone could be administered safely (Tosi 2009). The International Myeloma Working Group (IMWG) suggests that thalidomide may be safely administered to patients with renal impairment, including those on dialysis (Dimopoulos 2016). The IMWG recommends the use of the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (preferred) or the Modification of Diet in Renal Disease (MDRD) formula to evaluate renal function estimation in multiple myeloma patients with a stable serum creatinine.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). However, thalidomide does not appear to undergo significant hepatic metabolism.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Incidences of adverse reactions may include combination therapy with dexamethasone.

>10%:

Cardiovascular: Deep vein thrombosis (13%), edema (13%), ischemic heart disease (11%), peripheral edema (34%), venous thromboembolism (23%)

Endocrine & metabolic: Hyperglycemia (15%)

Gastrointestinal: Constipation (50%), dyspepsia (11%), nausea (13%)

Nervous system: Anxiety (12%), dizziness (23%), fatigue (21%), paresthesia (12%) peripheral neuropathy (≥10%; grade 3/4: 3%)

Neuromuscular & skeletal: Asthenia (24%), tremor (26%)

Respiratory: Pneumonia (15%)

1% to 10%:

Cardiovascular: Acute myocardial infarction (1%), atrial fibrillation (grade 3/4: 5%), bradycardia (≥3%), cerebrovascular accident (3%), hypotension (≥3%), orthostatic hypotension (≥3%), pulmonary embolism (grade 3/4: 7%), syncope (grade 3/4: 3%), transient ischemic attacks (≥3%)

Endocrine & metabolic: Hypokalemia (grade 3/4: 3%), weight gain (grade 3/4: 3%)

Gastrointestinal: Gastrointestinal perforation (≥3%; including diverticular and intestinal perforation), peritonitis (≥3%), vomiting (≥3%), xerostomia (≥3%)

Hematologic & oncologic: Neutropenia (grade 3/4: 3%)

Nervous system: Confusion (grade 3/4: 2%), depression (10%), drowsiness (≥3%), hypoesthesia (≥3%), mood changes (≥3%), peripheral sensory neuropathy (10%), polyneuropathy (≥3%), vertigo (grade 3/4: 2%)

Ophthalmic: Blurred vision (≥3%)

Respiratory: Bronchitis (≥3%), bronchopneumonia (grade 3/4: 3%)

Frequency not defined:

Cardiovascular: Facial edema

Dermatologic: Fungal dermatitis, maculopapular rash, nail disease, pruritus, skin rash

Gastrointestinal: Abdominal pain, diarrhea, oral candidiasis

Genitourinary: Impotence

Nervous system: Chills, headache, malaise, pain

Neuromuscular & skeletal: Back pain, neck pain, neck stiffness

Respiratory: Pharyngitis, rhinitis, sinusitis

Postmarketing:

Cardiovascular: ECG abnormality, myxedema, Raynaud’s disease, septic shock, sick sinus syndrome

Dermatologic: Erythema multiforme, erythema nodosum, Stevens-Johnson syndrome, toxic epidermal necrolysis

Endocrine & metabolic: Amenorrhea, galactorrhea not associated with childbirth, gynecomastia, hypercalcemia, hypomagnesemia, hyponatremia, hypothyroidism

Gastrointestinal: Aphthous stomatitis, biliary obstruction, gastric ulcer

Genitourinary: Oliguria, sexual disorder, urinary incontinence, uterine hemorrhage

Hematologic & Oncologic: Change in prothrombin time, chronic myelocytic leukemia, erythroleukemia, febrile neutropenia, Hodgkin’s lymphoma, lymphedema, lymphocytopenia, pancytopenia, petechia, purpuric disease, thrombocytopenia, tumor lysis syndrome

Hepatic: Increased serum alkaline phosphatase

Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction

Immunologic: Drug reaction with eosinophilia and systemic symptoms, organ transplant rejection

Infection: Cytomegalovirus disease, reactivation of HBV, sepsis, severe infection, varicella zoster infection, viral infection

Nervous system: Carpal tunnel syndrome, hangover effect, impaired consciousness, lethargy, loss of consciousness, mental status changes, migraine, Parkinson’s disease, progressive multifocal leukoencephalopathy, seizure (including tonic-clonic movements), status epilepticus, stupor, suicidal tendencies

Neuromuscular & skeletal: Foot-drop

Ophthalmic: Diplopia, nystagmus disorder

Otic: Auditory impairment

Renal: Acute kidney injury, renal failure syndrome

Respiratory: Interstitial pulmonary disease, pleural effusion, pulmonary hypertension

Contraindications

Hypersensitivity to thalidomide or any component of the formulation; pregnancy

Canadian labeling: Additional contraindications (not in the US labeling): Hypersensitivity to lenalidomide or pomalidomide; females at risk of becoming pregnant and male patients who are unable to follow or comply with conditions for use (refer to manufacturer labeling); breastfeeding

Warnings/Precautions

Concerns related to adverse effects:

• Bone marrow suppression: May cause leukopenia and neutropenia; avoid initiating therapy if ANC <750/mm3. Persistent neutropenia may require treatment interruption. Thrombocytopenia (including grades 3 and 4) has been reported; may require dose reduction, treatment delay, or discontinuation. Monitor for signs and symptoms of bleeding (including petechiae, epistaxis, and GI bleeding), especially if concomitant medication may increase the risk of bleeding. Monitor CBC with differential and platelets. Anemia has also been observed.

• Bradycardia: May cause bradycardia; use with caution when administering concomitantly with medications that may also decrease heart rate. May require thalidomide dose reduction or discontinuation.

• CNS effects: May cause dizziness, drowsiness, and/or somnolence; caution patients about performing tasks which require mental alertness (eg, operating machinery or driving). Avoid ethanol and concomitant medications that may exacerbate these symptoms; dose reductions may be necessary for excessive drowsiness or somnolence.

• Constipation: Constipation may commonly occur. May require treatment interruption or dosage reduction.

• Dermatologic reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported (may be fatal). Withhold or discontinue therapy for grade 2 or 3 rash. Permanently discontinue for grade 4 rash or if rash is exfoliative, bullous, or severe (eg, SJS, TEN, DRESS).

• Hepatotoxicity: Abnormal liver function tests, hepatitis, and cholestatic jaundice have been reported. Hepatotoxicity (including hepatocellular and cholestatic injury) has been observed rarely (case reports), with a mean time to development of 46 days; most events resolved after discontinuing thalidomide (Vilas-Boas 2012).

• Hypersensitivity: Hypersensitivity, including angioedema, anaphylactic reaction, and erythematous macular rash, possibly associated with fever, tachycardia, and hypotension, have been reported. Permanently discontinue for angioedema or anaphylaxis. May require treatment interruption for other severe reactions; discontinue if recurs with rechallenge.

• Orthostatic hypotension: May cause orthostatic hypotension; use with caution in patients who would not tolerate transient hypotensive episodes. When arising from a recumbent position, advise patients to sit upright for a few minutes prior to standing.

• Peripheral neuropathy: Thalidomide is commonly associated with peripheral neuropathy; may be irreversible. Neuropathy generally occurs following chronic use (over months), but may occur with short-term use; onset may be delayed. Use caution with other medications that may also cause peripheral neuropathy. Monitor for signs/symptoms of neuropathy monthly for the first 3 months of therapy and regularly thereafter. Electrophysiological testing may be considered at baseline and every 6 months to detect asymptomatic neuropathy. To limit further damage, immediately discontinue (if clinically appropriate) in patients who develop neuropathy. Reinitiate therapy only if neuropathy returns to baseline; may require dosage reduction or permanent discontinuation.

• Secondary malignancy: Increased incidence of second primary malignancies (SPMs), including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), has been observed in previously untreated multiple myeloma patients receiving thalidomide in combination with melphalan, and prednisone. In addition to AML and MDS, solid tumors have been reported with thalidomide maintenance treatment for multiple myeloma (Usmani 2012). Carefully evaluate patients for SPMs prior to and during treatment and manage as clinically indicated.

• Seizures: Seizures (including grand mal convulsions) have been reported in postmarketing data; monitor closely for clinical changes indicating potential seizure activity in patients with a history of seizures, concurrent therapy with drugs that alter seizure threshold, or conditions that predispose to seizures.

• Thromboembolic events: Thalidomide use for the treatment of multiple myeloma is associated with an increased risk for venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism. Ischemic heart disease, including MI and stroke, also occurred at a higher rate (compared to placebo) in myeloma patients receiving thalidomide plus dexamethasone who had not received prior treatment. Assess individual risk factors for thromboembolism and consider thromboprophylaxis. The American Society of Clinical Oncology guidelines for VTE prophylaxis and treatment recommend thromboprophylaxis for patients receiving thalidomide in combination with chemotherapy and/or dexamethasone; either aspirin or low molecular weight heparin (LMWH) is recommended for lower risk patient and LMWH is recommended for higher-risk patients (Lyman 2013; Lyman 2015). Anticoagulant prophylaxis should be individualized and selected based on the venous thromboembolism risk of the combination treatment regimen, using the safest and easiest to administer (Palumbo 2008). Monitor for signs/symptoms of thromboembolism and advise patients to seek immediate care if symptoms (shortness of breath, chest pain, arm/leg swelling) develop. Other medications that are also associated with thromboembolism should be used with caution.

• Tumor lysis syndrome: Patients with a high tumor burden may be at risk for tumor lysis syndrome; monitor closely; institute appropriate management for hyperuricemia.

Disease-related concerns:

• Heart failure: In a scientific statement from the American Heart Association, thalidomide has been determined to be an agent that may exacerbate underlying myocardial dysfunction (magnitude: minor) (AHA [Page 2016]).

• Multiple myeloma: An increase in mortality was noted in 2 clinical studies in patients with multiple myeloma who received pembrolizumab in combination with a thalidomide analogue and dexamethasone. Causes of death in the experimental arm (containing pembrolizumab, dexamethasone, and a thalidomide analogue [pomalidomide or lenalidomide]) included myocarditis, SJS, MI, pericardial hemorrhage, cardiac failure, respiratory tract infection, neutropenic sepsis, sepsis, multiple organ dysfunction, respiratory failure, intestinal ischemia, cardiopulmonary arrest, suicide, pulmonary embolism, cardiac arrest, pneumonia, sudden death, and large intestine perforation. Multiple myeloma is not an approved indication for PD-1 or PD-L1 blocking antibodies; pembrolizumab should not be used to treat multiple myeloma in combination with a thalidomide analogue and dexamethasone unless as part of a clinical trial.

Special populations:

• Older adult: Certain adverse reactions (constipation, fatigue, weakness, nausea, hypokalemia, hyperglycemia, DVT, pulmonary embolism, atrial fibrillation) are more likely in elderly patients.

• HIV-infected patients: Thalidomide is associated with increased viral loads in studies conducted prior to the use of antiretroviral therapy. Monitor viral load after the first and third months of therapy, and every 3 months thereafter.

Other warnings/precautions:

• Blood donation: Patients should not donate blood during thalidomide treatment and for 4 weeks after therapy discontinuation.

• REMS program: Prescribers and pharmacies must be certified with the program to prescribe or dispense thalidomide. Patients must sign an agreement and comply with the REMS program requirements.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Thalomid: 50 mg, 100 mg

Thalomid: 150 mg, 200 mg [contains fd&c blue #2 (indigotine,indigo carmine)]

Generic Equivalent Available: US

No

Pricing: US

Capsules (Thalomid Oral)

50 mg (per each): $205.08

100 mg (per each): $332.89

150 mg (per each): $355.94

200 mg (per each): $379.01

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Thalomid: 50 mg, 100 mg

Thalomid: 200 mg [contains fd&c blue #2 (indigotine,indigo carmine)]

Extemporaneous Preparations

20 mg/mL Oral Suspension

A 20 mg/mL oral suspension may be prepared with capsules and a 1:1 mixture of Ora-Sweet and Ora-Plus. Empty the contents of twelve 100 mg capsules into a glass mortar. Add small portions of the vehicle and mix to a uniform paste; mix while adding the vehicle in incremental proportions to almost 60 mL; transfer to an amber calibrated bottle, rinse mortar with vehicle, and add quantity of vehicle sufficient to make 60 mL. Label "shake well," "protect from light," and "refrigerate". Stable for 35 days refrigerated.

Kraft S, Johnson CE, and Tyler RP, "Stability of an Extemporaneously Prepared Thalidomide Suspension," Am J Health Syst Pharm, 2011, 69(1):56-8.22180553
Prescribing and Access Restrictions

Canada: Access to thalidomide is restricted through a controlled distribution program called RevAid. Only physicians and pharmacists enrolled in this program are authorized to prescribe or dispense thalidomide. Patients must be enrolled in the program by their physicians. Further information is available at www.RevAid.ca or by calling 1-888-738-2431.

Administration: Pediatric

Oral: Wear gloves to prevent cutaneous exposure. Do not open or crush capsules. Avoid extensive handling of capsules; capsules should remain in blister pack until ingestion. If skin exposure to the powder content from broken capsules or body fluids from patients receiving thalidomide, wash the exposed area with soap and water; if mucous membranes are exposed flush thoroughly with water. Administer with water, preferably at bedtime, once daily on an empty stomach, at least 1 hour after the evening meal. Doses at the higher end of the range (ie, 400 mg/day) may be given in divided doses. For missed doses, if <12 hours have passed, patient may receive dose; if >12 hours have passed, wait until next dose is due.

Administration: Adult

Administer orally, preferably at bedtime once daily, at least 1 hour after the evening meal. Doses >400 mg/day may be given in divided doses at least 1 hour after meals. Swallow capsules whole with water. Capsules should not be opened or crushed.

Capsules should remain in blister pack until ingestion. If exposed to the powder content from broken capsules or body fluids from patients receiving thalidomide, the exposed area should be washed immediately and thoroughly with soap and water.

Missed doses: For missed doses, if <12 hours patient may receive dose; if >12 hours wait until next dose due.

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2016 [group 2]).

Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2016; USP-NF 2020).

Note: Facilities may perform risk assessment of some hazardous drugs to determine if appropriate for alternative handling and containment strategies (USP-NF 2020). Refer to institution-specific handling policies/procedures.

Storage/Stability

Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Protect from light. Keep in original package.

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020785s071lbl.pdf#page=21, must be dispensed with this medication.

Use

Treatment of and suppressive maintenance therapy for cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) (FDA approved in ages ≥12 years and adults); treatment of newly diagnosed multiple myeloma in combination with dexamethasone (FDA approved in adults). Note: Thalidomide is not indicated as monotherapy for erythema nodosum leprosum treatment in the presence of moderate to severe neuritis. Has also been used for treatment of inflammatory bowel disease when other therapies have failed, refractory chronic graft-versus-host disease, AIDS-related aphthous stomatitis, systemic juvenile idiopathic arthritis, and various malignancies.

Medication Safety Issues
Sound-alike/look-alike issues:

Thalidomide may be confused with flutamide, lenalidomide, pomalidomide

Thalomid may be confused with Revlimid, thiamine

High alert medication:

This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes that have a heightened risk of causing significant patient harm when used in error.

International issues:

Thalomid [US, Canada] may be confused with Thilomide brand name for lodoxamide [Greece, Turkey]

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

5-Aminosalicylic Acid Derivatives: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

Abatacept: Anti-TNF Agents may enhance the immunosuppressive effect of Abatacept. Risk X: Avoid combination

Alizapride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Anakinra: Anti-TNF Agents may enhance the adverse/toxic effect of Anakinra. An increased risk of serious infection during concomitant use has been reported. Risk X: Avoid combination

Azelastine (Nasal): May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

Bisphosphonate Derivatives: Angiogenesis Inhibitors (Systemic) may enhance the adverse/toxic effect of Bisphosphonate Derivatives. Specifically, the risk for osteonecrosis of the jaw may be increased. Risk C: Monitor therapy

Bradycardia-Causing Agents: May enhance the bradycardic effect of other Bradycardia-Causing Agents. Risk C: Monitor therapy

Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Bromopride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Bromperidol: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Canakinumab: Anti-TNF Agents may enhance the adverse/toxic effect of Canakinumab. Specifically, the risk for serious infections and/or neutropenia may be increased. Risk X: Avoid combination

Cannabinoid-Containing Products: CNS Depressants may enhance the CNS depressant effect of Cannabinoid-Containing Products. Risk C: Monitor therapy

Ceritinib: Bradycardia-Causing Agents may enhance the bradycardic effect of Ceritinib. Management: If this combination cannot be avoided, monitor patients for evidence of symptomatic bradycardia, and closely monitor blood pressure and heart rate during therapy. Risk D: Consider therapy modification

Certolizumab Pegol: Anti-TNF Agents may enhance the immunosuppressive effect of Certolizumab Pegol. Risk X: Avoid combination

Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy

Chloramphenicol (Systemic): Myelosuppressive Agents may enhance the myelosuppressive effect of Chloramphenicol (Systemic). Risk X: Avoid combination

Chlorphenesin Carbamate: May enhance the adverse/toxic effect of CNS Depressants. Risk C: Monitor therapy

Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk X: Avoid combination

CNS Depressants: May enhance the CNS depressant effect of Thalidomide. Risk X: Avoid combination

Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider therapy modification

DexAMETHasone (Systemic): May enhance the dermatologic adverse effect of Thalidomide. DexAMETHasone (Systemic) may enhance the thrombogenic effect of Thalidomide. Management: Consider using venous thromboembolism prophylaxis (eg, low-molecular-weight heparin or warfarin [INR 2.0 to 3.0]) in patients with multiple myeloma receiving both thalidomide and dexamethasone. Monitor for increased dermatologic adverse effects (eg, rash) Risk D: Consider therapy modification

DexmedeTOMIDine: CNS Depressants may enhance the CNS depressant effect of DexmedeTOMIDine. Management: Monitor for increased CNS depression during coadministration of dexmedetomidine and CNS depressants, and consider dose reductions of either agent to avoid excessive CNS depression. Risk D: Consider therapy modification

Difelikefalin: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Dimethindene (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Risk X: Avoid combination

Erythropoiesis-Stimulating Agents: May enhance the thrombogenic effect of Thalidomide. Risk C: Monitor therapy

Estrogen Derivatives: May enhance the thrombogenic effect of Thalidomide. Risk C: Monitor therapy

Etrasimod: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Fexinidazole: Bradycardia-Causing Agents may enhance the arrhythmogenic effect of Fexinidazole. Risk X: Avoid combination

Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination

Fingolimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Fingolimod. Management: Consult with the prescriber of any bradycardia-causing agent to see if the agent could be switched to an agent that does not cause bradycardia prior to initiating fingolimod. If combined, perform continuous ECG monitoring after the first fingolimod dose. Risk D: Consider therapy modification

Flunarizine: CNS Depressants may enhance the CNS depressant effect of Flunarizine. Risk X: Avoid combination

Hormonal Contraceptives: May enhance the thrombogenic effect of Thalidomide. Risk C: Monitor therapy

Ivabradine: Bradycardia-Causing Agents may enhance the bradycardic effect of Ivabradine. Risk C: Monitor therapy

Ixabepilone: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Kava Kava: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Kratom: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Lisuride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Lofexidine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Metoclopramide: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

MetyroSINE: CNS Depressants may enhance the sedative effect of MetyroSINE. Risk C: Monitor therapy

Midodrine: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Minocycline (Systemic): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Nabilone: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Olaparib: Myelosuppressive Agents may enhance the myelosuppressive effect of Olaparib. Risk C: Monitor therapy

Olopatadine (Nasal): May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Risk X: Avoid combination

Oxomemazine: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Ozanimod: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Pamidronate: Thalidomide may enhance the nephrotoxic effect of Pamidronate. Risk C: Monitor therapy

Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Risk X: Avoid combination

Pembrolizumab: May enhance the adverse/toxic effect of Thalidomide Analogues. Specifically, mortality may be increased when this combination is used for treatment of refractory multiple myeloma. Risk X: Avoid combination

Piribedil: CNS Depressants may enhance the CNS depressant effect of Piribedil. Risk C: Monitor therapy

Ponesimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Ponesimod. Management: Avoid coadministration of ponesimod with drugs that may cause bradycardia when possible. If combined, monitor heart rate closely and consider obtaining a cardiology consult. Do not initiate ponesimod in patients on beta-blockers if HR is less than 55 bpm. Risk D: Consider therapy modification

Pramipexole: CNS Depressants may enhance the sedative effect of Pramipexole. Risk C: Monitor therapy

Procarbazine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Rilonacept: Anti-TNF Agents may enhance the adverse/toxic effect of Rilonacept. Risk X: Avoid combination

Ropeginterferon Alfa-2b: Myelosuppressive Agents may enhance the myelosuppressive effect of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider therapy modification

Ropeginterferon Alfa-2b: CNS Depressants may enhance the adverse/toxic effect of Ropeginterferon Alfa-2b. Specifically, the risk of neuropsychiatric adverse effects may be increased. Management: Avoid coadministration of ropeginterferon alfa-2b and other CNS depressants. If this combination cannot be avoided, monitor patients for neuropsychiatric adverse effects (eg, depression, suicidal ideation, aggression, mania). Risk D: Consider therapy modification

ROPINIRole: CNS Depressants may enhance the sedative effect of ROPINIRole. Risk C: Monitor therapy

Rotigotine: CNS Depressants may enhance the sedative effect of Rotigotine. Risk C: Monitor therapy

Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Risk C: Monitor therapy

Siponimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Siponimod. Management: Avoid coadministration of siponimod with drugs that may cause bradycardia. If combined, consider obtaining a cardiology consult regarding patient monitoring. Risk D: Consider therapy modification

Tofacitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Valerian: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Vedolizumab: Anti-TNF Agents may enhance the adverse/toxic effect of Vedolizumab. Risk X: Avoid combination

Zoledronic Acid: Thalidomide may enhance the adverse/toxic effect of Zoledronic Acid. Specifically, the risk for ONJ or renal impairment may be increased. Risk C: Monitor therapy

Reproductive Considerations

[US Boxed Warning]: Thalidomide should never be used by females who could become pregnant while taking thalidomide. When alternative treatments are not available, females of reproductive potential may be treated when adequate precautions are taken to avoid pregnancy. [US Boxed Warning]: In an effort to make the chance of embryo-fetal exposure to thalidomide as negligible as possible, thalidomide is approved for marketing only through a special restricted distribution program: Thalomid REMS program, approved by the Food and Drug Administration. Information about Thalomid and the Thalomid REMS program is available at https://www.thalomidrems.com or by calling the REMS Call Center 1-888-423-5436.

Females of reproductive potential must avoid pregnancy beginning 4 weeks prior to therapy, during therapy, during therapy interruptions, and for ≥4 weeks after therapy is discontinued. A negative pregnancy test (sensitivity of ≥50 milliunits/mL) 10 to 14 days prior to therapy, within 24 hours prior to beginning therapy, weekly during the first 4 weeks, and every 4 weeks (every 2 weeks for females with irregular menstrual cycles) thereafter is required for women of childbearing potential. Two forms of reliable contraception must be used simultaneously in females of reproductive potential (unless they commit to total abstinence from heterosexual intercourse): One highly effective method (eg, tubal ligation, IUD, hormonal birth control methods) or partners vasectomy; plus one additional effective method (eg, male latex or synthetic condom, diaphragm, or cervical cap). Contraception is required even in cases of infertility (unless due to hysterectomy). Thalidomide must be immediately discontinued for a missed period, abnormal pregnancy test, or abnormal menstrual bleeding. Some forms of contraception may not be appropriate in certain patients. An intrauterine device or implantable contraceptive may increase the risk of infection or bleeding; estrogen-containing products may increase the risk of thromboembolism.

Females of reproductive potential (including health care workers and caregivers) must also avoid contact with thalidomide capsules.

Thalidomide is also present in the semen of males. Males taking thalidomide (even those vasectomized) must use a latex or synthetic condom during any sexual contact with women of childbearing potential and for up to 28 days following discontinuation of therapy. Males taking thalidomide must not donate sperm.

Pregnancy Considerations

Use is contraindicated in pregnant females. [US Boxed Warning]: If thalidomide is taken during pregnancy, it can cause severe birth defects or embryo-fetal death. Thalidomide should never be used by females who are pregnant or who could become pregnant while taking thalidomide. Even a single dose (1 capsule [regardless of strength]) taken by a pregnant woman during pregnancy may cause severe birth defects. Thalidomide induces a high frequency of severe and life-threatening birth defects. Anomalies observed in humans include amelia, phocomelia, bone defects, ear and eye abnormalities, facial palsy, congenital heart defects, urinary and genital tract malformations; mortality in ~40% of infants at or shortly after birth has also been reported. Discontinue thalidomide immediately if pregnancy occurs during treatment and refer patient to a reproductive toxicity specialist.

A pregnancy exposure registry has been created to monitor outcomes in females exposed to thalidomide during pregnancy and female partners of male patients and to understand the root cause for the pregnancy. The pregnancy exposure registry may be contacted at 1-888-423-5436. If pregnancy occurs during treatment, thalidomide must be immediately discontinued and the patient referred to a reproductive toxicity specialist. Any suspected fetal exposure to thalidomide must be reported to the FDA via the MedWatch program (1-800-FDA-1088) and to the REMS Call Center (1-888-423-5436).

Monitoring Parameters

CBC with differential, platelets; thyroid function tests (thyroid-stimulating hormone at baseline then every 2 to 3 months during thalidomide treatment [Hamnvik 2011]). In HIV-seropositive patients: Viral load after 1 and 3 months, then every 3 months. Pregnancy testing (sensitivity of ≥50 mIU/mL) is required 10 to 14 days prior to therapy, within 24 hours prior to initiation of therapy, weekly during the first 4 weeks, then every 4 weeks in women with regular menstrual cycles or every 2 weeks in women with irregular menstrual cycles. Signs of neuropathy monthly for the first 3 months, then periodically during treatment; consider monitoring of sensory nerve application potential amplitudes (at baseline and every 6 months) to detect asymptomatic neuropathy. Monitor for signs and symptoms of thromboembolism (shortness of breath, chest pain, arm/leg swelling), bleeding (petechiae, epistaxis, GI bleeding), tumor lysis syndrome, bradycardia, and syncope; monitor for clinical changes indicating potential seizure activity (in patients with a history of seizure).

Reference Range

Graft-versus-host disease: Target plasma thalidomide concentration of ≥5 mcg/mL 2 hours post-dose has been suggested (Vogelsang 1992).

Mechanism of Action

Thalidomide exhibits immunomodulatory and antiangiogenic characteristics; immunologic effects may vary based on conditions. Thalidomide may suppress excessive tumor necrosis factor-alpha production in patients with erythema nodosum leprosum, yet may increase plasma tumor necrosis factor-alpha levels in HIV-positive patients. In multiple myeloma, thalidomide is associated with an increase in natural killer cells and increased levels of interleukin-2 and interferon gamma. Other proposed mechanisms of action include suppression of angiogenesis, prevention of free-radical-mediated DNA damage, increased cell mediated cytotoxic effects, and altered expression of cellular adhesion molecules.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Slow, good

Distribution: Vd: 1.1 L/kg

Protein binding: 55% to 66%

Metabolism: Minimal (unchanged drug is the predominant circulating component)

Half-life elimination: 5.5 to 7.3 hours

Time to peak, plasma: ~2 to 5 hours

Excretion: Urine (~92%; <4% of the dose as unchanged drug); feces (<2%)

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Hansen disease: Based on data from a small study, in relation to healthy subjects, patients with Hansen disease may have increased thalidomide bioavailability, manifested as increased area under the curve and peak plasma levels.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AT) Austria: Thalidomide celgene | Thalidomide pharmion;
  • (BD) Bangladesh: Midothal;
  • (BE) Belgium: Thalidomide celgene | Thalidomide pharmion;
  • (CH) Switzerland: Thalidomide pharmion;
  • (CI) Côte d'Ivoire: Thalide;
  • (CZ) Czech Republic: Thalidomide celgene;
  • (DE) Germany: Thalidomide celgene;
  • (DO) Dominican Republic: Tadomid;
  • (EE) Estonia: Sauramide | Thalidomide celgene;
  • (EG) Egypt: Thalidomide pharmion;
  • (ES) Spain: Talidomida accord | Thalidomide celgene;
  • (FR) France: Thalidomide accord | Thalidomide bms | Thalidomide celgene | Thalidomide laphal;
  • (GB) United Kingdom: Thalidomide pharmion;
  • (GR) Greece: Thalidomide celgene | Thalix;
  • (HR) Croatia: Thalidomide celgene;
  • (HU) Hungary: Thalidomide accord | Thalidomide celgene;
  • (IN) India: Mythal | Thaangio | Thaldo | Thalide | Thaliglob | Thalinat | Thalix | Thaloda | Thalogen | Thaloma | Thycad;
  • (IT) Italy: Talidomide accord | Thalidomide celgene;
  • (JP) Japan: Thaled;
  • (KR) Korea, Republic of: Celgene thalidomide | Thalide | Thaliglob | Thaloma;
  • (LB) Lebanon: Thalidomide pharmion;
  • (LT) Lithuania: Thalidomide celgene;
  • (LU) Luxembourg: Thalidomide celgene;
  • (LV) Latvia: Thalidomide celgene;
  • (MY) Malaysia: Domide | Thado | Thalix;
  • (NO) Norway: Sauramide | Thalidomide bms | Thalidomide celgene;
  • (NZ) New Zealand: Thalomid;
  • (PE) Peru: Thalidokem;
  • (PH) Philippines: Thalidomide Invida;
  • (PK) Pakistan: Bludomide | Medomide | Thalimid | Tld;
  • (PL) Poland: Sauramide | Thalidomide celgen | Thalix;
  • (PT) Portugal: Talidomida | Talidomida accord | Talidomida Celgene;
  • (PY) Paraguay: Talidomida imedic;
  • (RU) Russian Federation: Thalidomide celgen;
  • (SE) Sweden: Thalidomide celgene | Thalidomide pharmion;
  • (SG) Singapore: Domide;
  • (SI) Slovenia: Talidomid accord;
  • (TH) Thailand: Thado;
  • (TW) Taiwan: Thado | Thali
  1. <800> Hazardous Drugs—Handling in Healthcare Settings. United States Pharmacopeia and National Formulary (USP 43-NF 38). Rockville, MD: United States Pharmacopeia Convention; 2020:74-92.
  2. Alexanian R, Weber D, Anagnostopoulos A, Delasalle K, Wang M, Rankin K. Thalidomide with or without dexamethasone for refractory or relapsing multiple myeloma. Semin Hematol. 2003;40(4 suppl 4):3-7. [PubMed 15015890]
  3. Antonioli E, Nozzoli C, Gianfaldoni G, et al, “Pulmonary Hypertension Related to Thalidomide Therapy in Refractory Multiple Myeloma,” Ann Oncol, 2005, 16(11):1849-50. [PubMed 16012178]
  4. Brinker BT, Walker EK, Leong T, et al, “Maintenance Therapy With Thalidomide Improves Overall Survival After Autologous Hematopoietic Progenitor Cell Transplantation for Multiple Myeloma,” Cancer, 2006, 106(10):2171-80. [PubMed 16598756]
  5. Britton WJ and Lockwood DN, "Leprosy," Lancet, 2004, 363(9416):1209-19. [PubMed 15081655]
  6. Browne PV, Weisdorf DJ, DeFor T, et al, “Response to Thalidomide Therapy in Refractory Chronic Graft-Versus-Host Disease,” Bone Marrow Transplant, 2000, 26(8):865-9. [PubMed 11081386]
  7. Cavo M, Tacchetti P, Patriarca F, et al, “Bortezomib With Thalidomide Plus Dexamethasone Compared With Thalidomide Plus Dexamethasone as Induction Therapy Before, and Consolidation Therapy After, Double Autologous Stem-Cell Transplantation in Newly Diagnosed Multiple Myeloma: A Randomised Phase 3 Study,” Lancet, 2010, 376(9758):2075-85. [PubMed 21146205]
  8. Dimopoulos MA, Sonneveld P, Leung N, et al. International Myeloma Working Group recommendations for the diagnosis and management of myeloma-related renal impairment. J Clin Oncol. 2016;34(13):1544-1557. [PubMed 26976420]
  9. Dimopoulos MA, Terpos E, Chanan-Khan A, et al, “Renal Impairment in Patients With Multiple Myeloma: A Consensus Statement on Behalf of the International Myeloma Working Group,” J Clin Oncol, 2010, 28(33):4976-84. [PubMed 20956629]
  10. Ehrenpreis ED, Kane SV, Cohen LB, et al, "Thalidomide Therapy for Patients With Refractory Crohn's Disease: An Open-Label Trial," Gastroenterology, 1999, 117(6):1271-7. [PubMed 10579967]
  11. Eriksson T, Höglund P, Turesson I, et al, “Pharmacokinetics of Thalidomide in Patients With Impaired Renal Function and While On and Off Dialysis,” J Pharm Pharmacol, 2003, 55(12):1701-6. [PubMed 14738599]
  12. Facchini S, Candusso M, Martelossi S, et al, "Efficacy of Long-Term Treatment With Thalidomide in Children and Young Adults With Crohn Disease: Preliminary Results," J Pediatr Gastroenterol Nutr, 2001, 32(2):178-81. [PubMed 11321389]
  13. Facon T, Mary JY, Hulin C, et al, "Melphalan and Prednisone Plus Thalidomide Versus Melphalan and Prednisone Alone or Reduced-Intensity Autologous Stem Cell Transplantation in Elderly Patients With Multiple Myeloma (IFM 99-06): A Randomised Trial," Lancet, 2007, 370(9594):1209-18. [PubMed 17920916]
  14. Felipez LM, Gokhale R, Tierney MP, Kirschner BS. Thalidomide use and outcomes in pediatric patients with Crohn disease refractory to infliximab and adalimumab. J Pediatr Gastroenterol Nutr. 2012;54(1):28-33. [PubMed 21681114]
  15. Garderet L, Iacobelli S, Moreau P, et al. Superiority of the triple combination of bortezomib-thalidomide-dexamethasone over the dual combination of thalidomide-dexamethasone in patients with multiple myeloma progressing or relapsing after autologous transplantation: the MMVAR/IFM 2005-04 Randomized Phase III Trial from the Chronic Leukemia Working Party of the European Group for Blood and Marrow Transplantation. J Clin Oncol. 2012;30(20):2475-2482. [PubMed 22585692]
  16. Hamnvik OP, Larsen PR, and Marqusee E, “Thyroid Dysfunction From Antineoplastic Agents,” J Natl Cancer Inst, 2011, 103(21):1572-87. [PubMed 22010182]
  17. Hamuryudan V, Mat C, Saip S, et al, “Thalidomide in the Treatment of the Mucocutaneous Lesions of the Behçet Syndrome. A Randomized, Double-Blind, Placebo-Controlled Trial,” Ann Intern Med, 1998, 128(6):443-50. [PubMed 9499327]
  18. Hulin C, Facon T, Rodon P, et al, “Efficacy of Melphalan and Prednisone Plus Thalidomide in Patients Older Than 75 Years With Newly Diagnosed Multiple Myeloma: IFM 01/01 Trial,” J Clin Oncol, 2009, 27(22):3664-70. [PubMed 19451428]
  19. Hwang JP, Feld JJ, Hammond SP, et al. Hepatitis B virus screening and management for patients with cancer prior to therapy: ASCO provisional clinical opinion update. J Clin Oncol. 2020;38(31):3698-3715. doi:10.1200/JCO.20.01757 [PubMed 32716741]
  20. Jacobson JM, Greenspan JS, Spritzler J, et al, “Thalidomide for the Treatment of Oral Aphthous Ulcers in Patients With Human Immunodeficiency Virus Infection. National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group,” N Engl J Med, 1997, 336(21):1487-93. [PubMed 9154767]
  21. Kaufman JL, Nooka A, Vrana M, et al, “Bortezomib, Thalidomide, and Dexamethasone as Induction Therapy for Patients With Symptomatic Multiple Myeloma: A Retrospective Study,” Cancer, 2010, 116(13):3143-51. [PubMed 20564642]
  22. Kulkarni S, Powles R, Sirohi B, et al, “Thalidomide After Allogeneic Haematopoietic Stem Cell Transplantation: Activity in Chronic But Not in Acute Graft-Versus-Host Disease,” Bone Marrow Transplant, 2003, 32(2):165-70. [PubMed 12838281]
  23. Kyle RA and Rajkumar SV, “Multiple Myeloma,” N Engl J Med, 2004, 351(18): 1860-73. [PubMed 15575057]
  24. Lazzerini M, Martelossi S, Magazzù G, et al. Effect of thalidomide on clinical remission in children and adolescents with refractory Crohn disease: a randomized clinical trial. JAMA. 2013;310(20):2164-2173. [PubMed 24281461]
  25. Lazzerini M, Martelossi S, Magazzù G, et al. Effect of thalidomide on clinical remission in children and adolescents with ulcerative colitis refractory to other immunosuppressives: pilot randomized clinical trial. Inflamm Bowel Dis. 2015;21(8):1739-1749. [PubMed 26185909]
  26. Lazzerini M, Martelossi S, Marchetti F, et al, "Efficacy and Safety of Thalidomide in Children and Young Adults With Intractable Inflammatory Bowel Disease: Long-Term Results," Aliment Pharmacol Ther, 2007, 25(4):419-27. [PubMed 17269997]
  27. Lee CK, Barlogie B, Munshi N, et al. DTPACE: an effective, novel combination chemotherapy with thalidomide for previously treated patients with myeloma. J Clin Oncol. 2003;21(14):2732-2739. [PubMed 12860952]
  28. Lehman TJ, Schechter SJ, Sundel RP, et al, "Thalidomide for Severe Systemic Onset Juvenile Rheumatoid Arthritis: A Multicenter Study," J Pediatr, 2004, 145(6):856-7. [PubMed 15580219]
  29. Lokhorst HM, van der Holt B, Zweegman S, et al, “A Randomized Phase 3 Study on the Effect of Thalidomide Combined With Adriamycin, Dexamethasone, and High-Dose Melphalan, Followed by Thalidomide Maintenance in Patients With Multiple Myeloma,” Blood, 2010, 115(6):1113-20. [PubMed 19880501]
  30. Lyman GH, Bohlke K, Khorana AA, Venous thromboembolism prophylaxis and treatment in patients with cancer: american society of clinical oncology clinical practice guideline update 2014. J Clin Oncol. 2015;33(6):654-656. [PubMed 25605844]
  31. Lyman GH, Khorana AA, Kuderer NM, et al. Venous thromboembolism prophylaxis and treatment in patients with cancer: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. 2013;31(17):2189-2204. [PubMed 23669224]
  32. Martelossi S, Marchetti F, Lenhard A, et al, "Treatment With Thalidomide in Children and Adolescents With Inflammatory Bowel Disease," J Pediatr Gastroenterol Nutr, 2004, 39(1):S282-3.
  33. Matthews SJ and McCoy C, "Thalidomide: A Review of Approved and Investigational Uses," Clin Ther, 2003, 25(2):342-95. [PubMed 12749503]
  34. Mehta P, Kedar A, Graham-Pole J, et al, "Thalidomide in Children Undergoing Bone Marrow Transplantation: Series at a Single Institution and Review of the Literature," Pediatrics, 1999, 103(4):e44. [PubMed 10103336]
  35. Mohty M, Attal M, Marit G, et al. Thalidomide salvage therapy following allogeneic stem cell transplantation for multiple myeloma: a retrospective study from the Intergroupe Francophone du Myélome (IFM) and the Société Française de Greffe de Moelle et Thérapie Cellulaire (SFGM-TC). Bone Marrow Transplant. 2005;35(2):165-169. [PubMed 15531895]
  36. Moreau P, Attal M, Hulin C, et al. Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (CASSIOPEIA): a randomised, open-label, phase 3 study [published correction appears in Lancet. 2019;pii: S0140-6736(19)31403-5]. Lancet. 2019;394(10192):29-38. doi: 10.1016/S0140-6736(19)31240-1. [PubMed 31171419]
  37. Okafor MC, "Thalidomide for Erythema Nodosum Leprosum and Other Applications," Pharmacotherapy, 2003, 23(4):481-93. [PubMed 12680478]
  38. Onozawa M, Hashino S, Sogabe S, et al, “Side Effects and Good Effects from New Chemotherapeutic Agents. Case 2. Thalidomide-Induced Interstitial Pneumonitis,” J Clin Oncol, 2005, 23(10):2425-6. [PubMed 15800335]
  39. Page RL 2nd, O'Bryant CL, Cheng D, et al; American Heart Association Clinical Pharmacology and Heart Failure and Transplantation Committees of the Council on Clinical Cardiology; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular and Stroke Nursing; and Council on Quality of Care and Outcomes Research. Drugs That May Cause or Exacerbate Heart Failure: A Scientific Statement From the American Heart Association [published correction appears in Circulation. 2016;134(12):e261]. Circulation. 2016;134(6):e32-e69. [PubMed 27400984]
  40. Palumbo A, Bringhen S, Larocca A, et al. Bortezomib-melphalan-prednisone-thalidomide followed by maintenance with bortezomib-thalidomide compared with bortezomib-melphalan-prednisone for initial treatment of multiple myeloma: updated follow-up and improved survival. J Clin Oncol. 2014;32(7):634-640. [PubMed 24449241]
  41. Palumbo A, Bringhen S, Liberati AM, et al, "Oral Melphalan, Prednisone, and Thalidomide in Elderly Patients With Multiple Myeloma: Updated Results of a Randomized Controlled Trial," Blood, 2008, 112(8):3107-14. [PubMed 18505783]
  42. Palumbo A, Bringhen S, Rossi D, et al, “Bortezomib-Melphalan-Prednisone-Thalidomide Followed by Maintenance With Bortezomib-Thalidomide Compared With Bortezomib-Melphalan-Prednisone for Initial Treatment of Multiple Myeloma: a Randomized Controlled Trial,” J Clin Oncol, 2010, 28(34):5101-9. [PubMed 20940200]
  43. Palumbo A, Giaccone L, Bertola A, et al. Low-dose thalidomide plus dexamethasone is an effective salvage therapy for advanced myeloma. Haematologica. 2001;86(4):399-403. [PubMed 11325646]
  44. Palumbo A, Rajkumar SV, Dimopoulos MA, et al, “Prevention of Thalidomide- and Lenalidomide-Associated Thrombosis in Myeloma,” Leukemia, 2008, 22(2): 414-23. [PubMed 18094721]
  45. Parker PM, Chao N, Nademanee A, et al, “ Thalidomide as Salvage Therapy for Chronic Graft-Versus-Host Disease,” Blood, 1995, 86(9):3604-9. [PubMed 7579470]
  46. Priolo T, Lamba LD, Giribaldi G, et al, "Childhood Thalidomide Neuropathy: A Clinical and Neurophysiologic Study," Pediatr Neurol, 2008, 38(3):196-9. [PubMed 18279755]
  47. Rajkumar SV, Blood E, Vesole D, et al, “Phase III Clinical Trial of Thalidomide Plus Dexamethasone Compared With Dexamethasone Alone in Newly Diagnosed Multiple Myeloma: A Clinical Trial Coordinated by the Eastern Cooperative Oncology Group,” J Clin Oncol, 2006, 24(3):431-6. [PubMed 16365178]
  48. Richardson PG, Delforge M, Beksac M, et al, “Management of Treatment-Emergent Peripheral Neuropathy in Multiple Myeloma,” Leukemia, 2012, 26(4):595-608. [PubMed 22193964]
  49. Rovelli A, Arrigo C, Nesi F, et al, “The Role of Thalidomide in the Treatment of Refractory Chronic Graft-Versus-Host Disease Following Bone Marrow Transplantation in Children,” Bone Marrow Transplant, 1998, 21(6):577-81. [PubMed 9543061]
  50. Ruemmele FM, Veres G, Kolho KL, et al. Consensus guidelines of ECCO/ESPGHAN on the medical management of pediatric Crohn's disease. J Crohns Colitis. 2014;8(10):1179-1207. [PubMed 24909831]
  51. Schuler U and Ehninger G, “Thalidomide: Rationale for Renewed Use in Immunological Disorders,” Drug Saf, 1995, 12(6):364-9. [PubMed 8527011]
  52. Seol Y, Chung J, Kwon B, et al, “Treatment for Patients With Multiple Myeloma Complicated by Renal Failure by Thalidomide-Based Regimens,” J Clin Oncol, 2010, 28(suppl):e13093 [abstract e13093 from 2010 ASCO Annual Meeting].
  53. Sharma D, Kwatra SG. Thalidomide for the treatment of chronic refractory pruritus. J Am Acad Dermatol. 2016;74(2):363-369. [PubMed 26577510]
  54. Singhal S, Mehta J, Desikan R, et al. Antitumor activity of thalidomide in refractory multiple myeloma. N Engl J Med. 1999;341(21):1565-1571. [PubMed 10564685]
  55. Spencer A, Prince HM, Roberts AW, et al, “Consolidation Therapy With Low-Dose Thalidomide and Prednisolone Prolongs the Survival of Multiple Myeloma Patients Undergoing a Single Autologous Stem-Cell Transplantation Procedure,” J Clin Oncol, 2009, 27(11):1788-93. [PubMed 19273705]
  56. Stewart AK, Trudel S, Bahlis NJ, et al. A randomized phase 3 trial of thalidomide and prednisone as maintenance therapy after ASCT in patients with MM with a quality-of-life assessment: the National Cancer Institute of Canada Clinicals Trials Group Myeloma 10 Trial.Blood. 2013;121(9):1517-1523. [PubMed 23297129]
  57. Teo SK, Colburn WA, Tracewell WG, et al, "Clinical Pharmacokinetics of Thalidomide," Clin Pharmacokinet, 2004, 43(5):311-27. [PubMed 15080764]
  58. Thalomid (thalidomide) [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company; March 2023.
  59. Thalomid (thalidomide) [product monograph]. Saint-Laurent, Quebec, Canada: Celgene Inc; March 2021.
  60. Thompson JL and Hansen LA, "Thalidomide Dosing in Patients With Relapsed or Refractory Multiple Myeloma," Ann Pharmacother, 2003, 37(4):571-6. [PubMed 12659617]
  61. Tosi P, Zamagni E, Tacchetti P, et al, “Thalidomide-Dexamethasone as Induction Therapy Prior to Autologous Stem-Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma and Renal Failure,” Blood, 2009, 114(22):4934 [abstract 4934 from 2009 ASH Annual Meeting].
  62. Treon SP, Soumerai JD, Branagan AR, et al, “Thalidomide and Rituximab in Waldenstrom Macroglobulinemia,” Blood, 2008, 112(12):4552-7. [PubMed 18713945]
  63. Uhl K, Cox E, Rogan R, et al, “Thalidomide Use in the US: Experience With Pregnancy Testing in the S.T.E.P.S. Programme,” Drug Saf, 2006, 29(4):231-9. [PubMed 16524322]
  64. US Department of Health and Human Services; Centers for Disease Control and Prevention; National Institute for Occupational Safety and Health. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2016. https://www.cdc.gov/niosh/docs/2016-161/default.html. Updated September 2016. Accessed October 5, 2016.
  65. Usmani S, Sexton R, Hoering A, et al, “Second Malignancies in Total Therapy 2 and 3 Trials for Newly Diagnosed Multiple Myeloma: Influence of Thalidomide and Lenalidomide during Maintenance,” Blood, 2012, 120(8):1597-600. [PubMed 22674807]
  66. Vasiliauskas EA, Kam LY, Abreu-Martin MT, et al, "An Open-Label Pilot Study of Low-Dose Thalidomide in Chronically Active, Steroid-Dependent Crohn's Disease," Gastroenterology, 1999, 117(6):1278-87. [PubMed 10579968]
  67. Vilas-Boas F, Gonçalves R, Sobrinho Simões M, et al. Thalidomide-induced acute cholestatic hepatitis: case report and review of the literature. Gastroenterol Hepatol. 2012;35(8):560-566. [PubMed 22789729]
  68. Vogelsang GB, Farmer ER, Hess AD, et al, “Thalidomide for the Treatment of Chronic Graft-Versus-Host Disease,” N Engl J Med, 1992, 326(16):1055-8. [PubMed 1549151]
  69. von Lilienfeld-Toal M, Hahn-Ast C, Furkert K, et al. A systematic review of phase II trials of thalidomide/dexamethasone combination therapy in patients with relapsed or refractory multiple myeloma. Eur J Haematol. 2008;81(4):247-252. [PubMed 18637031]
  70. Wechalekar AD, Goodman HJ, Lachmann HJ, et al, “Safety and Efficacy of Risk-Adapted Cyclophosphamide, Thalidomide, and Dexamethasone in Systemic AL Amyloidosis,” Blood, 2007, 109(2):457-64. [PubMed 16990593]
  71. Wijermans P, Schaafsma M, Termorshuizen F, et al, “Phase III Study of the Value of Thalidomide Added to Melphalan Plus Prednisone in Elderly Patients With Newly Diagnosed Multiple Myeloma: the HOVON 49 Study,” J Clin Oncol, 2010, 28(19):3160-6. [PubMed 20516439]
  72. Witzig TE, Laumann KM, Lacy MQ, et al. A phase III randomized trial of thalidomide plus zoledronic acid versus zoledronic acid alone in patients with asymptomatic multiple myeloma.Leukemia. 2013;27(1):220-225. [PubMed 22902362]
  73. Wolff D, Schleuning M, von Harsdorf S, et al. Consensus Conference on Clinical Practice in Chronic GVHD: second-line treatment of chronic graft-versus-host disease. Biol Blood Marrow Transplant. 2011;17(1):1-17. [PubMed 20685255]
  74. Zheng CF, Xu JH, Huang Y, et al, "Treatment of Pediatric Refractory Crohn's Disease With Thalidomide," World J Gastroenterol, 2011, 17(10):1286-91. [PubMed 21455327]
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