Version May 2024
Note: Nausea and vomiting may commonly occur; consider prophylactic antiemetics to prevent nausea and vomiting. Consider prophylactic or empiric anti-infective treatment (bacterial, viral, fungal).
Hematopoietic stem cell conditioning regimen: IV: 10 g/m2/day for 3 days on days −4, −3, and −2 prior to stem cell infusion (total dose/course is 30 g/m2) (in combination with fludarabine), followed by stem cell infusion on day 0 (Beelen 2020).
Missed doses: A missed dose would increase the risk of primary graft failure.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Mild or moderate impairment: No dosage adjustment necessary.
Severe impairment: Use is contraindicated.
Mild or moderate impairment: No dosage adjustment necessary.
Severe impairment: Use is contraindicated.
Hematopoietic stem cell transplantation:
Hematologic toxicity:Administer growth factors (G-CSF, GM-CSF), platelet, and/or red blood cell support as clinically indicated.
Refer to adult dosing.
(For additional information see "Treosulfan (United States: Not available): Pediatric drug information")
Note: Not available in the United States. Dose, frequency, number of doses, and/or start date may vary by protocol. Refer to individual protocols. Dosing presented as g/m2; use caution. Nausea and vomiting may commonly occur; consider prophylactic antiemetics to prevent nausea and vomiting.
Hematopoietic stem cell transplantation (allogeneic) conditioning regimen, hematologic malignancies:
Note: Other conditioning regimens (ie, total body irradiation-based regimens) are preferred over chemoconditioning for children ≥4 years and adolescents with acute lymphoblastic leukemia receiving allogeneic stem cell transplantation (Peters 2021).
Canadian labeling: Acute myeloid leukemia, myelodysplastic syndrome:
Children and Adolescents: IV: 10 g/m2/dose once daily for 3 days on days −4, −3, and −2 prior to stem cell infusion (in combination with fludarabine) (Trecondyv Canadian product labeling 2021).
European labeling:
Infants, Children, and Adolescents: Limited data available (Kalwak 2020; Nemecek 2018; Trecondi European Medicines Agency 2019):
BSA ≤0.5 m2: IV: 10 g/m2/dose once daily for 3 days on days −6, −5, and −4 prior to stem cell infusion (in combination with fludarabine ± thiotepa).
BSA >0.5 to ≤1 m2: IV: 12 g/m2/dose once daily for 3 days on days −6, −5, and −4 prior to stem cell infusion (in combination with fludarabine ± thiotepa).
BSA >1 m2: IV:14 g/m2/dose once daily for 3 days on days −6, −5, and −4 prior to stem cell infusion (in combination with fludarabine ± thiotepa).
Hematopoietic stem cell transplantation (allogeneic) conditioning regimen, nonmalignancy (eg, primary immune deficiency): Note: Various regimens have been described (Chiesa 2020; Morillo-Gutierrez 2020; Slatter 2017):
Infants ≤3 months: IV: 10 g/m2/dose once daily for 3 days on days −7, −6, and −5 prior to stem cell infusion (in combination with fludarabine and either alemtuzumab or anti-thymocyte globulin) (Chiesa 2020).
Infants >3 to 12 months: IV: 12 g/m2/dose once daily for 3 doses administered on 3 consecutive days (in combination with fludarabine and either alemtuzumab or anti-thymocyte globulin); reported days of treosulfan doses prior to stem cell infusion varied; one trial reported administration on days −7, −6, and −5 (Chiesa 2020) and a retrospective report described administration on days −6, −5, and −4 in patients with chronic granulomatous disease (Morillo-Gutierrez 2020).
Children and Adolescents: IV: 14 g/m2/dose once daily for 3 doses administered on 3 consecutive days (in combination with fludarabine and either alemtuzumab or anti-thymocyte globulin); reported days of treosulfan doses prior to stem cell infusion varied; one trial reported administration on days −7, −6, and −5 (Chiesa 2020) and a retrospective report described administration on days −6, −5, and −4 in patients with chronic granulomatous disease (Morillo-Gutierrez 2020).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Infants, Children, and Adolescents:
Mild or moderate impairment: No dosage adjustments necessary.
Severe impairment: Use is contraindicated.
Infants, Children, and Adolescents:
Mild or moderate impairment: No dosage adjustments necessary.
Severe impairment: Use is contraindicated.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported for combination therapy in adults unless otherwise indicated.
>10%:
Cardiovascular: Hypertension (14%), peripheral edema (23%)
Dermatologic: Maculopapular rash (12%)
Gastrointestinal: Abdominal pain (children, adolescents, and adults: 11% to 17%), constipation (12%), diarrhea (children and adolescents: 35%; adults: 16%; grade 3/4: 2%), nausea (children and adolescents: 28%; adults: 33%; grade 3/4: 3%), stomatitis (children and adolescents: 67%; adults: 38%; grade 3/4: 6%), vomiting (children and adolescents: 42%; adults: 22%; grade 3/4: <1%)
Hematologic & oncologic: Febrile neutropenia (11%)
Hepatic: Hepatotoxicity (children and adolescents: 26%), increased serum alanine aminotransferase (children, adolescents, and adults: 9% to 11%), increased serum bilirubin (9%)
Infection: Infection (children, adolescents, and adults: 12% to 27%)
Nervous system: Fatigue (12%), headache (16%)
Neuromuscular & skeletal: Back pain (15%), ostealgia (14%)
Miscellaneous: Fever (children, adolescents, and adults: 13% to 34%)
1% to 10%:
Cardiovascular: Hypotension (7%)
Dermatologic: Alopecia (children and adolescents: 10%), pruritus (children, adolescents, and adults: 6% to 10%)
Endocrine & metabolic: Hypomagnesemia (5%), increased gamma-glutamyl transferase (7%), weight gain (7%)
Gastrointestinal: Anorexia (9%)
Hematologic & oncologic: Purpuric disease (5%)
Hepatic: Increased serum aspartate aminotransferase (9%)
Hypersensitivity: Hypersensitivity reaction (6%)
Local: Localized edema (6%)
Nervous system: Chills (7%), dizziness (6%), limb pain (9%), pain (6%), vertigo (4%)
Neuromuscular & skeletal: Arthralgia (10%)
Respiratory: Dyspnea (5%), epistaxis (7%)
Frequency not defined (all populations):
Cardiovascular: Acute myocardial infarction, capillary leak syndrome, cardiac arrhythmia (including atrial fibrillation, sinoatrial nodal rhythm disorder), edema, embolism, flushing, heart failure, pericardial effusion, septic shock, syncope
Dermatologic: Acneiform eruption, bullous dermatitis, dermal ulcer, dermatitis, diaper rash, erythema multiforme, erythema of skin (including scrotal erythema), exfoliative dermatitis, hyperhidrosis, palmar plantar erythrodysesthesia syndrome, skin hyperpigmentation, skin necrosis, skin rash, skin pain, urticaria, xeroderma
Endocrine & metabolic: Acidosis, alkalosis, electrolyte disorder, hyperglycemia, impaired glucose tolerance/prediabetes, increased lactate dehydrogenase, weight loss
Gastrointestinal: Abdominal distension, dyspepsia, dysphagia, esophageal pain, esophagitis, gastritis, gastrointestinal hemorrhage, gastrointestinal pain, hiccups, mouth pain, mouth ulcer, neutropenic enterocolitis, proctitis, proctocolitis (anal inflammation), xerostomia
Genitourinary: Cystitis (noninfective), dysuria, hematuria, hemorrhagic cystitis, urinary tract pain
Hematologic & oncologic: C-reactive protein increased, hematoma, hemorrhage, oral hemorrhage, second primary malignant neoplasm
Hepatic: Hepatic sinusoidal obstruction syndrome, hepatic failure, hepatomegaly, increased serum alkaline phosphatase, liver pain
Infection: Sepsis
Local: Injection site reaction
Nervous system: Agitation, confusion, encephalopathy, extrapyramidal reaction, insomnia, intracranial hemorrhage, myasthenia, noncardiac chest pain, paresthesia, peripheral sensory neuropathy, sensation of cold, voice disorder
Neuromuscular & skeletal: Myalgia
Ophthalmic: Conjunctival hemorrhage, dry eye syndrome
Renal: Acute kidney injury, increased serum creatinine, renal failure syndrome
Respiratory: Cough, hypoxia, laryngeal edema, oropharyngeal pain, pharyngeal edema, pharyngolaryngeal pain, pleural effusion, pneumonitis
Postmarketing: Nervous system: Seizure (children)
Hypersensitivity to treosulfan or any component of the formulation; active non-controlled infectious disease; severe concomitant cardiac, lung, liver, or renal impairment; Fanconi anemia and other DNA breakage repair disorders; pregnancy; administration of live vaccine
Concerns related to adverse effects:
Bone marrow suppression: Treosulfan causes severe and prolonged myelosuppression. Hematopoietic stem cell transplantation is required to prevent potentially fatal complications of the prolonged myelosuppression. Profound myelosuppression with pancytopenia is the desired effect of treosulfan-based conditioning treatment, occurring in all patients. The risk of infection is increased during severe neutropenia. The median duration of neutropenia is 14 to 17.5 days in adults.
• Cardiovascular toxicity: Treosulfan-based conditioning is associated with cardiac arrhythmias (eg, atrial fibrillation, sinus arrhythmia) and rare cardiac failure. Treatment-emergent serious cardiac adverse events (left ventricular systolic dysfunction, myocardial infarction, paroxysmal atrial tachycardia, right ventricular dysfunction) have been observed, although may not be attributed to treosulfan. Safety and efficacy have not been established in patients with severe cardiac impairment and left ventricular ejection fraction <40%; these patients were excluded from the clinical study.
• Dermatologic toxicity: An increased incidence of skin disorders (eg, rash, dermatitis) was observed when patients received sodium bicarbonate–containing hydration in the course of treosulfan infusion, which may accelerate the pH-dependent formation of alkylating epoxides. Omit skin creams on the days of chemotherapy.
• Extravasation: Treosulfan is an irritant; ensure proper needle or catheter placement prior to and during infusion. Avoid extravasation.
• GI toxicities: Oral mucositis (including severe events) commonly occurs with treosulfan-based transplant conditioning regimen. Mucositis prophylaxis (eg, topical antimicrobials, barrier protectants, cryotherapy, adequate oral hygiene) is recommended.
• Graft-versus-host disease: Allogeneic hematopoietic stem cell transplantation has been commonly associated with graft-versus-host disease (acute and chronic).
• Hemorrhage: Epistaxis has been reported.
• Hepatotoxicity: Increases in transaminases, bilirubin, gamma-glutamyl transferase, and alkaline phosphatase are commonly observed with treosulfan-based conditioning therapy.
• Neurologic toxicity: Treosulfan may cause headache or dizziness. Treatment-emergent serious adverse events such as intracranial hemorrhage and/or syncope have been reported. A case of encephalitis infection and intracranial hemorrhage (as a complication of sepsis) was reported. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery.
• Pulmonary toxicity: Dyspnea has occurred with treosulfan. Treatment-emergent serious respiratory adverse events (including respiratory failure, bronchopulmonary hemorrhage, lung infection) have been reported, although only lung infection was considered related to treosulfan. Patients with severe pulmonary impairment were excluded from the clinical study.
• Secondary malignancy: Long-term survival following allogeneic hematopoietic stem cell transplantation has been associated with secondary malignancies.
Other warnings/precautions:
• Immunizations: Avoid immunization with live vaccines; may result in severe infection or lack of vaccine response.
Duration of neutropenia following therapy may be longer in pediatric as compared to adult patients; median duration of neutropenic period was 21 to 24 days in pediatric patients as compared to 14 to 17.5 days in adults. Consider prophylactic or empiric anti-infective treatment (eg, bacterial, viral, fungal).
Seizures have been reported in pediatric patients; one trial reported seizures in 3 patients ≤4 months of age with primary immunodeficiencies following conditioning with treosulfan (Slatter 2017); another trial reported idiopathic epilepsy in a patient 47 months of age (Morillo-Gutierrez 2020). Monitor for signs of neurological adverse reactions, including seizures; consider seizure prophylaxis (Trecondi European Medicines Agency 2019; Trecondyv Canadian product labeling 2021).
Respiratory toxicity (grade 3/4) is more common in infants than older patients (Trecondi European Medicines Agency 2019). Hepatotoxicity is commonly observed in all age groups; associated disorientation/confusion may be more common in children and adolescents (Trecondyv Canadian product labeling 2021).
Diaper dermatitis may occur in infants and young children due to treosulfan excretion in the urine. Frequent diaper changes are required in the 6 to 8 hours following treosulfan infusion.
Not available in the United States.
Yes
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intravenous:
Trecondyv: 5 g (1 ea)
IV: Hematopoietic stem cell transplant: Infuse over 2 hours; administer treosulfan prior to fludarabine on the days when both medications are administered.
Irritant. Ensure proper needle or catheter placement prior to and during infusion; avoid extravasation. If extravasation occurs, implement general extravasation management measures.
Nausea and vomiting may commonly occur; consider prophylactic antiemetics to prevent nausea and vomiting. Mucositis prophylaxis (eg, topical antimicrobials, barrier protectants, cryotherapy, adequate oral hygiene) is recommended.
Note: Nausea and vomiting may commonly occur; consider prophylactic antiemetics to prevent nausea and vomiting.
Parenteral: IV: Infuse over 2 hours. Administer prior to fludarabine on days when both medications are administered. On days treosulfan administered, use of topical creams should be avoided and diapers should be changed frequently during the 6 to 8 hours following each infusion.
Irritant: Ensure proper needle or catheter placement prior to and during infusion; avoid extravasation. If extravasation occurs, discontinue infusion immediately and infuse remaining portion through another vein.
This medication is not on the NIOSH (2016) list; however, it meets the criteria for a hazardous drug. Treosulfan is a cytotoxic drug (per product labeling).
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: Not approved in the United States.
Hematopoietic stem cell conditioning regimen: Indicated (in combination with fludarabine) as part of conditioning treatment prior to allogeneic hematopoietic stem cell transplantation (alloHSCT) in adults with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) at increased risk for standard conditioning therapies or pediatric patients >1 year of age with AML or MDS.
Limitations of use: Not indicated for patients undergoing alloHSCT for Fanconi anemia and other DNA breakage repair disorders.
Treosulfan may be confused with busulfan.
This medication is in a class the Institute for Safe Medication Practices includes among its list of drug classes which have a heightened risk of causing significant patient harm when used in error.
None known.
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
Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination
Antithymocyte Globulin (Equine): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of cytotoxic chemotherapy is reduced. Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy
Baricitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination
BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
BCG Products: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Brincidofovir: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy
Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination
Chikungunya Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Chikungunya Vaccine (Live). 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
Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk X: Avoid combination
Cladribine: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination
CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor therapy
Coccidioides immitis Skin Test: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing cytotoxic chemotherapy several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification
COVID-19 Vaccine (Adenovirus Vector): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy
COVID-19 Vaccine (mRNA): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider therapy modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy
COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy
CYP2C19 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors): Treosulfan may increase the serum concentration of CYP2C19 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk X: Avoid combination
CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors): Treosulfan may increase the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). 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
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Denosumab: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and cytotoxic chemotherapy. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider therapy modification
Deucravacitinib: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination
Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Risk X: Avoid combination
Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination
Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination
Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination
Inebilizumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy
Influenza Virus Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating chemotherapy if possible. If vaccination occurs less than 2 weeks prior to or during chemotherapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification
Leflunomide: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents, such as cytotoxic chemotherapy. Risk D: Consider therapy modification
Lenograstim: Antineoplastic Agents may diminish the therapeutic effect of Lenograstim. Management: Avoid the use of lenograstim 24 hours before until 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Risk D: Consider therapy modification
Lipegfilgrastim: Antineoplastic Agents may diminish the therapeutic effect of Lipegfilgrastim. Management: Avoid concomitant use of lipegfilgrastim and myelosuppressive cytotoxic chemotherapy. Lipegfilgrastim should be administered at least 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Risk D: Consider therapy modification
Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination
Nadofaragene Firadenovec: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination
Natalizumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination
Ocrelizumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy
Ofatumumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy
Olaparib: Myelosuppressive Agents may enhance the myelosuppressive effect of Olaparib. Risk C: Monitor therapy
Palifermin: May enhance the adverse/toxic effect of Antineoplastic Agents. Specifically, the duration and severity of oral mucositis may be increased. Management: Do not administer palifermin within 24 hours before, during infusion of, or within 24 hours after administration of myelotoxic chemotherapy. Risk D: Consider therapy modification
Pidotimod: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy
Pimecrolimus: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination
Pneumococcal Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination
Polymethylmethacrylate: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the potential for allergic or hypersensitivity reactions to Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification
Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Rabies Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification
Ritlecitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ritlecitinib. 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
Ruxolitinib (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination
Sipuleucel-T: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants, such as cytotoxic chemotherapy, prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification
Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk C: Monitor therapy
Tacrolimus (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination
Talimogene Laherparepvec: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination
Tertomotide: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination
Tofacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Tofacitinib. Risk X: Avoid combination
Typhoid Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination
Ublituximab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy
Upadacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination
Vaccines (Inactivated/Non-Replicating): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of chemotherapy when possible. Patients vaccinated less than 14 days before initiating or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification
Vaccines (Live): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Vaccines (Live) may diminish the therapeutic effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination
Yellow Fever Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
Males and females of reproductive potential should use effective contraception during treosulfan treatment and for 6 months after the last treosulfan dose.
Treosulfan may impair fertility. Treosulfan has been associated with ovarian suppression and amenorrhea prior to menopause. Infertility may be permanent in males; sperm cryo-conservation should be considered prior to therapy.
A long-term study followed patients for up to 12 years who received treosulfan as part of the conditioning treatment prior to allogeneic hematopoietic stem cell transplantation. Successful pregnancies and fatherhood were reported (Lazzari 2021).
Use is contraindicated during pregnancy. Pregnant caregivers should avoid handling treosulfan.
It is not known if treosulfan is present in breast milk.
According to the manufacturer, breastfeeding should be discontinued during treosulfan treatment.
Hematopoietic stem cell transplantation: CBC with differential and platelets (daily until engraftment; frequently until hematopoietic recovery); hepatic function (transaminases, alkaline phosphatase, bilirubin; daily through post-transplant day 28); renal function (baseline). Assess cardiac function regularly. Monitor infusion site during infusion. Monitor for signs/symptoms of infection, dermatologic toxicity, pulmonary toxicity, hemorrhagic cystitis, and mucositis.
The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.
Treosulfan is a bifunctional alkylating agent prodrug with cytotoxic activity in hematopoietic stem cells. Treosulfan undergoes spontaneous, pH-dependent conversion into a mono-epoxide intermediate and di-epoxybutan; the epoxides alkylate and cross-link DNA, and are considered responsible for the stem cell depleting, immune-suppressive, and antineoplastic effects.
Distribution: Rapidly distributed to body (with limited blood brain barrier penetration). Vd: Adults: IV: 20 to 47 L.
Metabolism: Converted spontaneously (non-enzymatically) into the active mono-epoxide intermediate and finally to di-epoxybutan.
Half-life elimination: Adults: IV: ~2 hours.
Time to peak, plasma: IV: At the end of the infusion.
Excretion: Urine: IV: 14% to 40% (within 24 hours) as unchanged drug.
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