Secukinumab: Drug information

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

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)

Brand Names: US

Cosentyx;
Cosentyx (300 MG Dose);
Cosentyx Sensoready (300 MG);
Cosentyx Sensoready Pen;
Cosentyx UnoReady

Brand Names: Canada

Cosentyx

Pharmacologic Category

Anti-interleukin 17A Monoclonal Antibody;
Antipsoriatic Agent;
Monoclonal Antibody

Dosing: Adult

Dosage guidance:

Safety: Prior to initiation, certain assessments (clinical and laboratory) are required with documentation and ensure age-appropriate vaccinations are up to date. In general, live vaccines should not be administered within 4 weeks prior to starting therapy (Ref). Refer to institutional protocols for vaccination and monitoring requirements prior to initiating therapy.

Ankylosing spondylitis

Ankylosing spondylitis:

IV:

With a loading dose: 6 mg/kg at week 0 followed by 1.75 mg/kg (do not exceed 300 mg) every 4 weeks.

Without a loading dose: 1.75 mg/kg (do not exceed 300 mg) every 4 weeks.

SUBQ:

With a loading dose: 150 mg at weeks 0, 1, 2, 3, and 4 followed by 150 mg every 4 weeks; consider an increase to 300 mg every 4 weeks in patients who continue to have active ankylosing spondylitis.

Without a loading dose: 150 mg every 4 weeks; consider an increase to 300 mg every 4 weeks in patients who continue to have active ankylosing spondylitis.

Axial spondyloarthritis

Axial spondyloarthritis (nonradiographic):

IV:

With a loading dose: 6 mg/kg at week 0 followed by 1.75 mg/kg (do not exceed 300 mg) every 4 weeks.

Without a loading dose: 1.75 mg/kg (do not exceed 300 mg) every 4 weeks.

SUBQ :

With a loading dose: 150 mg at weeks 0, 1, 2, 3, and 4 followed by 150 mg every 4 weeks.

Without a loading dose: 150 mg every 4 weeks.

Hidradenitis suppurativa

Hidradenitis suppurativa: SUBQ: 300 mg at weeks 0, 1, 2, 3, and 4 followed by 300 mg every 4 weeks; consider an increase to 300 mg every 2 weeks in patients who have an inadequate response.

Plaque psoriasis

Plaque psoriasis: SUBQ : 300 mg once weekly at weeks 0, 1, 2, 3, and 4 followed by 300 mg every 4 weeks. Some patients may only require 150 mg per dose.

Psoriatic arthritis

Psoriatic arthritis:

IV:

With a loading dose: 6 mg/kg at week 0 followed by 1.75 mg/kg (do not exceed 300 mg) every 4 weeks.

Without a loading dose: 1.75 mg/kg (do not exceed 300 mg) every 4 weeks.

SUBQ :

With a loading dose: 150 mg at weeks 0, 1, 2, 3, and 4 followed by 150 mg every 4 weeks; consider an increase to 300 mg every 4 weeks in patients who continue to have active psoriatic arthritis.

Without a loading dose: 150 mg every 4 weeks; consider an increase to 300 mg every 4 weeks in patients who continue to have active psoriatic arthritis.

Coexistent moderate to severe plaque psoriasis: 300 mg once weekly at weeks 0, 1, 2, 3, and 4 followed by 300 mg every 4 weeks. Some patients may only require 150 mg per dose.

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

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Adjustment for Toxicity: Adult

Eczematous eruptions: Consider discontinuation for severe eruptions, including atopic dermatitis-like eruptions, dyshidrotic eczema, and erythroderma to resolve symptoms; some patients were successfully treated while remaining on secukinumab therapy.

Hypersensitivity reactions: Discontinue immediately and institute appropriate therapy.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Secukinumab: Pediatric drug information")

Enthesitis-related arthritis, active

Enthesitis-related arthritis, active:

Children ≥4 years and Adolescents:

15 to <50 kg: SUBQ: 75 mg once weekly at weeks 0, 1, 2, 3, and 4, followed by 75 mg every 4 weeks.

≥50 kg: SUBQ: 150 mg once weekly at weeks 0, 1, 2, 3, and 4, followed by 150 mg every 4 weeks.

Plaque psoriasis, moderate to severe

Plaque psoriasis, moderate to severe:

Children ≥6 years and Adolescents <18 years:

15 to <50 kg: SUBQ: 75 mg once weekly at weeks 0, 1, 2, 3, and 4, followed by 75 mg every 4 weeks (Ref).

≥50 kg: SUBQ: 150 mg once weekly at weeks 0, 1, 2, 3, and 4, followed by 150 mg every 4 weeks (Ref); some may require higher dose of 300 mg every 4 weeks (Ref).

Adolescents ≥18 years: SUBQ: 300 mg once weekly at weeks 0, 1, 2, 3, and 4, followed by 300 mg every 4 weeks. Some patients may only require 150 mg/dose (Ref).

Psoriatic arthritis

Psoriatic arthritis:

Children ≥2 years and Adolescents <18 years:

15 to <50 kg: SUBQ: 75 mg once weekly at weeks 0, 1, 2, 3, and 4, followed by 75 mg every 4 weeks.

≥50 kg: SUBQ: 150 mg once weekly at weeks 0, 1, 2, 3, and 4, followed by 150 mg every 4 weeks.

Adolescents ≥18 years:

With a loading dose: SUBQ: 150 mg at weeks 0, 1, 2, 3, and 4 followed by 150 mg every 4 weeks; consider an increase to 300 mg every 4 weeks in patients who continue to have active psoriatic arthritis.

Without a loading dose: SUBQ: 150 mg every 4 weeks; consider an increase to 300 mg every 4 weeks in patients who continue to have active ankylosing spondylitis.

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: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Adverse Reactions (Significant): Considerations

Dermatologic reactions

Various cutaneous reactions have been reported, including psoriasiform eruption (either new onset or exacerbation), eczematous rash, lupus-like syndrome, bullous pemphigoid, alopecia, skin granuloma, pyoderma gangrenosum, hidradenitis suppurativa, and hypersensitivity angiitis (Ref). In one systematic review, eczematous rash incidence was reported in 2.6% to 7.6% of patients and led to discontinuation in 76% of patients (Ref).

Mechanism: Not clearly established; psoriasiform reactions, eczematous rashes: Possibly related to imbalances of Th1/Th2 immune response. Hypersensitivity angiitis: Possibly related to cytokine imbalance (Ref). Skin granulomas due to sarcoidosis: Proposed imbalance between interleukin-17 and IFN-γ producing T cells that induce IFN-γ secretion, resulting in granuloma formation (Ref).

Onset: Alopecia: Delayed; 2 to 13 months after initiation (Ref). Eczematous rashes: Delayed; mean 20 weeks (range: 2 to 76 weeks) after initiation (Ref).

Infection

Secukinumab may increase the risk of infection, including serious infection (and sometimes fatal). A higher rate of infections was observed with secukinumab treatment in clinical trials, including nasopharyngitis, upper respiratory tract infection, and candidiasis. Other infections include, but are not limited to, herpes virus infection and staphylococcal infection.

Mechanism: Dose-related; cytokine inhibition leads to diminished inflammatory response, especially adaptive immunity, against pathogens. Interleukin (IL)-17 is involved in host immunity against extracellular bacteria and fungi (Ref). Defects in IL-17 immunity are associated with serious infections, including Staphylococcus aureus and herpesvirus skin infections (Ref).

Risk factors:

• History of chronic or recurrent infection

Inflammatory bowel disease

Treatment with secukinumab may cause exacerbations or new onset of inflammatory bowel disease (IBD). Crohn disease, exacerbation of Crohn disease, ulcerative colitis, exacerbation of ulcerative colitis, undifferentiated cases of IBD, and colitis (including microscopic and undifferentiated cases) have been reported with interleukin (IL)-17 inhibitor use, including secukinumab; fatal cases have occurred (Ref). Overall incidence of IBD with secukinumab is low (Ref).

Mechanism: IL-17 may play a protective role in gastrointestinal inflammation, inhibiting a Th1 immune-mediated response (Ref).

Onset: Varied; usually within 6 months but may occur as late as 39 months (Ref).

Risk factors:

• Psoriasis, psoriatic arthritis, or ankylosing spondylitis (Ref)

• Smoking (Ref)

• Females (Ref)

Tuberculosis

Adult and pediatric patients treated with secukinumab may be at risk for tuberculosis (TB) disease (including reactivated TB). However, an overall low rate of TB has been reported with secukinumab (Ref).

Mechanism: Interleukin (IL)-17 may promote intracellular growth of Mycobacterium tuberculosis by inhibiting apoptosis of infected macrophages (Ref). Hence, IL-17 inhibition appears to be favorable regarding TB infection; may limit intracellular growth of Mycobacterium tuberculosis by enhancing apoptosis of infected macrophages (Ref).

Risk factors:

• Residence in an area with high TB prevalence (Ref)

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Infection: Infection (29% to 48%; serious infection: ≤1%) (table 1)Infection

**Secukinumab: Adverse Reaction: Infection**
Drug (Secukinumab)	Placebo	Population	Dosage Form	Indication	Number of Patients (Secukinumab)	Number of Patients (Placebo)
48%	N/A	Adults	SUBQ	Plaque psoriasis	3,430	N/A
29%	19%	Adults	SUBQ	Plaque psoriasis	1,382	694
Serious: 1%	N/A	Adults	SUBQ	Plaque psoriasis	3,430	N/A
Serious: 0.1%	Serious: 0.3%	Adults	SUBQ	Plaque psoriasis	1,382	694

Respiratory: Nasopharyngitis (11% to 12%) (table 2)Nasopharyngitis

**Secukinumab: Adverse Reaction: Nasopharyngitis**
Drug (Secukinumab)	Placebo	Population	Dose	Dosage Form	Indication	Number of Patients (Secukinumab)	Number of Patients (Placebo)
12%	9%	Adults	150 mg	SUBQ	Plaque psoriasis	692	694
11%	9%	Adults	300 mg	SUBQ	Plaque psoriasis	691	694

1% to 10%:

Dermatologic: Urticaria (≤1%)

Endocrine & metabolic: Hypercholesterolemia (≥2%)

Gastrointestinal: Diarrhea (3% to 4%), inflammatory bowel disease (≤1%; Crohn disease, exacerbation of Crohn disease, exacerbation of ulcerative colitis, ulcerative colitis: <1%), mucocutaneous candidiasis (1%), nausea (≥2%), oral herpes simplex infection (≤1%)

Infection: Fungal infection (4% to 5%)

Nervous system: Headache (≥2%)

Respiratory: Pharyngitis (1%), rhinitis (1%), rhinorrhea (≤1%), upper respiratory tract infection (3%) (table 3)Upper Respiratory Tract Infection

**Secukinumab: Adverse Reaction: Upper Respiratory Tract Infection**
Drug (Secukinumab)	Placebo	Population	Dose	Dosage Form	Indication	Number of Patients (Secukinumab)	Number of Patients (Placebo)
3%	0.7%	Adults	300 mg	SUBQ	Plaque psoriasis	691	694
3%	0.7%	Adults	150 mg	SUBQ	Plaque psoriasis	692	694

<1%:

Dermatologic: Impetigo, tinea pedis

Gastrointestinal: Oral candidiasis

Hematologic & oncologic: Neutropenia

Hepatic: Increased serum transaminases

Immunologic: Antibody development (including neutralizing; effect of neutralizing antibodies on safety, efficacy, or PK/PD is unknown)

Ophthalmic: Conjunctivitis

Otic: Otitis externa, otitis media

Respiratory: Sinusitis, tonsillitis

Frequency not defined:

Gastrointestinal: Colitis, gastritis, hematochezia, lower abdominal pain

Genitourinary: Urinary tract infection

Hypersensitivity: Anaphylaxis

Postmarketing:

Dermatologic: Alopecia (Öğüt 2023), bullous pemphigoid (Wang 2023), eczematous rash (Caldarola 2020), psoriasiform eruption (Karamanakos 2021), pyoderma gangrenosum (Avci 2023), skin granuloma (Fox 2020)

Hypersensitivity: Hypersensitivity angiitis (Ak 2023)

Immunologic: Sarcoidosis (Nyckowski 2017)

Infection: Candidiasis (Davidson 2022), herpes virus infection (Davidson 2022), staphylococcal infection (Davidson 2022)

Local: Injection-site reaction (Grace 2020)

Neuromuscular & skeletal: Lupus-like syndrome (Liang 2022)

Contraindications

Serious hypersensitivity reaction to secukinumab or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Eczematous eruptions: Severe eczematous eruptions (sometimes requiring hospitalization), including atopic dermatitis-like eruptions, dyshidrotic eczema, and erythroderma have been reported; the onset ranged from days to months after the first dose. Consider discontinuation of therapy until eczematous eruptions resolve.

• Hypersensitivity reactions: Urticaria and anaphylaxis have been reported; discontinue immediately if signs/symptoms of a serious hypersensitivity reaction develop and initiate appropriate treatment.

• Infections: Secukinumab may increase the risk of infections. Serious and sometimes fatal infections have been reported. A higher rate of infections was observed with secukinumab treatment in clinical trials, including nasopharyngitis, upper respiratory tract infection, and mucocutaneous candida infection; the incidence of some types of infection appeared to be dose-dependent. Use with caution in patients with a chronic infection or a history of recurrent infection. In patients who develop a serious infection, monitor closely and discontinue use until the infection resolves.

• Tuberculosis: Patients should be evaluated for tuberculosis (TB) infection (latent TB) prior to initiating therapy; avoid therapy in patients with TB disease (active TB). Consider antituberculosis therapy if an adequate course of treatment cannot be confirmed in patients with a history of TB disease or infection. Monitor all patients for signs and symptoms of TB disease during and after treatment.

Disease related concerns:

• Inflammatory bowel disease: Treatment with secukinumab may cause exacerbations (some serious) and new onset of inflammatory bowel of inflammatory bowel disease.

Special populations:

• Patients with rheumatic musculoskeletal disease undergoing hip or knee replacement surgery: Hold biologic disease-modifying antirheumatic drugs (DMARDs) prior to surgery and plan surgery after the next dose is due. Surgery can occur after holding medication for 1 full dosing cycle (eg, for medications administered every 4 weeks, schedule surgery 5 weeks from last administered dose); therapy can be restarted once surgical wound shows evidence of healing (eg, no swelling, erythema, or drainage), sutures/staples are removed, and no ongoing nonsurgical site infections (typically ~14 days to reduce infection risk). Decisions to withhold therapy should be based on shared decision making; ensure the patient and their provider weigh risks of interrupting therapy and disease control versus risks of continuing therapy and surgical complications (ACR/AAHKS [Goodman 2022]).

Dosage form specific issues:

• Latex: Some dosage forms may contain dry natural rubber (latex).

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.

Other warnings/precautions:

• Immunizations: Patients should be brought up to date with all immunizations before initiating therapy. Live vaccines should not be given concurrently during therapy; non-live vaccines administered during secukinumab therapy may not elicit an immune response sufficient to prevent disease.

Dosage Forms: US

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

Solution, Intravenous [preservative free]:

Cosentyx: 125 mg/5 mL (5 mL) [contains polysorbate 80]

Solution Auto-injector, Subcutaneous [preservative free]:

Cosentyx Sensoready (300 MG): 150 mg/mL (1 mL) [contains mouse (murine) and/or hamster protein, polysorbate 80]

Cosentyx Sensoready Pen: 150 mg/mL (1 mL) [contains polysorbate 80]

Cosentyx UnoReady: 300 mg/2 mL (2 mL) [contains polysorbate 80]

Solution Prefilled Syringe, Subcutaneous:

Cosentyx: 75 mg/0.5 mL (0.5 mL) [contains polysorbate 80]

Solution Prefilled Syringe, Subcutaneous [preservative free]:

Cosentyx: 150 mg/mL (1 mL) [contains polysorbate 80]

Cosentyx (300 MG Dose): 150 mg/mL (1 mL) [contains mouse (murine) and/or hamster protein, polysorbate 80]

Generic Equivalent Available: US

Pricing: US

Solution (Cosentyx Intravenous)

125 mg/5 mL (per mL): $507.60

Solution Auto-injector (Cosentyx Sensoready (300 MG) Subcutaneous)

150 mg/mL (per mL): $4,445.38

Solution Auto-injector (Cosentyx Sensoready Pen Subcutaneous)

150 mg/mL (per mL): $8,890.75

Solution Auto-injector (Cosentyx UnoReady Subcutaneous)

300 mg/2 mL (per mL): $4,445.38

Solution Prefilled Syringe (Cosentyx (300 MG Dose) Subcutaneous)

150 mg/mL (per mL): $4,445.38

Solution Prefilled Syringe (Cosentyx Subcutaneous)

75 mg/0.5 mL (per 0.5 mL): $4,445.38

150 mg/mL (per mL): $8,890.75

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.

Solution, Subcutaneous:

Cosentyx: 150 mg/mL (1 mL) [contains mouse (murine) and/or hamster protein, polysorbate 80]

Solution Prefilled Syringe, Subcutaneous:

Cosentyx: 75 mg/0.5 mL (0.5 mL) [contains polysorbate 80]

Administration: Adult

IV: Dilute prior to use. Infuse over 30 minutes (~3.3 mL/minute for 100 mL bag or 1.7 mL/minute for a 50 mL bag), using an infusion set with an in-line, sterile, nonpyrogenic, low protein-binding 0.2-micron filter. After infusion is complete, flush line with ≥50 mL of NS. Do not infuse in the same line with other medications.

SUBQ : Allow to reach room temperature 15 to 30 minutes (Sensoready pen, 75 mg/0.5 mL prefilled syringe, 150 mg/mL prefilled syringe) or 30 to 45 minutes (UnoReady pen) prior to injection. Inject into the front of thighs, lower abdomen (≥2 inches away from the navel) or outer upper arms; administer each injection at a different anatomic location than a previous injection and avoid areas where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis, or where there are scars or stretch marks. The pens and prefilled syringes may be self-injected by the patient or caregiver following proper training in SUBQ injection technique.

Administration: Pediatric

Parenteral: SUBQ: Allow to reach room temperature prior to injection. Inject into the thighs, any quadrant of the abdomen (≥2 inches away from the navel), or outer upper arms; administer each injection at a different anatomic location than a previous injection and avoid areas where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis, or where there are scars or stretch marks. Do not shake injection device. Pediatric doses of the Sensoready pen or prefilled syringe should be administered by an adult caregiver; trained adult patients may self-administer.

The 300 mg dose should be divided into two 150 mg SUBQ injections.

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:

Cosentyx: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125504s063lbl.pdf#page=34

Use: Labeled Indications

Ankylosing spondylitis: Treatment of active ankylosing spondylitis in adults.

Axial spondyloarthritis (nonradiographic): Treatment of active nonradiographic axial spondyloarthritis in adults with objective signs of inflammation.

Enthesitis-related arthritis: Treatment of active enthesitis-related arthritis in pediatric patients ≥4 years of age.

Hidradenitis suppurativa: Treatment of moderate to severe hidradenitis suppurative in adults.

Plaque psoriasis: Treatment of moderate to severe plaque psoriasis in patients ≥6 years of age who are candidates for systemic therapy or phototherapy.

Psoriatic arthritis: Treatment of active psoriatic arthritis in patients ≥2 years of age.

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.

Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

Anifrolumab: Biologic Anti-Psoriasis Agents may enhance the immunosuppressive effect of Anifrolumab. Risk X: Avoid combination

Antithymocyte Globulin (Equine): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Therapeutic Immunosuppressant Agents) 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 (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination

BCG Products: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination

Belimumab: May enhance the immunosuppressive effect of Biologic Anti-Psoriasis Agents. Management: Consider alternatives to the use of belimumab with other biologic therapies. Monitor closely for increased toxicities related to additive immunosuppression (ie, infection, malignancy) if combined. Risk D: Consider therapy modification

Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy

Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

Chikungunya Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination

Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination

Coccidioides immitis Skin Test: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing therapeutic immunosuppressants 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 (Therapeutic Immunosuppressant Agents) 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 (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy

COVID-19 Vaccine (mRNA): Immunosuppressants (Therapeutic Immunosuppressant Agents) 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 (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy

COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy

Dengue Tetravalent Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination

Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Denosumab. Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor for signs/symptoms of serious infections. Risk D: Consider therapy modification

Deucravacitinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy

InFLIXimab: May enhance the immunosuppressive effect of Biologic Anti-Psoriasis Agents. Risk X: Avoid combination

Influenza Virus Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate 2 to 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification

Leflunomide: Immunosuppressants (Therapeutic Immunosuppressant Agents) 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. Risk D: Consider therapy modification

Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) 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 (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination

Nadofaragene Firadenovec: Immunosuppressants (Therapeutic Immunosuppressant Agents) 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 (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination

Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy

Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy

Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy

Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Pimecrolimus. Risk X: Avoid combination

Pneumococcal Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination

Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) 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

Rabies Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) 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 (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination

Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination

Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification

Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk C: Monitor therapy

Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination

Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) 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 (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination

Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Use with non-biologic disease-modifying antirheumatic drugs (DMARDs) was permitted in psoriatic arthritis clinical trials. Risk X: Avoid combination

Typhoid Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination

Ublituximab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy

Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination

Vaccines (Inactivated/Non-Replicating): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider therapy modification

Vaccines (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination

Yellow Fever Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination

Reproductive Considerations

The American Academy of Dermatology considers secukinumab for the treatment of psoriasis to be likely compatible for use in male patients planning to father a child (AAD-NPF [Menter 2019]). Males and females with well-controlled psoriasis who are planning a pregnancy and wish to avoid fetal exposure can consider discontinuing secukinumab 19 weeks prior to attempting pregnancy (Rademaker 2018).

Based on limited information, use of secukinumab may be continued through conception in patients with rheumatic and musculoskeletal diseases who are planning to become pregnant and not able to use alternative therapies; use should be discontinued once pregnancy is confirmed. Conception should be planned during a period of quiescent/low disease activity. Recommendations for use of secukinumab to treat rheumatic and musculoskeletal diseases in patients who are planning to father a child are not available due to limited data (ACR [Sammaritano 2020]).

Possible failure of tubal sterilization following placement of an implantable birth control device (Essure) was observed in a female treated with secukinumab (Nardin 2018). Note: Distribution of Essure in the United States was stopped in December 2018.

Pregnancy Considerations

Secukinumab is a humanized monoclonal antibody (IgG₁). Placental transfer of human IgG is dependent upon the IgG subclass, maternal serum concentrations, birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009).

Outcome information following exposure to secukinumab during pregnancy is limited (Liu 2020; Nardin 2018; Warren 2018).

Until additional information is available, secukinumab is not currently recommended for the treatment of rheumatic and musculoskeletal diseases during pregnancy. Secukinumab should be discontinued once pregnancy is confirmed (ACR [Sammaritano 2020]). Agents other than secukinumab are preferred for the treatment of plaque psoriasis during pregnancy (Yeung 2020).

Breastfeeding Considerations

It is not known if secukinumab is present in breast milk.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Treatment with secukinumab may be continued or initiated in breastfeeding patients with rheumatic and musculoskeletal diseases (ACR [Sammaritano 2020]).

Monitoring Parameters

Prior to therapy start:

• Evaluate for malignancy (especially skin cancer), current or latent infection, lymphadenopathy, signs and symptoms of inflammatory bowel disease, and ensure age-appropriate vaccinations are up to date and, in general, no live vaccines are administered within 4 weeks of starting therapy (AAD [Menter 2019]; EuroGuiDerm [Nast 2020]). Refer to institutional protocols for vaccination and monitoring requirements prior to initiating therapy.

• Labs: CBC with differential; complete metabolic panel; testing for tuberculosis (TB) infection (latent TB) (eg, Quantiferon Gold) or interferon gamma release assay for TB for patients who have had Bacillus Calmette-Guérin (BCG) vaccine; chest radiograph if testing for TB infection is positive; serologic testing for hepatitis B virus (hepatitis B surface antigen, hepatitis B surface antibody, hepatitis B core antibody), hepatitis C virus antibody, HIV; pregnancy test, C-reactive protein (AAD [Menter 2019]; EuroGuiDerm [Nast 2020]).

During therapy:

• Evaluate for infection, malignancy (specifically skin cancer screening, especially for patients who have a history of skin cancer or UV phototherapy), infusion/injection site reactions, exacerbation, or development of inflammatory bowel disease (AAD [Menter 2019]; EuroGuiDerm [Nast 2020]).

• Labs: CBC and LFTs after 3 to 6 months or as clinically indicated, pregnancy test as needed; annual testing/chest radiograph for TB in high-risk patients (eg, contact with individuals with TB disease [active TB]) (AAD [Menter 2019]; EuroGuiDerm [Nast 2020]); hepatitis B carriers should be periodically evaluated for signs/symptoms of active hepatitis B infection (AAD [Menter 2019]).

After therapy:

• Periodically evaluate patients who are hepatitis B carriers for signs/symptoms of active hepatitis B infection (AAD [Menter 2019]).

Mechanism of Action

Secukinumab is a human IgG1 monoclonal antibody that selectively binds to the interleukin-17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine involved in normal inflammatory and immune responses. Secukinumab inhibits the release of proinflammatory cytokines and chemokines.

Pharmacokinetics (Adult Data Unless Noted)

Note: Weight: Secukinumab clearance and volume of distribution increase as body weight increases.

Onset of action: Psoriasis: SUBQ: Response best determined after 12 weeks (AAD-NPF [Menter 2019]).

Distribution: V_d: SUBQ: 7.1 to 8.6 L.

Metabolism: Expected to be degraded into small peptides and amino acids via catabolic pathways similar to that which is seen with endogenous IgG.

Bioavailability: SUBQ: 55% to 77%.

Half-life elimination: SUBQ: 22 to 31 days.

Time to peak: SUBQ: ~6 days.

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(AE) United Arab Emirates: Cosentyx;
(AR) Argentina: Cosentyx;
(AT) Austria: Cosentyx;
(AU) Australia: Cosentyx;
(BE) Belgium: Cosentyx;
(BR) Brazil: Cosentyx;
(CH) Switzerland: Cosentyx;
(CL) Chile: Cosentyx;
(CO) Colombia: Cosentyx;
(CZ) Czech Republic: Cosentyx;
(DE) Germany: Cosentyx;
(EC) Ecuador: Cosentyx;
(EE) Estonia: Cosentyx;
(EG) Egypt: Cosentyx;
(ES) Spain: Cosentyx;
(FI) Finland: Cosentyx;
(FR) France: Cosentyx;
(GB) United Kingdom: Cosentyx;
(GR) Greece: Cosentyx;
(HK) Hong Kong: Cosentyx;
(HR) Croatia: Cosentyx;
(HU) Hungary: Cosentyx;
(IE) Ireland: Cosentyx;
(IT) Italy: Cosentyx;
(JO) Jordan: Cosentyx;
(JP) Japan: Cosentyx;
(KR) Korea, Republic of: Cosentyx | Cosentyx sensoready;
(KW) Kuwait: Cosentyx;
(LB) Lebanon: Cosentyx;
(LT) Lithuania: Cosentyx;
(LU) Luxembourg: Cosentyx;
(LV) Latvia: Cosentyx;
(MA) Morocco: Cosentyx;
(MX) Mexico: Cosentyx;
(MY) Malaysia: Cosentyx | Fraizeron;
(NL) Netherlands: Cosentyx;
(NO) Norway: Cosentyx;
(NZ) New Zealand: Cosentyx;
(PE) Peru: Cosentyx;
(PH) Philippines: Cosentyx;
(PK) Pakistan: Cosentyx;
(PL) Poland: Cosentyx;
(PR) Puerto Rico: Cosentyx;
(PT) Portugal: Cosentyx;
(QA) Qatar: Cosentyx | Cosentyx (300 mg Dose) | Cosentyx Sensoready | Cosentyx Sensoready (300 mg Dose);
(RO) Romania: Cosentyx;
(RU) Russian Federation: Cosentyx;
(SA) Saudi Arabia: Cosentyx;
(SE) Sweden: Cosentyx;
(SG) Singapore: Cosentyx;
(SI) Slovenia: Cosentyx;
(SK) Slovakia: Cosentyx;
(TH) Thailand: Cosentyx;
(TN) Tunisia: Cosentyx;
(TW) Taiwan: Cosentyx;
(ZA) South Africa: Cosentyx

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Topic 99569 Version 205.0

خرید پکیج

Secukinumab: Drug information