Cosentyx

— THERAPEUTIC CATEGORIES —
  • Arthritis/rheumatic disorders
  • Miscellaneous dermatological conditions
  • Psoriasis

Cosentyx Generic Name & Formulations

General Description

Secukinumab 75mg/0.5mL, 150mg/mL, 300mg/2mL; soln for SC inj; 125mg/vial; soln for IV infusion after dilution; preservative-free.

Pharmacological Class

Interleukin-17A antagonist.

How Supplied

Single-dose UnoReady pen (300mg)—1; Single-dose Sensoready pen (150mg)—1, 2; Single-dose prefilled syringe (300mg)—1; (150mg)—1, 2; (75mg)—1; Single-dose vial (5mL)—1

Generic Availability

NO

Mechanism of Action

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

Cosentyx Indications

Indications

Active psoriatic arthritis (PsA) in patients aged ≥2yrs. Active ankylosing spondylitis (AS) in adults. Active non-radiographic axial spondyloarthritis (nraxSpA) in adults with objective signs of inflammation. Active enthesitis-related arthritis (ERA) in pediatric patients aged ≥4yrs.

Cosentyx Dosage and Administration

Adult

Give by SC inj into upper arms, thighs, or any quadrant of abdomen (rotate inj site) or by IV infusion over 30mins (only for PsA, AS, and nr-axSPA). ≥18yrs: PsA with coexistent plaque psoriasis: 300mg by SC inj at Weeks 0, 1, 2, 3, and 4 then 300mg every 4 weeks. Other PsA (with a loading dose): 150mg by SC inj at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter; or 6mg/kg IV at Week 0, followed by 1.75mg/kg every 4 weeks thereafter. Other PsA (without a loading dose): 150mg SC every 4 weeks, consider 300mg SC every 4 weeks if PsA continues; or 1.75mg/kg IV every 4 weeks. Cosentyx may be administered with or without MTX. AS (with a loading dose): 150mg by SC inj at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter; or 6mg/kg IV at Week 0, followed by 1.75mg/kg every 4 weeks thereafter. AS (without a loading dose): 150mg every 4 weeks, consider 300mg SC every 4 weeks if AS continues; or 1.75mg/kg IV every 4 weeks. nraxSpA (with a loading dose): 150mg by SC inj at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter; or 6mg/kg IV at Week 0, followed by 1.75mg/kg every 4 weeks thereafter. nraxSpA (without a loading dose): 150mg SC every 4 weeks; or 1.75mg/kg IV every 4 weeks. For 1.75mg/kg maintenance dose in PsA, AS, and nr-axSPA: max 300mg per infusion.

Children

AS or nraxSpA (<18yrs): not established. PsA (<2yrs or <15kg) or ERA (<4yrs or <15kg): not established. Give by SC inj into upper arms, thighs, or any quadrant of abdomen (rotate inj site). PsA (≥2yrs): ≥15–<50kg: 75mg by SC inj at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter; ≥50kg: 150mg by SC inj at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter. Cosentyx may be administered with or without MTX. ERA (≥4yrs): ≥15–<50kg: 75mg by SC inj at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter; ≥50kg: 150mg by SC inj at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter.

Cosentyx Contraindications

Not Applicable

Cosentyx Boxed Warnings

Not Applicable

Cosentyx Warnings/Precautions

Warnings/Precautions

May increase risk of infections. Chronic or history of recurrent infection. If a serious infection develops, monitor closely and discontinue until resolves. History of latent or active TB; consider anti-TB therapy prior to initiation. Evaluate for TB infection prior to initiation. Monitor for active TB during and after therapy. Patients with active TB infection: do not initiate. Inflammatory bowel disease; monitor. Discontinue if anaphylaxis or serious allergic reactions occur. May need to discontinue if severe eczematous eruptions occur. Complete all immunizations based on current guidelines prior to initiation. Latex allergy (Sensoready pen and prefilled syringe only). Pregnancy. Nursing mothers.

Cosentyx Pharmacokinetics

Absorption

Peak mean (± SD) serum concentrations (Cmax) of 13.7 ± 4.8 mcg/mL and 27.3 ± 9.5 mcg/mL, respectively, were reached by ~6 days post dose after administration of a single SC dose of 150 mg or 300 mg secukinumab.

Patients who received the Sensoready pens were observed to have 23–30% higher mean trough concentrations vs those who received the lyophilized powder and 23–26% higher than those who received the prefilled syringe.

Steady-state concentrations were achieved by Week 24 after the every 4-week dosing regimens.

Bioavailability ranged from 55–77%.

Distribution

Mean volume of distribution: 7.10–8.60 L.

 

Metabolism

Catabolic pathways.

Elimination

Half-life: 22–31 days. Mean systemic clearance: 0.14–0.22 L/day.

Cosentyx Interactions

Interactions

Concomitant live vaccines: not recommended. Non-live vaccines: may get suboptimal response. Concomitant CYP450 substrates with a narrow therapeutic index (eg, warfarin, cyclosporine); monitor and consider adjusting dose.

Cosentyx Adverse Reactions

Adverse Reactions

Nasopharyngitis, diarrhea, upper respiratory tract infection; inflammatory bowel disease, hypersensitivity reactions, other serious infections.

Cosentyx Clinical Trials

See Literature

Cosentyx Note

Not Applicable

Cosentyx Patient Counseling

See Literature

Cosentyx Generic Name & Formulations

General Description

Secukinumab 75mg/0.5mL, 150mg/mL, 300mg/2mL; soln for SC inj; 125mg/vial; soln for IV infusion after dilution; preservative-free.

Pharmacological Class

Interleukin-17A antagonist.

How Supplied

Single-dose UnoReady pen (300mg)—1; Single-dose Sensoready pen (150mg)—1, 2; Single-dose prefilled syringe (300mg)—1; (150mg)—1, 2; (75mg)—1; Single-dose vial (5mL)—1

Generic Availability

NO

Mechanism of Action

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

Cosentyx Indications

Indications

Moderate to severe hidradenitis suppurativa.

Cosentyx Dosage and Administration

Adult

Give by SC inj into upper arms, thighs, or any quadrant of abdomen (rotate inj site). ≥18yrs: 300mg at Weeks 0, 1, 2, 3, and 4 then 300mg every 4 weeks. If inadequate response, consider 300mg every 2 weeks.

Children

Not established.

Cosentyx Contraindications

Not Applicable

Cosentyx Boxed Warnings

Not Applicable

Cosentyx Warnings/Precautions

Warnings/Precautions

May increase risk of infections. Chronic or history of recurrent infection. If a serious infection develops, monitor closely and discontinue until resolves. History of latent or active TB; consider anti-TB therapy prior to initiation. Evaluate for TB infection prior to initiation. Monitor for active TB during and after therapy. Patients with active TB infection: do not initiate. Inflammatory bowel disease; monitor. Discontinue if anaphylaxis or serious allergic reactions occur. May need to discontinue if severe eczematous eruptions occur. Complete all immunizations based on current guidelines prior to initiation. Latex allergy (Sensoready pen and prefilled syringe only). Pregnancy. Nursing mothers.

Cosentyx Pharmacokinetics

Absorption

Peak mean (± SD) serum concentrations (Cmax) of 13.7 ± 4.8 mcg/mL and 27.3 ± 9.5 mcg/mL, respectively, were reached by ~6 days post dose after administration of a single SC dose of 150 mg or 300 mg secukinumab.

Patients who received the Sensoready pens were observed to have 23–30% higher mean trough concentrations vs those who received the lyophilized powder and 23–26% higher than those who received the prefilled syringe.

Steady-state concentrations were achieved by Week 24 after the every 4-week dosing regimens.

Bioavailability ranged from 55–77%.

Distribution

Mean volume of distribution: 7.10–8.60 L.

 

Metabolism

Catabolic pathways.

Elimination

Half-life: 22–31 days. Mean systemic clearance: 0.14–0.22 L/day.

Cosentyx Interactions

Interactions

Concomitant live vaccines: not recommended. Non-live vaccines: may get suboptimal response. Concomitant CYP450 substrates with a narrow therapeutic index (eg, warfarin, cyclosporine); monitor and consider adjusting dose.

Cosentyx Adverse Reactions

Adverse Reactions

Nasopharyngitis, diarrhea, upper respiratory tract infection; inflammatory bowel disease, hypersensitivity reactions, other serious infections.

Cosentyx Clinical Trials

See Literature

Cosentyx Note

Not Applicable

Cosentyx Patient Counseling

See Literature

Cosentyx Generic Name & Formulations

General Description

Secukinumab 75mg/0.5mL, 150mg/mL, 300mg/2mL; soln for SC inj; 125mg/vial; soln for IV infusion after dilution; preservative-free.

Pharmacological Class

Interleukin-17A antagonist.

How Supplied

Single-dose UnoReady pen (300mg)—1; Single-dose Sensoready pen (150mg)—1, 2; Single-dose prefilled syringe (300mg)—1; (150mg)—1, 2; (75mg)—1; Single-dose vial (5mL)—1

Generic Availability

NO

Mechanism of Action

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

Cosentyx Indications

Indications

Moderate to severe plaque psoriasis in patients who are candidates for systemic therapy or phototherapy.

Cosentyx Dosage and Administration

Adult

Give by SC inj into upper arms, thighs, or any quadrant of abdomen; rotate inj site. ≥18yrs: 300mg at Weeks 0, 1, 2, 3, and 4 then 300mg every 4 weeks. For some patients, 150mg SC dose may be acceptable.

Children

<6yrs: not established. Give by SC inj into upper arms, thighs, or any quadrant of abdomen; rotate inj site. Administer at Weeks 0, 1, 2, 3, and 4 then every 4 weeks thereafter. ≥6yrs (<50kg): 75mg; (≥50kg): 150mg.

Cosentyx Contraindications

Not Applicable

Cosentyx Boxed Warnings

Not Applicable

Cosentyx Warnings/Precautions

Warnings/Precautions

May increase risk of infections. Chronic or history of recurrent infection. If a serious infection develops, monitor closely and discontinue until resolves. History of latent or active TB; consider anti-TB therapy prior to initiation. Evaluate for TB infection prior to initiation. Monitor for active TB during and after therapy. Patients with active TB infection: do not initiate. Inflammatory bowel disease; monitor. Discontinue if anaphylaxis or serious allergic reactions occur. May need to discontinue if severe eczematous eruptions occur. Complete all immunizations based on current guidelines prior to initiation. Latex allergy (Sensoready pen and prefilled syringe only). Pregnancy. Nursing mothers.

Cosentyx Pharmacokinetics

Absorption

Peak mean (± SD) serum concentrations (Cmax) of 13.7 ± 4.8 mcg/mL and 27.3 ± 9.5 mcg/mL, respectively, were reached by ~6 days post dose after administration of a single SC dose of 150 mg or 300 mg secukinumab.

Patients who received the Sensoready pens were observed to have 23–30% higher mean trough concentrations vs those who received the lyophilized powder and 23–26% higher than those who received the prefilled syringe.

Steady-state concentrations were achieved by Week 24 after the every 4-week dosing regimens.

Bioavailability ranged from 55–77%.

Distribution

Mean volume of distribution: 7.10–8.60 L.

 

Metabolism

Catabolic pathways.

Elimination

Half-life: 22–31 days. Mean systemic clearance: 0.14–0.22 L/day.

Cosentyx Interactions

Interactions

Concomitant live vaccines: not recommended. Non-live vaccines: may get suboptimal response. Concomitant CYP450 substrates with a narrow therapeutic index (eg, warfarin, cyclosporine); monitor and consider adjusting dose.

Cosentyx Adverse Reactions

Adverse Reactions

Nasopharyngitis, diarrhea, upper respiratory tract infection; inflammatory bowel disease, hypersensitivity reactions, other serious infections.

Cosentyx Clinical Trials

See Literature

Cosentyx Note

Not Applicable

Cosentyx Patient Counseling

See Literature

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