Secukinumab
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 that is involved in normal inflammatory and immune responses. Secukinumab inhibits the release of proinflammatory cytokines and chemokines.
COSENTYX is a human interleukin-17A antagonist indicated for the treatment of:
- moderate to severe plaque psoriasis (PsO) in patients 6 years and older who are candidates for systemic therapy or phototherapy.
- active psoriatic arthritis (PsA) in patients 2 years of age and older.
- adults with active ankylosing spondylitis (AS).
- adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.
- active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older.
- adults with moderate to severe hidradenitis suppurativa (HS).
- Prior to COSENTYX initiation, complete all age-appropriate vaccinations, evaluate patients for tuberculosis (TB). See Full Prescribing Information for instructions on preparation and administration of COSENTYX.
- Administration of Intravenous Formulation: COSENTYX for intravenous use must be diluted prior to administration. Administer as an intravenous infusion after dilution over a period of 30 minutes.
- Plaque Psoriasis:
- Subcutaneous Dosage in Adults: Recommended dosage is 300 mg by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 followed by 300 mg every 4 weeks. For some patients, a dose of 150 mg may be acceptable.
- Subcutaneous Dosage in Pediatric Patients 6 Years and Older: Recommended weight-based dosage is administered by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter.
- For patients < 50 kg (at the time of dosing), the dose is 75 mg.
- For patients ≥ 50 kg (at the time of dosing), the dose is 150 mg.
- Psoriatic Arthritis:
Adult Patients
Subcutaneous Dosage:
-
- For PsA patients with coexistent moderate to severe PsO, use the dosage and administration for PsO.
- For other PsA patients, administer with or without a loading dosage.
- With a loading dosage: 150 mg at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter
- Without a loading dosage: 150 mg every 4 weeks
- If a patient continues to have active PsA, consider a dosage of 300 mg every 4 weeks.
Intravenous Dosage:
The recommended intravenous dosages are:
-
- With a loading dosage: 6 mg/kg given at Week 0 as a loading dose, followed by 1.75 mg/kg every 4 weeks thereafter (max. maintenance dose 300 mg per infusion).
- Without a loading dosage: 1.75 mg/kg every 4 weeks (max. maintenance dose 300 mg per infusion).
Pediatric Patients 2 Years and Older
Subcutaneous Dosages: Administer by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter:
-
- For patients ≥ 15 kg and < 50 kg the dose is 75 mg.
- For patients ≥ 50 kg the dose is 150 mg.
- Ankylosing Spondylitis:
Subcutaneous Dosage:
Administer with or without a loading dosage.
The recommended dosages are:
-
- With a loading dosage: 150 mg at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter.
- Without a loading dosage: 150 mg every 4 weeks.
- If a patient continues to have active ankylosing spondylitis, consider a dosage of 300 mg every 4 weeks.
Intravenous Dosage:
The recommended intravenous dosages are:
-
- With a loading dosage: 6 mg/kg given at Week 0 as a loading dose, followed by 1.75 mg/kg every 4 weeks thereafter (max. maintenance dose 300 mg per infusion).
- Without a loading dosage: 1.75 mg/kg every 4 weeks (max. maintenance dose 300 mg per infusion).
- Non-Radiographic Axial Spondyloarthritis:
Subcutaneous Dosage:
Administer with or without a loading dosage. The recommended dosage is:
-
- With a loading dosage: 150 mg at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter.
- Without a loading dosage: 150 mg every 4 weeks.
Intravenous Dosage:
The recommended intravenous dosages are:
-
- With a loading dosage: 6 mg/kg given at Week 0 as a loading dose, followed by 1.75 mg/kg every 4 weeks thereafter (max. maintenance dose 300 mg per infusion).
- Without a loading dosage: 1.75 mg/kg every 4 weeks (max. maintenance dose 300 mg per infusion).
- Enthesitis-Related Arthritis: Recommended weight-based dosage is administered by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter.
- For patients ≥ 15 kg and < 50 kg the dose is 75 mg.
- For patients ≥ 50 kg the dose is 150 mg.
- Hidradenitis Suppurativa: Recommended dosage is 300 mg administered by subcutaneous injection at Weeks 0, 1, 2, 3 and 4 and every 4 weeks thereafter. If a patient does not adequately respond, consider increasing the dosage to 300 mg every 2 weeks.
Serious hypersensitivity to secukinumab or any excipients in COSENTYX.
- Infections: Serious infections have occurred. Exercise caution when considering the use of COSENTYX in patients with a chronic infection or a history of recurrent infection. If a serious infection develops, discontinue COSENTYX until the infection resolves.
- Hypersensitivity Reactions: If an anaphylactic reaction or other serious allergic reaction occurs, discontinue COSENTYX immediately and initiate appropriate therapy.
- Tuberculosis (TB): Prior to initiating treatment with COSENTYX, evaluate for TB.
- Inflammatory Bowel Disease (IBD): Cases of IBD were observed in clinical trials. Exercise caution when prescribing COSENTYX to patients with IBD.
- Eczematous Eruptions: Cases of severe eczematous eruptions have occurred in patients receiving COSENTYX.
- Immunizations: Avoid use of live vaccines in patients treated with COSENTYX.