Secukinumab

Secukinumab is a prescription medication used to treat Plaque Psoriasis, Psoriatic Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis. 

• Secukinumab is available under the following different brand names: Cosentyx.

Adult and pediatric dosage

• Iyophilized powder for reconstitution
• 150mg/vial

Solution for injection

• 75mg/prefilled syringe
• 150mg/prefilled syringe
• 150mg/Sensoready pen

Plaque Psoriasis

Adult dosage

• 300 mg SC at weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter
• For some patients, a dose of 150 mg may be acceptable 

Pediatric dosage

• Children younger than 6 years of age: Safety and efficacy not established
• Children 6 years of age or older: 
• Weighing less than 50 kg: 75 mg SC at weeks 0, 1, 2, 3, and 4 followed by 75 mg SC every 4 weeks
• Weighing 50 kg or over: 150 mg SC at weeks 0, 1, 2, 3, and 4 followed by 150 mg SC every 4 weeks

Psoriatic Arthritis

Adult dosage

• For patients with coexistent moderate to severe plaque psoriasis, use dosage and administration for plaque psoriasis
• With loading dose: 150 mg SC at weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter
• Without a loading dose: 150 mg SC every 4 weeks

Pediatric dosage

• Children younger than 2 years of age: Safety and efficacy not established
• Children 2 years of age or older: 
• Weight 15 kg to 50 kg: 75 mg SC at weeks 0, 1, 2, 3, and 4 followed by 75 mg SC every 4 weeks
• Weight 50 kg or over: 150 mg SC at weeks 0, 1, 2, 3, and 4 followed by 150 mg SC every 4 weeks

Ankylosing Spondylitis 

Adult dosage

• Administer with or without a loading dosage by SC injection 
• With loading dose: 150 mg SC at weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter
• Without a loading dose: 150 mg SC every 4 weeks
• If a patient continues to have active ankylosing spondylitis, consider increasing dose to 300 mg every 4 weeks

Non-radiographic Axial Spondyloarthritis

Adult dosage

• Administer with or without loading dose
• With loading dose: 150 mg SC at weeks 0, 1, 2, 3, and 4, then every 4 weeks thereafter
• Without loading dose: 150 mg SC every 4 weeks

Enthesitis-Related Arthritis

Pediatric dosage 

• Children younger than 4 years of age: Safety and efficacy not established
• Children older than 4 years of age: 
• Weight 15 kg to 50 kg: 75 mg SC at weeks 0, 1, 2, 3, and 4 followed by 75 mg SC every 4 weeks
• Weight 50 kg or over: 150 mg SC at weeks 0, 1, 2, 3, and 4 followed by 150 mg SC every 4 weeks

Dosage Considerations – Should be Given as Follows: 

• See "Dosages."

Common side effects of Secukinumab include:

• diarrhea, 
• stuffy nose, 
• sneezing, and 
• sore throat

Serious side effects of Secukinumab include:

• hives, 
• chest tightness, 
• difficult breathing, 
• lightheadedness, 
• swelling in the face or throat, 
• redness, warmth, or painful sores on the skin, 
• cough, 
• shortness of breath, 
• cough with red or pink mucus, 
• increased urination, 
• burning sensation while passing urine, 
• sores or white patches in the mouth or throat, 
• diarrhea, 
• stomach pain, 
• fever, 
• chills, 
• sweating, 
• muscle pain, and 
• weight loss

Rare side effects of Secukinumab include:

• none 

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Secukinumab has severe interactions with at least 13 other drugs.
• Secukinumab has serious interactions with at least 27 other drugs.
• Secukinumab has moderate interactions with at least 25 other drugs.
• Secukinumab has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this drug, tell your doctor or pharmacist of all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Contraindications

• Hypersensitivity 

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Secukinumab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Secukinumab?”

Cautions

• May increase risk of infections; caution when considering use in patients with chronic infection or a history of recurrent infection
• In the postmarketing setting, serious and some fatal infections reported; instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur; if a patient develops a serious infection, monitor the patient closely and discontinue therapy until infection resolves
• Evaluate patients for tuberculosis (TB) infection before initiating; do not administer with active TB; for latent TB, initiate anti-TB therapy prior to initiation of secukinumab in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed; monitor patients closely for signs and symptoms of active TB during and after treatment
• May exacerbate Crohn disease
• Anaphylaxis and cases of urticaria reported; if this occurs, discontinue secukinumab immediately and initiate anaphylaxis treatment
• Caution if latex allergic; the removable cap on the Sensoready pen and prefilled syringe contains natural rubber
• Use caution when prescribing drug to patients with inflammatory bowel disease; exacerbations, in some cases serious, reported in clinical trials in plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis
• Drug interaction overview
  • Immunizations
    • Prior to initiating therapy, consider completion of all age-appropriate immunizations according to current immunization guidelines
    • Patients treated with secukinumab should not receive live vaccines
    • Nonlive vaccines received during a course of secukinumab may not elicit an immune response sufficient to prevent disease
    • Therapy may alter a patient's immune response to live vaccines; avoid use of live vaccines in patients receiving treatment
• CYP450 substrates
  • CYP450 enzymes are suppressed by increased levels of cytokines (e.g., IL-1, IL-6, IL-10, TNF-alpha) during chronic inflammation
  • Results from a drug-drug interaction study in patients with moderate-to-severe psoriasis showed no clinically relevant interaction for drugs metabolized by CYP3A4.
  • Upon initiation or discontinuation of secukinumab in patients taking CYP450 substrates with narrow therapeutic indices, consider monitoring for therapeutic effect or drug concentration; adjust dose as needed

Pregnancy and Lactation

• Limited available human data regarding use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. 
• Unknown if excreted in human milk or absorbed systemically after ingestion; data are unavailable regarding effects on breastfed children or milk production.