Secukinumab

What is Secukinumab?

Secukinumab (COSENTYX) is a human interleukin-17A antagonist used treatment of psoriasis, ankylosing spondylitis, psoriatic arthritis and non-radiographic axial spondyloarthritis.

What are the uses of this medicine?

• This medicine is used to treat:
• people 6 years of age and older with moderate to severe plaque psoriasis that involves large areas or many areas of the body, and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light alone or with systemic therapy)
• adults with active psoriatic arthritis
• adults with active ankylosing spondylitis
• adults with active non-radiographic axial spondyloarthritis and objective signs of inflammation

COSENTYX may improve your psoriasis, psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis but it may also lower the ability of your immune system to fight infections.

How does this medicine work?

• Secukinumab (sek" ue kin' ue mab) is a recombinant, human IgG1 monoclonal antibody to interleukin (IL)-17A, a cytokine involved in the release of proinflammatory mediators.
• The binding of the monoclonal antibody blocks the interaction of IL-17A with its receptor and thus decreases immune and inflammatory pathways. Secukinumab is considered an immunomodulatory agent and has been evaluated in several immune mediated diseases.
• In large clinical trials in severe plaque psoriasis, secukinumab was shown to be beneficial and was subsequently approved for this use in the United States in 2015.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients in COSENTYX.

What drug interactions can this medicine cause?

• Upon initiation or discontinuation of COSENTYX in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect or drug concentration and consider dosage adjustment of the CYP450 substrate as needed.

Is this medicine FDA approved?

• It was approved for use in the United States in 2015.

How should this medicine be used?

• Evaluate patients for tuberculosis (TB) infection. COSENTYX initiation is not recommended in patients with active TB infection. Initiate treatment of latent TB prior to initiation of COSENTYX.
• Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with COSENTYX.

Recommended Dosage:

Plaque Psoriasis Adults

• The recommended dosage is 300 mg by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 followed by 300 mg every 4 weeks. Each 300 mg dosage is given as 2 subcutaneous injections of 150 mg.
• For some patients, a dose of 150 mg may be acceptable.

Pediatric Patients

Recommended dosage based on body weight and administered by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter as fallows:

Body Weight at Time of Dosing	Recommended Dose
Less than 50 kg	75 mg
Greater than or equal to 50 kg	150 mg

Psoriatic Arthritis:

• For psoriatic arthritis patients with coexistent moderate to severe plaque psoriasis, use the dosage and administration for plaque psoriasis. (2.2)
• For other psoriatic arthritis 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 psoriatic arthritis, consider a dosage of 300 mg every 4 weeks.

Ankylosing Spondylitis: 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.

Non-Radiographic Axial Spondyloarthritis: 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.

Administration

• Use COSENTYX exactly as prescribed by your healthcare provider.
• COSENTYX comes in a Sensoready pen or prefilled syringes that you or your caregiver may use at home to give injections. Your healthcare provider will decide which type of COSENTYX is best for you to use at home.
• If your healthcare provider decides that you or a caregiver may give your injections of COSENTYX at home, you should receive training on the right way to prepare and inject COSENTYX. Do not try to inject COSENTYX yourself, until you or your caregiver has been shown how to inject COSENTYX by your healthcare provider.
• Children should not inject themselves with the Sensoready pen or the prefilled syringes. An adult caregiver should prepare and inject COSENTYX after receiving training on the right way to prepare and inject COSENTYX.
• Your healthcare provider will prescribe the dose of COSENTYX that is right for you or your child based on their body weight.
• If your prescribed dose of COSENTYX is 75 mg, you must give 1 injection of COSENTYX 75 mg/0.5 mL for each dose.
• If your prescribed dose of COSENTYX is 150 mg, you must give 1 injection of COSENTYX 150 mg/mL for each dose.
• If your prescribed dose of COSENTYX is 300 mg, you must give 2 injections of COSENTYX 150 mg/mL for each dose.
• COSENTYX is given as an injection under your skin (subcutaneous injection), in your upper legs (thighs) or stomach-area (abdomen) by you or a caregiver. A caregiver may also give you an injection of COSENTYX in your upper outer arm.
• Do not give an injection in an area of the skin that is tender, bruised, red or hard, or in an area of skin that is affected by psoriasis.
• Each injection should be given at a different site. Do not use the 2-inch area around your navel (belly button).
• If you inject more COSENTYX than prescribed, call your healthcare provider or go to the nearest emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 150 mg/mL solution in a single-dose Sensoready® pen and in a single-dose prefilled syringe.
• Injection: 75 mg/0.5 mL solution in a single-dose prefilled syringe (for pediatric patients).
• For Injection: 150 mg, lyophilized powder in a single-dose vial for reconstitution (for healthcare professional use only).

This medicine is available in fallowing brand namesː

• COSENTYX

What side effects can this medication cause?

The most common side effects of this medicine include:

• cold symptoms
• diarrhea
• upper respiratory infections

COSENTYX may cause serious side effects including:

• Inflammatory bowel disease
• Serious allergic reactions

What special precautions should I follow?

• COSENTYX may increase the risk of infections. Caution should be exercised 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.
• Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with COSENTYX. Avoid administration of COSENTYX to patients with active TB infection. Initiate treatment of latent TB prior to administering COSENTYX.
• Cases of inflammatory bowel disease were observed in clinical trials. Caution should be exercised when prescribing COSENTYX to patients with inflammatory bowel disease.
• Anaphylaxis and cases of urticaria occurred in COSENTYX treated subjects in clinical trials. If an anaphylactic reaction or other serious allergic reaction occurs, discontinue COSENTYX immediately and initiate appropriate therapy.
• Avoid use of live vaccines in patients treated with COSENTYX.

What to do in case of emergency/overdose?

• Doses up to 30 mg/kg intravenously have been administered in clinical trials without dose-limiting toxicity.

Management for overdosage:

• In the event of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.

Can this medicine be used in pregnancy?

• Limited available human data with COSENTYX use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes.

Can this medicine be used in children?

• The safety and effectiveness of COSENTYX have been established in pediatric subjects aged 6 years and older with moderate to severe plaque psoriasis.
• Safety and effectiveness of COSENYX in pediatric patients with plaque psoriasis below the age of 6 years have not been established.
• The safety and effectiveness of COSENTYX in pediatric patients in other indications have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: secukinumab
• Inactive ingredients: Sensoready pen and prefilled syringes: L-histidine/histidine hydrochloride monohydrate, L-methionine, polysorbate 80, trehalose dihydrate, and sterile water for injection.
• Vial: L-histidine/histidine hydrochloride monohydrate, polysorbate 80, and sucrose.

Who manufactures and distributes this medicine?

• Manufactured by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey

What should I know about storage and disposal of this medication?

• Store COSENTYX in a refrigerator, between 36°F to 46°F (2°C to 8°C).
• Keep COSENTYX in the original carton until ready for use to protect from light.
• COSENTYX Sensoready pen and COSENTYX 150 mg/mL prefilled syringe may be stored at room temperature, not to exceed temperatures above 86°F (30°C), for up to 4 days.
• Write the date COSENTYX Sensoready pen or COSENTYX 150 mg/mL prefilled syringe was removed from the refrigerator in the space provided on the carton.
• If unused and not stored above 30°C (86°F), COSENTYX Sensoready pen and 150 mg/mL prefilled syringe may be returned to the refrigerator.
• Throw away COSENTYX Sensoready pen or COSENTYX 150 mg/mL prefilled syringe if it has been kept outside of the refrigerator and not been used in over 4 days.
• Do not freeze COSENTYX.
• Do not shake COSENTYX.
• Throw away (dispose of) any unused COSENTYX Sensoready pen or prefilled syringes.
• Keep COSENTYX and all medicines out of the reach of children.

• Dailymed label info on Secukinumab
• FDA Secukinumab

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