Cosentyx

The most common side effects of secukinumab are:

• Cold symptoms
• Diarrhea
• Upper respiratory tract infections

Secukinumab may reduce the ability of the immune system to fight infections, increasing the risk of infections such as tuberculosis (TB), and infections caused by bacteria, fungi, or viruses. It also may cause a flare up of Crohn's disease. The cap of the Sensoready pen and the prefilled syringe in which secukinumab is packaged contains natural rubber latex which may cause an allergic reaction in latex-sensitive people.

Live vaccines should not be administered to patients treated with secukinumab because they may develop active disease from the live viruses contained in the vaccine because of their weakened immune system. Vaccine containing killed virus may not generate an adequate immune response because secukinumab suppresses the immune system.

• Solution for injection: 150 mg in Sensoready Pen or single use prefilled syringe
• Powder for injection: 150 mg single use vial

Secukinumab Sensoready pens, prefilled syringes and vials must be refrigerated at 2 C to 8 C (36 F to 46 F). They should not be frozen and should be kept in their original cartons to protect them from light until the time of administration.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

Moderate-to-severe plaque psoriasis

The recommended dose of Cosentyx (secukinumab) for the treatment of moderate-to-severe plaque psoriasis is 300 mg by subcutaneous injection on weeks 0, 1, 2, 3, and 4, followed by every 4 weeks thereafter. For some patients, a dose of 150 mg would be appropriate. 

Psoriatic arthritis

• The recommended dose of Cosentyx (secukinumab) for the treatment of psoriatic arthritis with moderate to severe plaque psoriasis is the same dose used to treat moderate to severe plaque psoriasis. 
• For other psoriatic arthritis patients administer with or without a loading dosage. The recommended dosage:
  • With a loading dosage is 150 mg at weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter
  • Without a loading dosage is 150 mg every 4 weeks
  • If a patient continues to have active psoriatic arthritis, consider a dosage of 300 mg

Ankylosing spondylitis

The recommended dose of Cosentyx (secukinumab) for the treatment of ankylosing spondylitis is:

• With a loading dosage is 150 mg at weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter
• Without a loading dosage is 150 mg every 4 weeks

• Store Cosentyx under refrigeration.
• Cosentyx should be kept in its original carton to protect it from light 
• Keep this and all medicines out of the reach of children.

You should not use secukinumab if you are allergic to it.

Tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.

To make sure secukinumab is safe for you, tell your doctor if you have:

• an active or recent infection;

• Crohn's disease; or

• tuberculosis (or if you have close contact with someone who has tuberculosis).

This medicine is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether secukinumab passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Absorption

Bioavailability

Bioavailability is 55–77% following sub-Q administration.1

Peak serum concentrations achieved by approximately 6 days following sub-Q administration of secukinumab 150 or 300 mg.1

Steady-state concentrations achieved by week 24 following sub-Q administration of secukinumab every 4 weeks.1

Cross-study comparisons suggest that administration by injection pen may result in higher trough concentrations (23–26% higher compared with prefilled syringe or 23–30% higher compared with sub-Q injection of reconstituted powder).1 10

Concentrations in interstitial fluid in lesional and nonlesional skin of patients with plaque psoriasis were 27–40% of those in serum at 1 and 2 weeks after a single 300-mg sub-Q dose.1

Pharmacokinetics are dose proportional over a sub-Q dose range of 25–300 mg.1

Special Populations

Serum concentrations higher in patients with lower body weight than in those with higher body weight.10

Distribution

Extent

Not known whether distributed into human milk.1

Special Populations

Volume of distribution increases as body weight increases.1

Elimination

Metabolism

Metabolic pathway not characterized.1

Expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.1

Half-life

22–31 days.1

Special Populations

Pharmacokinetics not formally studied in renal or hepatic impairment.1

Population analysis suggests age does not substantially affect clearance in adults with plaque psoriasis.1 Clearance appears to be similar in patients ≥65 years of age and younger adults.1

Clearance increases as body weight increases.1

• Binds to IL-17A and inhibits interaction with the IL-17 receptor.1 2 4 11

• Neutralizes biologic activity of IL-17A and inhibits release of proinflammatory cytokines, chemokines, and mediators of tissue damage.1 2 4 11

• Elevated levels of IL-17A found in psoriatic lesions and blood of individuals with psoriasis.1 4 7 13

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Signs of a common cold.
• Nose or throat irritation.
• Loose stools (diarrhea).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Store in a refrigerator. Do not freeze.
• Store in original container.
• Protect from light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Drug interaction trials have not been conducted with Cosentyx.

     Live Vaccines

Patients treated with Cosentyx may not receive live vaccinations [see Warnings and Precautions (5.6)].

     Non-Live Vaccines

Patients treated with Cosentyx may receive non-live vaccinations. Healthy individuals who received a single 150 mg dose of Cosentyx 2 weeks prior to vaccination with a non-U.S. approved group C meningococcal polysaccharide conjugate vaccine and a non-U.S. approved inactivated seasonal influenza vaccine had similar antibody responses compared to individuals who did not receive Cosentyx prior to vaccination. The clinical effectiveness of meningococcal and influenza vaccines has not been assessed in patients undergoing treatment with Cosentyx [see Warnings and Precautions (5.6)].

     CYP450 Substrates

A role for IL-17A in the regulation of CYP450 enzymes has not been reported. The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g., IL-1, IL-6, IL-10, TNFα, IFN) during chronic inflammation. Thus, Cosentyx, an antagonist of IL-17A, could normalize the formation of CYP450 enzymes. 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 (e.g., for warfarin) or drug concentration (e.g., for cyclosporine) and consider dosage modification of the CYP450 substrate.

     How Supplied

Cosentyx Sensoready pen:

• NDC 0078-0639-41: Carton of two 150 mg/mL (300 mg dose) Sensoready pens (injection)
• NDC 0078-0639-68: Carton of one 150 mg/mL single-use Sensoready pen (injection)

Cosentyx prefilled syringe:

• NDC 0078-0639-98: Carton of two 150 mg/mL (300 mg dose) single-use prefilled syringes (injection)
• NDC 0078-0639-97: Carton of one 150 mg/mL single-use prefilled syringe (injection)

The removable cap of the Cosentyx Sensoready pen and prefilled syringe contains natural rubber latex. Each Sensoready pen and prefilled syringe is equipped with a needle safety guard.

Cosentyx vial (for healthcare professional use only):

• NDC 0078-0657-61: Carton of one 150 mg lyophilized powder in a single-use vial (for injection)

     Storage and Handling

Cosentyx Sensoready pens, prefilled syringes and vials must be refrigerated at 2ºC to 8ºC (36ºF to 46ºF). Keep the product in the original carton to protect from light until the time of use. Do not freeze. To avoid foaming do not shake. Cosentyx does not contain a preservative; discard any unused portion.

Advise the patient to read FDA-approved patient labeling [Medication Guide and Instructions for Use].

Patient Counseling

Instruct patients to read the Medication Guide before starting Cosentyx therapy and to reread the Medication Guide each time the prescription is renewed.

Advise patients of the potential benefits and risks of Cosentyx.

Infections

Inform patients that Cosentyx may lower the ability of their immune system to fight infections. Instruct patients of the importance of communicating any history of infections to the doctor and contacting their doctor if they develop any symptoms of infection [see Warnings and Precautions (5.1)].

Hypersensitivity

Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [see Warnings and Precautions (5.4)].

Instruction on Injection Technique

Perform the first self-injection under the supervision of a qualified healthcare professional. If a patient or caregiver is to administer Cosentyx, instruct him/her in injection techniques and assess their ability to inject subcutaneously to ensure the proper administration of Cosentyx [see Medication Guide and Instructions for Use].

Instruct patients or caregivers in the technique of proper syringe and needle disposal, and advise them not to reuse these items. Instruct patients to inject the full amount of Cosentyx (1 or 2 subcutaneous injections of 150 mg) according to the directions provided in the Medication Guide and Instructions for Use. Dispose of needles, syringes and pens in a puncture-resistant container.

Manufactured by:
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936

US License No. 1244

© Novartis

T2016-01
January 2016

INSTRUCTIONS FOR USE

CosentyxTM (koe-sen’-tix)

(secukinumab)

For Injection

The following information is intended for medical or healthcare professionals only.

IMPORTANT:

• The single-use vial contains 150 mg of Cosentyx for reconstitution with Sterile Water for Injection (SWFI). Do not use the vial after the expiry date shown on the outer box or vial. If it has expired, return the entire pack to the pharmacy.
• The preparation of the solution for subcutaneous injection shall be done without interruption ensuring that aseptic technique is used. The preparation time from piercing the stopper until end of reconstitution on average takes 20 minutes and should not exceed 90 minutes.
• Throw away (dispose of) the used syringe right away after use. Do not re-use a syringe. See “How should I dispose of a used syringe?” at the end of this Instructions for Use.

How should I store Cosentyx?

• Store the vial of Cosentyx in the refrigerator between 2°C to 8°C (36°F to 46°F).

To prepare Cosentyx 150 mg for injection, please adhere to the following instructions:

Instructions for reconstitution of Cosentyx 150 mg for injection:

INSTRUCTIONS FOR USE

CosentyxTM (koe-sen’-tix)

(secukinumab)

Injection

Prefilled Syringe

Be sure that you read, understand, and follow this Instructions for Use before injecting Cosentyx. Your healthcare provider should show you how to prepare and inject Cosentyx properly using the prefilled syringe before you use it for the first time. Talk to your healthcare provider if you have any questions.

Important:

• Do not use the Cosentyx prefilled syringe if either the seal on the outside carton or the seal of the blister are broken. Keep the Cosentyx prefilled syringe in the sealed carton until you are ready to use it.
• Inject Cosentyx within 1 hour after taking it out of the refrigerator.
• Do not shake the Cosentyx prefilled syringe.
• The needle caps of the prefilled syringes contain latex. Do not handle the prefilled syringes if you are sensitive to latex.
• The prefilled syringe has a needle guard that will be activated to cover the needle after the injection is finished. The needle guard will help to prevent needle stick injuries to anyone who handles the prefilled syringe.
• Do not remove the needle cap until just before you give the injection.
• Avoid touching the syringe guard wings before use. Touching them may cause the syringe guard to be activated too early.
• Throw away (dispose of) the used Cosentyx prefilled syringe right away after use. Do not re-use a Cosentyx prefilled syringe. See “How should I dispose of used Cosentyx prefilled syringes?” at the end of this Instructions for Use.

How should I store Cosentyx?

• Store your carton of Cosentyx prefilled syringes in a refrigerator, between 36°F to 46°F (2°C to 8°C).
• Keep Cosentyx prefilled syringes in the original carton until ready to use to protect from light.
• Do not freeze Cosentyx prefilled syringes.

Keep Cosentyx and all medicines out of the reach of children.

INSTRUCTIONS FOR USE

CosentyxTM (koe-sen’-tix)

(secukinumab)

Injection

Sensoready® Pen

Be sure that you read, understand, and follow this Instructions for Use before injecting Cosentyx. Your healthcare provider should show you how to prepare and inject Cosentyx properly using the Sensoready Pen before you use it for the first time. Talk to your healthcare provider if you have any questions.

Important:

• Do not use the Cosentyx Sensoready Pen if either the seal on the outer carton or the seal on the pen is broken. Keep the Cosentyx Sensoready Pen in the sealed outer carton until you are ready to use it.
• Inject Cosentyx within 1 hour after taking it out of the refrigerator.
• Do not shake the Cosentyx Sensoready Pen.
• The caps of the Sensoready Pens contain latex. Do not handle the Sensoready Pens if you are sensitive to latex.
• If you drop your Cosentyx Sensoready Pen, do not use it if the Sensoready Pen looks damaged, or if you dropped it with the cap removed.
• Throw away (dispose of) the used Cosentyx Sensoready Pen right away after use. Do not re-use a Cosentyx Sensoready Pen. See “How should I dispose of used Cosentyx Sensoready Pens?” at the end of this Instructions for Use.

How should I store Cosentyx?

• Store your carton of Cosentyx Sensoready Pen in a refrigerator, between 36°F to 46°F (2°C to 8°C).
• Keep Cosentyx Sensoready Pen in the original carton until ready to use to protect from light.
• Do not freeze Cosentyx Sensoready Pen.

Keep Cosentyx and all medicines out of the reach of children.

PRINCIPAL DISPLAY PANEL

CosentyxTM

(secukinumab)

Injection

150 mg/mL

1 Prefilled Syringe

NDC 0078-0639-97

Single-use Prefilled Syringe

ATTENTION: Dispense with enclosed Medication Guide

For Subcutaneous Use Only

Sterile Solution - Contains No Preservative

Caution: Contains Natural Rubber Latex Which May Cause Allergic Reaction.

Rx only

Usual Adult Dose for Plaque Psoriasis:

300 mg subcutaneously at Weeks 0, 1, 2, 3, and 4 followed by 300 mg every 4 weeks (each 300 mg dose is given as 2 subcutaneous injections of 150 mg)

Comments:
-Each injection should be administered at a different anatomic location (such as upper arms, thighs, or any quadrant of abdomen) than the previous injection, and not into areas where the skin is tender, bruised, erythematous, indurated or affected by psoriasis.

Use: For the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Cosentyx is used to treat moderate to severe plaque psoriasis. It’s used in adults with psoriasis that covers a large area or many areas of the body.

This drug comes as a solution in a prefilled pen or prefilled syringe for injection. You or your caregiver may give this drug at home. It’s also available as a powder that’s made into a solution for injection. The solution made from a powder is only injected by a healthcare provider. Your doctor will decide which form of this drug is best for you.

Cosentyx is a brand name for the drug secukinumab. This drug is not available as a generic drug.

The more common side effects of this drug can include cold symptoms, upper respiratory infections, and diarrhea.

In some cases, Cosentyx can cause serious side effects. These include lowering the ability of your immune system to fight off infections. This side effect may increase your risk of infections.

• Infections See Details

• Live vaccines See Details

What is Cosentyx?

This drug is a prescription drug. It’s available as an injectable solution in a prefilled pen or prefilled syringe. It’s self-injectable. This means that you or your caregiver may give the drug at home. It’s also available as a powder that’s made into a solution for injection by a healthcare provider.

Cosentyx is a brand name for the drug secukinumab. This drug is not available as a generic drug.

This drug may be used as part of a combination therapy. This means you may need to take it with other medications.

Why it's used

This drug is used to treat moderate to severe plaque psoriasis. With this condition, your body makes skin cells too quickly, causing red, scaly patches of skin.

More Details

How it works

This drug belongs to a class of drugs called biologics or immunomodulators. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

More Details

Cosentyx can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Medications that might interact with this drug

Do not take these drugs with Cosentyx. Doing so can cause dangerous effects in the body. Examples of these drugs include:

• Live vaccines, such as the varicella (chickenpox) vaccine, shingles vaccine, and measles, mumps, and rubella vaccine. You shouldn’t receive live vaccines while taking this drug. Your immune system may not be strong enough to receive a live vaccine. You may be more prone to an infection. Tell your doctor if you’ve recently received or plan to receive a vaccine before starting this drug.

Taking Cosentyx with certain medications can increase or decrease the amount of the other drug in your body. This can raise your risk of side effects from these drugs or make these drugs not work as well. Examples of these drugs include:

• Warfarin. Your doctor will monitor your blood levels of warfarin. This includes your international normalized ratio (INR). Your doctor may adjust your warfarin dose.
• Cyclosporine. Your doctor will monitor your blood levels of this drug to make sure it’s at a normal level. Your doctor may adjust your cyclosporine dose.

People with infections

This drug may lower your immune system’s ability to fight off infections. This may increase your risk of infection. If you’re being treated for an infection, have an infection that doesn’t go away, or have an infection that keeps coming back, tell your doctor before starting this drug.

People with tuberculosis (TB)

If you have an active TB infection, you shouldn’t take this drug. If you have a dormant form of TB or if your doctor feels you’re at risk for TB, they may give you medications to treat TB before starting you on this drug. You should also let your doctor know if you’ve been in close contact with someone who has TB.

People with Crohn's disease

This drug can cause Crohn’s disease flare-ups. These flare-ups can be serious. Tell your doctor if your Crohn’s disease symptoms get worse while you’re taking this drug.

People with a sensitivity to latex

Let your doctor know if you’re allergic to latex. The needle cap on the pen and prefilled syringe of this drug contain latex.

Pregnant women

This drug is a category B pregnancy drug. That means two things:

1. Research in animals has not shown a risk to the fetus when the mother takes the drug.
2. There aren’t enough studies done in humans to show if the drug poses a risk to the fetus.

Talk to your doctor if you’re pregnant or planning to become pregnant. Animal studies do not always predict the way humans would respond. Therefore, this drug should only be used in pregnancy if clearly needed.

Women who are breast-feeding

It isn’t known if this drug passes into breast milk. If it does, it may cause side effects in a child who is breastfed.

Talk to your doctor if you breastfeed your child. You may need to decide whether to stop breastfeeding or stop taking this medication.

For children

This drug hasn’t been studied in children. It shouldn’t be used in people younger than 18 years.

Allergies

This drug can cause a severe allergic reaction. Symptoms can include:

• feeling faint
• swelling of your face, eyelids, lips, mouth, tongue, or throat
• trouble breathing or throat tightness
• chest tightness
• skin rash

If you have an allergic reaction, call your doctor or local poison control center right away. If your symptoms are severe, call 9-1-1 or go to the nearest emergency room.

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).