Secukinumab

Secukinumab (Cosentyx) is a prescription medication used to treat types of plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, enthesitis-related arthritis, hidradenitis suppurativa (HS), and non-radiographic axial spondyloarthritis, which are autoimmune conditions. Secukinumab is a monoclonal antibody that targets interleukin-17A (IL-17A), a protein involved in the inflammatory process. Secukinumab helps reduce inflammation and related symptoms by blocking IL-17A.

Secukinumab brand name is Cosentyx by Novartis Pharmaceuticals Corporation.

Secukinumab is from the drug class interleukin (IL) inhibitors.

Secukinumab can be given as an injection under the skin (subcutaneous injection) for all conditions or as an intravenous infusion by your HCP for psoriatic arthritis (PsA), ankylosing spondylitis (AS), or non-radiographic axial spondyloarthritis (nr-axSPA). Secukinumab is often given as a weekly dose for the first 4 weeks, then monthly thereafter, however, the dose schedule may vary with age, administration type, or condition being treated.

Secukinumab FDA approval was received on January 21, 2015, for plaque psoriasis, and since then, other autoimmune conditions have been included. FDA approved secukinumab brand name is Cosentyx by Novartis Pharmaceuticals Corporation.

Secukinumab may improve your symptoms, but it may also lower the ability of your immune system to fight infections.

Secukinumab is an FDA-approved medicine used to treat:

• Plaque psoriasis that is moderate to severe that covers large or many areas of the body for 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.
• Active ankylosing spondylitis in adults and children 12 years of age and older.
• Active non-radiographic axial spondyloarthritis (nr-axSpA) in adults who have objective signs of inflammation.
• Active enthesitis-related arthritis (ERA) in patients 4 years of age and older.
• Hidradenitis suppurativa (HS) that is a moderate to severe disease in adults and pediatric patients 12 years and older.

The secukinumab mechanism of action is as an IL-17A blocker. Cosentyx works by targeting and blocking IL-17A, which helps calm down the immune system, reducing inflammation and improving symptoms.

In autoimmune conditions, the overactive immune system produces too much IL-17A, a protein that is believed to play a role in inflammation, pain, and damage, which causes the symptoms of these conditions.

Secukinumab subcutaneous injection can be self-administered or administered by a caregiver in your own home. Pediatric patients should not self-administer this medicine, an adult caregiver can inject this medicine after proper training in subcutaneous injection technique.

Use secukinumab exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Ask your doctor or pharmacist if you don't understand how to use an injection.

Secukinumab can also be administered as an intravenous infusion by your healthcare professional (HCP) for psoriatic arthritis (PsA), ankylosing spondylitis (AS), or non-radiographic axial spondyloarthritis (nr-axSPA). Cosentyx intravenous infusion should be administered over a period of 30 minutes

Subcutaneous secukinumab

Secukinumab for self-administration at home is injected under the skin (subcutaneous injection).

• Take the injection pen out of the refrigerator and let it reach room temperature for 15 to 30 minutes before use. Give the injection within 1 hour after removing the medicine from the refrigerator. Do not try to warm the medication by heating it in a microwave, placing it in hot water, or through any other method.
• Prepare an injection only when you are ready to give it. You may need to use 2 injections to get your total dose.
• The solution should be clear or light-yellow. Call your pharmacist if the liquid in your vial, pen, or syringe looks cloudy, has changed colors, or has particles in it.
• Do not shake the syringe or dosing pen.
• The injection can be given anywhere on the front of your thighs (upper leg), upper outer arms, or abdomen (stomach) except your navel and the area 2 inches (5 centimeters) around it. Do not inject into the same place two times in a row. Avoid injecting into the skin that is hard, red, bruised, swollen, tender, or affected by psoriasis.
• Throw away a prefilled syringe or injection pen after one use, even if there is still medicine left inside.
• Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of them following state or local laws. Keep out of the reach of children and pets.

You may get infections more easily, even serious infections. You will need frequent medical tests.

See the detailed “Instructions for Use” which for information and diagrams on how to prepare and inject a dose of secukinumab and how to properly throw away (dispose of) used secukinumab Sensoready pen and prefilled syringes.

You may get infections more easily while using secukinumab, as it lowers your immune system's ability to fight infections. Call your doctor right away if you have signs of infection such as fever, chills, sweats, muscle aches, skin sores, stomach pain, diarrhea, burning when you urinate, weight loss, cough, shortness of breath, or a cough with red or pink mucus.

Tell your doctor if you have an active infection or have ever been diagnosed with tuberculosis or inflammatory bowel disease before using this medicine.

You should not use secukinumab if you are allergic to it or any of the inactive ingredients contained in the medicine.

Tell your doctor if you've had or been exposed to tuberculosis, or if you recently traveled. Some infections are more common in certain parts of the world, and you may have been exposed during travel.

To make sure you can safely use secukinumab, tell your doctor if you have ever had:

• an active or chronic infection, including hepatitis B;
• inflammatory bowel disease (Crohn's disease or ulcerative colitis);
• an allergy to latex (the removal cap on the Sensoready pen and prefilled syringes contains natural rubber latex, which may cause an allergic reaction in people sensitive to latex), or
• if you currently have signs of infection such as fever, sweats, chills, muscle pain, cough, shortness of breath, cough with bloody mucus, weight loss, skin sores, stomach pain, diarrhea, or painful urination.

Make sure you are current on all vaccines before you start using this medicine. You should not have any vaccinations during your treatment with secukinumab without first talking to your doctor.

Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if secukinumab can harm your unborn baby. You and your healthcare provider should decide if you will use this medicine.

Breastfeeding

Tell your doctor or healthcare professional if you are breastfeeding or plan to breastfeed. It is not known if secukinumab passes into your breast milk.

Secukinumab pregnancy and breastfeeding warnings (more detail)

Common secukinumab side effects

Common secukinumab side effects may include diarrhea or cold symptoms such as stuffy nose, sneezing, and sore throat.

Serious secukinumab side effects

Get emergency medical help if you have signs of an allergic reaction to secukinumab, including hives; chest tightness, difficulty breathing; feeling like you might pass out; and swelling of your face, lips, tongue, or throat.

Call your doctor right away if you have signs of infection such as

• redness, warmth, or painful sores on your skin;
• cough, shortness of breath, cough with red or pink mucus;
• increased urination, burning when you urinate;
• sores or white patches in your mouth or throat (yeast infection or "thrush");
• new or worsening diarrhea or stomach pain; or
• fever, chills, sweating, muscle pain, weight loss.

Further doses may be delayed until your infection clears up.

Tell your doctor if you develop severe skin reactions that look like eczema, such as redness, rash, itching, dry or leathery skin, blisters, or skin peeling.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Secukinumab is supplied as a Cosentyx Sensoready pen, Cosentyx prefilled syringe, or Cosentyx single-dose vial.

Intravenous dosing (administered by a healthcare provider)

Intravenous dosing can be used for psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis. Dilute before use. Administer infusion over 30 minutes.

• With a loading dose: 6 mg/kg initially at week 0 followed by 1.75 mg/kg every 4 weeks thereafter (maximum 300mg per infusion).
• Without a loading dose: 1.75 mg/kg every 4 weeks (maximum 300mg per infusion).

Subcutaneous Dosing

Usual Adult Secukinumab Dose for Plaque Psoriasis

Dose:

• 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.
• For some patients, a dose of 150 mg subcutaneously may be acceptable.

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

Usual Pediatric Secukinumab Dose for Plaque Psoriasis (6 years and older)

Dose:

• Dose is based on body weight, given by subcutaneous injection at Weeks 0, 1, 2, 3, and 4, followed by dosing every 4 weeks.
• Body weight less than 50kg: recommended dose is 75mg.
• Body weight is greater than or equal to 50kg: recommended dose 150mg.
• Safety and effectiveness of Cosentyx in pediatric patients with plaque psoriasis below the age of 6 years have not been established.

Use: Moderate to severe plaque psoriasis in pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy.

Usual Adult Dose for Psoriatic Arthritis

Dose:

• With a loading dose: 150 mg subcutaneously at weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter.
• Without a loading dose: 150 mg subcutaneously every 4 weeks; if the patient continues to have active psoriatic arthritis, consider increasing the dose to 300 mg subcutaneously every 4 weeks.

Comments:

• For psoriatic arthritis patients with coexistent moderate to severe plaque psoriasis, use the dosage for plaque psoriasis.
• This drug may be administered with or without methotrexate.

Use: Active psoriatic arthritis.

Usual Pediatric Dose for Psoriatic Arthritis (2 years and older)

Dose:

• Dose is based on body weight, given by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 followed by dosing every 4 weeks.
• Body weight 15 kg to less than 50kg: recommended dose is 75mg
• Body weight is greater than or equal to 50kg: recommended dose 150mg.
• The safety and effectiveness of Cosentyx in pediatric patients below the age of 2 years and with a body weight of less than 15 kg (33 pounds) have not been established.

Comment: This drug may be administered with or without methotrexate.

Use: Active psoriatic arthritis in patients 2 years and older.

Usual Adult Dose for Ankylosing Spondylitis

Dose:

• With a loading dose: 150 mg subcutaneously at weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter.
• Without a loading dose: 150 mg subcutaneously every 4 weeks.

Comment: If a patient continues to have active AS, consider a dosage of 300 mg every 4 weeks.

Uses: For active ankylosing spondylitis.

Usual Adult Dose for Non-Radiographic Axial Spondyloarthritis

Dose:

• 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

Use: Active non-radiographic axial spondyloarthritis (nr-axSpA) in adult patients who have objective signs of inflammation.

Usual Dose for Enthesitis-Related Arthritis

Dose:

• Dose is based on body weight, given by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 followed by dosing every 4 weeks.
• Body weight 15 kg to less than 50kg: the recommended dose is 75mg
• Body weight is greater than or equal to 50kg: recommended dose 150mg.

Use: Active enthesitis-related arthritis (ERA) in patients 4 years of age and older.

Usual Dose for Hidradenitis Suppurativa:

Adult Dose:

• 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.

Pediatric Patients 12 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 ≥ 30 kg and < 90 kg, the dose is 150 mg. For patients ≥ 90 kg, the dose is 300 mg.

Use: moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years and older.

Subcutaneous Injection

• Cosentyx Sensoready pen: 150 mg/mL single dose.
• Cosentyx UnoReady pen and single-dose prefilled syringe: 300 mg/2 mL.
• Cosentyx prefilled syringe (for pediatric patients less than 50 kg): 75 mg/0.5 mL single dose.

Intravenous Infusion

• Cosentyx injection: 125 mg/5 mL in a single-dose vial (healthcare professional use only)

Call your doctor for instructions if you miss a dose of Cosentyx.

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

HCPs and patients often use the Secukinumab Package Insert (PI) - Cosentyx for more detailed information about this medicine. The Package Insert contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your HCP (health care professional). This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called Secukinumab Prescribing Information (PI) or FDA label.

Secukinumab J code is J3247 (1 mg, intravenous).J codes are used for medicines that are not taken orally and include injections, inhalations, and chemotherapies. J codes are important for accurate and consistent coding for billing and reimbursement purposes.

The secukinumab J code is only required for the intravenous infusion.

Your physician will need the Secukinumab J code when filling out forms for your treatment.

Avoid receiving a "live" vaccine. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

Secukinumab may interact with other products, so tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take and keep a list to show your healthcare provider and pharmacist when you start a new medicine or stop a regular medicine.

When starting or stopping this medicine for patients who are receiving a CYP450 substrate medicine, particularly those with a narrow therapeutic index, your therapeutic effect or drug concentration may be monitored, and you may need to have a dosage adjustment of the CYP450 substrate. Not all possible interactions are listed here. To check for interactions with secukinumab, click on the link below.

• Store this medicine in a refrigerator, between 36°F to 46°F (2°C to 8°C).
• Keep this medicine in the original carton until ready for use to protect from light.
• Secukinumab Sensoready pen and secukinumab 150 mg/mL secukinumab prefilled syringe may be stored at room temperature, up to 86°F (30°C), for up to 4 days.
• Write the date the Sensoready pen or 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), secukinumab Sensoready pen and 150 mg/mL prefilled syringe may be returned to the refrigerator only 1 time.
• Throw away secukinumab Sensoready pen or secukinumab 150 mg/mL prefilled syringe if it has been kept outside of the refrigerator and has not been used in over 4 days.
• Do not freeze this medicine.
• Do not shake this medicine.
• Throw away (dispose of) any unused secukinumab Sensoready pen or prefilled syringes.
• Keep all medicines out of the reach of children.

Active ingredient: secukinumab.

Inactive ingredients:

Cosentyx Sensoready pen and prefilled syringe: L-histidine/histidine hydrochloride monohydrate, L-methionine, polysorbate 80, trehalose dihydrate, and sterile water for injection.

Cosentyx Vial: L-histidine/histidine hydrochloride monohydrate, polysorbate 80, and sucrose.

Cosentyx is manufactured by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936.