Pronunciation:

sek-ue-KIN-ue-mab

Brand Names:

• Cosentyx

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antipsoriatic

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Secukinumab injection is used to treat moderate to severe plaque psoriasis in patients who may benefit from receiving phototherapy (ultraviolet light treatment) or other treatments. It is also used alone or together with other medicines (eg, methotrexate) to treat active psoriatic arthritis.

Secukinumab injection is also used to treat active ankylosing spondylitis, non-radiographic axial spondyloarthritis (a type of arthritis in the spine) with objective signs of swelling, and enthesitis-related arthritis.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of secukinumab prefilled syringe or pen in children younger than 6 years of age with plaque psoriasis, in children younger than 4 years of age weighing less than 15 kilograms (kg) with enthesitis-related arthritis, and in children younger than 2 years of age weighing less than 15 kg with psoriatic arthritis. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of secukinumab vial in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies on the relationship of age to the effects of secukinumab injection have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abatacept
• Adenovirus Vaccine, Live
• Anifrolumab-fnia
• Bacillus of Calmette and Guerin Vaccine, Live
• Baricitinib
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Ebola Zaire Vaccine, Live
• Influenza Virus Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine, Live Non-Replicating
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Inflammatory bowel disease (eg, Crohn disease or ulcerative colitis)—Use with caution. May make this condition worse.

• Infection, or history of—Secukinumab is not recommended for patients with an active infection, including tuberculosis. Caution should be used if you have a chronic infection or history of a recurring infection.

• Tuberculosis infection, inactive—Should be treated first before starting therapy with this medicine.

Proper Use of This Medicine:

Vial: A nurse or other trained health professional will give you or your child this medicine in a medical facility. It is given through an IV that is placed in one of your veins to treat active ankylosing spondylitis, non-radiographic axial spondyloarthritis, or psoriatic arthritis. It must be given slowly, so the needle will have to remain in place for at least 30 minutes.

Prefilled syringe or pen: You may also be taught how to give your medicine at home. It is usually given as a shot under the skin of your stomach, thigh, or upper arm to treat ankylosing spondylitis, enthesitis-related arthritis, non-radiographic axial spondyloarthritis, plaque psoriasis, or psoriatic arthritis.

This medicine comes with a Medication Guide and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Secukinumab comes in 6 forms: a Sensoready® pen, an UnoReady® pen, a 300 mg/2 mL prefilled syringe, a 150 mg/mL prefilled syringe, a 75 mg/0.5 mL prefilled syringe for children (these 5 forms may be used at home), and vial (which is to be used only in the hospital or doctor's office). Your doctor will tell you which dosage form you should use.

You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections. Do not inject into skin areas that are red, bruised, tender, hard, or affected by psoriasis.

Allow the medicine to warm to room temperature for 15 to 30 minutes (for Sensoready® pen, 150 mg/mL prefilled syringe, and 75 mg/0.5 mL prefilled syringe) and 30 to 45 minutes (for UnoReady® pen and 300 mg/2 mL prefilled syringe) before using it.

You might not use all of the medicine in each pen or prefilled syringe. Use each pen or prefilled syringe only one time. Do not save an open pen or syringe. If the medicine in the pen or syringe has changed color, or if you see particles in it, do not use it. Do not shake the medicine.

The removable cap of the Sensoready® pen or prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start receiving this medicine.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (prefilled syringe or pen):
  • For ankylosing spondylitis:
    • Adults—150 milligrams (mg) every 4 weeks. Some patients may first receive "loading" doses of 150 mg at weeks 0, 1, 2, 3, and 4 and then begin the every-4-weeks regimen. Patients with continuing active ankylosing spondylitis may receive a dose of 300 mg every 4 weeks given as one 300 mg injection or two 150 mg injection.
    • Children—Use and dose must be determined by your doctor.
  • For enthesitis-related arthritis:
    • Adults and children 4 years of age and older weighing 50 kilograms (kg) or more—150 milligrams (mg) injected under your skin at weeks 0, 1, 2, 3, and 4. Followed by 150 mg every 4 weeks.
    • Children 4 years of age and older weighing 15 kg to less than 50 kg—75 milligrams (mg) injected under your skin at weeks 0, 1, 2, 3, and 4. Followed by 75 mg every 4 weeks.
    • Children younger than 4 years of age or weighing less than 15 kg—Use and dose must be determined by your doctor.
  • For non-radiographic axial spondyloarthritis:
    • Adults—150 milligrams (mg) every 4 weeks. Some patients may first receive "loading" doses of 150 mg at weeks 0, 1, 2, 3, and 4 and then begin the every-4-weeks regimen.
    • Children—Use and dose must be determined by your doctor.
  • For plaque psoriasis:
    • Adults—At first, 300 milligrams (mg) injected under your skin at weeks 0, 1, 2, 3, and 4. Followed by 300 mg every 4 weeks given as one 300 mg injection or two 150 mg injection. Some patients may receive a dose of 150 mg.
    • Children 6 years of age and older weighing 50 kilograms (kg) or more—150 milligrams (mg) injected under your skin at weeks 0, 1, 2, 3, and 4. Followed by 150 mg every 4 weeks.
    • Children 6 years of age and older weighing less than 50 kg—75 milligrams (mg) injected under your skin at weeks 0, 1, 2, 3, and 4. Followed by 75 mg every 4 weeks.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
  • For psoriatic arthritis:
    • Adults—150 milligrams (mg) injected under your skin every 4 weeks. Some patients may first receive "loading" doses of 150 mg at weeks 0, 1, 2, 3, and 4, and then begin the every-4-weeks regimen. Patients with continuing active psoriatic arthritis may receive a dose of 300 mg every 4 weeks given as one 300 mg injection or two 150 mg injection. Patients who also have moderate to severe plaque psoriasis should receive the dose for plaque psoriasis.
    • Children 2 years of age and older weighing 50 kilograms (kg) or more—150 milligrams (mg) injected under your skin at weeks 0, 1, 2, 3, and 4. Followed by 150 mg every 4 weeks.
    • Children 2 years of age and older weighing 15 kg to less than 50 kg—75 milligrams (mg) injected under your skin at weeks 0, 1, 2, 3, and 4. Followed by 75 mg every 4 weeks.
    • Children younger than 2 years of age or weighing less than 15 kg—Use and dose must be determined by your doctor.

Missed dose—

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Keep the medicine in the original carton until you are ready to use it. This medicine may be stored for up to 4 days at room temperature if removed from the refrigerator. Throw the medicine away if it has been stored at room temperature for more than 4 days. Write the date the medicine is removed from and returned to the refrigerator. This medicine may be returned to the refrigerator once and then stored in the refrigerator until used or expired.

Do not reuse syringes and needles. Put used syringes and needles in a puncture-resistant disposable container, or dispose of them as directed by your doctor.

Precautions While Using This Medicine:

It is very important that the doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause you to get infections more easily (eg, mouth, skin, or upper respiratory tract infections). It is important to check with your doctor if you have fever or chills, cough or hoarseness, lower back or side pain, painful or difficult urination, runny or stuffy nose, skin itching or scaling, or sores or white patches on your lips, mouth, or throat.

You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis test or been exposed to tuberculosis.

Inflammatory bowel disease may occur while you are using this medicine. Tell your doctor right away if you have rectal bleeding, severe stomach pain, or severe diarrhea while using this medicine.

This medicine may cause serious skin reactions, including atopic dermatitis-like eruptions, dyshidrotic eczema, and erythroderma. Check with your doctor right away if you have blistering, crusting, dryness, irritation, itching, peeling, redness, scaling, or swelling of the skin.

This medicine may cause serious allergic reactions including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

While you are being treated with secukinumab, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Secukinumab may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Bladder pain

bloody or cloudy urine

burning feeling in the chest or stomach

difficult, burning, or painful urination

fever

frequent urge to urinate

headache

indigestion

loss of appetite

lower back or side pain

muscle aches

nausea or vomiting

passing of gas

rectal bleeding

sore throat

stomach pain, cramps, fullness, discomfort, tenderness, or upset

stuffy or runny nose

unusual tiredness or weakness

watery or bloody diarrhea

Less common

Body aches or pain

chills

cough or hoarseness

difficulty with breathing or swallowing

dryness of the throat

ear congestion

hives or welts, itching, or skin rash

loss of voice or voice changes

painful cold sores or blisters on the lips

redness, scaling of the skin

sore mouth or tongue

tender, swollen glands in the neck

white patches in the mouth or on the tongue

Rare

Severe diarrhea

weight loss

Incidence not known

Blistering, crusting, irritation, itching, reddening, peeling, or swelling of the skin

chest tightness

cracked, dry, scaly skin

dizziness

fast heartbeat

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

skin feels like leather

small bumps or patches

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.