Secukinumab Subcutaneous

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 secukinumab, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to secukinumab 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.

Pediatric

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

Geriatric

Although 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.

Pregnancy

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.

Interactions with 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 secukinumab, 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 secukinumab 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.

• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Alfentanil
• Aminophylline
• Artemether
• Astemizole
• Bacillus of Calmette and Guerin Vaccine, Live
• Carbamazepine
• Cisapride
• Cyclosporine
• Dihydroergotamine
• Ergotamine
• Fentanyl
• Fosphenytoin
• Iloperidone
• Influenza Virus Vaccine, Live
• Lumefantrine
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Paclitaxel
• Phenytoin
• Pimozide
• Poliovirus Vaccine, Live
• Quinidine
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Sirolimus
• Smallpox Vaccine
• Tacrolimus
• Terfenadine
• Theophylline
• Typhoid Vaccine
• Varicella Virus Vaccine
• Warfarin
• Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

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 secukinumab. 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 secukinumab.

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:

• Fever
• headache
• muscle aches
• sore throat
• stuffy or runny nose
• unusual tiredness or weakness

• Body aches or pain
• chills
• cough
• difficulty with breathing
• ear congestion
• hives or welts, itching, or skin rash
• loss of voice
• redness of the skin

• Diarrhea
• difficulty with swallowing
• dizziness
• fast heartbeat
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rectal bleeding
• severe diarrhea
• severe stomach pain
• tightness in the chest
• weight loss

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.

This medication is used to treat plaque psoriasis and certain types of arthritis (such as arthritis of the spine, psoriatic arthritis). Secukinumab belongs to a class of drugs known as monoclonal antibodies. It works by blocking a certain natural protein in your body (interleukin-17A) that may cause inflammation and swelling.

How to use Secukinumab Syringe

Read the Medication Guide and the Instructions for Use leaflet provided by your pharmacist before you start using secukinumab and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Before treatment with this medication, your doctor will test you for tuberculosis (TB). Your doctor should also monitor you for symptoms of TB during and after treatment with this drug. If needed, treatment for tuberculosis or other infections should be given before receiving this medication.

This medication is given by injection under your skin as directed by your doctor. The injection is given in the upper arms, thighs, or abdomen (at least 2 inches from your belly button). The dosage is based on your medical condition and response to treatment. Follow your doctor's instructions carefully.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product instructions. Wash your hands before using this medication. Remove the medication from the refrigerator 15 to 30 minutes before you inject it to allow it to reach room temperature. Do not shake the medication. The medication should be clear or slightly yellow. Before using, check this product visually for cloudiness, particles, or discoloration. If you see any of these things, do not use the liquid. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject the drug into areas of the skin with scars or stretch marks or into skin that is irritated, sore, bruised, red, hardened, or affected by psoriasis. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely. Do not reuse syringes.

Use this medication regularly to get the most benefit from it. It may help to mark your calendar with a reminder.

Tell your doctor if your condition does not improve or if it worsens.

Before using secukinumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as latex found in the needle cover on the prefilled syringe/pen), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: current/recent/returning infection (such as tuberculosis, herpes), bowel disease (such as Crohn's disease, ulcerative colitis).

Secukinumab can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as complete blood count) may be performed periodically to monitor your progress or to check for side effects. Consult your doctor for more details.

Missed Dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule. Do not double the dose to catch up.

Storage

Store in the refrigerator. Do not freeze. Keep the product in the original carton to protect from light until the time of use. The medication should be used within 1 hour after taking it out of the refrigerator. Discard any unused portion after use.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.