Secukinumab

Secukinumab is an injectable biologic drug that suppresses the immune system and is used for the treatment of psoriasis. It is an antibody that binds to interleukin 17A (IL-17A), a chemical produced by cells in the body that stimulates immune reactions. Scientists believe that psoriasis is caused by an increase in the production of T-lymphocytes in response to the attachment of a stimulant, such as interleukin, to the lymphocyte. Stimulated T-lymphocytes cause skin cells to grow rapidly, and the rapid growth of the skin cells produces the skin plaques of psoriasis. Secukinumab reduces symptoms of psoriasis (inflammation and excessive production of skin cells) by attaching to IL-17A, preventing it from binding and activating T-lymphocytes. The FDA approved secukinumab in January, 2015.

Secukinumab is an immunosuppressant that reduces the effects of a chemical substance in the body that can cause inflammation.

Secukinumab is used to treat moderate to severe plaque psoriasis (raised, silvery flaking of the skin) in adults.

Secukinumab may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

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.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

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

Common side effects may include:

• diarrhea; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

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 FDA at 1-800-FDA-1088.

Do not receive a "live" vaccine while using secukinumab. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Make sure you are current on all vaccines before you begin treatment with secukinumab.

Other drugs may interact with secukinumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

If you take too much secukinumab, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If secukinumab is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

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

Secukinumab is a prescription medication used to treat adults:

• 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)
• with active ankylosing spondylitis
• with active psoriatic arthritis

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Secukinumab is part of the drug class:

• Interleukin inhibitors

Storage

Parenteral

Injection pen or prefilled syringe: 2–8°C.1 Keep in original carton and protect from light.1 Do not freeze.1

2–8°C.1 Keep in original package and protect from light.1 Do not freeze.1

Reconstituted solution: 2–8°C for up to 24 hours.1 Do not freeze.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

• It is used to treat plaque psoriasis.
• It is used to treat psoriatic arthritis.
• It is used to treat ankylosing spondylitis.
• It may be given to you for other reasons. Talk with the doctor.

• AIN457

Adverse events were not observed in animal reproduction studies. In general, maternal use of monoclonal antibodies during pregnancy may increase the risk of infection to the exposed infant or interfere with vaccine administration in the newborn (Mervic 2014). Other agents are currently preferred for the treatment of plaque psoriasis in pregnant women (Hsu 2012).