Brodalumab Injection

IMPORTANT WARNING:

Some people who used brodalumab injection had suicidal thoughts and behavior (thinking about harming or killing oneself or planning or trying to do so). It is not known whether brodalumab injection causes suicidal thoughts and behavior. Tell your doctor and pharmacist if you have a history of depression or suicidal thoughts. If you experience any of the following symptoms, call your doctor immediately: new or worsening depression or anxiety; thoughts of suicide, dying, or hurting yourself, or planning or trying to do so; changes in your behavior or mood; or acting on dangerous impulses. Your healthcare provider will give you a Patient Wallet Card with a list of symptoms. If any of these symptoms occur, you should get medical help right away. Carry the card with you at all times during your treatment with brodalumab injection, and show it to all of your healthcare providers.

Because of the risk of suicidal thoughts and behavior with this medication, brodalumab injection is only available through a special program called Siliq REMS^®. You, your doctor, and your pharmacist must be enrolled in this program before you can receive brodalumab injection. All people who are prescribed brodalumab injection must have a prescription from a doctor who is registered with Siliq REMS^® and have the prescription filled at a pharmacy that is registered with Siliq REMS^® in order to receive this medication. Ask your doctor for more information about this program and how you will receive your medication.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with brodalumab injection and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risks of using brodalumab injection.

WHY is this medicine prescribed?

Brodalumab injection is used to treat moderate to severe plaque psoriasis (skin disease in which red, scaly patches form on some areas of the body) in people whose psoriasis is too severe to be treated by topical medications alone and who have not been treated successfully with other medications. Brodalumab injection is in a class of medications called monoclonal antibodies. It works by blocking the action of a certain natural substance in the body that causes the symptoms of psoriasis.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Brodalumab injection comes as a liquid in a prefilled syringe to be injected subcutaneously (under the skin). It is usually injected once a week for the first 3 doses and then once every 2 weeks. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use brodalumab injection exactly as directed. Do not inject more or less of it or inject it more often than prescribed by your doctor.

You can inject brodalumab injection yourself or have a friend or relative perform the injections. Before you use brodalumab injection for the first time, carefully read the manufacturer's instructions. Ask your doctor or pharmacist to show you or the person who will be injecting the medication how to inject it.

Use each prefilled syringe only once and inject all the solution in the syringe. Dispose of used syringes and pens in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

If you are using a prefilled syringe that has been refrigerated, place the syringe on a flat surface without removing the needle cap and allow it to warm to room temperature for approximately 30 minutes before using. Do not try to warm the medication by heating it in a microwave, placing it in hot water, or through any other method. Do not put the prefilled syringe back in the refrigerator after it has reached room temperature.

Do not shake the medication.

Always look at brodalumab solution before you inject it. The medication should be clear and colorless to slightly yellow. Do not use the syringe if the medicine is cloudy, discolored, or contains flakes or particles.

Do not use a syringe if it has been dropped on a hard surface. Part of the syringe may be broken even if you cannot see the break.

You can inject brodalumab injection anywhere on the your thighs (upper leg), upper outer arms, or stomach except your navel and the area 2 inches (5 centimeters) around it. To reduce the chances of soreness or redness, use a different site for each injection. Do not inject into an area where the skin is tender, bruised, red, hard, thick, scaly, affected by psoriasis, or where you have scars or stretch marks.

Your healthcare provider may tell you to stop using brodalumab injection if your psoriasis does not improve within 12 to 16 weeks of treatment. Talk to your doctor about how you are feeling during your treatment.

What SPECIAL PRECAUTIONS should I follow?

Before using brodalumab injection,

• tell your doctor and pharmacist if you are allergic to brodalumab, any other medications, or any of the ingredients in brodalumab injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: cyclosporine (Gengraf, Neoral, Sandimmune) and warfarin (Coumadin, Jantoven). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with brodalumab injection, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor if you have Crohn's disease (condition in which the immune system attacks the lining of the digestive tract causing pain, diarrhea, weight loss, and fever). Your doctor will probably tell you not to use brodalumab injection.

• tell your doctor if you have or have ever had any medical condition.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using brodalumab injection, call your doctor.

• check with your doctor to see if you need to receive any vaccinations. It is important to have all vaccines appropriate for your age before beginning your treatment with brodalumab injection. Do not have any vaccinations during your treatment without talking to your doctor.

• you should know that brodalumab injection may decrease your ability to fight infection from bacteria, viruses, and fungi and increase the risk that you will get a serious or life-threatening infection. Tell your doctor if you often get any type of infection or if you have or think you may have any type of infection now. This includes minor infections (such as open cuts or sores), infections that come and go (such as herpes or cold sores), and chronic infections that do not go away. If you experience any of the following symptoms during or shortly after your treatment with brodalumab injection, call your doctor immediately: fever, sweats, or chills; muscle aches; cough; shortness of breath; sore throat or difficulty swallowing; warm, red, or painful skin or sores on your body; diarrhea; stomach pain; frequent, urgent, or painful urination; or other signs of infection.

• you should know that using brodalumab injection increases the risk that you will develop tuberculosis (TB; a serious lung infection), especially if you are already infected with TB but do not have any symptoms of the disease. Tell your doctor if you have or have ever had TB, if you have lived in a country where TB is common, or if you have been around someone who has TB. Your doctor will check you for TB before starting treatment with brodalumab injection and may treat you for TB if you have a history of TB or have active TB. If you have any of the following symptoms of TB or if you develop any of these symptoms during your treatment, call your doctor immediately: cough, coughing up blood or mucus, weakness or tiredness, weight loss, loss of appetite, chills, fever, or night sweats.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Use the missed dose as soon as you remember it and then continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Brodalumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• joint or muscle pain
• nausea
• pain, redness, bruising, bleeding, or itching in the area where the medication was injected

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section or SPECIAL PRECAUTIONS section, call your doctor immediately:

• painful diarrhea
• bloody stools
• sudden or uncontrollable bowel movements
• stomach pain or cramping
• constipation
• weight loss

Brodalumab injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store brodalumab prefilled syringes in the refrigerator, but do not freeze them. Keep the syringes in their original cartons to protect from light. When necessary, prefilled syringes can be stored at room temperature for up to 14 days. Discard syringes after 14 days at room temperature. Do not place prefilled syringes stored at room temperature back into the refrigerator.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.