Brodalumab (broe-DAL-ue-mab)

Treats plaque psoriasis.

Brand Name(s):

Siliq

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. It is usually given in your thighs, stomach, or upper arm.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• 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. Do not inject into skin areas that are bruised, red, hard, tender, thick, or scaly, or areas with psoriasis.
• Prefilled syringe:
  • Wash your hands with soap and water before and after using this medicine.
  • Allow 30 minutes for the prefilled syringe to warm up to room temperature. Do not warm using heat sources (including hot water, microwave, or sunlight).
  • Check the liquid in the prefilled syringe. It should be clear and colorless to slightly yellow. Do not use it if it is cloudy, discolored, or has flakes or particles in it. Do not shake.
  • Pull the gray needle cap straight off and away from your body. Do not twist or bend the gray needle cap. Do not recap the needle.
  • Pinch skin firmly between your thumb and fingers. Insert the needle into your skin.
  • Push the plunger rod all the way down until it reaches the bottom. Gently lift the syringe and pull the needle our of your skin.
• Use a new needle and syringe each time you inject your medicine.
• You might not use all of the medicine in each prefilled syringe. Use each prefilled syringe only one time. Do not save an open syringe.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Call your doctor or pharmacist for instructions.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. Keep the medicine in the original carton until you are ready to use it. You may store the prefilled syringe at room temperature, for up to 14 days. Do not put it back in the refrigerator once it has reached room temperature. Throw away any unused medicine that has been stored at room temperature after 14 days. Do not freeze.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how brodalumab works. Tell your doctor if you are using cyclosporine or a blood thinner (including warfarin).
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, a history of depression, suicidal thoughts or behavior, or tuberculosis. Tell your doctor if you have any type of infection or an infection that keeps coming back.
• This medicine may cause the following problems:
  • Changes in behavior or mood, including thoughts of suicide
  • Increased risk of infection
  • Serious skin reactions that look like eczema
• You will need to have a skin test for tuberculosis (TB) before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive TB skin test or has been exposed to TB.
• Call your doctor if your symptoms do not improve or if they get worse.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Diarrhea that may contain blood, stomach pain
• Fever, chills, cough, sore throat, stuffy or runny nose, body aches
• Unusual moods or behaviors, depression, thoughts of hurting yourself or others

If you notice these less serious side effects, talk with your doctor:

• Headache
• Muscle or joint pain
• Pain, itching, burning, swelling, or a lump under your skin where the shot was given
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

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