brodalumab

What is the most important information I should know about brodalumab?

Some people have thoughts about suicide while taking this medicine. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor, such as mood changes, anxiety, or depression.

What is brodalumab?

Brodalumab is used to treat moderate to severe plaque psoriasis in adults.

Brodalumab is usually given after other treatments have failed.

Brodalumab is available only under a special program. You must be registered in the program and understand the risks and benefits of this medicine.

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

What should I discuss with my healthcare provider before using brodalumab?

Tell your doctor if you have ever had:

• an active or chronic infection;
• tuberculosis; or
• anxiety, depression, mental illness, or a mood disorder.

Tell your doctor if you have ever had tuberculosis or if anyone in your household has tuberculosis. Also tell your doctor if you have recently traveled. Tuberculosis is more common in certain parts of the world, and you may have been exposed during travel.

Tell your doctor if you are pregnant or breastfeeding.

How is brodalumab given?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Brodalumab is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.

Brodalumab is usually given once a week for 3 weeks, and then once every 2 weeks thereafter. Follow your doctor's dosing instructions.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Take the medicine out of the refrigerator and let it reach room temperature for 30 minutes before injecting your dose. Do not heat the medicine in a microwave oven or place it into hot water. Leave the needle cap in place while the medicine warms to room temperature.

Any syringe warmed to room temperature should not be placed back into a refrigerator.

Each prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Brodalumab affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

It may take up to 16 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 12 weeks of using brodalumab.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

What should I avoid while taking brodalumab?

Do not receive a "live" vaccine while using brodalumab. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

What are the possible side effects of brodalumab?

Brodalumab comes with a Medication Guide and a Patient Wallet Card listing symptoms of a serious side effect. Read this information and learn what symptoms to watch for. Keep the Wallet Card with you at all times.

• fever, chills, sweating, tiredness;
• sore throat, cough, trouble breathing or swallowing;
• skin sores with warmth, redness, or swelling;
• stomach cramps, loss of appetite, constipation;
• painful diarrhea, bloody stools, weight loss;
• increased urination, pain or burning when you urinate;
• unusual changes in mood or behavior;
• suicidal thoughts; or
• new or worsening anxiety or depression.

Common side effects may include:

• fever, chills, flu-like symptoms;
• itching, skin redness;
• muscle or joint pain;
• nausea, diarrhea;
• headache, tiredness;
• mouth pain; or
• pain, redness, bruising, itching, or bleeding where the medicine was injected.

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.

What other drugs will affect brodalumab?

Other drugs may affect brodalumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about brodalumab.