brodalumab

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Pronunciation: broe DAL ue mab

Brand: Siliq

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.

Brodalumab is available only from a certified pharmacy under a special program.

What is brodalumab?

Brodalumab is a monoclonal antibody that blocks certain proteins in the body that can affect inflammation and other immune responses.

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

Brodalumab is usually given after other psoriasis medicines have been tried without success.

Brodalumab is available only from a certified pharmacy under a special program called Siliq REMS. You must be registered in the program and understand the risks and benefits of taking 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?

You should not use brodalumab if you are allergic to it, or if you have:

  • Crohn's disease.

To make sure brodalumab is safe for you, tell your doctor if you have:

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

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. Your doctor may perform tests to make sure you do not have tuberculosis or other infections.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether brodalumab passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Brodalumab is not approved for use by anyone younger than 18 years old.

How is brodalumab given?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Brodalumab is injected under the skin. You may be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and syringes.

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

Read all instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

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

Store prefilled syringes in their original container in the refrigerator. Protect from light and do not freeze.

Take the medicine out of the refrigerator and allow it to reach room temperature for 30 minutes before injecting your dose. Do 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.

You may store a syringe for up to 14 days at room temperature. Keep the syringe in its original container and protect it from heat and light.

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

Each single-use prefilled syringe is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Brodalumab can lower blood cells that help your body fight infections. You may get an infection more easily. Call your doctor if you have signs of infection such as fever, chills, flu symptoms, diarrhea, painful urination, and skin warmth or redness.

It may take several 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.

Brodalumab comes with a Medication Guide and a Patient Wallet Card that lists the symptoms of a serious side effect. Read this information carefully and carry the Wallet Card with you at all times so you will know what symptoms to watch for.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking brodalumab?

Avoid injecting brodalumab into skin that is bruised or tender, or skin that is affected by psoriatic plaques (red, thick, or scaly).

Do not receive a "live" vaccine while using brodalumab. 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.

What are the possible side effects of brodalumab?

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

Call your doctor at once if you have:

  • suicidal thoughts;
  • unusual changes in mood or behavior;
  • new or worsening anxiety or depression;
  • increased urination, pain or burning when you urinate;
  • skin sores with warmth, redness, or swelling;
  • stomach cramps, loss of appetite, diarrhea or constipation, bloody or watery stools;
  • low white blood cell counts --fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing;
  • signs of an ear infection --ear pain or full feeling, trouble hearing, drainage from the ear; or
  • signs of other infections --fever, chills, sweating, sore throat, trouble swallowing, body aches, breathing problems, diarrhea, stomach pain.

Common side effects may include:

  • muscle or joint pain;
  • nausea, diarrhea;
  • flu-like symptoms;
  • headache, tiredness;
  • sore throat, 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 interact with brodalumab, 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.

Where can I get more information?

Your pharmacist can provide more information about brodalumab.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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