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

Siliq is used to treat moderate to severe plaque psoriasis in adults. It is usually given after other psoriasis medicines have been tried without success.

Siliq 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.

Some people have thoughts about suicide while taking Siliq. 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 affects your immune system. You may get infections more easily. Call your doctor if you have symptoms such as fever, chills, cough, skin sores, diarrhea, stomach cramps, or burning urination.

Use Siliq exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

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

Siliq 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.

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

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

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 Siliq.

Usual Adult Dose for Plaque Psoriasis:

210 mg subcutaneously at Weeks 0, 1, and 2 followed by 210 mg subcutaneously every 2 weeks

Comments:
-Continued therapy beyond 16 weeks in patients who have not achieved an adequate response is not likely to result in greater success.
-Evaluate patients for tuberculosis (TB) infection prior to initiating therapy.

Use: For the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies

You should not use Siliq if you have Crohn's disease.

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

• 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.

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

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.

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

Avoid injecting Siliq 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. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

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

Siliq 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.

Call your doctor at once if you have:

• 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 Siliq 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.

Other drugs may interact with 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.