Siliq

Siliq

What is Siliq?

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

Siliq is only available at a certified pharmacy under a special program called Siliq REMS. You must be enrolled in the program and understand the risks and benefits of taking this medication.

Warnings

Some people have suicidal thoughts while taking Siliq. Watch for mood changes or symptoms. Report any new or worsening symptoms, such as mood changes, anxiety, or depression, to your doctor.

Brodalumab affects your immune system.You may get infections more easily.Call your doctor if you notice symptoms such as fever, chills, cough, skin sores, diarrhea, stomach cramps, or burning urination.

Before you take this medicine

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 some parts of the world and you may have been exposed to it while traveling.

Tell your doctor if you are pregnant or breastfeeding.

Siliq is not approved for use by anyone under 18 years of age.

How is Siliq administered?

Use Siliq exactly as your doctor has told you. Follow all instructions on your prescription label and read any medication guides or instructions for use.

Siliq is injected under the skin. A doctor can teach you how to properly use the medication yourself.

Siliq is usually given once a week for three weeks and every two weeks thereafter. Follow your doctor's dosage instructions.

Carefully read and follow all instructions for use that come with your medicine. Ask your doctor or pharmacist if you do not understand all the instructions.

Do not prepare an injection until you are ready to give it. Do not use if the medicine looks cloudy, has changed color, or contains particles. Call your pharmacist for a new medicine.

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

Remove the medicine from the refrigerator and allow it to come to room temperature for 30 minutes before injecting your dose. Do not heat the medicine in the microwave or place it in hot water. Leave the needle cap in place while the medicine warms to room temperature.

You can store a pre-filled syringe in the original container at room temperature for up to 14 days. Protect it from heat and light.

Syringes that have warmed to room temperature should not be placed back in the refrigerator.

Each pre-filled syringe is for single use only. Throw it away after one use, even if it still contains medicine.

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

Brodalumab affects your immune system. You can get infections more easily, even serious or fatal infections. Your doctor must examine you regularly.

It may take up to 16 weeks for your symptoms to improve. Continue taking the medication as directed and tell your doctor if your symptoms do not improve after 12 weeks of using Siliq.

Dosage information

Usual Adult Dose for Plaque Psoriasis:

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

Comments:
– Continuation of therapy beyond 16 weeks is unlikely to result in greater success in patients who have not achieved an adequate response.
-Screen patients for tuberculosis (TB) infection before 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 not responded or are no longer responding to other systemic therapies

What happens if I miss a dose?

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

What happens if I overdose?

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

What to avoid

Avoid injecting Siliq into skin that is bruised or tender, or into skin 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).

Side effects of Siliq

If necessary, get emergency medical helpSigns 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 card listing the symptoms of a serious side effect. Read this information and learn what symptoms you should look out for. Always carry the wallet card with you.

Call your doctor immediately if you have:

• fever, chills, sweating, tiredness;

• sore throat, cough, difficulty 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 urinating;

• unusual changes in mood or behavior;

• suicidal thoughts; or

• new or worsening anxiety or depression.

Common side effects of Siliq may include:

• fever, chills, flu-like symptoms;

• itching, redness of the skin;

• muscle or joint pain;

• nausea, diarrhea;

• headache, fatigue;

• mouth pain; or

• Pain, redness, bruising, itching, or bleeding at the injection site.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You can report side effects to FDA at 1-800-FDA-1088.

What other medications affect Siliq?

Other medications may interact with brodalumab, including prescription and over-the-counter medications, vitamins, and herbal products. Tell your doctor about all medications you are currently taking and any medications you are taking or stopping.

• Was sind die neuen Medikamente gegen Plaque-Psoriasis?
• Was ist das Siliq REMS-Programm?

More information

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