Siliq

Siliq is a prescription medication used to treat adults with moderate to severe plaque psoriasis (a skin condition in which red patches with silvery scales form on some areas of the body).

Siliq belongs a class of medications called monoclonal antibodies. It works by blocking the action of a certain natural substance in the body that causes the symptoms of psoriasis.

This medication is available in an injectable form to be given just under the skin (subcutaneously). 

Common side effects of Siliq include joint pain, headache, and tiredness.

Siliq is a prescription medication used to treat adults with moderate to severe plaque psoriasis (a skin condition in which red patches with silvery scales form on some areas of the body) who may benefit from taking injections or pills (systemic treatment) or phototherapy (ultraviolet light treatment). This medication is a treatment option for those who have not been treated successfully with other systemic medications.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Valeant Pharmaceuticals, Inc.

Serious side effects have been reported with Siliq. See the “Siliq Precautions” section.

Common side effects of Siliq include the following:

• joint pain
• headache
• tiredness 
• diarrhea 
• mouth or throat pain
• nausea
• muscle pain
• injection site reactions (pain, redness, bruising, bleeding, or itching)
• flu (influenza)
• low white blood count (neutropenia)
• fungal infections of the skin

This is not a complete list of Siliq side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that use the enzyme CYP450 such as budesonide (Entocort), cyclosporine (Neoral, Gengraf, Sandimmune), darifenacin (Enablex), dihydroergotamine (Migranal), fentanyl (Abstral, Fentora, Onsolis, Actiq), pimozide (Orap), quinidine (Cardioquin, Duraquin, Quinact), sirolimus (Rapamune), tacrolimus (Prograf), terfenadine (Seldane), fluticasone (Flovent HFA, Flonase), eletriptan (Relpax), lovastatin (Mevacor), quetiapine (Seroquel), sildenafil (Viagra, Revatio), and simvastatin (Zocor)
• Live vaccines. It is recommended to avoid live vaccines while being treated with Siliq. 

This is not a complete list of Siliq drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Siliq including the following: 

• Suicidal ideation (thoughts) and behavior. Some people who used Siliq had suicidal thoughts and behavior (thinking about harming or killing oneself or planning or trying to do so). It is not known whether Siliq causes suicidal thoughts or behavior. Tell your doctor and pharmacist if you have a history of depression or suicidal thoughts. If you experience any of the following symptoms, call your doctor immediately: new or worsening depression or anxiety; thoughts of suicide, dying, or hurting yourself, or planning or trying to do so; changes in your behavior or mood; or acting on dangerous impulses. Your healthcare provider will give you a Siliq Patient Wallet Card about symptoms you should get medical help right away. Carry the card with you at all times during treatment with Siliq and show it to all of your healthcare providers.

  • Because of the risk of suicidal thoughts and behavior with this medication, Siliq is only available through a special program called Siliq REMS. You, your doctor, and your pharmacist must be enrolled in this program before you can receive Siliq. All people who are prescribed Siliq must have a prescription from a doctor who is registered with Siliq REMS and have the prescription filled at a pharmacy that is registered with Siliq REMS in order to receive this medication. Ask your doctor for more information about this program and how you will receive your medication.

• Serious infections. Siliq may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should watch you closely for signs and symptoms of infection during and after treatment with Siliq. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:
  • fever
  • sweats, or chills
  • muscle aches
  • cough
  • shortness of breath
  • sore throat or difficulty swallowing
  • warm, red, or painful skin or sores on your body
  • diarrhea or stomach pain
  • burning when you urinate or urinate more often than normal
• Risk for tuberculosis infection. Your healthcare provider will check you for tuberculosis (TB) before starting treatment with Siliq and may treat you for TB before you begin treatment with Siliq if you have a history of TB or have active TB. Your healthcare provider will monitor you closely for signs and symptoms of infection and TB during and after treatment with Siliq. 
• Crohn’s Disease (condition in which the immune system attacks the lining of the digestive tract causing stomach pain, diarrhea, weight loss, and fever). Do not use Siliq if you have Crohn’s disease. Tell your healthcare provider if you develop diarrhea, painful diarrhea, bloody stools, stomach pain or cramping, sudden or uncontrollable bowel movements, loss of appetite, constipation, weight loss, fever, or tiredness.
• Immunizations. It is recommended live vaccines be avoided while being treated with Siliq.

Do not take Siliq if you:

• are allergic to Siliq or to any of its ingredients
• have Crohn’s disease

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Siliq, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Siliq, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Siliq or to any of its ingredients
• have a history of mental problems, including suicidal thoughts, depression, anxiety, or mood problems.
• have an infection that does not go away or that keeps coming back.
• have TB or have been in close contact with someone with TB.
• have recently received or are scheduled to receive an immunization (vaccine). It is recommended you avoid receiving live vaccines during treatment with Siliq.
• are pregnant or plan to become pregnant. It is not known if Siliq can harm your unborn baby. If you are pregnant or plan on becoming pregnant, consult with your healthcare provider.
• are breastfeeding or plan to breastfeed. It is not known if Siliq passes into your breast milk.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. 

There are no well-done studies that have been done in humans with Siliq. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Siliq crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Siliq.

Take Siliq exactly as prescribed.

If your healthcare provider decides that you or a caregiver can give your injections of Siliq at home, it is very important you receive training on how to accurately prepare and inject Siliq. Do not try to inject Siliq until you have been shown how to accurately give the injections by your healthcare provider. 

Siliq injection comes as a liquid in a pre-filled syringe and is injected under the skin (subcutaneously) in the thigh, stomach area (except for the 2-inch area around your belly button, and in the outer area of the upper arm (this location is if someone else is giving you the injection). 

• Siliq is typically injected once a week for the first 3 doses and then once every 2 weeks.
• Do not inject Siliq into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis. Inject the full dose of Siliq (1.5mL).
• Choose a different site each time you administer Siliq. If the same injection site is desired, make sure it is not the same spot on the injection site that you used for a previous injection.

Use each pre-filled syringe only once and inject all the solution in the syringe. Dispose of used syringes and pens in an FDA-cleared sharps disposal container (puncture-resistant container). Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

If you are using a prefilled syringe that has been refrigerated, place the syringe on a flat surface without removing the needle cap and allow it to warm to room temperature for approximately 30 minutes before using. Do not try to warm the medication by heating it in a microwave, placing it in hot water, or through any other method. Do not put the prefilled syringe back in the refrigerator after it has reached room temperature.

Do not shake the medication.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended Siliq dose is 210 mg (1.5mL) injected under the skin usually once a week for the first 3 doses and then once every 2 weeks.

Your healthcare provider may stop Siliq if your plaque psoriasis does not improve within 12 to 16 weeks of treatment.

If you take too much Siliq, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Siliq refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light and physical damage during storage.
• When necessary, prefilled syringes can be stored at room temperature up to a maximum of 77°F (25°C) in the original carton for a maximum single period of 14 days with protection from light and sources of heat. Once the prefilled syringe has reached room temperature, do not place back into the refrigerator. Discard after 14 days at room temperature.
• Do not freeze.
• Do not shake.
• Keep this and all medicines out of the reach of children. 

Warning: suicidal ideation and behavior

Suicidal thoughts or behavior have happened in some people treated with Siliq. Some people have ended their own lives. Your risk of suicidal thoughts and behavior may be increased if you have a history of suicidal thoughts or depression. Tell your doctor immediately if you notice any signs of suicidal thoughts or behavior, new onset or worsening depression, anxiety, or other mood changes. Your healthcare professional might refer you to a mental health professional, as appropriate. 

Because of the observed suicidal behavior in subjects treated with Siliq, Siliq is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Siliq REMS Program.

Your healthcare provider will give you a Siliq Patient Wallet Card about symptoms you should get medical help for right away. Carry the card with you at all times during treatment with Siliq and show it to all of your healthcare providers.