Siliq (brodalumab) Injection

WARNING

SUICIDAL IDEATION AND BEHAVIOR

Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with Siliq. Prior to prescribing Siliq, weigh the potential risks and benefits in patients with a history of depression and/or suicidal ideation or behavior.

Patients with new or worsening suicidal ideation and behavior should be referred to a mental health professional, as appropriate. Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation or behavior, new onset or worsening depression, anxiety, or other mood changes.

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.

Siliq may cause serious side effects, including:

• 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.

The most common side effects of Siliq include:

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

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

• The recommended Siliq dose is 210 mg administered by subcutaneous injection at Weeks 0, 1, and 2 followed by 210 mg every 2 weeks.
• If an adequate response has not been achieved after 12 to 16 weeks of treatment with Siliq, consider discontinuing therapy. Continued treatment beyond 16 weeks in patients who have not achieved an adequate response is not likely to result in greater success.

Tuberculosis Assessment Prior To Initiation Of Siliq

• Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Siliq.

Important Administration Instructions

• Administer Siliq subcutaneously. Each prefilled syringe is for single dose only.
• Instruct patients to review the Medication Guide before use. Siliq is intended for use under the guidance and supervision of a healthcare professional. Patients may self-inject Siliq when deemed appropriate by a healthcare professional and after proper training in subcutaneous injection technique using the prefilled syringe.
• Advise patients who are self-administering to inject the full dose and to read the Instructions for Use before administration.
• Do not inject Siliq into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis.

Preparation Of Siliq Prefilled Syringe

• Allow Siliq prefilled syringe to reach room temperature (approximately 30 minutes) before injecting. Do not warm in any other way. Do not remove the gray needle cap on the prefilled syringe while allowing it to reach room temperature.
• Visually inspect Siliq for particles and discoloration prior to administration. Siliq is a clear to slightly opalescent, colorless to slightly yellow solution practically free from particles. Do not use Siliq if it is cloudy or discolored or if foreign matter is present.
• Instruct patients to use the prefilled syringe and to inject the full amount (1.5 mL), which provides 210 mg of Siliq, according to the directions provided in the Instructions for Use.

Live Vaccinations

• Avoid use of live vaccines in patients treated with Siliq .

CYP450 Substrates

• The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g., IL-1, IL-6, IL-10, TNFα, IFN) during chronic inflammation. Treatment with Siliq may modulate serum levels of some cytokines.
• Therefore, upon initiation or discontinuation of Siliq in patients who are receiving concomitant drugs which are CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for effect (e.g., for warfarin) or drug concentration (e.g., for cyclosporine) and consider dosage modification of the CYP450 substrate.

• There are no human data on Siliq use in pregnant women to inform a drug-associated risk. Human IgG antibodies are known to cross the placental barrier; therefore, Siliq may be transmitted from the mother to the developing fetus.
• There are no data on the presence of brodalumab in human milk, the effects on the breastfed infant, or the effects on milk production.
• Brodalumab was detected in the milk of lactating cynomolgus monkeys.
• The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Siliq and any potential adverse effects on the breastfed infant from Siliq or from the underlying maternal condition.