Brodalumab

What is Brodalumab?

• Brodalumab (Siliq) is a human interleukin-17 receptor A (IL-17RA) antagonist used to treat adults with moderate to severe plaque psoriasis.

What are the uses of this medicine?

This medicine is used to treat adults with moderate to severe plaque psoriasis:

• who may benefit from taking injections or pills (systemic therapy) or phototherapy (ultraviolet light treatment), and
• who have not responded or lost response to other systemic therapy.

How does this medicine work?

• Brodalumab is a human monoclonal IgG2 antibody that selectively binds to human IL-17RA and inhibits its interactions with cytokines IL-17A, IL-17F, IL-17C, IL-17A/F heterodimer, and IL-25.
• IL-17RA is a protein expressed on the cell surface and is a required component of receptor complexes utilized by multiple IL-17 family cytokines.
• Blocking IL-17RA inhibits IL-17 cytokine-induced responses including the release of pro-inflammatory cytokines and chemokines.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with Crohn’s disease because Siliq may cause worsening of disease.

What drug interactions can this medicine cause?

• Avoid use of live vaccines in patients treated with 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.

Is this medicine FDA approved?

• It was approved for use in the United States in 2017.

How should this medicine be used?

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

Recommended Dosageː

• The recommended Siliq dose is 210 mg administered by subcutaneous injection at Weeks 0, 1, and 2 followed by 210 mg every 2 weeks.

Administration

• Use Siliq exactly as your healthcare provider tells you to use it.
• Your healthcare provider may stop Siliq if your plaque psoriasis does not improve within 12 to 16 weeks of treatment.
• Administer Siliq subcutaneously. Each prefilled syringe is for single dose only.
• Siliq is intended for use under the guidance and supervision of a healthcare professional.
• 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.
• 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 210 mg/1.5 mL solution in a single-dose prefilled syringe.

This medicine is available in fallowing brand namesː

• Siliq

What side effects can this medication cause?

The most common side effects of this medicine include:

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

Siliq may cause serious side effects, including:

• Suicidal thoughts or behavior
• Serious infections

What special precautions should I follow?

• Siliq may increase the risk of infections. Serious infections have occurred. Consider the risks and benefits prior to initiating Siliq in patients with a chronic infection or a history of recurrent infection. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue Siliq until the infection resolves.
• Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Siliq. Do not administer Siliq to patients with active TB infection.
• Crohn’s disease occurred in one subject during treatment with Siliq and led to discontinuation of therapy. Siliq is contraindicated in patients with Crohn’s disease.
• Avoid use of live vaccines in patients treated with Siliq.
• Siliq is available only through a restricted program under a REMS called the Siliq REMS Program because of the observed suicidal ideation and behavior in subjects treated with Siliq.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no human data on Siliq use in pregnant women to inform a drug-associated risk.

Can this medicine be used in children?

• The safety and effectiveness of Siliq have not been evaluated in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active ingredients:

BRODALUMAB

Who manufactures and distributes this medicine?

Distributed by: Bausch Health US, LLC Bridgewater, NJ 08807 USA

Manufactured by: Bausch Health Ireland, Limited Dublin, Leinster, Ireland 24

What should I know about storage and disposal of this medication?

• Store refrigerated at 2° to 8°C (36° 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.

• Dailymed label info on Brodalumab
• FDA Brodalumab

Brodalumab Resources
Need Help Finding a Doctor? Need help finding a doctor or specialist anywhere in the world? Explore our world directory. WikiMD's DocFinder can assist you in locating millions of physicians.	Medical Knowledge Access the latest research - Most recent articles Ongoing trials.

Translate to: East Asian 中文, 日本, 한국어, South Asian हिन्दी, Urdu, বাংলা, తెలుగు, தமிழ், ಕನ್ನಡ,
Southeast Asian Indonesian, Vietnamese, Thai, မြန်မာဘာသာ, European español, Deutsch, français, русский, português do Brasil, Italian, polski

Brodalumab Resources
Need Help Finding a Doctor? Need help finding a doctor or specialist anywhere in the world? Explore our world directory. WikiMD's DocFinder can assist you in locating millions of physicians.	Medical Knowledge Access the latest research - Most recent articles Ongoing trials.

Translate to: East Asian 中文, 日本, 한국어, South Asian हिन्दी, Urdu, বাংলা, తెలుగు, தமிழ், ಕನ್ನಡ,
Southeast Asian Indonesian, Vietnamese, Thai, မြန်မာဘာသာ, European español, Deutsch, français, русский, português do Brasil, Italian, polski

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