Siliq

BRODALUMAB

Manufacturer: Bausch Health US LLC

Score: 144.0

Quick Summary

Siliq (BRODALUMAB) is a human monoclonal IgG2 antibody used for the treatment of moderate to severe plaque psoriasis in adult patients. It works by selectively binding to human IL-17RA and inhibiting its interactions with cytokines. The recommended dose is 210 mg administered by subcutaneous injection at Weeks 0, 1, and 2 followed by 210 mg every 2 weeks. Important safety information includes a warning about suicidal ideation and behavior, contraindications in patients with Crohn’s disease, and common adverse reactions such as arthralgia, headache, and fatigue. Special population considerations include use during pregnancy, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Treatment of moderate to severe plaque psoriasis in adult patients
Selective binding to human IL-17RA and inhibition of its interactions with cytokines
Indicated for patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies

Important Safety Information

Warning

Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with SILIQ

Contraindications

Crohn’s disease

Adverse Reactions

Arthralgia
Headache
Fatigue
Diarrhea
Oropharyngeal pain
Nausea
Myalgia
Injection site reactions
Influenza
Neutropenia
Tinea infections

Dosing Recommendations

General Guidance

If an adequate response has not been achieved after 12 to 16 weeks of treatment with SILIQ, consider discontinuing therapy

Moderate to severe plaque psoriasis

Adult Dose

210 mg administered by subcutaneous injection at Weeks 0, 1, and 2 followed by 210 mg every 2 weeks

Pediatric Dose

Special Population Considerations

Pregnancy

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

Nursing Mothers

Pediatric Use

The safety and effectiveness of SILIQ have not been evaluated in pediatric patients

Geriatric Use

Of the 3066 plaque psoriasis subjects initially randomized to SILIQ in clinical trials, 192 (6%) were ≥ 65 years old and no subjects were ≥ 75 years old
Although no differences in safety or efficacy were observed between older and younger subjects, the number of subjects aged 65 years and older was not sufficient to determine whether they responded differently from younger subjects

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