Usual Adult Dose for Plaque Psoriasis

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

Comments:

• Continued therapy beyond 16 weeks in patients who have not achieved an adequate response is not likely to result in greater success.
• Evaluate patients for tuberculosis (TB) infection prior to 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 failed to respond or have lost response to other systemic therapies

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNINGS:
Suicidal Ideation/Behavior:

• Suicidal ideation and behavior, including completed suicides, have been reported.
• Weigh risks and benefits in patients with a history of depression and/or suicidal ideation or behavior.
• Patients with new or worsening suicidal thoughts 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.
• This drug is available only through a restricted program called the SILIQ REMS Program.

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for brodalumab. It includes elements to assure safe use and implementation system. For additional information: http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Each syringe is for single-dose only.
• Do not inject into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis.

Storage requirements:

• The manufacturer product information should be consulted.

Reconstitution/preparation techniques:

• Allow the prefilled syringe to reach room temperature (approximately 30 minutes) before injecting; do not warm any other way. Do not remove the gray needle cap on the prefilled syringe while allowing it to reach room temperature.
• Visually inspect the solution for particles and discoloration prior to administration. The liquid should be clear to slightly opalescent, colorless to slightly yellow. A few translucent to white, amorphous proteinaceous particles may be present. Do not use if cloudy or discolored or if foreign matter is present.

Patient advice:

• Patients should review the Medication Guide before use.
• Patients may self-inject when deemed appropriate by a healthcare professional and after proper training in subcutaneous injection technique using the prefilled syringe.

Frequently asked questions

• What are the new drugs for the treatment of plaque psoriasis?