Siliq (brodalumab)

No dosing information is available for this tab.

Brodalumab is administered by subcutaneous injection. Brodalumab is intended for use under the guidance and supervision of a clinician; however, the drug may be self-administered if the clinician determines that the patient and/or their caregiver is competent to safely administer the drug following appropriate training.

Administer brodalumab subcutaneously into the upper arms, thighs, or any quadrant of the abdomen; avoid injections within 2 inches of the navel. Administration of brodalumab into the upper outer arm should be performed by a caregiver or clinician. Do not inject into areas where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis or into scars or stretch marks. Rotate injection sites.

Brodalumab injection is commercially available in prefilled syringes. The injection is a clear to slightly opalescent, colorless to slightly yellow solution practically free from particles. Prior to administration, inspect brodalumab solution visually for particulate matter or discoloration; discard the solution if it is cloudy or discolored or if foreign particles are present. Brodalumab prefilled syringes are for single use only; the drug contains no preservatives. Inject the full amount (1.5 mL) of solution contained within the prefilled syringe, providing 210 mg of brodalumab.

Protect the injection from light and store at 2-8degreesC in the original carton until administration; do not freeze or shake the injection. When refrigeration is not available, the manufacturer states that individual prefilled syringes may be stored at room temperature (up to 25degreesC) in the original carton for a maximum single period of 14 days, with protection from light and heat. Once a prefilled syringe has reached room temperature, do not return it to the refrigerator. If not used within 14 days when stored at room temperature, discard the prefilled syringe. Allow the prefilled syringe to sit at room temperature for approximately 30 minutes prior to subcutaneous injection. The solution should not be warmed in any other way. Do not remove the needle cap while the syringe is warming to room temperature.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Patients with Crohn disease since the drug may exacerbate the disease.

*Clinically significant hypersensitivity to brodalumab, any of its excipients, or components of the container.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Adverse effects reported in >=1% of patients receiving brodalumab include arthralgia, headache, fatigue, diarrhea, oropharyngeal pain, nausea, myalgia, injection site reactions, influenza, neutropenia, and tinea infections.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

Safety and efficacy of brodalumab in pediatric patients <18 years of age have not been established.

Data regarding use or risks of brodalumab in pregnant women are lacking.

Human immunoglobulin G (IgG) is known to cross the placenta. Thus, the potential exists for fetal exposure to the drug. No evidence of embryofetal toxicity or malformations and no adverse effects on morphologic, functional, or immunologic development of offspring were observed in a study in cynomolgus monkeys given subcutaneous brodalumab weekly during organogenesis through parturition at doses up to 26 times the maximum recommended human dose.

It is not known whether brodalumab is distributed into human milk, affects milk production, or affects the breast-fed infant. Brodalumab is distributed into milk in cynomolgus monkeys. Consider the benefits of breast-feeding and the importance of brodalumab to the woman along with potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.

The manufacturer makes no specific dosage recommendations for geriatric patients.

Of the 3066 patients with plaque psoriasis who were initially randomized to receive brodalumab in clinical trials, 6% were >=65 years of age while no patients were >=75 years of age. Although no overall differences in efficacy or safety between geriatric patients and younger adults were observed, the clinical trials did not include sufficient numbers of patients 65 years of age and older to determine whether geriatric patients respond differently than younger adults. Clearance of brodalumab in patients >=65 years of age appears to be similar to that in younger adults.