Brodalumab

Brodalumab is used for moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies.

Brodalumab is available under the following different brand names: Siliq.

Dosages of Brodalumab:

Dosage Forms and Strengths

Solution for Subcutaneous (SC) Injection

• 210mg/1.5mL (single-dose prefilled syringe)

Dosage Considerations – Should be Given as Follows:

Psoriasis

• Indicated for moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies
• 210 mg subcutaneously (SC) at Weeks 0, 1, and 2, THEN
• 210 mg SC every 2 weeks
• If an adequate response has not been achieved after 12-16 weeks, 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

Dosing Considerations

• Evaluate patients for tuberculosis (TB) before initiating
• Safety and efficacy not established in pediatric patients

Common side effects of brodalumab include:

• Headache
• Joint pain
• Fungal infections
• Injection site reaction
• Fatigue
• Diarrhea
• Mouth/throat pain
• Nausea

Less common side effects of brodalumab include:

• Serious infections
• Influenza
• Low white blood cell count (neutropenia)
• Tinea infections
• Conjunctivitis
• Candida infections

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Brodalumab has no listed severe interactions with other drugs.
• Serious interactions of brodalumab include:
  • anthrax vaccine adsorbed
  • BCG vaccine live
  • cholera vaccine
  • influenza virus vaccine quadrivalent, recombinant
  • influenza virus vaccine trivalent, recombinant
  • meningococcal A C Y and W-135 diphtheria conjugate vaccine
  • meningococcal A C Y and W-135 polysaccharide vaccine combined
  • meningococcal C and Y/haemophilus influenza type B vaccine
  • meningococcal group B vaccine
  • modified ragweed tyrosine adsorbate
  • pneumococcal vaccine 13-valent
  • pneumococcal vaccine heptavalent
  • pneumococcal vaccine polyvalent
  • tetanus toxoid adsorbed or fluid
  • typhoid polysaccharide vaccine
  • typhoid vaccine live
• Moderate interactions of brodalumab include:
  • carbamazepine
  • clonidine
  • cyclosporine
  • dengue vaccine
  • disopyramide
  • fosphenytoin
  • Haemophilus influenzae type b vaccine
  • phenobarbital
  • phenytoin
  • primidone
  • quinidine
  • quinine
  • sirolimus
  • tacrolimus
  • theophylline
  • trastuzumab
  • valproic acid
  • warfarin
• Brodalumab has no listed mild interactions with other drugs.

Warnings

• This medication contains brodalumab. Do not take Siliq if you are allergic to brodalumab or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Black Box Warnings

• Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with brodalumab
• Before prescribing, 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, brodalumab is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the SILIQ REMS Program

Patient wallet card

• Give patients the Patient Wallet Card and instruct them to carry it with them at all times
• Patients should seek medical evaluation and show the card, to the treating healthcare provider, if they experience symptoms of suicide or depression described on the card
• They should also call the National Suicide Prevention Lifeline at 1-800-273-8255 if they experience suicidal thoughts

Contraindications

• Crohn's disease

Effects of Drug Abuse

• No information is available.

Short-Term Effects

• See "What Are Side Effects Associated with Using Brodalumab?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Brodalumab?"

Cautions

• Suicidal ideation and behavior, including 4 completed suicides, occurred in subjects treated in the psoriasis clinical trials; there were no completed suicides in the 12-week placebo-controlled portion of the trials; brodalumab users with a history of suicidality or depression had an increased incidence of suicidal ideation and behavior as compared with users without such a history
• Available only through a restricted access program
• May increase risk of infections; in patients with a chronic infection or a history of recurrent infection, consider the risks and benefits before prescribing; if a patient develops a serious infection or is not responding to standard therapy for the infection, monitor the patient closely and discontinue the drug until the infection resolves
• Evaluate patients for TB before initiating; do not administer to patients with active TB; initiate treatment for latent TB before administering brodalumab; closely monitor patients for signs and symptoms of active TB during and after treatment
• In psoriasis trials, which excluded subjects with active Crohn’s disease, Crohn’s disease occurred in 1 subject during treatment and led to brodalumab discontinuation; in other trials, exacerbation of Crohn disease was observed with brodalumab

Drug interaction overview

• Avoid the use of live vaccines; no data are available on the ability of live or inactive vaccines to elicit an immune response in patients being treated with brodalumab
• CYP450 substrates
  • The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g., IL-1, IL-6, IL-10, TNF-alpha, IFN) during chronic inflammation
  • Brodalumab may modulate serum levels of some cytokines
  • Therefore, upon initiating or discontinuing brodalumab in patients who are receiving concomitant drugs that 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

Pregnancy and Lactation

• There are no human data regarding the use of brodalumab in pregnant women to inform a drug-associated risk. Human IgG antibodies are known to cross the placental barrier; therefore, brodalumab may be transmitted from the mother to the developing fetus. Consult your doctor.
• It is unknown if brodalumab is distributed in human breast milk. Brodalumab is detected in the milk of lactating cynomolgus monkeys. Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for brodalumab, and any potential adverse effects on the breastfed infant from the drug or the underlying maternal condition.