bimekizumab (Rx)

>10%

Upper respiratory tract infections (15%)

1-10%

Oral candidiasis (9%)

Headache (3%)

Injection site reactions (3%)

Tinea infections (3%)

Gastroenteritis (2%)

Passive suicidal ideation (1.8%)

Herpes simplex infection (1%)

Acne (1%)

Folliculitis (1%)

Other Candida infections (1%)

Fatigue (1%)

Contraindications

None

Cautions

Infections

• May increase risk of infections
• Do not initiate treatment in patients with any clinically important active infection until infection resolves or is adequately treated
• In patients with a chronic infection or a history of recurrent infection, consider risks and benefits before prescribing
• Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur
• If an infection develops or patient is not responding to standard therapy, closely monitor patient and discontinue therapy until infection resolves

• Tuberculosis

  • Evaluate for tuberculosis (TB) infection before initiating treatment
  • Avoid use in patients with active TB infection
  • Initiate treatment of latent TB before administering
  • Consider anti-TB therapy before initiating in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed
  • Closely monitor for signs and symptoms of active TB during and after treatment

Liver abnormalities

• May increase liver enzymes
• Liver serum transaminase elevations >3x the upper limit of normal (ULN) were reported
• Elevated liver serum transaminases resolved after discontinuation
• Test liver enzymes, alkaline phosphatase, and bilirubin at baseline, periodically during treatment, and according to routine patient management
• If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt therapy until liver injury is ruled out
• Permanently discontinue in patients with causally associated combined elevations of transaminases and bilirubin
• Avoid use in patients with acute liver disease or cirrhosis; such patients may be at increased risk for severe hepatic injury

Inflammatory bowel disease

• Cases of inflammatory bowel disease (IBD) have been reported in patients treated with interleukin-17 (IL-17) inhibitors
• Avoid use in patients with active IBD
• During treatment, monitor for signs and symptoms of IBD and discontinue treatment if new onset or worsening of signs and symptoms occurs

Suicidal ideation and behavior

• In clinical trials, higher rates of suicidal ideation were reported in treated patients compared with placebo
• Weigh potential risks and benefits before use in patients with a history of severe depression or suicidal ideation or behavior
• Advise monitoring for emerging or worsening of depression, suicidal ideation, or other mood changes
• If such changes occur, advise them to promptly seek medical attention or call the National Suicide and Crisis Lifeline at 988
• Refer treated patients with new or worsening symptoms of depression or suicidal ideation and/or behavior to a mental health professional, as appropriate
• Re-evaluate the risks and benefits of continuing treatment if such events occur

Drug interaction overview

• Immunizations

  • Before initiating therapy, complete all age-appropriate vaccinations according to current immunization guidelines
  • Avoid the use of live vaccines in treated patients
  • Limited data are available regarding coadministration with non-live vaccines

• CYP450 substrates

  • Upon initiation or discontinuation of bimekizumab in patients who are receiving concomitant drugs that are CYP450 substrates with a narrow therapeutic index, consider monitoring for effect (eg, for warfarin) or drug concentration (eg, cyclosporine) and consider dosage modification of the CYP450 substrate
  • Formation of CYP450 enzymes can be altered by increased levels of certain cytokines (eg, IL-1, IL-6, IL-10, TNF-alpha, IFN) during chronic inflammation
  • Bimekizumab may modulate serum levels of some cytokines

Pregnancy

Available data on use in pregnant females are insufficient to evaluate for drug-associated risks of major birth defects, miscarriages, or other adverse maternal or fetal outcomes

Transport of human IgG antibody across the placenta increases as pregnancy progresses and peaks during the third trimester; therefore, bimekizumab may be transmitted from the mother to the developing fetus

Since bimekizumab may interfere with immune response to infections, consider risks and benefits before administering live vaccines to infants exposed in utero

There are no data regarding infant serum levels of bimekizumab at birth and duration of persistence of bimekizumab in infant serum after birth

Although a specific timeframe to delay live virus immunizations in infants exposed in utero is unknown, may consider a minimum of 4 months after birth because of the half-life of bimekizumab

Pregnancy exposure registry

• Monitors pregnancy outcome in females exposed to bimekizumab during pregnancy
• For more information, healthcare providers or patients can contact the Organization of Teratology Information Specialists (OTIS) Autoimmune Diseases Study at 1-877-311- 8972 or visit http://mothertobaby.org/pregnancy-studies/

Animal data

• No adverse developmental effects were observed in infants born to pregnant monkeys after SC administration of bimekizumab during organogenesis through parturition at doses up to 38 times the maximum recommended human dose (MRHD)

Lactation

There are no data on presence of bimekizumab in human or animal milk, effects on breastfed infants, or effects on milk production

Endogenous IgG and monoclonal antibodies are transferred in human milk

Effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to bimekizumab are unknown

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Humanized monoclonal IgG1 antibody that selectively inhibits interleukin-17A (IL-17A) and IL-17F

Interleukins are naturally occurring cytokines involved in normal inflammatory and immune responses and play a key role in the pathogenesis of plaque psoriasis

Absorption

Peak plasma concentration: 25 mcg/mL

Peak plasma time: 3-4 days

Bioavailability: 70% (healthy subjects)

Distribution

Vd (steady-state): 11.2 L

Metabolism

Expected to be degraded into small peptides by catabolic pathways

Elimination

Clearance: 0.337 L/day

Half-life: 23 days

SC Preparation

Before injecting, remove carton from refrigerator and allow vial to reach room temperature (30-45 minutes) without removing prefilled syringes or autoinjectors from carton to protect from light

Inspect visually for particulate matter and discoloration before administering, whenever solution and container permit; solution is clear to slightly opalescent, and colorless to pale brownish- yellow

Discard if solution contains visible particles, is discolored, or cloudy

SC Administration

Use under guidance and supervision of a healthcare professional

May self-inject after training in SC injection technique

Provide proper training to patients and/or caregivers on SC injection technique

Each prefilled syringe or autoinjector contains 160 mg of bimekizumab

For each dose, inject 2 separate 160 mg single-dose prefilled syringes or autoinjectors SC at different anatomic locations (eg, thighs, abdomen, or back of upper arm)

Discard the syringes or autoinjectors after use; do not reuse

Do not inject within 2 inches (5 cm) of navel or into areas where skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis

Administration in the upper, outer arm may only be performed by a healthcare professional or caregiver

Missed dose

• Administer dose as soon as possible
• Thereafter, resume dosing at regularly scheduled time

Storage

Refrigerate at between 2-8ºC (36-46ºF)

Keep in original carton to protect it from light until time of use

Do not freeze

Do not shake

Do not use beyond expiration date

Does not contain a preservative; discard any unused portion

Not made with natural rubber latex

Prefilled syringe or autoinjector removed from refrigerator

• May be store at room temperature up to 25ºC (77ºF) in original carton for a single period of up to 30 days
• Once prefilled syringes or autoinjectors have been stored at room temperature, do not place back in refrigerator
• Write date removed from the refrigerator in space provided on carton and discard if not used within a 30-day period