bimekizumab

REMS

Moderate to severe plaque psoriasis in patients who are candidates for systemic therapy or phototherapy.
Active psoriatic arthritis.
Active non-radiographic axial spondyloarthritis with objective signs of inflammation.
Active ankylosing spondylitis.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Active infection;
Acute liver disease or cirrhosis;
Active inflammatory bowel disease.

Use Cautiously in:

History of severe depression or suicidal ideation/behavior;
History of chronic or recurrent infection;
History of exposure to tuberculosis (TB);
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: acne

GI: ↑liver enzymes, inflammatory bowel disease

Local: injection site reactions

Neuro: fatigue, headache, SUICIDAL IDEATION/BEHAVIOR

Misc: infection (including reactivation of TB)

Interactions ⬆ ⬇

Drug-drug:

May ↓ antibody response to live-virus vaccines and ↑ risk of adverse reactions; avoid concurrent use.
May affect activity of CYP450 enzymes and may alter the effectiveness/toxicity of CYP450 substrate, including warfarin and cyclosporine; close monitoring is recommended and necessary dose modifications undertaken.

Availability ⬆ ⬇

Solution for solution (prefilled syringes and prefilled autoinjectors): 160 mg/mL

Route/Dosage ⬆ ⬇

Plaque Psoriasis

PO (Adults ≥120 kg): 320 mg (as two 160-mg injections) every 4 wk.
PO (Adults <120 kg): 320 mg (as two 160-mg injections) every 4 wk for the first 16 wk; then 320 mg (as two 160-mg injections) every 8 wk.

Psoriatic Arthritis

PO (Adults ): Without concomitant plaque psoriasis: 160 mg every 4 wk. With concomitant plaque psoriasis: Use regimen indicated for plaque psoriasis.

Non-Radiographic Axial Spondyloarthritis and Ankylosing Spondylitis

PO (Adults ): 160 mg every 4 wk.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Monoclonal antibody that prevents interleukin (IL) 17A and 17F from interacting with the IL17 receptor, which inhibits the release of proinflammatory cytokines.

Therapeutic effects:

Reduced severity of plaques in plaque psoriasis.
Reduced disease activity in psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis.

Classifications ⬆ ⬇

Therapeutic Classification: antipsoriatics

Pharmacologic Classification: monoclonal antibodies, interleukin antagonists

Pharmacokinetics ⬆ ⬇

Absorption: 70% absorbed following SUBQ administration.

Distribution: Not widely distributed to tissues.

Metabolism/Excretion: Degraded into small peptides by catabolic pathways. Excretion pathway unknown.

Half-Life: 23 days.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	3–4 days	unknown

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy and with each Rx refill. Provide proper training on subcutaneous injection technique. If a dose is missed, take as soon as remembered then resume dosing at the regular scheduled time. Do not double dose.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Instruct patient to notify a health care professional if signs and symptoms of infection or change in bowel movements occur.
Advise patients and caregivers to monitor for the emergence or worsening of depression, suicidal ideation, or other mood changes. If changes occur, seek medical attention immediately, or call the National Suicide and Crisis Lifeline at 988.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Advise patient there is a pregnancy exposure registry that monitors pregnancy outcomes in women. Health care professionals or patients can contact the Organization of Teratology Information Specialists AutoImmune Diseases Study at 1-877-3118972 or visit http://mothertobaby.org/pregnancy-studies/.

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Indications ⬇