BIMZELX (bimekizumab-bkzx)

There are 1 contraindications. Absolute contraindication.

Contraindication List
Active tuberculosis

There are 5 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Depression
Inactive tuberculosis
Infection
Inflammatory bowel disease
Suicidal ideation

There are 0 moderate contraindications.

There are 4 severe adverse reactions.

More Frequent	Less Frequent
None.	Candidiasis

Rare/Very Rare
Hypersensitivity drug reaction Inflammatory bowel disease Suicidal ideation

There are 35 less severe adverse reactions.

More Frequent	Less Frequent
Cough Diarrhea Musculoskeletal pain Myalgia Oral candidiasis Pharyngitis Tonsillitis Upper respiratory infection Urinary tract infection Vulvovaginal candidiasis	Acne vulgaris Bronchitis Dermatophytosis Eczema Fatigue Folliculitis Gastroenteritis Headache disorder Herpes simplex infection Infection of ear Injection site erythema Injection site inflammation Injection site pain Oropharyngeal candidiasis Pain in oropharynx Skin inflammation Skin rash Stomatitis

Rare/Very Rare
Abnormal hepatic function tests Acute bacterial otitis media Conjunctivitis Cutaneous candidiasis Esophageal candidiasis Neutropenic disorder Otitis externa

Limited data regarding use of bimekizumab-bkzx in pregnant women are insufficient to inform a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Human immunoglobulin G (IgG) is known to cross the placenta, with transport peaking during the third trimester; thus, the potential exists for fetal exposure to the drug. Reproductive and developmental toxicity studies in pregnant monkeys revealed no evidence of adverse developmental effects with bimekizumab-bkzx exposure levels up to 38 times the human exposure at the maximum recommended human dose.

Because bimekizumab-bkzx may interfere with immune responses to infections, consider the risks and benefits prior to administering live vaccines to infants exposed to bimekizumab-bkzx in utero. Although a specific time frame to delay live virus immunizations in infants exposed in utero has not been established, a minimum of 4 months after birth may be considered based on the drug half-life. A pregnancy registry has been established to monitor fetal outcomes of pregnant women who are exposed to bimekizumab-bkzx; patients or clinicians may contact the registry at 1-877-311-8972 for more information.

It is not known whether bimekizumab-bkzx is distributed into human milk; the effects of the drug on the breast-fed infant or on milk production are also unknown. Endogenous maternal IgG and monoclonal antibodies are transferred in human milk. The effects of local gastrointestinal and limited systemic exposure in the breast-fed infant are unknown. Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for the drug and any potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.

Of the 1789 patients with plaque psoriasis who received subcutaneous bimekizumab-bkzx in clinical trials, a total of 153 patients were >=65 years of age, and 18 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 to determine whether geriatric patients respond differently than younger adults.