TREMFYA PEN (guselkumab)

There are 1 contraindications. Absolute contraindication.

Contraindication List
Active tuberculosis

There are 4 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Acute hepatic failure
Hepatic cirrhosis
Inactive tuberculosis
Infection

There are 0 moderate contraindications.

There are 5 severe adverse reactions.

More Frequent	Less Frequent
Infection	Abnormal hepatic function tests

Rare/Very Rare
Anaphylaxis Hypersensitivity drug reaction Neutropenic disorder

There are 15 less severe adverse reactions.

More Frequent	Less Frequent
Acute abdominal pain Injection site sequelae Upper respiratory infection	Arthralgia Bronchitis Dermatophytosis Diarrhea Fatigue Gastroenteritis Headache disorder Herpes simplex infection Tinea cruris Tinea manuum Tinea pedis

Rare/Very Rare
Skin rash

Clinical data from the biomedical literature, postmarketing reports, and an ongoing pregnancy registry are insufficient to establish a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes with guselkumab administration during pregnancy. Human immunoglobulin G (IgG) is known to cross the placenta; thus, the potential exists for fetal exposure to the drug. An embryofetal development study in cynomolgus monkeys revealed no evidence of adverse developmental effects after subcutaneous guselkumab administration during organogenesis through parturition; however, neonatal deaths in monkeys were observed at dose exposures 4 to 18 times the exposure in humans.

No guselkumab-related effects on functional or immunologic development were observed in the offspring from birth through 6 months of age. A pregnancy registry has been established to monitor fetal outcomes of pregnant women exposed to guselkumab; patients or clinicians may contact the registry at 1-877-311-8972 or by visiting https://mothertobaby.org/ongoing-study/tremfya-guselkumab/.

It is not known whether guselkumab is distributed into human milk, affects milk production, or affects the breast-fed infant. Endogenous maternal IgG and monoclonal antibodies are transferred into human milk; the effects of local GI exposure and the extent of systemic exposure in the breastfed infant to guselkumab are unknown. Consider the benefits of breast-feeding and the importance of guselkumab to the woman along with potential adverse effects on the breast-fed infant from the drug or underlying maternal condition.

Of the 4303 patients with plaque psoriasis, psoriatic arthritis, or ulcerative colitis who received guselkumab in clinical trials, 240 patients were >=65 years of age, and 23 patients were >=75 years of age. The clinical trials for each indication did not include sufficient numbers of patients >=65 years of age to determine whether geriatric patients respond differently than younger adults. Age was not associated with any clinically meaningful differences in the pharmacokinetics of guselkumab.