SKYRIZI PEN (risankizumab-rzaa)

There are 1 contraindications. Absolute contraindication.

Contraindication List
Active tuberculosis

There are 2 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Inactive tuberculosis
Severe infection

There are 0 moderate contraindications.

There are 11 severe adverse reactions.

More Frequent	Less Frequent
Infection	None.

Rare/Very Rare
Anaphylaxis Cellulitis Herpes zoster Hyperbilirubinemia Hypersensitivity drug reaction Increased alanine transaminase Increased alkaline phosphatase Osteomyelitis Pneumonia Sepsis

There are 18 less severe adverse reactions.

More Frequent	Less Frequent
Dermatophytosis Fatigue Headache disorder Upper respiratory infection	Acute abdominal pain Anemia Arthralgia Back pain Fever Hypercholesterolemia Injection site sequelae Urinary tract infection

Rare/Very Rare
Allergic rhinitis Eczema Facial edema Folliculitis Skin rash Urticaria

Available data regarding use of risankizumab in pregnant women are inadequate for establishing a drug-associated risk of major birth defects, miscarriage , or other adverse maternal or fetal outcomes. Monoclonal antibodies can cross the placenta and may cause immunosuppression in the in utero-exposed infant. Consider the risks and benefits of administering live vaccines to infants exposed to risankizumab in utero.

Since the duration of persistence of risankizumab in infant serum after birth is not well established and a specific time frame to delay immunization is unknown, consider delaying administration of live vaccines for a minimum of 5 months after birth due to the half-life of risankizumab. In an enhanced pre- and post-natal developmental study, pregnant cynomolgus monkeys received risankizumab 5 or 50 mg/kg once weekly during the period of organogenesis up to parturition. Fetal/infant loss was observed at the 50 mg/kg dose, which resulted in approximately 5 times the exposure in humans administered the maximum recommended 1200 mg induction dose and 32 times the exposure to the maximum recommended 360 mg maintenance dose.

No malformations and no adverse effects on growth and development, immunologic development, or neurobehavioral development were observed in infant monkeys from birth through 6 months of age. Following delivery, most adult female monkeys and all infant monkeys from the risankizumab-treated groups had measurable serum concentrations of the drug for up to 91 days postpartum. The clinical relevance of these findings is unknown.

A pregnancy exposure registry has been established to monitor outcomes in women who become pregnant while receiving risankizumab-rzaa; patients may be enrolled by calling 877-302-2161or visiting https://glowpregnancyregistry.com.

It is not known whether risankizumab is distributed into human milk, affects milk production, or affects breast-fed infants. Endogenous maternal IgG and monoclonal antibodies are transferred in human milk. Because risankizumab is a large protein molecule, absorption by a breast-fed infant is thought to be unlikely since the drug will probably be destroyed in the infant's GI tract.

The effects of local GI and limited systemic exposure in the breast-fed infant are unknown. Consider the benefits of breast-feeding along with the mother's clinical need for risankizumab and any potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.

The manufacturer makes no specific dosage recommendations for geriatric patients. Of the 6862 patients who received risankizumab-rzaa in clinical trials, 664 were >=65 years of age and 71 were >=75 years of age. Clinical trials of patients for each approved indication did not include sufficient numbers of patients >=65 years of age to determine whether geriatric patients respond differently than younger adults. No clinically meaningful differences in the pharmacokinetics of risankizumab-rzaa were observed based on age.