ZYNYZ (retifanlimab-dlwr)

There are 1 contraindications. Absolute contraindication.

Contraindication List
Lactation

There are 1 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Pregnancy

There are 2 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Hyperthyroidism
Hypothyroidism

There are 39 severe adverse reactions.

More Frequent	Less Frequent
None.	Autoimmune hepatitis Colitis Hyperthyroidism Interstitial nephritis Interstitial pneumonitis

Rare/Very Rare

Adrenocortical insufficiency Aplastic anemia Atrial fibrillation Autoimmune hemolytic anemia Diabetes mellitus DRESS syndrome Duodenitis Eaton-lambert syndrome Encephalitis Gastritis Guillain-barre syndrome Hemolytic anemia Hemophagocytic lymphohistiocytosis Histiocytic necrotizing lymphadenitis Hypoparathyroidism Hypophysitis Idiopathic thrombocytopenic purpura Iritis Meningitis Myelitis Myocarditis Myositis Organ transplant rejection Pancreatitis Pericarditis Polymyalgia rheumatica Polyneuropathy Rhabdomyolysis Sarcoidosis Stevens-johnson syndrome Thyroiditis Toxic epidermal necrolysis Uveitis Vasculitis

There are 9 less severe adverse reactions.

More Frequent	Less Frequent
Diarrhea Elevated serum lipase Fatigue Fever Musculoskeletal pain Nausea Pruritus of skin Skin rash	Hypothyroidism

Rare/Very Rare
None.

Retifanlimab-dlwr may cause fetal harm if administered to a pregnant woman based on its mechanism of action and findings from animal reproduction studies. There are no available human data on retifanlimab-dlwr use during pregnancy. In animals, inhibition of the PD-1/PD-L1 pathway has been shown to increase the risk of immune-mediated rejection of the developing fetus, resulting in fetal death.

Since human immunoglobulin G4 (IgG4) is known to cross the placenta, retifanlimab-dlwr has the potential to be transmitted from the mother to the developing fetus. Perform pregnancy testing in females of reproductive potential prior to initiating retifanlimab-dlwr. Advise pregnant women of the potential risk to a fetus.

It is unknown whether retifanlimab-dlwr distributes into human milk; effects on milk production or the breast-fed infant are also unknown. Maternal immunoglobulin G (IgG) is known to be distributed into human milk. The effects of local GI exposure and limited systemic exposure to retifanlimab-dlwr in the breast-fed infant are unknown. Because of the potential for serious adverse reactions in breast-fed infants, advise women to not breast-feed during treatment with retifanlimab-dlwr and for 4 months after the last dose.

Contraindicated
Absolute contraindication. (Human data usually available to support recommendations.) This drug should not be given to breast feeding mothers.

Drug Name	Excretion Potential	Effect on Infant	Notes
Retifanlimab-dlwr	Unknown. It is unknown whether the drug is excreted in human breast milk.	It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data)	Mfr recommends avoiding breastfeeding during tx and 4 months after last dose

The manufacturer makes no specific dosage recommendations for geriatric patients. Of the 65 patients with metastatic or recurrent locally advanced Merkel cell carcinoma treated with retifanlimab-dlwr, 79 and 37% were >=65 years and >=75 years of age, respectively. Clinical studies evaluating retifanlimab-dlwr did not include sufficient numbers of younger adults to determine whether geriatric patients respond differently than younger adults. No clinically important differences in retifanlimab-dlwr pharmacokinetics were observed based on age (range, 18-94 years).