ANKTIVA (nogapendekin alfa inbakicept-pmln)

There are 0 contraindications.

There are 0 severe contraindications.

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
No disease contraindications

There are 1 severe adverse reactions.

More Frequent	Less Frequent
Hematuria	None.

Rare/Very Rare
None.

There are 12 less severe adverse reactions.

More Frequent	Less Frequent
Chills Dysuria Fever Hyperkalemia Increased urinary frequency Musculoskeletal pain Urinary tract infection	Bladder irritability Diarrhea Fatigue Nausea Nocturia

Rare/Very Rare
None.

Systemic exposure of nogapendekin alfa inbakicept-pmln following intravesical administration at the approved dosage was below the limit of quantitation. Based on its mechanism of action, nogapendekin alfa inbakicept-pmln may cause fetal harm when administered to a pregnant woman if systemic exposure occurs. There are no available data on use of the drug in pregnant women to inform a drug-associated risk.

Animal reproductive and developmental toxicity studies have not been conducted with nogapendekin alfa inbakicept-pmln. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

There are no data on the presence of nogapendekin alfa inbakicept-pmln in human milk, or the effects on the breastfed child, or on milk production. Systemic exposure of nogapendekin alfa inbakicept-pmln in patients receiving intravesical administration at the approved dosage was below the limit of quantitation, indicating any amount in the milk will be low. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for nogapendekin alfa inbakicept and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.

Of the total number of patients in clinical studies of nogapendekin alfa inbakicept-pmln for BCG-unresponsive NMIBC, 84% were 65 years of age or older and 40% were 75 years or older. Clinical studies of nogapendekin alfa inbakicept-pmln did not include sufficient numbers of younger adult patients to determine if patients 65 years of age and older respond differently than younger adult patients.