ADAKVEO (crizanlizumab-tmca)

There are 0 contraindications.

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

Severe List
Pregnancy

There are 0 moderate contraindications.

There are 0 severe adverse reactions.

There are 20 less severe adverse reactions.

More Frequent	Less Frequent
Arthralgia Back pain Fever Nausea	Acute abdominal pain Chills Diarrhea Dizziness Dyspnea Fatigue Hyperhidrosis Injection site sequelae Myalgia Non-cardiac chest pain Pain in oropharynx Pruritus of skin Urticaria Vomiting Vulvovaginitis Wheezing

Rare/Very Rare
None.

Based on data from animal studies, crizanlizumab-tmca has the potential to cause fetal harm when administered to a pregnant woman. In an animal reproduction study, IV administration of crizanlizumab-tmca to pregnant cynomolgus monkeys from the onset of organogenesis through delivery resulted in a non-dose related increase in fetal loss (abortions/stillbirths) at doses approximately 2.8 times the exposure at the recommended clinical dosage (5 mg/kg/dose once every 4 weeks).

There are insufficient human data on crizanlizumab-tmca use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Women with sickle cell disease have an increased risk of adverse pregnancy outcomes for the mother and the fetus. Pregnant women are at greater risk for vasoocclusive crises, pre-eclampsia, eclampsia, and maternal mortality.

For the fetus, there is an increased risk for intrauterine growth restriction, preterm delivery, low birth weight, and perinatal mortality. Advise pregnant women of the potential risk of crizanlizumab-tmca to a fetus. Crizanlizumab-tmca should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the fetus.

There are no data on the presence of crizanlizumab-tmca in human or animal milk, the effects on the breastfed child, or the effects on milk production. Maternal IgG is known to be present in human milk. The effects of local GI exposure and limited systemic exposure in the breastfed child to crizanlizumab-tmca are unknown. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for crizanlizumab-tmca and any potential adverse effects on the breastfed child from crizanlizumab-tmca or from the underlying maternal condition.

The manufacturer makes no specific dosage recommendations for geriatric patients. Clinical studies of crizanlizumab-tmca did not include sufficient numbers of patients >=65 years of age to determine whether they respond differently from younger patients.