WARNINGS AND PRECAUTIONS
Fractures
ISEMBYLD may increase the risk of fractures, including serious
fractures. Use with caution in patients with a history of low
bone density or multiple fractures. In patients who experience
fractures, weigh the risks and benefits of continuing ISEMBYLD.
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥20% of patients
treated with ISEMBYLD and more frequent than placebo) were upper
respiratory tract infections, vomiting, cough, other viral infections,
headache, gastroenteritis, pharyngitis, and hypersensitivity.
USE IN SPECIFIC POPULATIONS
Pregnancy and Lactation
Based on animal data, ISEMBYLD may cause fetal harm. There are
no adequate data on the developmental risk associated with the
use of ISEMBYLD in pregnant women.
There are no data on the presence of ISEMBYLD in human milk, the
effects on the breastfed infant, or the effects of the drug on
milk production. The developmental and health benefits of
breastfeeding should be considered along with the mother’s
clinical need for ISEMBYLD, and any potential adverse effects on
the breastfed infant.
Females and Males of Reproductive Potential
Based on animal data, ISEMBYLD may affect male and/or female
reproductive function.
Please see full
Prescribing Information.
