Exenatide 2mg powder and solvent for prolonged-release suspension for injection pre-filled disposable devices

In animal studies, exenatide was associated with fetal deformities of ribs and vertebrae as well as slowed growth[Label]. In humans, uncontrolled hyperglycemia can be associated with an up to 25% risk of miscarriage[Label]. No human studies in pregnancy have been performed with exenatide and so exenatide should only be prescribed in pregnancy if the benefit to the mother and fetus outweigh the risks[Label].

In mice, exenatide is excreted in the milk at a concentration 2.5% of the plasma concentration though this data may not be applicable to humans[Label]. The effect of exenatide on breastfed infants is also unknown and so the risk and benefit of breastfeeding while taking exenatide must be weighed[Label]. There is no data for the use of exenatide in pediatric patients[Label].

Geriatric patients do not have different results for safety and efficacy of exenatide though caution should still be used in this group as they are at higher risk of renal impairment or other comorbidities that may affect the liklihood of adverse effects[Label]. No dosage adjustments are necessary for patients with creatinine clearance ≥50mL/min, though prescribing to patients with creatinine clearance 30-50mL/min should be done cautiously[Label]. Exenatide is not recommended for patients with creatinine clearance <30mL/min[Label].

Hepatic impairment is not expected to affect clearance of exenatide though no studies have been performed to confirm this[Label].