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Prolia (Denosumab) - Drug Interactions, Contraindications, Overdosage, etc



In subjects with postmenopausal osteoporosis, Prolia (60 mg subcutaneous injection) did not affect the pharmacokinetics of midazolam, which is metabolized by cytochrome P450 3A4 (CYP3A4), indicating that it should not affect the pharmacokinetics of drugs metabolized by this enzyme in this population [see Clinical Pharmacology].


There is no experience with overdosage with Prolia.



Pre-existing hypocalcemia must be corrected prior to initiating therapy with Prolia [see Warnings and Precautions ].


Prolia may cause fetal harm when administered to a pregnant woman.  In utero denosumab exposure in cynomolgus monkeys resulted in increased fetal loss, stillbirths, and postnatal mortality, along with evidence of absent lymph nodes, abnormal bone growth and decreased neonatal growth.  Prolia is contraindicated in women who are pregnant.  If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see Use in Specific Populations].


Prolia is contraindicated in patients with a history of systemic hypersensitivity to any component of the product.  Reactions have included anaphylaxis, facial swelling and urticaria [see Warnings and Precautions Adverse Reactions].

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