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Use in Pregnancy: Embryo-fetal Toxicity: OPSYNVI is contraindicated for use during pregnancy because it may cause fetal harm based on animal data [see Use in Pregnancy under Contraindications, Use in Pregnancy: Embryo-fetal Toxicity under Precautions, Use in Pregnancy & Lactation].
Therefore, for females of reproductive potential, exclude pregnancy before the start of treatment with OPSYNVI. Advise use of effective contraception before the initiation of treatment, during treatment, and for one month after stopping treatment with OPSYNVI [see Pregnancy Testing in Females of Reproductive Potential under Dosage & Administration, Use in Pregnancy & Lactation]. When pregnancy is detected, discontinue OPSYNVI as soon as possible [see Use in Pregnancy: Embryo-fetal Toxicity under Precautions].
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