Original Boxed Alcohol Warning

Revised Boxed Alcohol Warning

Contraindicated with Alcohol

Interaction with Alcohol

The use of ADDYI and alcohol increases the risk of severe hypotension and syncope [see Warnings and Precautions (5.1)]. Therefore, alcohol use is contraindicated in patients taking ADDYI [see Contraindications (4)]. Before prescribing ADDYI, assess the likelihood of the patient abstaining from alcohol, taking into account the patient’s current and past drinking behavior, and other pertinent social and medical history. Counsel patients who are prescribed ADDYI about the importance of abstaining from alcohol use.

Because of the increased risk of hypotension and syncope due to an interaction with alcohol, ADDYI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ADDYI REMS Program [see Warnings and Precautions (5.2)].

The use of ADDYI and alcohol together close in time increases the risk of severe hypotension and syncope [see Warnings and Precautions (5.1)]. Counsel patients to wait at least two hours after consuming one or two standard alcoholic drinks before taking ADDYI at bedtime or to skip their ADDYI dose if they have consumed three or more standard alcoholic drinks that evening.

Sprout’s Addyi Loses Blanket Alcohol Contraindication And REMS Distribution Restrictions

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