Opsynvi Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling.
Embryo-Fetal Toxicity: Counsel female patients of reproductive potential about the need to use effective methods of contraception prior to initiation of treatment with OPSYNVI, during treatment, and for one month after treatment discontinuation. Females of reproductive potential should have a negative pregnancy test prior to treatment with OPSYNVI [see Use in Pregnancy under Contraindications, and Use in Pregnancy & Lactation].
Patients should be instructed to contact their physician if they suspect they may be pregnant. Patients should seek additional contraceptive advice from a gynecologist or similar expert as needed.
Educate and counsel females of reproductive potential on the use of emergency contraception in the event of unprotected sex or contraceptive failure.
Advise pre-pubertal females to report any changes in their reproductive status immediately to her prescriber.
Review the Medication Guide with female patients.
Lactation: Advise women not to breastfeed during treatment with OPSYNVI [see Use in Pregnancy & Lactation].
Infertility: Advise males of reproductive potential that OPSYNVI may impair fertility [see Decreased Sperm Count under Precautions, Pharmacology: Pharmacodynamics and Toxicology: Preclinical safety data: Carcinogenesis, Mutagenesis, Impairment of Fertility under Actions, and Use in Pregnancy & Lactation].
Hepatotoxicity: Some members of this pharmacological class are hepatotoxic. Educate patients on signs of hepatotoxicity. Advise patients that they should contact their doctor if they have unexplained nausea, vomiting, right upper quadrant pain, fatigue, anorexia, jaundice, dark urine, fever, or itching.
Hemoglobin Decrease: Advise patients that they may develop anemia. Advise patients that they will have blood tests to check their red blood cells before starting OPSYNVI.
Use with Organic Nitrates or Guanylate Cyclase (GC) Stimulators: Inform patients of contraindication of OPSYNVI with any use of organic nitrates or GC stimulators.
Vision Loss: Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking OPSYNVI. Such an event may be a sign of NAION. Also discuss with patients that there is an increased risk of NAION in individuals who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators such as PDE5 inhibitors.
Hearing Loss: Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking OPSYNVI. These events may be accompanied by tinnitus and dizziness.
Fluid Retention: Educate patients on signs of fluid retention. Advise patients that they should contact their doctor if they have unusual weight increase or swelling of the ankles or legs.
Administration: Patients should be advised not to cut, crush, or chew tablets.