Important information about opsynvi

• OPSYNVI can cause serious birth defects if taken during pregnancy.¹
• Females should not be pregnant when they start taking OPSYNVI or become pregnant during treatment with OPSYNVI.¹
• Females who are able to get pregnant should have a negative pregnancy test before beginning treatment with OPSYNVI.¹
  • Talk to your healthcare provider about your menstrual cycle. Your healthcare provider will decide when to do the pregnancy test and will order a pregnancy test for you depending on your menstrual cycle.
• Females who are able to get pregnant should use effective birth control before starting treatment with OPSYNVI, during treatment, and for 1 month after stopping OPSYNVI because the medicine may still be in the body.¹
  • Talk with your healthcare provider or gynecologist (a doctor who specializes in female reproduction) to find out about options for acceptable birth control that you may use to prevent pregnancy during treatment with OPSYNVI.
  • If you decide that you want to change the form of birth control that you use, talk with your healthcare provider or gynecologist to be sure that you choose another acceptable form of birth control.
• Do not have unprotected sex.¹
  • Talk to your healthcare provider or pharmacist right away if you have unprotected sex or if you think your birth control has failed. Your healthcare provider may talk with you about using emergency birth control.
• Tell your healthcare provider right away if you miss a menstrual period or think you may be pregnant.¹ 

SUMMARY

What are the Possible Side Effects of OPSYNVI?

• OPSYNVI can cause serious side effects, including¹:
  • Serious birth defects if taken during pregnancy.
    • See "Important Information about OPSYNVI" above.
  • Liver problems. OPSYNVI can cause liver problems. Your healthcare provider should do blood tests to check your liver before you start taking OPSYNVI. Tell your healthcare provider if you have any of the following symptoms of liver problems during treatment with OPSYNVI.
    • Nausea or vomiting
    • Yellowing of your skin or whites of your eyes
    • Pain in the upper right stomach
    • Dark urine
    • Tiredness
    • Fever
    • Loss of appetite
    • Itching
  • Decreased blood pressure (hypotension). OPSYNVI can cause low blood pressure that lasts for a short time.
  • Low red blood cell levels (anemia) can occur with OPSYNVI treatment, usually during the first weeks after starting therapy.
    • Your healthcare provider will do blood tests to check your red blood cells before starting and as needed during treatment with OPSYNVI.
  • Vision Loss. OPSYNVI can cause decreased eyesight or permanent loss of vision in 1 or both eyes, which could be a sign of non-arteritic ischemic optic neuropathy (NAION). There is an increased risk of NAION in people who have already had NAION in 1 eye.
    • If you notice a sudden decrease or loss of vision in 1 or both eyes, contact your healthcare provider right away.
  • Hearing problems. Sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness, can happen during treatment with OPSYNVI.
    • If you notice a sudden decrease or loss of hearing, contact your healthcare provider right away.
  • Too much fluid in your body (fluid retention). Fluid retention can happen within weeks after starting OPSYNVI and could lead to hospitalization.
    • Tell your healthcare provider right away if you have any unusual weight gain, trouble breathing, or swelling of your ankles or legs. Your healthcare provider will look for the cause of any fluid retention and may stop treatment with OPSYNVI.
  • Decreased sperm count. OPSYNVI can cause decreased sperm counts in males and may affect the ability to father a child.
    • Tell your healthcare provider if being able to have children is important to you.
  • Prolonged erection. Erections that last more than 4 hours, with or without pain, can happen during treatment with OPSYNVI. Painful erections (priapism) can cause permanent damage to the penis if not treated right away.
    • Tell your healthcare provider right away if you have an erection that lasts longer than 4 hours, with or without pain.
• The most common side effects of OPSYNVI include¹:
  • Too much fluid in your body (fluid retention) and swelling caused by fluid retention (edema)
  • Anemia
  • Headache, including migraine headache
• These are not all the possible side effects of OPSYNVI.¹
  • Call your doctor for medical advice about side effects. You may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088.

ADDITIONAL INFORMATION

This information is provided ONLY in response to your request and is not intended as medical advice, to promote the use of our product, or suggest using it in any manner other than as described in the PRESCRIBING INFORMATION. All decisions regarding your medical treatment should be made with your healthcare professional(s). Please contact your healthcare professional(s) to discuss the information in this response.

Please refer to the attached full PRESCRIBING INFORMATION and the PATIENT MEDICATION GUIDE for OPSYNVI.¹