Safety Information
SUNLENCA® Important Safety Information
IMPORTANT SAFETY INFORMATION
Who should not receive or take SUNLENCA?
Do not receive or take SUNLENCA if you take other medicines called strong CYP3A inducers. Ask your healthcare provider if you are not sure.
What are the possible side effects of SUNLENCA?
Serious side effects of SUNLENCA may include:
- Changes in your immune system. Your immune system may get stronger and begin to fight infections that may have been hidden in your body. Tell your healthcare provider if you have any new symptoms after you start taking SUNLENCA.
- Injection site reactions may happen and may include swelling, pain, redness, skin hardening, small mass or lump, and itching. Hardened skin or lumps at the injection site usually can be felt but not seen. If you develop hardened skin or a lump, it may take longer than other reactions at the injection site to go away, and the injection site may not completely heal on its own. Tell your healthcare provider if you have any injection site reactions.
The most common side effects of SUNLENCA were nausea and injection site reactions. These are not all the possible side effects. Tell your healthcare provider if you have any side effects that bother you or don’t go away.
What should I tell my healthcare provider before taking SUNLENCA?
- All your health problems.
- All the medicines you take, including prescription and over-the-counter medicines, antacids, laxatives, vitamins, and herbal supplements, including St. John’s wort. SUNLENCA and other medicines may affect each other. Keep a list of all your medicines and show it to your healthcare provider and pharmacist, and ask if it is safe to take SUNLENCA with all of your other medicines. Do not start other medicines without telling your healthcare provider. SUNLENCA may affect certain other medicines for up to 9 months after your last injection.
- If you are pregnant or plan to become pregnant. It is not known if SUNLENCA can harm your unborn baby. Tell your healthcare provider if you become pregnant while taking SUNLENCA.
- If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed. HIV-1 can be passed to the baby in breast milk.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
What is SUNLENCA?
SUNLENCA is a prescription medication that is used with other human immunodeficiency virus-1 (HIV-1) medicines to treat HIV-1 infection in adults:
- who have received HIV-1 medicines in the past, and
- who have HIV-1 virus that is resistant to many HIV-1 medicines, and
- whose current HIV-1 medicines are failing. Your HIV-1 medicines may be failing because the HIV-1 medicines are not working or no longer work, you are not able to tolerate the side effects, or there are safety reasons why you cannot take them.
SUNLENCA does not cure HIV-1 or AIDS. HIV-1 is the virus that causes AIDS.
