IMPORTANT SAFETY INFORMATION
Patients taking SELZENTRY have experienced serious side effects, including liver problems (liver toxicity). An allergic reaction may happen before liver problems occur. Stop taking SELZENTRY and call your healthcare provider right away if you get any of the following symptoms: an itchy rash on your body (allergic reaction), your skin or eyes look yellow (jaundice), dark (tea-colored) urine, vomiting, or upper right stomach area (abdominal) pain.
Who should not take SELZENTRY: People with severe kidney problems or who are on hemodialysis and are taking certain other medications should not take SELZENTRY. Talk to your healthcare provider before taking this medicine if you have kidney problems.
Before you take SELZENTRY, tell your healthcare provider if you have liver problems including a history of hepatitis B or C, heart problems, kidney problems, low blood pressure or take medicines to lower blood pressure, any other medical condition, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. It is not known if SELZENTRY may harm your unborn baby.
People taking SELZENTRY may still develop infections, including opportunistic infections, or other conditions that happen with HIV-1 infection.
Possible serious side effects of SELZENTRY include:
Liver problems (see above)
Serious skin rash and allergic reactions: Severe and potentially life-threatening skin and allergic reactions have been reported in some patients taking SELZENTRY. If you develop a rash with any of the following symptoms, stop using SELZENTRY and contact your doctor right away: fever, generally ill feeling, muscle aches, blisters or sores in your mouth, blisters or peeling of the skin, redness or swelling of the eyes, swelling of the mouth, face, or lips, problems breathing, yellowing of the skin or the whites of your eyes, dark or tea-colored urine, pain, aching, or tenderness on the right side below the ribs, loss of appetite, or nausea/vomiting
Heart problems, including heart attack
Low blood pressure when standing up (postural hypotension), which can cause dizziness or fainting. Do not drive a car or operate heavy machinery if you have dizziness while taking SELZENTRY. Low blood pressure may occur in patients with severe kidney problems
Changes in your immune system. A condition called Immune Reconstitution Syndrome can happen when you start taking HIV medicines. Your immune system may get stronger and could begin to fight infections that have been hidden in your body such as pneumonia, herpes virus, or tuberculosis. Tell your healthcare provider if you develop new symptoms after starting your HIV medicines
Possible chance of infection or cancer. SELZENTRY affects other immune system cells and therefore may possibly increase your chance for getting other infections or cancer
Do not breastfeed. You should not breastfeed because HIV-1 can be passed to your baby in your breast milk. We do not know whether SELZENTRY can be passed to your baby or whether it could harm your baby.
The long-term effects of SELZENTRY are not known at this time.
The most common side effects of SELZENTRY include colds, cough, fever, rash, and dizziness. Tell your healthcare provider about any side effect that bothers you or does not go away. These are not all of the side effects with SELZENTRY. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements. Certain other medicines may affect the levels of SELZENTRY in your blood. Your healthcare provider may need to change your dose of SELZENTRY when you take it with certain medicines.
Do not take products that contain St. John's wort (Hypericum perforatum) because it may lower the levels of SELZENTRY in your blood so that it will not work to treat your CCR5-tropic HIV-1 infection.
It is important to take all of your anti-HIV medicines as prescribed and at the same time(s) each day. Do not change your dose or stop taking SELZENTRY or your other anti-HIV medicines without first talking with your healthcare provider. If you take too much SELZENTRY, call your healthcare provider or the poison control center right away. If you forget to take SELZENTRY, take the next dose of SELZENTRY as soon as possible and then take your next scheduled dose at its regular time. If it is less than 6 hours before your next scheduled dose, do not take the missed dose. Instead, wait and take the next dose at the regular time. When your supply of SELZENTRY starts to run low, ask your healthcare provider or pharmacist for a refill.
SELZENTRY comes in 150-mg and 300-mg tablets. Take SELZENTRY 2 times a day. Swallow tablets whole. Do not chew the tablets. You can take SELZENTRY tablets with or without food.