IMPORTANT SAFETY INFORMATION Prescribing Information including Boxed WARNINGS and Medication Guide
Patients taking SELZENTRY have experienced serious side effects, including liver problems. 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.CONTINUED BELOW
SELZENTRY®(maraviroc)
You’ve Changed. Has Your HIV Treatment?
SELZENTRY is the only oral HIV medication that works on the outside of T-cells.
As part of combination therapy, SELZENTRY helps defend T-cells against CCR5 (also known as R5) HIV-1, a common type of HIV, by helping to keep R5 HIV-1 from entering T-cells. On this site, you will learn what SELZENTRY does, how it works, and ways to help pay for SELZENTRY. Talk to your doctor to see how a prescreening test can tell if SELZENTRY is an option for you.
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INDICATION
SELZENTRY (maraviroc) is a type of medicine called a CCR5 antagonist that is used to treat only CCR5-tropic HIV-1 in adults. SELZENTRY must be used with other HIV medicines and is not recommended in patients with dual/mixed or CXCR4-tropic HIV-1. Your healthcare provider will do a blood test (tropism test) to see if you have been infected with CCR5-tropic HIV-1 before prescribing SELZENTRY for you. SELZENTRY does not cure HIV-1 infection or AIDS, and it does not work in all people with CCR5-tropic HIV-1 infection. People taking SELZENTRY may still develop infections, including opportunistic infections or other conditions that happen with HIV-1 infection. The long-term effects of SELZENTRY are not known at this time. SELZENTRY has not been studied in children less than 16 years of age. It is very important that you stay under the care of your healthcare provider during treatment with SELZENTRY.


IMPORTANT SAFETY INFORMATION
Patients taking SELZENTRY have experienced serious side effects, including liver problems. 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.

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.

Avoid doing things that can spread HIV-1 infection:

  • Do not share needles or other injection equipment
  • Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades
  • Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood

Do not breastfeed. You should not breastfeed because HIV-1 can be passed to the baby in breast milk. We do not know whether SELZENTRY can be passed to your baby or whether it could harm your baby

It is important to take all of your anti-HIV medicines as prescribed and at the same time(s) each day. Do not alter the dose or discontinue therapy without consulting your healthcare provider. If you take too much SELZENTRY, call your healthcare provider or the poison control center right away. If a dose is missed, you should 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, you should 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.

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 or 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 increase your chance for getting other infections or cancer

MOST COMMON SIDE EFFECTS
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.

DRUG INTERACTIONS
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.

SELZENTRY is available in 150-mg and 300-mg tablets. Take SELZENTRY two times a day. Swallow tablets whole. Do not chew the tablets.

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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.