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 doctor right away if you get any of the following symptoms: an itchy rash on your body (allergic reaction), your skin or eyes look yellow and/or dark (tea-colored) urine, vomiting and/or upper right stomach area (abdominal) pain. CONTINUED BELOW
SELZENTRY was specially designed to target R5 HIV, a common type of HIV. To find out if you have R5 HIV, you can be prescreened with an HIV tropism test (sometimes called a tropism assay). This can let you see right away if SELZENTRY could be part of your personalized HIV therapy program.
What is the tropism test?
A tropism test is a blood test that reveals how your HIV enters T-cells. HIV can enter T-cells via an R5 or X4 co-receptor. A tropism test reveals which of these receptors your HIV uses.
You have R5-tropic HIV if HIV uses the R5 co-receptors to enter your T-cells. You have X4-tropic HIV if HIV uses the X4 co-receptors to enter your T-cells. You have dual or mixed tropic HIV if HIV uses both the R5 and the X4 co-receptors to enter your T-cells.
SELZENTRY is designed to prevent R5-tropic HIV from entering your T-cells.
By prescription only,
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 doctor right away if you get any of the following symptoms:
- an itchy rash on your body (allergic reaction)
- your skin or eyes look yellow and/or dark (tea-colored) urine
- vomiting and/or upper right stomach area (abdominal) pain.
Before you take SELZENTRY, tell your healthcare provider if you have liver problems including:
- history of hepatitis B or C
- have heart problems
- have kidney problems
- have low blood pressure or take medicines to lower blood pressure
- have any other medical condition
- are pregnant or plan to become pregnant
- are breastfeeding or plan to breastfeed
INDICATION AND USAGE
SELZENTRY® (maraviroc) is a CCR5 inhibitor that is used with other HIV medicines to treat CCR5-tropic HIV. SELZENTRY is not recommended in patients with dual/mixed or CXCR4-tropic HIV. It is for adult patients with CCR5-tropic HIV only. A tropism test is needed before starting SELZENTRY. SELZENTRY does not cure HIV infection or AIDS and does not lower the risk of passing HIV to other people.
People taking SELZENTRY may still develop infections, including opportunistic infections or other conditions that happen with HIV infection. The long-term effects of SELZENTRY are not known at this time. It is very important that you stay under the care of your healthcare provider during treatment with 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
Possible serious side effects of SELZENTRY include:
- Liver problems (see above)
- Heart problems, including heart attack
- Low blood pressure when standing up (postural hypertension). Low blood pressure when standing up 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 doctor 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 doctor about any side effect that bothers you or does not go away.
DRUG INTERACTIONS
Tell your doctor 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 doctor 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). St. John’s Wort may lower the levels of SELZENTRY in your blood so that it will not work to treat your CCR5-tropic HIV infection.
SELZENTRY is available in 150-mg and 300-mg tablets.
Please see full Prescribing Information including boxed warnings.