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 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

Interested in learning more about SELZENTRY? Click on a question below to get some answers. Be sure to talk to your doctor to learn more about SELZENTRY and how it fits into your HIV treatment plan.

What is SELZENTRY?

SELZENTRY is an anti-HIV medicine called a CCR5 antagonist. HIV (Human Immunodeficiency Virus) is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

SELZENTRY is used with other anti-HIV medicines in adults with R5-tropic HIV-1 infection who are already taking anti-HIV medicines and the medicines are not controlling their HIV infection.

  • SELZENTRY will not cure HIV infection.
  • People taking SELZENTRY may still develop infections, including opportunistic infections or other conditions that happen with HIV infection.
  • It is very important that you stay under the care of your doctor during treatment with SELZENTRY.
  • 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.
How does SELZENTRY work?

HIV enters cells in your blood by attaching itself to structures on the surface of the cell called receptors. SELZENTRY blocks a specific receptor called R5 that R5-tropic HIV-1 uses to enter the T-cells in your blood. Your doctor will do a blood test to see if you have R5-tropic HIV-1 before prescribing SELZENTRY for you.

How does SELZENTRY help me?

When used with other anti-HIV medicines, SELZENTRY may:

  • reduce the amount of HIV in your blood. This is called “viral load.
  • increase the number of white blood cells called T-cells.

SELZENTRY does not work in all patients with R5-tropic HIV-1.

How should I take SELZENTRY?

SELZENTRY comes in 150 mg and 300 mg tablets. Your doctor will prescribe the dose that is right for you. SELZENTRY is taken:

  • exactly as prescribed by your doctor
  • two times a day
  • whole; do not chew
  • with or without food
  • by people new to HIV medication, or by those who have been on HIV medication for a while
  • with the other anti-HIV drugs prescribed by your doctor
How should I store SELZENTRY?
  • Keep SELZENTRY and all medicines out of the reach of children.
  • Store SELZENTRY tablets at room temperature from 59°F to 86°F
    (15°C to 30°C) and keep it away from moisture.
  • Safely throw away medicine that is out of date or that you no longer need.
What are the ingredients in SELZENTRY?

Active Ingredient: maraviroc (in 150 mg or 300 mg)
Inactive Ingredients:
Tablet Core: microcrystalline cellulose, dibasic calcium phosphate (anhydrous), sodium starch glycolate, magnesium stearate
Film-Coat: FD&C blue #2 aluminum lake, soya lecithin, polyethylene glycol (macrogol 3350), polyvinyl alcohol, talc and titanium dioxide

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.

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