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

All medications carry some risks and side effects, so it’s important to stay informed. Read this Medication Guide before you start taking SELZENTRY and each time you get a refill. That way, you can see if there is any new information you should know or have forgotten about SELZENTRY. This information does not take the place of talking with your doctor about your medical condition or treatment.

What is the most important thing I should know about SELZENTRY?

Liver problems (liver toxicity) have occurred in patients taking SELZENTRY. 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
  • dark (tea-colored) urine
  • vomiting
  • upper-right stomach-area pain

You should see your doctor right away but continue taking SELZENTRY if you have any of the following other symptoms:

  • nausea
  • fever
  • flu-like symptoms
  • fatigue
Does SELZENTRY lower the risk of passing HIV to other people?

No, SELZENTRY does not lower the risk of passing HIV to other people through sexual contact, sharing needles, or exposing them to your blood.

  • Continue to practice safer sex.
  • Use latex or polyurethane condoms or other barrier methods to lower the chance of sexual contact with any body fluids. This includes semen, vaginal secretions, or blood.
  • Never re-use or share needles.
  • Ask your doctor if you have any questions about safer sex or how to prevent passing HIV to other people.
What should I tell my doctor before taking SELZENTRY?

Tell your doctor about all of your medical conditions, including if you have:

  • any allergies
  • liver problems, including a history of hepatitis B or C
  • heart problems
  • kidney problems
  • low blood pressure or take medicines to lower blood pressure

You should also mention if you are:

  • pregnant or planning to become pregnant. It is not known if SELZENTRY may harm your unborn baby. If you take SELZENTRY while you are pregnant, talk to your doctor about how you can be included in the Antiretroviral Pregnancy Registry.
  • breast-feeding or planning to breast-feed. It is recommended that HIV-positive women should not breastfeed their babies. This is because of the chance of passing HIV to your baby. Talk with your doctor about the best way to feed your baby.

Know the medicines you take. Keep a list of your medicines. Show the list to your doctor and pharmacist when you get a new medicine. When you meet with your doctor, tell him about these medicines, including:

  • prescription medicines
  • non-prescription medicines
  • vitamins
  • 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.

What should I know when taking SELZENTRY as prescribed?

Do not change your dose or stop taking SELZENTRY or your other anti-HIV medicines without first talking with your doctor.

  • If you take too much SELZENTRY, call your doctor 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 dose, do not take the missed dose. Wait and take the next dose at the regular time. Do not take a double dose to make up for a missed dose.
  • It is very important to take all your anti-HIV medicines as prescribed and at the same time each day. This can help your medicines work better. It also lowers the chance that your medicines will stop working to fight HIV (drug resistance).
  • When your SELZENTRY supply starts to run low, ask your doctor or pharmacist for a refill. This is very important because the amount of virus in your blood may increase and SELZENTRY could stop working if it is stopped for even a short period of time.
What are the possible side effects of SELZENTRY?

When SELZENTRY has been given with other anti-HIV drugs, there have been serious side effects including:

  • Liver problems. See “What is the most important information I should know about SELZENTRY?”
  • Heart problems, including heart attack
  • Low blood pressure when standing up (postural hypotension). 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.
  • 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 possibly increase your chance of getting other infections or cancer.

The most common side effects of SELZENTRY include cough, fever, colds, rash, muscle and joint pain, stomach pain, and dizziness. Tell your doctor about any side effects that bother you or do not go away.

These are not all of the side effects with SELZENTRY. For more information, ask your doctor or pharmacist.

What is some general information I should know about SELZENTRY?

Medicines are sometimes prescribed for conditions that are not mentioned in Medication Guides. Do not use SELZENTRY for a condition for which it was not prescribed. Do not give SELZENTRY to other people, even if they have the same symptoms you have. It may harm them.

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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