Selzentry is an antiviral medicine that prevents certain viral cells from multiplying in your body.

Selzentry prevents human immunodeficiency virus (HIV) from multiplying in your body.

Selzentry is used with other medications to treat CCR5-tropic HIV type 1, a virus that can cause acquired immunodeficiency syndrome (AIDS). Selzentry is not a cure for HIV or AIDS.

Selzentry is for use in adults and children who weigh at least 4.4 pounds (2 kilograms).

If you have severe kidney disease, you may not be able to take Selzentry if you use certain other medications. Tell your doctor about all other medications you use.

Selzentry may cause serious liver problems. Stop taking this medicine and seek medical treatment at once if you have a serious drug reaction that can harm your liver. Symptoms may include: itching or rash, vomiting, upper stomach pain, dark urine, or jaundice (yellowing of the skin or eyes).

Before you are treated with Selzentry, your doctor may perform a blood test to make sure Selzentry is the right treatment for your type of HIV.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Selzentry must be given in combination with other antiviral medications and it should not be used alone.

You may take Selzentry with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

Tell your doctor if the child taking this medicine has trouble swallowing the tablet whole.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Selzentry doses are based on weight in children. Your child's dose needs may change if the child gains or loses weight.

Use all HIV medications as directed and read all medication guides you receive. Do not change your dose or stop using a medicine without your doctor's advice. Every person with HIV should remain under the care of a doctor.

Store at room temperature away from moisture and heat.

Usual Adult Dose for HIV Infection:

With potent CYP450 3A inhibitors (with or without a potent CYP450 3A inducer) including protease inhibitors (except tipranavir/ritonavir), delavirdine, elvitegravir/ritonavir, ketoconazole, itraconazole, clarithromycin, other potent CYP450 3A inhibitors (e.g., nefazodone, telithromycin), boceprevir: 150 mg orally twice a day

With noninteracting concomitant medications, including tipranavir/ritonavir, nevirapine, raltegravir, all NRTIs, enfuvirtide: 300 mg orally twice a day

With potent CYP450 3A inducers (without a potent CYP450 3A inhibitor) including efavirenz, rifampin, etravirine, carbamazepine, phenobarbital, phenytoin: 600 mg orally twice a day

Comments:
-Noninteracting concomitant medications include all agents that are not potent CYP450 3A inhibitors or inducers.

Use: In combination with other antiretroviral agents, for the treatment of only C-C chemokine receptor type 5 (CCR5)-tropic HIV-1 infection

Usual Pediatric Dose for HIV Infection:

2 Years or Older:
With potent CYP450 3A inhibitors (with or without a potent CYP450 3A inducer) including protease inhibitors (except tipranavir/ritonavir), delavirdine, elvitegravir/ritonavir, ketoconazole, itraconazole, clarithromycin, other potent CYP450 3A inhibitors (e.g., nefazodone, telithromycin), boceprevir:
-Weight 10 to less than 20 kg: 50 mg orally twice a day
-Weight 20 to less than 30 kg:
---Oral solution: 80 mg orally twice a day
---Tablets: 75 mg orally twice a day
-Weight 30 to less than 40 kg: 100 mg orally twice a day
-Weight at least 40 kg: 150 mg orally twice a day

With noninteracting concomitant medications, including tipranavir/ritonavir, nevirapine, raltegravir, all NRTIs, enfuvirtide:
-Weight less than 30 kg: Not recommended.
-Weight at least 30 kg: 300 mg orally twice a day

With potent CYP450 3A inducers (without a potent CYP450 3A inhibitor) including efavirenz, rifampin, etravirine, carbamazepine, phenobarbital, phenytoin: Not recommended.

Comments:
-Recommended dose should be based on body weight and should not exceed the recommended adult dose.
-Noninteracting concomitant medications include all agents that are not potent CYP450 3A inhibitors or inducers.

Use: In combination with other antiretroviral agents, for the treatment of only CCR5-tropic HIV-1 infection

If you have severe or end-stage kidney disease, you may not be able to take Selzentry if you use certain medications, including some antibiotics or antifungal medications, some heart or blood pressure medicines, St. John's wort, and certain drugs to treat hepatitis or tuberculosis. Tell your doctor about all other medications you use.

To make sure Selzentry is safe for you, tell your doctor if you have ever had:

• kidney disease (or if you are on dialysis);

• liver disease, especially hepatitis B or C;

• heart disease; or

• low blood pressure.

Maraviroc affects your immune system and may possibly increase your risk of developing infections or cancer. Ask your doctor about this risk.

Tell your doctor if you are pregnant, and use your medications properly to control your infection. HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral medicine on the baby.

Women with HIV or AIDS should not breastfeed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Selzentry is not approved for a premature baby, or a child who weighs less than 4.4 pounds (2 kilograms).

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not take an herbal supplement containing St. John's wort.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Using this medicine may not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Get emergency medical help if you have signs of an allergic reaction to Selzentry (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Stop taking Selzentry and seek medical treatment at once if you have a serious drug reaction that can affect many parts of your body (especially your liver). Symptoms may include: itching or rash, fever, swollen glands, muscle or joint aches, severe weakness, unusual bruising, upper stomach pain, vomiting, dark urine, or jaundice (yellowing of the skin or eyes).

Call your doctor at once if you have a side effect such as:

• a light-headed feeling, like you might pass out; or

• chest pressure, tight feeling in your neck or jaw, sweating, pain spreading to your arm or shoulder.

Selzentry affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

• signs of a new infection - fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common Selzentry side effects may include:

• fever, cold symptoms, cough;

• indigestion, gas, bloating, nausea, vomiting, diarrhea, constipation;

• rash;

• dizziness; or

• (in newborns) abnormal blood tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs may interact with maraviroc. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.