An Overview of Selzentry (Maraviroc, Celsentri)

Brand Name: Selzentry
Other Name(s): MVC
Drug Class: Entry Inhibitor

WARNING:

Maraviroc can cause serious, life-threatening side effects. These include liver problems, skin reactions, and allergic reactions. An allergic reaction may happen before liver problems occur.

Stop taking maraviroc and contact your health care provider right away if you have any of the following symptoms:

• An itchy rash on the body (allergic reaction)
• Yellowing of your skin or the whites of your eyes (jaundice)
• Dark-colored urine
• Vomiting
• Abdominal pain (pain in the upper right stomach area)

Stop taking maraviroc and contact your health care provider right away if you develop a rash with any of the following symptoms:

• Fever
• General ill feeling
• Muscle aches
• Blisters or sores in your mouth
• Blisters or peeling of your skin
• Redness or swelling of your eyes
• Swelling of your face, mouth, or lips
• Trouble breathing
• Yellowing of the skin or whites of your eyes (jaundice)
• Dark-colored urine
• Pain, aching, or tenderness on the right side below your ribs
• Loss of appetite
• Nausea
• Vomiting

While taking maraviroc, it is important to keep all of your appointments with your health care provider.

What Is Maraviroc?

Maraviroc is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in people 2 years of age and older weighing at least 22 pounds (10 kilograms). Maraviroc is always used in combination with other HIV medicines.

Maraviroc belongs to a class (group) of HIV drugs called entry inhibitors. Entry inhibitors block HIV from getting into and infecting certain cells of the immune system. This prevents HIV from multiplying and can reduce the amount of HIV in the body.

Maraviroc works by attaching to a protein on the surface of the immune cells. The protein is called the CCR5 coreceptor. When maraviroc attaches to the CCR5 coreceptor, certain strains of HIV—called R5 tropic virus—cannot attach to, enter, or infect the cell.

Maraviroc should be used only in people whose strain of HIV uses the CCR5 coreceptor. Maraviroc is not recommended for people whose HIV uses the CXCR4 coreceptor or both the CCR5 and CXCR4 coreceptors. Your health care provider will do a blood test to see whether your HIV uses only the CCR5 coreceptor.

HIV medicines can't cure HIV/AIDS, but taking a combination of HIV medicines (called an HIV regimen) every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission.

What Should I Tell My Health Care Provider Before Taking Maraviroc?

Before taking maraviroc, tell your health care provider:

• If you are allergic to maraviroc or any other medicines.
• If you have liver problems, including a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
• If you have heart problems.
• If you have kidney problems.
• If you have low blood pressure or take medicines to lower blood pressure.
• If you have any other medical conditions.
• If you are pregnant or plan to become pregnant. Whether maraviroc can harm an unborn baby is unknown. Maraviroc should be used during pregnancy only if the potential benefits outweigh the risks. Talk to your health care provider about possible risks with taking maraviroc when pregnant.
• If you are breastfeeding or plan to breastfeed. Do not breastfeed if you are infected with HIV or are taking maraviroc.
• If you are using hormone-based birth control (such as pills, implants, or vaginal rings). For more information about using birth control and HIV medicines at the same time, view the AIDSinfo HIV and Birth Control infographic.
• About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Maraviroc may affect the way other medicines or products work, and other medicines or products may affect how maraviroc works. Certain other medicines may affect the levels of maraviroc in your blood. Your health care provider may need to change your dose of maraviroc when you take it with certain medicines. Taking maraviroc together with certain medicines or products may cause serious side effects.

How Should I Take Maraviroc?

Maraviroc (brand name: Selzentry) comes in tablet and oral solution form in five formulations:

• 20-mg/mL oral solution
• 25-mg tablets
• 75-mg tablets
• 150-mg tablets
• 300-mg tablets

Take maraviroc according to your health care provider's instructions.

Take maraviroc with or without food. Swallow maraviroc tablets whole. Do not chew the tablets.

Always take maraviroc in combination with other HIV medicines.

If you take too much maraviroc, contact your health care provider or local poison control center (1-800-222-1222) right away, or go to the nearest hospital emergency room.

For more information on how to take maraviroc, see the FDA drug label from DailyMed. (DailyMed is a federal website that includes the most recent drug labels submitted to FDA.)

What Should I Do if I Forget a Dose?

If you miss a dose of maraviroc, take the missed dose as soon as you remember it 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 two doses at the same time to make up for a missed dose.

What Side Effects Can Maraviroc Cause?

Maraviroc may cause side effects. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the AIDSinfo fact sheet on HIV Medicines and Side Effects for more information.

Some side effects of maraviroc can be serious. Serious side effects of maraviroc include liver problems, heart problems, skin reactions, and allergic reaction. An allergic reaction may happen before liver problems occur. (See the WARNING box above.)

Other possible serious side effects of maraviroc include:

• Low blood pressure when standing up (postural hypotension). This can cause dizziness or fainting.
• Changes in your immune system (called immune reconstitution inflammatory syndrome or IRIS). IRIS is a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection.
• Possible increased risk of other infections or cancer.

Tell your health care provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of maraviroc. To learn more about possible side effects of maraviroc, read the drug label or package insert or talk to your health care provider or pharmacist.

You can also report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online at https://www.accessdata.fda.gov/scripts/medwatch/.

How Should Maraviroc Be Stored?

• Store maraviroc at room temperature, 59°F to 86°F (15°C to 30°C).
• Do not use maraviroc if the original seal over the container opening is broken or missing.
• Throw away maraviroc that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
• Keep maraviroc and all medicines out of reach of children.

Where Can I Find More Information About Maraviroc?

More information about maraviroc is available:

• The maraviroc drug label, from DailyMed. The Patient Counseling Information section of the label includes information for people taking maraviroc.
• Maraviroc-related research studies, from the AIDSinfo database of ClinicalTrials.gov study summaries.
• A list of FDA-approved HIV medicines, from AIDSinfo.

Manufacturer Information

ViiV Healthcare
Main number: 877-844-8872
Patient assistance (ViiV Connect): 844-588-3288

The above Patient Version drug summary is based on the following FDA label(s): Tablet (film coated).