MEDICATION GUIDE

MEDICATION GUIDE Maraviroc (mə-RAV-i-rok) tablets
What is the most important information I should know about Maraviroc? Maraviroc can cause serious side effects including serious liver problems (liver toxicity). Some people who take Maraviroc can develop a severe rash or an allergic reaction before liver problems happen and may be life-threatening. Stop taking Maraviroc and call your healthcare provider right away if you get any of the following signs or symptoms of liver problems:
an itchy rash on your body (allergic reaction) your skin or the white part of your eyes turns yellow (jaundice) dark or “tea-colored” urine		vomiting pain, aching, or tenderness on the right side of your stomach area
Your healthcare provider will do blood tests to check your liver before you begin treatment with Maraviroc and as needed during treatment with Maraviroc.
What are Maraviroc tablets?
Maraviroc tablet is a prescription Human Immunodeficiency Virus-1 (HIV-1) medicine given with other HIV-1 medicines to treat CCR5-tropic HIV-1 infection in adults and children 2 years of age and older weighing at least 22 lb (10 kg).
HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). Use of Maraviroc is not recommended in people with dual/mixed- or CXCR4‑tropic HIV‑1. Maraviroc tablets should not be used in children weighing less than 22 pounds (10 kg).
Do not take Maraviroc if youhave severe kidney problems or are on hemodialysis and are also taking certain other medications.
Before you take Maraviroc, tell your healthcare provider about all of your medical conditions, including if you: • have or have had liver problems including hepatitis B or C virus infection. • have heart problems. • have kidney problems. • have low blood pressure or take medicines to lower blood pressure. • are pregnant or plan to become pregnant. It is not known if Maraviroc may harm your unborn baby. Pregnancy Registry. There is a pregnancy registry for women who take Maraviroc during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry. • are breastfeeding or plan to breastfeed. Do not breastfeed if you take Maraviroc. You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby. Talk to your healthcare provider about the best way to feed your baby.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. • Some medicines may interact with Maraviroc. Keep a list of your medicines to show your healthcare provider and pharmacist. • You can ask your healthcare provider or pharmacist for a list of medicines that interact with Maraviroc.
Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take Maraviroc with other medicines. Your healthcare provider may need to change your dose of Maraviroc when you take it with certain medicines. You should not take Maraviroc if you also take St. John’s wort ( Hypericum perforatum).
How should I take Maraviroc tablets? • Take Maraviroc exactly as your healthcare provider tells you. • Do not change your dose or stop taking Maraviroc without first talking with your healthcare provider. • If you miss a dose of Maraviroc, take it as soon as you remember. Do not take 2 doses at the same time. If you are not sure about your dosing, call your healthcare provider. • Stay under the care of a healthcare provider during treatment with Maraviroc. • Swallow Maraviroc tablets whole. Do not chew the tablets. • Maraviroc may be taken with or without food. • Your healthcare provider will prescribe a dose of Maraviroc based on your child’s body weight and other medicines they are taking. • Tell your healthcare provider if your child has trouble swallowing tablets. Maraviroc comes as tablets or as a liquid (oral solution). • Do not run out of Maraviroc. The virus in your blood may increase and the virus in your blood may become harder to treat. When your supply starts to run low, get more from your healthcare provider or pharmacy. • If you take too much Maraviroc, call your healthcare provider or go to the nearest hospital emergency room right away.
What are the possible side effects of Maraviroc? Maraviroc can cause serious side effects including:
• See “What is the most important information I should know about Maraviroc?”
• Severe skin rash and allergic reactions. Severe and potentially life-threatening skin reactions and allergic reactions have been reported in some people taking Maraviroc. If you develop a rash with any of the following symptoms, stop using Maraviroc and contact your healthcare provider right away:
fever generally ill feeling muscle aches blisters or sores in your mouth blisters or peeling of the skin redness or swelling of the eyes swelling of the mouth or face or lips	problems breathing yellowing of the skin or whites of your eyes dark or tea-colored urine pain, aching, or tenderness on the right side below the ribs loss of appetite nausea/vomiting
• Heart problemsincluding heart attack. • Low blood pressure when standing up(postural hypotension)that can cause dizziness or fainting. You should avoid driving or operating heavy machinery if you have dizziness during treatment with Maraviroc. • Changes in your immune system (Immune Reconstitution Syndrome)can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you develop new symptoms during treatment with Maraviroc. • Possible chance of infection or cancer.Maraviroc affects other immune system cells and therefore may possibly increase your chance for getting other infections or cancer.
The most common side effects of Maraviroc in adults include coldsand cold- like symptoms, cough, fever, rash, bloating and gas, indigestion, constipation, and dizziness. The most common side effects of Maraviroc in children includevomiting, abdominal pain, diarrhea, nausea, and dizziness. These are not all the possible side effects of Maraviroc. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088.
How should I store Maraviroc? • Store Maraviroc tablets at room temperature between 68°F to 77°F (20°C to 25°C). Keep Maraviroc and all medicines out of the reach of children.
General information about the safe and effective use of Maraviroc
Medicines are sometimes prescribed for purposes other than those mentioned in a Medication Guide. Do not use Maraviroc for a condition for which it was not prescribed. Do not give Maraviroc to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for the information about Maraviroc that is written for health professionals.
What are the ingredients in Maraviroc?
Active ingredient: maraviroc
Inactive ingredients: Tablets: Dibasic calcium phosphate (anhydrous), magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. Tablet film-coating contains: FD&C blue # 2 aluminum lake, soya lecithin, polyethylene glycol (macrogol 3350), polyvinyl alcohol, talc, and titanium dioxide.
Manufactured and distributed by: i3 Pharmaceuticals, LLC 200 Park Avenue Warminster, PA 18974
This Medication Guide has been approved by the U.S. Food and Drug Administration. OS025-02 REV.0823 Revised: 08/2023

Revised: 8/2023

Document Id: 0416607a-fd74-87e3-e063-6294a90ae6b5

Set id: f7b9c67b-10c6-45b5-b2a8-952cd350b0b1

Version: 3

Effective Time: 20230818

i3 Pharmaceuticals, LLC