Maraviroc (Oral Route)

HIV is the virus that causes acquired immune deficiency syndrome (AIDS). This medicine is usually given to patients who have received HIV treatments in the past .

Maraviroc will not cure or prevent HIV infection or AIDS . It helps keep the HIV virus from reproducing, and appears to slow down the destruction of the immune system . This may help delay the development of problems that usually result from AIDS or HIV disease. Maraviroc will not keep you from spreading HIV to other people . People who receive this medicine may continue to have some of the problems usually related to AIDS or HIV disease.

This medicine is available only with your doctor`s prescription.

This product is available in the following dosage forms:

• Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of maraviroc in children below 16 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of maraviroc in the elderly. However, elderly patients are more likely to have age-related liver or kidney problems, which may require caution in patients receiving maraviroc.

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Carbamazepine


• Efavirenz


• Etravirine


• Phenobarbital


• Phenytoin


• Rifabutin


• Rifampin


• St John`s Wort

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Atazanavir


• Ketoconazole


• Lopinavir


• Ritonavir


• Saquinavir

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart disease or


• Postural hypotension (low blood pressure after standing up quickly), history ofa€”May make these conditions worse.

• Hepatitis B infection or


• Hepatitis C infectiona€”May cause side effects to become worse.

• Kidney disease or


• Liver diseasea€”Use with caution. The effects may be increased because of slower removal of the medicine from the body .

Proper Use

It is important to take this medicine together with other medicines for HIV. Your dose will be based on the other medicines you are taking. Be sure to take all of the medicines your doctor ordered, and to take them at the right times.

Keep taking this medicine for the full time of treatment, even if you begin to feel better.

This medicine works best when there is a constant amount in the blood . To help do this, do not miss any doses. If you need help in planning the best times to take your medicine, check with your doctor .

Do not change your dose or stop taking this medicine without checking with your doctor first. When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.

You may take this medicine with or without food.

Swallow the tablets whole. Do not break, crush, or chew it.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor`s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  
  
  
  • For treatment of HIV infection:
    
    
    
    • Adults and adolescents 16 years of age and oldera€”150, 300, or 600 milligrams (mg) two times a day, and combined with other medicines. Your doctor will decide which medicines are needed.
    
    
    • Children younger than 16 years of agea€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

When you start taking HIV medicines, your immune system may get stronger. If you already have certain infections such as pneumonia, herpes virus, or tuberculosis, you may notice new symptoms when your body tries to fight them. If this occurs, be sure to tell your doctor .

This medicine may cause some people to become dizzy. If this happens, do not drive, use machines, or do anything else that could be dangerous if you are dizzy. You may also feel lightheaded when getting up suddenly from a lying or sitting position, so stand up slowly.

Liver problems may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you start having a skin rash, dark-colored urine, pain in the upper right stomach, vomiting, or yellow eyes or skin, especially after having an episode of systemic allergic reaction .

This medicine may increase your chances of having a serious infection or even cancer. Talk to your doctor about this risk if this concerns you.

Do not take other medicines unless they have been discussed with your doctor . This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John`s wort) or vitamin supplements.

This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand and practice safe sex, even if your partner also has HIV. Do not share needles with anyone.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention .

Check with your doctor immediately if any of the following side effects occur:

More common

• Body aches or pain


• Burning or stinging of the skin


• Chills


• Cough producing mucus


• Coughing


• Difficulty in breathing


• Dizziness when getting up from a lying or sitting position suddenly


• Ear congestion


• Headache


• Loss of voice


• Nasal congestion


• Pain or tenderness around the eyes and cheekbones


• Painful blisters on the trunk of the body


• Painful cold sores or blisters on the lips, nose, eyes, or genitals


• Shortness of breath or troubled breathing


• Sneezing


• Sore throat


• Stuffy or runny nose


• Tightness of the chest or wheezing


• Unusual tiredness or weakness

Less common

• Abdominal or stomach pain


• Abdominal tenderness


• Arm, back, or jaw pain


• Black, tarry stools


• Blood in the urine


• Blurred or double vision


• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• Burning, dry, or itching eyes


• Burning, itching, and pain in the hairy areas, pus at the root of the hair


• Change in consciousness


• Chest pain, discomfort, or heaviness


• Choking


• Clay-colored stools


• Cold, clammy skin


• Confusion


• Convulsions


• Dark-colored urine


• Diarrhea


• Dilated neck veins


• Discharge or excessive tearing


• Dizziness


• Drowsiness


• Earache


• Extreme fatigue


• Eye pain


• Fast, weak pulse


• Fever


• Frequent urge to urinate


• General feeling of discomfort or illness


• General feeling of tiredness or weakness


• Heavy jaw feeling


• Inability to speak


• Increased frequency of urination


• Irregular breathing


• Itching


• Joint pain


• Light-colored stools


• Lightheadedness


• Loosening of a tooth


• Loss of appetite


• Loss of bladder control


• Loss of taste


• Lumps in the tongue


• Muscle aches, pains, or stiffness


• Muscle cramps or spasms


• Nausea or vomiting


• Nervousness


• Noisy breathing


• Pain or burning during urination


• Pain or discomfort in the arms, jaw, back, or neck


• Pain, swelling, or numbness in the mouth or jaw


• Pale skin


• Pounding in the ears


• Rash


• Redness or swelling in the ear


• Redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid


• Sensitivity of the eye to light


• Severe abdominal or stomach cramps and pain


• Severe or sudden headache


• Shakiness in the legs, arms, hands, or feet


• Shivering


• Skin lumps


• Slow, fast, or irregular heartbeat


• Slurred speech


• Spread of cancer to the liver


• Stiff neck and/or back


• Stomach lumps


• Stomach pain, continuing


• Sudden loss of consciousness


• Sweating


• Swelling of the face, fingers, feet, or lower legs


• Swollen glands


• Tearing


• Temporary blindness


• Trembling or shaking of the hands or feet


• Trouble sleeping


• Troubled breathing with exertion


• Unable to speak


• Unpleasant breath odor


• Unsteadiness or awkwardness


• Unusual bleeding or bruising


• Vomiting of blood


• Warts on the genital area


• Watery and severe diarrhea, which may also be bloody


• Weakness in the arms, hands, legs, or feet


• Weakness on one side of the body, sudden and severe


• Weight gain


• Weight loss


• Yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Cold sweats


• Faintness or lightheadedness when getting up from lying or sitting position

Some side effects may occur that usually do not need medical attention . These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Difficulty having a bowel movement (stool)


• Difficulty in moving


• Increased or decreased appetite


• Swelling or redness in the joints

Less common

• Acid or sour stomach


• Belching


• Blistering, crusting, irritation, or reddening of the skin


• Canker sores


• Discouragement


• Feeling sad or empty


• Flushing or redness of the skin


• Heartburn


• Indigestion


• Irritability


• Loss of interest or pleasure


• Redistribution or accumulation of body fat


• Skin rash, encrusted, scaly, and oozing


• Sores, ulcers, or white spots on the lips or tongue or inside the mouth


• Stomach discomfort or upset


• Tiredness


• Trouble in concentrating


• Unusually warm skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional .

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.