Maraviroc (Oral route)
Hepatotoxicity has been reported with use of maraviroc. Severe rash or evidence of a systemic allergic reaction (eg, fever, eosinophilia, or elevated IgE) prior to the development of hepatotoxicity may occur. Patients with signs or symptoms of hepatitis or allergic reaction following use of maraviroc should be evaluated immediately .
Uses of This Medicine:
Maraviroc is used in combination with other medicines, in the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS). This medicine is usually given to patients who have received HIV treatment 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.
Before Using This Medicine:
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:
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.
Appropriate studies have not been performed on the relationship of age to the effects of maraviroc in children younger than 2 years of age. Safety and efficacy have not been established.
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.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
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.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- St John's Wort
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.
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.
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
- Liver problems (eg, hepatitis B or C), history of or
- Postural hypotension (low blood pressure after standing up quickly), history of—Use with caution. May make these conditions worse.
- Kidney disease or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
- Kidney disease, severe (may require dialysis) and also taking certain medicines—Should not be used in patients with this condition.
Proper Use of This Medicine:
This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
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.
Swallow the tablet whole. Do not break, crush, or chew it.
Measure the oral liquid with an oral dosing syringe and press-in bottle adapter. The average household teaspoon may not hold the right amount of liquid.
You may take this medicine with or without food.
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 forms (solution or tablets):
- For treatment of HIV infection:
- Adults—150, 300, or 600 milligrams (mg) two times a day, taken together with other medicines. Your doctor may adjust the dose as needed.
- Children 2 years of age and older weighing at least 10 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The dose is usually 50 to 150 mg (2.5 to 7.5 mL) two times a day, taken together with other medicines. Your doctor may adjust the dose as needed.
- Children younger than 2 years of age—Use and dose must be determined by your doctor.
- For treatment of HIV infection:
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.
If your next regular dose is less than 6 hours away, skip the missed dose and go back to your regular dosing schedule.
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 While Using This Medicine:
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Your immune system may get stronger when you start taking HIV medicines. Tell your doctor right away if you notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia, herpes, or tuberculosis. Autoimmune disorders such as Graves' disease, polymyositis, and Guillain-Barré syndrome may also occur.
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 with allergic reactions may occur while you are using this medicine. Check with your doctor right away if you have a skin rash with fever, dark-colored urine, pain in the upper right stomach area, vomiting, or yellow eyes or skin.
Serious allergic and skin reactions may occur while using this medicine. These could be life-threatening and require immediate medical attention. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, joint or muscle aches, sores or ulcers on the skin, or fever or chills while you are using this medicine.
Using this medicine may increase your risk of getting infections or cancer. Talk to your doctor if you have concerns about this risk.
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, by using a latex condom or other barrier method. This medicine will also not keep you from giving HIV to other people if they are exposed to your blood. Do not re-use or share needles with anyone.
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 (eg, St. John's wort) or vitamin supplements.
Side Effects of This Medicine:
- More common
- Body aches or pain
- burning or stinging of the skin
- cough producing mucus
- difficulty with breathing
- dizziness when getting up suddenly from a lying or sitting position
- ear congestion
- loss of voice
- 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
- sore throat
- stuffy or runny nose
- tightness of the chest
- troubled breathing
- unusual tiredness or weakness
- Less common
- Abdominal or stomach pain or 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
- clay-colored stools
- cold, clammy skin
- dark-colored urine
- dilated neck veins
- discharge or excessive tearing
- extreme fatigue
- eye pain
- fast, weak pulse
- 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 or rash
- joint pain
- light-colored stools
- 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
- 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
- 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
- skin lumps
- slow, fast, or irregular heartbeat
- slurred speech
- spread of cancer to the liver
- stiff neck or back
- stomach lumps
- stomach pain, continuing
- sudden loss of consciousness
- swelling of the face, fingers, feet, or lower legs
- swollen glands
- 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
- Incidence not known
- Blistering, peeling, or loosening of the skin
- muscle pain
- red skin lesions, often with a purple center
- red, irritated eyes
- sores, ulcers, or white spots in the mouth or on the lips
- More common
- Difficulty having a bowel movement (stool)
- difficulty with moving
- increased or decreased appetite
- swelling or redness in the joints
- Less common
- Acid or sour stomach
- blistering, crusting, irritation, or reddening of the skin
- canker sores
- feeling sad or empty
- flushing or redness of the skin
- 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
- trouble in concentrating
- unusually warm skin
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:
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:
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.
Last Updated: 9/4/2017