Brand Names:

• Selzentry

Dosage Forms:

• Tablet

Warnings:

Hepatotoxicity has been reported with maraviroc use. Evidence of a systemic allergic reaction (eg, pruritic rash, 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 .

Hepatotoxicity has been reported. May be preceded by evidence of systemic allergic reaction. Immediately evaluate patients with signs or symptoms of hepatitis or allergic reaction.

Classifications:

Therapeutic—

Antiretroviral Agent

Uses of This Medicine:

Maraviroc is used together with other medicines to treat certain types of 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 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 .

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:

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.

Children—

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 .

Older adults—

Appropriate studies performed to date have not demonstrated geriatrics-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—

	Pregnancy Category	Explanation
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.

Breast-feeding—

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.

Other medicines—

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
• Phenobarbital
• Phenytoin
• Rifampin
• St John's Wort

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)—May make these conditions worse .

• Hepatitis B infection or
• Hepatitis C infection—May cause side effects to become worse .

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body .

Proper Use of This Medicine:

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 .

You may take this medicine with or without food .

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 older—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 age—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 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 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 .

Side Effects of This Medicine:

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 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 eyes and cheekbones

painful blisters on trunk of body

painful cold sores or blisters on lips, nose, eyes, or genitals

shortness of breath or troubled breathing

sneezing

sore throat

stuffy or runny nose

tightness of chest or wheezing

unusual tiredness or weakness

Less common

Abdominal or stomach pain

abdominal tenderness

black, tarry stools

blood in urine

blurred or double vision

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

burning, itching, and pain in hairy areas, pus at root of hair

change in consciousness

chest pain, discomfort, or heaviness

choking

clay-colored stools

cold, clammy skin

confusion

dark-colored urine

diarrhea

dilated neck veins

dizziness

drowsiness

extreme fatigue

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

joint pain

light-colored stools

lightheadedness

loosening of a tooth

loss of appetite

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 arms, jaw, back, or neck

pain, swelling, or numbness in the mouth or jaw

pounding in the ears

rash

seizures

severe abdominal or stomach cramps and pain

severe or sudden headache

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

sweating

swelling of face, fingers, feet, or lower legs

swollen glands

temporary blindness

trouble sleeping

unable to speak

unpleasant breath odor

unsteadiness or awkwardness

vomiting of blood

warts on genital area

watery and severe diarrhea, which may also be bloody

weakness in 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 joints

Less common

Acid or sour stomach

belching

blistering, crusting, irritation, or reddening of skin

canker sores

discouragement

feeling sad or empty

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 lips or tongue or inside the mouth

stomach discomfort or upset

tiredness

trouble concentrating

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