Pronunciation:

mar-a-VIR-ok

Brand Names:

• Selzentry

Dosage Forms:

• Solution
• Tablet

Warnings:

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 .

Classifications:

Therapeutic—

Antiretroviral Agent

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:

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 younger than 2 years of age. Safety and efficacy have not been established. Use is not recommended in preterm infants or in children weighing less than 2 kilograms (kg).

Older adults—

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.

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—

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.

• Atazanavir
• Boceprevir
• Carbamazepine
• Clarithromycin
• Cobicistat
• Conivaptan
• Darunavir
• Delavirdine
• Efavirenz
• Enzalutamide
• Etravirine
• Fosamprenavir
• Fosphenytoin
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Levoketoconazole
• Lopinavir
• Nefazodone
• Nelfinavir
• Nirmatrelvir
• Phenobarbital
• Phenytoin
• Posaconazole
• Primidone
• Rifampin
• Ritonavir
• Saquinavir
• St John's Wort
• Telaprevir
• Telithromycin
• Voriconazole

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.

• Abametapir
• Adagrasib
• Belzutifan
• Cabotegravir
• Capmatinib
• Ceritinib
• Dabrafenib
• Duvelisib
• Fedratinib
• Fexinidazole
• Fluconazole
• Fosnetupitant
• Ivosidenib
• Larotrectinib
• Lefamulin
• Lenacapavir
• Lorlatinib
• Lumacaftor
• Mavacamten
• Netupitant
• Olutasidenib
• Omaveloxolone
• Pacritinib
• Pexidartinib
• Pirtobrutinib
• Ritlecitinib
• Tocilizumab
• Trofinetide
• Venetoclax

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
• 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.

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 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—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.
      • Weighing 40 kilograms (kg) or more—150 or 300 milligrams (mg) (7.5 to 15 mL) two times a day, taken together with other medicines. Your doctor may adjust the dose as needed.
      • Weighing 30 to less than 40 kg—100 or 300 mg (5 to 15 mL) two times a day, taken together with other medicines. Your doctor may adjust the dose as needed.
      • Weighing 20 to less than 30 kg—75 or 200 mg (4 to 10 mL) two times a day, taken together with other medicines. Your doctor may adjust the dose as needed.
      • Weighing 14 to less than 20 kg—50 or 200 mg (2.5 to 10 mL) two times a day, taken together with other medicines. Your doctor may adjust the dose as needed.
      • Weighing 10 to less than 14 kg—50 or 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.
      • Weighing 6 to less than 10 kg—100 mg (5 mL) two times a day, taken together with other medicines. Your doctor may adjust the dose as needed.
      • Weighing 4 to less than 6 kg—40 mg (2 mL) two times a day, taken together with other medicines. Your doctor may adjust the dose as needed.
      • Weighing 2 to less than 4 kg—30 mg (1.5 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.
    • Children weighing less than 2 kilograms (kg)—Use is not recommended.

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.

If your next regular dose is less than 6 hours away, skip the missed dose and go back to your regular dosing schedule.

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. 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 (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug rash with eosinophilia and systemic symptoms (DRESS)) 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:

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

dizziness when getting up suddenly from a lying or sitting position

ear congestion

headache

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

sneezing

sore throat

stuffy or runny nose

tightness of the chest

trouble breathing

unusual tiredness or weakness

Less common

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

dark-colored urine

diarrhea

dilated neck veins

discharge or excessive tearing

dizziness

drowsiness

earache

eye pain

fast, weak pulse

fever

frequent urge to urinate

general feeling of discomfort or illness

heavy jaw feeling

inability to speak

increased frequency of urination

irregular breathing

itching or rash

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, cramps, pains, spasms, or stiffness

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

redness or swelling in the ear

redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid

seizures

sensitivity of the eye to light

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 or back

stomach cramps, lumps, pain, or tenderness

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

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 or loss

yellow eyes or skin

Incidence not known

Blistering, peeling, or loosening of the skin

cough

muscle pain

red irritated eyes

red skin lesions, often with a purple center

sores, ulcers, or white spots in the mouth or on the lips

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 with 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.