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Maraviroc (Oral route)

Pronunciation:

mar-a-VIR-ok

Brand Names:

  • Selzentry

Dosage Forms:

  • Tablet

Warnings:

Oral route(Tablet)

Hepatotoxicity has been reported; may be preceded by severe rash or 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 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 16 years of age. Safety and efficacy have not been established.

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.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersBAnimal 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—

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
  • Enzalutamide
  • Fosphenytoin
  • Idelalisib
  • Imatinib
  • Indinavir
  • Itraconazole
  • Ketoconazole
  • Lopinavir
  • Nefazodone
  • Nelfinavir
  • Phenobarbital
  • Phenytoin
  • Posaconazole
  • Primidone
  • Rifabutin
  • Rifampin
  • Rifapentine
  • 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.

  • Ceritinib
  • Dabrafenib
  • Efavirenz
  • Eslicarbazepine Acetate
  • Etravirine
  • Lomitapide
  • Mitotane
  • Piperaquine
  • Siltuximab

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.

  • Fosamprenavir

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. 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 teenagers 16 years of age and older—150, 300, or 600 milligrams (mg) two times a day, taken together with other medicines. Your doctor may adjust the dose as needed.
      • Teenagers and 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.

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 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:

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 with breathing
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
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 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
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 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
Incidence not known
Blistering, peeling, or loosening of the skin
cough
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

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.


Last Updated: 11/4/2014

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