Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antiretroviral Agent
Pharmacologic Class: Protease Inhibitor
Darunavir is used in combination with ritonavir (Norvir®) and other medicines for the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS). darunavir is given to patients who have already had previous treatment for HIV or who have never taken HIV medicines in the past.
Darunavir will not cure HIV infection or prevent AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay problems that are usually related to AIDS or HIV disease from occurring. Darunavir will not keep you from spreading HIV to other people. People who receive darunavir may continue to have other problems related to AIDS or HIV disease.
darunavir is available only with your doctor's prescription.
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 darunavir, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to darunavir 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of darunavir in children 6 years of age and older. However, safety and efficacy have not been established in children 3 to 5 years of age.
Because of darunavir's toxicity, use in children below 3 years of age is not recommended.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of darunavir in the elderly. However, elderly patients are more likely to have age-related liver problems, which may require caution in patients receiving darunavir.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
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.
Using darunavir 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.
Using darunavir 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 darunavir 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.
The presence of other medical problems may affect the use of darunavir. Make sure you tell your doctor if you have any other medical problems, especially:
Take darunavir exactly as directed by your doctor. Do not change the dose or stop using darunavir without checking with your doctor first. When your supply of darunavir is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of darunavir.
darunavir is always taken with ritonavir (Norvir®). Take these two medicines at the same time, unless your doctor tells you otherwise.
It is important that darunavir be taken with food in order to work properly.
Swallow the tablet whole with water or milk. Do not crush, break, or chew it.
If you take darunavir once a day and you miss a dose or forget to use it, and it is since your last dose, wait and take your next dose at the normal time. If you miss a dose or forget to use it, and it is since your last dose, take it as soon as you can and take your next dose at the normal time. Do not use extra medicine to make up for a missed dose.
If you take darunavir two times a day and you miss a dose or forget to use it, and it is since your last dose, wait and take your next dose at the normal time. If you miss a dose or forget to use it, and it is since your last dose, take it as soon as you can and take your next dose at the normal time. Do not use extra medicine to make up for a missed dose.
darunavir comes with a patient package insert. Read and follow the instructions in this insert carefully. Ask your doctor or pharmacist if you have any questions.
The dose of darunavir 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 darunavir. 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.
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.
It is very important that your doctor check your progress at regular visits to make sure darunavir is working properly. Blood tests may be needed to check for unwanted effects.
Do not use darunavir if you are also using cisapride (Propulsid®), pimozide (Orap®), midazolam (Versed®), triazolam (Halcion®), rifampin (Rifadin®, Rimactane®), lovastatin (Altocor®), simvastatin (Zocor®), or ergot medicines (e.g., dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cafergot®, D.H.E. 45®, Ergomar®, Ergostat®, Ergotrate®, Methergine®, Migranal®, or Wigraine®).
Do not take other medicines unless they have been discussed with your doctor. This includes prescription and nonprescription (over-the-counter [OTC]) medicines, and herbal (e.g., St. John's wort) or vitamin supplements.
Check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.
darunavir may increase blood sugar levels. Check with your doctor if you notice a change in the results of your blood or urine sugar tests.
Birth control pills may not work as well while you are using darunavir. To keep from getting pregnant, use an additional form of birth control along with your pills. Other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies.
When you start taking HIV medicines, your immune system may get stronger. If you have certain infections, such as Pneumocystis pneumonia or tuberculosis, you may notice new symptoms when your body tries to fight them. If this occurs, be sure to tell your doctor.
Serious skin reactions can occur with darunavir. Check with your doctor right away if you have any of the following symptoms while taking darunavir: blistering, peeling, or loosening of the skin; chills; cough; diarrhea; itching; joint or muscle pain; red skin lesions, often with a purple center; skin rash; sore throat; sores, ulcers, or white spots in the mouth or on the lips; or unusual tiredness or weakness.
darunavir will not keep you from giving HIV to your partner during sex. Make sure you understand this and practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method. darunavir 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.
You should not breastfeed if you have HIV or AIDS, because you may give the infection to your baby through your breast milk.
darunavir may cause you to have excess body fat. Tell your doctor if you notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area. You might also lose fat from the legs, arms, and face.
Tell the doctor in charge that you are taking darunavir before you have any medical tests. The results of some tests may be affected by darunavir.
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:Less common
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
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.
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