Darunavir (Oral Route)

HIV is the virus that causes acquired immune deficiency syndrome (AIDS). This medicine 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 this medicine may continue to have other problems related to AIDS or HIV disease.

This medicine is available only with your doctor`s prescription.

This product is available in the following dosage forms:

• Tablet

Before Using

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.

Pediatric

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 .

Geriatric

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.

Pregnancy

Breastfeeding

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.

Drug Interactions

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.

• Astemizole


• Cisapride


• Dihydroergotamine


• Ergonovine


• Ergotamine


• Lovastatin


• Methylergonovine


• Midazolam


• Pimozide


• Rifampin


• Sildenafil


• Simvastatin


• St John`s Wort


• Terfenadine


• Triazolam

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.

• Amiodarone


• Bepridil


• Carbamazepine


• Dexamethasone


• Flecainide


• Fluticasone


• Lidocaine


• Lopinavir


• Propafenone


• Quinidine


• Rifabutin


• Saquinavir


• Tacrolimus


• Voriconazole

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.

• Atorvastatin


• Clarithromycin


• Digoxin


• Efavirenz


• Ethinyl Estradiol


• Etonogestrel


• Indinavir


• Ketoconazole


• Mestranol


• Norelgestromin


• Norethindrone


• Norgestrel


• Paroxetine


• Pravastatin


• Sertraline


• Warfarin

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:

• Diabetes mellitus or


• Hyperglycemia (high blood sugar)a€”May increase the amount of sugar in the blood .

• Hemophilia (a bleeding problem)a€”May increase the chance of bleeding.

• Liver disease or other liver problems (e.g., cirrhosis, hepatitis) or


• Sulfa allergy, known or suspecteda€”Use with caution. May make these conditions worse.

Proper Use

Take this medicine exactly as directed by your doctor . Do not change the dose or stop using 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.

This medicine is always taken with ritonavir (NorvirA®). 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 this medicine once a day and you miss a dose or forget to use it, and it is more than 12 hours 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 less than 12 hours 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 this medicine two times a day and you miss a dose or forget to use it, and it is more than 6 hours 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 less than 6 hours 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 .

This medicine 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.

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 HIV infection (patient already had HIV treatment):
    
    
    
    • Adultsa€”600 milligrams (mg) two times a day with 100 mg of ritonavir (NorvirA®).
    
    
    • Children and teenagers 6 years of age and abovea€”Dose is based on body weight and must be determined by your doctor . However, the usual dose is 375 to 600 milligrams of darunavir taken with 50 to 100 mg of ritonavir (NorvirA®) two times a day.
    
    
    • Children 3 to 5 years of agea€”Use and dose must be determined by your doctor .
    
    
    • Children below 3 years of agea€”Use is not recommended .
    
    
    
    
  
  
  
  
  
  
  • For HIV infection (patient never had HIV treatment):
    
    
    
    • Adultsa€”800 milligrams (mg) once a day with 100 mg of ritonavir (NorvirA®).
    
    
    • Children and teenagers 6 years of age and abovea€”Dose is based on body weight and must be determined by your doctor . However, the usual dose is 375 to 600 milligrams of darunavir taken with 50 to 100 mg of ritonavir (NorvirA®) two times a day.
    
    
    • Children 3 to 5 years of agea€”Use and dose must be determined by your doctor .
    
    
    • Children below 3 years of agea€”Use is not recommended .
    
    
    
    
  
  
  
  

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

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.

Do not use this medicine if you are also using cisapride (PropulsidA®), pimozide (OrapA®), midazolam (VersedA®), triazolam (HalcionA®), rifampin (RifadinA®, RimactaneA®), lovastatin (AltocorA®), simvastatin (ZocorA®), or ergot medicines (e.g., dihydroergotamine, ergonovine, ergotamine, methylergonovine, CafergotA®, D.H.E. 45A®, ErgomarA®, ErgostatA®, ErgotrateA®, MethergineA®, MigranalA®, or WigraineA®).

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 .

This medicine 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 this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: 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.

This medicine 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 . 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.

You should not breastfeed if you have HIV or AIDS, because you may give the infection to your baby through your breast milk.

This medicine 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 this medicine before you have any medical tests. The results of some tests may be affected by this medicine.

Side Effects

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

• Blurred vision


• Dry mouth


• Fatigue


• Flushed, dry skin


• Fruit-like breath odor


• Increased hunger


• Increased thirst


• Increased urination


• Skin rash


• Sweating


• Troubled breathing


• Unexplained weight loss

Rare

• Abdominal or stomach pain or tenderness


• Acid or sour stomach


• Belching


• Blistering, peeling, or loosening of the skin


• Bloating


• Chills


• Clay colored stools


• Constipation


• Cough


• Dark urine


• Decreased appetite


• Diarrhea


• Difficulty in moving


• Dizziness


• Excess air or gas in the stomach or intestines


• Fast heartbeat


• Fever


• Full feeling


• Headache


• Heartburn


• Indigestion


• Itching


• Joint or muscle pain


• Lack or loss of strength


• Light-colored stools


• Loss of appetite


• Muscle aching or cramping


• Nausea and vomiting


• Passing gas


• Red skin lesions, often with a purple center


• Red, irritated eyes


• Sore throat


• Sores, ulcers, or white spots in the mouth or on the lips


• Swelling of the feet or lower legs


• Swollen joints


• Unpleasant breath odor


• Unusual tiredness or weakness


• Vomiting of blood


• Yellow eyes or skin

Incidence not known

• Muscle pain or stiffness


• Swelling or puffiness of the face

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

• Muscle aches


• Stuffy or runny nose

Less common

• Constipation


• Difficulty having a bowel movement (stool)


• Gaining weight around your neck, upper back, breast, face, or waist

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.