Proper Use

Drug information provided by: Merative, Micromedex®

Take this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. Also, do not change the dose or stop using this medicine without checking first with your doctor. 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 (Norvir®). Take these two medicines at the same time, unless your doctor tells you otherwise.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

You may take this medicine with food.

Swallow the tablet whole with water or milk. Do not crush, break, or chew it.

If you are using the oral liquid, shake the bottle well before measuring each dose. Use the dosing syringe that comes with the package to measure each dose.

If you also use didanosine (Videx®), take it at least 1 hour before or 2 hours after taking this medicine and ritonavir.

Keep using this medicine for the full treatment time, even if you begin to feel better. It is also important to take this medicine together with other medicines for HIV. Be sure to take all of the medicines your doctor ordered, and to take them at the right times.

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 (suspension or tablets):
    • For HIV infection (patient already had HIV treatment):
      • For patients with no darunavir resistance associated substitution:
        • Adults—800 milligrams (mg) (one 800 mg tablet or 8 milliliters [mL]) once a day with 100 mg (1.25 mL) of ritonavir (Norvir®).
        • Children 3 to 17 years of age and weighing 15 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor.
          • Weighing 40 kg or more—800 mg (8 mL) with 100 mg (1.25 mL) of ritonavir once a day.
          • Weighing 30 kg to less than 40 kg—675 mg (6.8 mL) with 100 mg (1.25 mL) of ritonavir once a day.
          • Weighing 15 kg to less than 30 kg—600 mg (6 mL) with 100 mg (1.25 mL) of ritonavir once a day.
        • Children 3 to 17 years of age and weighing 10 kg to less than 15 kg—Dose is based on body weight and must be determined by your doctor.
          • Weighing 14 kg to less than 15 kg—490 mg (5 mL) with 96 mg (1.2 mL) of ritonavir once a day.
          • Weighing 13 kg to less than 14 kg—455 mg (4.6 mL) with 80 mg (1 mL) of ritonavir once a day.
          • Weighing 12 kg to less than 13 kg—420 mg (4.2 mL) with 80 mg (1 mL) of ritonavir once a day.
          • Weighing 11 kg to less than 12 kg—385 mg (4 mL) with 64 mg (0.8 mL) of ritonavir once a day.
          • Weighing 10 kg to less than 11 kg—350 mg (3.6 mL) with 64 mg (0.8 mL) of ritonavir once a day.
        • Children younger than 3 years of age—Use is not recommended.
      • For patients with at least one darunavir resistance associated substitution:
        • Adults—600 milligrams (mg) (one 600 mg tablet or 6 mL) 2 times a day with 100 mg (1.25 mL) of ritonavir (Norvir®).
        • Pregnant patients—600 mg taken with 100 mg of ritonavir (Norvir®) 2 times a day.
        • Children 3 to 17 years of age and weighing 15 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor.
          • Weighing 40 kg or more—600 mg (6 mL) with 100 mg (1.25 mL) of ritonavir 2 times a day.
          • Weighing 30 kg to less than 40 kg—450 mg (4.6 mL) with 60 mg (0.75 mL) of ritonavir 2 times a day.
          • Weighing 15 kg to less than 30 kg—375 mg (3.8 mL) with 48 mg (0.6 mL) of ritonavir 2 times a day.
        • Children 3 to 17 years of age and weighing 10 kg to less than 15 kg—Dose is based on body weight and must be determined by your doctor.
          • Weighing 14 kg to less than 15 kg—280 (2.8 mL) with 48 mg (0.6 mL) of ritonavir 2 times a day.
          • Weighing 13 kg to less than 14 kg—260 mg (2.6 mL) with 40 mg (0.5 mL) of ritonavir 2 times a day.
          • Weighing 12 kg to less than 13 kg—240 mg (2.4 mL) with 40 mg (0.5 mL) of ritonavir 2 times a day.
          • Weighing 11 kg to less than 12 kg—220 mg (2.2 mL) with 32 mg (0.4 mL) of ritonavir 2 times a day.
          • Weighing 10 kg to less than 11 kg—200 mg (2 mL) with 32 mg (0.4 mL) of ritonavir 2 times a day.
        • Children younger than 3 years of age—Use is not recommended.
    • For HIV infection (patient never had HIV treatment):
      • Adults—800 milligrams (mg) (one 800 mg tablet or 8 milliliters [mL]) of darunavir once a day with 100 mg (1.25 mL) of ritonavir (Norvir®).
      • Children 3 to 17 years of age and weighing 15 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor.
        • Weighing 40 kg or more—800 mg (8 mL) with 100 mg (1.25 mL) of ritonavir once a day.
        • Weighing 30 kg to less than 40 kg—675 mg (6.8 mL) with 100 mg (1.25 mL) of ritonavir once a day.
        • Weighing 15 kg to less than 30 kg—600 mg (6 mL) with 100 mg (1.25 mL) of ritonavir once a day.
      • Children 3 to 17 years of age and weighing 10 kg to less than 15 kg—Dose is based on body weight and must be determined by your doctor.
        • Weighing 14 kg to less than 15 kg—490 mg (5 mL) with 96 mg (1.2 mL) of ritonavir once a day.
        • Weighing 13 kg to less than 14 kg—455 mg (4.6 mL) with 80 mg (1 mL) of ritonavir once a day.
        • Weighing 12 kg to less than 13 kg—420 mg (4.2 mL) with 80 mg (1 mL) of ritonavir once a day.
        • Weighing 11 kg to less than 12 kg—385 mg (4 mL) with 64 mg (0.8 mL) of ritonavir once a day.
        • Weighing 10 kg to less than 11 kg—350 mg (3.6 mL) with 64 mg (0.8 mL) of ritonavir once a day.
      • Children younger than 3 years of age—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.

Storage

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.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep the oral liquid in its original container. Do not refrigerate or freeze it.