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Darunavir Dosage

Medically reviewed on April 23, 2018.

Applies to the following strengths: 300 mg; 600 mg; 400 mg; 75 mg; 150 mg; 100 mg/mL; 800 mg

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for HIV Infection

Therapy-Naive Patients and Therapy-Experienced Patients with No Darunavir Resistance-Associated Substitutions: Darunavir 800 mg plus ritonavir 100 mg orally once a day with food

Therapy-Experienced Patients with At Least 1 Darunavir Resistance-Associated Substitution or with No Baseline Resistance Information: Darunavir 600 mg plus ritonavir 100 mg orally twice a day with food

Pregnant Patients: Darunavir 600 mg plus ritonavir 100 mg orally twice a day with food

Comments:
-Baseline genotypic testing is recommended for dose selection in therapy-experienced patients; however, when genotypic testing is not possible, darunavir 600 mg plus ritonavir 100 mg twice a day is recommended.
-Darunavir resistance-associated substitutions: V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V
-Darunavir 800 mg plus ritonavir 100 mg once a day) should only be considered in certain pregnant patients who are already on a stable darunavir 800 mg plus ritonavir 100 mg once-daily regimen before pregnancy, who are virologically suppressed (HIV-1 RNA less than 50 copies/mL), and if switching to the twice-daily regimen may compromise tolerability/compliance.

Use: In combination with ritonavir and other antiretroviral agents, for the treatment of HIV-1 infection

Usual Pediatric Dose for HIV Infection

3 to less than 18 years:
Therapy-Naive Patients and Therapy-Experienced Patients with No Darunavir Resistance-Associated Substitutions:
Oral suspension:
-Weight 10 to less than 15 kg: Darunavir 35 mg/kg plus ritonavir 7 mg/kg orally once a day with food
or
-Weight 10 to less than 11 kg: Darunavir 350 mg plus ritonavir 64 mg orally once a day with food
-Weight 11 to less than 12 kg: Darunavir 385 mg plus ritonavir 64 mg orally once a day with food
-Weight 12 to less than 13 kg: Darunavir 420 mg plus ritonavir 80 mg orally once a day with food
-Weight 13 to less than 14 kg: Darunavir 455 mg plus ritonavir 80 mg orally once a day with food
-Weight 14 to less than 15 kg: Darunavir 490 mg plus ritonavir 96 mg orally once a day with food

Tablets and oral suspension:
-Weight 15 to less than 30 kg: Darunavir 600 mg plus ritonavir 100 mg orally once a day with food
-Weight 30 to less than 40 kg: Darunavir 675 mg plus ritonavir 100 mg orally once a day with food
-Weight at least 40 kg: Darunavir 800 mg plus ritonavir 100 mg orally once a day with food

Therapy-Experienced Patients with At Least 1 Darunavir Resistance-Associated Substitution:
Oral suspension:
-Weight 10 to less than 15 kg: Darunavir 20 mg/kg plus ritonavir 3 mg/kg orally twice a day with food
or
-Weight 10 to less than 11 kg: Darunavir 200 mg plus ritonavir 32 mg orally twice a day with food
-Weight 11 to less than 12 kg: Darunavir 220 mg plus ritonavir 32 mg orally twice a day with food
-Weight 12 to less than 13 kg: Darunavir 240 mg plus ritonavir 40 mg orally twice a day with food
-Weight 13 to less than 14 kg: Darunavir 260 mg plus ritonavir 40 mg orally twice a day with food
-Weight 14 to less than 15 kg: Darunavir 280 mg plus ritonavir 48 mg orally twice a day with food

Tablets and oral suspension:
-Weight 15 to less than 30 kg: Darunavir 375 mg plus ritonavir 48 mg orally twice a day with food
-Weight 30 to less than 40 kg: Darunavir 450 mg plus ritonavir 60 mg orally twice a day with food
-Weight at least 40 kg: Darunavir 600 mg plus ritonavir 100 mg orally twice a day with food

Comments:
-Special vigilance recommended during dose selection, medication order transcription, dispensing information, and dosing instructions to reduce risk for medication errors, overdose, and underdose.
-Pediatric dose should not exceed the recommended adult dose.
-Darunavir resistance-associated substitutions: V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V
-For suspension dosing convenience, the 350 mg, 375 mg, 385 mg, 450 mg, 455 mg, 490 mg, and 675 mg darunavir dose for the specified weight groups may be rounded up to 3.6 mL, 3.8 mL, 4 mL, 4.6 mL, 4.6 mL, 5 mL, and 6.8 mL, respectively.

Use: In combination with ritonavir and other antiretroviral agents, for the treatment of HIV-1 infection

Renal Dose Adjustments

Moderate renal dysfunction: No adjustment recommended.
Severe renal dysfunction or ESRD: Data not available

Liver Dose Adjustments

Mild to moderate liver dysfunction: No adjustment recommended.
Severe liver dysfunction: Not recommended.

Comments:
-Patients with underlying chronic hepatitis, cirrhosis, or pretreatment transaminase elevations should be monitored for elevated serum liver biochemistries during therapy, particularly during the first several months of therapy.

Precautions

CONTRAINDICATIONS:
With Ritonavir:
-Coadministration with drugs highly dependent on CYP450 3A for clearance and for which elevated plasma levels are associated with serious and/or life-threatening events (narrow therapeutic index)
-Coadministration with drugs which may lead to reduced darunavir efficacy
-Coadministration with alfuzosin, ranolazine, dronedarone, colchicine (in patients with renal and/or liver dysfunction), rifampin, lurasidone, pimozide, dihydroergotamine, ergotamine, methylergonovine, cisapride, oral midazolam, triazolam, St. John's Wort, elbasvir-grazoprevir, lovastatin, simvastatin, sildenafil (for treatment of pulmonary arterial hypertension)
-Contraindications to ritonavir

Safety and efficacy have not been established in patients weighing less than 10 kg; this drug (plus ritonavir) is not recommended for use in patients younger than 3 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Comments:
-This drug and ritonavir are highly bound to plasma proteins; significant removal by hemodialysis or peritoneal dialysis is unlikely.

Other Comments

Administration advice:
-Before starting this drug plus ritonavir in therapy-experienced patients, obtain treatment history and conduct genotypic and/or phenotypic testing to assess drug susceptibility of the HIV-1 virus.
-Before starting this drug plus ritonavir, conduct appropriate laboratory testing (e.g., serum liver biochemistries).
-Use in combination with ritonavir and other antiretroviral drugs.
-Administer with food.
-Coadminister with ritonavir and food to get desired antiviral effect; failure to correctly administer this drug with ritonavir and food will result in reduced darunavir plasma levels and loss of efficacy may occur.
-Swallow tablets whole with a drink (e.g., water or milk).
-Use the oral suspension in patients unable to reliably swallow a tablet.
-Shake the oral suspension well before each dose; administer with the included oral dosing syringe; consult the manufacturer product information for further instructions.
-Administer the 6.8 mL and 8 mL dose of the oral suspension as two (3.4 mL and 4 mL, respectively) administrations using the included oral dosing syringe.
-Consult the manufacturer product information regarding missed doses.

Storage requirements:
-Store at 25C (77F); excursions permitted to 15C to 30C (59F to 86F).
-Oral suspension: Do not refrigerate or freeze; avoid exposure to excessive heat; store in original container.

General:
-A 6 mL oral dosing syringe with 0.2 mL gradations is provided with the oral suspension.
-The manufacturer product information for ritonavir should be consulted.

Monitoring:
-General: Genotypic and/or phenotypic testing (before starting therapy)
-Hepatic: Appropriate laboratory testing, such as serum liver biochemistries (before starting and during therapy); for elevated serum liver biochemistries, including AST/ALT, in patients with underlying chronic hepatitis, cirrhosis, or pretreatment transaminase elevations (increased during therapy, particularly during first several months of therapy)
-Metabolic: Blood glucose levels

Patient advice:
-Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
-Do not alter the dose or stop therapy without consulting physician.
-Stop this drug (plus ritonavir) at once if signs/symptoms of severe skin reactions (including but not limited to severe rash or rash with fever, general malaise, fatigue, muscle/joint aches, blisters, oral lesions, conjunctivitis, hepatitis, and/or eosinophilia) develop.
-Notify healthcare provider at once of any symptoms of infection.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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