Darunavir Dosage

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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 (including V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, and L89V): Darunavir 600 mg plus ritonavir 100 mg orally twice a day with food

Comments:
-Genotypic testing is recommended for therapy-experienced patients; however, when genotypic testing is not possible, darunavir 600 mg plus ritonavir 100 mg twice a day is recommended.

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:
10 to less than 15 kg: Darunavir 35 mg/kg plus ritonavir 7 mg/kg orally once a day with food
-or-
10 to less than 11 kg: Darunavir 350 mg plus ritonavir 64 mg orally once a day with food
11 to less than 12 kg: Darunavir 385 mg plus ritonavir 64 mg orally once a day with food
12 to less than 13 kg: Darunavir 420 mg plus ritonavir 80 mg orally once a day with food
13 to less than 14 kg: Darunavir 455 mg plus ritonavir 80 mg orally once a day with food
14 to less than 15 kg: Darunavir 490 mg plus ritonavir 96 mg orally once a day with food

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

Therapy-experienced Patients with At Least 1 Darunavir Resistance Associated Substitution (including V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, and L89V):
Oral suspension:
10 to less than 15 kg: Darunavir 20 mg/kg plus ritonavir 3 mg/kg orally twice a day with food
-or-
10 to less than 11 kg: Darunavir 200 mg plus ritonavir 32 mg orally twice a day with food
11 to less than 12 kg: Darunavir 220 mg plus ritonavir 32 mg orally twice a day with food
12 to less than 13 kg: Darunavir 240 mg plus ritonavir 40 mg orally twice a day with food
13 to less than 14 kg: Darunavir 260 mg plus ritonavir 40 mg orally twice a day with food
14 to less than 15 kg: Darunavir 280 mg plus ritonavir 48 mg orally twice a day with food

Tablets and oral suspension:
15 to less than 30 kg: Darunavir 375 mg plus ritonavir 48 mg orally twice a day with food
30 to less than 40 kg: Darunavir 450 mg plus ritonavir 60 mg orally twice a day with food
40 kg or more: 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.
-Dose should not exceed the recommended adult dose.

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 end-stage renal disease: Data not available

Liver Dose Adjustments

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

Precautions

Safety and efficacy have not been established in patients weighing less than 10 kg. This drug should not be used in patients younger than 3 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Comments: Significant removal by hemodialysis or peritoneal dialysis unlikely (highly protein bound)

Other Comments

Administration advice:
-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).
-Consider using the oral suspension if a patient is unable to reliably swallow a tablet.
-Shake the oral suspension well before each dose; consult the manufacturer product information for further instructions.
-Consult the manufacturer product information regarding missed doses.

Storage requirements:
-Oral suspension: Do not refrigerate or freeze; avoid excessive heat; store in original container

General:
-Dose recommendations based on this drug (plus ritonavir) in combination with other antiretroviral drugs.
-The manufacturer product information for ritonavir should be consulted.
-In therapy-experienced adult and pediatric patients, the following should be taken into consideration when initiating therapy:
(a) Treatment history and, when available, genotypic or phenotypic testing should guide the use of this drug (plus ritonavir).
(b) The use of other active agents with this drug (plus ritonavir) is associated with a greater probability of treatment response.

Monitoring:
-Hematologic: Bleeding in hemophiliacs
-Hepatic: Liver function (before and during therapy)
-Metabolic: Blood glucose levels

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