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 orally twice a day with food is recommended.

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 is recommended during selection of dose, transcription of medication order, dispensing information, and dosing instructions to reduce the risk of medication errors in pediatric patients.
-The pediatric dose should not exceed the recommended adult dose.

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

Consult WARNINGS section for dosing related precautions.

Safety and effectiveness have not been established in pediatric patients weighing less than 10 kg. Darunavir/ritonavir should not be used in pediatric patients less than 3 years of age.

Dialysis

Darunavir is not significantly removed by hemodialysis or peritoneal dialysis.

Other Comments

Administration advice:
-Darunavir must be coadministered with ritonavir and food to exert its therapeutic effect; failure to correctly administer darunavir with ritonavir and food will result in reduced plasma levels of darunavir and loss of effectiveness may occur.
-Tablets should be swallowed whole with a drink (e.g., water or milk).
-If a patient is unable to reliably swallow a tablet, the use of darunavir oral suspension should be considered.
-The oral suspension should be shaken well before each dose.
-Missed Dose for Once-daily Dosing: If a patient misses a dose of darunavir or ritonavir by more than 12 hours, the patient should not take the missed dose, but resume the usual dosing schedule; if the dose is missed by less than 12 hours, the patient should take the missed dose at once and then resume the usual dosing schedule.
-Missed Dose for Twice-daily Dosing: If a patient misses a dose of darunavir or ritonavir by more than 6 hours, the patient should not take the missed dose, but resume the usual dosing schedule; if the dose is missed by less than 6 hours, the patient should take the missed dose at once and then resume the usual dosing schedule.

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

General:
-The dosage recommendations are based on darunavir/ritonavir in combination with other antiretroviral drugs.
-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 darunavir/ritonavir.
(b) The use of other active agents with darunavir/ritonavir is associated with a greater possibility of treatment response.

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

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