Darunavir Dosage
This dosage information may not include all the information needed to use Darunavir safely and effectively. See additional information for Darunavir.
The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.
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
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:
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 50 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
Once-daily dosing is not recommended for pediatric patients.
Renal Dose Adjustments
Moderate dysfunction: No adjustment recommended.
Severe dysfunction or end stage renal disease: Data not available
Liver Dose Adjustments
Mild to moderate dysfunction: No adjustment recommended.
Severe dysfunction: Not recommended.
Precautions
Darunavir coadministration is contraindicated with drugs that are highly dependent on CYP450 3A for clearance for which elevated plasma concentrations are associated with serious and/or life-threatening events including: alfuzosin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, pimozide, oral midazolam, triazolam, lovastatin, simvastatin, and sildenafil for treatment of pulmonary arterial hypertension. Other contraindicated drugs (which may lead to reduced efficacy of darunavir) include St. John's Wort and rifampin.
Appropriate laboratory testing should be performed before starting darunavir/ritonavir therapy and patients should be monitored throughout treatment. Increased monitoring of AST/ALT, especially during the first several months of treatment, should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients with pretreatment transaminase elevations. Interruption or discontinuation of treatment should be considered if there is evidence of new or worsening liver disease (including clinically significant elevation of liver enzymes and/or symptoms such as fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly).
Severe skin reactions (in some cases accompanied by fever and/or elevations of transaminases) and, rarely, Stevens-Johnson syndrome have been reported during the clinical development program. Toxic epidermal necrolysis has been reported during postmarketing experience. Darunavir/ritonavir should be discontinued at once if signs or symptoms of severe skin reactions develop.
Darunavir contains a sulfonamide moiety and should be used with caution in patients with a known sulfonamide allergy.
New onset diabetes mellitus, exacerbation of preexisting diabetes, hyperglycemia, and in some cases, diabetic ketoacidosis have been reported in HIV-infected patients receiving protease inhibitor therapy. However, no causal relationship has been established. Patients may require initiation or dose adjustments of insulin or oral hypoglycemic agents for treatment of these events. Hyperglycemia persisted in some cases after discontinuation of protease inhibitor therapy.
Spontaneous bleeding episodes including skin hematomas and hemarthrosis have been reported in hemophiliac patients while receiving protease inhibitors. Although no causal relationship has been established, the FDA and the manufacturers of protease inhibitors recommend that hemophiliacs be monitored closely for bleeding during therapy.
Immune reconstitution syndrome has occurred during combination antiretroviral therapy. Patients responding to therapy may develop an inflammatory response to indolent or residual opportunistic infections and require evaluation and treatment.
The potential for HIV cross-resistance among protease inhibitors exists and the effect of darunavir therapy on the activity of subsequently administered protease inhibitors is unknown. Selection of antiretroviral agents for a patient's regimen should be made cautiously.
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.
Safety and efficacy have not been established in pediatric patients weighing less than 10 kg. Darunavir plus 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
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 concentrations of darunavir and a loss of effectiveness may occur.
If a patient is unable to reliably swallow a tablet, the use of darunavir oral suspension should be considered.
The dosage recommendations are based on darunavir and ritonavir in combination with other antiretroviral drugs. In therapy-experienced adult and pediatric patients, the following should be taken into consideration when initiating therapy:
Treatment history and, when available, genotypic or phenotypic testing should guide the use of darunavir/ritonavir.
The use of other active agents with darunavir/ritonavir is associated with a greater possibility of treatment response.
