Active Ingredient: Darunavir
Darunavir, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection.
Darunavir be used to provide suitable dose regimens:
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: In case that patient weight is ≥ 40 kg, oral, 800 milligrams darunavir, once daily to meals.
Regimen B: In case that patient weight is ≥ 40 kg, oral, 600 milligrams darunavir, 2 times daily to meals.
Regimen C: In case that patient weight is ≥ 30 kg and patient weight is ≤ 40 kg, oral, 675 milligrams darunavir, once daily to meals.
Regimen D: In case that patient weight is ≥ 30 kg and patient weight is ≤ 40 kg, oral, 450 milligrams darunavir, 2 times daily to meals.
Regimen E: In case that patient weight is ≥ 15 kg and patient weight is ≤ 30 kg, oral, 600 milligrams darunavir, once daily to meals.
Regimen F: In case that patient weight is ≥ 15 kg and patient weight is ≤ 30 kg, oral, 375 milligrams darunavir, 2 times daily to meals.
The recommended dose regimen is 800 mg once daily with ritonavir 100 mg once daily taken with food.
The weight-based dose of darunavir and ritonavir in paediatric patients is provided in the table below.
Recommended dose for treatment-naïve paediatric patients with darunavir and ritonavira:
| Body weight (kg) | Dose (once daily with food) |
|---|---|
| ≥15 kg to <30 kg | 600 mg darunavir/100 mg ritonavir once daily |
| ≥30 kg to <40 kg | 675 mg darunavir/100 mg ritonavir once daily |
| ≥40 kg 800 mg | darunavir/100 mg ritonavir once daily |
a ritonavir oral solution: 80 mg/ml
The recommended dose regimens are as follows:
In ART-experienced patients without DRV-RAMs* and who have plasma HIV-1 RNA <100,000 copies/ml and CD4+ cell count ≥100 cells x 106/l a regimen of 800 mg once daily with ritonavir 100 mg once daily taken with food may be used.
* DRV-RAMs: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V and L89V
A once daily dose regimen of darunavir taken with ritonavir taken with food may be used in patients with prior exposure to antiretroviral medicinal products but without darunavir resistance associated mutations (DRV-RAMs)* and who have plasma HIV-1 RNA <100 000 copies/ml and CD4+ cell count ≥100 cells x 106/L.
* DRV-RAMs: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V and L89V
The recommended dose of darunavir with low dose ritonavir for paediatric patients is based on body weight and should not exceed the recommended adult dose (600/100 mg twice daily or 800/100 mg once daily).
Recommended dose for treatment-experienced paediatric patients with darunavir and ritonavira:
| Body weight (kg) | Dose (once daily with food) | Dose(twice daily with food) |
|---|---|---|
| ≥15 kg – <30 kg | 600 mg darunavir/100 mg ritonavir once daily | 375 mg darunavir/50 mg ritonavir twice daily |
| ≥30 kg – <40 kg | 675 mg darunavir/100 mg ritonavir once daily | 450 mg darunavir/60 mg ritonavir twice daily |
| ≥40 kg | 800 mg darunavir/100 mg ritonavir once daily | 600 mg darunavir/100 mg ritonavir twice daily |
a with ritonavir oral solution: 80 mg/ml
For ART-experienced paediatric patients HIV genotypic testing is recommended. However, when HIV genotypic testing is not feasible, the darunavir/ritonavir once daily dosing regimen is recommended in HIV protease inhibitor-naïve paediatric patients and the twice daily dosing regimen is recommended in HIV protease inhibitor-experienced patients.
If a once daily dose of darunavir and/or ritonavir is missed within 12 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of darunavir and ritonavir with food as soon as possible. If this is noticed later than 12 hours after the time it is usually taken, the missed dose should not be taken and the patient should resume the usual dosing schedule. This guidance is based on the half-life of darunavir in the presence of ritonavir and the recommended dosing interval of approximately 24 hours.
In case a dose of darunavir and/or ritonavir is missed within 6 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of darunavir and ritonavir with food as soon as possible. If this is noticed later than 6 hours after the time it is usually taken, the missed dose should not be taken and the patient should resume the usual dosing schedule. This guidance is based on the 15 hour half-life of darunavir in the presence of ritonavir and the recommended dosing interval of approximately 12 hours.
If a patient vomits within 4 hours of taking the medicinal product, another dose of darunavir with ritonavir should be taken with food as soon as possible. If a patient vomits more than 4 hours after taking the medicinal product, the patient does not need to take another dose of darunavir with ritonavir until the next regularly scheduled time.
Patients should be instructed to take darunavir with low dose ritonavir within 30 minutes after completion of a meal. The type of food does not affect the exposure to darunavir.
For:
Regimen A: Oral, 800 milligrams darunavir, once daily to meals.
Regimen B: Oral, 600 milligrams darunavir, 2 times daily to meals.
The recommended dose regimen is 800 mg once daily taken with ritonavir 100 mg once daily taken with food.
The recommended dose regimens are as follows:
* DRV-RAMs: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V and L89V
If a once daily dose of darunavir and/or ritonavir is missed within 12 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of darunavir and ritonavir with food as soon as possible. If this is noticed later than 12 hours after the time it is usually taken, the missed dose should not be taken and the patient should resume the usual dosing schedule.
In case a dose of darunavir and/or ritonavir is missed within 6 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of darunavir and ritonavir with food as soon as possible. If this is noticed later than 6 hours after the time it is usually taken, the missed dose should not be taken and the patient should resume the usual dosing schedule. This guidance is based on the 15 hour half-life of darunavir in the presence of ritonavir and the recommended dosing interval of approximately 12 hours.
If a patient vomits within 4 hours of taking the medicinal product, another dose of darunavir with ritonavir should be taken with food as soon as possible. If a patient vomits more than 4 hours after taking the medicinal product, the patient does not need to take another dose of darunavir with ritonavir until the next regularly scheduled time.
Limited information is available in this population, and therefore, darunavir should be used with caution in this age group.
Patients should be instructed to take darunavir with low dose ritonavir within 30 minutes after completion of a meal. The type of food does not affect the exposure to darunavir.
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