Active Ingredient: Dolutegravir
Dolutegravir is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children of at least 4 weeks of age or older and weighing at least 3 kg.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 50 milligrams dolutegravir, 1 to 2 times daily.
The recommended dose of dolutegravir is 50 mg orally once daily.
Dolutegravir should be administered twice daily in this population when co-administered with some medicines (e.g. efavirenz, nevirapine, tipranavir/ritonavir, or rifampicin).
The recommended dose of dolutegravir is 50 mg twice daily.
In the presence of documented resistance that includes Q148 + ≥2 secondary mutations from G140A/C/S, E138A/K/T, L74I, modelling suggests that an increased dose may be considered for patients with limited treatment options (less than 2 active agents) due to advanced multi class resistance.
The decision to use dolutegravir for such patients should be informed by the integrase resistance pattern.
If the patient misses a dose of dolutegravir, the patient should take dolutegravir as soon as possible, providing the next dose is not due within 4 hours. If the next dose is due within 4 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
Dolutegravir can be taken with or without food.
In the presence of integrase class resistance, dolutegravir should preferably be taken with food to enhance exposure (particularly in patients with Q148 mutations).
For:
Regimen A: Oral, 50 milligrams dolutegravir, once daily.
Regimen B: Oral, 25 milligrams dolutegravir, 2 times daily.
In adolescents (12 to less than 18 years of age and weighing at least 40 kg) infected with HIV-1 without resistance to the integrase class, the recommended dose of dolutegravir is 50 mg once daily. In the presence of integrase inhibitor resistance, there are insufficient data to recommend a dose for dolutegravir in adolescents.
If the patient misses a dose of dolutegravir, the patient should take dolutegravir as soon as possible, providing the next dose is not due within 4 hours. If the next dose is due within 4 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
Dolutegravir can be taken with or without food. In the presence of integrase class resistance, dolutegravir should preferably be taken with food to enhance exposure (particularly in patients with Q148 mutations).
For:
Regimen A: In case that patient weight is ≥ 3 kg and patient weight is ≤ 6 kg, tablet, effervescent oral, 5 milligrams dolutegravir, once daily.
Regimen B: In case that patient weight is ≥ 6 kg and patient weight is ≤ 10 kg, tablet, effervescent oral, between 10 milligrams dolutegravir and 15 milligrams dolutegravir, once daily.
Regimen C: In case that patient weight is ≥ 10 kg and patient weight is ≤ 14 kg, tablet, effervescent oral, 20 milligrams dolutegravir, once daily.
Regimen D: In case that patient weight is ≥ 14 kg and patient weight is ≤ 20 kg, tablet, effervescent oral, 25 milligrams dolutegravir, once daily.
Regimen E: In case that patient weight is ≥ 20 kg, tablet, effervescent oral, 30 milligrams dolutegravir, once daily.
Regimen F: In case that patient weight is ≥ 6 kg and patient weight is ≤ 10 kg, tablet, effervescent oral, between 5 milligrams dolutegravir and 10 milligrams dolutegravir, 2 times daily.
Regimen G: In case that patient weight is ≥ 10 kg and patient weight is ≤ 14 kg, tablet, effervescent oral, 10 milligrams dolutegravir, 2 times daily.
Regimen H: In case that patient weight is ≥ 14 kg and patient weight is ≤ 20 kg, tablet, effervescent oral, 15 milligrams dolutegravir, 2 times daily.
Regimen I: In case that patient weight is ≥ 20 kg, tablet, effervescent oral, 15 milligrams dolutegravir, 2 times daily.
Regimen J: In case that patient weight is ≥ 14 kg and patient weight is ≤ 20 kg, tablet, film coated oral, 40 milligrams dolutegravir, once daily.
Regimen K: In case that patient weight is ≥ 20 kg, tablet, film coated oral, 50 milligrams dolutegravir, once daily.
Regimen L: In case that patient weight is ≥ 14 kg and patient weight is ≤ 20 kg, tablet, film coated oral, 20 milligrams dolutegravir, 2 times daily.
Regimen M: In case that patient weight is ≥ 20 kg, tablet, film coated oral, 25 milligrams dolutegravir, 2 times daily.
The recommended dose of dolutegravir is determined according to weight and age.
Table 1. Paediatric dose recommendations for dispersible tablets:
| Body weight (kg) | Dose |
|---|---|
| 3 to less than 6 | 5 mg once daily |
| 6 to less than 10 <6 months ≥6 months | 10 mg once daily 15 mg once daily |
| 10 to less than 14 | 20 mg once daily |
| 14 to less than 20 | 25 mg once daily |
| 20 or greater | 30 mg once daily |
Alternatively, if preferred the dose may be divided equally into 2 doses, with one dose taken in the morning and one dose taken in the evening.
Table 2. Alternative paediatric dose recommendations for dispersible tablets:
| Body weight (kg) | Dose |
|---|---|
| 3 to less than 6 | --- |
| 6 to less than 10 <6 months ≥6 months | 5 mg twice daily 10 mg twice daily |
| 10 to less than 14 | 10 mg twice daily |
| 14 to less than 20 | 15 mg twice daily |
| 20 or greater | 15 mg twice daily |
Table 3. Paediatric dose recommendations for film-coated tablets:
| Body weight (kg) | Dose |
|---|---|
| 14 to less than 20 | 40 mg once daily |
| 20 or greater | 50 mg once daily |
Alternatively, if preferred the dose may be divided equally into 2 doses, with one dose taken in the morning and one dose taken in the evening.
Table 24 Alternative paediatric dose recommendations for film-coated tablets:
| Body weight (kg) | Dose |
|---|---|
| 14 to less than 20 | 20 mg twice daily |
| 20 or greater | 25 mg twice daily |
There are insufficient data to recommend a dose for dolutegravir in integrase inhibitor resistant adolescents, children and infants.
If the patient misses a dose of dolutegravir, the patient should take dolutegravir as soon as possible, providing the next dose is not due within 4 hours. If the next dose is due within 4 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
Dolutegravir can be taken with or without food.
In the presence of integrase class resistance, dolutegravir should preferably be taken with food to enhance exposure (particularly in patients with Q148 mutations).
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