Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Dolutegravir + abacavir + lamivudine

Generic name
Dolutegravir + abacavir + lamivudine
Brand name
ATC Code
J05AR13

Pharmacokinetics in children

The relative bioavailability of dolutegravir administered in a dispersible tablet is approximately 1.7x that of a film-coated tablet. The relative bioavailability of abacavir and lamivudine administered in a dispersible tablet is similar to that of a film-coated tablet.

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

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Available formulations

No information is present at this moment.

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Dosages

Treatment HIV infection
  • Oral
    • Orodispersable tablet
      • 20 up to 25 kg

        • Dolutegravir 30 mg + abacavir 360 mg + lamivudine 180 mg (equivalent to 6 dispersable tablets) per day in a single dose.

          With concomitant use of rifampicin, carbamazepine, oxcarbazepine, phenytoin, phenobarbital, St. John's wort,
          etravirine (without boosted protease inhibitors), efavirenz, nevirapine or tipranavir/ritonavir: give 1 additional dose of dolutegravir (30 mg) 12 hours after taking the combination tablet.

      • 14 up to 20 kg

        • Dolutegravir 25 mg + abacavir 300 mg + lamivudine 150 mg (equivalent to 5 dispersable tablets) per day in a single dose.

          With concomitant use of rifampicin, carbamazepine, oxcarbazepine, phenytoin, phenobarbital, St. John's wort,
          etravirine (without boosted protease inhibitors), efavirenz, nevirapine or tipranavir/ritonavir: give 1 additional dose of dolutegravir (25 mg) 12 hours after taking the combination tablet.

      • 10 up to 14 kg

        • Dolutegravir 20 mg + abacavir 240 mg + lamivudine 120 mg (equivalent to 4 dispersable tablets) per day in a single dose.

          With concomitant use of rifampicin, carbamazepine, oxcarbazepine, phenytoin, phenobarbital, St. John's wort,
          etravirine (without boosted protease inhibitors), efavirenz, nevirapine or tipranavir/ritonavir: give 1 additional dose of dolutegravir (20 mg) 12 hours after taking the combination tablet.

      • 6 up to 10 kg

        • Dolutegravir 15 mg + abacavir 180 mg + lamivudine 90 mg (equivalent to 3 dispersable tablets) per day in a single dose.

          With concomitant use of rifampicin, carbamazepine, oxcarbazepine, phenytoin, phenobarbital, St. John's wort,
          etravirine (without boosted protease inhibitors), efavirenz, nevirapine or tipranavir/ritonavir: give 1 additional dose of dolutegravir (15 mg) 12 hours after taking the combination tablet.

    • Film-coated tablet
      • ≥ 25 kg

        • Dolutegravir 50 mg + abacavir 600 mg + lamivudine 300 mg (equivalent to 1 tablet) per day in a single dose.

          With concomitant use of rifampicin, carbamazepine, oxcarbazepine, phenytoin, phenobarbital, St. John's wort,
          etravirine (without boosted protease inhibitors), efavirenz, nevirapine or tipranavir/ritonavir: give 1 additional dose of dolutegravir (50 mg) 12 hours after taking the combination tablet

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Renal impaiment in children > 3 months

Creatinine clearance <30 ml/min: avoid use of the fixed combination.

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

In children, the side effect profile is the same as in adults

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions

No information available on specific warnings and precautions in children.

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Nucleosides and nucleotides excl. reverse transcriptase inhibitors
J05AB01
J05AB12
J05AB06
J05AB16
J05AB04
J05AB11
J05AB14
Phosphonic acid derivatives
J05AD01
Protease inhibitors
J05AE08
J05AE10
J05AE07
J05AE02
J05AE04
J05AE03
J05AE01
Nucleoside and nucleotide reverse transcriptase inhibitors
J05AF06
J05AF02
J05AF09
J05AF10
J05AF05
J05AF04
J05AF07
J05AF13
J05AF13
J05AF01
Non-nucleoside reverse transcriptase inhibitors
J05AG06
J05AG03
J05AG04
J05AG01
J05AG05
Neuraminidase inhibitors
J05AH02
J05AH01
Antivirals for treatment of HIV infections, combinations
J05AR02
J05AR20
J05AR25
J05AR18
J05AR19
J05AR03
J05AR09
J05AR10
Other antivirals
J05AX28
J05AX12
J05AX07
J05AX09
J05AX08
J05AX24
ANTIVIRALS FOR TREATMENT OF HIV INFECTIONS, COMBINATIONS
J05AR02
J05AR20
J05AR25
J05AR18
J05AR19
J05AR03
J05AR09
J05AR10
Integrase inhibitors
J05AJ04
Antivirals for treatment of HCV infections
J05AP54
J05AP57
J05AP51
J05AP08
J05AP55

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Reference

  1. ViiV Healthcare UK Limited, SmPC Triumeq ( EU/1/14/940/001-002) Rev 35; 10-12-2024, www.ema.europa.eu

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Changes

Changes