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Abacavir / Dolutegravir / Lamivudine Dosage

Medically reviewed by Drugs.com. Last updated on Apr 28, 2022.

Applies to the following strengths: 600 mg-50 mg-300 mg; 60 mg-5 mg-30 mg

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for HIV Infection

Tablets: 1 tablet orally once a day

Comments:

  • The tablets for oral suspension must not be used in adults.

Usual Pediatric Dose for HIV Infection

Tablets for Oral Suspension:

  • Weight 10 to less than 14 kg: 4 tablets orally once a day
  • Weight 14 to less than 20 kg: 5 tablets orally once a day
  • Weight 20 to less than 25 kg: 6 tablets orally once a day

Tablets:
  • At least 25 kg: 1 tablet orally once a day

Comments:
  • The tablets are not recommended for patients weighing less than 25 kg.
  • The tablets for oral suspension are not recommended for patients weighing at least 25 kg.

Use: For the treatment of HIV-1 infection

Renal Dose Adjustments

CrCl less than 30 mL/min: Not recommended.

Comments:

  • Patients with sustained CrCl between 30 and 49 mL/min should be monitored for hematologic toxicities.
  • If lamivudine dose adjustment is indicated (e.g., patient develops new/worsening neutropenia or anemia), this drug should be discontinued and the individual components should be used.

Liver Dose Adjustments

Mild liver dysfunction (Child-Pugh A): Not recommended.
Moderate or severe liver dysfunction (Child-Pugh B or C): Contraindicated

Comments:

  • If abacavir dose adjustment is needed for patients with mild liver dysfunction, the individual components should be used.

Dose Adjustments

The dolutegravir dose in this combination drug (50 mg per tablet and 5 mg per tablet for oral suspension) is insufficient when coadministered with efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, carbamazepine, or rifampin (agents that may decrease dolutegravir levels); the following dolutegravir dosage regimen is recommended.

Adults and Pediatric Patients Weighing At Least 25 kg:

  • Since the recommended dolutegravir dosage regimen is 50 mg twice a day, an additional 50 mg of dolutegravir should be administered, separated by 12 hours from this combination drug.

Pediatric Patients Weighing 10 to Less Than 25 kg:
  • Weight 10 to less than 14 kg: An additional 20 mg of dolutegravir should be administered 12 hours after this combination drug.
  • Weight 14 to less than 20 kg: An additional 25 mg of dolutegravir should be administered 12 hours after this combination drug.
  • Weight 20 to less than 25 kg: An additional 30 mg of dolutegravir should be administered 12 hours after this combination drug.

Precautions

US BOXED WARNINGS:

  • HYPERSENSITIVITY REACTIONS: Serious and sometimes fatal hypersensitivity reactions (with multiple organ involvement) reported with abacavir. Patients with the human leukocyte antigen subtype B*5701 (HLA-B*5701) allele are at higher risk of abacavir hypersensitivity reactions; however, such reactions have occurred in patients without the HLA-B*5701 allele. This drug is contraindicated in patients with prior hypersensitivity reaction to abacavir and in HLA-B*5701-positive patients. All patients should be screened for the HLA-B*5701 allele before starting or restarting treatment with this drug (unless HLA-B*5701 allele assessment previously documented). Regardless of HLA-B*5701 status, this drug should be discontinued without delay if hypersensitivity reaction is suspected, even if other diagnoses are possible. After hypersensitivity reaction to this drug, NEVER restart this or any other abacavir-containing product as more severe symptoms (including death) can occur within hours. Similar severe reactions also reported after restarting abacavir-containing products in patients with no history of abacavir hypersensitivity
  • EMERGENCE OF LAMIVUDINE-RESISTANT HBV: All patients with HIV-1 should be tested for HBV before/when starting this drug. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens reported. If this drug is used in HBV/HIV-1-coinfected patients, additional treatment should be considered to appropriately treat chronic HBV; otherwise, an alternative regimen should be considered.
  • EXACERBATIONS OF HEPATITIS B: Severe acute exacerbations of hepatitis B reported in HBV/HIV-1-coinfected patients who have stopped lamivudine. Hepatic function of HBV/HIV-1-coinfected patients should be monitored closely; if appropriate, anti-HBV therapy should be started.

CONTRAINDICATIONS:
  • Presence of the HLA-B*5701 allele
  • Prior hypersensitivity reaction to any of the active components or to any of the ingredients
  • Coadministration with dofetilide
  • Moderate or severe liver dysfunction

Safety and efficacy have not been established in pediatric patients weighing less than 10 kg.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

  • Before/when starting this drug, test patients for HBV infection.
  • Tablets for oral suspension: Use in pediatric patients weighing 10 to less than 25 kg; do not use in patients weighing at least 25 kg. As a fixed-dose tablet, the dosage of individual components cannot be adjusted and may lead to suboptimal dosing for patients weighing at least 25 kg.
  • Do not chew, cut, or crush the tablet(s).
  • Administer products containing polyvalent cations and oral supplements containing calcium or iron (including multivitamins containing calcium or iron) 6 hours before or 2 hours after this drug; may administer supplements/multivitamins containing calcium or iron and this drug at the same time with food

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.