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

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

• 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.

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.

• 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.

• 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

Dialysis

Data not available

Other Comments

Administration advice:

• Before starting this drug, screen for the HLA-B*5701 allele and review medical history for prior exposure to any abacavir-containing product.
• Before/when starting this drug, test patients for HBV infection.
• Pregnancy testing is recommended before starting this drug in patients of childbearing potential.
• This drug is available in 2 dosage forms; do not interchange the tablets and the tablets for oral suspension on a mg-per-mg basis (due to differing pharmacokinetic profiles for dolutegravir).
• Tablets: Use in adults and pediatric patients weighing at least 25 kg.
• 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.
• Administer with or without food.
• Do not chew, cut, or crush the tablet(s).
• Fully disperse the tablets for oral suspension in 20 mL of drinking water in the supplied cup; swirl the suspension so no lumps remain. After full dispersion, administer the oral suspension within 30 minutes of mixing.
• 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
• Consult the manufacturer product information regarding missed doses.

• Store and dispense in original container, protect from moisture, and keep bottle tightly closed; do not remove desiccant.
• Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).

• Each tablet contains abacavir 600 mg, dolutegravir 50 mg, and lamivudine 300 mg; each tablet for oral suspension contains abacavir 60 mg, dolutegravir 5 mg, and lamivudine 30 mg.
• Limitations of Use: This drug should not be used alone in patients with resistance-associated integrase substitutions or clinically suspected integrase strand transfer inhibitor resistance; the dose of dolutegravir in this product is insufficient in such patients. The manufacturer product information for dolutegravir should be consulted.

• General: Pregnancy testing in patients of childbearing potential (before starting therapy)
• Hematologic: For hematologic toxicities in patients with sustained CrCl between 30 and 49 mL/min (during therapy)
• Hepatic: For hepatotoxicity (during therapy); hepatic function of HBV/HIV-1-coinfected patients with clinical and laboratory follow-up (for at least several months after stopping this drug)

• Read the US FDA-approved patient labeling (Medication Guide and Instructions for Use); read the Medication Guide and Warning Card (dispensed with each new and refill prescription) every time; carry the Warning Card with you.
• Contact health care provider immediately if signs/symptoms of hypersensitivity develop; do not restart this or any other abacavir-containing product after a hypersensitivity reaction (dispose of unused product).
• If this drug is stopped for any reason besides hypersensitivity, do not restart it (or any other abacavir-containing product) without consulting physician; medical care must be readily accessible.
• Patients of childbearing potential (including those actively trying to become pregnant): Discuss the risks and benefits of this drug with health care provider to decide if alternative therapy should be considered at time of conception through the first trimester of pregnancy; contact health care provider if pregnancy is confirmed in the first trimester.
• Patients of childbearing potential: The consistent use of effective contraception is recommended.
• Notify health care provider at once of any symptoms of infection.
• Notify health care provider if any unusual symptom develops or if any known symptom persists/worsens.
• Visually inspect the tablets to verify the correct formulation.

Frequently asked questions

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