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Dolutegravir/Emtricitabine/Tenofovir Alafenamide Tablets

NAFDAC Reg. No. A4-100042 · Drug

Registered with NAFDAC — registration activeAs of 5 November 2026 · synced automatically from official sources.
Product
Dolutegravir/Emtricitabine/Tenofovir Alafenamide Tablets
NAFDAC number
A4-100042
Active ingredient
Dolutegravir (Dolutegravir Sodium); Emtricitabine; Tenofovir Alafenamide Fumarate
Strength
50 mg; 200 mg; 25 mg
Form
Tablet
Manufacturer
Not listed
Applicant (holder)
Hetero Labs Nigeria Limited
Approved
7 May 2021
Status
Inactive View on NAFDAC ↗
Registration valid to
6 May 2026
WHO alerts
None found
Community reports
None
Times checked
0

RxVerify commentary

  • Dolutegravir/Emtricitabine/Tenofovir Alafenamide Tablets is on the NAFDAC register with an active registration (A4-100042). A valid number alone does not prove a pack is genuine — counterfeiters copy real numbers, so also check the expiry date, seal and print quality.

Generated automatically from the NAFDAC register, WHO alerts and community data as of today. Not medical advice — always follow your doctor or pharmacist.

What Dolutegravir/Emtricitabine/Tenofovir Alafenamide Tablets is used for

From the official U.S. FDA label for dolutegravir (dolutegravir sodium), the active ingredient registered with NAFDAC.

Boxed warning: HYPERSENSITIVITY REACTIONS, AND EXACERBATIONS OF HEPATITIS B Hypersensitivity Reactions Serious and sometimes fatal hypersensitivity reactions, with multiple organ involvement, have occurred with abacavir, a component of TRIUMEQ and TRIUMEQ PD (abacavir, dolutegravir, and lamivudine). …
What it is used for

TRIUMEQ and TRIUMEQ PD are indicated for the treatment of HIV-1 infection in adults and in pediatric patients aged at least 3 months and weighing at least 6 kg. Limitations of Use: TRIUMEQ and TRIUMEQ PD alone are not recommended in patients with resistance‑associated integrase substitutions or clinically suspected integrase strand transfer inhibitor (INSTI) resistance because the dose of dolutegravir in TRIUMEQ and TRIUMEQ PD is insufficient in these subpopulations. See full prescribing information for TIVICAY (dolutegravir). …

Possible side effects

The following adverse reactions are discussed in other sections of the labeling: • Serious and sometimes fatal hypersensitivity reaction [see Boxed Warning , Warnings and Precautions ( 5.1 )] . • Exacerbations of hepatitis B [see Boxed Warning , Warnings and Precautions ( 5.3 )] . • Hepatotoxicity [see Warnings and Precautions ( 5.3 )] . • Lactic acidosis and severe hepatomegaly with steatosis [see Warnings and Precautions ( 5.4 )] . • Immune reconstitution syndrome [see Warnings and Precautions ( 5.6 )] . • Myocardial infarction [see Warnings and Precautions ( 5.8 )] . …

Do not use if

TRIUMEQ and TRIUMEQ PD are contraindicated in patients: • who have the HLA-B*5701 allele [see Warnings and Precautions ( 5.1 )] . • with prior hypersensitivity reaction to abacavir, dolutegravir [see Warnings and Precautions ( 5.1 )] , or lamivudine. • receiving dofetilide due to the potential for increased dofetilide plasma concentrations and the risk for serious and/or life-threatening events with concomitant use of dolutegravir [see Drug Interactions ( 7 )] . …

Warnings

• Hepatotoxicity has been reported in patients receiving a dolutegravir-containing regimen. Monitoring for hepatotoxicity is recommended. ( 5.3 ) • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues. ( 5.4 ) • Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy. ( 5.6 ) • TRIUMEQ tablets and TRIUMEQ PD tablets for oral suspension are not substitutable. ( 2.3 , 5.7 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions have been reported with the use of abacavir or dolutegravir, components of TRIUMEQ and TRIUMEQ PD. …

Pregnancy & breastfeeding

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to TRIUMEQ during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1‑800‑258‑4263. …

General information only — not dosing advice. Always follow the leaflet in your pack and your doctor or pharmacist.

Check your pack of Dolutegravir/Emtricitabine/Tenofovir Alafenamide Tablets

Add the expiry date printed on your pack for a full Trust Score — or look up uses, side effects and cheaper generics.

3 free checks left today · no signup Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About Dolutegravir/Emtricitabine/Tenofovir Alafenamide Tablets

What is in Dolutegravir/Emtricitabine/Tenofovir Alafenamide Tablets?

Dolutegravir/Emtricitabine/Tenofovir Alafenamide Tablets contains Dolutegravir (Dolutegravir Sodium); Emtricitabine; Tenofovir Alafenamide Fumarate (50 mg; 200 mg; 25 mg), as tablet, according to its NAFDAC registration record.

Is Dolutegravir/Emtricitabine/Tenofovir Alafenamide Tablets registered with NAFDAC?

Yes. Dolutegravir/Emtricitabine/Tenofovir Alafenamide Tablets is listed on the NAFDAC register under registration number A4-100042, and its registration is active as of 5 November 2026.

Has Dolutegravir/Emtricitabine/Tenofovir Alafenamide Tablets been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Dolutegravir/Emtricitabine/Tenofovir Alafenamide Tablets in our automatically synced alert list.

How can I check that my pack of Dolutegravir/Emtricitabine/Tenofovir Alafenamide Tablets is genuine?

Run a free authenticity scan with the NAFDAC number A4-100042, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.

What is Dolutegravir/Emtricitabine/Tenofovir Alafenamide Tablets used for?

TRIUMEQ and TRIUMEQ PD are indicated for the treatment of HIV-1 infection in adults and in pediatric patients aged at least 3 months and weighing at least 6 kg. Limitations of Use: TRIUMEQ and TRIUMEQ PD alone are not recommended in patients with resistance‑associated integrase substitutions or clinically suspected integrase strand transfer inhibitor (INSTI) resistance because the dose of dolutegr (Summarised from the official U.S. FDA label for dolutegravir (dolutegravir sodium). Always follow your doctor or pharmacist.)

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