Generated automatically from the NAFDAC register, WHO alerts and community data as of today. Not medical advice — always follow your doctor or pharmacist.
From the official U.S. FDA label for dolutegravir (dolutegravir sodium), the active ingredient registered with NAFDAC.
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). …
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 )] . …
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 )] . …
• 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. …
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. …
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Dolutegravir Tablet contains Dolutegravir (Dolutegravir Sodium) (50 mg), as tablet, according to its NAFDAC registration record.
Yes. Dolutegravir Tablet is listed on the NAFDAC register under registration number A4-100884, and its registration is active as of 5 November 2026.
No WHO falsified or substandard medical product alert currently matches Dolutegravir Tablet in our automatically synced alert list.
Run a free authenticity scan with the NAFDAC number A4-100884, 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.
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.)
Reviews are personal experiences from RxVerify users, not medical advice. Report side effects to your doctor and to NAFDAC.