Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: Mylan (Pty) Ltd, 4 Brewery Street, Isando, Johannesburg, 1609, Republic of South Africa
ENVUTEG is indicated for use alone as a complete regimen for the treatment of human immunodeficiency virus type I (HIV-1) infection in adults and children weighing at least 40 kg.
ENVUTEG alone is not recommended in patients with resistance-associated integrase substitutions or clinically suspected integrase strand transfer inhibitor resistance because the dose of ENVUTEG is insufficient in these subpopulations. See the full prescribing information for dolutegravir.
Therapy should be initiated by a medical practitioner experienced in the management of HIV infection.
Perform pregnancy testing before initiation of ENVUTEG in adolescents and adults of childbearing potential (see section 4.4).
Prior to or when initiating ENVUTEG, test patients for hepatitis B virus (HBV) infection (see section 4.4).
Prior to initiation and during treatment with ENVUTEG, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus (see section 4.4).
ENVUTEG is a fixed-dose combination medicine containing 50 mg of dolutegravir, 300 mg of lamivudine (3TC), and 25 mg of tenofovir alafenamide (TAF). The recommended dosage regimen of ENVUTEG in adults and children weighing at least 40 kg is one tablet once daily orally with or without food.
Because ENVUTEG is a fixed-dose combination formulation and cannot be dose adjusted, it is not recommended in patients requiring dosage adjustment.
ENVUTEG tablets should only be administered to paediatric patients with a body weight of at least 40 kg because they are a fixed-dose combination that cannot be adjusted. The safety and efficacy have been established for the individual components in this weight group.
Clinical trials of individual components of ENVUTEG did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. Caution should be exercised in the administration of ENVUTEG in elderly patients reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy (see section 5.1).
ENVUTEG tablets are not recommended for patients with severe renal impairment (estimated creatinine clearance below 30 mL) because ENVUTEG is a fixed-dose combination and the dosage of the individual components cannot be adjusted. No dosage adjustment of ENVUTEG tablets is recommended in patients with mild or moderate renal impairment (estimated creatinine clearance greater than or equal to 30 mL per minute).
No dosage adjustment of ENVUTEG tablets is recommended in patients with mild (Child Pugh Class A) hepatic impairment. The effect of moderate or severe hepatic impairment (Child-Pugh Class B or C) on the pharmacokinetics of dolutegravir, lamivudine and tenofovir alafenamide has not been studied.
Therefore, ENVUTEG tablets are not recommended for use in patients with severe hepatic impairment (see sections 4.3 and 5.1).
There is no known specific treatment for overdose with dolutegravir, lamivudine and tenofovir alafenamide tablets. If overdose occurs, the patient should be monitored, and standard supportive treatment applied as required.
As dolutegravir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by dialysis.
Because a negligible amount of 3TC was removed via (4-hour) hemodialysis, continuous ambulatory peritoneal dialysis, and automated peritoneal dialysis, it is not known if continuous hemodialysis would provide clinical benefit in a 3TC overdose event.
Limited clinical experience is available at doses higher than the recommended dose of TAF. A single dose of 125 mg TAF (5 times the TAF dose in dolutegravir, lamivudine and tenofovir alafenamide tablets) was administered to 48 healthy subjects; no serious adverse reactions were reported. The effects of higher doses are unknown. Tenofovir is efficiently removed by hemodialysis with an extraction coefficient of approximately 54%.
24 months.
Store at or below 30ºC.
Store in the original container.
Keep the bottle tightly closed.
Store all medicines out of reach of children
Do not use after the expiry date state on the carton/label
Return all unused medicines to the pharmacist
Do not dispose of unused medicine in drains or sewerage systems.
The product is presented in the following marketable packs:
30’s Bottle Pack (with 4 g Molecular Sieve):
| Pack Type | Config-uration | Primary packaging components |
|---|---|---|
| HDPE Bottle Pack (with desiccant) | 30’s count | Container: Bottle HDPE 60 ml 33 mm Blue round (12 G) TP Closure: Closure 33 mm Blue screw with SG100 SP. Desiccant: 2 g Molecular Sieve Canister-SC (2 No.s) |
No special precautions are required.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
