Source: Health Products Regulatory Authority (ZA) Revision Year: 2025 Publisher: Emcure Pharmaceuticals SA (Pty) Ltd., Arizona House, First floor, South Wing, Aspen Business Park, 1 Madison Avenue, Aspen Lakes, Extension 13, Johannesburg South, 2190
LAVEM is indicated for the treatment of HIV-1 infection in adults aged 18 years and older.
Therapy should be initiated by a medical practitioner experienced in the management of HIV infection.
Rifampicin decreases the blood levels of dolutegravir. A supplementary dose of dolutegravir should be given to patients taking LAVEM.
The concentration of isoniazid is increased by concomitant administration of LAVEM.
The dose of LAVEM is one tablet taken orally, once daily, without regard to food.
For treatment-naive and treatment experienced patients the recommended dose is one tablet daily.
Dose adjustment for renal impairment: Significantly increased exposure occurred when tenofovir, as in LAVEM, was administered to patients with moderate to severe renal impairment (see section 4.3).
The pharmacokinetics of tenofovir, as in LAVEM, have not been evaluated in non- haemodialysis patients with creatinine clearance <80 ml/min); therefore, no dosing recommendations is available for these patients.
LAVEM is not suitable for use in patients with renal impairment with creatinine clearance less than 50 ml/min.
LAVEM is not recommended for use in patients younger than 18 years of age.
LAVEM is taken orally, once daily, without regard to food.
If overdose occurs the patient must be monitored for evidence of toxicity and palliative supportive treatment be applied as necessary. Tenofovir can be removed by haemodialysis; the median haemodialysis clearance of tenofovir is 134 ml/min. The elimination of tenofovir by peritoneal dialysis has not been studied.
Limited data are available on the consequences of ingestion of acute overdoses in humans. If overdosage occurs the patient should be monitored, and palliative supportive treatment applied as required.
Management should be as clinically indicated or as recommended by the national poisons centre, where available. There is no specific treatment for an overdose of LAVEM. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary. As LAVEM is highly bound to plasma proteins, it is unlikely that it will be significantly removed by dialysis.
36 months.
Store at or below 30°C. Keep HDPE containers tightly closed.
KEEP OUT OF REACH OF CHILDREN.
28 or 30 tablets are packed in a 100 cc, white opaque, HDPE container and closed with a 38 mm, white opaque, polypropylene closure. Each HDPE container contains a HDPE canister containing silica gel.
84 or 90 tablets are packed in a 200 cc, white opaque, HDPE container and closed with a 38 mm, white opaque, polypropylene closure. Each HDPE container contains a HDPE canister containing silica gel.
180 tablets are packed in a 400 cc, white opaque, HDPE container and closed with a 53 mm, white opaque, polypropylene closure. Each HDPE container contains a HDPE canister containing silica gel.
Not all pack sizes may be marketed.
No special requirements.
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