KOVATRAX Film-coated tablet Ref.[50484] Active ingredients: Dolutegravir Lamivudine Tenofovir disoproxil

Therapy should be initiated by a medical practitioner experienced in the management of HIV infection.

Adults

The dose of KOVATRAX TABLETS is one tablet taken orally, once daily, without regard to food.

Paediatrics

KOVATRAX TABLETS is not recommended for use in patients younger than 18 years of age.

Renal impairment: Significantly increased exposure occurred when tenofovir, as in KOVATRAX TABLETS, was administered to patients with renal impairment (see CONTRA-INDICATIONS). The pharmacokinetics of tenofovir, as in KOVATRAX TABLETS, have not been evaluated in non- haemodialysis patients with creatinine clearance < 80 ml/min); therefore, no dosing recommendations is available or possible with this combination for these patients.

KOVATRAX TABLETS is contraindicated for use in patients with renal impairment with creatinine clearance less than 80 ml/min.

Rifampicin decreases the blood levels of dolutegravir. A supplementary dose of dolutegravir 50 mg should be given to patients taking KOVATRAX TABLETS.

The combined use of isoniazid and dolutegravir, as contained in KOVATRAX TABLETS may result in unexpected toxicity due to endogenous cytokine release. Coadministration is not recommended unless further investigations are performed.

Tenofovir disoproxil fumarate

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.

Lamivudine

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.

Dolutegravir

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 KOVATRAX TABLETS. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary. As KOVATRAX TABLETS is highly bound to plasma proteins, it is unlikely that it will be significantly removed by dialysis.

Store at or below 25°C.

Protect from light and moisture.

Keep the containers tightly closed.

KEEP OUT OF REACH AND SIGHT OF CHILDREN.

HDPE container pack of 28 or 30 tablets: Tablets are packed in a 120 ml, round white HDPE bottle with 38-400 neck finish closed with 38 mm white, continuous thread polypropylene closure with pulp and heat seal 123 white printed liner. Each HDPE container contains a 3 g silica gel sachet. The labelled HDPE container is packed in a pre- printed unit carton.

HDPE container pack of 90 or 100 tablets: Tablets are packed in a 250 ml, round white HDPE bottle with 53-400 neck finish closed with 53 mm white, continuous thread polypropylene closure with pulp and heat seal 123 white printed liner. Each HDPE container contains a 3 g silica gel sachet. The labelled HDPE container is packed in a pre- printed unit carton.

HDPE container pack of 180 tablets: Tablets are packed in a 400 ml, round white HDPE bottle with 53-400 neck finish closed with 53 mm white, continuous thread polypropylene closure with pulp and heat seal 123 white printed liner. Each HDPE container contains a 3 g silica gel sachet. The labelled HDPE container is packed in a pre- printed unit carton.