LANOGRAV Film-coated tablet Ref.[51100] 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 Lanograv is one tablet taken orally, once daily, without regard to food.

Paediatrics

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

Dose adjustment for renal impairment

Significantly increased exposure occurred when tenofovir, as in Lanograv, was administered to patients with moderate to severe renal impairment (see section 4.3).

The pharmacokinetics of tenofovir, as in Lanograv, have not been evaluated in nonhaemodialysis patients with creatinine clear (<80 ml/min); therefore, no dosing recommendations is available for these patients.

Lanograv is not suitable 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 should be given to patients taking Lanograv.

There is evidence that the concentration of isoniazid is increased by dolutegravir, as contained in Lanograv.

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

24 months.

Store at or below 25°C. Protect from moisture and light.

Keep in the original container until required for use.

Keep the container tightly closed.

The film coated tablets are packed in a white opaque HDPE bottle pack of 28’s, 30’s and 90’s with 3 g silica or 5 g silica as desiccant and a white opaque polypropylene screw cap with an induction seal liner; with or without a carton.

No special requirements for disposal.