NUVACO Film-coated tablet Ref.[51229] Active ingredients: Dolutegravir Lamivudine Tenofovir disoproxil

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

NUVACO can be taken with or without food.

Adults

For treatment-naïve and treatment-experienced patients, the recommended dose of NUVACO is one tablet daily.

Special populations

Renal impairment

Significantly increased exposure occurred when tenofovir disoproxil fumarate, as in NUVACO, was administered to patients with renal impairment (see section 4.3).

The pharmacokinetics of tenofovir disoproxil fumarate, as in NUVACO, have not been evaluated in non-haemodialysis patients with creatinine clearance <80 mL/min); therefore, no dosing recommendations are available for these patients.

NUVACO is contraindicated in patients with renal impairment with creatinine clearance less than 80 mL/min.

Paediatric population

NUVACO is not recommended for use in patients younger than18 years of age.

Dosage recommendations with certain concomitant medications

Efavirenz, nevirapine, rifampicin and tipranavir in combination with ritonavir each reduced the plasma concentrations of dolutegravir significantly and require dolutegravir dose adjustment to 50 mg twice daily. A supplementary dose of 50 mg dolutegravir should be given to patients taking NUVACO.

There is evidence that the concentration of isoniazid is increased by dolutegravir as contained in NUVACO. Patients receiving NUVACO while on isoniazid and/or combination regimen containing isoniazid should be carefully monitored. Dosage adjustment of isoniazid should be considered if necessary.

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.

Tenofovir disoproxil fumarate

If overdose occurs, the patient must be monitored for evidence of toxicity and palliative supportive treatment be applied as necessary.

Tenofovir disoproxil fumarate can be removed by haemodialysis; the median haemodialysis clearance of tenofovir is 134 mL/min. The elimination of tenofovir disoproxil fumarate by peritoneal dialysis has not been studied.

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 NUVACO. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary. As NUVACO 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 the container tightly closed.

Keep in the original container until required for use.

Protect from light and moisture.

Pack sizes 28, 30, 56, 60, 84, 90, 100, 180 and 750 film-coated tablets: NUVACO tablets are packed in a white opaque high density polyethylene (HDPE) container with a cotton or rayon coil wadding and a desiccant canister containing silica gel. The HDPE container is closed with a white polypropylene, child-resistant cap with heat seal induction liner or pulp liner. Pack size of 30’s is packed in an outer carton.

Not all pack sizes may be marketed.

No special precautions.