ACRIPTEGA Film-coated tablet Ref.[115185] Active ingredients: Dolutegravir Lamivudine Tenofovir disoproxil

Posology

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

Adults

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

Special Populations

Paediatrics

ACRIPTEGA 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 ACRIPTEGA, was administered to patients with moderate to severe renal impairment (see section 4.3 Contraindications).

The pharmacokinetics of tenofovir, as in ACRIPTEGA, have not been evaluated in non-haemodialysis patients with creatinine clearance <50 ml/min); therefore, no dosing recommendations is available for these patients. ACRIPTEGA is not suitable for use in patients with renal impairment with creatinine clearance less than 50 ml/min.

Rifampicin decreases the blood levels of dolutegravir. A supplementary dose of dolutegravir should be given to patients taking ACRIPTEGA.

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

36 months.

Store at or below 30ºC.

Store in the original container.

Do not remove from the carton until required for use.

Keep the bottle tightly closed.

ACRIPTEGA will be packed in a round, blue, opaque High-Density Polyethylene (HDPE) bottle, round wide mouth, blue with blue opaque polypropylene (PP) screw closure and with wad containing aluminium induction sealing liner. Packed in an outer carton.

Pack sizes of 30’s, 84’s, 90’s and 180’s.*

^* Not all pack sizes may be marketed

No special requirements.