DOLTELAM Film-coated tablet Ref.[50525] Active ingredients: Dolutegravir Lamivudine Tenofovir disoproxil

Posology

DOLTELAM should be prescribed by a health care provider experienced in the management of HIV infection.

Adults

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

Special populations

Renal impairment

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

The pharmacokinetics of tenofovir, as in DOLTELAM, have not been evaluated in nonhaemodialysis patients with creatinine clearance ˂ 80 mL/min); therefore, no dosing recommendations is available for these patients.

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

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

Concomitant use with rifampicin

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

Paediatric population

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

Method of administration

Oral use.

It is recommended that DOLTELAM be swallowed whole with water.

Symptoms

If overdose occurs the patient must be monitored for evidence of toxicity (see sections 4.8 and 5.3), and standard supportive treatment applied as necessary.

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 overdose in humans. If overdosage occurs the patient should be monitored, and palliative supportive treatment applied are 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 DOLTELAM. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary. As DOLTELAM is highly bound to plasma proteins, it is unlikely that it will be significantly removed by dialysis.

24 Months.

Store at or below 30°C.

Store in the original container.

Discard 90 days after first opening.

Keep bottle tightly closed.

Round opaque white HDPE bottle with 38 mm child resistant closure of polypropylene with HS 12335 printed liner with one molecular sieve sachet of 5g containing 30 tablets.

Round opaque white HDPE bottle with 38 mm child resistant closure of polypropylene with HS 12335 printed liner with two molecular sieve sachets of 5g containing 60 tablets.

Not all pack sizes may be marketed.

No special requirements.