LOMIDA Film-coated tablet Ref.[115179] Active ingredients: Dolutegravir Lamivudine

Posology

Therapy should be initiated by a doctor experienced in the management of HIV infection. LOMIDA is a fixed-dose tablet and should not be prescribed for patients requiring dosage adjustments, such as those with creatinine clearance less than 50 mL/min.

A separate preparation of dolutegravir is available where a dose adjustment is required due to interactions (see section 4.5).

For patients with integrase inhibitor resistance, LOMIDA is not recommended. In this case, the doctor should refer to the dolutegravir tablet product information.

The recommended adult dose of LOMIDA in treatment naïve, treatment experienced, and integrase inhibitor naïve patients is one tablet (50/300 mg) once daily.

Special populations

Renal impairment

Whilst no dosage adjustment of dolutegravir is necessary in patients with renal impairment, a dose reduction of lamivudine is required due to decreased clearance. LOMIDA is not recommended for use in patients with a creatinine clearance less than 50 mL/min (see section 5.2).

Hepatic impairment

No dosage adjustment is necessary in patients with mild to moderate liver disease (Child-Pugh grade A or B) unless accompanied by renal impairment.

There is no data on the use of LOMIDA in patients with severe hepatic impairment, therefore caution should be exercised.

Elderly

There are limited data on the use of LOMIDA in patients aged 65 years and older. However, there is no evidence that elderly patients require a different dose than younger adult patients (see section 5.2). When treating elderly patients, consideration needs to be given to greater frequency of decreased hepatic and renal function, haematological abnormalities and concomitant medicines or disease.

Method of administration

LOMIDA is for oral administration and should be swallowed whole.

LOMIDA can be taken with or without food.

No specific signs and symptoms have been identified for the overdose of LOMIDA. An overdose could result in the increased severity of undesirable effects (see section 4.8).

Management of overdosage

There is no specific treatment for an overdose with LOMIDA. If an overdose occurs, the patient should be monitored and treated supportively. Since lamivudine can be removed with dialysis, haemodialysis could be used in the treatment of an overdose. As dolutegravir is highly bound by plasma proteins, it is unlikely that it will be removed by dialysis.

24 months.

Store at or below 25°C in the original container.

LOMIDA is packed in a 50 cc white round high density polyethylene (HDPE) bottle with 33 mm blue child resistant cap. Pack sizes are 28’s and 30’s.

No special requirements.