LOJUXTA Hard, capsule Ref.[27700] Active ingredients: Lomitapide

Treatment with Lojuxta should be initiated and monitored by a physician experienced in the treatment of lipid disorders.

Posology

The recommended starting dose is 5 mg once daily. After 2 weeks the dose may be increased, based on acceptable safety and tolerability, to 10 mg and then, at a minimum of 4-week intervals, to 20 mg, 40 mg, and to the maximum recommended dose of 60 mg (see section 4.8).

The dose should be escalated gradually to minimise the incidence and severity of gastrointestinal adverse reactions and aminotransferase elevations.

Administration with food may increase exposure to lomitapide. It should be taken on an empty stomach, at least 2 hours after the evening meal because the fat content of a recent meal may adversely impact gastrointestinal tolerability.

The occurrence and severity of gastrointestinal adverse reactions associated with the use of Lojuxta decreases in the presence of a low fat diet. Patients should follow a diet supplying less than 20% of energy from fat prior to initiating treatment, and should continue this diet during treatment. Dietary counselling should be provided.

Patients should avoid consumption of grapefruit juice (see sections 4.4 and 4.5).

For patients on a stable maintenance dose of Lojuxta who receive atorvastatin either:

• Separate the dose of the medicinal products by 12 hours

OR

• Decrease the dose of Lojuxta by half.

Patients on 5 mg should remain on 5 mg. Careful titration may then be considered according to LDL-C response and safety/tolerability. Upon discontinuation of atorvastatin the dose of Lojuxta should be up-titrated according to LDL-C response and safety/tolerability.

For patients on a stable maintenance dose of Lojuxta who receive any other weak CYP3A4 inhibitor, separate the dose of the medicinal products (Lojuxta and the weak CYP3A4 inhibitor) by 12 hours.

Consider limiting the maximum dose of Lojuxta according to desired LDL-C response. Exercise additional caution if administering more than 1 weak CYP3A4 inhibitor with Lojuxta.

Based on observations of decreased essential fatty acid and vitamin E levels in clinical studies, patients should take daily dietary supplements that provide 400 IU vitamin E and approximately 200 mg linoleic acid, 110 mg eicosapentaenoic acid (EPA), 210 mg alpha linolenic acid (ALA) and 80 mg docosahexaenoic acid (DHA) per day, throughout treatment with Lojuxta.

Special populations

Elderly population

There is limited experience with lomitapide in patients aged 65 years or older. Therefore, particular caution should be exercised in these patients.

Since the recommended dose regimen involves starting at the low end of the dosing range and escalating cautiously according to individual patient tolerability, no adjustment to the dosing regimen is recommended for the elderly.

Hepatic impairment

Lomitapide is contraindicated in patients with moderate or severe hepatic impairment including patients with unexplained persistent abnormal liver function tests (see sections 4.3 and 5.2).

Patients with mild hepatic impairment (Child-Pugh A) should not exceed 40 mg daily.

Renal impairment

Patients with end-stage renal disease receiving dialysis should not exceed 40 mg daily (see section 5.2).

Paediatric population

The safety and efficacy of lomitapide in children <18 years have not been established and the use of this medicinal product in children is therefore not recommended. No data are available.

Method of administration

Oral use.

There is no specific treatment in the event of overdose. In the event of overdose, the patient should be treated symptomatically and supportive measures instituted as required. Liver related tests should be monitored. Haemodialysis is unlikely to be beneficial given that lomitapide is highly protein bound.

In rodents, single oral doses of lomitapide ≥600 times higher than the maximum recommended human dose (1 mg/kg) were well tolerated. The maximum dose administered to human subjects in clinical studies was 200 mg as a single dose; there were no adverse reactions.

3 years.

Store below 30°C.

Keep the bottle tightly closed in order to protect from moisture.

High density polyethylene (HDPE) bottle fitted with a polyester/aluminium foil/cardboard induction seal and polypropylene screw cap.

Package sizes are: 28 capsules.

No special requirements.