1. Name of the medicinal product
Lojuxta 5 mg hard capsules

Lojuxta 10 mg hard capsules

Lojuxta 20 mg hard capsules

2. Qualitative and quantitative composition
Each 5 mg hard capsule contains lomitapide mesylate equivalent to 5 mg lomitapide.

Each 10 mg hard capsule contains lomitapide mesylate equivalent to 10 mg lomitapide.

Each 20 mg hard capsule contains lomitapide mesylate equivalent to 20 mg lomitapide.

Excipient with known effect:

Each 5 mg hard capsule contains 70.12 mg of lactose (as monohydrate) (see section 4.4).

Each 10 mg hard capsule contains 140.23 mg of lactose (as monohydrate) (see section 4.4).

Each 20 mg hard capsule contains 129.89 mg of lactose (as monohydrate) (see section 4.4).

For the full list of excipients, see section 6.1.

3. Pharmaceutical form
Capsule, hard.

The 5 mg capsule is an orange cap/orange body hard capsule of 19.4 mm, printed with black ink imprinted with “5 mg” on body and “A733” on cap.

The 10 mg capsule is an orange cap/white body hard capsule of 19.4 mm, printed with black ink imprinted with “10 mg” on body and “A733” on cap.

The 20 mg capsule is a white cap/white body hard capsule of 19.4 mm, printed with black ink imprinted with “20 mg” on body and “A733” on cap.

4. Clinical particulars
4.1 Therapeutic indications
Lojuxta is indicated as an adjunct to a low-fat diet and other lipid-lowering medicinal products with or without low density lipoprotein (LDL) apheresis in adult patients with homozygous familial hypercholesterolaemia (HoFH).

Genetic confirmation of HoFH should be obtained whenever possible. Other forms of primary hyperlipoproteinaemia and secondary causes of hypercholesterolaemia (e.g., nephrotic syndrome, hypothyroidism) must be excluded.

4.2 Posology and method of administration
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 side effects and aminotransferase elevations.

Administration with food may increase exposure to Lojuxta. Lojuxta 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 Lojuxta 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).

Patients on a stable maintenance dose of Lojuxta who receive a weak CYP3A4 inhibitor should reduce the dose of Lojuxta as follows:

• Patients on 40 mg or 60 mg should reduce to 10 mg

• Patients on doses < 40 mg should reduce to 5 mg

Careful up-titration may then be considered according to LDL-C response and safety/tolerability.

Consider limiting the maximum dose of Lojuxta according to desired LDL-C response. Upon discontinuation of the weak CYP3A4 inhibitor, the dose of Lojuxta should be up-titrated according to LDL-C response and safety/tolerability.

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