LOJUXTA Hard, capsule (2024)

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Περιεχόμενα

1. Name of the medicinal product

Lojuxta 5 mg hard capsules. Lojuxta 10 mg hard capsules. Lojuxta 20 mg hard capsules. Lojuxta 30 mg hard capsules. Lojuxta 40 mg hard capsules. Lojuxta 60 mg hard capsules.

2. Qualitative and quantitative composition

Lojuxta 5 mg hard capsules Each hard capsule contains lomitapide mesylate equivalent to 5 mg lomitapide. Excipient with known effect: Each hard capsule contains 70.12 mg of lactose (as monohydrate) ...

3. Pharmaceutical form

Hard, capsule. Lojuxta 5 mg hard capsules: The 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. Lojuxta 10 mg ...

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 ...

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 ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with moderate or severe hepatic impairment and those with unexplained persistent abnormal liver function ...

4.4. Special warnings and precautions for use

Liver enzyme abnormalities Lomitapide can cause elevations in the liver enzymes alanine aminotransferase [ALT] and aspartate aminotransferase [AST] and hepatic steatosis (see section 5.1). There have been ...

4.5. Interaction with other medicinal products and other forms of interaction

Effects of other medicinal products on lomitapide and other forms of interaction Table 2. Interactions between Lojuxta and other medicinal products and other forms of interaction: Medicinal products ...

4.6. Fertility, pregnancy and lactation

Use in women of child-bearing potential Before initiating treatment in women of child-bearing potential, the absence of pregnancy should be confirmed, appropriate advice on effective methods of contraception ...

4.7. Effects on ability to drive and use machines

Lojuxta has minor influence on the ability to drive and use machines.

4.8. Undesirable effects

Summary of the safety profile The most serious adverse reactions during treatment were liver aminotransferase abnormalities (see section 4.4). The most common adverse reactions were gastrointestinal effects. ...

4.9. Overdose

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 ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Lipid modifying agents, other lipid modifying agents ATC code: C10AX12 Mechanism of action Lomitapide is a selective inhibitor of microsomal transfer protein (MTP), ...

5.2. Pharmacokinetic properties

Absorption The absolute oral bioavailability of lomitapide is 7%. Absorption is not limited by penetration of the active substance across the intestinal barrier but is predominantly influenced by an extensive ...

5.3. Preclinical safety data

In repeat-dose oral toxicology studies in rodents and dogs, the principal drug-related findings were lipid accumulation in the small intestine and/or liver associated with decreases in serum cholesterol ...

6.1. List of excipients

Capsule content: Pregelatinised starch (maize) Sodium starch glycolate (Type A) Microcrystalline cellulose Lactose monohydrate Silica, colloidal anhydrous Magnesium stearate Capsule shell: ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store below 30°C. Keep the bottle tightly closed in order to protect from moisture.

6.5. Nature and contents of container

High density polyethylene (HDPE) bottle fitted with a polyester/aluminium foil/cardboard induction seal and polypropylene screw cap. Package sizes are: 28 capsules.

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

Chiesi Farmaceutici S.p.A., Via Palermo 26/A, 43122 Parma, Italy

8. Marketing authorization number(s)

EU/1/13/851/001 – Lojuxta 5 mg hard capsules EU/1/13/851/002 – Lojuxta 10 mg hard capsules EU/1/13/851/003 – Lojuxta 20 mg hard capsules EU/1/13/851/004 – Lojuxta 30 mg hard capsules EU/1/13/851/005 – ...

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 31 July 2013 Date of latest renewal: 26 May 2023

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