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Lojuxta (lomitapide) – Conditions or restrictions regarding supply and use - C10AX12

Updated on site: 08-Oct-2017

Medication nameLojuxta
ATC CodeC10AX12
Substancelomitapide
ManufacturerAegerion Pharmaceuticals

A.MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Catalent UK Packaging Limited

Lancaster Way

Wingates Industrial Estate

Westhoughton

Bolton

Lancashire

BL5 3XX

United Kingdom

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal products on “restricted” medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).

C. OTHER CONDITIONS AND REQUIREMENTS THEOF MARKETING AUTHORISATION

Periodic safety update reports

The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

Risk Management Plan (RMP)

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the

 

agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed

subsequent

 

updates of the RMP.

 

 

An updated RMP should be submitted:

 

 

At the request of the European Medicines Agency;

 

 

Whenever the risk management system is modified, especially as

the result

of new

information being received that may lead to a significant change to the benefit/risk profile or

 

as the result of an important (pharmacovigilance or risk minimisation)

milestone

being

reached.

 

 

If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.

Additional risk minimisation measures

The MAH shall provide an educational pack prior to launch targeting all physicianswho are expected to prescribe/use lomitapide.

The physician educational pack should contain:

The Summary of Product Characteristics

The Prescriber Guide

Patient Alert Cards

Patient Brochures

The MAH must agree the content and format of the educationterials matogether with a communication plan with the national competent authority in each Member State prior to distribution in their territory.

The Prescriber Guide shall include the following key elements:

Appropriate patient selection

Lojuxta is only indicated for use in adult patients with HoFH;

The safety and effectiveness of Lojuxta in children below the age of 18 have not been established;

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

• That Lojuxta was teratogenic in non-clinical studies and that women of child-bearing potential must be non-pregnant and using effective contraception prior to initiating treatment.

Gastrointestinal (GI) Effects

Information on undesirable effects, including diarrhoea, nausea, flatulence, abdominal pain or discomfort, abdominal distension, vomiting, dyspepsia, eructation and decreased appetite;

Contraindication for usein patients with a known significant or chronic bowel disease such as inflammatory bowel disease or malabsorption;

Advice on escalating Lojuxta dose gradually to improve tolerability of the medicine;

Advice to patients about:

The need to follow a low-fat diet (i.e. patients should follow a diet supplying less than 20% of

energy from fat);

− The timing of medicine intake (Lojuxta should be taken on an empty stomach, at least 2 hours

after the evening meal);

 

− The need to take daily dietary supplements

(i.e. 400IU vitamin E,approximately 200 mg

linoleic acid, 110 mg eicosapentaenoic acid

(EPA), 210 mg alphalinolenic acid (ALA) and

80 mg docosahexaenoic acid (DHA) per day).

 

Hepatic events related to elevated aminotransferases and progressive liver disease

Information about contraindication in patients with moderate or severe- xistingpre hepatic impairment/disease, including those with unexplained persistent abnormal liver function tests;

Information about clinical findings (i.e., hepatic enzyme increases and steatosis) in subjects treated with Lojuxta during the developmental phase;

Advice to exercise caution if Lojuxta is used with other hepatotoxic drugs and to consider more frequent monitoring of liver-related tests;

Advice to patients about the risk of concomitant alcohol intake;

Advice on monitoring liver function (measuring hepatic enzymes and total bilirubin)before and

during treatment with Lojuxtaand routine screening to detect presence of steatohepatitis and hepatic fibrosis including specific details of the screening tests at baseline and annually as follows:

-Imaging for tissue elasticity, e.g. Fibroscan, acoustic radiation force impulse (ARFI),or magnetic resonance (MR) elastography;

-Measurement of biomarkers and/or scoring methods. This should include at least one marker in each of the following categories:

gamma-GT, serum albumin (liver injury);

high sensitivity -Creactive protein (hs-CRP), erythrocyte sedimentation rate (ESR), CK-18 Fragment, NashTest (liver inflammation);

Enhanced Liver Fibrosis (ELF) panel, Fibrometer, AST/ALT ratio, Fib-4 score, Fibrotest (liver fibrosis).

Use in Women of Childbearing Potential

That Lomitapide was teratogenic in non-clinical studies and is contraindicated in women who are or may become pregnant. Women who become pregnant should be counselled and referred to an expert in teratology;

Before initiating treatment in women of child-bearing potential:

The absence of pregnancy should be confirmed;

Appropriate advice on effective methods of contraception should be provided, andeffective

contraception initiated;

Warning about possible loss of effectiveness of oral contraceptives due to diarrhoea vomitingor and need for additional contraception until 7 days after resolution of symptoms;

Women should tell their doctor immediately if they suspect that they might be pregnant.

Drug interactions

Information about interactions with CYP3A4 inhibitors andinducers, coumarin anticoagulants, statins, P-gp substrates, oral contraceptives, bile acid sequestrants and grapefruit juice;

Importance of fatty acid and soluble vitamins supplementation;

• Compliance with the supplementation

regimen should be verifiedregularat scheduled

appointments and the importance emphasised.

 

Educational materials for patients

Information that the educational materials for patients included in the prescribers pack can be usedfor patient counselling.

A copy of the patient brochureand patient alert card shall be providedto all patients at the time Lojuxta treatment is initiated.

Patients shall be informed of the necessity to carry the patient alert card with them and show it to all doctors that treat them.

Lomitapide Observational Worldwide Evaluation Registry

Information about the existence and importance of the registryaiming to systematically collect information on the safety and effectiveness outcomes of patients treated with lomitapide.

Prescribers are encouraged to enrol all patients treated with Lojuxta into a global registry.

Patient brochure

The patient brochure shall include the following key elements:

Not to take Lojuxta if patient has liver problems, or unexplained abnormal liver tests;

Information that Lojuxta may cause liver problems;

The need to inform their doctor if they have had any liver problems in the past;

The need to inform their doctor of all other medications they are taking as special care should be taken if other drugs which can cause liver problems are taken at the same time;

Symptoms of liver disease for which the patient should consult a doctor;

An explanation of the types of tests required (imaging and blood) to check liver function and the importance of them being performed regularly;

Information that Lojuxta was teratogenic in non-clinical studies and should not be takenduring pregnancy or by patients trying to get pregnant;

Women of childbearing potential should have adequate birth controland should tell their doctors immediately if they suspect they may be pregnant;

Lojuxta may cause diarrhoea and vomiting and if it does, patients using oral contraception should use additional contraceptive methods for 7 days after symptoms have resolved;

Information about interactions with CYP3A4 inhibitorsand inducers, coumarin anticoagulants, statins, P-gp substrates, oral contraceptives, bile acid sequestrants;

The need to avoid alcohol;

The need to avoid grapefruit juice;

Importance of fatty acid and fat soluble vitamin (Vitamin E) supplementation;

Information on the importance of following a low-fat diet (a diet supplying less than 20% of energy from fat);

Information about taking Lojuxta at bedtime with water at least 2 hours after the evening meal and without food;

Information about the existence andimportance of the Lomitapide Observational Worldwide Evaluation Registry aiming to systematically collect information on the safety and effectiveness outcomes of patients treated with lomitapide.

Patient Alert card

The purpose of the patient alert cardis to inform health care professionals of potential drug-drug interactions before any additional drug is prescribed.Patients will be instructed to carry this card and show it to all doctors who treat them.

This card will give information about interactions with:

o

CYP 3A4 inhibitors

o

CYP 3A4 inducers

o

coumarin anticoagulants

o

statins

o

P-gp substrates

oOestrogen-containing oral contraceptives

Obligation to conduct post-authorisation measures

The MAH shall complete, within the stated timeframe, the below measure:

Description

Due date

Based on CHMP approved protocol, the applicant shall conduct a

The final study report shall

clinical study with adequate surrogate endpoints on vascular outcomes

be submitted by

using imaging techniques to monitor vascular function, disease

31 December 2021.

stabilisation and/or regression.

 

E.SPECIFIC OBLIGATION TO COMPLETE POSTAUTHORISATION-MEASURES

FOR

THE

MARKETING

AUTHORISATION

UNDER

EXCEPTIONAL

CIRCUMSTANCES

 

 

 

 

This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:

Description

 

Due date

 

 

The applicant shall set up a long term prospective observational study to

Annual

reports

will

systematically collect information

on the safety and effective

submitted at time of annu

outcomes of patients treated with lomitapide.

reassessment

 

The objectives of the study are:

 

 

 

 

• To evaluate the occurrence of the following in patients treated

 

 

 

lomitapide:

 

 

 

 

o

Hepatic events

 

 

 

 

o

Gastrointestinal events

 

 

 

 

o Small bowel, hepatic, colorectal and pancreatic tumours

 

 

 

o Events associated with coagulopathy

 

 

 

o Major Adverse Cardiovascular Events (MACE) events

 

 

 

o Death, including cause of death

 

 

 

• To evaluate the occurrence and outcomes of pregnancy in females

 

 

 

reproductive potential treated with

lomitapide who decide to contin

 

 

 

the pregnancy following advice from a teratologist.

 

 

 

• To evaluate the long-term effectiveness of lomitapide in maintaining

 

 

 

control of serum lipid levels in clinical practice.

 

 

 

• To evaluate whether prescribers

of lomitapide are following

 

 

 

screening and monitoring recommendations as specified in the product

 

 

 

information and the educational materials.

 

 

 

 

 

 

 

 

 

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