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Yervoy (ipilimumab) – Conditions or restrictions regarding supply and use - L01XC11

Updated on site: 11-Oct-2017

Medication nameYervoy
ATC CodeL01XC11
Substanceipilimumab
ManufacturerBristol-Myers Squibb Pharma EEIG

A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer(s) of the biological active substance(s)

Bristol-Myers Squibb Company

6000 Thompson Road

East Syracuse, New York 13057

United States

Samsung Biologics Co. Ltd

300, Songdo Bio Way (Daero)

Yeonsu-gu, Incheon 21987

Korea

Name and address of the manufacturer(s) responsible for batch release

Bristol-Myers Squibb S.r.l.

Contrada Fontana del Ceraso

IT-03012 Anagni (FR)

Italy

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 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.

Additional risk minimisation measures

The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe YERVOY are provided with the following:

Healthcare Professional FAQ Brochure

Patient Information Brochures including Alert Cards

Key elements of the Healthcare Professional FAQ Brochure (Q&A format):

Brief introduction to ipilimumab (indication and the purpose of this tool).

List of important immune-related adverse reactions (irARs) and their symptoms, as outlined in section 4.4 of the Summary of Product Characteristics (SmPC):

o Inflammation of the gastrointestinal tract, such as colitis, which can lead to bowel perforation

o Inflammation of the liver, such as hepatitis, which can lead to liver failure

o Inflammation of the skin that can lead to severe skin reaction (toxic epidermal necrolysis) o Inflammation of the nerves that can lead to neuropathy

o Inflammation of the endocrine system. including the adrenal, pituitary, or thyroid glands o Inflammation of the eyes

o Other related irARs (e.g. pneumonitis, glomerulonephritis, multi-organ failure…) o Severe infusion reaction

Information that ipilimumab can cause serious side effects in many parts of the body that can lead to death and require early intervention, as outlined in the guidelines for the management of immune-related adverse reactions in section 4.4 of the SmPC.

Importance of evaluating liver function tests (LFTs), TSH and signs/symptoms of irARs before each treatment.

Follow-up of patients due to late onset (months after treatment) of irARs

Reminder to distribute the Patient Information Brochure, and to educate patients/caregivers about symptoms of irARs and of the need to report them immediately to the physician.

Key elements for the Patient Information Brochure and Alert Card:

Brief introduction to ipilimumab indication and the purpose of this tool.

Information that ipilimumab can cause serious side effects in many parts of the body that can lead to death and need to be addressed immediately

Request to inform the physician of all medical conditions before treatment.

Description of the main symptoms of irARs and the importance of notifying their treating physician immediately if symptoms occur, persist or worsen.

o Gastrointestinal: diarrhea, bloody stool, abdominal pain, nausea, or vomiting o Liver: yellowing of your skin or whites of your eyes

o Skin: rash, blisters and/or peeling, mouth sores o Eye: blurred vision, vision changes, eye pain,

o General: fever, headache, feeling tired, dizziness or fainting, dark urine, bleeding, weakness, numbness of legs, arms, or faces, changes in behavior, such as less sex drive, being irritable or forgetful

The importance of not attempting to self-treat any symptoms without consulting their Healthcare professional first.

Placeholder including the weblink of the Package Leaflet on the EMA website

The importance of carrying the detachable wallet-sized Patient Alert Card at all times to show it at all medical visits to healthcare professionals other than the prescriber (e.g. emergency healthcare professionals). The Card reminds patients about key symptoms that need to be reported immediately to the physician/nurse. It also contains prompts to enter contact details of the physician and to alert other physicians that the patient is treated with ipilimumab.

The Marketing Authorisation Holder shall agree the format and content of the above material with the National Competent Authority prior to launch in the Member State.

Obligation to conduct post-authorisation measures

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

Description

Due Date

 

 

The Marketing Authorisation Holder shall perform a randomized

Final study report:

comparison study of 3 mg/kg versus 10 mg/kg evaluating efficacy

4Q2017

and safety in advanced melanoma with a survival endpoint, based

 

on a CHMP-agreed protocol.

 

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