14 December 2017 EMA/PRAC/610978/2017 Pharmacovigilance Risk Assessment Committee (PRAC)

PRAC recommendations on signals Adopted at the 27-30 November 2017 PRAC meeting

This document provides an overview of the recommendations adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) on the signals discussed during the meeting of 27-30 November 2017 (including the signal European Pharmacovigilance Issues Tracking Tool [EPITT] 1 reference numbers). PRAC recommendations to provide supplementary information are directly actionable by the concerned marketing authorisation holders (MAHs). PRAC recommendations for regulatory action (e.g. amendment of the product information) are submitted to the Committee for Medicinal Products for Human Use (CHMP) for endorsement when the signal concerns Centrally Authorised Products (CAPs), and to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) for information in the case of Nationally Authorised Products (NAPs). Thereafter, MAHs are expected to take action according to the PRAC recommendations. When appropriate, the PRAC may also recommend the conduct of additional analyses by the Agency or Member States. MAHs are reminded that in line with Article 16(3) of Regulation No (EU) 726/2004 and Article 23(3) of Directive 2001/83/EC, they shall ensure that their product information is kept up to date with the current scientific knowledge including the conclusions of the assessment and recommendations published on the European Medicines Agency (EMA) website (currently acting as the EU medicines webportal). For CAPs, at the time of publication, PRAC recommendations for update of product information have been agreed by the CHMP at their plenary meeting (11-14 December 2017) and corresponding variations will be assessed by the CHMP. For nationally authorised medicinal products, it is the responsibility of the National Competent Authorities (NCAs) of the Member States to oversee that PRAC recommendations on signals are adhered to. Variations for CAPs are handled according to established EMA procedures. MAHs are referred to the available guidance. Variations for NAPs (including via mutual recognition and decentralised procedures) are handled at national level in accordance with the provisions of the Member States.

1

The relevant EPITT reference number should be used in any communication related to a signal.

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© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.

The timeline recommended by PRAC for submission of variations following signal assessment is applicable to both innovator and generic medicinal products, unless otherwise specified. For procedural aspects related to the handling of PRAC recommendations on signals (e.g. submission requirements, contact points, etc.) please refer to the Questions and Answers on signal management.

PRAC recommendations on signals EMA/PRAC/610978/2017

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1. Recommendations for update of the product information 2 1.1. Insulin (pre-filled pens and cartridges): insulin aspart; insulin bovine; insulin degludec; insulin degludec, insulin aspart; insulin degludec, liraglutide; insulin detemir; insulin glargine; insulin glulisine; insulin human (rDNA); insulin human, insulin isophane; insulin lispro; insulin porcine – Potential increased risk of medication error associated with withdrawing insulin from pre-filled pens and cartridges, leading to dysglycaemia Authorisation procedure

Centralised and non-centralised

EPITT No

18893

PRAC rapporteur(s)

Julie Williams (UK)

Date of adoption

30 November 2017

Recommendation Having considered the available evidence, including the views of the Health Care Professional (HCP) experts on medication errors and diabetes and of patients and the data submitted by the MAHs, the PRAC has agreed the following recommendation: 1. High-strength and fixed-combination insulin products For these products the PRAC has already made recommendations published on 29 May 2017. No further action is required.

2. Standard (100 units/mL) and lower (< 100 units/mL) strength insulin products The MAH(s) of standard or low strength insulin-containing medicinal products in cartridges (for use with reusable pens) and pre-filled pens should submit a variation within 2 months, to amend the product information as described below (new text to be added underlined, text to be adapted by MAHs to individual products in bold):

Summary of product characteristics (SmPC) 6.6. Special precautions for disposal and other handling The following text and any related package leaflet text should be removed: ‘If the malfunctions (see instructions for using the pen / infusion pump), the solution may be drawn from the cartridge into a syringe (suitable for an insulin with 100 units/mL) and injected.’

4.2. Posology and method of administration, and/or 4.4. Special warnings and precautions for use < is only suitable for subcutaneous injections from a reusable pen.

2

Translations in all official EU languages of the new product information adopted by PRAC are also available to MAHs on the EMA website. PRAC recommendations on signals EMA/PRAC/610978/2017

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< If administration by syringe, or is necessary, a vial should be used.>>

< is only suitable for subcutaneous injections. or is necessary, a vial should be used.>>

Package leaflet (PL) 2. What you need to know before you use , and 3. How to use is only suitable for injecting just under the skin using a reusable pen. Speak to your doctor if you need to inject your insulin by another method. is only suitable for injecting just under the skin. Speak to your doctor if you need to inject your insulin by another method.

3. ‘Umbrella’ product information Summary of product characteristics ‘Umbrella’ SmPCs (for different presentations of the same product) should make it clear that administration by syringe and/or other devices (and different routes of administration) do not apply to use with pre-filled pens/cartridges for reusable pens. The layout/order of text as well as the actual language used should be reviewed and amended as necessary. In addition, PRAC agreed that the references to different routes of administration (e.g. intravenous use, infusion pumps) that are inappropriate for use with pre-filled pens/cartridges for reusable pens, should be deleted from individual SmPCs and PLs. PRAC has also agreed key messages for communication to HCP and patients at the national level.

PRAC recommendations on signals EMA/PRAC/610978/2017

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1.2. Tofacitinib – Angioedema Authorisation procedure

Centralised

EPITT No

18904

PRAC rapporteur(s)

Sabine Straus (NL)

Date of adoption

30 November 2017

Recommendation Having considered the available evidence in EudraVigilance and the data submitted by the MAH on the association of tofacitinib and angioedema, the PRAC has agreed that the MAH of Xeljanz (Pfizer) should submit a variation within 2 months to amend the product information as described below (new text underlined).

Summary of product characteristics 4.4. Special warnings and precautions for use Hypersensitivity In post-marketing experience, cases of hypersensitivity associated with tofacitinib administration have been reported. Allergic reactions included angioedema and urticaria; serious reactions have occurred. If any serious allergic or anaphylactic reaction occurs, tofacitinib should be discontinued immediately.

4.8. Undesirable effects Immune system disorders Frequency ‘not known’: hypersensitivity; angioedema; urticaria

Package leaflet 4. Possible side effects Other side effects which have been observed with XELJANZ are listed below. Not known (frequency cannot be estimated from the available data): hives (itchy, bumpy rash)

PRAC recommendations on signals EMA/PRAC/610978/2017

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2. Recommendations for submission of supplementary information INN

Signal (EPITT No)

PRAC

Action for MAH

MAH

Rapporteur

Daratumumab

Dasatinib

Cytomegalovirus (CMV)

Márcia

Assess in the next

Janssen-Cilag

reactivation (19087)

Sofia Silva

PSUR (submission by

International NV

(PT)

24 January 2018)

Cytomegalovirus (CMV)

Doris I

Supplementary

Bristol-Myers

reactivation (19111)

Stenver

information requested

Squibb Pharma

(DK)

(submission by 7

EEIG

February 2018) Human normal

Lupus-like syndrome

Brigitte

Supplementary

MAHs of Human

immunoglobulin

and related terms

Keller-

information requested

normal

(19098)

Stanislaws

(submission by 7

immunoglobulin

ki (DE)

February 2018)

-containing products

Lapatinib

Vortioxetine

Pulmonary

Ulla

Supplementary

Novartis

hypertension (19089)

Wändel

information requested

Europharm

Liminga

(submission by 7

Limited

(SE)

February 2018)

Laurence

Supplementary

H. Lundbeck

de Fays

information requested

A/S

(BE)

(submission by 7

Angioedema (19099)

February 2018)

PRAC recommendations on signals EMA/PRAC/610978/2017

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3. Other recommendations INN

Signal (EPITT No)

PRAC

Action for MAH

MAH

Rapporteur

mTOR inhibitors:

Optic neuropathy and

Martin

Routine

Novartis

everolimus,

papilloedema (18901)

Huber (DE)

pharmacovigilance

Europharm Ltd,

sirolimus,

Pfizer Limited

temsirolimus Nivolumab

Tumour lysis syndrome

Brigitte

To be addressed within

Bristol-Myers

(19086)

Keller-

the ongoing PSUR

Squibb Pharma

Stanislaws

procedure

EEIG

ki (DE)

(EMEA/H/C/PSUSA/000 10379/201707)

Phenprocoumon

Risk of birth defects

Martin

Propose an updated

MEDA Pharma

and foetal loss following

Huber (DE)

product information

GmbH & Co. KG

first trimester exposure

(submission by 7

as a function of the

February 2018)

time of withdrawal (18902) Radium (223Ra)

Fractures and fatal

Patrick

Circulation of a Direct

dichloride

cases in chemotherapy-

Batty (UK)

Healthcare Professional

Bayer AG

Communication

naïve patients (19132)

(DHPC); further action to be addressed within the procedure under Article 20 of Regulation (EC) No 726/2004 for radium (223Ra) dichloride Ritonavir;

Interaction possibly

Menno van

lopinavir,

leading to decreased

der Elst

ritonavir;

levothyroxine efficacy

(NL)

levothyroxine

and hypothyroidism

No action at this stage

Not applicable

(18896)

PRAC recommendations on signals EMA/PRAC/610978/2017

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PRAC recommendations on signals adopted at the 27-30 November ...

Dec 14, 2017 - marketing authorisation holders (MAHs). PRAC recommendations for regulatory action (e.g. amendment of the product ... MAHs are reminded that in line with Article 16(3) of Regulation No (EU) 726/2004 and Article 23(3) of. Directive 2001/83/EC, they shall ensure that their product information is kept up to ...

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