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Lemtrada (alemtuzumab) – Package leaflet - L04AA34

Updated on site: 08-Oct-2017

Medication nameLemtrada
ATC CodeL04AA34
Substancealemtuzumab
ManufacturerGenzyme Therapeutics Ltd

Package leaflet: Information for the patient

LEMTRADA 12 mg concentrate for solution for infusion alemtuzumab

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you are administered this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor.

-If you get any side-effects talk to your doctor. This includes any possible side-effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What LEMTRADA is and what it is used for

2.What you need to know before you are administered LEMTRADA

3.How LEMTRADA will be administered

4.Possible side effects

5.How to store LEMTRADA

6.Contents of the pack and other information

1.What LEMTRADA is and what it is used for

LEMTRADA contains the active substance alemtuzumab, which is used to treat a form of multiple sclerosis (MS) in adults, called relapsing remitting MS (RRMS). LEMTRADA does not cure MS, but it can reduce the number of MS relapses. It can also help to slow down or reverse some of the signs and symptoms of MS. In clinical studies, patients treated with LEMTRADA had fewer relapses and were less likely to experience worsening of their disability compared to patients treated with a beta-interferon injected multiple times per week.

What is multiple sclerosis?

MS is an autoimmune disease that affects the central nervous system (brain and spinal cord). In MS your immune system mistakenly attacks the protective layer (myelin) around the nerve fibres, causing inflammation. When the inflammation causes symptoms this is often called an “attack” or a “relapse”. In RRMS patients experience relapses followed by periods of recovery.

The symptoms you experience are determined by which part of your central nervous system is affected. The damage done to your nerves during this inflammation may be reversible, but as your disease progresses the damage may accumulate and become permanent.

How LEMTRADA works

LEMTRADA adjusts your immune system to limit its attacks on your nervous system.

2. What you need to know before you are administered LEMTRADA

Do NOT use LEMTRADA if you are:

-allergic to alemtuzumab or any of the other ingredients of this medicine (listed in section 6)

-infected with human immunodeficiency virus (HIV).

Warnings and precautions

Talk to your doctor before LEMTRADA is given. After having a course of treatment with LEMTRADA you may be at greater risk of developing other autoimmune conditions, or experiencing serious infections. It is important you understand these risks and how to monitor for them. You will be given a Patient Alert Card and a Patient Guide with further information. It is important that you keep the Patient Alert Card with you during treatment and for 4 years after your last infusion with LEMTRADA, because side effects may occur many years after treatment. When you have medical treatment, even if it is not for your MS, show the Patient Alert Card to the doctor.

Your doctor will perform blood tests before you start treatment with LEMTRADA. These tests are done to see whether you may take LEMTRADA. Your doctor will also want to make sure that you do not have certain medical conditions or disorders before you start your treatment with LEMTRADA.

Autoimmune conditions

Treatment with LEMTRADA may increase the risk for autoimmune conditions. These are conditions in which your immune system mistakenly attacks your body. Information about some specific conditions that have been seen in MS patients who have been treated with LEMTRADA is provided below.

The autoimmune conditions can occur many years after treatment with LEMTRADA. Therefore, regular blood and urine tests are needed until 4 years after your last infusion. Testing is needed even if you are feeling well and your MS symptoms are under control. In addition, there are certain signs and symptoms that you should look out for yourself. Details about the signs and symptoms, testing, and actions you need to take are described in section 4 – autoimmune conditions.

More helpful information about these autoimmune conditions (and the testing for them) can be found in the

LEMTRADA Patient Guide.

o Immune Thrombocytopenic Purpura (ITP)

Uncommonly, patients have developed a bleeding disorder caused by a low level of blood platelets, called immune thrombocytopenic purpura (ITP). This must be diagnosed and treated early, as otherwise the effects can be serious or even fatal. Signs and symptoms of ITP are described in section 4.

o Kidney disease (such as anti-GBM disease)

Rarely, patients have experienced autoimmune related problems with their kidneys, such as anti- glomerular basement membrane disease (anti-GBM disease). Signs and symptoms of kidney disease are described in section 4. If untreated it can cause kidney failure requiring dialysis or transplantation, and may lead to death.

o Thyroid disorders

Very commonly, patients have experienced an autoimmune disorder of the thyroid gland affecting its ability to make or control hormones that are important for your metabolism. LEMTRADA may cause different types of thyroid disorders, including:

Over-active thyroid gland (hyperthyroidism) when the thyroid produces too much hormone

Under-active thyroid gland (hypothyroidism) when the thyroid does not produce enough hormone.

Signs and symptoms of thyroid disorders are described in section 4.

If you develop a thyroid disorder, in most cases you will need to be treated for the rest of your life with medicines to control your thyroid disorder, and in some cases your thyroid gland may have to be removed.

It is very important that you are properly treated for a thyroid disorder, especially if you become pregnant after using LEMTRADA. Having an untreated thyroid disorder could harm your unborn baby, or harm your baby after birth.

o Other autoimmune conditions

Rarely, patients have experienced autoimmune conditions involving red blood cells or white blood cells. These can be diagnosed from the blood tests that you will be having regularly after LEMTRADA treatment. If you develop one of these conditions your doctor will tell you, and take appropriate measures to treat it.

Infusion reactions

Most patients treated with LEMTRADA will experience side-effects at the time of the infusion or within 24 hours after the infusion. To try to reduce infusion reactions, your doctor will give you other medicine(s) (see section 4 – infusion reactions).

Infections

Patients treated with LEMTRADA are at a higher risk of getting a serious infection (see section 4 – infections). In general, the infections can be treated with standard medicines.

In order to reduce the chance of getting an infection, your doctor will check if other medicines you are taking might be affecting your immune system. Therefore, it is important to tell your doctor about all medicines you are taking.

Also, if you are suffering from an infection before the start of your LEMTRADA treatment, your doctor will consider delaying the treatment until the infection is under control or resolved.

Patients treated with Lemtrada are at a higher risk of developing herpes infection (e.g. a cold sore). In general, once a patient has had a herpes infection, they have an increased risk of developing another one. It is also possible to develop a herpes infection for the first time. It is recommended that your doctor prescribes a medicine to reduce the chance of developing a herpes infection, which should be taken on the days that you receive LEMTRADA treatment, and for one month following the treatment.

In addition, infections which can result in abnormalities of the cervix (the neck of the womb) are possible. Therefore, it is recommended that all female patients have an annual screening performed, such as a cervical smear. Your doctor will explain to you what tests you will need.

Patients treated with LEMTRADA are also at a higher risk of developing listeriosis/Listeria meningitis. To reduce this risk, you should avoid ingestion of uncooked or undercooked meats, soft cheeses and unpasteurized dairy products for at least one month after LEMTRADA treatment.

If you live in a region where tuberculosis infections are common, you may be at greater risk of infection with tuberculosis. Screening for tuberculosis will be arranged by your doctor.

If you are a carrier of hepatitis B or hepatitis C infection (these affect the liver), extra caution is needed before you receive LEMTRADA treatment as it is unknown if treatment could lead to activation of the hepatitis infection which could subsequently damage your liver.

Previously diagnosed cancer

If you have been diagnosed with cancer in the past, please inform your doctor about it.

Vaccines

It is not known if LEMTRADA affects your response to a vaccine. If you have not completed the standard required vaccinations, your doctor will consider whether you should have them before your LEMTRADA treatment. In particular, your doctor will consider vaccinating you against chickenpox if you have never had it. Any vaccination will need to be given to you at least 6 weeks before starting a LEMTRADA treatment course.

You must NOT receive certain types of vaccines (live viral vaccines) if you have recently received LEMTRADA.

Children and adolescents

LEMTRADA is not intended to be used in children and adolescents below 18 years old as it has not been studied in MS patients below 18 years old.

Other medicines and LEMTRADA

Tell your doctor or pharmacist if you are taking, have recently taken, or are planning to take any other medicines (including any vaccinations or herbal medecines).

Besides LEMTRADA, there are other treatments (including those for MS, or to treat other conditions) which could affect your immune system and so could affect your ability to fight infections. If you are using such a medicine, your doctor may ask you to stop this medicine before starting treatment with LEMTRADA.

Pregnancy

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being given this medicine.

Women who are able to conceive should use effective contraceptive methods during each treatment course with LEMTRADA and for 4 months after each course of treatment.

If you become pregnant after treatment with LEMTRADA and experience a thyroid dirorder during pregancy, extra caution is needed. Thyroid disorders could be harmful to the baby (see section 2 Warnings and precautions – autoimmune conditions).

Breast-feeding

It is unknown if LEMTRADA can be transferred to a baby through breast milk, but there is a possibility that it could be. It is recommended that you do not breast-feed during each course of treatment with LEMTRADA and for 4 months after each treatment course. However, there may be benefits of breast milk (which can help protect a baby from infections), so talk to your doctor if you are planning to breast-feed your baby. They will advise you what is right for you and your baby.

Fertility

During your treatment course and for 4 months afterwards, you may have LEMTRADA in your body. It is not known if LEMTRADA will have an effect on fertility during this period. Talk to your doctor if you are thinking about trying to become pregnant.

Driving and using machines

Many patients experience side effects at the time of the infusion or within 24 hours after the infusion with LEMTRADA, and some of these, for example dizziness, could make it unsafe to drive or use machines. If affected, stop these activities until you feel better.

LEMTRADA contains potassium and sodium

This medicine contains less than 1 mmol potassium (39 mg) per infusion, i.e. it is essentially ‘potassium- free’.

This medicinal product contains less than 1 mmol sodium (23 mg) per infusion, i.e. it is essentially ‘sodium- free’.

3.How LEMTRADA will be administered

Your doctor will explain to you how LEMTRADA will be given. Ask your doctor if you have any questions.

For the first treatment course you will receive one infusion per day for 5 days (course 1). One year later you will receive one infusion per day for 3 days (course 2).

There is no LEMTRADA treatment between the two courses.

The maximum daily dose is one infusion.

LEMTRADA will be given to you as an infusion into a vein. Each infusion will take approximately 4 hours. For most patients 2 treatment courses reduces MS activity for 2 years. Monitoring for side effects and regular testing must continue for 4 years after the last infusion.

To help you better understand the duration of the effects of treatment and the length of required follow-up, please refer to the diagram below.

Follow-up after treatment with LEMTRADA

Once you have received LEMTRADA, you will need to undergo regular tests to ensure that any potential side effects can be diagnosed and treated promptly. These tests must continue until 4 years after your last infusion and are described in section 4 most important side-effects.

If you are given more LEMTRADA than you should receive

Patients who were accidentally given too much LEMTRADA in one infusion have experienced serious reactions, such as headache, rash, low blood pressure or increased heart rate. Doses higher than the recommended dose may result in more serious or longer lasting infusion reactions (see section 4) or a stronger effect on the immune system. The treatment consists of stopping LEMTRADA administration and treating the symptoms.

If you have any further questions on the use of this medicine, ask your doctor.

4.Possible side effects

Like all medicines, LEMTRADA can cause side effects, although not everybody gets them.

The most important side effects are the autoimmune conditions described in section 2 which include:

ITP (bleeding disorders), (uncommon – may affect up to 1 in 100 people): may show as small scattered red, pink or purple spots on your skin; easy bruising; bleeding from a cut that is harder to stop; heavier, longer or more frequent menstrual periods than normal; bleeding between menstrual periods; bleeding from your gums or nose that is new or takes longer than usual to stop; or coughing up blood.

kidney disorders, (rare – may affect up to 1 in 1,000 people): may show as blood in the urine (your urine may be red or tea-coloured), or as swelling in your legs or feet. It can also lead to damage of your lungs, which can result in coughing up blood.

If you notice any of these signs or symptoms for bleeding or kidney disorders, call your doctor immediately to report the symptoms. If you cannot reach your doctor, you must seek immediate medical attention.

thyroid disorders (very common – may affect more than 1 in 10 people): may show as excessive sweating; unexplained weight-loss or gain; eye swelling; nervousness; fast heartbeat; feeling cold; worsening tiredness; or newly occurring constipation.

red and white blood cells disorders (rare – may affect up to 1 in 1,000 people): diagnosed from your blood tests.

All of these serious side effects can start many years after you have received LEMTRADA. If you notice any of these signs or symptoms, call your doctor right away to report them. You will also have regular blood and urine tests to ensure that if you develop any of these conditions, they are treated promptly.

Summary of tests you will have for autoimmune conditions:

Test

When?

For how long?

 

 

 

Blood test

Before treatment starts and every

Until 4 years after your last

(to diagnose all

important serious side

month after treatment

LEMTRADA infusion

effects listed above)

 

 

Urine test

Before treatment starts and every

Until 4 years after your last

(additional test to

diagnose kidney

month after treatment

LEMTRADA infusion

disorders)

 

 

After this time, if you have symptoms of ITP, kidney or thyroid disorders, your doctor will perform more tests. You should also continue looking for signs and symptoms of side effects beyond four years as detailed in your patient guide, and you should continue carrying the Patient Alert Card with you.

Another side effect is an increased risk of infections (see below for information on how often patients experience infections). In most cases, these are mild but serious infections can occur.

Tell your doctor right away if you have any of these signs of infection

fever and/or chills

swollen glands

To help reduce the risk of some infections your doctor may consider giving you vaccination against chickenpox and/or other vaccinations that they think are necessary for you (see section 2: What you need to know before you are administered LEMTRADA - Vaccines). Your doctor can also prescribe a medicine for cold sores (see section 2: What you need to know before you are administered LEMTRADA – Infections).

The most frequent side effects are infusion reactions (see below for information on how often patients experience these), which can happen at the time of the infusion or within 24 hours after the infusion. In most cases these are mild but some serious reactions are possible. Occasionally allergic reactions could occur.

To try to reduce infusion reactions, your doctor will give you medication (corticosteroids) before each of the first 3 infusions of a LEMTRADA course. Other treatments to limit these reactions can also be given before the infusion or when you experience symptoms. In addition, you will be monitored during the infusion and for 2 hours after the infusion has been completed. In case of serious reactions, the infusion may be slowed down or even stopped.

Please refer to the LEMTRADA Patient Guide for more information about these events.

These are the side effects that you may experience

Very common side effects (may affect more than 1 in 10 people):

Infusion reactions that can happen at the time of the infusion or within 24 hours after the infusion: headache, rash, fever, feeling sick, hives, itching, reddening of the face and neck, feeling tired

Infections: airway infections such as colds and sinus infections, cystitis

Decrease in white blood cell numbers (lymphocytes)

Common side effects (may affect up to 1 in 10 people):

Infusion reactions that can happen at the time of the infusion or within 24 hours after the infusion: changes in heart rate, indigestion, chills, chest discomfort, pain, dizziness, altered taste, difficulty sleeping, difficulty breathing or shortness of breath, rash over your body, low blood pressure

Infections: cough, ear infection, flu-like illness, bronchitis, pneumonia, oral thrush or vaginal thrush, shingles, chickenpox, cold sore, swollen or enlarged glands

pain at the site of the infusion, pain in the back, the neck, or in arms or legs, muscle pain, muscle spasms, joint pain, painful mouth or throat

inflammation of the mouth/gums/tongue

general discomfort, weakness, vomiting, diarrhoea, abdominal pain, gastric flu

heartburn

abnormalities that can be found during examinations: blood or protein in urine, decreased heart rate, irregular or abnormal heart beat, high blood pressure

MS relapse

trembling, loss of sensation, burning or prickling sensation

over-active or under-active thyroid gland, or goitre (swelling of the thyroid gland in the neck)

swelling of arms and/or legs

vision problems

feelings of anxiety

abnormally heavy, prolonged or irregular menstruation

acne, redness of the skin, excessive sweating

nose bleeds, bruises

hair loss

Uncommon side effects (may affect up to 1 in 100 people)

Infections: genital herpes, eye infection, tooth infection

problems with blood clotting, anaemia

athlete’s foot

abnormal vaginal smear

depression

increased sensation

difficulty swallowing

hiccups

decreased weight

constipation

bleeding of gums

abnormal liver test

blisters

Show the Patient Alert Card and this package leaflet to any doctor involved with your treatment, not only to your neurologist.

You will also find this information in the Patient Alert Card and Patient Guide that you have been given by your doctor.

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this

leaflet.You can also report side effects directly via the national reporting system listed in Appendix V. By

reporting side effects you can help provide more information on the safety of this medicine.

5.How to store LEMTRADA

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the outer carton and the vial label after EXP. The expiry date refers to the last day of the month.

Store in a refrigerator (2 C-8 C).

Do not freeze.

Store in the original package to protect from light.

It is recommended that the product is used immediately after dilution, due to a possible risk for microbial contamination. If it is not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 8 hours at 2oC to 8oC, under protection from light.

Do not use this medicine if you notice particles in the liquid and/or the liquid in the vial is discoloured.

Do not throw away any medicines via wastewater in order to help protect the environment.

6.Contents of the pack and other information

What LEMTRADA contains

The active substance is alemtuzumab.

Each vial contains 12 mg alemtuzumab in 1.2 ml.

The other ingredients are:

disodium phosphate dihydrate (E339)

disodium edetate dihydrate

potassium chloride (E508)

potassium dihydrogen phosphate (E340)

polysorbate 80 (E433)

sodium chloride

water for injections

What LEMTRADA looks like and contents of the pack

LEMTRADA is a clear, colourless to slightly yellow concentrate for solution for infusion (sterile concentrate) that comes in a glass vial with stopper.

There is 1 vial in each carton.

Marketing Authorisation Holder

Genzyme Therapeutics Ltd, 4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford, OX4 2SU, United Kingdom

Manufacturer

Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom.

Genzyme Ireland Limited, IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien/

Lietuva

Luxemburg/Luxembourg

UAB „SANOFI-AVENTIS LIETUVA“

Sanofi Belgium

Tel. +370 5 275 5224

Tél/Tel: + 32 2 710 54 00

 

България

Magyarország

Sanofi-Aventis Bulgaria EOOD

sanofi-aventis Zrt

тел: +359 2 9705300

Tel: +36 1 505 0050

Česká republika

Malta

sanofi-aventis, s.r.o.

Sanofi-Aventis Malta Ltd

Tel: +420 233086 111

Tel: +356 21493022

Danmark

Nederland

sanofi-aventis Denmark A/S

Genzyme Europe B.V.

Tlf: +45 45 16 70 00

Tel: +31 35 699 1200

Deutschland

Norge

Genzyme Therapeutics Ltd.

sanofi-aventis Norge AS

Tel: +49 (0) 6102 3674 451

Tlf: + 47 67 10 71 00

Eesti

Österreich

sanofi-aventis Estonia OÜ

sanofi-aventis GmbH

Tel. +372 6 273 488

Tel: + 43 1 80 185 - 0

Ελλάδα/Κύπρος

Polska

sanofi-aventis AEBE (Ελλάδα)

sanofi-aventis Sp. z o.o.

Τηλ: +30 210 900 1600

Tel.: +48 22 280 00 00

España

Portugal

Genzyme, S.L.U.

Sanofi – Produtos Farmacêuticos, Lda.

Tel: +34 93 485 94 00

Tel: +351 21 422 0100

sanofi-aventis, S.A.

 

Tel: +34 93 485 94 00

 

France

România

Genzyme S.A.S.

sanofi-aventis România S.R.L.

Tél : +33 (0) 825 825 863

Tel: +40 (0) 21 317 31 36

Hrvatska

Slovenija

sanofi-aventis Croatia d.o.o.

sanofi-aventis d.o.o.

Tel: +385 1 6003 400

Tel: +386 1 560 4800

Ísland

Slovenská republika

Vistor hf.

sanofi-aventis Pharma Slovakia s.r.o.

Sími: +354 535 7000

Tel.: +421 2 33 100 100

Ireland

Suomi/Finland

Genzyme Therapeutics Ltd. (United Kingdom)

sanofi-aventis Oy

Tel: +44 (0) 1865 405200

Puh/Tel: + 358 201 200 300

 

Italia

Sverige

Genzyme Srl

sanofi-aventis AB

Tel: +39 059 349 811

Tel: +46 (0)8 634 50 00

Latvija

United Kingdom

sanofi-aventis Latvia SIA

Genzyme Therapeutics Ltd. (United

Tel: +371 67 33 24 51

Kingdom)

 

Tel: +44 (0) 1865 405200

This leaflet was last revised in

 

Other sources of information

 

To assist in the education of patients regarding potential side-effects and instructions on what to do in case of certain side-effects, the following risk minimisation materials are available:

Patient Alert Card: For the patient to present to other healthcare providers to alert them to the use of

 

 

LEMTRADA in this patient

Patient Guide:

For further information on autoimmune reactions, infections and other information.

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

----------------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only:

Information on risk minimisation – autoimmune conditions

It is extremely important that your patient understands the commitment to having periodic testing performed (for 4 years after last infusion) even if they are asymptomatic and their MS disease is well controlled.

Together with your patient you need to plan and manage their periodic monitoring.

If non-compliant, patients may need further counseling to highlight the risks of missing scheduled monitoring tests.

You should monitor their test results and remain vigilant for symptoms of adverse events.

Review the LEMTRADA Patient Guide and Package Leaflet with your patient. Remind the patient to remain vigilant for symptoms related to autoimmune conditions, and to seek medical help if they have any concerns.

Educational Materials for Healthcare Providers are also available:

LEMTRADA Health Care Professional Guide

LEMTRADA Training Module

LEMTRADA Prescriber’s Check-list

Read the summary of product characteristics (available at the EMA website mentioned above) for more information.

Information on preparing to administer LEMTRADA and patient monitoring

Patients should be premedicated with corticosteroids immediately prior to LEMTRADA infusion for the first 3 days on any treatment course. Pretreatment with antihistimines and/or antipyretics prior to LEMTRADA administration may also be considered.

An oral anti-herpes agent should be administered to all patients during and for 1 month following treatment. In clinical trials, patients were administered aciclovir 200 mg twice a day or equivalent.

Complete baseline tests and screening as decribed in SmPC section 4.

The vial contents should be inspected for particulate matter and discolouration prior to administration. Do not use if particulate matter is present or the concentrate is discoloured. DO NOT SHAKE VIALS PRIOR TO USE.

Use aseptic techniques to withdraw 1.2 ml of LEMTRADA from the vial and inject into 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose (5%) solution for infusion. The bag should be inverted gently to mix the solution. Care should be taken to ensure the sterility of the prepared solution particularly as it contains no preservatives.

Administer LEMTRADA infusion solution via intravenous administration over approximately 4 hours.

Other medicinal products should not be added to the LEMTRADA infusion solution or simultaneously infused though the same intravenous line.

It is recommended that the product is used immediately after dilution, due to a possible risk for

microbial contamination. If it is not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 8 hours at 2oC to 8oC, under protection from light.

Procedures for proper handling and disposal should be observed. Any spillage or waste material should be disposed of in accordance with local requirements.

After each infusion, the patient should be observed for 2 hours for infusion associated reactions. Symptomatic treatment can be initiated if needed – see SmPC. Continue to test the patient every month for autoimmune conditions, until 4 years after last infusion. See LEMTRADA Health Care Professional Guide for more information, or read the summary of product characteristics available at the EMA website mentioned above.

Annex IV

Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Scientific conclusions

Taking into account the PRAC Assessment Report on the PSUR for alemtuzumab, the scientific conclusions of CHMP are as follows:

Listeriosis/Listeria meningitis

Medicines that have a modulating effect on the immune system as Lemtrada might be associated with an increased risk of opportunistic infections. A total of 5 case reports all originating from the EU were identified. One alemtuzumab -treated MS clinical trial patient, enrolled in study CAMMS223, developed listeria meningitis and four spontaneous post-marketing cases of either systemic listeriosis or Listeria monocytogenes meningitis.

Bradycardia as an infusion related adverse reaction

Seventy-one cases (in 55 patients) of bradycardia (two of which were assessed as serious, the remainder as non-serious) were reported in clinical trials. A total of 1,505 alemtuzumab patients were exposed in these trials. In addition, thirty-nine cases of bradycardia (eight of which were assessed as serious, the remainder as non-serious) were reported from alemtuzumab post-marketing reports as of 01 May 2015. Each of the ten serious cases involving bradycardia occurred in the context of infusion- associated reactions.

Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing alemtuzumab were warranted. The section 4.4 of the summary of product characteristics and the relevant sections of the package leaflet were updated.

The CHMP agrees with the scientific conclusions made by the PRAC.

Grounds for the variation to the terms of the marketing authorisation

On the basis of the scientific conclusions for alemtuzumab the CHMP is of the opinion that the benefit- risk balance of the medicinal product containing alemtuzumab is unchanged subject to the proposed changes to the product information.

The CHMP recommends that the terms of the marketing authorisation should be varied.

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