Revlimid

Основна информация

  • Търговско наименование:
  • Revlimid
  • Използвай за:
  • Хората
  • Вид на лекарството:
  • алопатични наркотици

Документи

Локализация

  • Предлага се в:
  • Revlimid
    Европейски съюз
  • Език:
  • английски

Терапевтична информация

  • Терапевтична група:
  • Immunosuppressants,
  • Терапевтична област:
  • Multiple Myeloma, Lymphoma, Mantle-Cell, Myelodysplastic Syndromes
  • Терапевтични показания:
  • Multiple myeloma, Revlimid as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation., Revlimid as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant., Revlimid in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.Myelodysplastic syndromes Revlimid as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.Mantle cell lymphoma Revlimid as monotherapy is indicated for the treatment of adult pa
  • Каталог на резюме:
  • Revision: 38

Състояние

  • Източник:
  • EMA - European Medicines Agency
  • Статус Оторизация:
  • Authorised
  • Номер на разрешението:
  • EMEA/H/C/000717
  • Дата Оторизация:
  • 13-06-2007
  • EMEA код:
  • EMEA/H/C/000717
  • Последна актуализация:
  • 29-12-2019

Доклад обществена оценка

Official address

Domenico Scarlattilaan 6

1083 HS Amsterdam

The Netherlands

An agency of the European Union

Address for visits and deliveries

Refer to www.ema.europa.eu/how-to-find-us

Send us a question

Go to www.ema.europa.eu/contact

Telephone

+31 (0)88 781 6000

© European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged.

EMA/225905/2019

EMEA/H/C/000717

Revlimid (lenalidomide)

An overview of Revlimid and why it is authorised in the EU

What is Revlimid and what is it used for?

Revlimid is a medicine used for the treatment of multiple myeloma, myelodysplastic syndromes and

mantle cell lymphoma, which are conditions affecting blood cells and bone marrow.

In multiple myeloma, a cancer of a type of white blood cells called plasma cells, Revlimid is used:

in adults who have had a stem cell transplant (a procedure where the patient’s bone marrow is

cleared of cells and replaced by stem cells from a donor);

in adults with previously untreated (newly diagnosed) multiple myeloma, who cannot have

stem cell transplantation. It is used in combination with dexamethasone, or bortezomib and

dexamethasone, or melphalan and prednisone;

in adults whose disease has been treated at least once. It is used in combination with

dexamethasone.

In myelodysplastic syndromes, a group of bone marrow disorders that cause anaemia (low red blood

cell counts), Revlimid is used in patients who need blood transfusions to manage their anaemia. It is

used in patients with a genetic abnormality (called deletion 5q) when other treatments are not

adequate.

In mantle cell lymphoma, a blood cancer that affects a type of white blood cell called B lymphocytes,

Revlimid is used in adults whose disease has come back after treatment or does not improve with

treatment.

These diseases are rare, and Revlimid was designated an ‘orphan medicine’ (a medicine used in rare

diseases) on various dates. Further information on the orphan designations can be found on the

European Medicines Agency’s website (myelodysplastic syndromes: 8 March 2004;

mantle cell

lymphoma: 27 October 2011); Revlimid's orphan designation for multiple myeloma (12 December

2003) has now expired.

Revlimid contains the active substance lenalidomide.

Revlimid (lenalidomide)

EMA/225905/2019

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How is Revlimid used?

Revlimid can only be obtained with a prescription and treatment should be supervised by doctors who

have experience in the use of cancer medicines. It is available as capsules (2.5, 5, 7.5, 10, 15, 20 and

25 mg) to be taken by mouth.

Treatment is given in cycles, with Revlimid being used once a day on certain days of the cycles.

Treatment cycles are continued until the disease is no longer being controlled or side effects become

unacceptable. The dose of Revlimid depends on the disease it is being used for, the patient’s overall

health and blood test results. The dose may need to be reduced or treatment interrupted in case of

certain side effects.

For more information about using Revlimid, see the package leaflet or contact your doctor or

pharmacist.

How does Revlimid work?

The active substance in Revlimid, lenalidomide, is an immunomodulating agent. This means that it

affects the activity of the immune system (the body’s natural defences). Lenalidomide works in several

ways: it blocks the development of abnormal cells, prevents the growth of blood vessels within

tumours and also stimulates specialised cells of the immune system to attack the abnormal cells.

What benefits of Revlimid have been shown in studies?

Multiple myeloma

Revlimid was more effective than placebo (a dummy treatment) in two main studies in 1,074 patients

with newly diagnosed multiple myeloma and who had had stem cell transplantation. In the first study,

patients taking Revlimid lived longer without their disease getting worse (57 months) than patients in

the placebo group (29 months). In the second study, patients taking Revlimid also lived longer without

their disease getting worse (44 months) than patients in the placebo group (24 months).

In newly diagnosed multiple myeloma, Revlimid has been studied in two main studies involving 2,082

patients. The first study compared Revlimid with placebo, both taken with melphalan and prednisone.

In this study, patients taking Revlimid (plus melphalan and prednisone) lived longer without their

disease getting worse (27 months) than patients receiving placebo (13 months). In the second study,

Revlimid taken with low-dose dexamethasone was compared with standard treatment of melphalan,

prednisone and thalidomide. It took 26 months for the disease to get worse in patients taking Revlimid

plus dexamethasone, compared with 22 months for those on standard treatment.

Another main study involved 523 patients with multiple myeloma who had not been treated previously

and for whom stem-cell transplantation had not been planned. Patients treated with Revlimid and

dexamethasone lived for around 30 months without their disease getting worse compared with around

43 months for those who also received bortezomib.

Revlimid was also studied in two main studies involving 704 patients with previously treated multiple

myeloma. In both studies, Revlimid was compared with placebo, both taken with dexamethasone. The

results of the two studies taken together showed that, on average, patients taking Revlimid lived

longer without their disease getting worse (48 weeks) than patients receiving placebo (20 weeks).

Revlimid (lenalidomide)

EMA/225905/2019

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Myelodysplastic syndromes

Two main studies have also been carried out involving a total of 353 patients with lower risk

myelodysplastic syndromes. The first study did not compare Revlimid with any other treatment, while

the second study compared it with placebo. In the first study, 97 out of 148 patients (66%) taking

10 mg Revlimid did not need a blood transfusion for at least 8 weeks. In the second study, 38 out of

69 patients (55%) taking 10 mg Revlimid did not need a blood transfusion for at least 26 weeks,

compared with 4 out of 67 patients (6%) taking placebo.

Mantle cell lymphoma

One main study involved 254 patients with mantle cell lymphoma that had come back after previous

treatment or had not improved on previous treatment. Revlimid was compared with a medicine chosen

by the patients’ doctors. The average time before the disease got worse was 38 weeks in those treated

with Revlimid, compared with 23 weeks in those given other treatments.

What are the risks associated with Revlimid?

The most common side effects with Revlimid when used for the treatment of multiple myeloma are:

bronchitis (inflammation of the airways in the lungs), nasopharyngitis (inflammation of the nose and

throat), cough, gastroenteritis (inflammation of the stomach and intestines with diarrhoea and

vomiting), upper respiratory tract infection (nose and throat infections), tiredness, neutropenia (low

levels of neutrophils, a type of white blood cell), constipation, diarrhoea, muscle cramps, anaemia,

thrombocytopenia (low platelet counts), rash, back pain, insomnia (difficulty sleeping), decreased

appetite, fever, peripheral oedema (swelling of the limbs due to fluid retention), leucopenia (low white

blood cell counts), weakness, peripheral neuropathy (nerve damage in the hands and feet) and

hypocalcaemia (low levels of calcium in the blood).

The most common side effects with Revlimid when used for the treatment of myelodysplastic

syndromes are: neutropenia, thrombocytopenia, diarrhoea, constipation, nausea (feeling sick), itching,

rash, tiredness and muscle spasms.

The most common side effects with Revlimid when used for the treatment of mantle cell lymphoma

are: neutropenia, anaemia, diarrhoea, tiredness, constipation, fever and rash.

The most serious side effects with Revlimid are: neutropenia, venous thromboembolism (blood clots in

the veins) including pulmonary embolism (blood clots in the lungs), lung infections including

pneumonia, hypotension (low blood pressure), dehydration, kidney failure, febrile neutropenia

(neutropenia with fever), diarrhoea and anaemia.

Lenalidomide can be harmful to the unborn child. Therefore, Revlimid must not be used in women who

are pregnant. It must also not be used in women who could become pregnant, unless they take all the

necessary steps to ensure that they are not pregnant before treatment and that they do not become

pregnant during or soon after treatment.

For the full list of side effects and restrictions of Revlimid, see the package leaflet.

Why is Revlimid authorised in the EU?

Revlimid has been shown to prolong the time patients live without their disease getting worse. Side

effects are considered manageable. Therefore, the European Medicines Agency decided that Revlimid’s

benefits are greater than its risks and it can be authorised for use in the EU.

Revlimid (lenalidomide)

EMA/225905/2019

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What measures are being taken to ensure the safe and effective use of

Revlimid?

The company that makes Revlimid will provide a letter and educational kits for healthcare

professionals, and brochures for patients, explaining that the medicine can be harmful to the unborn

child and detailing the steps that need to be taken for the medicine to be used safely. It will also

supply cards to patients about the safety measures patients should take.

The company has also set up a pregnancy prevention programme in each member state and will collect

information on the medicine’s use outside its approved uses. The boxes containing Revlimid capsules

also include a warning stating that lenalidomide can be harmful to the unborn child.

In addition, the company will carry out a study in patients with myelodysplastic syndromes to gather

further safety data, as well as a safety study in patients with newly diagnosed multiple myeloma not

eligible for transplantation.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe

and effective use of Revlimid have also been included in the summary of product characteristics and

the package leaflet.

As for all medicines, data on the use of Revlimid are continuously monitored. Side effects reported with

Revlimid are carefully evaluated and any necessary action taken to protect patients.

Other information about Revlimid

Revlimid received a marketing authorisation valid throughout the EU on 14 June 2007.

Further information on Revlimid can be found on the Agency’s website:

ema.europa.eu/medicines/human/EPAR/revlimid

This overview was last updated in 04-2019.

Листовка за пациента: състав, показания, Нежелани лекарствени реакции, дозиране, взаимодействия, бременност, кърмене

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Revlimid 2.5 mg hard capsules

Revlimid 5 mg hard capsules

Revlimid 7.5 mg hard capsules

Revlimid 10 mg hard capsules

Revlimid 15 mg hard capsules

Revlimid 20 mg hard capsules

Revlimid 25 mg hard capsules

lenalidomide

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 start taking 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 or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if

their signs of illness are the same as yours.

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not

listed in this leaflet. See section 4.

What is in this leaflet

What Revlimid is and what it is used for

What you need to know before you take Revlimid

How to take Revlimid

Possible side effects

How to store Revlimid

Contents of the pack and other information

1.

What Revlimid is and what it is used for

What Revlimid is

Revlimid contains the active substance ‘lenalidomide’. This medicine belongs to a group of medicines which

affect how your immune system works.

What Revlimid is used for

Revlimid is used in adults for:

Multiple myeloma

Myelodysplastic syndromes

Mantle cell lymphoma

Multiple myeloma

Multiple myeloma is a type of cancer which affects a certain kind of white blood cell, called the plasma cell.

These cells collect in the bone marrow and divide, becoming out of control. This can damage the bones and

kidneys.

Multiple myeloma generally cannot be cured. However, the signs and symptoms can be greatly reduced or

disappear for a period of time. This is called a ‘response’.

Newly diagnosed multiple myeloma – in patients who have had a bone marrow transplant

Revlimid is used on its own as a maintenance therapy after patients have recovered enough following a bone

marrow transplant.

Newly diagnosed multiple myeloma – in patients who cannot have a bone marrow transplant

Revlimid is taken with other medicines. These may include:

a chemotherapy medicine called ‘bortezomib’

an anti-inflammatory medicine called ‘dexamethasone’

a chemotherapy medicine called ‘melphalan’ and

an immunosuppressant medicine called ‘prednisone’.

You will take these other medicines at the start of treatment and then continue to take Revlimid on its own.

If you are aged 75 years or older or have moderate to severe kidney problems - your doctor will check you

carefully before starting treatment.

Multiple myeloma – in patients who have had treatment before

Revlimid is taken together with an anti-inflammatory medicine called ‘dexamethasone’.

Revlimid can stop the signs and symptoms of multiple myeloma getting worse. It has also been shown to

delay multiple myeloma from coming back following treatment.

Myelodysplastic syndromes (MDS)

MDS are a collection of many different blood and bone marrow diseases. The blood cells become abnormal

and do not function properly. Patients can experience a variety of signs and symptoms including a low red

blood cell count (anemia), the need for a blood transfusion, and be at risk of infection.

Revlimid is used alone to treat adult patients who have been diagnosed with MDS, when all of the following

apply:

you need regular blood transfusions to treat low levels of red blood cells (‘transfusion-dependent

anemia’)

you have an abnormality of cells in the bone marrow called an ‘isolated deletion 5q cytogenetic

abnormality’. This means your body does not make enough healthy blood cells

other treatments have been used before, are not suitable or do not work well enough.

Revlimid can increase the number of healthy red blood cells that the body produces by reducing the number

of abnormal cells:

this can reduce the number of blood transfusions needed. It is possible that no transfusions will be

needed.

Mantle cell lymphoma (MCL)

MCL is a cancer of part of the immune system (the lymph tissue). It affects a type of white blood cell called

‘B-lymphocytes’ or B-cells. MCL is a disease where B-cells grow in an uncontrolled way and build up in the

lymph tissue, bone marrow or blood.

Revlimid is used alone to treat adult patients who have previously been treated with other medicines.

How Revlimid works

Revlimid works by affecting the body’s immune system and directly attacking the cancer. It works in a

number of different ways:

by stopping the cancer cells developing

by stopping blood vessels growing in the cancer

by stimulating part of the immune system to attack the cancer cells.

2.

What you need to know before you take Revlimid

You must read the package leaflet of all medicinal products to be taken in combination with Revlimid

before starting treament with Revlimid.

Do not take Revlimid:

if you are pregnant, think you may be pregnant or are planning to become pregnant,

as Revlimid is

expected to be harmful to an unborn child

(see section 2, ‘Pregnancy, breast-feeding and

contraception – information for women and men’).

if you are able to become pregnant, unless you follow all the necessary measures to prevent you from

becoming pregnant (see section 2, ‘Pregnancy, breast-feeding and contraception – information for

women and men’). If you are able to become pregnant, your doctor will record with each prescription

that the necessary measures have been taken and provide you with this confirmation.

if you are allergic to lenalidomide or any of the other ingredients of this medicine listed in section 6. If

you think you may be allergic, ask your doctor for advice.

If any of these apply to you, do not take Revlimid. Talk to your doctor if you are not sure.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Revlimid if:

you have had blood clots in the past - you have an increased risk of developing blood clots in the veins

and arteries during treatment

you have any signs of an infection, such as a cough or fever

you have or have ever had previous viral infection, particularly: hepatitis B infection, varicella zoster,

HIV. If you are in doubt, talk to your doctor. Treatment with Revlimid may cause the virus to become

active again, in patients who carry the virus. This results in a recurrence of the infection. Your doctor

should check whether you have ever had hepatitis B infection

you have kidney problems - your doctor may adjust your dose of Revlimid

you have had a heart attack, have ever had a blood clot, or if you smoke, have high blood pressure or

high cholesterol levels

you have had an allergic reaction whilst taking thalidomide (another medicine used to treat multiple

myeloma) such as rash, itching, swelling, dizziness or trouble breathing

you have experienced in the past a combination of any of the following symptoms: widespread rash, red

skin, high body temperature, flu-like symptoms, liver enzyme elevations, blood abnormalities

(eosinophilia), enlarged lymph nodes – these are signs of a severe skin reaction called Drug Reaction

with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity

syndrome. (see also section 4 “Possible side effects”).

If any of the above apply to you, tell your doctor, pharmacist or nurse before starting treatment.

At any time during or after your treatment, tell your doctor or nurse immediately if you: experience blurred,

loss of or double vision, difficulty speaking, weakness in an arm or a leg, a change in the way you walk or

problems with your balance, persistent numbness, decreased sensation or loss of sensation, memory loss or

confusion. These may all be symptoms of a serious and potentially fatal brain condition known as

progressive multifocal leukoencephalopathy (PML). If you had these symptoms prior to treatment with

lenalidomide, tell your doctor about any change in these symptoms.

Tests and checks

Before and during the treatment with Revlimid you will have regular blood tests. This is because Revlimid

may cause a fall in the blood cells that help fight infection (white blood cells) and help the blood to clot

(platelets).

Your doctor will ask you to have a blood test:

before treatment

every week for the first 8 weeks of treatment

then at least every month after that.

For patients with MDS taking Revlimid

If you have MDS, you may be more likely to get a more advanced condition called acute myeloid leukaemia

(AML). In addition, it is not known how Revlimid affects the chances of you getting AML. Your doctor may

therefore do tests to check for signs which may better predict the likelihood of you getting AML during your

treatment with Revlimid.

For patients with MCL taking Revlimid

Your doctor will ask you to have a blood test:

before treatment

every week for the first 8 weeks (2 cycles) of treatment

then every 2 weeks in cycles 3 and 4 (see section 3 ‘Treatment cycle’ for more information)

after this it will happen at the start of each cycle and

at least every month.

Your doctor may check if you have a high total amount of tumour throughout the body, including your bone

marrow. This could lead to a condition where the tumours break down and cause unusual levels of chemicals

in the blood which can lead to kidney failure (this condition is called ‘Tumour Lysis Syndrome’).

Your doctor may check you for changes to your skin such as red spots or rashes.

Your doctor may adjust your dose of Revlimid or stop your treatment based on the results of your blood tests

and on your general condition. If you are newly diagnosed, your doctor may also assess your treatment based

on your age and other conditions you already have.

Blood donation

You should not donate blood during treatment and for at least 7 days after the end of treatment.

Children and adolescents

Revlimid is not recommended for use in children and adolescents under 18 years.

Elderly and people with kidney problems

If you are aged 75 years or older or have moderate to severe kidney problems - your doctor will check you

carefully before starting treatment.

Other medicines and Revlimid

Tell your doctor or nurse if you are taking or have recently taken any other medicines. This is because

Revlimid can affect the way some other medicines work. Also, some other medicines can affect the way

Revlimid works.

In particular, tell your doctor or nurse if you are taking any of the following medicines:

some medicines used to prevent pregnancy such as oral contraceptives, as they may stop working

some medicines used for heart problems – such as digoxin

some medicines used to thin the blood – such as warfarin.

Pregnancy, breast-feeding and contraception - information for women and men

Pregnancy

For women taking Revlimid

You must not take Revlimid if you are pregnant, as it is expected to be harmful to an unborn baby.

You must not become pregnant while taking Revlimid. Therefore you must use effective methods of

contraception if you are a woman of childbearing potential (see ‘Contraception’).

If you do become pregnant during your treatment with Revlimid, you must stop the treatment and inform

your doctor immediately.

For men taking Revlimid

If your partner becomes pregnant whilst you are taking Revlimid, you should inform your doctor

immediately. It is recommended that your partner seeks medical advice.

You must also use effective methods of contraception (see ‘Contraception’).

Breast-feeding

You must not breast-feed when taking Revlimid, as it is not known if Revlimid passes into breast milk.

Contraception

For women taking Revlimid

Before starting the treatment, ask your doctor if you are able to become pregnant, even if you think this is

unlikely.

If you are able to become pregnant

you will have pregnancy tests under the supervision of your doctor (before every treatment, at least every

4 weeks during treatment, and at least 4 weeks after the treatment has finished) except where it has been

confirmed that the fallopian tubes have been severed and sealed, to stop eggs from reaching the uterus

(tubal sterilisation)

you must use effective methods of contraception for at least 4 weeks before starting treatment, during

treatment, and until at least 4 weeks after stopping treatment. Your doctor will advise you on appropriate

methods of contraception.

For men taking Revlimid

Revlimid passes into human semen. If your female partner is pregnant or able to become pregnant, and she

does not use effective methods of contraception, you must use condoms during treatment and for at least 7

days after the end of treatment, even if you have had a vasectomy.

Driving and using machines

Do not drive or operate machines if you feel dizzy, tired, sleepy, have vertigo or blurred vision after taking

Revlimid.

Revlimid contains lactose

Revlimid contains lactose. If you have been told by your doctor that you have intolerance to some sugars,

contact your doctor before taking this medicine.

3.

How to take Revlimid

Revlimid must be given to you by healthcare professionals with experience in treating multiple myeloma,

MDS or MCL.

When Revlimid is used to treat multiple myeloma in patients who cannot have a bone marrow transplant

or have had other treatments before, it is taken with other medicines (see section 1 ‘What Revlimid is

used for’).

When Revlimid is used to treat multiple myeloma in patients who have had a bone marrow transplant or

to treat patients with MDS or MCL, it is taken alone.

Always take Revlimid exactly as your doctor has told you. Check with your doctor or pharmacist if you are

not sure.

If you are taking Revlimid in combination with other medicines, you should refer to the package leaflets for

these medicines for further information on their use and effects.

Treatment cycle

Revlimid is taken on certain days over 3 weeks (21 days).

Every 21 days is called a ‘treatment cycle’.

Depending on the day of the cycle, you will take one or more of the medicines. However, on some days

you do not take any of the medicines.

After completing every 21-day cycle, you should start a new ‘cycle’ over the next 21 days.

Revlimid is taken on certain days over 4 weeks (28 days).

Every 28 days is called a ‘treatment cycle’.

Depending on the day of the cycle, you will take one or more of the medicines. However, on some days

you do not take any of the medicines.

After completing every 28-day cycle, you should start a new ‘cycle’ over the next 28 days.

How much Revlimid to take

Before you start treatment, your doctor will tell you:

how much Revlimid you should take

how much of the other medicines you should take in combination with Revlimid, if any

on what days of your treatment cycle to take each medicine.

How and when to take Revlimid

swallow the capsules whole, preferably with water.

do not break, open or chew the capsules. If powder from a broken Revlimid capsule makes contact with

the skin, wash the skin immediately and thoroughly with soap and water.

the capsules can be taken either with or without food.

you should take Revlimid at about the same time on the scheduled days.

Taking this medicine

To remove the capsule from the blister:

press only one end of the capsule out to push it through the foil

do not put pressure on the centre of the capsule, as this can cause it to break.

Duration of the treatment with Revlimid

Revlimid is taken in treatment cycles, each cycle lasting 21 or 28 days (see above ‘Treatment cycle’). You

should continue the cycles of treatment until your doctor tells you to stop.

If you take more Revlimid than you should

If you take more Revlimid than was prescribed, tell your doctor immediately.

If you forget to take Revlimid

If you forget to take Revlimid at your regular time and:

less than 12 hours have passed - take your capsule immediately.

more than 12 hours have passed - do not take your capsule. Take your next capsule at the usual time the

next day.

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

4.

Possible side effects

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

Serious side effects which may affect more than 1 in 10 people (very common)

Revlimid may reduce the number of white blood cells that fight infection and also the blood cells which help

the blood to clot (platelets) which may lead to bleeding disorders such as nosebleeds and bruising.

Revlimid may also cause blood clots in the veins (thrombosis).

Therefore

you must tell your doctor immediately

if you experience:

Fever, chills, sore throat, cough, mouth ulcers or any other symptoms of infection including within the

bloodstream (sepsis)

Bleeding or bruising in the absence of injury

Chest pain or leg pain

Shortness of breath

Other side effects

It is important to note that a small number of patients may develop additional types of cancer, and it is

possible that this risk may be increased with Revlimid treatment. Therefore your doctor should carefully

evaluate the benefit and risk when you are prescribed Revlimid.

Very common

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

A fall in the number of red blood cells which may cause anemia leading to tiredness and weakness

Constipation, diarrhoea, nausea, redness of skin, rashes, vomiting, muscle cramps, muscle weakness,

muscle pain, muscle aches, bone pain, joint pain, back pain, pain in the extermities, tiredness,

generalised swelling including swelling of your arms and legs

Fever and flu like symptoms including fever, muscle ache, headache, earache and chills

Numbness, tingling or burning sensation to the skin, pains in hands or feet, dizziness, tremor, changes

in the way things taste

Chest pain spreading to the arms, neck, jaw, back or stomach, feeling sweaty and breathless, feeling

sick or vomiting, which may be symptoms of a heart attack (myocardial infarction)

Decreased appetite

Low levels of potassium and/or sodium in the blood

Leg pain (which could be a symptom of thrombosis), chest pain or shortness of breath (which may be a

symptom of blood clots in the lungs, called pulmonary embolism)

Infections of all types

Infection of the lung and the upper respiratory tract, shortness of breath

Blurred vision

Clouding of your eye (cataract)

Kidney problems

Increase in liver test results

Changes to a protein in the blood that can cause swelling of the arteries (vasculitis)

Increases in your blood sugar level (diabetes)

Decreases in your blood sugar

Headache

Dry skin

Stomach pain

Mood change, difficulty sleeping

Cough

A fall in blood pressure

Sore inflamed mouth, dry mouth

Dehydration

Common

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

Infection of the sinuses that surround the nose

Bleeding from the gums, stomach, or bowels

Increase in pain, tumour size, redness around the tumour

Increased blood pressure, slow, fast or irregular heart beat

Darkening of your skin

Skin eruptions, skin cracking, flaking or peeling skin

Hives, itching, increased sweating

Difficulty swallowing

Heartburn

Production of much more or much less urine than usual (which may be a symptom of kidney failure),

passing blood in the urine

Shortness of breath especially when lying down (which may be a symptom of heart failure)

Difficulty getting an erection

Stroke, fainting, temporary loss of consciousness

Muscle weakness

Joint swelling

Changes to blood thyroid hormone, low levels of calcium, phosphate or magnesium in the blood

Depression

Deafness

Difficulty speaking

Abnormal liver test results, liver injury

Impaired balance, difficulty moving

Ringing in the ears (tinnitus)

Nerve pain, unpleasant abnormal sensation especially to touch

An excess of iron in the body

Thirst

Confusion

Toothache

Weight loss

Uncommon

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

Bleeding within the skull

Circulatory problems

Loss of vision

Loss of sex drive (libido)

Passing large amount of urine with bone pain and weakness, which may be symptoms of a kidney

disorder (Fanconi syndrome)

Stomach pain, bloating, or diarrhoea, which may be symptoms of inflammation in the large intestine

(called colitis or caecitis)

Passing much more or much less urine than usual, which may be a symptom of a type of kidney

problem (called renal tubular necrosis)

Changes to the colour of your skin, sensitivity to sunlight

Certain types of skin tumour

Hives, rashes, swelling of eyes, mouth or face, difficulty breathing, or itching, which may be symptoms

of an allergic reaction

Widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia),

enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and

Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome). Stop using

lenalidomide if you develop these symptoms and contact your doctor or seek medical attention

immediately. See also section 2.

Rare

side effects (may affect up to 1 in 1,000 people):

Serious allergic reaction that may begin as a rash in one area but spread with extensive loss of skin over

the whole body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).

Tumour lysis syndrome - metabolic complications that can occur during treatment of cancer and

sometimes even without treatment. These complications are caused by the break-down products of

dying cancer cells and may include the following: changes to blood chemistry - high

potassium, phosphorus, uric acid, and low calcium consequently leading to changes in kidney

function, heart beat, seizures, and sometimes death.

Not known

side effects (frequency cannot be estimated from the available data):

Sudden, or mild but worsening pain in the upper stomach and/or back, which remains for a few days,

possibly accompanied by nausea, vomiting, fever and a rapid pulse – these symptoms may be due to

inflammation of the pancreas.

Wheezing, shortness of breath or a dry cough, which may be symptoms caused by inflammation of the

tissue in the lungs.

Yellow pigmentation to the skin, mucus membrane or eyes (jaundice), pale coloured stools, dark

coloured urine, skin itch, rash, pain or swelling of the stomach – these may be symptoms of injury to

the liver (hepatic disorder).

Rare cases of muscle breakdown (muscle pain, weakness or swelling) which can lead to kidney

problems (rhabdomyolysis) have been observed, some of them when Revlimid is administered with a

statin (a type of cholesterol lowering medicines).

A condition affecting the skin caused by inflammation of small blood vessels, along with pain in the

joints and fever (leukocytoclastic vasculitis).

Breakdown of the wall of the stomach or gut. This may lead to very serious infection. Tell your doctor

if you have severe stomach pain, fever, nausea, vomiting, blood in your stool, or changes in bowel

habits.

Viral infections, including herpes zoster (also known as ‘shingles’, a viral disease that causes a painful

skin rash with blisters) and recurrence of hepatitis B infection (which can cause yellowing of the skin

and eyes, dark brown-colored urine, right-sided stomach pain, fever and feeling nauseous or being sick).

Rejection of solid organ transplant (such as kidney, heart).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Revlimid

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 blister and on the carton after

‘EXP’. The expiry date refers to the last day of that month.

This product does not require any special storage conditions.

Do not use this medicine if you notice any damage or signs of tampering to the pack.

Do not throw away any medicines via wastewater or household waste. Please return unused medicines

to your pharmacist. These measures will help protect the environment.

6.

Contents of the pack and other information

What Revlimid contains

Revlimid 2.5 mg hard capsules:

The active substance is lenalidomide. Each capsule contains 2.5 mg of lenalidomide.

The other ingredients are:

capsule contents: anhydrous lactose (see section 2), microcrystalline cellulose, croscarmellose

sodium and magnesium stearate

capsule shell: gelatine, titanium dioxide (E171), indigo carmine (E132) and yellow iron oxide

(E172)

printing ink: shellac, propylene glycol, potassium hydroxide and black iron oxide (E172).

Revlimid 5 mg hard capsules:

The active substance is lenalidomide. Each capsule contains 5 mg of lenalidomide.

The other ingredients are:

capsule contents: anhydrous lactose (see section 2), microcrystalline cellulose, croscarmellose

sodium and magnesium stearate

capsule shell: gelatine and titanium dioxide (E171)

printing ink: shellac, propylene glycol, potassium hydroxide and black iron oxide (E172).

Revlimid 7.5 mg hard capsules:

The active substance is lenalidomide. Each capsule contains 7.5 mg of lenalidomide.

The other ingredients are:

capsule contents: anhydrous lactose (see section 2), microcrystalline cellulose, croscarmellose

sodium and magnesium stearate

capsule shell: gelatine, titanium dioxide (E171) and yellow iron oxide (E172)

printing ink: shellac, propylene glycol, potassium hydroxide and black iron oxide (E172).

Revlimid 10 mg hard capsules:

The active substance is lenalidomide. Each capsule contains 10 mg of lenalidomide.

The other ingredients are:

capsule contents: anhydrous lactose (see section 2), microcrystalline cellulose, croscarmellose

sodium and magnesium stearate

capsule shell: gelatine, titanium dioxide (E171), indigo carmine (E132) and yellow iron oxide

(E172)

printing ink: shellac, propylene glycol, potassium hydroxide and black iron oxide (E172).

Revlimid 15 mg hard capsules:

The active substance is lenalidomide. Each capsule contains 15 mg of lenalidomide.

The other ingredients are:

capsule contents: anhydrous lactose (see section 2), microcrystalline cellulose, croscarmellose

sodium and magnesium stearate

capsule shell: gelatine, titanium dioxide (E171) and indigo carmine (E132)

printing ink: shellac, propylene glycol, potassium hydroxide and black iron oxide (E172).

Revlimid 20 mg hard capsules:

The active substance is lenalidomide. Each capsule contains 20 mg of lenalidomide.

The other ingredients are:

capsule contents: anhydrous lactose (see section 2), microcrystalline cellulose, croscarmellose

sodium and magnesium stearate

capsule shell: gelatine and titanium dioxide (E171), indigo carmine (E132) and yellow iron oxide

(E172)

printing ink: shellac, propylene glycol, potassium hydroxide and black iron oxide (E172).

Revlimid 25 mg hard capsules:

The active substance is lenalidomide. Each capsule contains 25 mg of lenalidomide.

The other ingredients are:

capsule contents: anhydrous lactose (see section 2), microcrystalline cellulose, croscarmellose

sodium and magnesium stearate

capsule shell: gelatine and titanium dioxide (E171)

printing ink: shellac, propylene glycol, potassium hydroxide and black iron oxide (E172).

What Revlimid looks like and contents of the pack

Revlimid 2.5 mg hard capsules are blue-green/white, with ‘REV 2.5 mg’ written on them.

The capsules are provided in packs. Each pack contains one or three blisters, each blister with seven

capsules. This gives a total of 7 or 21 capsules per pack.

Revlimid 5 mg hard capsules are white, with ‘REV 5 mg’ written on them.

The capsules are provided in packs. Each pack contains one or three blisters, each blister with seven

capsules. This gives a total of 7 or 21 capsules per pack.

Revlimid 7.5 mg hard capsules are pale yellow/white, with ‘REV 7.5 mg’ written on them.

The capsules are provided in packs. Each pack contains three blisters, each blister with seven capsules. This

gives a total of 7 or 21 capsules per pack.

Revlimid 10 mg hard capsules are blue-green/pale yellow, with ‘REV 10 mg’ written on them.

The capsules are provided in packs. Each pack contains one or three blisters, each blister with seven

capsules. This gives a total of 7 or 21 capsules per pack.

Revlimid 15 mg hard capsules are pale blue/white, with ‘REV 15 mg’ written on them.

The capsules are provided in packs. Each pack contains one or three blisters, each blister with seven

capsules. This gives a total of 7 or 21 capsules per pack.

Revlimid 20 mg hard capsules are blue-green/pale blue, with ‘REV 20 mg’ written on them.

The capsules are provided in packs. Each pack contains three blisters, each blister with seven capsules. This

gives a total of 7 or 21 capsules per pack.

Revlimid 25 mg hard capsules are white, with ‘REV 25 mg’ written on them.

The capsules are provided in packs. Each pack contains three blisters, each blister with seven capsules. This

gives a total of 7 or 21 capsules per pack.

Marketing Authorisation Holder

Celgene Europe B.V.

Winthontlaan 6 N

3526 KV Utrecht

Netherlands

Manufacturer

Celgene Distribution B.V.

Winthontlaan 6 N

3526 KV Utrecht

Netherlands

This leaflet was last revised in

Other sources of information:

Detailed information on this medicine is available on the website of the European Medicines Agency:

http://www.ema.europa.eu/.

There are also links to other websites about rare diseases and treatments.