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

1. What Revlimid is and what it is used for
2. What you need to know before you take Revlimid
3. How to take Revlimid
4. Possible side effects
5. How to store Revlimid
6. Contents of the pack and other information

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:

1. Multiple myeloma
2. Myelodysplastic syndromes (MDS)
3. Mantle cell lymphoma (MCL)

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 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:

• 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 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 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.

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 zona, HIV. If you are in doubt, talk to your doctor. Treatment with Revlimid may cause virus to become active again, in patients who carry the virus, resulting 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

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

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.

Tests and checks

Before and during the treatment with Revlimid you will have regular blood tests as 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 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 1 week 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’ below).
• 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’ below).

Breast-feeding

You must not breast-feed when taking Revlimid, as it is not known if Revlimid passes into human 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, every 4 weeks during treatment, and 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)

AND

• you must use effective methods of contraception for 4 weeks before starting treatment, during treatment, and until 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 1 week 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.

Treatment cycle

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

• Each 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 each 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 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.

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 aches, bone pain, joint pain, 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 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
• Changes to a protein in the blood that can cause swelling of the arteries (vasculitis)
• Increases in your blood sugar level (diabetes)
• Headache
• Dry skin
• Stomach pain
• Mood change, difficulty sleeping

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 or a fall in blood pressure, slow, fast or irregular heart beat
• Darkening of your skin
• Skin eruptions, skin cracking, flaking or peeling skin
• Hives, itching, increased sweating, dehydration
• Sore inflamed mouth, dry mouth, 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 symptoms of heart failure)
• Difficulty getting an erection
• Stroke, fainting
• Muscle weakness
• Joint swelling
• Changes to blood thyroid hormone, low levels of calcium, phosphate or magnesium in the blood
• Depression
• Deafness
• Abnormal liver test results
• Impaired balance, difficulty moving
• Ringing in the ears (tinnitus)
• 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

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

• Serious allergic reaction that may begin as 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 (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).

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 Yellow Card Scheme at www.mhra.gov.uk/yellowcard (Freephone 0808 100 3352). By reporting side effects you can help provide more information on the safety of this medicine.

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 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 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 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 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 21 capsules per pack.

Marketing Authorisation Holder

Manufacturer