Revlimid

Package leaflet: Information for the user

Revlimid 2.5 mg hard capsules, 5 mg hard capsules, 7.5 mg hard capsules, 10 mg hard capsules, 15 mg hard capsules, 20 mg hard capsules, 25 mg hard capsules

lenalidomide
This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. You can help by reporting any side effects you may experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Revlimid is and what it is used for
2. What you need to know before taking Revlimid
3. How to take Revlimid
4. Possible side effects
5. How to store Revlimid
6. 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
that affect the functioning of the immune system.
What Revlimid is used for
Revlimid is used in adults for:

• Multiple myeloma
• Myelodysplastic syndromes
• Mantle cell lymphoma
• Follicular lymphoma

Multiple myeloma
Multiple myeloma is a type of cancer that affects a certain type of white blood cells called plasma cells.
These cells accumulate in the bone marrow and divide uncontrollably. This can damage the bones and kidneys.
Multiple myeloma is generally incurable. However, signs and symptoms can be significantly reduced or disappear for a certain period. This outcome is called a "response".

Newly diagnosed multiple myeloma: in patients undergoing bone marrow transplantation
Revlimid is used alone as maintenance therapy in patients who have adequately recovered after bone marrow transplantation.

Newly diagnosed multiple myeloma: in patients who cannot undergo bone marrow transplantation
Revlimid is taken with other medicines, which may include:

• a chemotherapy medicine called "bortezomib"
• an anti-inflammatory medicine called "dexamethasone"
• a chemotherapy medicine called "melphalan" and
• an immunosuppressive medicine called "prednisone".
  You will take these other medicines at the beginning of treatment and then continue taking Revlimid alone.

If you are aged 75 years or older or have moderate to severe kidney problems, your doctor will closely monitor you before starting treatment.

Multiple myeloma: in previously treated patients
Revlimid is taken together with an anti-inflammatory medicine called "dexamethasone".
Revlimid can stop the worsening of signs and symptoms of multiple myeloma. It has also been shown to delay the return of multiple myeloma after treatment.

Myelodysplastic syndromes (MDS)
MDS are a group of different blood and bone marrow diseases. Blood cells become abnormal and do not function properly. Patients may experience various signs and symptoms, including a low number of red blood cells (anaemia), the need for blood transfusions, and risk of infection.

Revlimid alone is used to treat adult patients diagnosed with MDS who meet all of the following conditions:

• if you require regular blood transfusions to treat low levels of red blood cells ("transfusion-dependent anaemia")
• if you have an abnormality in bone marrow cells called "isolated 5q cytogenetic abnormality". This means your body does not produce enough healthy blood cells
• if previous treatments have not been suitable or have not been effective enough.

Revlimid can increase the number of healthy red blood cells produced by the body, reducing the number of abnormal cells:

• this may reduce the number of blood transfusions needed. You may no longer require any transfusions.

Mantle cell lymphoma (MCL)
MCL is a cancer of part of the immune system (lymphatic tissue). It affects a type of white blood cells called B-lymphocytes, or B-cells. In MCL, B-lymphocytes grow uncontrollably and accumulate in lymphatic tissue, bone marrow, or blood.
Revlimid is used alone to treat adult patients previously treated with other medicines.

Follicular lymphoma (FL)
FL is a slow-growing form of cancer affecting B-lymphocytes, a type of white blood cell that helps the body fight infections. In FL, an excessive number of these B-lymphocytes may accumulate in the blood, bone marrow, lymph nodes, and spleen.
Revlimid is taken together with another medicine called "rituximab" for the treatment of adult patients with previously treated follicular lymphoma.

How Revlimid works
Revlimid acts on the body's immune system and directly on the tumour in several ways:

• by stopping the development of tumour cells
• by stopping the growth of blood vessels that supply blood to tumour cells
• by stimulating part of the immune system to attack tumour cells.

2. What you need to know before taking Revlimid

Before starting treatment with Revlimid, you must read the package leaflet of all the medicines you
are required to take in combination with Revlimid.
Do not take Revlimid

• If you are pregnant, think you may be pregnant, or are planning a pregnancy, because Revlimid is expected to be harmful to the unborn baby (see section 2, 'Pregnancy, breastfeeding and contraception – information for women and men').
• If there is any possibility that you may become pregnant unless you follow all necessary measures to avoid pregnancy (see section 2 'Pregnancy, breastfeeding and contraception – information for women and men'). If there is any possibility of becoming pregnant, your doctor will record and confirm at each prescription that the necessary measures to prevent pregnancy have been taken.
• If you are allergic to lenalidomide or to any of the other ingredients of this medicine (listed in section 6). If you think you are allergic, consult your doctor.

If any of these conditions apply to you, do not take Revlimid. If you have any doubts, consult your doctor.
Warnings and precautions
Consult your doctor, pharmacist, or nurse before taking Revlimid if:

• you have previously experienced episodes of blood clots, as the risk of developing blood clots in veins and arteries increases during treatment
• you have any signs of infection, such as cough or fever
• you have or have previously had a viral infection, particularly: hepatitis B infection, varicella-zoster, HIV. If you are in doubt, consult your doctor. Treatment with Revlimid may cause reactivation of the virus in patients who carry the virus, leading to recurrence of the infection. Your doctor should check whether you have previously had hepatitis B infection
• you have kidney problems – your doctor may adjust the dose of Revlimid
• you have had a heart attack, have had a blood clot, or if you smoke, have high blood pressure, or high cholesterol levels
• you have had an allergic reaction during treatment with thalidomide (another medicine used to treat multiple myeloma), such as rash, itching, swelling, dizziness, or difficulty breathing
• you have previously experienced a combination of any of the following symptoms: widespread rash, skin redness, high body temperature, flu-like symptoms, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes; these are signs of a serious skin reaction called drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome (see also section 4 “Possible side effects”).

If any of these conditions apply to you, inform your doctor, pharmacist, or nurse before starting treatment.
At any time during or after treatment, inform your doctor or nurse immediately if:

• you experience blurred vision, loss of vision or double vision, difficulty speaking, weakness in one arm or leg, changes in the way you walk or problems with balance, persistent numbness, decreased sensation or loss of sensation, memory loss or confusion. These may be symptoms of a serious brain condition that can be life-threatening, known as

progressive multifocal leukoencephalopathy (PML). If you had these symptoms before treatment with Revlimid, inform your doctor of any changes in these symptoms.

• you experience shortness of breath, fatigue, dizziness, chest pain, rapid heartbeat, or swelling in your legs or ankles. These may be symptoms of a serious condition known as pulmonary hypertension (see section 4).

Tests and monitoring
Before and during treatment with Revlimid, you will undergo regular blood tests. This is because Revlimid can cause a reduction in blood cells that protect you from infections (white blood cells) and in those that help blood clotting (platelets).
Your doctor will ask you to have a blood test:

• before starting treatment
• every week for the first 8 weeks of treatment
• then at least once a month thereafter.

You may be assessed for signs of cardiopulmonary problems before and during treatment with lenalidomide.
For patients with MDS taking Revlimid
If you have MDS, you have a higher risk of developing a more advanced disease called acute myeloid leukaemia (AML). Furthermore, the role of Revlimid in the risk of developing AML is not known. Your doctor may request certain tests to monitor signs that could more accurately predict your risk of developing AML during treatment with Revlimid.
For patients with MCL taking Revlimid
Your doctor will ask you to have a blood test:

• before starting treatment
• every week for the first 8 weeks (2 cycles) of treatment
• then every 2 weeks during cycles 3 and 4 (for further information see section 3 “Treatment cycle”)
• subsequently at the beginning of each cycle and
• at least once a month.

For patients with FL taking Revlimid
Your doctor will ask you to have a blood test:

• before starting treatment
• every week for the first 3 weeks (1 cycle) of treatment
• then every 2 weeks during cycles 2 to 4 (for further information see section 3 “Treatment cycle”)
• subsequently at the beginning of each cycle and
• at least once a month.

Your doctor may check whether you have a high tumour burden throughout your body, including in the bone marrow. This could lead to a condition in which tumours break down and cause abnormally high levels of chemicals in the blood, potentially leading to kidney failure (this condition is called “tumour lysis syndrome”).
Your doctor may monitor you for skin changes, such as red spots or rashes.
Your doctor may decide to adjust the dose of Revlimid or stop treatment depending on the results of blood tests and your general condition. If you are a newly diagnosed patient, your doctor may also consider treatment based on your age and any other pre-existing conditions.
Blood donation
You must not donate blood during treatment with lenalidomide and for at least 7 days after stopping treatment.
Children and adolescents
The use of Revlimid is not recommended in children and adolescents under 18 years of age.
Elderly and patients with kidney problems
If you are 75 years of age or older, or have moderate to severe kidney problems, your doctor will closely monitor you before starting treatment.
Other medicines and Revlimid
Inform your doctor or nurse if you are taking or have recently taken any other medicines.
This is because Revlimid may affect the action of other medicines, and other medicines may affect the action of Revlimid.
In particular, inform your doctor or nurse if you are taking any of the following medicines:

• certain medicines used to prevent pregnancy, such as oral contraceptives, because they may become less effective
• certain medicines used for heart problems, such as digoxin
• certain medicines used to thin the blood, such as warfarin.

Pregnancy, breastfeeding and contraception – information for women and men
Pregnancy
For women taking Revlimid

• You must not take Revlimid if you are pregnant, because this medicine is expected to be harmful to the unborn baby.
• During treatment with Revlimid, you must not become pregnant. If there is any possibility of becoming pregnant, you must use effective contraceptive methods (see the section “Contraception”).
• If you become pregnant during treatment with Revlimid, you must stop treatment immediately and inform your doctor.

For men taking Revlimid

• If your partner becomes pregnant while you are taking Revlimid, inform your doctor immediately. It is also recommended that your partner contacts her doctor.
• In addition, you must use effective contraceptive methods (see the section “Contraception”).

Breastfeeding
You must not breastfeed while taking Revlimid, as it is not known whether this medicine passes into breast milk.
Contraception
For women taking Revlimid
Before starting treatment, ask your doctor whether there is any possibility that you could become pregnant, even if you think it is unlikely.
If there is any possibility of becoming pregnant

• you will need to undergo pregnancy tests under your doctor’s supervision (before each treatment, at least every 4 weeks during treatment, and at least 4 weeks after stopping treatment), except in cases where it has been confirmed that your fallopian tubes have been cut and sealed to prevent eggs from reaching the uterus (sterilisation by tubal ligation) AND
• you must use effective contraceptive methods for at least 4 weeks before starting treatment, during treatment, and for at least 4 weeks after stopping treatment. Your doctor will provide you with full guidance on appropriate contraceptive methods.

For men taking Revlimid
Revlimid passes into human seminal fluid. If there is any possibility that your partner is pregnant or may become pregnant and she is not using effective contraceptive methods, you must use condoms during treatment and for at least 7 days after stopping treatment, even if you have had a vasectomy. You must not donate seminal fluid or sperm during treatment with lenalidomide and for at least 7 days after stopping treatment.
Driving and using machines
Do not drive or operate machinery if you experience dizziness, fatigue, drowsiness, vertigo, or blurred vision after taking Revlimid.
Revlimid contains lactose
Revlimid contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Revlimid

Revlimid must be prescribed and administered by healthcare professionals experienced in the treatment of multiple myeloma, MDS, MCL, or FL.

• When Revlimid is used for the treatment of multiple myeloma in patients who cannot undergo bone marrow transplantation or who have previously received other treatments, it is taken in combination with other medicines (see section 1, "What Revlimid is and what it is used for").
• When Revlimid is used for the treatment of multiple myeloma in patients who have undergone bone marrow transplantation, or for treating patients with MDS or MCL, it is taken alone.
• When Revlimid is used to treat follicular lymphoma, it is taken together with another medicine called "rituximab".

Always take Revlimid exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.
If you are taking Revlimid in combination with other medicines, please refer to the package leaflet of those medicines for further information on their use and effects.

Treatment cycle
Revlimid is taken on certain days over a period of 3 weeks (21 days).

• Each 21-day period 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 will not take any medicine.

• After completing each 21-day cycle, you should start a new "cycle" within the following 21 days.
  OR
  Revlimid is taken on certain days over a period of 4 weeks (28 days).

• Each 28-day period 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 will not take any medicine.

• After completing each 28-day cycle, you should start a new "cycle" within the following 28 days.

Dose of Revlimid to be taken
Before starting treatment, your doctor will inform you:

• of the dose of Revlimid to take
• of the dose of any other medicines to be taken in combination with Revlimid, if prescribed
• on which days of the 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 the powder from a broken Revlimid capsule comes into contact with the skin, wash the skin immediately and thoroughly with soap and water.
• Healthcare providers, caregivers, and family members should wear disposable gloves when handling the blister pack or capsule. Gloves should then be carefully removed to avoid skin exposure, placed in a sealed polyethylene bag, and disposed of according to local regulations. Hands should then be washed thoroughly with soap and water. Pregnant women (confirmed or suspected) must not handle the blister pack or capsule.
• The capsules may be taken with or without food.
• You must take Revlimid on the scheduled days at approximately the same time each day.

How to take this medicine
To remove the capsule from the blister:

• Press on one side of the capsule, pushing it through the aluminium foil.
• Do not press in the center of the capsule, as this may cause it to break.

Duration of treatment with Revlimid
Revlimid is taken in treatment cycles, each lasting 21 or 28 days (see above, "Treatment cycle"). You must continue the treatment cycles until your doctor tells you to stop.

If you take more Revlimid than you should
If you have taken more Revlimid than prescribed, inform your doctor immediately.

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

• less than 12 hours have passed: take your capsule immediately
• more than 12 hours have passed: do not take the missed capsule; instead, take the next capsule at the usual time the following day.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Revlimid and contact your doctor immediately if you experience any of the following
serious side effects – you may need urgent medical treatment:

• Hives, skin rash, swelling of the eyes, mouth or face, difficulty breathing or itching, which may be symptoms of serious types of allergic reactions called angioedema and anaphylactic reaction.
• Severe allergic reaction, which may start as a rash in one area but spread with extensive skin loss over the body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).
• Widespread rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.

Contact your doctor immediately if you experience any of the following side effects:

• Fever, chills, sore throat, cough, mouth ulcers, or any other sign of infection including in the bloodstream (sepsis)
• Bleeding or bruising without injury
• Chest or leg pain
• Shortness of breath
• Bone pain, muscle weakness, confusion or fatigue, which may be due to high levels of calcium in the blood.

Revlimid may reduce the number of white blood cells that fight infection and also the blood cells that help 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).
Other side effects
It is important to note that a small number of patients may develop other types of cancer, and this risk may possibly increase with treatment with Revlimid. Therefore, your doctor must carefully evaluate the benefits and risks when prescribing Revlimid to you.
Very common side effects (may affect more than 1 in 10 people):

• Decrease in the number of red blood cells (anaemia), which may cause tiredness and weakness
• Rash, itching
• Muscle cramps, muscle weakness, muscle pain, muscle tenderness, bone pain, joint pain, back pain, pain in limbs
• Generalised swelling, including swelling of arms and legs
• Weakness, fatigue
• Fever and flu-like symptoms, including fever, muscle pain, headache, earache, cough and chills
• Numbness, tingling or burning sensation on the skin, pain in hands or feet, dizziness, tremor
• Loss of appetite, altered sense of taste
• Increase in pain, size of tumour or redness around tumour
• Loss of body weight
• Constipation, diarrhoea, nausea, vomiting, stomach pain, heartburn
• Low levels of potassium or calcium and/or sodium in the blood
• Underactive thyroid gland
• Leg pain (which may be a symptom of thrombosis), chest pain or shortness of breath (which may be symptoms of blood clots in the lungs, called pulmonary embolism)
• Any type of infection, including infections of the sinuses around the nose, lungs and upper respiratory tract
• Shortness of breath
• Blurred vision
• Clouding of the lens of the eye (cataract)
• Kidney problems, including impaired kidney function or inability of the kidneys to maintain normal function
• Abnormal liver function tests
• Increased liver function tests
• Changes in a protein in the blood that may cause swelling of the arteries (vasculitis)
• Increased blood sugar levels (diabetes)
• Decreased blood sugar levels
• Headache
• Nosebleeds
• Dry skin
• Depression, mood changes, difficulty sleeping
• Cough
• Decreased blood pressure
• Vague feeling of physical discomfort, malaise
• Inflammation of the mouth, dry mouth
• Dehydration

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

• Destruction of red blood cells in the blood (haemolytic anaemia)
• Some types of skin cancer
• Bleeding from gums, stomach or intestine
• Increased blood pressure, slow, fast or irregular heartbeat
• Increase in a substance resulting from the normal and abnormal breakdown of red blood cells
• Increase in a type of protein indicating inflammation in the body
• Darkening of the skin, skin colour changes due to bleeding under the skin, typically caused by bruising, swelling of the skin due to blood, bruising
• Increased uric acid in the blood
• Skin rashes, redness of the skin, skin cracking, peeling or flaking, hives
• Increased sweating, night sweats
• Difficulty swallowing, sore throat, voice quality problems or voice changes
• Runny nose
• Urinating much more or much less than usual or inability to control the urge to urinate
• Presence of blood in the urine
• Shortness of breath, especially when lying down (which may be a symptom of heart failure)
• Difficulty achieving an erection
• Stroke, fainting, dizziness (inner ear problem causing a sensation that everything is spinning), temporary loss of consciousness
• Chest pain spreading to arms, neck, jaw, back or stomach, sweating and breathlessness, feeling of discomfort or vomiting, which may be symptoms of a heart attack (myocardial infarction)
• Muscle weakness, lack of energy
• Neck pain, chest pain
• Chills
• Swelling of joints
• Slowing or blockage of bile flow from the liver
• Low levels of phosphate or magnesium in the blood
• Difficulty speaking
• Liver damage
• Balance problems, difficulty moving
• Hearing loss, ringing in the ears (tinnitus)
• Nerve pain, altered sensation, especially of touch
• Excess iron in the blood
• Thirst
• Confusion
• Toothache
• Falls, which may result in injury

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)
• Excessive urination with bone pain and weakness, which may be symptoms of a kidney disorder (Fanconi syndrome)
• Yellowing of the skin, mucous membranes or eyes (jaundice), pale stools, dark urine, itchy skin, rash, stomach pain or swelling. These may be symptoms of liver damage (liver failure).
• Stomach pain, swelling or diarrhoea, which may be symptoms of inflammation of the large intestine (called colitis or typhlitis)
• Damage to kidney cells (called renal tubular necrosis)
• Changes in skin colour, sensitivity to sunlight
• Tumour lysis syndrome: metabolic complications that may occur during anti-tumour treatment and sometimes even without treatment. These complications are caused by the breakdown products of dying tumour cells and may include changes in blood parameters with high levels of potassium, phosphate and uric acid and low levels of calcium, leading to changes in kidney function and heart rhythm, seizures and, sometimes, death.
• Increased blood pressure in the blood vessels leading to the lungs (pulmonary hypertension).

Side effects with frequency not known (frequency cannot be estimated from the available data):

• Sudden or mild but worsening pain in the upper abdomen and/or back, lasting for several days, possibly accompanied by nausea, vomiting, fever and rapid pulse; these symptoms may be due to inflammation of the pancreas.
• Wheezing, shortness of breath or dry cough, which may be symptoms caused by inflammation of lung tissue.
• Rare cases of muscle breakdown (muscle pain, weakness or swelling), which may lead to kidney problems (rhabdomyolysis), some of which occurred when Revlimid was given with a statin (a type of cholesterol-lowering medicine).
• A disease affecting the skin caused by inflammation of small blood vessels, with joint pain and fever (leukocytoclastic vasculitis).
• Deterioration of the stomach or intestinal wall, which may lead to very serious infections. Inform your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in stools or changes in bowel habits.
• Viral infections, including herpes zoster (also known as shingles, a viral disease causing a painful rash with blisters) and reactivation of hepatitis B infection (which may cause yellowing of the skin and eyes, dark brown urine, stomach pain on the right side, fever and nausea or feeling unwell).
• Rejection of solid organ transplant (such as kidney, heart)

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system listed in Annex 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 stated on the blister and carton after "Exp.". The expiry date refers to the last day of that month.
• This medicine requires no special storage conditions.
• Do not use this medicine if you notice damaged packaging or signs of tampering.
• Do not dispose of any medicine via wastewater or household waste. Return unused medicines to the pharmacist. This will help protect the environment.

6. Package contents 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 components are:
  • capsule contents: anhydrous lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate
  • capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132) and yellow iron oxide (E172)
  • printing ink: shellac, propylene glycol (E1520), 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 components are:
  • capsule contents: anhydrous lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate
  • capsule shell: gelatin and titanium dioxide (E171)
  • printing ink: shellac, propylene glycol (E1520), 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 components are:
  • capsule contents: anhydrous lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate
  • capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172)
  • printing ink: shellac, propylene glycol (E1520), 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 components are:
  • capsule contents: anhydrous lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate
  • capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132) and yellow iron oxide (E172)
  • printing ink: shellac, propylene glycol (E1520), 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 components are:
  • capsule contents: anhydrous lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate
  • capsule shell: gelatin, titanium dioxide (E171) and indigo carmine (E132)
  • printing ink: shellac, propylene glycol (E1520), 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 components are:
  • capsule contents: anhydrous lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate
  • capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132) and yellow iron oxide (E172)
  • printing ink: shellac, propylene glycol (E1520), 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 components are:
  • capsule contents: anhydrous lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate
  • capsule shell: gelatin and titanium dioxide (E171)
  • printing ink: shellac, propylene glycol (E1520), potassium hydroxide and black iron oxide (E172).

Description of the appearance of Revlimid and package contents
Revlimid 2.5 mg hard capsules are blue-green/white in colour, marked with 'REV 2.5 mg'.
The capsules are supplied in packs, each containing one or three blisters. Each blister contains seven capsules, giving a total of 7 or 21 capsules per pack.
Revlimid 5 mg hard capsules are white in colour, marked with 'REV 5 mg'.
The capsules are supplied in packs, each containing one or three blisters. Each blister contains seven capsules, giving a total of 7 or 21 capsules per pack.
Revlimid 7.5 mg hard capsules are light yellow/white in colour, marked with 'REV 7.5 mg'.
The capsules are supplied in packs, each containing one or three blisters. Each blister contains seven capsules, giving a total of 7 or 21 capsules per pack.
Revlimid 10 mg hard capsules are blue-green/light yellow in colour, marked with 'REV 10 mg'.
The capsules are supplied in packs, each containing one or three blisters. Each blister contains seven capsules, giving a total of 7 or 21 capsules per pack.
Revlimid 15 mg hard capsules are light blue/white in colour, marked with 'REV 15 mg'.
The capsules are supplied in packs, each containing one or three blisters. Each blister contains seven capsules, giving a total of 7 or 21 capsules per pack.
Revlimid 20 mg hard capsules are blue-green/light blue in colour, marked with 'REV 20 mg'.
The capsules are supplied in packs, each containing one or three blisters. Each blister contains seven capsules, giving a total of 7 or 21 capsules per pack.
Revlimid 25 mg hard capsules are white in colour, marked with 'REV 25 mg'.
The capsules are supplied in packs, each containing one or three blisters. Each blister contains seven capsules, giving a total of 7 or 21 capsules per pack.

Marketing Authorisation Holder
Bristol-Myers Squibb Pharma EEIG
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland

Manufacturer
Celgene Distribution B.V.
Orteliuslaan 1000
3528 BD Utrecht
The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien Lietuva
N.V. Bristol-Myers Squibb Belgium S.A. Swixx Biopharma UAB
Tél/Tel: + 32 2 352 76 11 Tel: + 370 52 369140
[email protected] [email protected]

България Luxembourg/Luxemburg
Swixx Biopharma EOOD N.V. Bristol-Myers Squibb Belgium S.A.
Teл.: + 359 2 4942 480 Tél/Tel: + 32 2 352 76 11
[email protected] [email protected]

Česká republika Magyarország
Bristol-Myers Squibb spol. s r.o. Bristol-Myers Squibb Kft.
Tel: + 420 221 016 111 Tel.: + 36 1 301 9797
[email protected] [email protected]

Danmark Malta
Bristol-Myers Squibb Denmark A.M. Mangion Ltd
Tlf: + 45 45 93 05 06 Tel: + 356 23976333
[email protected] [email protected]

Deutschland Nederland
Bristol-Myers Squibb GmbH & Co. KGaA Bristol-Myers Squibb B.V.
Tel: 0800 0752002 (+ 49 89 121 42 350) Tel: + 31 (0)30 300 2222
[email protected] [email protected]

Eesti Norge
Swixx Biopharma OÜ Bristol-Myers Squibb Norway AS
Tel: + 372 640 1030 Tlf: + 47 67 55 53 50
[email protected] [email protected]

Ελλάδα Österreich
Bristol-Myers Squibb A.E. Bristol-Myers Squibb GesmbH
Τηλ: + 30 210 6074300 Tel: + 43 1 60 14 30
[email protected] [email protected]

España Polska
Bristol-Myers Squibb, S.A. Bristol-Myers Squibb Polska Sp. z o.o.
Tel: + 34 91 456 53 00 Tel.: + 48 22 2606400
[email protected] [email protected]

France Portugal
Bristol-Myers Squibb SAS Bristol-Myers Squibb Farmacêutica Portuguesa, S.A.
Tél: + 33 (0)1 58 83 84 96 Tel: + 351 21 440 70 00
[email protected] [email protected]

Hrvatska România
Bristol-Myers Squibb Marketing Services S.R.L.
Tel: + 40 (0)21 272 16 19
[email protected] [email protected]

Ireland Slovenija
Bristol-Myers Squibb Pharmaceuticals uc
Tel: 1 800 749 749 (+ 353 (0)1 483 3625) Tel: + 386 1 2355 100
[email protected] [email protected]

Ísland Slovenská republika
Vistor hf.
Sími: + 354 535 7000 Tel: + 421 2 20833 600
[email protected] [email protected]
[email protected]

Italia Suomi/Finland
Bristol-Myers Squibb S.r.l. Oy Bristol-Myers Squibb (Finland) Ab
Tel: + 39 06 50 39 61 Puh/Tel: + 358 9 251 21 230
[email protected] [email protected]

Κύπρος Sverige
Bristol-Myers Squibb A.E. Bristol-Myers Squibb Aktiebolag
Τηλ: 800 92666 (+ 30 210 6074300) Tel: + 46 8 704 71 00
[email protected] [email protected]

Latvija
Swixx Biopharma SIA
Tel: + 371 66164750
[email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
In addition, links to other websites on rare diseases and their treatments are provided.