Revlimid 20 mg hard capsules: detailed information

Patient Information Leaflet

Introduction

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 medicinal product is subject to additional monitoring, which will allow quicker identification of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is provided at the end of section 4.

Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.

Keep this leaflet, as you may need to refer to it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only and must not be given to others, even if they have the same symptoms as you. It could harm them.
If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet

What Revlimid is and what it is used for
What you need to know before taking 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 that affect how the immune system works.

What Revlimid is used for

Revlimid is used in adults for:

Multiple myeloma
Myelodysplastic syndromes (MDS)
Mantle cell lymphoma (MCL)
Follicular lymphoma (FL)

Multiple myeloma

Multiple myeloma is a type of cancer that affects a specific type of white blood cells called plasma cells. These cells accumulate in the bone marrow and multiply uncontrollably. This can damage bones and kidneys.

Multiple myeloma is generally not curable. However, signs and symptoms can be greatly reduced or may disappear for a period of time. This is called "remission".

Newly diagnosed multiple myeloma: in patients who have undergone a bone marrow transplant

Revlimid is used as maintenance treatment after adequate recovery from a bone marrow transplant.

Newly diagnosed multiple myeloma: in patients who cannot be treated with a bone marrow transplant

Revlimid is taken in combination with other medicines, including:

a chemotherapy medicine called "bortezomib"
an anti-inflammatory medicine called "dexamethasone"
a chemotherapy medicine called "melphalan" and
an immunosuppressant called "prednisone".

You will take these medicines at the beginning of treatment and then continue taking Revlimid alone.

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

Multiple myeloma: in previously treated patients

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

Revlimid may slow the progression 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 a variety of signs and symptoms, including low red blood cell count (anaemia), the need for blood transfusions, and increased risk of infection.

Revlimid is used to treat adult patients diagnosed with MDS when all of the following apply:

you require periodic blood transfusions to treat low red blood cell levels ("transfusion-dependent anaemia")
you have an abnormality in the bone marrow cells called "isolated 5q cytogenetic abnormality". This means your body does not produce enough healthy blood cells
other treatments you have previously used are not suitable or have not worked well enough.

Revlimid can increase the number of healthy red blood cells your body produces by reducing the number of abnormal cells:

this may reduce the number of blood transfusions needed. Blood transfusions may no longer be required.

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. MCL is a disease in which B-cells grow uncontrollably and accumulate in lymphatic tissue, bone marrow, or blood.

Revlimid is used as monotherapy to treat adult patients who have previously received treatment with other medicines.

Follicular lymphoma (FL)

FL is a slow-growing cancer that affects B-lymphocytes. These are a type of white blood cells that help the body fight infections. In patients with FL, too many of these B-lymphocytes may accumulate in the blood, bone marrow, lymph nodes, and spleen.

Revlimid is used in combination with another medicine called "rituximab" for the treatment of adult patients who have received prior therapy for follicular lymphoma.

How Revlimid works

Revlimid works by affecting the body's immune system and directly attacking cancer cells. It acts in several ways:

stops the development of cancer cells
inhibits the growth of blood vessels in cancer
stimulates part of the immune system to attack cancer cells.

2. What you need to know before taking Revlimid

You must read the package leaflet of all medicines you are going to take in combination with Revlimid before starting treatment with Revlimid.

Do not take Revlimid:

if you are pregnant, think you might be pregnant, or intend to become pregnant, as Revlimid is expected to be harmful to the fetus (see section 2, “Pregnancy, breastfeeding and contraception: information for women and men”).
if you can become pregnant, unless you follow all necessary measures to prevent pregnancy (see section 2, “Pregnancy, breastfeeding and contraception: information for women and men”). If you can become pregnant, your doctor will confirm with each prescription that all necessary precautions have been taken and will 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, consult your doctor.

If any of these conditions apply to you, do not take Revlimid. If in doubt, consult your doctor.

Warnings and precautions

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

you have ever had blood clots; during treatment, you have an increased risk of developing blood clots in veins and arteries
you have any signs of infection, such as cough or fever
you have or have previously had a viral infection, especially hepatitis B, varicella zoster, or HIV. If in doubt, consult your doctor. Treatment with Revlimid may reactivate the virus in patients who carry it, leading to 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, previously had a blood clot, or if you smoke, have high blood pressure, or high cholesterol levels
you have had an allergic reaction while using thalidomide (another medicine used to treat multiple myeloma), such as rash, itching, swelling, dizziness, or breathing problems
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 (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 the above 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, change in walking or balance problems, persistent numbness, reduced sensation or loss of sensation, memory loss or confusion. These may be symptoms of a serious and potentially life-threatening brain disease called progressive multifocal leukoencephalopathy (PML). If you have any of these symptoms before starting Revlimid treatment, inform your doctor if you notice any changes in these symptoms.
shortness of breath, fatigue, dizziness, chest pain, faster heartbeat, or swelling in legs or ankles. These may be symptoms of a serious condition known as pulmonary hypertension (see section 4).

Blood tests and monitoring

Before starting and during treatment with Revlimid, you will have regular blood tests. This is because Revlimid may cause a decrease in blood cells that help fight infections (white blood cells) and those involved in blood clotting (platelets).

Your doctor will ask you to have blood tests:

before treatment
weekly during the first 8 weeks of treatment
thereafter, at least once a month.

You may be evaluated for signs of heart or lung problems before and during treatment with lenalidomide.

For patients with MDS taking Revlimid

If you have MDS, you may be at higher risk of developing a more advanced disease called acute myeloid leukemia (AML). In addition, it is not known how Revlimid affects the likelihood of developing AML. Therefore, your doctor may perform blood tests to detect signs that could better predict the possibility of developing AML during treatment with Revlimid.

For patients with CLL taking Revlimid

Your doctor will ask you to have blood tests:

before treatment
weekly during the first 8 weeks (2 cycles) of treatment
then every 2 weeks during cycles 3 and 4 (see section 3 “Treatment cycle” for more information)
after this, 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 blood tests:

before treatment
weekly during the first 3 weeks (1 cycle) of treatment
then every 2 weeks during cycles 2 to 4 (see section 3 “Treatment cycle” for more information)
after this, at the beginning of each cycle and
at least once a month.

Your doctor may check whether you have a high total tumor burden in the body, including in the bone marrow. This could lead to a condition in which tumors break down and release unusual levels of chemicals into the blood, which in turn may cause kidney failure (this condition is called “tumor lysis syndrome”).

Your doctor may examine you for skin changes such as red spots or rashes.

Your doctor may adjust the dose of Revlimid or interrupt your treatment depending on the results of your blood tests and your overall condition. If you are a newly diagnosed patient, your doctor may also evaluate your treatment based on your age and other existing conditions.

Blood donation

You must not donate blood during treatment or for at least 7 days after treatment ends.

Children and adolescents

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

Elderly patients and patients with kidney problems

If you are 75 years of age or older or have moderate to severe kidney problems, your doctor will carefully evaluate you before starting treatment.

Other medicines and Revlimid

Tell your doctor or nurse if you are taking, have recently taken, or might need to take any other medicines. This is because Revlimid may affect how other medicines work. In addition, some medicines may affect how Revlimid works.

Specifically, inform your doctor or nurse if you are taking any of the following medicines:

certain medicines used to prevent pregnancy, such as oral contraceptives, as 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

Women taking Revlimid

You must not take Revlimid if you are pregnant, as it is expected to be harmful to the fetus.
You must not become pregnant while taking Revlimid. Therefore, you must use effective contraceptive methods if there is any possibility you could become pregnant (see “Contraception”).
If you become pregnant during treatment with Revlimid, you must stop treatment and inform your doctor immediately.

Men taking Revlimid

If your partner becomes pregnant while you are taking Revlimid, you must inform your doctor immediately. It is recommended that your partner seeks medical advice.
You must also use effective contraceptive methods (see “Contraception”).

Breastfeeding

You must not breastfeed while taking Revlimid, as it is not known whether Revlimid passes into breast milk.

Contraception

For women taking Revlimid

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

If you can become pregnant:

you will be tested for pregnancy under medical supervision (before each treatment cycle, at least every 4 weeks during treatment, and for at least 4 weeks after treatment ends), unless it has been confirmed that your fallopian tubes have been closed (tubal ligation) to prevent eggs from reaching the uterus

And

you must use effective contraceptive methods starting at least 4 weeks before beginning treatment, during treatment, and for at least 4 weeks after treatment ends. Your doctor will advise you on the most appropriate contraceptive methods.

For men taking Revlimid

Revlimid passes into human semen. If your partner is pregnant or could become pregnant and is not using an effective contraceptive method, you must use condoms during treatment and for at least 7 days after treatment ends, even if you have had a vasectomy. You must not donate semen or sperm during treatment or for at least 7 days after treatment ends.

Driving and using machines

Do not drive or operate machinery if you feel dizzy, tired, drowsy, have vertigo, or blurred vision after taking Revlimid.

Revlimid contains lactose

Revlimid contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with your doctor before taking this medicine.

3. How to take Revlimid

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

When Revlimid is used to treat multiple myeloma in patients who cannot undergo a bone marrow transplant or who have received prior therapy, it is taken in combination with other medications (see section 1 “What Revlimid is used for”).
When Revlimid is used to treat multiple myeloma in patients who have undergone a bone marrow transplant, or to treat patients with MDS or CLL, it is taken alone.
When Revlimid is used to treat follicular lymphoma, it is taken together with another medicine called “rituximab”.

Always follow your doctor’s instructions exactly when taking Revlimid. If you are unsure, 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 additional information about their use and side effects.

Treatment cycle

Revlimid is taken on certain days during a 3-week (21-day) period.

A “treatment cycle” consists of 21 days.
Depending on the day of the cycle, you will take one or more medicines. However, on some days you will not take any medicine.
After completing each 21-day cycle, you must start a new “cycle” for the following 21 days.

Revlimid is taken on certain days during a 4-week (28-day) period.

A “treatment cycle” consists of 28 days.
Depending on the day of the cycle, you will take one or more medicines. However, on some days you will not take any medicine.
After completing each 28-day cycle, you must start a new “cycle” for the following 28 days.

How much Revlimid to take

Before starting treatment, your doctor will inform you:

of the dose of Revlimid you should take,
of the dose of any other medicines you should take together with Revlimid, if applicable,
on which days of the treatment cycle you should 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 comes into contact with your skin, wash the skin immediately and thoroughly with water and soap.
Healthcare professionals, 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 sealable polyethylene plastic bag, and disposed of according to local requirements. Hands should then be thoroughly washed with water and soap. Pregnant women or women who suspect they may be pregnant must not handle the blister pack or capsule.
The capsules may be taken with or without food.
You should take Revlimid at approximately the same time each scheduled day.

How to take this medicine

To remove the capsule from the blister pack:

Press only on one end of the capsule so that it comes through the foil.
Do not press in the middle of the capsule, as this may break it.

Schematic drawing showing the steps to open a pill pack by pressing with the thumb on the edges to lift the lid

Duration of treatment with Revlimid

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

If you take more Revlimid than you should

If you take 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 the capsule immediately.
more than 12 hours have passed: do not take the missed capsule. Take the next capsule the following day at your usual time.

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

4. Possible adverse effects

Like all medicines, Revlimid can cause adverse effects, although not everyone will experience them.

If you experience any of the following serious adverse effects, stop treatment with Revlimid and contact a doctor immediately, as you may require urgent medical treatment:

Hives, rash, swelling of the eyes, mouth or face, difficulty breathing or itching, which may be symptoms of severe allergic reactions known as angioedema and anaphylactic reaction.
Severe allergic reaction that may start as a rash in one area but spreads, causing extensive skin loss throughout the body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).
Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and effects on 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 notice any of the following serious adverse effects:

Fever, chills, sore throat, cough, mouth ulcers, or any other sign of infection including in the bloodstream (sepsis)
Bleeding (haemorrhage) or bruising (haematoma) not due to injury
Chest (thoracic) or leg pain
Difficulty breathing
Bone pain, muscle pain, 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 infections and also reduce 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 veins (thrombosis).

Other adverse effects

It is important to note that a small number of patients may develop other types of cancer, and this risk may increase with treatment with Revlimid. Therefore, your doctor must carefully evaluate the benefits and risks before prescribing Revlimid.

Adverse effects very common (may affect more than 1 in 10 people):

A decrease in the number of red blood cells, which may lead to anaemia causing tiredness and weakness
Skin rash, itching
Muscle cramps, muscle weakness, muscle pain, muscle discomfort, bone pain, joint pain, back pain, limb pain
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 in the skin, pain in hands or feet, dizziness, tremor
Loss of appetite, changes in taste
Increase in pain, size of tumour or redness around the tumour
Weight loss
Constipation, diarrhoea, nausea, vomiting, stomach pain, heartburn
Low levels of potassium, calcium and/or sodium in the blood
Underactive thyroid function
Leg pain (which could be a symptom of thrombosis), chest pain or difficulty breathing (which could be a symptom of blood clots in the lungs, known as pulmonary embolism)
Infections of all types, including infection of the sinuses around the nose (sinusitis), lung infection and upper respiratory tract infections
Difficulty breathing
Blurred vision
Clouding of the eye (cataracts)
Kidney problems including kidneys that do not function properly or that are unable to maintain normal function
Abnormal results in liver function tests
High values in liver function test results
Changes in a blood protein 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
Low blood pressure
A general feeling of being unwell, feeling ill
Painful inflammation of the mouth, dry mouth
Dehydration

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

Destruction of red blood cells (haemolytic anaemia)
Certain types of skin tumours
Bleeding from gums, stomach or intestines
Increased blood pressure, slow, fast or irregular heartbeat
Increased levels of a substance released following normal or abnormal destruction of red blood cells
Increased levels of a protein indicating inflammation in the body
Darkening of skin colour; skin colour change due to internal bleeding, usually caused by bruising; skin inflammation due to blood accumulation; bruising
Increased uric acid in the blood
Skin rashes, skin redness, cracked skin, skin peeling or exfoliation, hives
Increased sweating, night sweats
Difficulty swallowing, sore throat, difficulty maintaining voice quality or voice changes
Runny nose
Marked increase or decrease in urine volume compared to normal or inability to control urination
Blood in the urine
Difficulty breathing, especially when lying down (which could be a symptom of heart failure)
Difficulty achieving an erection
Stroke, fainting, dizziness (inner ear disorder causing a sensation of spinning), temporary loss of consciousness
Chest pain spreading to arms, neck, jaw, back or stomach, sweating and shortness of breath, nausea 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
Slowed or blocked flow of bile from the liver
Low levels of phosphate or magnesium in the blood
Difficulty speaking
Liver damage
Loss of balance, movement difficulties
Deafness, ringing in the ears (tinnitus)
Nerve pain, abnormal and unpleasant sensation, especially on touch
Excess iron in the body
Thirst
Confusion
Toothache
Falls that may cause injury

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

Bleeding inside the skull
Circulatory problems
Loss of vision
Loss of sexual desire (libido)
Excretion of large amounts of urine with bone pain and weakness, which may be symptoms of a kidney disorder (Fanconi syndrome)
Yellow pigmentation of the skin, mucous membranes or eyes (jaundice), pale stools, dark urine, skin itching, rash, stomach pain or swelling; these may be symptoms of liver damage (liver failure)
Stomach pain, abdominal 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 may occur during cancer treatment and sometimes even without treatment. These complications arise from the breakdown products of dying tumour cells and may include: changes in blood biochemistry, high levels of potassium, phosphate, uric acid and low calcium levels, leading to changes in kidney function and heart rhythm, seizures and, occasionally, death.
Increased blood pressure in the blood vessels supplying the lungs (pulmonary hypertension).

Adverse effects frequency not known (cannot be estimated from available data):

Sudden or mild pain in the upper abdomen and/or back that worsens over several days, possibly accompanied by nausea, vomiting, fever and a rapid pulse. These symptoms may be due to inflammation of the pancreas.
Wheezing or whistling when breathing, difficulty breathing or dry cough, which may be symptoms caused by inflammation of lung tissue.
Rare cases of muscle breakdown (muscle pain, weakness or swelling) have been observed, which may lead to kidney problems (rhabdomyolysis), some of them occurring when Revlimid is administered with a statin (a type of medicine used to lower cholesterol).
A skin disease caused by inflammation of small blood vessels, accompanied by joint pain and fever (leucocytoclastic vasculitis).
Perforation of the stomach or intestinal wall. This may lead to a serious infection. Inform your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in the stools or changes in bowel habits.
Viral infections, including herpes zoster (also known as shingles, a viral disease causing a painful blistering skin rash) 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 transplants (such as kidney, heart).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Revlimid Storage

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 “CAD”/“EXP”. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice any visible signs of deterioration or evidence of tampering.
Medicines must not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Revlimid

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) and 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).

Appearance of the product and contents of the container

Revlimid 2.5 mg hard capsules are greenish-blue/white, with the imprint “REV 2.5 mg”.