Introduction

Patient Information Leaflet: Revlimid

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 help speed up the detection of any new information about its safety. You can help by reporting any side effects you get. The final part of section 4 includes information on how to report these 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 even if their symptoms are the same as yours. It may harm them.
If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1.What Revlimid is and what it is used for

2.What you need to know before you start taking Revlimid

3.How to take Revlimid

4.Possible side effects

5.Storage of Revlimid

6.Contents of the pack and additional information

1. What is Revlimid and what is it used for

What is Revlimid

Revlimid contains the active ingredient “lenalidomide”. This medication belongs to a group of medications that affect how the immune system works.

What is Revlimid used for

Revlimid is used in adults for:

Multiple Myeloma
Myleodysplastic Syndromes (MDS)
mantle cell lymphoma (MCL)
Follicular lymphoma

Multiple Myeloma

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

Multiple Myeloma usually does not have a cure. However, the symptoms and signs can be greatly reduced or 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 recovering adequately from a bone marrow transplant.

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

Revlimid is taken with other medications, including:

a chemotherapy medication called “bortezomib”
a corticosteroid called “dexamethasone”
a chemotherapy medication called “melphalan” and
an immunosuppressant called “prednisone”.

You will take these medications when starting treatment and then continue taking Revlimid alone.

If you are 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 with a corticosteroid called “dexamethasone”.

Revlimid can slow the progression of multiple myeloma symptoms. It has also been shown to delay the recurrence of multiple myeloma after treatment.

Myleodysplastic Syndromes (MDS)

MDS is a group of many different blood and bone marrow diseases. Blood cells become abnormal and do not function correctly. Patients may experience a variety of symptoms, including low red blood cell count (anemia), the need for blood transfusions, and the risk of infection.

Revlimid is used to treat adult patients diagnosed with MDS, when the following points are applicable:

you need periodic blood transfusions to treat low red blood cell levels (“anemia-dependent transfusions”)
you have a bone marrow cell anomaly called “isolated deletion 5q cytogenetic abnormality”. This means your body does not produce enough healthy blood cells
other treatments you have used previously are not suitable or do not work well enough.

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

this can reduce the number of blood transfusions needed. You may not need transfusions.

Mantle cell lymphoma (MCL)

MCL is a cancer of a part of the immune system (lymphoid tissue). It affects a type of white blood cell in the blood called “B lymphocytes” or B cells. MCL is a disease in which B cells grow uncontrollably and accumulate in lymphoid tissue, bone marrow, or blood.

Revlimid is used in monotherapy to treat adult patients who have received previous treatment with other medications.

Follicular lymphoma (FL)

FL is a slow-growing cancer that affects B lymphocytes. These are a type of white blood cell that helps the body fight infections. When a person has FL, they may store too many of these B lymphocytes in the blood, bone marrow, lymph nodes, and spleen.

Revlimid is used with another medication called “rituximab” for the treatment of adult patients who have received previous treatment for follicular lymphoma.

How Revlimid works

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

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

2. What you need to know before starting Revlimid

You must read the patient information leaflet for all medicines you are taking with Revlimid before starting treatment with Revlimid.

Do not take Revlimid:

if you are pregnant, think you may 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 avoid it (see section 2, “Pregnancy, breastfeeding and contraception: information for women and men”). If you can become pregnant, your doctor will note on each prescription that all necessary measures have been taken and will provide you with this confirmation.
ifyou are allergic to lenalidomide or to any of the other components of this medicine (including in section6). If you think you may be allergic, consult your doctor.

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

Warnings and precautions

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

you have ever had blood clots; during treatment, you have a higher risk of developing blood clots in veins and arteries
you have any sign of infection, such as cough or fever
you have or have had previously a viral infection, especially hepatitis B, varicella zoster or HIV. In case of doubt, consult your doctor. Treatment with Revlimid may make the virus become active again in patients who are carriers of the virus. This leads to the reappearance of the infection. Your doctor must check if you have ever had a hepatitis B infection
you have kidney problems; your doctor may adjust your Revlimid dose
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 while using thalidomide (another medicine used to treat multiple myeloma), such as for example skin rash, itching, swelling, dizziness or respiratory problems
you have experienced in the past a combination of any of the following symptoms: generalised rash, skin redness, high body temperature, flu-like symptoms, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes (these are signs of a severe skin reaction called drug reaction with eosinophilia and systemic symptoms, also known as DRESS for its English acronym or drug hypersensitivity syndrome)(see also section4 “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, a change in the way you walk or balance problems, persistent numbness, decreased sensitivity or loss of sensitivity, memory loss or confusion. All of these can be symptoms of a severe and potentially life-threatening brain disease called progressive multifocal leukoencephalopathy (PML). If you have any of these symptoms before starting treatment with Revlimid, inform your doctor if you notice any change in these symptoms.

shortness of breath, fatigue, dizziness, chest pain, rapid heartbeat or swelling in the legs or ankles. These can be symptoms of a serious condition called pulmonary hypertension (see section 4).

Analysis and tests

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

Your doctor will ask you to have a blood test:

before treatment
every week for the first 8 weeks of treatment
subsequently, at least every month.

You may be evaluated to detect signs of cardiovascular problems before and during treatment with lenalidomide.

For patients with SMD taking Revlimid

If you have SMD, you may be more prone to developing a more advanced disease called acute myeloid leukemia (AML). Additionally, it is unknown how Revlimid affects your chances of developing AML. Your doctor may perform tests to detect signs that may predict better the likelihood of developing AML during treatment with Revlimid.

For patients with MM taking Revlimid

Your doctor will ask you to have a blood test:

before treatment
every week for the first 8weeks (2cycles) of treatment
subsequently, every 2weeks in cycles3 and 4 (see section3 “Treatment cycle” for more information)
then at the start 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 treatment
every week for the first 3weeks (1cycle) of treatment
subsequently, every 2weeks in cycles2 to 4 (see section3 “Treatment cycle” for more information)
then at the start of each cycle and
at least, once a month.

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

Your doctor may examine you to check if you have developed changes in your skin, such as red patches or skin rashes.

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

Blood donation

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

Children and adolescents

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

Older adults and patients with kidney problems

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

Other medicines and Revlimid

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

Specifically, inform 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 to treat heart problems, such as digoxin
some 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 a possibility that you may 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 yourpartnerbecomes pregnant while you are taking Revlimid, you must inform your doctor immediately. It is recommended that your partner seek medical advice.
Youalsomust use effective contraceptive methods (see “Contraception”).

Breastfeeding

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

Contraception

For women taking Revlimid

Before starting treatment, ask your doctor if you are capable of becoming pregnant, even if you think this is unlikely.

If you can become pregnant:

you will have pregnancy tests under medical supervision (before each treatment, at least every 4weeks during treatment and for at least 4weeks after finishing treatment) except that tubal ligation has been confirmed so that eggs do not reach the uterus (tubal ligation)

And

you must use effective contraceptive methods from at least 4weeks before starting treatment, during treatment and until at least 4weeks after finishing treatment. Your doctor will advise you on the most suitable contraceptive methods.

For men taking Revlimid

Revlimid passes into human semen. If your partner becomes pregnant or may become pregnant and does not use any effective contraceptive method, you must use condoms during treatment and for at least 7days after finishing treatment, even if you have undergone a vasectomy.You must not donatesemen or spermduring treatment or for at least 7days after finishing treatment.

Driving and using machines

You must not drive or use machines 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 him before taking this medicine.

3. How to Take Revlimid

Revlimid should be administered by a healthcare professional with experience in the treatment of multiple myeloma, SMD, LCM, or LF.

When Revlimid is used for the treatment of multiple myeloma in patients who cannot be treated with a bone marrow transplant or have undergone other treatments beforehand, it is taken with other medications (see section1 “What Revlimid is used for”).
When Revlimid is used for the treatment of multiple myeloma in patients who have received a bone marrow transplant or to treat patients with SMD or LCM, it is taken alone.
WhenRevlimid is used for the treatment of follicular lymphoma, it is taken with another medication called “rituximab”.

Follow exactly the administration instructions for Revlimid indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

If you are taking Revlimid with other medications, you should consult the leaflet of those other medications to obtain additional information on their use and effects.

Treatment cycle

Revlimid is taken on certain days during the period of 3weeks (21days).

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

Revlimid is taken on certain days during the period of 4weeks (28days).

A “treatment cycle” consists of 28days.
Dependingon the day of the cycle, you will take one or more medications. However, some days you will not take any medication.
Aftercompleting each cycle of 28days, you must start a new “cycle” during the following 28days.

How much Revlimid to take

Before starting treatment, your doctor will indicate:

what amount of Revlimid you should take
what amount of the other medications you should take with Revlimid, if applicable
which days of the treatment cycle you should take each medication.

How and when to take Revlimid

Swallow the capsules whole, preferably with water.
Do not break, open, or chew the capsules. In the event that the powder from a broken Revlimid capsule comes into contact with the skin, wash the skin immediately and carefully with water and soap.
Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister pack or capsule. Subsequently, they should carefully remove the gloves to avoid skin exposure, place them in a plastic polyethylene bag, and dispose of them in accordance with local requirements. They should then wash their hands thoroughly with water and soap. Pregnant women or those who suspect they may be pregnant should not handle the blister pack or capsule.
The capsules can be taken with or without food.
Youshould take Revlimid approximately at the same time on the scheduled days.

Medication intake

To remove the capsule from the blister pack:

Pressonly one end of the capsule to make it come out through the foil.
Do not press in the center of the capsule as it may break.

Duration of Revlimid treatment

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

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

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

If you experience any of the following serious side effects, stop taking Revlimid and seek medical attention immediately, as it may require emergency medical treatment:

Urticaria, rashes, swelling of the eyes, mouth, or face, difficulty breathing, or itching, which can be symptoms of severe allergic reactions called angioedema and anaphylaxis.
Severe allergic reaction that can start as a rash in one area but spreads, causing significant skin loss throughout the body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).
Generalized rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and effects on other organs of the body (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.

Seek immediate medical attention if you notice any of the following serious side effects:

Fever, chills, sore throat, cough, mouth ulcers, or any other symptoms of infection, including sepsis.
Bleeding (hemorrhage) or hematoma (bruise) not due to injury.
Chest pain (thoracic) or leg pain.
Difficulty breathing.
Bone pain, muscle pain, confusion, or fatigue that may be due to high levels of calcium in the blood.

Revlimid can reduce the number of white blood cells that fight infections and also the cells in the blood that help to clot blood (platelets), which can cause bleeding disorders such as nosebleeds and bruises. Revlimid can also cause blood clots in the veins (thrombosis).

Other side effects

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

Side effectsvery common(may affect more than 1 in 10 people):

Decreased red blood cell count, which can cause anemia leading to fatigue and weakness.
Rash, itching.
Muscle cramps, muscle weakness, muscle pain, muscle discomfort, bone pain, joint pain, back pain, limb pain.
Generalized swelling, including swelling of the arms and legs.
Weakness, fatigue.
Fever and flu-like symptoms, including fever, muscle pain, headache, ear pain, cough, and chills.
Numbness, tingling, or prickling sensation in the skin, hand or foot pain, dizziness, tremors.
Decreased appetite, changes in the taste of things.
Increased pain, tumor size, or redness around the tumor.
Weight loss.
Constipation, diarrhea, nausea, vomiting, stomach pain, heartburn.
Low levels of potassium, calcium, or sodium in the blood.
Decreased thyroid function.
Chest pain (which could be a symptom of a heart attack), difficulty breathing (which could be a symptom of a blood clot in the lungs, called pulmonary embolism).
Infections of all types, including sinusitis, pneumonia, and upper respiratory tract infections.
Difficulty breathing.
Blurred vision.
Cataracts.
Renal problems, including kidneys that do not function correctly or are unable to maintain normal function.
Abnormal liver test results.
High levels of liver test results.
Changes in a blood protein that can cause swelling of the arteries (vasculitis).
Increased blood sugar levels (diabetes).
Decreased blood sugar levels.
Headache.
Nosebleeds.
Dry skin.
Depression, changes in mood, difficulty sleeping.
Cough.
Low blood pressure.
A vague feeling of discomfort in the body, feeling unwell.
Inflammation of the mouth, dry mouth.
Dehydration.

Side effectscommon(may affect up to 1 in 10 people):

Red blood cell destruction (hemolytic anemia).
Certain types of skin cancer.
Bleeding of the gums, stomach, or intestines.
Increased blood pressure, slow, fast, or irregular heartbeat.
Increased levels of a substance released after normal or abnormal destruction of red blood cells.
Increased levels of a type of protein that indicates inflammation in the body.
Darkening of the skin; change in skin color due to internal bleeding, usually caused by hematomas; inflammation of the skin caused by the accumulation of blood; hematoma.
Increased uric acid levels in the blood.
Rashes, redness of the skin, dry skin, peeling or exfoliation of the skin, urticaria.
Increased sweating, nocturnal sweating.
Difficulty swallowing, sore throat, difficulty maintaining voice quality or changes in voice.
Nasal discharge.
Significant increase or decrease in urine output 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, vertigo (inner ear disorder that causes the sensation of everything spinning), temporary loss of consciousness.
Chest pain that radiates to arms, neck, jaw, spine, or stomach, sensation of sweating and shortness of breath, nausea or vomiting, which can be symptoms of a heart attack (myocardial infarction).
Muscle weakness, lack of energy.
Neck pain, chest pain.
Chills.
Joint swelling.
Slowed or blocked bile flow from the liver.
Low levels of phosphate or magnesium in the blood.
Difficulty speaking.
Liver damage.
Balance problems, difficulty moving.
Deafness, tinnitus (ringing in the ears).
Nerve pain, abnormal and unpleasant sensation, especially when touched.
Excess iron in the body.
Thirst.
Confusion.
Toothache.
Fall that can cause injuries.

Side effectsuncommon(may affect up to 1 in 100 people):

Brain hemorrhage.
Circulatory problems.
Loss of vision.
Loss of libido (sex drive).
Expulsion of large amounts of urine with bone pain and weakness, which can be symptoms of a kidney disorder (Fanconi syndrome).
Yellow pigmentation in the skin, mucous membranes, or eyes (jaundice), pale stools, dark urine, itching skin, rash, stomach pain, or swelling; these can be symptoms of liver damage (hepatic insufficiency).
Stomach pain, abdominal swelling, or diarrhea, which can be symptoms of inflammation of the large intestine (colitis or typhlitis).
Damage to kidney cells (necrotic tubular renal).
Changes in skin color, sensitivity to sunlight.
Tumor lysis syndrome – complications can occur during cancer treatment and sometimes even without treatment. These complications occur as a result of the breakdown products of tumor cells that die and can include: changes in blood biochemistry, high levels of potassium, phosphorus, uric acid, and low levels of calcium, which can cause changes in kidney function and heart rhythm, seizures, and sometimes death.
Increased blood pressure within the blood vessels that supply the lungs (pulmonary hypertension).

Side effectsof unknown frequency(cannot be estimated from available data):

Sudden, sharp, or worsening pain in the upper stomach and/or back, lasting several days, possibly accompanied by nausea, vomiting, fever, and rapid pulse. These symptoms may be due to pancreatitis.
Wheezing or ringing in the lungs, difficulty breathing, or dry cough, which can be symptoms caused by inflammation of the lung tissue.
Rare cases of muscle degradation (pain, weakness, or swelling) that can lead to kidney problems (rhabdomyolysis), some of which occur when Revlimid is administered with a statin (a type of medication to reduce cholesterol).
A disease that affects the skin caused by inflammation of small blood vessels, accompanied by joint pain and fever (leucocytoclastic vasculitis).
Perforation of the stomach or intestine wall. This can lead to a severe infection. Inform your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in the stool, or changes in bowel habits.
Viruses, including herpes zoster (also known as shingles, a viral disease that causes a painful rash with blisters) and the reappearance of hepatitis B infection (which can cause yellowing of the skin and eyes, dark urine, stomach pain on the right side, fever, and nausea or feeling sick).
Rejection of solid organ transplants (such as kidney, heart).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Revlimid

Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the blister pack and the box after “CAD”/“EXP”. The expiration date is the last day of the month indicated.
This medication does not require special conditions for conservation.
Do not use this medication if you observe visible signs of deterioration or signs of improper handling.
Unused medications should not be flushed down the drain or thrown away. Return unused medication to your pharmacist. This will help protect the environment.

6. Contents of the packaging and additional information

Composition of Revlimid

Revlimid 2.5 mg hard capsules:

The active ingredient is lenalidomide. Each capsule contains 2.5 mg of lenalidomide.
The other components are:

Fill: 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).
Ink: shellac, propylene glycol (E1520), potassium hydroxide and black iron oxide (E172).

Revlimid 5 mg hard capsules:

The active ingredient is lenalidomide. Each capsule contains 5 mg of lenalidomide.
The other components are:

Fill: anhydrous lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
Capsule shell: gelatin and titanium dioxide (E171).
Ink: shellac, propylene glycol (E1520), potassium hydroxide and black iron oxide (E172).

Revlimid 7.5 mg hard capsules:

The active ingredient is lenalidomide. Each capsule contains 7.5 mg of lenalidomide.
The other components are:

Fill: anhydrous lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
Capsule shell: gelatin, titanium dioxide (E171) and yellow iron oxide (E172).
Ink: shellac, propylene glycol (E1520), potassium hydroxide and black iron oxide (E172).

Revlimid 10 mg hard capsules:

The active ingredient is lenalidomide. Each capsule contains 10 mg of lenalidomide.
The other components are:

Fill: 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).
Ink: shellac, propylene glycol (E1520), potassium hydroxide and black iron oxide (E172).

Revlimid 15 mg hard capsules:

The active ingredient is lenalidomide. Each capsule contains 15 mg of lenalidomide.
The other components are:

Fill: anhydrous lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
Capsule shell: gelatin, titanium dioxide (E171) and indigo carmine (E132).
Ink: shellac, propylene glycol (E1520), potassium hydroxide and black iron oxide (E172).

Revlimid 20 mg hard capsules:

The active ingredient is lenalidomide. Each capsule contains 20 mg of lenalidomide.
The other components are:

Fill: 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).
Ink: shellac, propylene glycol (E1520), potassium hydroxide and black iron oxide (E172).

Revlimid 25 mg hard capsules:

The active ingredient is lenalidomide. Each capsule contains 25 mg of lenalidomide.
The other components are:

Fill: anhydrous lactose (see section 2), microcrystalline cellulose, sodium croscarmellose and magnesium stearate.
Capsule shell: gelatin and titanium dioxide (E171).
Ink: shellac, propylene glycol (E1520), potassium hydroxide and black iron oxide (E172).

Appearance of the product and contents of the pack:

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