Lenalidomide Mylan 5 mg hard capsules EFG: detailed information

Patient Information Leaflet

Introduction

Patient Information Leaflet

Lenalidomida Mylan 2.5 mg hard capsules EFG

Lenalidomida Mylan 5 mg hard capsules EFG

Lenalidomida Mylan 7.5 mg hard capsules EFG

Lenalidomida Mylan 10 mg hard capsules EFG

Lenalidomida Mylan 15 mg hard capsules EFG

Lenalidomida Mylan 20 mg hard capsules EFG

Lenalidomida Mylan 25 mg hard capsules EFG

lenalidomide

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

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only; do not give it to others, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

What Lenalidomida Mylan is and what it is used for
What you need to know before taking Lenalidomida Mylan
How to take Lenalidomida Mylan
Possible side effects
How to store Lenalidomida Mylan
Contents of the pack and other information

1. What Lenalidomida Mylan is and what it is used for

Lenalidomida Mylan contains the active substance "lenalidomide". This medicine belongs to a group of medicines that affect how the immune system works.

Lenalidomida Mylan 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 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 incurable. However, signs and symptoms can be greatly reduced or may disappear for a period of time. This is known as "remission".

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

Lenalidomida Mylan 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

Lenalidomida Mylan is taken together 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 Lenalidomida Mylan 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

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

Lenalidomida Mylan 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 disorders. 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), need for blood transfusions, and risk of infection.

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

you require regular blood transfusions to treat low red blood cell levels ("transfusion-dependent anaemia");
you have an abnormality in the bone marrow cells called "isolated deletion 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.

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

this may reduce the need for blood transfusions. Transfusions may no longer be needed.

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.

Lenalidomida Mylan 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.

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

How Lenalidomida Mylan works

Lenalidomida Mylan 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 inhibits 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 Lenalidomida Mylan

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

Do not take Lenalidomida Mylan

if you are pregnant, think you might be pregnant, or intend to become pregnant, as Lenalidomida Mylan is expected to be harmful to the unborn baby (see section 2, “Pregnancy, breastfeeding and contraception: information for women and men”);
if you are capable of becoming pregnant, unless you follow all necessary measures to prevent pregnancy (see section 2, “Pregnacy, breastfeeding and contraception: information for women and men”). If you are capable of becoming pregnant, your doctor will document 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 Lenalidomida Mylan. If in doubt, consult your doctor.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting Lenalidomida Mylan if:

you have ever had blood clots; during treatment, your risk of developing blood clots in veins and arteries is increased;
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 Lenalidomida Mylan may cause the virus to become active again in patients who carry the virus, leading to reactivation 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 Lenalidomida Mylan;
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 taking 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 (these are signs of a serious skin reaction called drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome 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, double vision, difficulty speaking, weakness in one arm or leg, change in walking pattern 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 treatment with lenalidomide, inform your doctor if you notice any changes in these symptoms.
shortness of breath, fatigue, dizziness, chest pain, faster heartbeat, or swelling in the legs or ankles. These may be symptoms of a serious condition known as pulmonary hypertension (see section 4).

Blood tests and monitoring

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

Your doctor will ask you to have blood tests:

before starting treatment;
every week during the first 8 weeks of treatment;
thereafter, at least once a month.

You may be evaluated for signs of cardiopulmonary problems before and during treatment with lenalidomide.

For patients with MDS taking Lenalidomida Mylan

If you have MDS, you may be more likely to develop a more advanced disease called acute myeloid leukaemia (AML). In addition, it is unknown how lenalidomide affects the risk of developing AML. Therefore, your doctor may perform blood tests to detect signs that could better predict the likelihood of developing AML during treatment with Lenalidomida Mylan.

For patients with MCL taking Lenalidomida Mylan

Your doctor will ask you to have blood tests:

before starting treatment;
every week during the first 8 weeks (2 cycles) of treatment;
thereafter, every 2 weeks during cycles 3 and 4 (see section 3 “Treatment cycle” for more information);
after this, at the beginning of each cycle;
at least once a month.

For patients with FL taking Lenalidomida Mylan

Your doctor will ask you to have blood tests:

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

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

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

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

Blood donation

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

Children and adolescents

Lenalidomida Mylan 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 Lenalidomida Mylan

Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines.

This is because Lenalidomida Mylan may affect how other medicines work. In addition, some medicines may affect how Lenalidomida Mylan 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 conditions, 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 Lenalidomida Mylan

You must not take Lenalidomida Mylan if you are pregnant, as it is expected to be harmful to the unborn baby.
You must not become pregnant while taking Lenalidomida Mylan. 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 Lenalidomida Mylan, you must stop treatment and inform your doctor immediately.

Men taking Lenalidomida Mylan

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

Breastfeeding

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

Contraception

For women taking Lenalidomida Mylan

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

If you are capable of becoming pregnant:

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

And

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

For men taking Lenalidomida Mylan

Lenalidomida Mylan is present in 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 stopping treatment, even if you have had a vasectomy.

Driving and use of machines

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

Lenalidomida Mylan contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule: that is, essentially “sodium-free”.

3. How to take Lenalidomida Mylan

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

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

Always follow exactly the dosing instructions for Lenalidomida Mylan provided by your doctor. If in doubt, consult your doctor or pharmacist.

If you are taking Lenalidomida Mylan together with other medicines, you should read the package leaflet of those other medicines for additional information about their use and side effects.

Treatment cycle

Lenalidomida Mylan is taken on certain days within a 3-week period (21 days).

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.

Lenalidomida Mylan is taken on certain days within a 4-week period (28 days).

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 Lenalidomida Mylan to take

Before starting treatment, your doctor will inform you:

of the dose of Lenalidomida Mylan you should take;
of the dose of any other medicines you should take together with Lenalidomida Mylan, if applicable;
on which days of the treatment cycle you should take each medicine.

How and when to take Lenalidomida Mylan

Swallow the capsules whole, preferably with water.
Do not break, open, or chew the capsules. If the powder from a broken Lenalidomida Mylan capsule comes into contact with the skin, wash the skin immediately and thoroughly with soap and water.
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 into a sealed polyethylene plastic bag, and disposed of according to local requirements. Hands should then be washed thoroughly with soap and water. 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 Lenalidomida Mylan at approximately the same time each scheduled day.

How to take this medicine

To remove the capsule from the blister:

A finger pressing the button of an oval medical device with a grey and white section to activate the mechanism

Press only one end of the capsule so it comes through the foil.

Line drawing of a hand pressing the thumb on a bicolored capsule

Do not press in the center of the capsule, as this may break it.

Technical drawing showing two steps for the

Duration of treatment with Lenalidomida Mylan

Lenalidomida Mylan 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 treatment.

If you take more Lenalidomida Mylan than you should

If you take more Lenalidomida Mylan than prescribed, inform your doctor immediately.

If you forget to take Lenalidomida Mylan

If you forget to take your usual dose of Lenalidomida Mylan:

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

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

4. Possible adverse effects

Like all medicines, Lenalidomida Mylan can cause adverse effects, although not everyone experiences them.

If you experience any of the following serious adverse effects, stop treatment with Lenalidomida Mylan and seek immediate medical attention, as you may require urgent medical treatment:

Hives, rashes, swelling of the eyes, mouth or face, difficulty breathing or itching, which may be symptoms of severe allergic reactions called angioedema and anaphylactic reaction.
Severe allergic reaction that may start as a rash in one area but spreads, causing significant 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 syndrome 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 signs of infection, including in the bloodstream (sepsis).
Bleeding or bruising not caused by injury.
Chest (thoracic) pain or leg pain.
Difficulty breathing.
Bone pain, muscle pain, confusion, or fatigue, which may be due to high levels of calcium in the blood.

Lenalidomida Mylan 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.

Lenalidomida Mylan may also cause blood clots in the 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 Lenalidomida Mylan. Therefore, your doctor must carefully evaluate the benefits and risks before prescribing Lenalidomida Mylan.

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

A decrease in the number of red blood cells, which may lead to anemia causing fatigue and weakness.
Skin 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, 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.
Increased pain, size, or redness around the tumor.
Weight loss.
Constipation, diarrhea, 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 symptoms 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 are unable to maintain normal function.
Abnormal liver function test results.
High values in liver function tests.
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 discomfort or malaise.
Painful inflammation of the mouth, dry mouth.
Dehydration.

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

Destruction of red blood cells (hemolytic anemia).
Certain types of skin tumors.
Bleeding from the gums, stomach, or intestines.
High 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 protein indicating inflammation in the body.
Darkening of the skin; skin color changes due to internal bleeding, usually caused by bruising; skin inflammation due to blood accumulation; bruising.
Increased uric acid levels in the blood.
Skin rashes, skin redness, cracked skin, skin peeling or flaking, hives.
Increased sweating, night sweats.
Difficulty swallowing, sore throat, difficulty maintaining voice quality or voice changes.
Runny nose.
Marked 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, dizziness (an inner ear disorder causing a sensation of spinning), temporary loss of consciousness.
Chest pain spreading to arms, neck, jaw, back, or stomach, accompanied by sweating, 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 the joints.
Slowed or blocked bile flow from the liver.
Low levels of phosphate or magnesium in the blood.
Difficulty speaking.
Liver damage.
Loss of balance, difficulty with movement.
Deafness, ringing in the ears (tinnitus).
Nerve pain, abnormal and unpleasant sensation, especially upon touch.
Excess iron in the body.
Thirst.
Confusion.
Toothache.
Falls that may cause injuries.

Uncommon (may affect up to 1 in 100 people):

Bleeding inside the skull.
Circulatory problems.
Increased blood pressure in the blood vessels supplying the lungs (pulmonary hypertension).
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, itchy skin, skin rash, stomach pain or swelling; these may be symptoms of liver damage (liver failure).
Stomach pain, abdominal swelling, or diarrhea, 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 color, sensitivity to sunlight.
Tumor lysis syndrome – metabolic complications may occur during cancer treatment and sometimes even without treatment. These complications arise from the breakdown products of dying tumor cells and may include: changes in blood chemistry, high levels of potassium, phosphate, and uric acid, and low calcium levels, leading to changes in kidney function and heart rhythm, seizures, and sometimes death.

Frequency not known (cannot be estimated from available data):

Sudden or mild pain that worsens in the upper abdomen and/or back lasting 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 sounds 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 which occurred when lenalidomide was administered with a statin (a type of medication to lower cholesterol).
A skin disease caused by inflammation of small blood vessels, accompanied by joint pain and fever (leukocytoclastic vasculitis).
Perforation of the stomach or intestinal wall. This may 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.
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 or 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 listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lenalidomida Mylan

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.
Do not store above 30°C.
Do not use this medicine if you notice any visible signs of deterioration or evidence of tampering.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lenalidomida Mylan

Lenalidomida Mylan 2.5 mg hard capsules:

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

? Capsule contents: pregelatinized maize starch, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, sodium stearyl fumarate.

? Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172) and indigo carmine (E132).

? Printing ink: shellac, propylene glycol (E1520), potassium hydroxide and black iron oxide (E172).

Lenalidomida Mylan 5 mg hard capsules:

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