Lenalidomide Teva

Leaflet accompanying the packaging: patient information

Lenalidomide Teva, 5 mg, hard capsules

Lenalidomide Teva, 10 mg, hard capsules

Lenalidomide Teva, 15 mg, hard capsules

Lenalidomide Teva, 25 mg, hard capsules

Lenalidomide

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Lenalidomide Teva and what is it used for
• 2. Important information before taking Lenalidomide Teva
• 3. How to take Lenalidomide Teva
• 4. Possible side effects
• 5. How to store Lenalidomide Teva
• 6. Contents of the pack and other information

1. What is Lenalidomide Teva and what is it used for

What is Lenalidomide Teva

Lenalidomide Teva contains the active substance "lenalidomide". This medicine belongs to a group of medicines that affect the immune system.

What is Lenalidomide Teva used for

Lenalidomide Teva is used in adult patients to treat:

• 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 cell called plasma cells. These cells accumulate in the bone marrow and undergo uncontrolled divisions. This can lead to bone and kidney damage.

In principle, multiple myeloma is incurable. However, it is possible to temporarily alleviate or eliminate the signs and symptoms of the disease. We call this "remission".

Newly diagnosed multiple myeloma - in patients after bone marrow transplantation

In this indication, Lenalidomide Teva is used without other medicines as maintenance treatment after achieving a suitable state after transplantation.

Newly diagnosed multiple myeloma - in patients who are not eligible for bone marrow transplantation treatment

Lenalidomide Teva is taken with other medicines, including:

• a chemotherapy medicine called "bortezomib";
• an anti-inflammatory medicine called "dexamethasone";
• a chemotherapy medicine called "melphalan" and
• a medicine that suppresses the immune system called "prednisone". The patient starts treatment with additional medicines and then continues with Lenalidomide Teva alone.

If the patient is 75 years old or older, or has moderate to severe kidney problems, the doctor will perform thorough tests before starting treatment.

Multiple myeloma - in patients who have received previous treatment

Lenalidomide Teva is taken in combination with an anti-inflammatory medicine called "dexamethasone".

Lenalidomide Teva may stop the progression of multiple myeloma symptoms and signs. It has also been shown to delay the recurrence of multiple myeloma after treatment.

Myelodysplastic syndromes (MDS)

Myelodysplastic syndromes (MDS) are a group of different blood and bone marrow diseases. Abnormal blood cells are present that do not function properly. Patients may experience various subjective and objective symptoms, including a low number of red blood cells (anemia), the need for blood transfusions, and the risk of infection.

Lenalidomide Teva is used as monotherapy in the treatment of adult patients with MDS, if all of the following conditions are met:

• the patient has a low number of red blood cells and needs regular blood transfusions ("transfusion-dependent anemia");
• the patient has a cytogenetic abnormality in bone marrow cells called "isolated deletion 5q". This means that the patient's body does not produce enough healthy blood cells;
• the patient has previously used other treatments that have proven to be ineffective or insufficient.

Taking Lenalidomide Teva may lead to an increase in the number of healthy blood cells produced by the body, by reducing the number of abnormal cells:

• this may lead to a reduction in the number of blood transfusions required. It is possible that transfusions will no longer be needed.

Mantle cell lymphoma (MCL)

MCL is a cancer of the immune system (lymphoid tissue). It affects a type of white blood cell called B lymphocytes or B cells. Mantle cell lymphoma is a disease characterized by uncontrolled growth of B lymphocytes, resulting in their accumulation in lymphoid tissue, bone marrow, or blood.

Lenalidomide Teva is used as monotherapy in the treatment of adult patients who have previously been treated with other medicines.

Follicular lymphoma (FL)

Follicular lymphoma (FL) is a slow-growing malignant cancer that affects B lymphocytes. It is a type of white blood cell that helps the body fight infections. In patients with FL, there may be an accumulation of too many B lymphocytes in the blood, bone marrow, lymph nodes, and spleen.

Lenalidomide Teva is taken with another medicine called "rituximab" in the treatment of adult patients with previously treated follicular lymphoma.

How Lenalidomide Teva works

Lenalidomide Teva works by affecting the immune system and directly attacking cancer cells. The medicine works in several different ways:

• by inhibiting the growth of cancer cells;
• by inhibiting the growth of blood vessels in the tumor;
• by stimulating part of the immune system to attack cancer cells.

2. Important information before taking Lenalidomide Teva

Before starting treatment with Lenalidomide Teva, read the leaflets of all medicines taken in combination with Lenalidomide Teva.

When not to take Lenalidomide Teva:

as Lenalidomide Teva is expected to be harmful to the unborn child(see section 2 "Pregnancy, breastfeeding, and contraception - information for women and men");

If any of these points apply to the patient, do not take Lenalidomide Teva. In case of doubts, consult a doctor.

Warnings and precautions

Before starting Lenalidomide Teva, discuss with your doctor, pharmacist, or nurse if:

• the patient has a history of blood clots - this means an increased risk of developing blood clots in veins and arteries during treatment;
• the patient has any symptoms of infection, such as cough or fever;
• the patient currently has or has had a viral infection, especially chickenpox and shingles, hepatitis B, HIV infection. In case of doubts, consult a doctor. Treatment with Lenalidomide Teva may cause the reactivation of viruses in patients who have been infected in the past, leading to the recurrence of the infection. The doctor will check if the patient has had hepatitis B in the past;
• the patient has kidney problems - the doctor may adjust the dose of Lenalidomide Teva;
• the patient has had a heart attack, has ever had a blood clot, smokes, has high blood pressure, or high cholesterol levels;
• the patient has had allergic reactions when taking thalidomide (another medicine used to treat multiple myeloma), such as rash, itching, swelling, dizziness, or difficulty breathing;
• the patient has had a combination of any of the following symptoms: widespread rash, redness of the skin, high body temperature, flu-like symptoms, elevated liver enzyme activity, blood abnormalities (eosinophilia), swollen lymph nodes
• these are symptoms of a severe skin reaction called drug reaction with eosinophilia and systemic symptoms (DRESS) or "drug hypersensitivity syndrome" (see also section 4 "Possible side effects").

If any of the above points apply to the patient, consult a doctor, pharmacist, or nurse.

Tell your doctor or nurse immediately if, at any time during or after treatment, the patient experiences:

• vision disturbances, loss of vision, or double vision, difficulty speaking, weakness in the arm or leg, change in walking or balance disturbances, persistent numbness, decreased sensation, or loss of sensation, memory loss, or disorientation. These may be symptoms of a severe and potentially life-threatening brain disease called progressive multifocal leukoencephalopathy (PML). If the patient had such symptoms before treatment with Lenalidomide Teva, they should inform their doctor about any changes;
• shortness of breath, fatigue, dizziness, chest pain, rapid heartbeat, or swelling of the feet or ankles. These may be symptoms of a severe condition called pulmonary hypertension (see section 4).

Tests and examinations

Before and during treatment with Lenalidomide Teva, the patient will undergo regular blood tests, as Lenalidomide Teva may cause a decrease in the number of blood cells that help fight infection (white blood cells) and help blood clot (platelets). The doctor will call the patient for blood tests:

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

Before starting lenalidomide treatment and during treatment, the patient may undergo an assessment for circulation and breathing problems.

Patients with MDS taking Lenalidomide Teva

If the patient has myelodysplastic syndromes, there is an increased chance of developing a severe disease called acute myeloid leukemia. Additionally, it is not known how Lenalidomide Teva affects the likelihood of developing acute myeloid leukemia. Therefore, the doctor may perform tests to check for signs that can better predict the risk of acute myeloid leukemia during treatment with Lenalidomide Teva.

Patients with MCL taking Lenalidomide Teva

The doctor will ask for a blood test:

• before treatment,
• every week for the first 8 weeks (2 cycles) of treatment,
• then every 2 weeks in cycles 3 and 4 (more information is provided in section 3 "Treatment cycle"),
• then at the beginning of each cycle and
• at least once a month.

Patients with FL taking Lenalidomide Teva

The doctor will ask for a blood test:

• before treatment,
• every week for the first 3 weeks (1 cycle) of treatment,
• then every 2 weeks in cycles 2 to 4 (more information is provided in section 3 "Treatment cycle"),
• then at the beginning of each cycle and
• at least once a month.

The doctor may perform a test to check if the patient has a large amount of tumor tissue in the body, including in the bone marrow. This can lead to a situation where the tumor tissue starts to die and causes abnormal growth of various substances in the blood, which can lead to kidney failure (a condition called tumor lysis syndrome).

The doctor may perform a test to check for skin changes, such as red spots or rash.

The doctor may change the dose of Lenalidomide Teva or stop treatment based on the results of the patient's blood tests and overall condition. If the disease is newly diagnosed, the doctor may also assess treatment based on the patient's age and other conditions that may have occurred in the past.

Blood donation

During treatment and for at least 7 days after stopping treatment, the patient must not donate blood.

Children and adolescents

Lenalidomide Teva is not recommended for children and adolescents under 18 years of age.

Elderly and patients with kidney problems

If the patient is 75 years old or older, or has moderate to severe kidney problems, the doctor will perform thorough tests before starting treatment.

Lenalidomide Teva and other medicines

Tell your doctor or nurse about all medicines the patient is taking, has recently taken, or might take. This is necessary because Lenalidomide Teva may affect the action of other medicines. Other medicines may also affect the action of Lenalidomide Teva.

In particular, inform your doctor or nurse if the patient is taking:

• certain contraceptives, such as oral contraceptives, as they may stop working;
• certain medicines for heart problems - such as digoxin;
• certain medicines for blood thinning - such as warfarin.

Pregnancy, breastfeeding, and contraception - information for women and men

Pregnancy

For women taking Lenalidomide Teva

• Do not take Lenalidomide Teva if pregnant, as it is expected to be harmful to the unborn child.
• Women must not become pregnant while taking Lenalidomide Teva. Therefore, women who can become pregnant must use effective contraception (see "Contraception").
• If the patient becomes pregnant during treatment with Lenalidomide Teva, she must stop treatment immediately and inform her doctor.

For men taking Lenalidomide Teva

• If the partner of a man taking Lenalidomide Teva becomes pregnant, she should inform her doctor immediately. The partner should seek medical advice.
• Men must also use effective contraception (see "Contraception").

Breastfeeding

Do not breastfeed while taking Lenalidomide Teva, as it is not known whether Lenalidomide Teva passes into human milk.

Contraception

Women taking Lenalidomide Teva

Before starting treatment, ask your doctor about the possibility of becoming pregnant, even if the patient thinks it is unlikely.

Women who can become pregnant:

• will have pregnancy tests performed under medical supervision (before each treatment, at least every 4 weeks during treatment, and at least 4 weeks after stopping treatment), except in cases where the fallopian tubes have been cut and blocked to prevent the egg from entering the uterus (tubal sterilization) AND
• must use effective contraception methods for at least 4 weeks before starting treatment, during treatment, and for at least 4 weeks after stopping treatment. The doctor will recommend the appropriate contraception methods to the patient.

Men taking Lenalidomide Teva

Lenalidomide Teva is present in human semen. If a woman is pregnant or may become pregnant and is not using effective contraception, her partner should use a condom during treatment and for at least 7 days after stopping treatment. This also applies to men who have had a vasectomy. During treatment and for at least 7 days after stopping treatment, the patient must not donate semen.

Driving and using machines

Do not drive or operate machinery if the patient experiences dizziness, fatigue, drowsiness, balance disturbances caused by dizziness, or blurred vision after taking Lenalidomide Teva.

Lenalidomide Teva contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially "sodium-free".

3. How to take Lenalidomide Teva

Lenalidomide Teva must be administered by medical personnel who have experience in treating multiple myeloma, MDS, MCL, or FL.

• When Lenalidomide Teva is used to treat multiple myeloma in patients who are not eligible for bone marrow transplantation or have received previous treatment, the medicine is taken with other medicines (see section 1 "What is Lenalidomide Teva used for").
• When Lenalidomide Teva is used to treat multiple myeloma in patients after bone marrow transplantation or to treat patients with MDS or MCL, the medicine is taken as monotherapy.
• When Lenalidomide Teva is used to treat follicular lymphoma, it is taken with another medicine called "rituximab".

Lenalidomide Teva should always be taken as directed by the doctor. In case of doubts, consult a doctor or pharmacist.

If the patient is taking Lenalidomide Teva with other medicines, they should read the leaflet accompanying the packaging of those medicines to learn about their use and effects.

Treatment cycle

Lenalidomide Teva is taken on specific days during a period of three weeks (21 days).

• Each 21-day period is called a treatment cycle.
• Depending on the day of the cycle, the patient will take one or more medicines. However, on some days, the patient will not take any medicines.
• After completing each 21-day cycle, the patient should start a new 21-day cycle. OR

Lenalidomide Teva is taken on specific days during a period of four weeks (28 days).

• Each 28-day period is called a treatment cycle.
• Depending on the day of the cycle, the patient will take one or more medicines. However, on some days, the patient will not take any medicines.
• After completing each 28-day cycle, the patient should start a new 28-day cycle.

Recommended dose of Lenalidomide Teva

Before starting treatment, the doctor will inform the patient:

• how much Lenalidomide Teva to take;
• how many other medicines to take in combination with Lenalidomide Teva, if other medicines are required;
• on which days of the cycle to take which medicines.

How and when to take Lenalidomide Teva

• Swallow the capsule whole, preferably with water.
• Do not break, open, or chew the capsules. If the powder from a damaged Lenalidomide Teva capsule comes into contact with the skin, wash the skin immediately with soap and water.
• Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister or capsule. The gloves should then be carefully removed to avoid skin exposure, placed in a sealed plastic bag, and disposed of in accordance with local regulations. Then, wash hands thoroughly with soap and water. Pregnant or potentially pregnant women should not touch the blister or capsule.
• The capsules can be taken with or without food.
• Lenalidomide Teva should be taken at approximately the same time every day, on the days when the product is scheduled to be taken.

Taking this medicine

To remove a capsule from the blister:

• press the capsule only from one side and push it through the foil;
• do not press the center of the capsule, as this may damage it.

Duration of treatment with Lenalidomide Teva

Lenalidomide Teva is used in treatment cycles; each cycle lasts 21 or 28 days (see above "Treatment cycle"). Treatment cycles should be continued until the doctor decides to stop treatment.

Taking more Lenalidomide Teva than prescribed

If more Lenalidomide Teva than prescribed is taken, inform the doctor immediately.

Missing a dose of Lenalidomide Teva

If a dose of Lenalidomide Teva is missed and

• less than 12 hours have passed since the scheduled time: take the capsule immediately;
• more than 12 hours have passed since the scheduled time: do not take the capsule. Take the next capsule at the scheduled time the next day.

In case of further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Lenalidomide Teva can cause side effects, although not everybody gets them.

If any of the following severe side effects occur, stop taking Lenalidomide Teva and consult a doctor immediately - immediate treatment may be necessary:

• hives, rash, swelling of the eyes, lips, or face, difficulty breathing, or itching, which may be symptoms of severe allergic reactions called angioedema and anaphylaxis;
• a severe allergic reaction that starts as a rash in one area and spreads to the whole body, accompanied by a high body temperature, elevated liver enzyme activity, 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");

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

• fever, chills, sore throat, cough, mouth sores, or any other signs of infection (including blood infections (sepsis));
• bleeding or bruising without injury;
• chest pain or leg pain;
• shortness of breath;
• bone pain, muscle weakness, feeling of confusion, or fatigue that may be due to high calcium levels in the blood.

Lenalidomide Teva may decrease the number of white blood cells that fight infection and the number of blood cells that help blood clot (platelets), which can lead to bleeding disorders, such as nosebleeds and bruising.

Lenalidomide Teva may also cause the formation of blood clots in the veins (thrombosis).

Other side effects

Note that in a small number of patients, Lenalidomide Teva may cause the development of other types of cancer, and it is possible that this risk may increase with treatment with Lenalidomide Teva. Therefore, the treating doctor should carefully weigh the benefits and risks when prescribing Lenalidomide Teva to a patient.

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

• decrease in the number of red blood cells, which may cause anemia leading to fatigue and weakness;
• rash, itching;
• muscle spasms, muscle weakness, muscle pain, muscle tenderness, bone pain, joint pain, back pain, limb pain;
• generalized swelling, including swelling of the hands and feet;
• weakness, fatigue;
• flu and flu-like symptoms, including fever, muscle pain, headache, ear pain, cough, and chills;
• numbness, tingling, or burning sensation of the skin, pain in the hands or feet, dizziness, tremors;
• decreased appetite, altered taste;
• increased pain, tumor growth, or redness around the tumor;
• weight loss;
• constipation, diarrhea, nausea, vomiting, abdominal pain, heartburn;
• low levels of potassium, calcium, or sodium in the blood;
• abnormal thyroid function;
• leg pain (which may be a sign of thrombosis), chest pain, or shortness of breath (which may be symptoms of blood clots in the lungs, called pulmonary embolism);
• all types of infections, including sinusitis, pneumonia, and upper respiratory tract infections;
• shortness of breath;
• blurred vision;
• blurred vision (cataract);
• kidney problems, including abnormal kidney function or inability to maintain normal kidney function;
• abnormal liver test results;
• increased liver enzyme activity;
• changes in blood proteins leading to blood vessel inflammation (vasculitis);
• increased blood sugar levels (diabetes);
• decreased blood sugar levels;
• headache;
• nosebleeds;
• dry skin;
• depression, mood changes, sleep disturbances;
• cough;
• low blood pressure;
• general feeling of discomfort, malaise;
• painful inflammation of the mouth, dry mouth;
• dehydration.

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

• red blood cell breakdown (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 produced by the breakdown of red blood cells;
• increased levels of a protein that indicates inflammation in the body;
• skin darkening; skin discoloration due to bleeding under the skin, usually caused by bruising; skin swelling filled with blood, bruising;
• increased levels of uric acid in the blood;
• skin rashes, redness of the skin, peeling, cracking, or flaking of the skin, hives;
• excessive sweating, night sweats;
• difficulty swallowing, sore throat, voice problems, or voice changes;
• runny nose (rhinitis);
• passing much more or much less urine than normal, or inability to control the timing of urination;
• passing blood in the urine;
• shortness of breath, especially when lying down (which may be a symptom of heart failure);
• erectile dysfunction;
• stroke, fainting, dizziness (inner ear disturbances that cause a feeling of spinning), transient loss of consciousness;
• chest pain radiating to the arms, neck, jaw, back, or abdomen, feeling of 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;
• joint swelling;
• slowing or blocking of bile flow from the liver;
• low levels of phosphate or magnesium in the blood;
• difficulty speaking;
• liver damage;
• balance disturbances, difficulty walking;
• hearing loss, ringing in the ears (tinnitus);
• nerve pain, unpleasant abnormal sensations, especially in response to touch;
• excessive iron in the body;
• thirst;
• feeling of confusion;
• toothache;
• fall that may lead to injury.

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

• bleeding in the brain;
• circulation problems;
• vision loss;
• loss of libido;
• passing large amounts of urine, with accompanying bone pain and weakness, which may be symptoms of kidney disease (Fanconi syndrome);
• yellowing of the skin, mucous membranes, or eyes (jaundice), pale stools, dark urine, itching of the skin, rash, pain, or swelling of the abdomen - these may be symptoms of liver damage (liver failure);
• abdominal pain, bloating, or diarrhea, which may be symptoms of colon inflammation (colitis);
• kidney cell damage (tubular necrosis);
• skin color changes, sensitivity to sunlight;
• tumor lysis syndrome - a complication of metabolism that can occur during cancer treatment, as well as sometimes without treatment. These complications are caused by the breakdown products of dying cancer cells and can include changes in blood chemistry; high levels of potassium, phosphorus, uric acid, and low levels of calcium, leading to kidney function disorders, heart rhythm disturbances, seizures, and sometimes death;
• increased blood pressure in the blood vessels that lead to the lungs (pulmonary hypertension).

Side effects with a frequency that cannot be estimated(frequency cannot be determined from available data):

• sudden or gradual, but worsening, pain in the upper abdomen and/or back, lasting for several days, usually accompanied by nausea, vomiting, fever, and rapid heartbeat - these symptoms may occur in connection with pancreatitis;
• wheezing, shortness of breath, or dry cough, which may be caused by lung inflammation;
• rare cases of muscle breakdown (pain, weakness, or swelling of the muscles) that can lead to kidney problems (rhabdomyolysis), some of which occurred when Lenalidomide Teva was taken with a statin (a type of cholesterol-lowering medicine);
• a skin disease caused by inflammation of small blood vessels, accompanied by joint pain and fever (leukocytoclastic vasculitis);
• rupture of the stomach or intestine wall, which can lead to a very severe infection. Inform your doctor if you experience severe stomach pain, fever, nausea, vomiting, blood in the stool, or changes in bowel function;
• viral infections, including chickenpox and shingles, and reactivation of hepatitis B virus infection (which can cause yellowing of the skin and eyes, dark urine, abdominal pain on the right side, fever, nausea, and vomiting);
• rejection of a transplanted solid organ (e.g., kidney, heart).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides.

Al. Jerozolimskie 181C, 02-222 Warsaw

Tel.: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lenalidomide Teva

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" or Expiry Date (EXP). The expiry date refers to the last day of the month stated.

There are no special storage instructions for this medicine.

Do not use this medicine if you notice any damage or signs of opening of the packaging.

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Lenalidomide Teva contains

• The active substance of Lenalidomide Teva is lenalidomide. Each capsule contains lenalidomide hydrochloride monohydrate, micronized, in an amount equivalent to 5 mg, 10 mg, 15 mg, or 25 mg of lenalidomide.
• Other ingredients are:
• capsule contents: silicon dioxide, anhydrous, microcrystalline cellulose, type 301, croscarmellose sodium, type A, talc,
• capsule shell: Lenalidomide Teva, 5 mg: gelatin, titanium dioxide (E171)

Lenalidomide Teva, 10 mg: gelatin, titanium dioxide (E171), yellow iron oxide (E172), indigo carmine (E132)

Lenalidomide Teva, 15 mg: gelatin, titanium dioxide (E171), indigo carmine (E132)

Lenalidomide Teva, 25 mg: gelatin, titanium dioxide (E171)

Ink for printing:

Shellac, propylene glycol (E1520), black iron oxide (E172), potassium hydroxide, and ammonium hydroxide, concentrated (E527).

What Lenalidomide Teva looks like and contents of the pack

Lenalidomide Teva, 5 mg, hard capsules, are non-transparent hard gelatin capsules, size 4 (approximately 14.3 mm in length), with black printing "5" on a white body and a white cap, containing powder or compressed powder that is white to light yellow or beige in color.

Lenalidomide Teva, 10 mg, hard capsules, are non-transparent hard gelatin capsules, size 2 (approximately 18 mm in length), with black printing "10" on an ivory-colored body and a green cap, containing powder or compressed powder that is white to light yellow or beige in color.

Lenalidomide Teva, 15 mg, hard capsules, are non-transparent hard gelatin capsules, size 1 (approximately 19.4 mm in length), with black printing "15" on a white body and a blue cap, containing powder or compressed powder that is white to light yellow or beige in color.

Lenalidomide Teva, 25 mg, hard capsules, are non-transparent hard gelatin capsules, size 0 (approximately 21.7 mm in length), with black printing "25" on a white body and a white cap, containing powder or compressed powder that is white to light yellow or beige in color.

Package sizes

Lenalidomide Teva, 5 mg, 10 mg, 15 mg, is available in blisters containing 7, 21, or 63 hard capsules, and in single-dose blisters containing 7 x 1, 21 x 1, or 63 x 1 hard capsules.

Lenalidomide Teva, 25 mg, is available in blisters containing 21 or 63 hard capsules, and in single-dose blisters containing 21 x 1 or 63 x 1 hard capsules.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Manufacturer

Pliva Hrvatska d.o.o.

Prilaz baruna Filipovića 25

10000, Zagreb, Croatia

Merckle GmbH,

Ludwig-Merckle-Strasse 3

89143 Blaubeuren

Germany

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80

31-546 Kraków

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Greece

Lenalidomide/Teva

Poland

Lenalidomide Teva

Romania

Lenalidomidă TEVA 5 mg, 10 mg, 15 mg, 20 mg, capsule

For further information on this medicine, please contact the marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o.

ul. Emilii Plater 53

00-113 Warsaw

tel. (22) 345 93 00

Date of last revision of the leaflet:February 2024