Package Leaflet: Information for the Patient
Lenalidomide Sandoz, 25 mg, Hard Capsules
Lenalidomide
Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
- Keep this leaflet, you may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medication has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.
Table of Contents of the Package Leaflet
- 1. What is Lenalidomide Sandoz and what is it used for
- 2. Important information before taking Lenalidomide Sandoz
- 3. How to take Lenalidomide Sandoz
- 4. Possible side effects
- 5. How to store Lenalidomide Sandoz
- 6. Contents of the pack and other information
1. What is Lenalidomide Sandoz and what is it used for
What is Lenalidomide Sandoz
Lenalidomide Sandoz contains the active substance lenalidomide and belongs to a group of medicines that affect the immune system.
What is Lenalidomide Sandoz used for
Lenalidomide Sandoz is used in adults for the treatment of:
- multiple myeloma,
- myelodysplastic syndromes,
- mantle cell lymphoma,
- follicular lymphoma.
Multiple Myeloma
Multiple myeloma is a type of cancer that arises from the proliferation of a certain type of white blood cell called plasma cells. These cells accumulate in the bone marrow and divide uncontrollably. This can lead to bone and kidney damage. Multiple myeloma is generally incurable. However, it is possible to achieve significant temporary relief or removal of disease symptoms. This condition is called "remission". Newly diagnosed multiple myeloma - in patients who have undergone bone marrow transplantation Lenalidomide Sandoz is used as maintenance therapy in patients who have achieved a satisfactory condition after bone marrow transplantation. Newly diagnosed multiple myeloma - in patients who are not eligible for bone marrow transplantation Lenalidomide Sandoz is taken with other medications, including:
- a chemotherapy drug called "bortezomib"
- an anti-inflammatory drug called "dexamethasone"
- a chemotherapy drug called "melphalan" and
- an immunosuppressive drug called "prednisone".
The patient starts treatment by taking Lenalidomide Sandoz with additional medications, and then continues treatment with Lenalidomide Sandoz alone. If the patient is 75 years of age or older, or has moderate or severe kidney function impairment, the doctor will perform thorough tests before starting Lenalidomide Sandoz. Multiple myeloma - in patients receiving previous treatment Lenalidomide Sandoz is taken with the anti-inflammatory drug dexamethasone. Lenalidomide Sandoz may prevent the worsening of multiple myeloma symptoms. 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 disorders. Abnormal blood cells are present that do not function properly. Patients may experience various subjective and objective symptoms, including a low red blood cell count (anemia), the need for blood transfusions, and an increased risk of infections. Lenalidomide Sandoz is used alone in the treatment of adult patients with MDS, provided that all of the following conditions are met:
- the patient has a low red blood cell count and requires 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 received other treatments that have been ineffective or insufficient.
Taking Lenalidomide Sandoz 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 part 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 Sandoz is used alone in the treatment of adult patients who have previously received other medications.
Follicular Lymphoma (FL)
Follicular lymphoma is a slow-growing malignant tumor that affects B lymphocytes. It is a type of white blood cell that helps the body fight infections. In patients with follicular lymphoma, there may be an accumulation of too many B lymphocytes in the blood, bone marrow, lymph nodes, and spleen. Lenalidomide Sandoz is taken with another drug called "rituximab" in the treatment of adult patients with previously treated follicular lymphoma.
How Lenalidomide Sandoz works
The drug works by affecting the immune system and directly attacking cancer cells. Its mechanism of action includes:
- inhibiting the growth of cancer cells
- inhibiting the formation of blood vessels in the tumor
- stimulating part of the immune system to attack cancer cells.
2. Important information before taking Lenalidomide Sandoz
Before starting treatment with Lenalidomide Sandoz, read the package leaflets of all medicinal products taken in combination with Lenalidomide Sandoz.
When not to take Lenalidomide Sandoz
If any of the above situations apply to you, do not take Lenalidomide Sandoz. If in doubt, consult your doctor.
Warnings and precautions
Before taking Lenalidomide Sandoz, discuss with your doctor, pharmacist, or nurse if:
- you have had blood clots in the past, as 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 had a viral infection, especially hepatitis B virus, varicella-zoster virus, or HIV. If in doubt, consult your doctor. Taking Lenalidomide Sandoz may cause the virus to reactivate, leading to a recurrence of the infection. Your doctor should check if you have had hepatitis B virus.
- you have kidney function impairment - your doctor may adjust your dose of Lenalidomide Sandoz
- you have had a heart attack, had a blood clot, smoke, have high blood pressure, or high cholesterol levels
- you have had an allergic reaction after taking thalidomide (another drug used to treat multiple myeloma), such as rash, itching, swelling, dizziness, or difficulty breathing
- you have had a combination of any of the following symptoms in the past: widespread rash, redness of the skin, high body temperature, flu-like symptoms, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes - these are symptoms of a severe skin reaction called drug rash 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 situations apply to you, tell your doctor, pharmacist, or nurse before starting treatment. You should immediately consult your doctor, pharmacist, or nurse if you experience any of the following at any time during or after treatment:
- vision disturbances, loss of vision, or double vision, difficulty speaking, weakness of the arm or leg, change in gait, 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 you have had such symptoms before treatment with lenalidomide, inform your doctor of 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 examinationsBefore starting treatment with Lenalidomide Sandoz and during treatment, you will undergo regular blood tests, as this drug may cause a decrease in the number of blood cells that help fight infection (white blood cells) and those that help blood clot (platelets). Your doctor will order blood tests:
- before treatment
- every week for the first 8 weeks of treatment
- then at least once a month.
Patients with MDS taking Lenalidomide Sandoz If you have myelodysplastic syndromes, there is an increased risk of developing a severe disease called acute myeloid leukemia. Additionally, it is not known how Lenalidomide Sandoz affects the likelihood of developing acute myeloid leukemia. Therefore, your doctor may perform tests and check for symptoms that can help predict the risk of acute myeloid leukemia during treatment with Lenalidomide Sandoz. Patients with MCL taking Lenalidomide Sandoz Your doctor will ask you to have 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 follicular lymphoma taking Lenalidomide Sandoz Your doctor will ask you to have 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.
Before starting treatment with lenalidomide and during treatment, you may undergo an assessment for circulation and respiratory problems. Your doctor may perform a test to check if you have a large amount of tumor tissue in your body, including in the bone marrow. This can lead to a condition where the tumor tissue breaks down, causing an abnormal increase in the levels of various chemicals in the blood and potentially leading to kidney failure (a condition called "tumor lysis syndrome"). Your doctor may examine your skin to check for changes, such as red spots or rash. Your doctor may adjust your dose of Lenalidomide Sandoz or interrupt treatment based on your blood test results and overall condition. If the disease has been recently diagnosed, your doctor may also assess treatment taking into account your age and other conditions you have.
Blood donation
Do not donate blood during treatment and for at least 7 days after treatment has stopped.
Children and adolescents
Lenalidomide Sandoz is not recommended for use in children and adolescents under 18 years of age.
Elderly and patients with kidney function impairment
If you are 75 years of age or older, or have moderate or severe kidney function impairment, your doctor will perform thorough tests before starting treatment.
Lenalidomide Sandoz and other medicines
Tell your doctor or nurse about all medicines you are taking, or have recently taken, as Lenalidomide Sandoz and some other medicines may affect each other's action. In particular, tell your doctor or nurse if you are taking:
- certain contraceptives, such as oral contraceptives, as they may lose their effectiveness
- certain heart medications, such as digoxin
- certain blood-thinning medications, such as warfarin
Pregnancy, breastfeeding, and contraception - information for women and men
PregnancyInformation for women taking Lenalidomide Sandoz
- Do not take Lenalidomide Sandoz if you are pregnant, as it may harm the fetus.
- Women of childbearing age must not become pregnant while taking Lenalidomide Sandoz. Therefore, women of childbearing age must use effective methods of contraception (see "Contraception").
- If you become pregnant while taking Lenalidomide Sandoz, you must stop treatment immediately and inform your doctor.
Information for men taking Lenalidomide Sandoz
- If your partner becomes pregnant, you must immediately inform your doctor. It is recommended that your partner consult a doctor.
- You must also use effective contraception (see "Contraception").
BreastfeedingDo not breastfeed while taking Lenalidomide Sandoz, as it is not known whether it passes into breast milk. ContraceptionInformation for women taking Lenalidomide Sandoz Before starting treatment, you should ask your doctor if you can become pregnant, even if you think it is unlikely. If you are of childbearing age:
- you will have pregnancy tests under medical supervision (before each treatment, at least every 4 weeks during treatment, and at least 4 weeks after treatment has stopped), unless your doctor confirms that your fallopian tubes have been cut and blocked to prevent eggs from reaching the uterus (tubal sterilization) AND
- you must use effective methods of contraception for at least 4 weeks before starting treatment, during treatment, and for at least 4 weeks after treatment has stopped. Your doctor will recommend suitable contraceptive methods.
Information for men taking Lenalidomide Sandoz Lenalidomide Sandoz passes into human semen. If your partner is pregnant or may become pregnant and is not using effective contraception, you must use condoms during treatment and for at least 7 days after treatment has stopped, even if you have had a vasectomy. During treatment and for at least 7 days after treatment has stopped, you must not donate sperm or semen.
Driving and using machines
If you experience dizziness, fatigue, drowsiness, a feeling of spinning, or blurred vision after taking Lenalidomide Sandoz, do not drive or operate machinery.
Lenalidomide Sandoz contains lactose and sodium
If you have been told that you have an intolerance to some sugars, consult your doctor before taking this medicine. The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially "sodium-free".
3. How to take Lenalidomide Sandoz
Lenalidomide Sandoz must be administered by a healthcare professional with experience in the treatment of multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma, or follicular lymphoma.
- If Lenalidomide Sandoz is used to treat multiple myeloma in patients who are not eligible for bone marrow transplantation or have received previous treatment, the drug is taken with other medications (see section 1 "What is Lenalidomide Sandoz used for").
- If Lenalidomide Sandoz is used to treat multiple myeloma in patients who have undergone bone marrow transplantation or to treat myelodysplastic syndromes or mantle cell lymphoma, the drug is used alone (as monotherapy).
- If Lenalidomide Sandoz is used to treat follicular lymphoma, it is taken with another drug called "rituximab".
Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist. If you are taking Lenalidomide Sandoz with other medications, you should read the package leaflets of these medications to learn about their use and action.
Treatment cycle
Lenalidomide Sandoz is taken on specific days during a 3-week period (21 days).
- Each 21-day period is called a "treatment cycle".
- Depending on the day of the cycle, you will take one or more medications. However, on some days, you will not take any medication.
- After completing each 21-day cycle, you should start a new 21-day cycle. OR Lenalidomide Sandoz is taken on specific days for 4 weeks (28 days).
- Each 28-day period is called a "treatment cycle".
- Depending on the day of the cycle, you will take one or more medications. However, on some days, you will not take any medication.
- After completing each 28-day cycle, you should start a new 28-day cycle.
How much Lenalidomide Sandoz to take
Before starting treatment, your doctor will inform you:
- how much Lenalidomide Sandoz to take
- how many other medications (if any) to take with Lenalidomide Sandoz
- on which days of the cycle to take each of these medications.
How and when to take Lenalidomide Sandoz
- Swallow the capsule whole, preferably with water.
- Do not break, open, or chew the capsule. If the powder from a damaged Lenalidomide Sandoz capsule comes into contact with your skin, wash the area thoroughly 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 your hands thoroughly with soap and water. Pregnant or potentially pregnant women should not handle the blister or capsule.
- The capsules can be taken with or without food.
- Take the medication at the designated times, approximately at the same time each day.
Taking this medication
To remove the capsule from the blister:
- press the capsule only on one side and push it through the foil
- do not press on the center of the capsule, as this may damage it.
Duration of treatment with Lenalidomide Sandoz
Lenalidomide Sandoz is used in treatment cycles, each lasting 21 or 28 days (see above "Treatment cycle"). Treatment should be continued until your doctor decides to stop it.
Taking more Lenalidomide Sandoz than prescribed
If you take more capsules than you should, contact your doctor immediately.
Missing a dose of Lenalidomide Sandoz
If you forget to take Lenalidomide Sandoz at the usual time:
- and it has been less than 12 hours since then, take the capsule as soon as possible
- and it has been more than 12 hours since then, do not take the missed capsule. Take the next dose at the usual time the next day.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Lenalidomide Sandoz can cause side effects, although not everybody gets them.
If you experience any of the following serious side effects, stop taking Lenalidomide Sandoz and contact your doctor immediately - you may need urgent medical attention:
- hives, rash, swelling of the eyes, lips, or face, difficulty breathing, or itching, which may be symptoms of severe allergic reactions called angioedema and anaphylactic reaction
severe allergic reaction that can start as a rash in one area of the body and spread to the entire body, accompanied by a significant loss of skin (Stevens-Johnson syndrome and/or toxic epidermal necrolysis)
- widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other organs (drug rash with eosinophilia and systemic symptoms, also known as "DRESS" or "drug hypersensitivity syndrome"). See also section 2.
Tell your doctor immediately if you experience any of the following serious 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 Sandoz may cause a decrease in the number of white blood cells that fight infection and platelets that help blood clot, which can lead to bleeding disorders, such as nosebleeds and bruising. Lenalidomide Sandoz may also cause the formation of blood clots in veins (thrombosis).
Other side effects
In a small number of patients, another type of cancer may develop, and it is possible that the risk of its development is increased during treatment with Lenalidomide Sandoz. Therefore, before prescribing this medicine, your doctor will carefully weigh the benefits and risks of treatment. Very commonside effects (may affect more than 1 in 10 people)
- decrease in red blood cell count, 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
- fever, flu-like symptoms, including fever, muscle pain, headache, ear pain, cough, and chills
- numbness, tingling, or burning sensation of the skin, tingling of the hands or feet, dizziness, tremors
- decreased appetite, changes in taste
- increased pain, increased tumor size, 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
- cloudy vision (cataract)
- kidney problems, including abnormal kidney function or inability to maintain normal kidney function
- abnormal liver test results
- increased liver enzyme values
- 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)- breakdown 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 produced by the breakdown of red and abnormal blood cells
- increased levels of a protein that indicates inflammation in the body
- darkening of the skin, discoloration of the skin due to bleeding, usually caused by bruising
- increased levels of uric acid in the blood
- skin rashes, redness of the skin, peeling, cracking, or shedding of the skin, hives
- excessive sweating, night sweats
- difficulty swallowing, sore throat, voice changes, or hoarseness
- 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 sign of heart failure)
- erectile dysfunction
- stroke, fainting, dizziness (inner ear disturbances that cause a feeling of spinning), 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 cause injury
Uncommonside effects (may affect up to 1 in 100 people)
- bleeding in the brain
- circulatory disorders
- loss of vision
- loss of sex drive
- passing large amounts of urine with accompanying bone pain and weakness - these may be symptoms of kidney function disorders (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 inflammation of the colon (colitis or proctitis)
- kidney cell damage (renal 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, phosphate, uric acid, and low levels of calcium, leading to kidney function disorders, heart rhythm disturbances, seizures, and sometimes death
- high blood pressure in the blood vessels that supply the lungs (pulmonary hypertension)
Rareside effects (may affect up to 1 in 1,000 people)
- sudden or mild but worsening abdominal pain and/or back pain that persists for several days and may be accompanied by nausea, vomiting, fever, and rapid heartbeat. These symptoms may be caused by pancreatitis
- wheezing, shortness of breath, or dry cough - these may be symptoms of inflammation of the lung tissue
- observed rare cases of muscle breakdown (muscle pain, weakness, or swelling) that can lead to kidney function disorders (rhabdomyolysis), some of which occurred when lenalidomide was administered with a statin (a cholesterol-lowering medication)
- 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 severe infection. Tell your doctor if you experience severe abdominal pain, fever, nausea, vomiting, blood in the stool, or changes in bowel movements
- viral infections, including varicella-zoster virus (a viral disease that causes a painful rash with blisters) and hepatitis B virus reactivation (which can cause yellowing of the skin and eyes, dark urine, abdominal pain, fever, nausea, or vomiting)
- rejection of a transplanted organ (such as a kidney, heart)
Reporting side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: 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 Sandoz
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the month stated. There are no special storage precautions. Do not use this medicine if it is damaged or if the packaging is broken. 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 Sandoz contains
- The active substance is lenalidomide. One capsule contains 25 mg of lenalidomide.
- The other ingredients are lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate. Capusle shell:gelatin and titanium dioxide (E171) Printing ink: shellac, propylene glycol, potassium hydroxide, iron oxide black (E172).
What Lenalidomide Sandoz looks like and contents of the pack
The capsule is white, matte, with a white, matte body and white, matte cap, approximately 21.7 mm in length, marked with "L9NL" and "25". The hard capsules are packaged in blisters of OPA/Aluminum/PVC/Aluminum foil. Pack sizes: blisters of OPA/Aluminum/PVC/Aluminum foil: packs containing 21 hard capsules. Single-dose blisters of OPA/Aluminum/PVC/Aluminum foil: packs containing 21 x 1 hard capsule.
Marketing authorization holder
Sandoz GmbH Biochemiestrasse 10 6250 Kundl, Austria
Manufacturer/Importer
Synthon Hispania, S.L. C/ Castelló no1, Pol. Las Salinas Sant Boi de Llobregat 08830 Barcelona, Spain Synthon BV Microweg 22 6545 CM Nijmegen, Netherlands Salutas Pharma GmbH Otto-von-Guericke-Allee 1 39179 Barleben, Germany
For further information on this medicine, including its names in the Member States of the European Economic Area, please contact:
Sandoz Polska Sp. z o.o. ul. Domaniewska 50 C 02-672 Warszawa tel. 22 209 70 00 Date of last revision of the leaflet:06/2023 Sandoz logo