Lenalidomide Sandoz

Leaflet accompanying the packaging: patient information

Lenalidomide Sandoz, 5 mg, hard capsules

Lenalidomide

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a 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 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 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 packaging 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 to treat:

• multiple myeloma,
• myelodysplastic syndromes,
• mantle cell lymphoma,
• follicular lymphoma.

Multiple myeloma

Multiple myeloma is a type of cancer that occurs when a certain type of white blood cell, called plasma cells, grow out of control. 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 symptoms. This condition is called "remission". Newly diagnosed multiple myeloma - in patients who have undergone bone marrow transplantation Lenalidomide Sandoz is used alone as maintenance treatment in patients who have achieved a suitable 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 medicines, including:

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

The patient starts treatment by taking Lenalidomide Sandoz with additional medicines, 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 who have received previous treatment Lenalidomide Sandoz is taken with the anti-inflammatory medicine dexamethasone. Lenalidomide Sandoz may delay 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 to treat adult patients with MDS, if all of the following conditions are met:

• the patient has a low red blood cell count and needs regular blood transfusions ("transfusion-dependent anemia")
• the patient has a genetic abnormality in bone marrow cells called "isolated cytogenetic deletion 5q". This means that the patient's body does not produce enough healthy blood cells
• the patient has previously received other treatments that were not suitable or effective.

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 decrease 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 (lymph 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 lymph tissue, bone marrow, or blood. Lenalidomide Sandoz is used alone to treat adult patients who have previously received other medicines.

Follicular lymphoma (FL)

Follicular lymphoma 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 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 medicine called "rituximab" to treat adult patients with previously treated follicular lymphoma.

How Lenalidomide Sandoz works

The medicine 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 leaflets of all medicines taken in combination with Lenalidomide Sandoz.

When not to take Lenalidomide Sandoz

as Lenalidomide Sandoz may harm the fetus(see "Pregnancy, breastfeeding, and contraception - information for women and men" in section 2)

If any of the above situations apply to the patient, they should not take Lenalidomide Sandoz. In case of doubts, consult a doctor.

Warnings and precautions

Before taking Lenalidomide Sandoz, discuss with a doctor, pharmacist, or nurse if:

• the patient has a history of blood clots, as they have an increased risk of developing blood clots in veins and arteries
• the patient has any symptoms of infection, such as cough or fever
• the patient has or has had a viral infection, especially hepatitis B virus, chickenpox, and shingles. In case of doubts, consult a doctor. Taking Lenalidomide Sandoz may cause the virus to reactivate, leading to a recurrence of the infection. The doctor should check if the patient has had hepatitis B.
• the patient has kidney function impairment - the doctor may adjust the dose of Lenalidomide Sandoz
• the patient has had a heart attack, has had a blood clot, smokes, has high blood pressure, or high cholesterol levels
• the patient has had an allergic reaction to thalidomide (another medicine used to treat multiple myeloma), such as a rash, itching, swelling, dizziness, or difficulty breathing
• the patient has had a combination of any of the following symptoms in the past: widespread rash, skin redness, 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 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 the patient, they should tell their doctor, pharmacist, or nurse before starting treatment.

Tests and examinations

Before starting and during treatment with Lenalidomide Sandoz, the patient will undergo regular blood tests, as this medicine may cause a decrease in the number of blood cells that help fight infection (white blood cells) and those that help blood clot (platelets). The 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 the patient has 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 risk of developing acute myeloid leukemia. Therefore, the doctor may perform tests to better predict the risk of acute myeloid leukemia during treatment with Lenalidomide Sandoz.

Blood donation

Do not donate blood during and for at least 7 days after treatment.

Children and adolescents

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

Elderly and patients with kidney function impairment

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 treatment.

Lenalidomide Sandoz and other medicines

Tell the doctor or nurse about all medicines the patient is taking, as Lenalidomide Sandoz and some other medicines may affect each other's action. In particular, tell the doctor or nurse if the patient is taking any of the following medicines or products:

• certain contraceptives, such as oral contraceptives, as they may lose their effectiveness
• certain medicines for heart conditions, such as digoxin
• certain medicines to thin the blood, such as warfarin.

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

Pregnancy

• Do not take Lenalidomide Sandoz if pregnant, as it may harm the fetus.
• Women of childbearing age must not become pregnant while taking Lenalidomide Sandoz. Therefore, they must use effective methods of contraception (see "Contraception").
• If the patient becomes pregnant while taking Lenalidomide Sandoz, they must stop treatment immediately and inform their doctor.

Men taking Lenalidomide Sandoz

• If the partner of a man taking Lenalidomide Sandoz becomes pregnant, they should inform their doctor immediately. It is recommended that the partner consult a doctor.
• The patient must also use effective contraception (see "Contraception").

Breastfeeding

Do not breastfeed while taking Lenalidomide Sandoz, as it is not known if it passes into breast milk.

Contraception

Women taking Lenalidomide Sandoz Before starting treatment, the patient should ask their doctor if they can become pregnant, even if they think it is unlikely. If the patient is of childbearing age:

• they will have pregnancy tests under medical supervision (before each treatment, at least every 4 weeks during treatment, and at least 4 weeks after the end of treatment), unless the doctor confirms that their fallopian tubes have been cut and blocked to prevent eggs from reaching the uterus (tubal ligation) AND
• they must use effective methods of contraception for at least 4 weeks before starting treatment, during treatment, and for at least 4 weeks after the end of treatment. The doctor will recommend suitable contraceptive methods.

Men taking Lenalidomide Sandoz Lenalidomide Sandoz is present in human semen. If the patient's partner is pregnant or may become pregnant and is not using effective contraception, the patient must use condoms during treatment and for at least 7 days after the end of treatment, even if they have had a vasectomy. During treatment and for at least 7 days after the end of treatment, the patient must not donate sperm or semen.

Driving and using machines

If the patient experiences dizziness, fatigue, drowsiness, a feeling of spinning, or blurred vision after taking Lenalidomide Sandoz, they should not drive or operate machinery.

Lenalidomide Sandoz contains lactose and sodium

If the patient has an intolerance to some sugars, they should consult their doctor before taking this medicine. The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is "sodium-free".

3. How to take Lenalidomide Sandoz

Lenalidomide Sandoz must be administered by medical personnel with experience in treating 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 medicine is taken with other medicines (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 medicine is taken alone (as monotherapy).
• If Lenalidomide Sandoz is used to treat follicular lymphoma, it is taken with another medicine called "rituximab".

This medicine should always be taken as directed by the doctor. In case of doubts, consult a doctor or pharmacist. If the patient is taking Lenalidomide Sandoz with other medicines, they should read the leaflets of those medicines to obtain information on 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, 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 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, 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.

How much Lenalidomide Sandoz to take

Before starting treatment, the doctor will inform the patient:

• how much Lenalidomide Sandoz to take
• how many other medicines (if any) to take with Lenalidomide Sandoz
• on which days of the cycle to take each of these medicines.

How and when to take Lenalidomide Sandoz

• The capsule should be swallowed whole, preferably with water.
• The capsule should not be broken, opened, or chewed. If the powder from a damaged Lenalidomide Sandoz 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 according to 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.
• The medicine should be taken on the designated days at approximately the same time.

Taking this medicine

To remove a 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 taken in treatment cycles, each lasting 21 or 28 days (see above "Treatment cycle"). Treatment should be continued until the doctor recommends stopping it.

Taking more Lenalidomide Sandoz than prescribed

If the patient takes more capsules than they should, they should consult a doctor immediately.

Missing a dose of Lenalidomide Sandoz

If the patient forgets to take Lenalidomide Sandoz at the usual time:

• and it has been less than 12 hours since then, they should take the capsule immediately
• and it has been more than 12 hours since then, they should not take the missed capsule. The next dose should be taken at the usual time the next day.

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

4. Possible side effects

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

If any of the following serious side effects occur, stop taking Lenalidomide Sandoz 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 anaphylactic reaction

severe allergic reaction that can start as a rash in one area and spread to the whole body, accompanied by a significant skin peeling (Stevens-Johnson syndrome and/or toxic epidermal necrolysis)

• widespread rash, high body temperature, elevated liver enzyme activity, 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 a doctor immediately if any of the following serious side effects occur:

• 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, 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 the 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 higher during treatment with Lenalidomide Sandoz. Therefore, before prescribing this medicine, the 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 cells, which can 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, prickling sensation in the hands or feet, dizziness, tremors
• decreased appetite, changes in 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 a sign 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 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 physical discomfort, malaise
• painful inflammation of the mouth, dry mouth
• dehydration
Commonside effects (may affect less than 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 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 uric acid levels in the blood
• skin rashes, skin redness, peeling, cracking, or flaking of the skin, hives
• increased 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 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 disorders that cause a feeling of spinning), loss of consciousness
• chest pain that spreads to the arms, neck, jaw, back, or stomach, 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 the flow of bile from the liver
• low levels of phosphates or magnesium in the blood
• speech difficulties
• liver damage
• balance disorders, 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
• confusion
• toothache
• fall that may cause injury

Uncommonside effects (may affect less than 1 in 100 people)

• bleeding in the brain
• circulatory disorders
• vision loss
• loss of sexual desire
• 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, rash, or abdominal pain and swelling - these may be symptoms of liver damage (liver failure)
• abdominal pain, bloating, or diarrhea, which may be symptoms of colon inflammation (colitis or proctitis)
• kidney cell damage (tubular necrosis)
• skin color changes, sensitivity to sunlight
• syndrome of tumor breakdown - metabolic complications 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
• high blood pressure in the blood vessels that supply the lungs (pulmonary hypertension)

Unknown frequencyside effects (frequency cannot be estimated from available data)

• sudden or mild but worsening abdominal pain and/or back pain that persists for several days and may occur with 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 lung tissue inflammation (interstitial lung disease)
• 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 taken with a statin (a cholesterol-lowering medicine)
• a skin disease caused by inflammation of small blood vessels, accompanied by joint pain and fever (leukocytoclastic vasculitis)
• breakdown of the stomach or intestine wall, which can lead to a serious infection. Tell a doctor if you experience severe abdominal pain, fever, nausea, vomiting, blood in the stool, or changes in bowel movements
• viral infections, including shingles (a viral disease that causes a painful rash) and hepatitis B virus reactivation (which can cause yellowing of the skin and eyes, dark urine, abdominal pain, fever, nausea, or vomiting)
• organ transplant rejection (such as kidney, heart, etc.).

Reporting side effects

If side effects occur, including any not listed in this leaflet, tell a 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, more information can be gathered on the safety of this medicine.

5. How to store Lenalidomide Sandoz

Store the medicine out of 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 the medicine if it is damaged or if the packaging is broken. Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Lenalidomide Sandoz contains

• The active substance is lenalidomide. One capsule contains 5 mg of lenalidomide.
• The other ingredients are: lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate. Capsule 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 has a matte white body and a matte white cap, approximately 18.0 mm in length, with the marking "L9NL" and "5". 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

To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, contact:

Sandoz Polska Sp. z o.o. ul. Domaniewska 50 C 02-672 Warsaw tel. 22 209 70 00 Date of last revision of the leaflet:06/2023 Sandoz logo