Lenalidomide Fresenius Kabi

Leaflet accompanying the packaging: patient information

Lenalidomide Fresenius Kabi, 2.5 mg, hard capsules

Lenalidomide Fresenius Kabi, 5 mg, hard capsules Lenalidomide Fresenius Kabi, 7.5 mg, hard capsules

Lenalidomide Fresenius Kabi, 10 mg, hard capsules

Lenalidomide Fresenius Kabi, 15 mg, hard capsules

Lenalidomide Fresenius Kabi, 20 mg, hard capsules

Lenalidomide Fresenius Kabi, 25 mg, hard capsules

Lenalidomide

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should 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 Fresenius Kabi and what is it used for
• 2. Important information before taking Lenalidomide Fresenius Kabi
• 3. How to take Lenalidomide Fresenius Kabi
• 4. Possible side effects
• 5. How to store Lenalidomide Fresenius Kabi
• 6. Contents of the packaging and other information

1. What is Lenalidomide Fresenius Kabi and what is it used for

Lenalidomide Fresenius Kabi contains the active substance "lenalidomide". This medicine belongs to a group of medicines that affect the functioning of the immune system.
Lenalidomide Fresenius Kabi is used in adult patients for the treatment of:

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

Multiple myeloma

Multiple myeloma is a type of cancer that attacks 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.
Multiple myeloma is essentially incurable. However, it is possible to temporarily significantly 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, after achieving a suitable condition after transplantation, Lenalidomide Fresenius Kabi is used as maintenance therapy without other medicines.
Newly diagnosed multiple myeloma – in patients who are not eligible for bone marrow transplantation treatment
Lenalidomide Fresenius Kabi is used 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 with additional medicines, and then continues treatment using only Lenalidomide Fresenius Kabi.

If the patient is 75 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 Fresenius Kabi is used in combination with an anti-inflammatory medicine called "dexamethasone".
Lenalidomide Fresenius Kabi 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 are a group of different blood and bone marrow diseases. There are abnormal blood cells 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 Fresenius Kabi is used as monotherapy in the treatment of adult patients who have been diagnosed with myelodysplastic syndromes, 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 an abnormality in bone marrow cells called "isolated cytogenetic abnormality with 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.

Lenalidomide Fresenius Kabi may lead to an increase in the number of healthy blood cells produced by the body, by limiting 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)

Mantle cell lymphoma is a cancer of part of the immune system (lymphoid tissue).
It attacks a certain 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 Fresenius Kabi is used as monotherapy in the treatment of adult patients who have previously been treated with other medicines.

Follicular lymphoma (FL)

Follicular lymphoma is a slow-growing malignant cancer that attacks 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 Fresenius Kabi is taken with another medicine called "rituximab" in the treatment of adult patients with previously treated follicular lymphoma.

How Lenalidomide Fresenius Kabi works

Lenalidomide Fresenius Kabi works by affecting the functioning of 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 Fresenius Kabi

Before starting treatment with Lenalidomide Fresenius Kabi, you should carefully read the leaflets of all medicines taken in combination with Lenalidomide Fresenius Kabi.

When not to take Lenalidomide Fresenius Kabi:

• If the patient is pregnant, suspects pregnancy, or plans to become pregnant, as it is suspected that Lenalidomide Fresenius Kabi is harmful to the unborn child(see section 2 "Pregnancy, breastfeeding, and contraception - information for women and men").
• If the patient may become pregnant, unless all required contraceptive measures are used (see section 2 "Pregnancy, breastfeeding, and contraception - information for women and men"). If the patient may become pregnant, the doctor will always make a note when prescribing the medicine that the necessary measures have been taken and will inform the patient about it.
• If the patient is allergic to lenalidomide or any of the other ingredients of this medicine (listed in section 6). In case of suspected allergy, you should consult your doctor.

If any of these points apply to the patient, they should not take Lenalidomide Fresenius Kabi. In case of doubts, you should consult your doctor.

Warnings and precautions

Before starting treatment with Lenalidomide Fresenius Kabi, you should discuss it with your doctor, pharmacist, or nurse if the patient:

• has had blood clots in the past - this means an increased risk of forming blood clots in the veins and arteries during treatment;
• has any symptoms of infection, such as cough or fever;
• has a current or past viral infection, especially chickenpox and shingles, hepatitis B, HIV. In case of doubts, you should consult your doctor. Treatment with Lenalidomide Fresenius Kabi may cause reactivation of viruses in patients who have been infected in the past, leading to recurrence of the infection. The doctor will check if the patient has had hepatitis B in the past;
• has kidney problems - the doctor may adjust the dose of Lenalidomide Fresenius Kabi;
• has had a heart attack, has had a blood clot, smokes, has high blood pressure, or high cholesterol levels;
• has had allergic symptoms when taking thalidomide (another medicine used to treat multiple myeloma), such as rash, itching, swelling, dizziness, or difficulty breathing;
• 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 points apply to the patient, they should consult their doctor, pharmacist, or nurse before starting treatment.
You should immediately tell your doctor or nurse 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 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 the patient had such symptoms before lenalidomide treatment, they should inform their doctor about any changes.
• shortness of breath, fatigue, dizziness, chest pain, rapid heartbeat, or swelling of the legs 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 Fresenius Kabi, the patient will undergo regular blood tests, as Lenalidomide Fresenius Kabi 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.
Patient with myelodysplastic syndromes taking Lenalidomide Fresenius Kabi
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 Fresenius Kabi affects the likelihood of developing acute myeloid leukemia. Therefore, the doctor may perform tests and check for signs that will help better predict the risk of acute myeloid leukemia during treatment with Lenalidomide Fresenius Kabi.
Patient with mantle cell lymphoma taking Lenalidomide Fresenius Kabi
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.

Patient with follicular lymphoma taking Lenalidomide Fresenius Kabi
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 bone marrow. This may lead to a situation where the tumor tissue begins 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 if the patient has skin changes, such as red spots or rash.
The doctor may change the dose of Lenalidomide Fresenius Kabi or stop treatment based on the results of the patient's blood tests and their overall condition. If the disease is newly diagnosed, the doctor may also assess treatment based on the patient's age and other diseases that may have occurred in the past.
Blood donation
During treatment and for at least 7 days after stopping treatment, the patient should not donate blood.

Children and adolescents

Lenalidomide Fresenius Kabi is not recommended for use in children and adolescents under 18 years of age.

Elderly patients and patients with kidney problems

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

Lenalidomide Fresenius Kabi and other medicines

The patient should tell their doctor or nurse about all medicines they are currently taking or have recently taken. This is necessary because Lenalidomide Fresenius Kabi may affect the action of other medicines. Other medicines may also affect the action of Lenalidomide Fresenius Kabi.
In particular, the patient should inform their doctor or nurse if they are taking:

• certain contraceptive medicines, 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 Fresenius Kabi

• Lenalidomide Fresenius Kabi should not be taken if the patient is pregnant, as it is suspected to be harmful to the unborn child.
• A woman should not become pregnant while taking Lenalidomide Fresenius Kabi. Therefore, in women who may become pregnant, it is necessary to use effective contraception (see "Contraception").
• If the patient becomes pregnant during treatment with Lenalidomide Fresenius Kabi, she should stop treatment immediately and inform her doctor.

For men taking Lenalidomide Fresenius Kabi

• If the partner of a man taking Lenalidomide Fresenius Kabi becomes pregnant, he should immediately inform his doctor. The partner should consult a doctor.
• For men, it is also necessary to use effective contraception (see "Contraception").

Breastfeeding

Breastfeeding should not be done while taking Lenalidomide Fresenius Kabi, as it is not known whether Lenalidomide Fresenius Kabi passes into human milk.

Contraception

Women taking Lenalidomide Fresenius Kabi
Before starting treatment, the patient should ask their doctor about the possibility of becoming pregnant, even if they think it is unlikely.
Women who may 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), unless they have had their fallopian tubes cut and unblocked (tubal sterilization) AND
• must use effective contraceptive 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 contraceptive methods to the patient.

Men taking Lenalidomide Fresenius Kabi
Lenalidomide Fresenius Kabi passes into human semen. If the patient's partner is pregnant or may become pregnant and is not using effective contraception, the patient 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 should not donate semen.

Driving and using machines

The patient should not drive or operate machines if they experience dizziness, fatigue, drowsiness, or blurred vision after taking Lenalidomide Fresenius Kabi.

Lenalidomide Fresenius Kabi contains lactose

Lenalidomide Fresenius Kabi contains lactose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking Lenalidomide Fresenius Kabi.

Lenalidomide Fresenius Kabi contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "sodium-free".

3. How to take Lenalidomide Fresenius Kabi

Lenalidomide Fresenius Kabi must be dispensed by a healthcare professional who has experience in treating multiple myeloma, MDS, MCL, or FL.

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

Lenalidomide Fresenius Kabi should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
If the patient is taking Lenalidomide Fresenius Kabi with other medicines, they should read the leaflet that comes with their packaging to get information about their use and effects.

Treatment cycle

Lenalidomide Fresenius Kabi 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 "cycle" lasting 21 days. OR Lenalidomide Fresenius Kabi 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 "cycle" lasting 28 days.

Recommended dose of Lenalidomide Fresenius Kabi

Before starting treatment, the doctor will inform the patient:

• what dose of Lenalidomide Fresenius Kabi they should take;
• what dose of other medicines the patient should take in combination with Lenalidomide Fresenius Kabi, if it is necessary to take other medicines;
• on which days of the cycle to take which medicines.

How and when to take Lenalidomide Fresenius Kabi

• The capsule should be swallowed whole, preferably with water.
• Do not break, open, or chew the capsules. If the powder from a damaged Lenalidomide Fresenius Kabi capsule comes into contact with the skin, it should be washed immediately with soap and water.
• Healthcare professionals, caregivers, and family members should wear single-use 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, the hands should be washed 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 Fresenius Kabi should be taken at approximately the same time every day, on the days when the medicine 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 Fresenius Kabi

Lenalidomide Fresenius Kabi is used in treatment cycles; each cycle lasts 21 or 28 days (see above "Treatment cycle"). Treatment cycles should be continued until the doctor stops the treatment.

Taking a higher dose of Lenalidomide Fresenius Kabi than recommended

If a higher dose of Lenalidomide Fresenius Kabi than prescribed is taken, the doctor should be informed immediately.

Missing a dose of Lenalidomide Fresenius Kabi

If a dose of Lenalidomide Fresenius Kabi is missed and

• less than 12 hours have passed since the scheduled time: the capsule should be taken immediately;
• more than 12 hours have passed since the scheduled time: the capsule should not be taken. The next capsule should be taken at the scheduled time the next day.

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

If any of the following serious side effects occur, the patient should stop taking Lenalidomide Fresenius Kabi and immediately consult their doctor – 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, flu-like symptoms, elevated liver enzyme activity, blood abnormalities (eosinophilia), and swollen lymph nodes – these are symptoms of a severe skin reaction called Stevens-Johnson syndrome and 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.

The patient should immediately inform their doctor about any of the following serious side effects:

• fever, chills, sore throat, cough, mouth ulcers, or any other symptoms 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 Fresenius Kabi 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 Fresenius Kabi may also cause the formation of blood clots in the veins (thrombosis).

Other side effects

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

Very common side 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, 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 symptom 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 activity;
• changes in blood proteins, leading to blood vessel inflammation (vasculitis);
• high blood sugar levels (diabetes);
• low blood sugar levels;
• headache;
• nosebleeds;
• dry skin;
• depression, mood changes, sleep disturbances;
• cough;
• low blood pressure;
• general feeling of physical discomfort, malaise;
• mouth pain, dry mouth;
• dehydration.

Common side 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 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;
• high levels of uric acid in the blood;
• rash, skin redness, peeling, or flaking of the skin, hives;
• excessive sweating, night sweats;
• difficulty swallowing, sore throat, voice problems, or voice changes;
• nasal congestion (runny nose);
• 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;
• confusion;
• toothache;
• fall that may lead to injury.

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

• bleeding in the brain;
• circulation problems;
• vision loss;
• loss of sex drive (libido);
• passing large amounts of urine, accompanied by bone pain and weakness, which may be symptoms of kidney disease (Fanconi syndrome);
• yellowing of the skin, mucous membranes, or eyes (jaundice), pale stool, dark urine, itching, rash, abdominal pain, or swelling – 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 - 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, 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 lead to the lungs (pulmonary hypertension).

Side effects with unknown frequency (frequency cannot be estimated 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 association 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 Fresenius Kabi 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 severe infection. The patient should tell their doctor if they experience severe stomach pain, fever, nausea, vomiting, blood in the stool, or changes in bowel function;
• viral infections, including chickenpox and shingles, and recurrence 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 organ (e.g., kidney, heart).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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
phone: +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 collected on the safety of the medicine.

5. How to store Lenalidomide Fresenius Kabi

The medicine should be stored 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.
There are no special storage instructions for the 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. Unused medicines should be returned to the pharmacy. This will help protect the environment.

6. Contents of the packaging and other information

What Lenalidomide Fresenius Kabi contains

Lenalidomide Fresenius Kabi, 2.5 mg, hard capsules:

• The active substance of the medicine is lenalidomide. Each capsule contains 2.5 mg of lenalidomide.
• Other ingredients are:
• capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
• capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132), and yellow iron oxide (E172);
• printing ink: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E172).

Lenalidomide Fresenius Kabi, 5 mg, hard capsules:

• The active substance of the medicine is lenalidomide. Each capsule contains 5 mg of lenalidomide.
• Other ingredients are:
• capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
• capsule shell: gelatin and titanium dioxide (E171);
• printing ink: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E172).

Lenalidomide Fresenius Kabi, 7.5 mg, hard capsules:

• The active substance of the medicine is lenalidomide. Each capsule contains 7.5 mg of lenalidomide.
• Other ingredients are:
• capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate;
• capsule shell: gelatin, titanium dioxide (E171), and yellow iron oxide (E172);
• printing ink: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E172).

Lenalidomide Fresenius Kabi, 10 mg, hard capsules:

• The active substance of the medicine is lenalidomide. Each capsule contains 10 mg of lenalidomide.
• Other ingredients are:
• capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
• capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132), and yellow iron oxide (E172);
• printing ink: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E172).

Lenalidomide Fresenius Kabi, 15 mg, hard capsules:

• The active substance of the medicine is lenalidomide. Each capsule contains 15 mg of lenalidomide.
• Other ingredients are:
• capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
• capsule shell: gelatin, titanium dioxide (E171), and indigo carmine (E132);
• printing ink: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E172).

Lenalidomide Fresenius Kabi, 20 mg, hard capsules:

• The active substance of the medicine is lenalidomide. Each capsule contains 20 mg of lenalidomide.
• Other ingredients are:
• capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
• capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132), and yellow iron oxide (E172);
• printing ink: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E172).

Lenalidomide Fresenius Kabi, 25 mg, hard capsules:

• The active substance of the medicine is lenalidomide. Each capsule contains 25 mg of lenalidomide.
• Other ingredients are:
• capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
• capsule shell: gelatin and titanium dioxide (E171);
• printing ink: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E172).

How Lenalidomide Fresenius Kabi looks like and what the pack contains

Lenalidomide Fresenius Kabi, 2.5 mg, hard capsules, opaque with a white body and a green to light green cap, approximately 14.3 mm in length, with the imprint "L9NL" and "2.5".
Lenalidomide Fresenius Kabi, 5 mg, hard capsules, opaque with a white body and cap, approximately 18.0 mm in length, with the imprint "L9NL" and "5".
Lenalidomide Fresenius Kabi, 7.5 mg, hard capsules, with a white body and a yellow cap, approximately 18.0 mm in length, with the imprint "L9NL" and "7.5".
Lenalidomide Fresenius Kabi, 10 mg, hard capsules, opaque, with a yellow body and a green to light green cap, approximately 21.7 mm in length, with the imprint "L9NL" and "10".
Lenalidomide Fresenius Kabi, 15 mg, hard capsules, opaque with a white body and a blue to light blue cap, approximately 21.7 mm in length, with the imprint "L9NL" and "15".
Lenalidomide Fresenius Kabi, 20 mg, hard capsules, opaque, with a blue to light blue body and a green to light green cap, approximately 21.7 mm in length, with the imprint "L9NL" and "20".
Lenalidomide Fresenius Kabi, 25 mg, hard capsules, opaque with a white body and cap, approximately 21.7 mm in length, with the imprint "L9NL" and "25".
Each cardboard box contains 7 or 21 hard capsules.

Marketing Authorisation Holder

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Manufacturer/Importer

Synthon Hispania, S.L.
c/ Castelló, 1
08830 Sant Boi de Llobregat (Barcelona)
Spain

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

National Authorisation Numbers and Names:

Date of last revision of the leaflet:16.01.2024