Introduction

Leaflet: information for the user

Lenalidomida TecniGen 2.5 mg hard capsules EFG

Lenalidomida TecniGen 5 mg hard capsules EFG

Lenalidomida TecniGen 7.5 mg hard capsules EFG

Lenalidomida TecniGen 10 mg hard capsules EFG

Lenalidomida TecniGen 15 mg hard capsules EFG

Lenalidomida TecniGen 20 mg hard capsules EFG

Lenalidomida TecniGen 25 mg hard capsules EFG

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

-Keep this leaflet, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before taking Lenalidomida TecniGen

3. How to take Lenalidomida TecniGen

4. Possible side effects

5. Storage of Lenalidomida TecniGen

6. Contents of the pack and additional information

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

What is Lenalidomida TecniGen

Lenalidomida TecniGen contains the active ingredient “lenalidomida”. This medication belongs to a group of medications that affect how the immune system functions.

What is Lenalidomida TecniGen used for

Lenalidomida is used in adults for:

Multiple Myeloma
Myelodysplastic Syndromes (MDS)
mantle cell lymphoma (MCL)
Follicular lymphoma

Multiple Myeloma

Multiple myeloma is a type of cancer that affects a specific type of white blood cell in the blood, called plasma cells. These cells accumulate in the bone marrow and multiply, becoming uncontrolled. This can damage bones and kidneys.

Multiple myeloma generally does not have a cure. However, the symptoms and signs can be significantly reduced or disappear for a period of time. This is called “remission”.

Multiple Myeloma Newly Diagnosed: in patients who have undergone a bone marrow transplant

Lenalidomida is used as maintenance treatment after recovering adequately from a bone marrow transplant.

Multiple Myeloma Newly Diagnosed: in patients who cannot be treated with a bone marrow transplant

Lenalidomida is taken with other medications, including:

a chemotherapy medication called “bortezomib”
an anti-inflammatory called “dexametasona”
a chemotherapy medication called “melfalán” and
an immunosuppressant called “prednisona”.

You will take these medications when starting treatment and then continue taking lenalidomida alone.

If you are 75 years or older or have moderate to severe kidney problems, your doctor will closely monitor you before starting treatment.

Multiple Myeloma: in previously treated patients

Lenalidomida is taken with an anti-inflammatory called “dexametasona”.

Lenalidomida can slow the progression of multiple myeloma symptoms. It has also been shown to delay the recurrence of multiple myeloma after treatment.

Myelodysplastic Syndromes (MDS)

MDS are a group of many different blood and bone marrow diseases. Blood cells become abnormal and do not function correctly. Patients may experience a variety of symptoms, including low red blood cell count (anemia), the need for blood transfusions, and the risk of infection.

Lenalidomida is used to treat adult patients diagnosed with MDS, when the following points are applicable:

• you need periodic blood transfusions to treat low red blood cell levels (“anemia-dependent transfusions”)

• you have a bone marrow cell anomaly called “isolated 5q deletion cytogenetic anomaly”. This means your body does not produce enough healthy blood cells

• other treatments you have used previously are not suitable or do not work well enough.

Lenalidomida can increase the number of healthy red blood cells produced by the body by reducing the number of abnormal cells:

• this can reduce the number of blood transfusions needed. It may be possible to avoid transfusions.

Mantle Cell Lymphoma (MCL)

MCL is a cancer of a part of the immune system (lymphoid tissue). It affects a type of white blood cell in the blood called “B lymphocytes” or B cells. MCL is a disease in which B cells grow uncontrollably and accumulate in lymphoid tissue, bone marrow, or blood.

Lenalidomida is used in monotherapy to treat adult patients who have received previous treatment with other medications.

Follicular Lymphoma (FL)

FL is a slow-growing cancer that affects B lymphocytes. These are a type of white blood cell that helps the body fight infections. When a person has FL, they may store too many of these B lymphocytes in the blood, bone marrow, lymph nodes, and spleen.

Lenalidomida is used with another medication called “rituximab” for the treatment of adult patients who have received previous treatment for follicular lymphoma.

How Lenalidomida TecniGen works

Lenalidomida works by affecting the body's immune system and directly attacking cancer.

It acts in several ways:

stops the development of cancer cells
stops the growth of blood vessels in cancer
stimulates part of the immune system to attack cancer cells.

2. What you need to know before starting Lenalidomida TecniGen

You should read the leaflet for all the medicines you are going to take in combination with lenalidomide before starting treatment with this medicine.

Do not take lenalidomide:

if you are pregnant, think you may be pregnant or intend to become pregnant, as lenalidomide is expected to be harmful to the fetus (see section 2, “Pregnancy, breastfeeding and contraception: information for women and men”).
if you can become pregnant, unless you follow all the necessary measures to avoid it (see section 2, “Pregnancy, breastfeeding and contraception: information for women and men”). If you can become pregnant, your doctor will note on each prescription that all necessary measures have been taken and will provide you with this confirmation.
if you are allergic to lenalidomide or to any of the other components of this medicine included in section 6. If you think you may be allergic, consult your doctor.

If any of these conditions apply to you, do not take lenalidomide. In case of doubt, consult your doctor.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take lenalidomide if:

you have ever had blood clots; during treatment, you have a higher risk of developing blood clots in the veins and arteries
you have any sign of infection, such as cough or fever
you have or have had previously a viral infection, especially hepatitis B infection, varicella zoster or HIV. In case of doubt, consult your doctor. Treatment with lenalidomide may make the virus become active again, in patients who are carriers of the virus, leading to the reappearance of the infection. Your doctor must check if you have ever had a hepatitis B infection
you have kidney problems; your doctor may adjust your lenalidomide dose
you have had a heart attack, have ever had a blood clot, or if you smoke, have high blood pressure or high cholesterol levels
you have had an allergic reaction while using thalidomide (another medicine used to treat multiple myeloma), such as skin rash, itching, swelling, dizziness or respiratory problems
you have experienced in the past a combination of any of the following symptoms: generalised rash, skin redness, high fever, flu-like symptoms, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes (these are signs of a severe skin reaction called drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome or drug hypersensitivity syndrome) (see also section 4 “Possible side effects”).

If any of the above conditions apply to you, inform your doctor, pharmacist or nurse before starting treatment.

Inform your doctor, pharmacist or nurse immediately if you experience:

blurred vision, loss of vision or double vision, difficulty speaking, weakness in one arm or leg, a change in the way you walk or balance problems, persistent numbness, decreased sensitivity or loss of sensitivity, memory loss or confusion. All of these can be symptoms of a severe and potentially fatal brain disease called progressive multifocal leukoencephalopathy (PML). If you have any of these symptoms before starting treatment with lenalidomide, inform your doctor if you notice any change in these symptoms
shortness of breath, fatigue, dizziness, chest pain, faster heart rate or swelling in the legs or ankles. These can be symptoms of a severe condition called pulmonary hypertension (see section 4).

Analysis and tests

Before starting treatment with lenalidomide and during treatment, you will have regular blood tests, as lenalidomide may cause a decrease in the white blood cells that help fight infections and platelets that participate in blood clotting.

Your doctor will ask you to have a blood test:

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

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

For patients with SMD who take lenalidomide

If you have SMD, you may be more prone to developing a more advanced disease called acute myeloid leukemia (AML). Additionally, it is unknown how lenalidomide affects your chances of developing AML. Your doctor may perform tests to detect signs that may better predict your chances of developing AML during treatment with lenalidomide.

For patients with MCL who take lenalidomide

Your doctor will ask you to have a blood test:

before treatment
every week for the first 8 weeks (2 cycles) of treatment
subsequently, every 2 weeks in cycles 3 and 4 (see section 3 “Treatment cycle” for more information)
then at the start of each cycle
at least once a month

For patients with LF who take lenalidomide

Your doctor will ask you to have a blood test:

before treatment;
every week for the first 3 weeks (1 cycle) of treatment;
subsequently, every 2 weeks in cycles 2 to 4 (see section 3 “Treatment cycle” for more information).
then at the start of each cycle and
at least once a month

Your doctor may check if you have a high total tumor burden in the body, including the bone marrow. This could lead to a disease in which the tumors break down and produce unusual levels of chemical substances in the blood that, in turn, may cause kidney failure (this disease is called tumour lysis syndrome).

Your doctor may examine you to check if any changes have occurred in your skin, such as red spots or skin rashes.

Your doctor may adjust your lenalidomide dose or interrupt your treatment, depending on the results of your blood tests and your overall condition. If you are a new diagnosis patient, your doctor may also evaluate your treatment based on your age and any other conditions you already have.

Blood donation

You should not donate blood during treatment or for at least 7 days after the end of treatment.

Children and adolescents

The use of lenalidomide is not recommended in children and adolescents under 18 years old.

Older adults and patients with kidney problems

If you are 75 years old or more or have moderate to severe kidney problems, your doctor will carefully examine you before starting treatment.

Other medicines and Lenalidomide TecniGen

Inform your doctor or nurse if you are taking, have recently taken or may need to take any other medicine. This is because lenalidomide may affect how other medicines work. Additionally, some medicines may affect how lenalidomide works.

Specifically, inform your doctor or nurse if you are taking any of the following medicines:

some medicines used to prevent pregnancy, such as oral contraceptives, as they may stop working
some medicines used to treat heart problems, such as digoxin
some medicines used to thin the blood, such as warfarin

Pregnancy, breastfeeding and contraception: information for women and men

Pregnancy

Women taking lenalidomide

You should not take lenalidomide if you are pregnant, as it is expected to be harmful to the fetus.
You should not become pregnant while taking lenalidomide. Therefore, you must use effective contraceptive methods if there is a possibility that you may become pregnant (see “Contraception”).
If you become pregnant during treatment with lenalidomide, you must stop treatment and inform your doctor immediately.

Men taking lenalidomide

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

Breastfeeding

You should not breastfeed while taking lenalidomide, as it is unknown whether lenalidomide passes into breast milk.

Contraception

For women taking lenalidomide

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

If you can become pregnant

you will have pregnancy tests under medical supervision (before each treatment, at least every 4 weeks during treatment and for at least 4 weeks after completing treatment) except that you have confirmed tubal ligation so that eggs do not reach the uterus (tubal ligation)

And

you must use effective contraceptive methods from at least 4 weeks before starting treatment, during treatment and for at least 4 weeks after completing treatment. Your doctor will advise you on the most suitable contraceptive methods.

For men taking lenalidomide

Lenalidomide passes into human semen. If your partner becomes pregnant or may become pregnant and does not use any effective contraceptive method, you must use condoms during treatment and for at least 7 days after completing treatment, even if you have undergone a vasectomy.

Driving and operating machinery

You should not drive or operate machinery if you feel dizzy, tired, drowsy, have vertigo or blurred vision after taking lenalidomide.

Lenalidomide TecniGen contains lactose

Lenalidomide TecniGen contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Lenalidomide TecniGen contains sodium

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

3. How to Take Lenalidomide TecniGen

Lenalidomide should be administered by a healthcare professional with experience in the treatment of multiple myeloma, SMD, LCM or LF..

When lenalidomide is used for the treatment of multiple myeloma in patients who cannot be treated with a bone marrow transplant or have undergone other treatments before, it is taken with other medications (see section 1 “What Lenalidomide TecniGen is used for”).
When lenalidomide is used for the treatment of multiple myeloma in patients who have undergone a bone marrow transplant or to treat patients with myelodysplastic syndromes or mantle cell lymphoma, it is taken alone.
When lenalidomide is used for the treatment of follicular lymphoma, it is taken with another medication called “rituximab”.

Follow exactly the administration instructions of lenalidomide indicated by your doctor.In case of doubt, consult your doctor or pharmacist.

If you are taking lenalidomide with other medications, you must consult the leaflet of those other medications to obtain additional information on their use and effects.

Treatment cycle

Lenalidomide is taken on certain days during the period of 3 weeks (21 days).

A “treatment cycle” consists of 21 days.
Depending on the day of the cycle, you will take one or more medications. However, some days you will not take any medication.
After completing each cycle of 21 days, you must start a new “cycle” during the following 21 days.

Lenalidomide is taken on certain days during the period of 4 weeks (28 days).

A “treatment cycle” consists of 28 days.
Depending on the day of the cycle, you will take one or more medications. However, some days you will not take any medication.
After completing each cycle of 28 days, you must start a new “cycle” during the following 28 days.

How much lenalidomide to take

Before starting treatment, your doctor will indicate:

what amount of lenalidomide you should take
what amount of the other medications you should take with lenalidomide, if applicable
which days of the treatment cycle you should take each medication.

How and when to take lenalidomide

swallow the capsules whole, preferably with water.
do not break, open or chew the capsules. In the event that the powder from a broken lenalidomide capsule comes into contact with the skin, wash the skin immediately and carefully with water and soap.
Healthcare professionals, caregivers and family members should wear disposable gloves when handling the blister pack or capsule. Afterwards, they should carefully remove the gloves to avoid skin exposure, put them in a plastic polyethylene bag and dispose of them according to local requirements. Then, they should wash their hands thoroughly with water and soap. Pregnant women or those who suspect they may be pregnant should not handle the blister pack or capsule.
the capsules can be taken with or without food.
you should take lenalidomide approximately at the same time on the scheduled days.

Administration of this medication

To remove the capsule from the blister:

press only one end of the capsule so that it comes out through the foil.
do not press in the center of the capsule as it may break.

Duration of treatment with lenalidomide

Lenalidomide is taken in treatment cycles, each cycle lasting 21 or 28 days (see “Treatment cycle” above). You must continue the treatment cycles until your doctor informs you to stop treatment.

If you take more lenalidomide than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take lenalidomide

If you forget to take lenalidomide at your usual time and

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

If you have any other doubts about the use of thismedication, ask your doctororpharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any of the following serious side effects, stop taking lenalidomide and seek medical attention immediately, as it may require emergency medical treatment:

Urticaria, rashes, swelling of the eyes, mouth, or face, difficulty breathing, or itching, which can be symptoms of severe types of allergic reactions called angioedema and anaphylactic reaction.
Severe allergic reaction that can start as a rash in one area, but spreads, causing significant skin loss throughout the body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).
Generalized rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and effects on other organs of the body (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.

Seek immediate medical attention if you notice any of the following serious side effects:

Fever, chills, sore throat, cough, mouth ulcers, or any other symptom of infection, including in the bloodstream (sepsis).
Bleeding (hemorrhage) or hematoma (bruise) not due to injury.
Chest pain (thoracic) or leg pain.
Difficulty breathing.
Bone pain, muscle weakness, confusion, or fatigue that may be due to high levels of calcium in the blood.

Lenalidomide can reduce the number of white blood cells that fight infections and also the cells in the blood that help to clot the blood (platelets), which can cause bleeding disorders such as nosebleeds and bruises.

Lenalidomide can also cause blood clots in the veins (thrombosis).

Other side effects

It is essential to note that a reduced number of patients may develop other types of cancer, and it is possible that this risk may increase with lenalidomide treatment. Therefore, your doctor must carefully evaluate the benefits and risks of prescribing lenalidomide.

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

A decrease in the number of red blood cells, which can cause anemia leading to fatigue and weakness.
Rash, itching.
Muscle cramps, muscle weakness, muscle pain, muscle discomfort, bone pain, joint pain, back pain, limb pain.
Generalized swelling, including swelling of the arms and legs.
Weakness, fatigue.
Fever and pseudogripal symptoms, including fever, muscle pain, headache, ear pain, cough, and chills.
Numbness, tingling, or prickling sensation in the skin, hand or foot pain, dizziness, tremors.
Decreased appetite, changes in the taste of things.
Increased pain, tumor size, or redness around the tumor.
Weight loss.
Constipation, diarrhea, nausea, vomiting, stomach pain, heartburn.
Low levels of potassium, calcium, or sodium in the blood.
Subnormal thyroid function.
Chest pain (which could be a symptom of pulmonary embolism), leg pain (which could be a symptom of deep vein thrombosis), or difficulty breathing (which could be a symptom of pulmonary embolism).
All types of infections, including sinusitis, pneumonia, and upper respiratory tract infections.
Difficulty breathing.
Blurred vision.
Cataracts.
Renal problems, including kidneys that do not function correctly or are unable to maintain normal function.
Abnormal liver test results.
High levels of liver test results.
Changes in a blood protein that can cause swelling of the arteries (vasculitis).
Increased blood sugar levels (diabetes).
Decreased blood sugar levels.
Headache.
Nosebleeds.
Dry skin.
Depression, changes in mood, difficulty sleeping.
Cough.
Low blood pressure.
A vague feeling of discomfort in the body, feeling unwell.
Inflammatory pain in the mouth, dry mouth.
Dehydration.

Side effectscommon(may affect up to 1 in 10 people):

Red blood cell destruction (hemolytic anemia).
Certain types of skin tumors.
Bleeding from the gums, stomach, or intestines.
Increased blood pressure, slow, fast, or irregular heartbeat.
Increased levels of a substance released after normal or abnormal destruction of red blood cells.
Increased levels of a type of protein that indicates inflammation in the body.
Darkening of the skin; change in skin color due to internal bleeding, usually caused by hematomas; inflammation of the skin caused by the accumulation of blood; hematoma.
Increased uric acid levels in the blood.
Rashes, redness of the skin, dry skin, peeling or exfoliation of the skin, urticaria.
Increased sweating, nocturnal sweating.
Difficulty swallowing, sore throat, difficulty maintaining voice quality or changes in voice.
Nasal discharge.
Significant increase or decrease in urine output compared to normal or inability to control urination.
Blood in the urine.
Difficulty breathing, especially when lying down (which could be a symptom of heart failure).
Difficulty achieving an erection.
Stroke, fainting, vertigo (inner ear disorder that causes the sensation of everything spinning), temporary loss of consciousness.
Chest pain that radiates to arms, neck, jaw, spine, or stomach, sensation of sweating and shortness of breath, nausea or vomiting, which can be symptoms of a heart attack (myocardial infarction).
Weakness, lack of energy.
Cervical pain, chest pain.
Chills.
Joint swelling.
Slower or blocked bile flow from the liver.
Low levels of phosphate or magnesium in the blood.
Difficulty speaking.
Liver damage.
Balance disorder, difficulty moving.
Deafness, tinnitus (ringing in the ears).
Nerve pain, abnormal and unpleasant sensation, especially when touched.
Excess iron in the body.
Thirst.
Confusion.
Dental pain.
Fall that can cause injuries.

Side effectsinfrequent(may affect up to 1 in 100 people):

Brain hemorrhage.
Circulatory problems.
Loss of vision.
Loss of libido (sex drive).
Expulsion of large amounts of urine with bone pain and weakness, which can be symptoms of kidney disease (Fanconi syndrome).
Yellow pigmentation in the skin, mucous membranes, or eyes (jaundice), pale stools, dark urine, itching skin, rash, stomach pain, or swelling; these can be symptoms of liver damage (hepatic insufficiency).
Stomach pain, abdominal swelling, or diarrhea, which can be symptoms of inflammation of the large intestine (colitis or enteritis).
Damage to kidney cells (renal tubular necrosis).
Changes in skin color, sensitivity to sunlight.
Tumor lysis syndrome – complications can occur during cancer treatment and sometimes even without treatment. These complications occur as a result of the breakdown products of tumor cells that die and can include: changes in blood biochemistry, high levels of potassium, phosphorus, uric acid, and low levels of calcium, which can cause changes in kidney function and heart rhythm, seizures, and sometimes death.
Increased blood pressure within the blood vessels that supply the lungs (pulmonary hypertension).

Side effects ofunknown frequency(cannot be estimated from available data):

Sudden, severe, or worsening pain in the upper stomach and/or back, which lasts for several days, possibly accompanied by nausea, vomiting, fever, and rapid pulse. These symptoms may be due to pancreatitis.
Wheezing or ringing in the lungs, difficulty breathing, or dry cough, which can be symptoms caused by inflammation of the lung tissue.
Rare cases of muscle degradation (pain, weakness, or swelling) that can lead to kidney problems (rhabdomyolysis), some of which occur when lenalidomide is administered with a statin (a type of medication to reduce cholesterol).
A disease that affects the skin caused by inflammation of small blood vessels, accompanied by joint pain and fever (leucocytoclastic vasculitis).
Perforation of the stomach or intestine wall. This can lead to a very serious infection. Inform your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in the stool, or changes in bowel habits.
Rejection of solid organ transplants (such as kidney, heart).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Lenalidomida TecniGen

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and blister, after “CAD”. The expiration date is the last day of the month indicated.

Lenalidomida TecniGen 2.5 mg, 5 mg, 7.5 mg hard capsules: store below 30°C.

Lenalidomida TecniGen 10 mg, 15 mg, 20 mg, 25 mg hard capsules: this medication does not require special storage conditions.

Do not use this medication if you observe visible signs of deterioration or signs of improper handling on the packaging.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

6. Contents of the packaging and additional information

Composition of Lenalidomida TecniGen

Lenalidomida TecniGen 2.5 mg hard capsules EFG

The active ingredient is lenalidomide. Each capsule contains 2.5 mg of lenalidomide.

The other components are: