LENALIDOMIDE TARBIS 5 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Lenalidomide Tarbis 5 mg Hard Capsules EFG

lenalidomide

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Lenalidomide Tarbis and what is it used for
2. What you need to know before you take Lenalidomide Tarbis
3. How to take Lenalidomide Tarbis
4. Possible side effects
5. Storage of Lenalidomide Tarbis
6. Contents of the pack and other information

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

What is Lenalidomide Tarbis

Lenalidomide Tarbis contains the active substance “lenalidomide”. This medicine belongs to a group of medicines that affect how the immune system works.

What is Lenalidomide Tarbis used for

Lenalidomide Tarbis is used in adults to:

• Multple Myeloma
• Myelodysplastic Syndromes (MDS)
• Follicular Lymphoma

Multple Myeloma

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

Multple myeloma usually has no cure. However, the signs and symptoms can be greatly reduced or may disappear for a period of time. This is called “remission”.

Newly diagnosed multple myeloma: in patients who have undergone a bone marrow transplant, lenalidomide is used as maintenance treatment after recovering adequately from the bone marrow transplant.

Newly diagnosed multple myeloma: in patients who cannot be treated with a bone marrow transplant

Lenalidomide is taken with other medicines, including:

• a chemotherapy medicine called “bortezomib”;
• a chemotherapy medicine called “melphalan”;

You will take these medicines at the start of treatment and then continue to take lenalidomide alone.

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

Multple myeloma: in previously treated patients

Lenalidomide is taken along with an anti-inflammatory called “dexamethasone”.

Lenalidomide may slow down the worsening of multple myeloma symptoms. It has also been shown to delay the return of multple myeloma after treatment.

Myelodysplastic Syndromes (MDS)

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

Lenalidomide is used to treat adult patients diagnosed with MDS, when all of the following apply:

• need regular blood transfusions to treat low red blood cell counts (“transfusion-dependent anemia”)
• have a bone marrow cell abnormality called “isolated deletion 5q cytogenetic abnormality”. This means that your body does not produce enough healthy blood cells
• other treatments you have used before are not suitable or do not work well enough.

Lenalidomide may increase the number of healthy red blood cells your body produces by reducing the number of abnormal cells:

• this may reduce the number of blood transfusions needed. You may not need transfusions at all.

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.

Lenalidomide is used with another medicine called “rituximab” to treat adult patients who have received previous treatment for follicular lymphoma.

How Lenalidomide Tarbis works

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

It works in several ways:

• stops the growth of cancer cells;
• stops the growth of blood vessels in the cancer;
• stimulates part of the immune system to attack cancer cells

2. What you need to know before you take Lenalidomide Tarbis

You must read the package leaflet of all medicines you are going to take in combination with Lenalidomide Tarbis before starting treatment with Lenalidomide Tarbis.

Do not take Lenalidomide Tarbis:

as lenalidomide is expected to be harmful to the fetus(see section 2, “Pregnancy, breastfeeding and contraception: information for women and men”);

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

Warnings and precautions

Tell your doctor, pharmacist or nurse before you start taking Lenalidomide Tarbis 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 signs of infection, such as cough or fever;
• you have or have had a viral infection, especially hepatitis B, chickenpox or HIV. If in doubt, consult your doctor. Treatment with lenalidomide may cause the virus to become active again in patients who carry the virus. This can lead to the return of the infection. Your doctor should 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 multple myeloma), such as skin rash, itching, swelling, dizziness or breathing problems;
• you have experienced in the past a combination of any of the following symptoms: widespread rash, skin redness, high body temperature, 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).

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

If at any time during or after treatment you experience:

• blurred vision, loss of vision or double vision, difficulty speaking, weakness in an arm or leg, a change in the way you walk or balance problems, numbness, decreased sensitivity or loss of sensitivity, memory loss or confusion. These can be symptoms of a serious and potentially life-threatening 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, tiredness, dizziness, chest pain, faster heart rate or swelling in the legs or ankles. These can be symptoms of a serious condition called pulmonary hypertension (see section 4).

Tests and examinations

Before starting treatment with lenalidomide and during treatment, you will have regular blood tests. This is because lenalidomide can cause a decrease in the blood cells that help fight infections (white blood cells) and those that help the blood to clot (platelets).

Your doctor will ask you to have a blood test:

• before treatment;
• every week during the first 8 weeks of treatment;
• then at least every month.

You may be evaluated for signs of heart and lung problems before and during treatment with lenalidomide.

For patients with MDS taking lenalidomide:

If you have MDS, you may be more likely to develop a more advanced disease called acute myeloid leukemia (AML). Additionally, it is not known how lenalidomide affects the chances of developing AML. Your doctor will therefore have you undergo tests to detect signs that may predict a higher likelihood of developing AML during your treatment with lenalidomide.

For patients with FL taking Lenalidomide

Your doctor will ask you to have a blood test:

• before treatment;
• every week during the first 3 weeks (1 cycle) of treatment;
• then every 2 weeks in cycles 2 to 4 (see section 3 “Treatment cycle” for more information).
• after this, at the start of each cycle and
• at least every 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 condition where the tumors break down and produce unusual levels of chemicals in the blood that can cause kidney failure (this condition is called “tumor lysis syndrome”).

Your doctor may examine you to check for changes in your skin, such as red spots or 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 newly diagnosed patient, your doctor may also evaluate your treatment based on your age and other conditions you already have.

Blood donation

You must 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.

Elderly and patients with kidney problems

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

Other medicines and Lenalidomide Tarbis

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. This is because lenalidomide may affect how other medicines work. Also, some medicines may affect how lenalidomide works.

In particular, tell 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 for 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

• Do not take lenalidomide if you are pregnant, as it is expected to be harmful to the fetus.
• Do not become pregnant while taking lenalidomide. You must therefore use effective contraceptive methods if you can become pregnant (see “Contraception”).
• If you become pregnant during treatment with lenalidomide, stop treatment and inform your doctor immediately.

Men taking Lenalidomide

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

Breastfeeding

Do not breastfeed while taking lenalidomide, as it is not known whether lenalidomide passes into breast milk.

Contraception

For women taking Lenalidomide

Before starting treatment, ask your doctor if you are able to become 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 the end of treatment) unless you have had your fallopian tubes closed (tubal ligation) so that eggs cannot reach the uterus;

And

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

For men taking Lenalidomide

Lenalidomide passes into human semen. If your partner is pregnant or can become pregnant and does not use any effective contraceptive method, you must use condoms during treatment and for at least 7 days after the end of treatment, even if you have had a vasectomy.

Driving and using machines

Do not drive or use machines if you feel dizzy, tired, drowsy, have vertigo or blurred vision after taking lenalidomide.

Lenalidomide Tarbis contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Lenalidomide Tarbis contains sodium

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

3. How to take Lenalidomida Tarbis

Lenalidomida should be administered by a healthcare professional with experience in the treatment of multiple myeloma, MDS, or MF.

• When Lenalidomida is used to treat 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 Lenalidomida Tarbis is used for").
• When Lenalidomida is used to treat multiple myeloma in patients who have received a bone marrow transplant or to treat patients with MDS, it is taken alone.
• When Lenalidomida is used to treat follicular lymphoma, it is taken with another medication called "rituximab".

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

If you are taking Lenalidomida with other medications, you should consult the package insert of those other medications for additional information on their use and effects.

Treatment cycle

Lenalidomida is taken on certain days during a 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, on some days, you will not take any medication.
• After completing each 21-day cycle, you should start a new "cycle" during the following 21 days.

Or

Lenalidomida is taken on certain days during a 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, on some days, you will not take any medication.
• After completing each 28-day cycle, you should start a new "cycle" during the following 28 days.

How much Lenalidomida Tarbis to take

Before starting treatment, your doctor will indicate:

• what quantity of Lenalidomida you should take;
• what quantity of other medications you should take with this medication, if applicable;
• which days of the treatment cycle you should take each medication.

How and when to take Lenalidomida Tarbis

• Swallow the capsules whole, preferably with water.
• Do not break, open, or chew the capsules. In the event that the powder from a broken Lenalidomida 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 or capsule. Afterwards, they should carefully remove the gloves to avoid skin exposure, place them in a sealable polyethylene plastic bag, and dispose of them according to local requirements. Then, they should wash their hands well with water and soap. Pregnant women or those who suspect they may be pregnant should not handle the blister or capsule.
• The capsules can be taken with or without food.
• You should take Lenalidomida approximately at the same time on the scheduled days.

Taking 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 Lenalidomida Tarbis

Lenalidomida is taken in treatment cycles, each cycle lasting 21 or 28 days (see "Treatment cycle" above). You should continue the treatment cycles until your doctor tells you to stop the treatment.

If you take more Lenalidomida Tarbis than you should

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

If you forget to take Lenalidomida Tarbis

If you forget to take Lenalidomida 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 this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not all people experience them.

If you experience any of the following serious side effects, stop treatment with Lenalidomida Tarbis and consult a doctor immediately, as you may need urgent medical treatment:

• Hives, rash, swelling of the eyes, mouth, or face, difficulty breathing or itching, which can be symptoms of serious allergic reactions called angioedema and anaphylactic reaction.
• A 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).
• Widespread 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.

Consult your doctor immediately 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 (bleeding) or hematoma (bruise) not due to an injury.
• Chest pain (thoracic) or in the legs.
• Difficulty breathing.
• Bone pain, muscle pain, confusion, or fatigue that may be due to high levels of calcium in the blood.

Lenalidomida may reduce the number of white blood cells that fight infections and also the cells in the blood that help blood to clot (platelets), which can cause bleeding disorders such as nosebleeds and bruising. Lenalidomida can also cause blood clots in the veins (thrombosis).

Other side effects

It is essential to note that a small number of patients may develop other types of cancer, and this risk may increase with treatment with Lenalidomida. Therefore, your doctor should carefully evaluate the benefits and risks when prescribing Lenalidomida.

Side effects 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.
• Skin rash, itching.
• Muscle cramps, muscle weakness, muscle pain, muscle discomfort, bone pain, joint pain, back pain, pain in the limbs.
• Generalized swelling, including swelling of the arms and legs.
• Weakness, fatigue.
• Fever and flu-like symptoms, including fever, muscle pain, headache, ear pain, cough, and chills.
• Numbness, tingling, or a prickling sensation on the skin, pain in the hands or feet, dizziness, tremors.
• Decreased appetite, changes in taste.
• 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.
• Underactive thyroid function.
• Pain in the legs (which could be a symptom of thrombosis), chest pain, or difficulty breathing (which could be a symptom of blood clots in the lungs, called pulmonary embolism).
• Infections of all kinds, including sinusitis, lung infection, and upper respiratory tract infection.
• Difficulty breathing.
• Blurred vision.
• Eye opacity (cataracts).
• Kidney problems, including kidney dysfunction or inability to maintain normal kidney function.
• Abnormal liver function test results.
• High liver function test results.
• Changes in a blood protein that can cause artery swelling (vasculitis).
• Increased blood sugar levels (diabetes).
• Decreased blood sugar levels.
• Decrease in blood sugar levels.
• Headache.
• Nosebleeds.
• Dry skin.
• Depression, mood changes, difficulty sleeping.
• Cough.
• Low blood pressure.
• A vague feeling of discomfort in the body, feeling unwell.
• Painful inflammation of the mouth, dry mouth.
• Dehydration.

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

• Destruction of red blood cells (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 red blood cell destruction.
• Increased levels of a protein that indicates inflammation in the body.
• Darkening of skin color; change in skin color due to internal bleeding, usually caused by bruising; skin inflammation caused by blood accumulation; bruising.
• Increased uric acid levels in the blood.
• Skin rash, redness of the skin, cracked skin, skin peeling or flaking, hives.
• Increased sweating, night sweats.
• Difficulty swallowing, sore throat, difficulty maintaining voice quality or changes in voice.
• Runny nose.
• Strong increase or decrease in urine output compared to usual or inability to control urination.
• Blood in the urine.
• Difficulty breathing, especially when lying down (which could be a symptom of heart failure).
• Difficulty having an erection.
• Stroke, fainting, vertigo (inner ear disorder that causes a sensation of spinning), temporary loss of consciousness.
• Chest pain that spreads to the arms, neck, jaw, back, or stomach, sensation of sweating and shortness of breath, nausea or vomiting, which can be symptoms of a heart attack (myocardial infarction).
• Muscle weakness, lack of energy.
• Neck pain, chest pain.
• Chills.
• Swollen joints.
• Slowed or blocked bile flow from the liver.
• Low levels of phosphate or magnesium in the blood.
• Difficulty speaking.
• Liver damage.
• Balance disturbance, difficulty moving.
• Deafness, ringing in the ears (tinnitus).
• Pain in the nerves, abnormal and unpleasant sensation, especially when touched.
• Excess iron in the body.
• Thirst.
• Confusion.
• Toothache.
• Fall that can cause injuries.

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

• Bleeding inside the skull.
• Circulatory problems.
• Vision loss.
• Loss of sexual desire (libido).
• Excretion of large amounts of urine with bone pain and weakness, which can be symptoms of a kidney disorder (Fanconi syndrome).
• Yellowing of the skin, mucous membranes, or eyes (jaundice), pale stools, dark urine, itching, skin rash, abdominal pain or swelling; these can be symptoms of liver damage (liver failure).
• Abdominal pain, abdominal swelling, or diarrhea, which can be symptoms of inflammation of the large intestine (called colitis or typhlitis).
• Kidney cell damage (called tubular necrosis).
• Changes in skin color, sensitivity to sunlight.
• Tumor lysis syndrome - metabolic complications can occur during cancer treatment and sometimes even without treatment. These complications occur as a result of the breakdown products of dying tumor cells 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 in the blood vessels that supply the lungs (pulmonary hypertension).

Side effects of unknown frequency(cannot be estimated from the available data):

• Sudden, mild, or worsening pain in the upper abdomen and/or back, which lasts for several days, possibly accompanied by nausea, vomiting, fever, and a rapid pulse. These symptoms can be due to pancreatitis.
• Wheezing or whistling when breathing, difficulty breathing, or dry cough, which can be symptoms caused by inflammation of the lung tissue.
• Rare cases of muscle breakdown (pain, weakness, or swelling of the muscles) have been observed, which can lead to kidney problems (rhabdomyolysis), some of which occur when Lenalidomida is administered with a statin (a type of medication to lower cholesterol).
• A disease that affects the skin, caused by inflammation of small blood vessels, accompanied by joint pain and fever (leukocytoclastic vasculitis).
• Rupture of the stomach or intestine wall. This can lead to a severe infection. Inform your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in the stool, or changes in bowel habits.
• Viral infections, including herpes zoster (also known as shingles, a viral disease that causes a painful rash with blisters) and the recurrence of hepatitis B infection (which can cause yellowing of the skin and eyes, dark urine, stomach pain on the right side, fever, and nausea or feeling sick).

• Rejection of solid organ transplants (such as kidney, heart).

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this package insert. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Lenalidomida Tarbis

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

Do not use this medication after the expiration date shown on the blister and carton after "EXP". The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not use this medication if you observe visible signs of deterioration or signs of tampering.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Lenalidomida

The active ingredient is lenalidomida. Each capsule contains 5 mg of lenalidomida.

The other ingredients are:

Capsule contents:Anhydrous lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.

Capsule shell:Gelatin and titanium dioxide (E171).

Printing ink:Shellac, black iron oxide (E172), and potassium hydroxide.

Appearance of the product and package contents

Lenalidomida Tarbis 5 mg hard capsules have a white opaque cap and a white opaque body, hard gelatin capsules of size "2", printed with 'H' on the cap and 'L2' on the body, filled with a white to pale yellow powder.

The capsules are provided in blisters of 7 and 21 capsules.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

or

Amarox Pharma B.V.,

Rouboslaan 32,

2252 TR Voorschoten,

Netherlands

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

Netherlands: Lenalidomide Amarox 5 mg hard capsules

Spain: Lenalidomida Tarbis 5 mg hard capsules EFG

Date of the last revision of this package insert: June 2025

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/