Prospect: information for the patient

Lenalidomida Tarbis 15 mg hard capsules EFG

lenalidomida

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

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

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

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

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

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

2. What you need to know before starting to take Lenalidomida Tarbis

3. How to take Lenalidomida Tarbis

4. Possible adverse effects

5. Storage of Lenalidomida Tarbis

6. Contents of the package and additional information

What is Lenalidomida Tarbis

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

What Lenalidomida Tarbis is used for

Lenalidomida Tarbis is used in adults for:

• Multiple Myeloma
• Follicular Lymphoma

Multiple Myeloma

Multiple Myeloma is a type of cancer that affects a specific type of white blood cells 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 patients who have undergone a bone marrow transplantLenalidomida is used as maintenance treatment after recovering adequately from a bone marrow transplant.

Multiple Myeloma: newly diagnosed patients who cannot be treated with a bone marrow transplant

Lenalidomida is taken with other medications, including:

• a chemotherapy medication called “bortezomib”;
• a corticosteroid called “dexametasona”;
• a chemotherapy medication called “melfalán”; and
• a 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: previously treated patients

Lenalidomida is taken with a corticosteroid 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.

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 Tarbis works

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

It acts in several ways:

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

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

Do not take Lenalidomida Tarbis:

• if you are pregnant, think you may be pregnant or intend to become pregnant, as Lenalidomida is expected to be harmful to the fetus (see section 2, “Pregnancy, breastfeeding and contraception: information for women and men”);since Lenalidomida 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 lenalidomida or to any of the other components of this medicine (including in section 6). If you think you may be allergic, consult your doctor.

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

Warnings and precautions

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

• you have ever had blood clots; during treatment, you have a higher risk of developing blood clots in 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, varicella zoster or HIV. In case of doubt, consult your doctor. Treatment with Lenalidomida may make the virus become active again in patients who are carriers of the virus. This leads 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 Lenalidomida 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 for example 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 body temperature, flu-like symptoms, increased 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.

At any time, during or after treatment, inform your doctor 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 Lenalidomida, 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 serious condition called pulmonary hypertension (see section 4).

Analysis and tests

Before starting treatment with Lenalidomida and during treatment, you will have regular blood tests. This is because Lenalidomida can cause a decrease in the white blood cells that help fight infections and the 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 every month.

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

For patients with MM who take Lenalidomida

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).
• after this, it will be done 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 disease in which the tumors break down and produce unusual levels of chemical substances in the blood that, in turn, can 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 patches or skin rashes.

Your doctor may adjust your Lenalidomida 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 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 Lenalidomida is not recommended in children and adolescents under 18 years of age.

Older people and people with kidney problems

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

Other medicines and Lenalidomida Tarbis

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

• You must not take Lenalidomida if you are pregnant, as it is expected to be harmful to the fetus.
• You must not become pregnant while taking Lenalidomida. 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 Lenalidomida, you must stop treatment and inform your doctor immediately.

Men taking Lenalidomida

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

Breastfeeding

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

Contraception

For women taking Lenalidomida

Before starting treatment, ask your doctor if you are capable of becoming pregnant, although you may 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 treatment is completed) except that you have had tubal ligation to prevent the egg from reaching 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 treatment is completed. Your doctor will advise you on the most suitable contraceptive methods.

For men taking Lenalidomida

Lenalidomida 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 treatment is completed, even if you have had a vasectomy.

Driving and operating machinery

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

Lenalidomida Tarbis contains lactose

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

Lenalidomida Tarbis contains sodium

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

Lenalidomide should be administered by a healthcare professional with experience in the treatment of multiple myeloma or lymphoma.

• 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 Tarbis is used for”).
• When Lenalidomide is used for the treatment of multiple myeloma in patients who have received a bone marrow transplant, 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 for Lenalidomide indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

If you are taking Lenalidomide with other medications, you should 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.

Or

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 Tarbis 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 this medication, if applicable;
• which days of the treatment cycle you should take each medication.

How and when to take Lenalidomide 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 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. Subsequently, they should carefully remove the gloves to avoid skin exposure, place them in a plastic polyethylene bag, and dispose of them in accordance with 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 pack:

• Press only one end of the capsule to allow it to come out through the foil.
• Do not press in the center of the capsule as it may break.

Duration of treatment with Lenalidomide Tarbis

Lenalidomide 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 informs you to stop treatment.

If you take more Lenalidomide Tarbis than you should

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

If you forget to take Lenalidomide Tarbis

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 following day at your usual time.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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 Lenalidomida Tarbis 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 body organs (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 sepsis.
• Bleeding (hemorrhage) or hematoma (bruise) not due to injury.
• Chest pain (thoracic) or leg pain.
• Difficulty breathing.
• Bone pain, muscle pain, confusion, or fatigue that may be due to high levels of calcium in the blood.

Lenalidomida can reduce the number of white blood cells that fight infections and also the cells in the blood that help to clot (platelets), which can cause bleeding disorders such as nosebleeds and bruises. Lenalidomida 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 this risk may increase with Lenalidomida treatment. Therefore, your doctor must carefully evaluate the benefits and risks of prescribing Lenalidomida.

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

• Decreased red blood cell count, 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 flu-like 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 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.
• 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 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.
• 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.
• Inflammation of 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 cancer.
• 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; skin inflammation caused by blood accumulation; hematoma.
• Increased uric acid levels in the blood.
• Rashes, redness of the skin, skin peeling, dry skin, urticaria.
• Increased sweating, nocturnal sweating.
• Difficulty swallowing, sore throat, difficulty maintaining voice quality or changes in voice.
• Nasal discharge.
• Increased or decreased urine output, or inability to control urination.
• Blood in the urine.
• Difficulty breathing, especially when lying down (which could be a symptom of heart failure).
• Impotence.
• Stroke, fainting, dizziness (inner ear disorder that causes a sensation of spinning), temporary loss of consciousness.
• Chest pain that radiates to arms, neck, jaw, spine, or stomach, feeling 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.
• Slowed or blocked bile flow from the liver.
• Low levels of phosphate or magnesium in the blood.
• Difficulty speaking.
• Liver damage.
• Balance problems, difficulty moving.
• Deafness, tinnitus (ringing in the ears).
• Nerve pain, abnormal and unpleasant sensation, especially when touched.
• Excess iron in the body.
• Thirst.
• Confusion.
• Toothache.
• Fall that can cause injuries.

Side effectsuncommon(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 typhlitis).
• Damage to kidney cells (renal tubular necrosis).
• Changes in skin color, sensitivity to sunlight.Syndrome of tumor lysis – complications may 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 may include: changes in blood biochemistry, high levels of potassium, phosphorus, uric acid, and low levels of calcium, which generate changes in renal function and heart rhythm, convulsions, and sometimes death.
• Increased blood pressure within the blood vessels that supply the lungs (pulmonary hypertension).

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

• Sudden, severe, or worsening pain in the upper stomach and/or back, lasting 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 Lenalidomida 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.

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

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

This medication does not require special conditions for conservation.

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

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Lenalidomide

The active ingredient is lenalidomide. Each capsule contains 15 mg of lenalidomide.

The other components are:

Contents of the capsules:Anhydrous lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.

Capsule coating:Gelatin, titanium dioxide (E171), and iron oxide red (E172).

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

Appearance of the product and contents of the packaging

Lenalidomida Tarbis 15 mg hard capsuleshave a red opaque cap and a white opaque body, hard gelatin capsules of size “0”, printed with 'H' on the cap and 'L5' on the body, filled with a pale yellowish to whitish powder.

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

Only some packaging sizes may be commercially available

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

or

Amarox Pharma B.V.,

Rouboslaan 32,

2252 TR Voorschoten,

Netherlands

This medicine is authorized in the member states of the European Economic Area with the following names:

Netherlands:Lenalidomide Amarox 15 mg hard capsules

Spain:Lenalidomida Tarbis 15 mg hard capsules EFG

Last revision date of this leaflet: October 2021

Further information and updates on this medicine are available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/