Pomalidomide Erawya 3 mg hard capsules EFG

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

Pomalidomide Erawya 1 mg hard capsules EFG

Pomalidomide Erawya 2 mg hard capsules EFG

Pomalidomide Erawya 3 mg hard capsules EFG

Pomalidomide Erawya 4 mg hard capsules EFG

Pomalidomide Erawya is expected to cause severe birth defects and may result in fetal death. Do not take this medicine if you are pregnant or may be pregnant. You must follow the contraceptive measures described in this leaflet.

Read the entire leaflet carefully before you start taking this medicine, as 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, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if these are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Pomalidomide Erawya is and what it is used for
2. What you need to know before taking Pomalidomide Erawya
3. How to take Pomalidomide Erawya
4. Possible adverse effects
5. How to store Pomalidomide Erawya
6. Contents of the pack and other information

1. What is Pomalidomida Erawya and what is it used for

What is Pomalidomida Erawya

Pomalidomida Erawya contains the active substance “pomalidomide”. This medicine is related to thalidomide and belongs to a group of medicines that affect the immune system (the body's natural defences).

What Pomalidomida Erawya is used for

Pomalidomida Erawya is used to treat adults with a type of cancer called “multiple myeloma”.

Pomalidomida Erawya is used in combination with:

• Two other medicines called “bortezomib” (a type of chemotherapy medicine) and “dexamethasone” (an anti-inflammatory medicine) in people who have received at least one other treatment, including lenalidomide.

or

• Another medicine called “dexamethasone” in people whose myeloma has worsened despite having received at least two other types of treatment, including the medicines lenalidomide and bortezomib.

What is multiple myeloma

Multiple myeloma is a type of cancer that affects a specific type of white blood cells (called “plasma cells”). These cells grow uncontrollably and accumulate in the bone marrow, damaging bones and kidneys.

Multiple myeloma usually cannot be cured. However, treatment may reduce the signs and symptoms of the disease or make them disappear for a period of time. When this occurs, it is referred to as a “response”.

How Pomalidomida Erawya works

Pomalidomide works in several ways:

• It stops the growth of myeloma cells;
• It stimulates the immune system to attack cancer cells;
• It inhibits the formation of blood vessels that supply nutrients to cancer cells.

Benefit of using pomalidomide with bortezomib and dexamethasone

When pomalidomide is used in combination with bortezomib and dexamethasone in people who have received at least one other treatment, it can delay the progression of multiple myeloma:

• Typically, the combination of pomalidomide with bortezomib and dexamethasone delayed the recurrence of multiple myeloma for up to 11 months, compared with 7 months observed in patients receiving bortezomib and dexamethasone alone.

Benefit of using pomalidomide with dexamethasone

When pomalidomide is used with dexamethasone in people who have received at least two prior treatments, it may delay the progression of multiple myeloma:

• Typically, the combination of pomalidomide and dexamethasone delayed the recurrence of multiple myeloma for up to 4 months, compared with 2 months observed in patients receiving dexamethasone alone.

2. What you need to know before starting Pomalidomide Erawya

Do not take Pomalidomide Erawya:

• if you are pregnant, think you might be pregnant, or intend to become pregnant, as pomalidomide is expected to be harmful to the fetus. (Men and women taking this medicine should read the section “Pregnancy, contraception and breastfeeding – information for women and men” below);
• if you could become pregnant, unless you are taking all necessary measures to prevent pregnancy (see “Pregnancy, contraception and breastfeeding – information for women and men”). If you could become pregnant, your doctor will document with each prescription that all necessary precautions have been taken and will provide you with this confirmation;
• if you are allergic to pomalidomide or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, consult your doctor.

If you are unsure whether any of the situations described above apply to you, consult your doctor, pharmacist, or nurse before taking Pomalidomide Erawya.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting pomalidomide if:

• you have ever had blood clots in the past. During treatment with pomalidomide, you have an increased risk of developing blood clots in your veins or arteries. Your doctor may recommend additional treatments (e.g., warfarin) or reducing your pomalidomide dose to lower the risk of blood clots;
• you have previously experienced an allergic reaction such as rash, itching, swelling, dizziness, or breathing problems while taking related medicines called “thalidomide” or “lenalidomide”;
• you have had a heart attack, have heart failure, have difficulty breathing, or, if you are a smoker, have high blood pressure or high cholesterol levels;
• you have a high total tumor burden in the body, including in the bone marrow. This could lead to a condition in which tumors break down and release unusual levels of chemicals into the blood, which in turn may cause kidney failure. You may also experience irregular heartbeats. This condition is called tumor lysis syndrome;
• you currently have or have previously had neuropathy (nerve damage causing tingling or pain in your feet or hands);
• you have or have previously had hepatitis B virus infection. Treatment with pomalidomide may reactivate the hepatitis B virus in carriers, leading to a recurrence of the infection. Your doctor should check whether you have ever had hepatitis B virus infection;
• you are currently experiencing or have previously experienced a combination of any of the following symptoms: facial or widespread rash, skin redness, high fever, flu-like symptoms, swollen lymph nodes (symptoms of a serious skin reaction called drug reaction with eosinophilia and systemic symptoms, or DRESS syndrome, or drug hypersensitivity syndrome, toxic epidermal necrolysis [TEN], or Stevens-Johnson syndrome [SJS]). See also section 4 “Possible side effects”).

It is important to note that patients with multiple myeloma treated with pomalidomide may develop other types of cancer, so your doctor must carefully evaluate the benefits and risks before prescribing this medicine.

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, balance problems, persistent numbness, reduced sensation, or loss of sensation, memory loss, or confusion. These may be symptoms of a serious and potentially life-threatening brain disease known as progressive multifocal leukoencephalopathy (PML). If you had any of these symptoms before starting treatment with pomalidomide, inform your doctor if you notice any changes in these symptoms.

At the end of treatment, you must return all unused capsules to the pharmacist.

Pomalidomide Erawya contains lactose (a type of sugar) and sodium

If your doctor has diagnosed you with an intolerance to certain sugars, consult with them before taking this medicine.

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

Children and adolescents

The use of pomalidomide is not recommended in children and adolescents under 18 years of age.

Other medicines and Pomalidomide Erawya

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

In particular, inform your doctor, pharmacist, or nurse before taking pomalidomide if you are taking any of the following medicines:

• certain antifungals such as ketoconazole;
• certain antibiotics (e.g., ciprofloxacin, enoxacin);
• certain antidepressants such as fluvoxamine.

Pregnancy, contraception and breastfeeding: information for men and women

You must follow the instructions outlined in the pomalidomide Pregnancy Prevention Programme. Men and women taking pomalidomide must not father children or become pregnant. This is because pomalidomide is expected to be harmful to the fetus. You and your partner must use effective contraceptive methods while taking this medicine.

Women

Do not take pomalidomide if you are pregnant, think you might be pregnant, or intend to become pregnant. This is because this medicine is expected to be harmful to the fetus. Before starting treatment, you must inform your doctor if there is any possibility you could become pregnant, even if you consider this unlikely.

If you could become pregnant:

• you must use effective contraceptive methods starting at least 4 weeks before beginning treatment, throughout the entire treatment period, and for at least 4 weeks after stopping treatment. Your doctor will advise you on the most appropriate contraceptive methods;
• each time your doctor prescribes a new prescription, they will ensure that you understand the necessary measures to prevent pregnancy;
• your doctor will schedule pregnancy tests before treatment, at least every 4 weeks during treatment, and at least 4 weeks after treatment ends.

If you become pregnant despite preventive measures:

• you must stop treatment immediately and inform your doctor immediately.

Breastfeeding

It is unknown whether pomalidomide passes into human breast milk. Inform your doctor if you are breastfeeding or intend to breastfeed. Your doctor will advise you whether you can continue or should stop breastfeeding.

Men

Pomalidomide passes into human semen.

• If your partner is pregnant or could become pregnant, you must use condoms throughout the entire treatment period and for 7 days after stopping treatment.
• If your partner becomes pregnant while you are taking pomalidomide, inform your doctor immediately.

Your partner must also inform their doctor immediately.

You must not donate semen or sperm during treatment and for 7 days after stopping treatment.

Blood donation and blood tests

You must not donate blood during treatment and for 7 days after stopping treatment.

Before starting treatment with pomalidomide and during treatment, you will have periodic blood tests. This is because your medicine may cause a decrease in the number of blood cells that help fight infections (white blood cells) and in the number of cells that help stop bleeding (platelets).

Your doctor will request that you have blood tests:

• before treatment begins;
• weekly during the first 8 weeks of treatment;
• at least once a month while continuing pomalidomide treatment.

Your doctor may adjust the dose of pomalidomide or interrupt your treatment, depending on the results of these tests. Your doctor may also adjust the dose or interrupt this medicine due to your overall health condition.

Driving and use of machines

Some people experience fatigue, fainting, confusion, or reduced alertness while taking pomalidomide. If this happens to you, do not drive or operate tools or machinery.

3. How to take Pomalidomide Erawya

Pomalidomide must be prescribed and administered by a physician experienced in the treatment of multiple myeloma.

Always follow exactly the instructions for taking the medicines as provided by your doctor. If in doubt, consult your doctor, pharmacist, or nurse.

When to take pomalidomide with other medicines

Pomalidomide in combination with bortezomib and dexamethasone

• Refer to the package leaflet provided with bortezomib and dexamethasone for additional information on their use and effects.
• Pomalidomide, bortezomib, and dexamethasone are taken in treatment cycles. Each cycle lasts 21 days (3 weeks).
• Refer to the following chart to see which medicines you should take each day of the 3-week cycle:
  • Each day, check the chart and identify the correct day to see which medicines you should take.
  • On some days you will take all three medicines, on other days only one or two medicines, and on some days none of them.

POM: pomalidomide; BOR: bortezomib; DEX: dexamethasone

Cycles 1 to 8

Cycle 9 onwards

• After completing each 21-day cycle, begin a new one.

Pomalidomide with dexamethasone alone

• Refer to the package leaflet provided with dexamethasone for additional information on its use and effects.
• Pomalidomide and dexamethasone are taken in "treatment cycles". Each cycle lasts 28 days (4 weeks).
• Refer to the following chart to see which medicines you should take each day of the 4-week cycle:
  • Each day, check the chart and identify the correct day to see which medicines you should take.
  • On some days you will take both medicines, on other days only one medicine, and on some days neither.

POM: pomalidomide; DEX: dexamethasone

	Name of the medicine
Day	POM	DEX
1	√	√
2	√
3	√
4	√
5	√
6	√
7	√
8	√	√
9	√
10	√
11	√
12	√
13	√
14	√
15	√	√
16	√
17	√
18	√
19	√
20	√
21	√
22		√
23
24
25
26
27
28

• After completing each 4-week cycle, begin a new one.

How much pomalidomide to take with other medicines

Pomalidomide with bortezomib and dexamethasone

• The recommended starting dose of pomalidomide is 4 mg once daily.
• The recommended starting dose of bortezomib will be calculated by your doctor according to your height and weight (1.3 mg/m2 body surface area).
• The recommended starting dose of dexamethasone is 20 mg once daily. However, if you are over 75 years of age, the recommended starting dose is 10 mg once daily.

Pomalidomide with dexamethasone alone

• The recommended dose of pomalidomide is 4 mg once daily.
• The recommended starting dose of dexamethasone is 40 mg once daily. However, if you are over 75 years of age, the recommended starting dose is 20 mg once daily.

Your doctor may need to reduce the dose of pomalidomide, bortezomib, or dexamethasone, or interrupt one or more of these medicines based on your blood test results and general condition, whether you are taking other medicines (e.g., ciprofloxacin, enoxacin, and fluvoxamine), and if you experience adverse effects (especially rash or swelling) as a result of treatment.

If you have liver or kidney problems, your doctor will carefully monitor your condition while you are receiving this medicine.

How to take Pomalidomide Erawya

• Do not break, open, or chew the capsules. If the powder from a broken capsule comes into contact with the skin, wash the skin immediately and thoroughly with soap and water.
• Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister pack or capsule. Afterwards, gloves should be carefully removed to avoid skin exposure, placed into a sealable polyethylene plastic bag, and disposed of according to local requirements. Hands should then be thoroughly washed with soap and water. Pregnant women or women who suspect they may be pregnant should not handle the blister pack or capsule.
• Swallow the capsules whole, preferably with water.
• You may take the capsules with or without food.
• You should take the capsules at approximately the same time each day.

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.

Your doctor will advise you on how and when to take pomalidomide if you have kidney problems and are receiving dialysis treatment.

Duration of treatment with Pomalidomide Erawya

You should continue treatment cycles until your doctor tells you to stop treatment.

If you take more Pomalidomide Erawya than you should

If you take more pomalidomide than you should, inform your doctor or go to hospital immediately. Bring the medicine packaging with you.

If you forget to take Pomalidomide Erawya

If you forget to take pomalidomide on the day you were supposed to, take the next capsule the following day at your usual time. Do not take extra capsules to make up for the missed dose of pomalidomide.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

Serious adverse effects

If you experience any of the following serious adverse effects, stop treatment with Pomalidomide Erawya and seek immediate medical attention, as you may require urgent medical treatment:

• Fever, chills, sore throat, cough, mouth ulcers, or any other sign of infection (due to decreased white blood cells responsible for fighting infection).
• Bleeding or bruising without apparent cause, including nosebleeds and intestinal or stomach bleeding (due to effects on blood cells called "platelets").
• Rapid breathing, fast pulse, fever and chills, little or no urine output, nausea and vomiting, confusion, unconsciousness (due to a blood infection called sepsis or septic shock).
• Severe, persistent, or bloody diarrhea (possibly accompanied by stomach pain or fever) caused by the bacterium Clostridium difficile.
• Chest or leg pain and swelling, especially in the lower leg or calves (caused by blood clots).
• Difficulty breathing (due to a severe chest infection, lung inflammation, heart failure, or blood clots).
• Swelling of the face, lips, tongue, and throat, which may cause difficulty breathing (due to severe types of allergic reactions called angioedema and anaphylactic reaction).
• Certain types of skin cancer (squamous cell carcinoma and basal cell carcinoma), which may cause changes in the appearance of the skin or skin lumps. If you notice any skin changes while taking Pomalidomide Erawya, inform your doctor as soon as possible.
• Reactivation of hepatitis B virus infection, which may cause yellowing of the skin and eyes, dark brown urine, abdominal pain on the right side, fever, nausea, or malaise. Inform your doctor immediately if you notice any of these symptoms.
• Widespread rash, high body temperature, swollen lymph nodes, and effects on other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome or drug hypersensitivity syndrome, toxic epidermal necrolysis, or Stevens-Johnson syndrome). Stop taking pomalidomide if you experience these symptoms and contact your doctor or seek immediate medical attention. See also section 2.

If you experience any of the following serious adverse effects, stop treatment with Pomalidomide Erawya and seek immediate medical attention, as you may require urgent medical treatment.

Other adverse effects

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

• Difficulty breathing (dyspnea).
• Lung infection (pneumonia and bronchitis).
• Infections of the nose, sinuses, and throat caused by bacteria or viruses.
• Flu-like symptoms (influenza).
• Low red blood cell count, which may cause anemia leading to fatigue and weakness.
• Low blood potassium levels (hypokalemia), which may cause weakness, muscle cramps and pain, palpitations, tingling or numbness, dyspnea, and mood changes.
• High blood sugar levels.
• Fast and irregular heartbeat (atrial fibrillation).
• Loss of appetite.
• Constipation, diarrhea, or nausea.
• Vomiting.
• Abdominal pain.
• Lack of energy.
• Difficulty falling or staying asleep.
• Dizziness, tremor.
• Muscle spasms, muscle weakness.
• Bone pain, back pain.
• Numbness, tingling, or burning sensation in the skin, pain in hands or feet (peripheral sensory neuropathy).
• Generalized swelling, including swelling of arms and legs.
• Skin rashes.
• Urinary tract infection, which may cause a burning sensation when urinating or the need to urinate more frequently.

Common (may affect up to 1 in 10 people):

• Falls.
• Bleeding within the skull.
• Reduced ability to move or feel (sensation) in the hands, feet, and legs due to neurological damage (peripheral sensorimotor neuropathy).
• Numbness, itching, or tingling of the skin (paresthesia).
• Sensation of dizziness or spinning, making it difficult to stand and move normally.
• Swelling due to fluid retention.
• Hives (urticaria).
• Itching of the skin.
• Shingles (herpes zoster).
• Heart attack (chest pain spreading to the arms, neck, and jaw, sweating, shortness of breath, nausea or vomiting).
• Chest pain, chest infection.
• Increased blood pressure.
• Reduction in the number of red blood cells, white blood cells, and platelets simultaneously (pancytopenia), making you more prone to bleeding and bruising. You may feel tired and weak and have difficulty breathing. You will also be more susceptible to infections.
• Decreased lymphocyte count (a type of white blood cell), often caused by infection (lymphopenia).
• Low blood magnesium levels (hypomagnesemia), which may cause fatigue, generalized weakness, muscle cramps, and irritability, and may lead to low blood calcium levels (hypocalcemia), causing numbness or tingling in hands, feet, or lips, muscle cramps, muscle weakness, dizziness, confusion.
• Low blood phosphate levels (hypophosphatemia), which may cause muscle weakness, irritability, or confusion.
• High blood calcium levels (hypercalcemia), which may slow reflexes and cause skeletal muscle weakness.
• High blood potassium levels, which may cause an abnormal heart rhythm.
• Low blood sodium levels, which may cause fatigue and confusion, muscle twitching, seizures (epileptic convulsions), or coma.
• High blood uric acid levels, which may cause a type of arthritis called gout.
• Low blood pressure, which may cause dizziness or fainting.
• Mouth pain or dryness.
• Changes in taste perception.
• Bloating.
• Confusion.
• Feeling low (depressed mood).
• Loss of consciousness, fainting.
• Clouding of the eye (cataract).
• Kidney damage.
• Inability to urinate.
• Abnormal results in liver function tests.
• Pelvic pain.
• Weight loss.

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

• Stroke.
• Liver inflammation (hepatitis), which may cause skin itching, yellowing of the skin and whites of the eyes (jaundice), pale stools, dark urine, and abdominal pain.
• Breakdown of tumor cells resulting in the release of toxic substances into the bloodstream (tumor lysis syndrome). This may lead to kidney problems.
• Underactive thyroid gland, which may cause symptoms such as fatigue, lethargy, muscle weakness, slow heart rate, and weight gain.

Frequency not known (cannot be estimated from available data):

• Rejection of solid organ transplants (such as heart or liver).

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pomalidomide Erawya

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

Do not use this medicine after the expiry date which is stated on the blister pack and the carton after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice any visible signs of deterioration or evidence of improper handling or tampering.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pomalidomida Erawya

• The active substance is pomalidomide.

Each 1 mg capsule contains 1 mg of pomalidomide
Each 2 mg capsule contains 2 mg of pomalidomide
Each 3 mg capsule contains 3 mg of pomalidomide
Each 4 mg capsule contains 4 mg of pomalidomide

• The other components are:

Capsule contents: anhydrous lactose, pregelatinized starch (corn), and sodium stearyl fumarate.

Capsule shell:

Pomalidomida Erawya 1 mg: gelatin, titanium dioxide (E171), indigo carmine (E132), yellow iron oxide (E172), and erythrosine (E127)

Pomalidomida Erawya 2 mg: gelatin, titanium dioxide (E171), yellow iron oxide (E172), indigo carmine (E132), and erythrosine (E127)

Pomalidomida Erawya 3 mg: gelatin, titanium dioxide (E171), indigo carmine (E132), yellow iron oxide (E172), black iron oxide (E172), patent blue V (E131), and erythrosine (E127)

Pomalidomida Erawya 4 mg: gelatin, titanium dioxide (E171), indigo carmine (E132), patent blue V (E131), yellow iron oxide (E172), and erythrosine (E127)

Printing ink:

Black ink (Pomalidomida Erawya 1 mg): shellac, black iron oxide (E172), propylene glycol, and ammonium hydroxide

White ink (Pomalidomida Erawya 2 mg, 3 mg and 4 mg): shellac, titanium dioxide (E171), and propylene glycol (E1520)

Appearance of Pomalidomida Erawya and contents of the pack

Pomalidomida Erawya 1 mg hard capsules EFG (14.3 mm long) have an opaque dark blue cap and an opaque ivory-colored body, with the inscription “1 mg” in black.

Pomalidomida Erawya 2 mg hard capsules EFG (14.3 mm long) have an opaque dark blue cap and an opaque light orange-colored body, with the inscription “2 mg” in white.

Pomalidomida Erawya 3 mg hard capsules EFG (18 mm long) have an opaque dark blue cap and an opaque light green-colored body, with the inscription “3 mg” in white.

Pomalidomida Erawya 4 mg hard capsules EFG (18 mm long) have an opaque dark blue cap and an opaque light blue-colored body, with the inscription “4 mg” in white.

Pomalidomida Erawya is available in packs containing 14 or 21 capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratórios Basi - Indústria Farmacêutica, S.A.
Parque Industrial Manuel Lourenço Ferreira, Lote 15
3450-232 Mortágua
Portugal
Tel.: +351 231 920 250 | Fax: +351 231 921 055
E-mail: [email protected]

Local Representative

LAPHYSAN, S.A.U.
Anabel Segura 11, Edificio A, Planta 4, Puerta D,
28108 Alcobendas - Madrid
Spain

Manufacturer

Laboratórios Basi - Indústria Farmacêutica, S.A.
Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15, 16
3450-232 Mortágua
Portugal

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

Portugal: Pomalidomida Erawya

Spain: Pomalidomida Erawya 1 mg hard capsules EFG
Pomalidomida Erawya 2 mg hard capsules EFG
Pomalidomida Erawya 3 mg hard capsules EFG
Pomalidomida Erawya 4 mg hard capsules EFG

Date of the most recent review of this leaflet: September 2024

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