Pomalidomid Reig Iofre

Leaflet accompanying the packaging: patient information

Pomalidomide Reig Jofre, 3 mg, hard capsules

Pomalidomide Reig Jofre, 4 mg, hard capsules

Pomalidomide

It should be expected that Pomalidomide Reig Jofre will cause severe birth defects and may lead to fetal death.

• The medicine must not be taken if the patient is pregnant or may become pregnant.
• Contraceptive advice presented in this leaflet must be followed.

The leaflet should be read carefully before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor, pharmacist, or nurse should be consulted.
• The medicine has been prescribed for a specific person. It must not be passed on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. See section 4.

Table of contents of the leaflet

• 1. What is Pomalidomide Reig Jofre and what is it used for
• 2. Important information before taking Pomalidomide Reig Jofre
• 3. How to take Pomalidomide Reig Jofre
• 4. Possible side effects
• 5. How to store Pomalidomide Reig Jofre
• 6. Contents of the packaging and other information

1. What is Pomalidomide Reig Jofre and what is it used for

What is Pomalidomide Reig Jofre

Pomalidomide Reig Jofre contains the active substance pomalidomide. This medicine is similar to thalidomide and belongs to a group of medicines that affect the immune system (the system responsible for the body's natural defense).

What is Pomalidomide Reig Jofre used for

Pomalidomide Reig Jofre is used to treat adults with a type of cancer called multiple myeloma.

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

Or

• One other medicine, dexamethasone in patients with multiple myeloma that has worsened despite previous treatment with at least two other types of treatment, including lenalidomide and bortezomib.

What is multiple myeloma

Multiple myeloma is a cancer that attacks a type of white blood cell (called plasma cells). These cells grow uncontrollably and accumulate in the bone marrow, causing damage to bones and kidneys.

How does Pomalidomide Reig Jofre work

Pomalidomide Reig Jofre works in several ways:

• by inhibiting the growth of myeloma cells
• by stimulating the immune system to attack cancer cells
• by inhibiting the formation of blood vessels that supply cancer cells.

Benefits of using Pomalidomide Reig Jofre with bortezomib and dexamethasone

• Pomalidomide Reig Jofre used with bortezomib and dexamethasone in patients who have already received at least one other type of treatment may slow down the progression of multiple myeloma:

Benefits of using Pomalidomide Reig Jofre with dexamethasone

• Pomalidomide Reig Jofre used with dexamethasone in patients who have already received at least two other types of treatment may slow down the progression of multiple myeloma:

2. Important information before taking Pomalidomide Reig Jofre

When not to take Pomalidomide Reig Jofre:

• -if the patient is allergic to pomalidomide or any of the other ingredients of this medicine (listed in section 6). If an allergy to the medicine is suspected, the doctor should be consulted.
• if the patient is pregnant, suspects that she may be pregnant, or plans to become pregnant - because it should be expected that Pomalidomide Reig Jofre will be harmful to the unborn child(men and women taking this medicine must read the section "Pregnancy, contraception, and breastfeeding - information for men and women", below).
• if the patient may become pregnant, unless all necessary measures to prevent pregnancy are taken (see section "Pregnancy, contraception, and breastfeeding - information for men and women"). If the patient may become pregnant, the doctor will note the necessary measures when prescribing the medicine and provide the patient with confirmation.

If the patient is unsure whether any of the above situations apply to them, they should consult their doctor, pharmacist, or nurse before starting to take Pomalidomide Reig Jofre.

Warnings and precautions

Before starting to take Pomalidomide Reig Jofre, the doctor, pharmacist, or nurse should be consulted if:

• the patient has ever had blood clots in the past. During treatment with Pomalidomide Reig Jofre, there is an increased risk of blood clots in veins and arteries. The doctor may recommend additional treatment (e.g., warfarin) or reduce the dose of Pomalidomide Reig Jofre to reduce the risk of blood clots.
• the patient has ever had an allergic reaction, such as a rash, itching, swelling, dizziness, or breathing problems when taking similar medicines called thalidomide and lenalidomide.
• the patient has had a heart attack, has heart failure, has breathing difficulties, or smokes, has high blood pressure, or high cholesterol levels.
• the patient has extensive cancerous changes in the body, including in the bone marrow. These may lead to a condition in which tumors break down, releasing toxic substances into the blood, which can lead to kidney failure. The patient may also experience irregular heartbeat.
• the patient has or has had nerve damage (causing numbness or pain in the hands or feet).
• the patient has or has had a hepatitis B virus infection. Taking Pomalidomide Reig Jofre may cause the virus to reactivate in previously infected patients, leading to a recurrence of the infection. The doctor should check if the patient has been infected with the hepatitis B virus in the past.
• the patient has or has had any of the following symptoms: rash on the face or widespread rash, redness of the skin, high fever, flu-like symptoms, swollen lymph nodes (observed by the patient as symptoms of a severe skin reaction called "drug reaction with eosinophilia and systemic symptoms" (DRESS) or drug hypersensitivity syndrome, toxic epidermal necrolysis (TEN), or Stevens-Johnson syndrome (SJS), see also section 4 "Possible side effects").

It is essential to note that in patients with multiple myeloma treated with pomalidomide, additional types of cancer may develop. Therefore, the treating doctor should carefully assess the benefits and risks associated with prescribing this medicine to the patient.

Children and adolescents

Pomalidomide Reig Jofre is not recommended for use in children and adolescents under 18 years of age.

Pomalidomide Reig Jofre and other medicines

The doctor, pharmacist, or nurse should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, as Pomalidomide Reig Jofre may affect the action of other medicines. Other medicines may also affect the action of Pomalidomide Reig Jofre.

Pregnancy, contraception, and breastfeeding - information for men and women

As indicated below, during treatment with Pomalidomide Reig Jofre, the conditions of the Pregnancy Prevention Program must be followed. Women taking Pomalidomide Reig Jofre must not become pregnant, and men taking pomalidomide must not impregnate their partner, as it should be expected that this medicine will harm the unborn child. Both the patient and their partner should use effective contraception during treatment with this medicine.

Women

Pomalidomide Reig Jofre must not be taken if the patient is pregnant, suspects that she may be pregnant, or plans to become pregnant, as it should be expected that this medicine will harm the unborn child. Before starting treatment, the patient should inform the doctor if she may become pregnant, even if she thinks it is unlikely.

• she must use effective methods of pregnancy prevention for at least 4 weeks before starting treatment, during treatment, and for at least 4 weeks after treatment. The patient should discuss with the doctor which method of pregnancy prevention is best for her.
• each time the medicine is prescribed, the doctor will ensure that the patient understands all the necessary methods of pregnancy prevention that she must use to prevent pregnancy.
• the doctor will order pregnancy tests before treatment, no less frequently than every 4 weeks during treatment, and after at least 4 weeks after treatment.

If, despite taking preventive measures, the patient becomes pregnant:

• she must stop treatment immediately and inform the doctor immediately.

Breastfeeding

It is not known whether Pomalidomide Reig Jofre passes into human milk. If the patient is breastfeeding or plans to breastfeed, she should inform the doctor. The doctor will inform the patient whether she should stop or continue breastfeeding.

Men

Pomalidomide Reig Jofre passes into human semen.

• If the partner is pregnant or may become pregnant, the man must use condoms during the entire treatment period and for 7 days after treatment.
• If the partner of a man taking Pomalidomide Reig Jofre becomes pregnant, the doctor should be informed immediately. The partner should also consult a doctor immediately.

The patient should not donate sperm or semen during treatment and for 7 days after treatment.

Blood donation and blood tests

During treatment and for 7 days after treatment, the patient should not donate blood.

Driving and using machines

Some people taking Pomalidomide Reig Jofre may experience fatigue, dizziness, fainting, confusion, or decreased alertness. If these symptoms occur, the patient should not drive, use tools, or operate machinery.

Pomalidomide Reig Jofre contains sodium

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

Pomalidomide Reig Jofre contains isomalt

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Pomalidomide Reig Jofre

Pomalidomide Reig Jofre must be prescribed by a doctor with experience in treating multiple myeloma.

This medicine should always be taken as directed by the doctor. If there are any doubts, the doctor, pharmacist, or nurse should be consulted.

When to take Pomalidomide Reig Jofre with other medicines

Pomalidomide Reig Jofre with bortezomib and dexamethasone

• The patient should read the leaflets accompanying the medicines containing bortezomib and dexamethasone for further information on their use and effects.
• Pomalidomide Reig Jofre, bortezomib, and dexamethasone are taken in treatment cycles. Each cycle lasts 21 days (3 weeks).
• The following table shows which medicines to take on which days of the 3-week cycle: each day, find the corresponding day in the table and check which medicines to take. On some days, all 3 medicines should be taken, on some days only 2 medicines or 1 medicine, and on some days no medicines should be taken.

POM: Pomalidomide Reig Jofre; BOR: bortezomib; DEX: dexamethasone

Cycles 1 to 8. Cycle 9 and subsequent cycles

• After completing each 3-week cycle, a new cycle should be started.

Pomalidomide Reig Jofre only with dexamethasone

• The patient should read the leaflet accompanying the medicine containing dexamethasone for further information on its use and effects.
• Pomalidomide Reig Jofre and dexamethasone are taken in treatment cycles. Each cycle lasts 28 days (4 weeks).
• The following table shows which medicines to take on which days of the 4-week cycle: each day, find the corresponding day in the table and check which medicines to take. On some days, both medicines should be taken, on some days only 1 medicine, and on some days no medicine should be taken.

POM: Pomalidomide Reig Jofre; DEX: dexamethasone

• After completing each 4-week cycle, a new cycle should be started.

What dose of Pomalidomide Reig Jofre to take with other medicines

Pomalidomide Reig Jofre with bortezomib and dexamethasone

• The recommended starting dose of Pomalidomide Reig Jofre is 4 mg per day.
• The recommended starting dose of bortezomib will be determined by the doctor based on the patient's weight and body surface area (1.3 mg/m2 body surface area).
• The recommended starting dose of dexamethasone is 20 mg per day. However, in patients over 75 years of age, the recommended starting dose is 10 mg per day.

Pomalidomide Reig Jofre only with dexamethasone

• The recommended dose of Pomalidomide Reig Jofre is 4 mg per day.
• The recommended starting dose of dexamethasone is 40 mg per day. However, in patients over 75 years of age, the recommended starting dose is 20 mg per day.

The doctor may reduce the dose of Pomalidomide Reig Jofre, bortezomib, or dexamethasone or recommend stopping one or more of these medicines based on the patient's blood test results, overall health, use of other medicines (e.g., ciprofloxacin, enoxacin, and fluvoxamine), and if the patient experiences side effects resulting from treatment (especially rash and swelling).

How to take Pomalidomide Reig Jofre

• Do not break, open, or chew the capsules. If the powder from a damaged Pomalidomide Reig Jofre capsule comes into contact with the skin, the skin should be washed immediately with soap and water.
• Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister or capsule.
• Capsules should be swallowed whole, preferably with water.
• Capsules can be taken with or without food.
• Pomalidomide Reig Jofre should be taken at approximately the same time every day.

To remove a capsule from the blister, press the blister only on one end of the capsule and push it through the foil. Do not press the blister in the middle of the capsule, as this may damage the capsule.

If the patient has kidney problems and is on dialysis, the doctor will advise on how and when to take Pomalidomide Reig Jofre.

Duration of treatment with Pomalidomide Reig Jofre

Treatment cycles should be continued until the doctor recommends stopping treatment.

Taking a higher dose of Pomalidomide Reig Jofre than recommended

If a higher dose of Pomalidomide Reig Jofre than recommended is taken, the doctor or hospital should be consulted immediately. The patient should take the packaging of the medicine with them.

Missing a dose of Pomalidomide Reig Jofre

If the patient misses a dose of Pomalidomide Reig Jofre on the day it was supposed to be taken, the next dose should be taken at the scheduled time the next day. A double dose should not be taken to make up for the missed capsule of Pomalidomide Reig Jofre.

4. Possible side effects

Like all medicines, Pomalidomide Reig Jofre can cause side effects, although not everybody gets them.

Severe side effects

If any of the following severe side effects occur, treatment with Pomalidomide Reig Jofre should be stopped and the doctor should be consulted immediately - immediate treatment may be necessary:

• fever, chills, sore throat, cough, mouth ulcers, or any other signs of infection (due to a low number of white blood cells that fight infection);
• bleeding or bruising without cause, including nosebleeds, intestinal, or stomach bleeding (due to the effect of the medicine on blood cells called platelets);
• rapid breathing, rapid heartbeat, fever, and chills, low urine output, nausea, and vomiting, confusion, loss of consciousness (due to a blood infection called sepsis or septic shock);
• severe, persistent, or bloody diarrhea (also with abdominal pain or fever) caused by bacteria called Clostridium difficile;
• chest pain or leg pain and swelling, especially in the legs and calves (caused by blood clots);
• shortness of breath (due to severe chest infections, pneumonia, heart failure, or blood clots);
• swelling of the face, lips, tongue, and throat, which can cause difficulty breathing (due to severe allergic reactions called angioedema and anaphylaxis);
• certain types of skin cancer (squamous cell carcinoma and basal cell carcinoma), which can cause changes in the appearance of the skin or the formation of growths on the skin. If the patient notices any changes in the skin while taking Pomalidomide Reig Jofre, they should inform the doctor as soon as possible;
• recurrence of hepatitis B virus infection, which can cause yellowing of the skin and eyes, dark urine, abdominal pain on the right side, fever, nausea, and vomiting. The doctor should be consulted immediately if these symptoms are observed;
• widespread rash, high body temperature, swollen lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome, toxic epidermal necrolysis, or Stevens-Johnson syndrome). If these symptoms occur, treatment with pomalidomide should be stopped immediately, and medical help should be sought immediately. See also section 2.

If any of the above severe side effects occur, treatment with Pomalidomide Reig Jofre should be stopped and the doctor should be consulted immediately- immediate treatment may be necessary.

Other side effects

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

• shortness of breath (dyspnea);
• lung infections (pneumonia and bronchitis);
• infections of the nose, sinuses, and throat caused by bacteria or viruses;
• flu-like symptoms (influenza);
• reduced number of red blood cells, which can cause anemia leading to fatigue and weakness;
• low potassium levels in the blood (hypokalemia), which can cause weakness, muscle cramps, muscle pain, irregular heartbeat, tingling, or numbness, shortness of breath, mood changes;
• high blood sugar levels;
• rapid and irregular heartbeat (atrial fibrillation);
• loss of appetite;
• constipation, diarrhea, or nausea;
• vomiting;
• abdominal pain;
• lack of energy;
• difficulty sleeping or maintaining sleep continuity;
• dizziness, tremors;
• muscle cramps, muscle weakness;
• bone pain, back pain;
• numbness, tingling, or burning sensation of the skin, pain in the hands or feet (peripheral sensory neuropathy);
• swelling of the body, including hands and feet;
• rash;
• urinary tract infection, which can cause burning during urination or frequent urination.

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

• falls;
• bleeding in the brain;
• reduced ability to move or feel in the hands, arms, feet, and legs due to nerve damage (peripheral sensory-motor neuropathy);
• numbness, tingling, and burning sensation of the skin (paresthesia);
• feeling of spinning, making it difficult to maintain a steady position and move properly;
• swelling caused by fluid accumulation;
• hives;
• itching;
• shingles;
• heart attack (chest pain radiating to the arms, neck, jaw, feeling of sweating, and shortness of breath, nausea, or vomiting);
• chest pain, infection in the chest;
• high blood pressure;
• reduced number of all types of blood cells (pancytopenia), which can cause increased susceptibility to bleeding and bruising. The patient may feel tired, weak, and short of breath, and is more prone to infections;
• reduced number of lymphocytes (a type of white blood cell), often caused by infection (lymphopenia);
• low magnesium levels in the blood (hypomagnesemia), which can cause fatigue, general weakness, muscle cramps, irritability, and low calcium levels in the blood (hypocalcemia), which can cause numbness, tingling, or burning sensation of the hands, feet, or lips, muscle cramps, muscle weakness, dizziness, confusion;
• low phosphate levels in the blood (hypophosphatemia), which can cause muscle weakness and irritability or confusion;
• high calcium levels in the blood (hypercalcemia), which can cause slowed reflexes and muscle weakness;
• high potassium levels in the blood, which can cause irregular heartbeat;
• low sodium levels in the blood, which can cause fatigue, confusion, tremors, seizures (epileptic fits), or coma;
• high uric acid levels in the blood, which can lead to gout;
• low blood pressure, which can cause dizziness or fainting;
• pain or dryness in the mouth;
• changes in taste;
• swelling of the abdomen;
• feeling of confusion;
• feeling of depression;
• loss of consciousness, fainting;
• clouding of the eye (cataract);
• kidney damage;
• inability to urinate;
• abnormal liver test results;
• pelvic pain;
• weight loss.

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

• stroke;
• hepatitis, which can cause itching, yellowing of the skin and eyes, light-colored stools, dark urine, abdominal pain, and fever;
• breakdown of cancer cells, leading to the release of toxic substances into the blood (tumor lysis syndrome), which can cause kidney problems;
• underactive thyroid, which can cause symptoms such as fatigue, lethargy, muscle weakness, slow heartbeat, weight gain.

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

• rejection of a transplanted solid organ (such as a heart or liver).

Reporting side effects

If side effects occur, including any not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

5. How to store Pomalidomide Reig Jofre

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and carton after EXP.

The expiry date refers to the last day of the month stated.

There are no special storage instructions for the medicine.

Do not use Pomalidomide Reig Jofre if the packaging is damaged or shows signs of opening.

Medicines should not be disposed of via wastewater or household waste. After treatment, unused medicine should be returned to the pharmacist in the pharmacy. This will help protect the environment.

6. Contents of the packaging and other information

What Pomalidomide Reig Jofre contains

• The active substance is pomalidomide.
• The other ingredients are isomalt 801 (E 953), isomalt 721 (E 953), cornstarch, and sodium stearyl fumarate.

Pomalidomide Reig Jofre, 3 mg, hard capsules:

• Each hard capsule contains 3 mg of pomalidomide.
• The capsule shell contains gelatin, titanium dioxide (E 171), brilliant blue FCF (E 133), and black ink.

Pomalidomide Reig Jofre, 4 mg, hard capsules:

• Each hard capsule contains 4 mg of pomalidomide.
• The capsule shell contains gelatin, brilliant blue FCF (E 133), titanium dioxide (E 171), erythrosine (E 172), and black ink.

The printing ink contains shellac (E 904), concentrated ammonia solution, potassium hydroxide, and iron oxide black (E 172).

What Pomalidomide Reig Jofre looks like and contents of the pack

Pomalidomide Reig Jofre, 3 mg, hard capsules: The capsule is size 2 (approximately 18 mm x 6 mm), with a light blue, opaque cap and a light blue, opaque body, with "LP" printed in black ink on the cap and "690" on the body, containing a yellow, granular powder.

Pomalidomide Reig Jofre, 4 mg, hard capsules: The capsule is size 2 (approximately 18 mm x 6 mm), with a blue, opaque cap and a blue, opaque body, with "LP" printed in black ink on the cap and "667" on the body, containing a yellow, granular powder.

Package sizes:

Blisters with PVC/PCTFE/ACLAR/Aluminum or blisters with OPA/Aluminum/PVC/Aluminum foil, in a cardboard box:

14 hard capsules (blisters)

14x1 hard capsule (perforated single-dose blisters)

21 hard capsules (blisters)

21x1 hard capsule (perforated single-dose blisters)

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Reig Jofre Sp. z o.o.

ul. Ostródzka 74N

03-289 Warsaw

e-mail: biuro@reigjofre.com

Tel.: +48 22 487 88 49

Importer

Qualimetrix S.A.
579 Mesogeion Avenue
Agia Paraskevi
15343 Athens
Greece
Adalvo Limited
Malta Life Sciences Park
Building 1, Level 4, Sir Temi Zammit Buildings
San Gwann SGN 3000
Malta
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA 3000
Malta

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

European Economic Area:

Denmark:
Pomalidomide Bioglan
Finland:
Pomalidomide Bioglan
France:
Pomalidomide Reig Jofre 1 mg, 2 mg, 3 mg and 4 mg capsules
Spain:
Pomalidomida Sala 3 mg hard capsules EFG
Pomalidomida Sala 4 mg hard capsules EFG
Netherlands:
Pomalidomide Reig Jofre 1 mg hard capsules
Pomalidomide Reig Jofre 2 mg hard capsules
Pomalidomide Reig Jofre 3 mg hard capsules
Pomalidomide Reig Jofre 4 mg hard capsules
Poland:
Pomalidomid Reig Jofre
Sweden:
Pomalidomide Bioglan
Italy:
Pomalidomide Reig Jofre

Date of the last update of the leaflet: