Pomalidomide Reig Jofre

Package leaflet: Information for the patient

Pomalidomide Reig Jofre 2 mg hard capsules, 3 mg hard capsules, 4 mg hard capsules

pomalidomide
Equivalent medicine
Pomalidomide Reig Jofre is expected to cause birth defects and may result in fetal death.

• Do not take this medicine if you are pregnant or may become pregnant.
• Follow the advice on contraceptive methods described in this leaflet.

Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Pomalidomide Reig Jofre is and what it is used for
2. What you need to know 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 pack and other information

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

What Pomalidomide Reig Jofre is
Pomalidomide Reig Jofre contains the active substance "pomalidomide". This medicine is related to
thalidomide and belongs to a group of medicines that act on the immune system (the body's natural defences).

What Pomalidomide Reig Jofre is used for
Pomalidomide Reig Jofre is used to treat adults with a type of cancer called "multiple myeloma".
Pomalidomide Reig Jofre is used in combination with:

• two other medicines, called "bortezomib" (a type of chemotherapy medicine) and "dexamethasone" (an anti-inflammatory medicine), in patients who have received at least one other therapy containing lenalidomide. Or
• one other medicine, called "dexamethasone", in patients whose myeloma has worsened despite having received at least two prior therapies containing lenalidomide and bortezomib.

What is multiple myeloma
Multiple myeloma is a type of cancer that affects a certain type of white blood cells (called "plasma cells"). These cells grow uncontrollably and accumulate in the bone marrow. This leads to damage to the bones and kidneys.
Multiple myeloma is generally incurable. However, treatment can reduce or eliminate signs and symptoms of the disease for a certain period of time. When this occurs, it is referred to as a "response".

How Pomalidomide Reig Jofre works
Pomalidomide Reig Jofre works in several ways:

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

Benefit of using Pomalidomide Reig Jofre with bortezomib and dexamethasone
When Pomalidomide Reig Jofre is used together with bortezomib and dexamethasone in patients who have received at least one other therapy, it can prevent multiple myeloma from worsening:

• On average, pomalidomide used with bortezomib and dexamethasone delayed the progression of multiple myeloma for up to 11 months, compared to 7 months in patients treated with bortezomib and dexamethasone alone.

Benefit of using Pomalidomide Reig Jofre with dexamethasone
When Pomalidomide Reig Jofre is used together with dexamethasone in patients who have received at least two prior therapies, it can prevent multiple myeloma from worsening:

• On average, Pomalidomide Reig Jofre used with dexamethasone delayed the progression of multiple myeloma for up to 4 months, compared to 2 months in patients treated with dexamethasone alone.

2. What you should know before taking Pomalidomide Reig Jofre

Do not take Pomalidomide Reig Jofre

• 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 pregnant or think you may be pregnant, or if you are planning a pregnancy, because Pomalidomide Reig Jofre is expected to be harmful to the unborn child. (Men and women taking this medicine must read the section “Pregnancy, contraception and breastfeeding – information for women and men” below);
• if there is any possibility that you may become pregnant unless you follow all necessary measures to avoid pregnancy (see “Pregnancy, contraception and breastfeeding – information for women and men”). If there is any possibility of becoming pregnant, at each prescription your doctor will record that the necessary measures have been taken and will provide you with confirmation of this.

If you are unsure whether any of the conditions listed above apply to you, consult your doctor, pharmacist,
or nurse before taking Pomalidomide Reig Jofre.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Pomalidomide Reig Jofre if:

• you have previously had episodes of blood clots. There is an increased risk of developing blood clots in veins and arteries during treatment with Pomalidomide Reig Jofre. Your doctor may recommend additional treatments (e.g. warfarin) or reduce the dose of Pomalidomide Reig Jofre to reduce the likelihood of blood clots forming;
• you have previously had an allergic reaction, such as rash, itching, swelling, dizziness, or difficulty breathing, during treatment with related medicines called “thalidomide” or “lenalidomide”;
• you have had a heart attack, have heart failure, have breathing difficulties, or if you smoke, have high blood pressure, or high cholesterol levels;
• you have a high tumour burden throughout the body, including in the bone marrow. This could lead to a condition in which tumours break down and cause abnormal levels of chemicals in the blood, which may result in kidney failure. An irregular heartbeat may also occur. This condition is called tumour lysis syndrome;
• you have or have previously had neuropathy (nerve damage causing tingling or pain in the hands or feet);
• you have or have previously had hepatitis B infection. Treatment with Pomalidomide Reig Jofre may cause reactivation of the hepatitis B virus in patients carrying this virus, leading to a recurrence of the infection. Your doctor must check whether you have ever had hepatitis B infection;
• you have or have previously had any combination of the following symptoms: rash on the face or more widespread, skin redness, high fever, flu-like symptoms, swollen lymph nodes (these are signs of a serious 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 important to note that patients with multiple myeloma treated with pomalidomide may develop other
types of cancer; therefore, your doctor must carefully evaluate the benefit and risk when prescribing this
medicine.
At any time during or after treatment, immediately inform your doctor or nurse if you experience blurred vision,
loss of vision or double vision, difficulty speaking, weakness in one arm or leg, changes in the way you walk or
balance problems, persistent numbness, reduced sensation or loss of sensation, memory loss or confusion. These
may be symptoms of a serious and potentially fatal brain disease known as progressive multifocal
leucoencephalopathy (PML).
If you had these symptoms before starting treatment with Pomalidomide Reig Jofre, inform your doctor of any
changes in these symptoms.
At the end of treatment, you must return all unused capsules to the pharmacist.
Children and adolescents
Pomalidomide Reig Jofre is not recommended for use in children and young people under 18 years of age.
Other medicines and Pomalidomide Reig Jofre
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. This is because Pomalidomide Reig Jofre may affect the action of other medicines.
Other medicines may also affect the action of Pomalidomide Reig Jofre.
In particular, inform your doctor, pharmacist, or nurse before taking Pomalidomide Reig Jofre 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 women and men
The following instructions must be followed, as indicated in the Pomalidomide Reig Jofre Pregnancy Prevention Programme. Women and men taking Pomalidomide Reig Jofre must not initiate a pregnancy or father a child. This is because pomalidomide is expected to be harmful to the unborn child. You and your partner must use effective contraceptive measures during treatment with this medicine.
Women
Do not take Pomalidomide Reig Jofre if you are pregnant, suspect you may be pregnant, or are planning a
pregnancy. This is because this medicine is expected to be harmful to the unborn child. Before starting treatment, you must inform your doctor if there is any possibility that you could become pregnant, even if you think it is unlikely.
If there is any possibility of becoming pregnant:

• you must use effective contraceptive methods for at least 4 weeks before starting treatment, throughout the duration of treatment, and for at least 4 weeks after stopping treatment. Consult your doctor about the most suitable contraceptive method for you.
• At each prescription, your doctor will ensure that you understand the necessary measures to prevent pregnancy.
• Your doctor will arrange 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 consult your doctor right away.

Breastfeeding
It is not known whether Pomalidomide Reig Jofre passes into breast milk. Inform your doctor if you are breastfeeding or intend to breastfeed. Your doctor will advise you whether to stop or continue breastfeeding.
Men
Pomalidomide Reig Jofre passes into human seminal fluid.

• If your partner is pregnant or there is a possibility she may become pregnant, you must use condoms throughout the duration of treatment and for 7 days after treatment ends.
• If your partner becomes pregnant during treatment with Pomalidomide Reig Jofre, inform your doctor immediately. Your partner must also inform her doctor immediately.

You must not donate seminal fluid or sperm during treatment and for 7 days after treatment ends.
Blood donation and blood tests
You must not donate blood during treatment and for 7 days after treatment ends. Before and during treatment with Pomalidomide Reig Jofre, you will undergo regular blood tests. This is because the medicine may cause a reduction in blood cells that fight infections (white blood cells) and cells that stop bleeding (platelets).
Your doctor will ask you to have blood tests:

• before starting treatment;
• weekly for the first 8 weeks of treatment;
• at least once a month thereafter, throughout the duration of treatment with Pomalidomide Reig Jofre.

Based on the results of these tests, your doctor may adjust the dose of Pomalidomide Reig Jofre or stop treatment. Your doctor may also adjust the dose or stop treatment based on your overall health status.
Driving and using machines
Some people may experience fatigue, dizziness, fainting, confusion, or reduced alertness when taking Pomalidomide Reig Jofre. If this occurs, do not drive or operate tools or machinery.
Pomalidomide Reig Jofre contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.
Pomalidomide Reig Jofre contains isomaltitol
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Pomalidomide Reig Jofre

Pomalidomide Reig Jofre must be prescribed and administered by a physician experienced in the treatment of multiple myeloma.
Always take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor, pharmacist, or nurse.

For markets where Pomalidomide Reig Jofre is not available in 1 mg or 2 mg strengths
In cases where dosage strengths cannot be achieved with Pomalidomide Reig Jofre 3 mg and Pomalidomide Reig Jofre 4 mg capsules, another medicinal product containing pomalidomide as the active substance in the appropriate dosage strength and formulation should be used.

When to take Pomalidomide Reig Jofre with other medicines
Pomalidomide Reig Jofre with bortezomib and dexamethasone

• Read the package leaflet for bortezomib and dexamethasone for further information on their use and effects.
• Pomalidomide Reig Jofre, bortezomib, and dexamethasone are administered in “treatment cycles”. Each cycle lasts 21 days (3 weeks).
• Refer to the table below to see which medicines to take each day of the 3-week cycle:
  • Each day, check the schedule and find the correct day to determine which medicines to take.
  • On some days you will take all three medicines, on some days only two or one medicine, and on other days no medicine at all.
    POM: Pomalidomide (Pomalidomide Reig Jofre); BOR: Bortezomib; DEX: Dexamethasone

Cycles 1 to 8                      From Cycle 9 onwards

• After completing each 3-week cycle, start a new one.

Pomalidomide Reig Jofre with dexamethasone alone

• Consult the dexamethasone package leaflet for more information on its use and effects.
• Pomalidomide Reig Jofre and dexamethasone are taken in treatment cycles. Each cycle lasts 28 days (4 weeks).
• Refer to the following table to know which medicines to take each day of the 4-week cycle:
  • Each day, check the chart and find the correct day to know which medicines to take.
• On some days you will take both medicines, on some days only one medicine, and on other days no medicine at all.

POM: Pomalidomide (Pomalidomide Reig Jofre); DEX: Dexamethasone

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

Dose of Pomalidomide Reig Jofre to be taken with other medicines
Pomalidomide Reig Jofre with bortezomib and dexamethasone

• The recommended starting dose of Pomalidomide Reig Jofre is 4 mg once daily.
• The recommended starting dose of bortezomib will be determined by your doctor based on your height and weight (1.3 mg/m² of 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 Reig Jofre with dexamethasone alone

• The recommended starting dose of Pomalidomide Reig Jofre 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 Reig Jofre, bortezomib, or dexamethasone, or
discontinue one or more of these medicines based on the results of blood tests, your general condition, other
medicines you may be taking (e.g. ciprofloxacin, enoxacin, and fluvoxamine), and if you experience adverse
effects (particularly rash or swelling) due to treatment.
If you have liver or kidney problems, your doctor will monitor your condition very closely during treatment with
this medicine.
How to take Pomalidomide Reig Jofre

• Do not split, open, or chew the capsules. If the powder from a broken Pomalidomide Reig Jofre capsule comes into contact with the skin, wash the skin immediately and thoroughly with soap and water.
• Healthcare providers, caregivers, and family members should wear disposable gloves when handling the blister pack or capsule. Gloves should then be removed carefully to avoid skin exposure, placed in a sealed polyethylene bag, and disposed of according to local regulations. Hands should then be thoroughly washed with soap and water. Pregnant women (confirmed or suspected) must not handle the blister pack or capsule.
• Swallow the capsules whole, preferably with water.
• The capsules may be taken with or without food.
• Take Pomalidomide Reig Jofre every day at approximately the same time.

To remove the capsule from the blister, press on one side of the capsule, pushing it through the aluminium foil.
Do not press in the centre of the capsule, as it may break.

Your doctor will advise you on how and when to take Pomalidomide Reig Jofre if you have kidney problems and
are on dialysis.
Duration of treatment with Pomalidomide Reig Jofre
You must continue the treatment cycles until your doctor tells you to stop.
If you take more Pomalidomide Reig Jofre than you should
If you take more Pomalidomide Reig Jofre than you should, consult your doctor or go to hospital
immediately. Take the medicine pack with you.
If you forget to take Pomalidomide Reig Jofre
If you forget to take Pomalidomide Reig Jofre on the prescribed day, take the next capsule as usual the
following day. Do not increase the number of capsules to make up for the missed dose of Pomalidomide Reig
Jofre the previous day.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Stop taking Pomalidomide Reig Jofre and contact your doctor immediately if you experience any of the
following side effects – urgent medical treatment may be required:

• Fever, chills, sore throat, cough, mouth ulcers, or any other sign of infection (due to reduced number of white blood cells, which fight infections).
• Bleeding or bruising without reason, including nosebleeds and bleeding from the intestine or stomach (due to effects on blood cells called "platelets").
• Rapid breathing, fast pulse, fever and chills, little or no urination, nausea and vomiting, confusion, unconsciousness (due to a blood infection called sepsis or septic shock).
• Severe, persistent or bloody diarrhoea (possibly with stomach pain or fever) caused by bacteria called Clostridium difficile.
• Chest pain or pain and swelling in the legs, especially in the lower leg or calf (caused by blood clots).
• Shortness of breath (due to severe chest infection, lung inflammation, heart failure or blood clot).
• 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 growths. If you notice any skin changes during treatment with Pomalidomide Reig Jofre, inform your doctor as soon as possible.
• Reactivation of hepatitis B infection, which may cause yellowing of the skin and eyes, dark brown urine, pain in the right side of the abdomen, fever, nausea or vomiting. Inform your doctor immediately if you notice any of these symptoms.
• 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). Stop taking pomalidomide if these symptoms occur and contact your doctor or seek immediate medical help. See also section 2.

Stop taking Pomalidomide Reig Jofre and contact your doctor immediately if any of the above-mentioned serious side effects occur: urgent medical treatment may be required.

Other side effects

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

• Shortness of breath (dyspnoea).
• Lung infections (pneumonia and bronchitis).
• Infections of the nose, sinuses and throat caused by bacteria or viruses.
• Flu-like symptoms (influenza).
• Low number of red blood cells, which may cause anaemia resulting in tiredness and weakness.
• Low levels of potassium in the blood (hypokalaemia), which may cause weakness, muscle cramps, muscle pain, palpitations, tingling or numbness, shortness of breath, mood changes.
• High blood sugar levels.
• Fast and irregular heartbeat (atrial fibrillation).
• Loss of appetite.
• Constipation, diarrhoea or nausea.
• Feeling unwell (vomiting).
• Abdominal pain.
• Lack of energy.
• Difficulty falling asleep or staying asleep.
• Dizziness, tremor.
• Muscle spasms, muscle weakness.
• Bone pain, back pain.
• Numbness, tingling or burning sensation on the skin, pain in hands or feet (peripheral sensory neuropathy).
• Swelling of the body, including arms and legs.
• Skin rashes.
• Urinary tract infection, possibly causing a burning sensation when urinating or a 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 sensations in the hands, arms, feet and legs due to nerve system damage (peripheral sensory-motor neuropathy).
• Numbness, itching and sensation of pins and needles on the skin (paraesthesia).
• Feeling of dizziness, with difficulty standing up and moving normally.
• Swelling caused by fluid retention.
• Hives.
• Itching of the skin.
• Herpes zoster (shingles).
• Heart attack (chest pain spreading to the arms, neck, jaw, feeling of sweating and shortness of breath, nausea or vomiting).
• Chest pain, chest infection.
• Increased blood pressure.
• Simultaneous reduction in the number of red blood cells, white blood cells and platelets (pancytopenia), making you more prone to bleeding and bruising. You may feel tired, weak and breathless and may be more likely to develop infections.
• Reduced number of lymphocytes (a type of white blood cells), often caused by infection (lymphopenia).
• Low levels of magnesium in the blood (hypomagnesaemia), which may cause fatigue, generalized weakness, muscle cramps, irritability and may lead to low levels of calcium in the blood (hypocalcaemia), possibly causing numbness and/or tingling in the hands, feet or lips, muscle cramps, muscle weakness, dizziness, confusion.
• Low levels of phosphate in the blood (hypophosphataemia), which may cause muscle weakness and irritability or confusion.
• High levels of calcium in the blood (hypercalcaemia), which may cause slowed reflexes and weakness of the skeletal muscles.
• High levels of potassium in the blood, which may cause an abnormal heart rhythm.
• Low levels of sodium in the blood, which may cause tiredness and confusion, muscle spasms, seizures or coma.
• High levels of uric acid in the blood, which may cause a form of arthritis called gout.
• Low blood pressure, which may cause dizziness or fainting.
• Painful or dry mouth.
• Altered sense of taste.
• Swollen abdomen.
• Feeling confused.
• Feeling low in mood (depressed mood).
• Loss of consciousness, fainting.
• Blurred vision (cataract).
• Kidney damage.
• Inability to urinate.
• Abnormalities in liver function tests.
• Pelvic pain.
• Weight loss.

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

• Stroke.
• Inflammation of the liver (hepatitis), which may cause itching, yellowing of the skin and whites of the eyes (jaundice), pale stools, dark urine and abdominal pain.
• Breakdown of tumour cells, causing the release of toxic substances into the bloodstream (tumour lysis syndrome). This may cause kidney problems.
• Underactive thyroid gland, which may cause symptoms such as fatigue, lethargy, muscle weakness, slow heartbeat and weight gain.

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

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

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pomalidomide Reig Jofre

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and on the carton after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use Pomalidomide Reig Jofre if you notice damage or signs of tampering with the medicine packaging.
Do not dispose of any medicine via wastewater or household waste. Unused medicine must be returned to the pharmacist at the end of treatment. This will help protect the environment.

6. Package contents and other information

What Pomalidomide Reig Jofre contains

• The active substance is pomalidomide.
• The other components are isomaltitol 801, isomaltitol 721, pregelatinized maize starch and sodium stearyl fumarate.

Pomalidomide Reig Jofre 2 mg hard capsules

• Each hard capsule contains 2 mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172) and black ink.

Pomalidomide Reig Jofre 3 mg hard capsules

• Each hard capsule contains 3 mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E171), brilliant blue FCF (E133) 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 (E133), titanium dioxide (E171), erythrosine (E127) and black ink.

The printing ink contains shellac (E904), strong ammonia solution, potassium hydroxide and black iron oxide (E172).
Description of the appearance of Pomalidomide Reig Jofre and package contents
Pomalidomide Reig Jofre 2 mg Hard Capsules: opaque orange cap and opaque orange body, capsule size no. 3 (approximately 16 mm x 6 mm), with "LP" printed in black ink on the cap and "665" on the body, containing yellow granular powder.
Pomalidomide Reig Jofre 3 mg Hard Capsules: opaque powder blue cap and opaque powder blue body, capsule size no. 2 (approximately 18 mm x 6 mm), with "LP" printed in black ink on the cap and "690" on the body, containing yellow granular powder.
Pomalidomide Reig Jofre 4 mg Hard Capsules: opaque blue cap and opaque blue body, capsule size no. 2 (approximately 18 mm x 6 mm), with "LP" printed in black ink on the cap and "667" on the body, containing yellow granular powder.
Pack sizes:
PVC/PCTFE (Aclar) – Aluminium and OPA/Al/PVC – Aluminium blisters:
14 hard capsules (blister)
14 x 1 hard capsule (unit dose divisible blisters)
21 hard capsules (blister)
21 x 1 hard capsule (unit dose divisible blisters)
Not all pack sizes may be marketed.
Marketing Authorization Holder
Laboratorio Reig Jofre S.A.
Gran Capitan, 10
08970 Sant Joan Despí (Barcelona)
Spain
Manufacturers
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 in the European Economic Area Member States under the following names:
Denmark: Pomalidomide Bioglan
Spain: Pomalidomida Sala 3 mg y 4 mg cápsulas duras EFG
Finland: Pomalidomide Bioglan
France: Pomalidomide Reig Jofre 1 mg, 2 mg, 3 mg et 4 mg gélule
Netherlands: Pomalidomide Reig Jofre 1 mg, 2 mg, 3 mg en 4 mg harde capsule
Italy: Pomalidomide Reig Jofre 2 mg, 3 mg, 4 mg capsule rigide
Poland: Pomalidomid Reig Jofre
Sweden: Pomalidomide Bioglan