Pomalidomide olpha

Package leaflet: Information for the patient

Pomalidomide Olpha, 1 mg, hard capsules
Pomalidomide Olpha, 2 mg, hard capsules
Pomalidomide Olpha, 3 mg, hard capsules
Pomalidomide Olpha, 4 mg, hard capsules
Pomalidomide
Pomalidomide Olpha is expected to cause severe birth defects and may result in fetal death.

• Do not take Pomalidomide Olpha if you are pregnant or may become pregnant.
• You must strictly follow the contraceptive advice provided in this leaflet.

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to anyone else. It may harm other people, even if their symptoms are the same as yours.
• If you get any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

1. What Pomalidomide Olpha is and what it is used for

What Pomalidomide Olpha is
Pomalidomide Olpha contains the active substance pomalidomide. This medicine is similar to thalidomide and belongs to a group of medicines that affect the immune system (the body's natural defences).

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

• two other medicines, bortezomib (a chemotherapy medicine) and dexamethasone (an anti-inflammatory medicine), in patients who have already received at least one prior treatment containing lenalidomide or
• one other medicine, dexamethasone, in patients with multiple myeloma whose disease has worsened despite having previously received at least two prior treatments containing lenalidomide and bortezomib.

What is multiple myeloma
Multiple myeloma is a cancer that affects a certain type of white blood cells (called plasma cells). These cells grow uncontrollably and accumulate in the bone marrow, causing damage to bones and kidneys.
Multiple myeloma is generally incurable. However, treatment may relieve symptoms or cause the disease to go into remission for a period of time — this is called a response to treatment.

How Pomalidomide Olpha works
Pomalidomide Olpha works in several different 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 tumour cells with nutrients.

Benefits of using Pomalidomide Olpha with bortezomib and dexamethasone
When used in combination with bortezomib and dexamethasone in patients who have received at least one prior treatment, Pomalidomide Olpha can slow the progression of multiple myeloma.

• Pomalidomide Olpha used with bortezomib and dexamethasone typically delayed the recurrence of multiple myeloma for up to 11 months — compared to 7 months in patients who received only bortezomib and dexamethasone.

Benefits of using Pomalidomide Olpha with dexamethasone
When used in combination with dexamethasone in patients who have received at least two prior treatments, Pomalidomide Olpha can slow the progression of multiple myeloma.

• Pomalidomide Olpha used with dexamethasone typically delayed the recurrence of multiple myeloma for up to 4 months — compared to 2 months in patients who received only dexamethasone.

2. Important information before using Pomalidomide Olpha

When not to take Pomalidomide Olpha:

• if the patient is pregnant, suspects she may be pregnant, or plans to become pregnant, because Pomalidomide Olpha is expected to be harmful to the unborn child (both men and women taking this medicine must read the section "Pregnancy, contraception and breastfeeding – information for women and men" below).
• if the patient could become pregnant unless she uses all required methods of contraception (see section "Pregnancy, contraception and breastfeeding – information for women and men"). If the patient could become pregnant, the doctor will always document at each prescription that necessary precautions have been taken and will confirm this with the patient.
• if the patient is allergic to pomalidomide or any of the other ingredients of this medicine (listed in section 6). If an allergic reaction to the medicine is suspected, consult a doctor for advice.

If the patient is unsure whether any of the above situations apply, consult a doctor, pharmacist, or nurse before starting treatment with Pomalidomide Olpha.

Warnings and precautions

Before starting treatment with Pomalidomide Olpha, discuss with the doctor, pharmacist, or nurse if:

• the patient has ever had blood clots in the past. Treatment with Pomalidomide Olpha increases the risk of blood clots in veins and arteries. The doctor may prescribe additional treatment (e.g. warfarin) or reduce the dose of Pomalidomide Olpha to lower the risk of blood clots.
• the patient has ever experienced an allergic reaction such as rash, itching, swelling, dizziness, or difficulty breathing while taking similar medicines called “thalidomide” and “lenalidomide”.
• the patient has had a heart attack, has heart failure, experiences breathing difficulties, or if the patient smokes, has high blood pressure, or high cholesterol levels.
• the patient has extensive tumour burden in the body, including in the bone marrow. This may lead to tumour lysis syndrome, in which tumours break down rapidly, causing abnormal levels of chemicals in the blood, potentially leading to kidney failure. The patient may also experience irregular heartbeats. This condition is known as tumour lysis syndrome.
• the patient has or has had neuropathy (nerve damage causing tingling or pain in the hands or feet).
• the patient has or has had hepatitis B virus infection. Taking Pomalidomide Olpha may reactivate the virus in previously infected patients, leading to a recurrence of infection. The doctor should check whether the patient has been previously infected with hepatitis B virus.
• the patient has or has had any of the following symptoms together: facial rash or widespread rash, redness of the skin, high fever, flu-like symptoms, or swollen lymph nodes (observed symptoms of a severe skin reaction known as “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”).

Please note that additional types of cancers may occur in patients with multiple myeloma treated with pomalidomide. Therefore, the doctor should carefully assess the benefits and risks of prescribing this medicine.

During or after treatment, immediately inform the doctor or nurse if any of the following symptoms occur: vision disturbances, loss of vision, double vision, difficulty speaking, weakness in arms or legs, changes in walking, balance problems, persistent numbness, reduced sensation, loss of sensation, memory loss, or disorientation. All these symptoms may indicate a serious and potentially fatal brain disease called progressive multifocal leukoencephalopathy (PML). If these symptoms occurred before treatment with Pomalidomide Olpha, inform the doctor of any changes in these symptoms.

After treatment ends, return any unused capsules to a pharmacy that accepts them.

Pregnancy, contraception and breastfeeding – information for women and men

As indicated below, pregnancy prevention programme requirements must be followed during treatment with Pomalidomide Olpha. Women taking Pomalidomide Olpha must not become pregnant, and men taking pomalidomide must not allow their female partners to become pregnant, because this medicine is expected to be harmful to the unborn child. The patient and his partner or her partner should use effective contraception methods during treatment with this medicine.

Women

Do not use Pomalidomide Olpha if the patient is pregnant, suspects she may be pregnant, or plans to become pregnant, because this medicine is expected to be harmful to the unborn child. Before starting treatment, the patient should inform the doctor that she could become pregnant, even if she considers it unlikely.

If the patient could become pregnant:

• she must use effective contraception methods for at least 4 weeks before starting treatment, throughout the treatment period, and for at least 4 weeks after stopping treatment. The patient should discuss with the doctor which contraception method is best for her.
• at each prescription, the doctor will ensure that the patient understands all necessary actions required to prevent pregnancy.
• the doctor will order pregnancy tests before treatment, at least every 4 weeks during treatment, and for at least 4 weeks after treatment ends.

If the patient becomes pregnant despite using preventive methods:

• she must immediately stop treatment and inform the doctor without delay.

Breastfeeding

It is not known whether Pomalidomide Olpha passes into human milk. If the patient is breastfeeding or intends to breastfeed, she must inform the doctor. The doctor will advise whether she should stop or continue breastfeeding.

Men

Pomalidomide Olpha passes into human semen.

• If the partner is pregnant or could become pregnant, the man must use a condom throughout the entire treatment period and for 7 days after treatment ends.
• If the female partner of a man being treated with Pomalidomide Olpha becomes pregnant, inform the doctor immediately. The partner should seek medical advice without delay.

The patient must not donate sperm during treatment and for 7 days after treatment ends.

Blood donation and blood tests

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

Before and during treatment with Pomalidomide Olpha, the patient will undergo regular blood tests. This is necessary because this medicine may reduce the number of blood cells (white blood cells) that help fight infections and reduce the number of platelets that help stop bleeding.

The doctor should order blood tests:

• before treatment,
• weekly during the first 8 weeks of treatment,
• then at least once a month for as long as the patient is taking Pomalidomide Olpha.

The doctor may adjust the dose of Pomalidomide Olpha or discontinue treatment based on the patient's blood test results. The doctor may also change the dose or discontinue treatment due to the patient's overall health condition.

Children and adolescents

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

Pomalidomide Olpha and other medicines

Inform the doctor, pharmacist, or nurse about all medicines the patient is currently taking, has recently taken, or plans to take, because Pomalidomide Olpha may affect the action of other medicines. Other medicines may also affect the action of Pomalidomide Olpha.

Before taking Pomalidomide Olpha, inform the doctor, pharmacist, or nurse, especially if the patient is taking any of the following medicines:

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

Driving and using machines

While taking Pomalidomide Olpha, some people may experience fatigue, dizziness, fainting, confusion, or reduced alertness. If the patient experiences any of these symptoms, he or she should not drive, operate tools, or use machinery.

Pomalidomide Olpha contains sucrose

If the patient has been previously diagnosed with an intolerance to certain sugars, the patient should consult the doctor before taking this medicine.

Pomalidomide Olpha contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning it is considered "sodium-free".

3. How to take Pomalidomide Olpha

Pomalidomide Olpha must be prescribed by a doctor experienced in the treatment of multiple myeloma.
This medicine should always be taken exactly as recommended by the doctor. If in doubt, consult the doctor, pharmacist, or nurse.
When to take Pomalidomide Olpha with other medicines
Pomalidomide Olpha with bortezomib and dexamethasone

• Read the package leaflets included with bortezomib and dexamethasone for further information on their use and effects.
• Pomalidomide Olpha, bortezomib, and dexamethasone are used in treatment cycles. Each cycle lasts 21 days (3 weeks).
• Refer to the table below to check which medicines should be taken on each day of the 3-week cycle:
  o Check the table every day to see which medicines should be taken on that day.
  o On some days, all three medicines are taken; on other days, only two or one medicine is taken, and on some days, no medicines are taken.

POM: Pomalidomide; BOR: Bortezomib; DEX: Dexamethasone

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

Pomalidomide Olpha with dexamethasone only

• Please refer to the package leaflet for dexamethasone for further information on its use and effects.
• Pomalidomide Olpha and dexamethasone are used in treatment cycles. Each cycle lasts 28 days (4 weeks).
• Refer to the table below to determine which medicines should be taken on each day of the 4-week cycle:
  o Each day, check the table to see which medicines should be taken on that day.
  o On some days, both medicines should be taken; on other days, only one medicine should be taken; and on some days, no medicine should be taken.

POM: Pomalidomide; DEX: Dexamethasone

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

What dose of Pomalidomide Olpha should be taken with other medicines
Pomalidomide Olpha with bortezomib and dexamethasone

• The recommended starting dose of Pomalidomide Olpha is 4 mg once daily.
• The recommended starting dose of bortezomib will be determined by the doctor based on the patient's height and body weight (1.3 mg/m² body surface area).
• The recommended starting dose of dexamethasone is 20 mg once daily. However, if the patient is over 75 years of age, the recommended starting dose is 10 mg once daily.

Pomalidomide Olpha with dexamethasone only

• The recommended dose of Pomalidomide Olpha is 4 mg once daily.
• The recommended starting dose of dexamethasone is 40 mg once daily. However, if the patient is over 75 years of age, the recommended starting dose is 20 mg once daily.

The doctor may reduce the dose of Pomalidomide Olpha, bortezomib, or dexamethasone, or
discontinue treatment with one or more of these medicines depending on the patient's blood test results,
general health condition, use of other medicines (e.g. ciprofloxacin, enoxacin,
and fluvoxamine), and if treatment-related adverse reactions occur
(especially rash or swelling).
If the patient has liver or kidney disease, the doctor will closely monitor the patient's health condition during treatment with this medicine.
How to take Pomalidomide Olpha

• Do not crush, open, or chew the capsules. If powder from a damaged 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. Gloves should then be carefully removed to avoid skin exposure, placed in a sealable polyethylene plastic bag, and disposed of according to local regulations. Hands should then be washed thoroughly 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.
• The capsules may be taken with or without food.
• The capsules should be taken at approximately the same time each day.

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

If the patient has kidney disease and is on dialysis, the doctor will advise how and when to take Pomalidomide Olpha.
Duration of treatment with Pomalidomide Olpha
Treatment cycles should be continued until the doctor decides to discontinue treatment.
Taking more than the recommended dose of Pomalidomide Olpha
If more than the recommended dose of Pomalidomide Olpha has been taken, contact a doctor immediately or go to a hospital. Take the medicine packaging with you.
Missed dose of Pomalidomide Olpha
If a dose of Pomalidomide Olpha is missed on the day it should have been taken, take the next capsule at the scheduled time on the following day. Do not take a double dose to make up for the missed Pomalidomide Olpha capsule.
If there are any further questions about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

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

Serious adverse reactions
If any of the following serious adverse reactions occur, discontinue treatment with Pomalidomide Olpha immediately and contact your doctor without delay – immediate medical treatment may be required:

• Fever, chills, sore throat, cough, mouth ulcers or any other signs of infection (due to reduced number of white blood cells, which help fight infections).
• Unexplained bleeding or bruising, including nosebleeds or gastrointestinal or stomach bleeding (due to the effect of the medicine on blood cells called platelets).
• Rapid breathing, fast heartbeat, fever and chills, passing very little or no urine, nausea and vomiting, confusion, loss of consciousness (due to a bloodstream infection called sepsis or septic shock).
• Severe, persistent or bloody diarrhoea (with or without abdominal pain or fever) caused by bacteria known as Clostridium difficile.
• Chest pain or leg pain and swelling, particularly in the calf or shin (due to blood clots).
• Shortness of breath (due to severe chest infections, pneumonia, heart failure or blood clots).
• Swelling of the face, lips, tongue or throat, which may cause difficulty breathing (due to severe allergic reactions known as 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 the development of skin lesions. If you notice any skin changes while taking Pomalidomide Olpha, inform your doctor as soon as possible.
• Reactivation of hepatitis B virus infection, which may cause yellowing of the skin and whites of the eyes, dark brown urine, pain in the right side of the abdomen, fever, nausea and vomiting. Contact your doctor immediately if you notice any of these symptoms.
• Widespread rash, high fever, swollen lymph nodes and involvement of other organs (drug rash with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome, toxic epidermal necrolysis or Stevens-Johnson syndrome). If any of these symptoms occur, stop taking pomalidomide immediately and contact your doctor or seek urgent medical help. See also section 2.

If any of the above serious adverse reactions occur, discontinue treatment with Pomalidomide Olpha immediately and contact your doctor without delay – immediate medical treatment may be required.

Other adverse reactions

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.
• Influenza-like symptoms (flu).
• Decreased number of red blood cells, which may lead to anaemia causing fatigue 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 levels of blood sugar.
• Fast and irregular heartbeat (atrial fibrillation).
• Loss of appetite.
• Constipation, diarrhoea or nausea.
• Vomiting.
• Abdominal pain.
• Lack of energy.
• Difficulty falling asleep or maintaining sleep.
• Dizziness, tremor.
• Muscle cramps, muscle weakness.
• Bone pain, back pain.
• Numbness, tingling or burning sensation of the skin, pain in hands or feet (sensory peripheral neuropathy).
• Swelling of the body, including hands and feet.
• Rash.
• Urinary tract infection, which may cause burning during urination 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 in the hands, arms, feet and legs due to nerve damage (sensory-motor peripheral neuropathy).
• Numbness, itching and tingling of the skin (paraesthesiae).
• Sensation of spinning in the head, making it difficult to maintain proper standing posture and movement.
• Swelling due to fluid accumulation.
• Urticaria (hives).
• Itching of the skin.
• Shingles (herpes zoster).
• Heart attack (chest pain spreading to arms, neck, jaw, feeling of sweating and shortness of breath, nausea or vomiting).
• Chest pain, infection in the chest area.
• High blood pressure.
• Simultaneous decrease in the number of red blood cells, white blood cells and platelets (pancytopenia), leading to increased risk of bleeding and bruising. The patient may feel tired, weak, short of breath and more susceptible to infections.
• Decreased number of lymphocytes (a type of white blood cell), often caused by infection (lymphopenia).
• Low levels of magnesium in the blood (hypomagnesaemia), which may cause fatigue, generalised weakness, muscle cramps, irritability and may lead to low levels of calcium in the blood (hypocalcaemia), which may cause numbness and/or tingling in hands, feet or lips, muscle cramps, muscle weakness, feeling of emptiness in the head, confusion.
• Low levels of phosphate in the blood (hypophosphataemia), which may cause muscle weakness, irritability or confusion.
• High levels of calcium in the blood (hypercalcaemia), which may cause slowed reflexes and skeletal muscle weakness.
• High levels of potassium in the blood (hyperkalaemia), which may cause irregular heart rhythm.
• Low levels of sodium in the blood (hyponatraemia), which may cause fatigue and confusion, muscle twitching, seizures (epileptic fits) or coma.
• High levels of uric acid in the blood, which may lead to joint inflammation in the form of gout.
• Low blood pressure, which may cause dizziness or fainting.
• Pain or dryness in the mouth.
• Changes in taste sensation.
• Abdominal bloating.
• Feeling confused.
• Depression.
• Loss of consciousness, fainting.
• Clouding of the eye (cataract).
• Kidney damage.
• Inability to pass urine.
• Abnormal liver function tests.
• Pelvic pain.
• Weight loss.

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

• Stroke.
• Hepatitis, which may cause itching of the skin, yellowing of the skin and whites of the eyes (jaundice), pale-coloured stools, dark-coloured urine and abdominal pain.
• Tumour lysis syndrome – breakdown of tumour cells leading to the release of toxic substances into the blood, which may lead to kidney problems.
• Hypothyroidism, 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 transplanted solid organs (such as heart or liver).

Reporting of adverse reactions
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration 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
Reporting adverse reactions helps provide more information on the safety of this medicine.
Adverse reactions may also be reported to the responsible entity.

5. How to store Pomalidomide Olpha

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and cardboard
container following: EXP or Expiry date (EXP). The expiry date refers to the last day of the
specified month.
No special storage instructions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Unused medicine
remaining after completion of treatment should be returned to a pharmacy that accepts such returns.
This practice helps protect the environment.

6. Contents of the pack and other information

What Pomalidomide Olpha contains

• The active substance is pomalidomide.
• The other ingredients are microcrystalline cellulose, pregelatinized starch, sucrose, and sodium stearyl fumarate. The printing ink (black) contains shellac (E904), propylene glycol (E1520), iron(III) oxide black (E172), potassium hydroxide (E525), and strong ammonia solution.

Pomalidomide Olpha 1 mg, hard capsules (capsules)

• Each capsule contains 1 mg of pomalidomide.
• The capsule shell contains: titanium dioxide (E171) and gelatin.

Pomalidomide Olpha 2 mg, hard capsules (capsules)

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

Pomalidomide Olpha 3 mg, hard capsules (capsules)

• Each capsule contains 3 mg of pomalidomide.
• The capsule shell contains: titanium dioxide (E171) and gelatin, iron(III) oxide red (E172).

Pomalidomide Olpha 4 mg, hard capsules (capsules)

• Each capsule contains 4 mg of pomalidomide.
• The capsule shell contains: titanium dioxide (E171) and gelatin.

What Pomalidomide Olpha looks like and contents of the pack
Pomalidomide Olpha 1 mg, hard capsules
Hard gelatin capsule, 10.7 – 11.5 mm in length (size 5), with a white, opaque cap and a white, opaque body, printed with “H” on the cap and “P6” on the body, filled with powder ranging from pale yellow to yellowish, free from physical defects.

Pomalidomide Olpha 2 mg, hard capsules
Hard gelatin capsule, 13.9 – 14.7 mm in length (size 4), with a white, opaque cap and a brown, opaque body, printed with “H” on the cap and “P7” on the body, filled with powder ranging from pale yellow to yellowish, free from physical defects.

Pomalidomide Olpha 3 mg, hard capsules
Hard gelatin capsule, 15.3 – 16.1 mm in length (size 3), with a white, opaque cap and a pink, opaque body, printed with “H” on the cap and “P8” on the body, filled with powder ranging from pale yellow to yellowish, free from physical defects.

Pomalidomide Olpha 4 mg, hard capsules
Hard gelatin capsule, 17.2 – 18.0 mm in length (size 2), with a white, opaque cap and a white, opaque body, printed with “H” on the cap and “P9” on the body, filled with powder ranging from pale yellow to yellowish, free from physical defects.

The capsules are packed in PVC/Aluminum/OPA/Aluminum blisters containing 14 and 21 hard capsules, and in single-dose perforated blisters containing 14 x 1 and 21 x 1 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia
E-mail: [email protected]

Manufacturer
Pharmadox Healthcare Ltd.,
KW20A Kordin Industrial Park, Paola,
PLA 3000,
Malta

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

Finland, Germany, Italy, Poland, Estonia, Czech Republic: Pomalidomide Olpha
Spain: Pomalidomida Olpha 1 mg, 2 mg, 3 mg, 4 mg cápsulas duras EFG
France: POMALIDOMIDE OLPHA 1 mg, 2 mg, 3 mg, 4 mg, gélule
Latvia: Pomalidomide Olpha 1 mg, 2 mg, 3 mg, 4 mg cietās kapsulas
Lithuania: Pomalidomide Olpha 1 mg, 2 mg, 3 mg, 4 mg kietos kapsulės
Slovakia: Pomalidomide Olpha 1 mg, 2 mg, 3 mg, 4 mg tvrdé kapsuly