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 may cause severe birth defects and can 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 this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet for future reference.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Do not share it with others. It may harm them even if their symptoms are the same as yours.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Pomalidomide Olpha is and what it is used for
2. Important information 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 previously received at least one other treatment regimen containing lenalidomide or
• one other medicine, dexamethasone, in patients with multiple myeloma whose disease has progressed despite having previously received at least two treatment regimens including 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, leading to bone and kidney damage.
Multiple myeloma is generally considered incurable. However, treatment may relieve symptoms or cause the disease to go into remission for a period of time—this is known as a treatment response.

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

• Pomalidomide Olpha combined with bortezomib and dexamethasone typically delayed disease progression for up to 11 months, compared to 7 months in patients receiving only bortezomib and dexamethasone.

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

• Pomalidomide Olpha combined with dexamethasone typically delayed disease progression for up to 4 months, compared to 2 months in patients receiving 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 (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 necessary methods of contraception (see the 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 the necessary measures 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 a doctor,
pharmacist, or nurse if:

• the patient has ever had blood clots in the past. Treatment with Pomalidomide Olpha increases the risk of developing blood clots in veins and arteries. The doctor may prescribe additional treatment (e.g. warfarin) or reduce the dose of Pomalidomide Olpha to reduce the risk of blood clots.
• the patient has ever had 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 he or she smokes, has high blood pressure, or high cholesterol levels.
• the patient has extensive tumour involvement in the body, including in the bone marrow. This may lead to tumour lysis, causing atypical concentrations of chemical components, which may result in kidney failure. The patient may also experience heart rhythm disturbances. This condition is known as tumour lysis syndrome.
• the patient has or has had neuropathy (nerve damage causing tingling or pain in 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 recurrent infection. The doctor should check whether the patient has been previously infected with hepatitis B virus.
• the patient has had or currently has any of the following symptoms together: facial rash or widespread rash, redness of the skin, high fever, flu-like symptoms, 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").

It should be noted that patients with multiple myeloma treated with pomalidomide may develop additional types of tumours. Therefore, the doctor should carefully assess the benefits and risks associated with prescribing this medicine to the patient.
At any time during or after treatment, immediately inform the doctor or nurse if the following symptoms occur: vision disturbances, loss of vision or double vision, difficulty speaking, weakness in arms or legs, change in walking pattern or balance problems, persistent numbness, reduced sensation or loss of sensation, memory loss or disorientation.
All of the above 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 about 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, the conditions of the pregnancy prevention programme must be observed during treatment with Pomalidomide Olpha. Women taking Pomalidomide Olpha must not become pregnant, and the partner of a man being treated with pomalidomide must not become pregnant, because this medicine is expected to be harmful to the unborn child. The patient and his partner should use effective contraceptive 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 this unlikely.
If the patient could become pregnant:

• she must use effective methods of contraception 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 method of contraception 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 at least 4 weeks after treatment ends.

If the patient becomes pregnant despite using preventive methods:

• treatment must be stopped immediately and the doctor must be informed immediately.

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 condoms throughout the entire treatment period and for 7 days after treatment ends.
• If the partner of a man being treated with Pomalidomide Olpha becomes pregnant, inform the doctor immediately. The partner should seek medical advice immediately.

The patient must not donate semen 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 cells (platelets) that help stop bleeding.
The doctor should order blood tests:

• before treatment,
• weekly during the first 8 weeks of treatment,
• thereafter 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 adjust the dose or discontinue treatment due to the patient's general 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 operating machinery
While taking Pomalidomide Olpha, some patients may experience fatigue, dizziness, fainting, confusion, or reduced alertness. If such symptoms occur, the patient should not drive, use tools, or operate machinery.
Pomalidomide Olpha contains sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, he or she should contact the doctor before taking this medicine.
Pomalidomide Olpha contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine 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 instructed 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

• Refer to the package leaflets provided with bortezomib and dexamethasone for further information on their use and effects.
• Pomalidomide Olpha, bortezomib, and dexamethasone are administered in treatment cycles. Each cycle lasts 21 days (3 weeks).
• Refer to the table below to determine which medicines should be taken on each day of the 3-week cycle:
  o Check the table daily 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 at all.

POM: Pomalidomide; BOR: Bortezomib; DEX: Dexamethasone

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

Pomalidomide Olpha with dexamethasone only

• Refer to the package leaflet for dexamethasone for further information on its use and effects.
• Pomalidomide Olpha and dexamethasone are administered 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 Check the table every day 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 status, concomitant use of other medicines (e.g. ciprofloxacin, enoxacin,
and fluvoxamine), and if treatment-related adverse reactions occur
(particularly rash or swelling).
If the patient has liver or kidney disease, the doctor will closely monitor the patient's health during treatment with this medicine.
How to take Pomalidomide Olpha

• Do not break, 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 sealed 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 on 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 the doctor immediately or go to the hospital. Take the medicine packaging with you.
Missing a dose of Pomalidomide Olpha
If the patient misses a dose of Pomalidomide Olpha on the day it should have been taken, take the next capsule at the scheduled time the following day. Do not take a double dose to make up for the missed Pomalidomide Olpha capsule.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Serious side effects
If any of the following serious side effects occur, stop taking Pomalidomide Olpha and seek
immediate medical advice – immediate treatment may be necessary:

• fever, chills, sore throat, cough, mouth ulcers or any other signs of infection (due to a lower number of white blood cells, which help fight infection).
• bleeding or bruising without cause, including nosebleeds, or bleeding from the intestines or stomach (due to the medicine’s effect 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 blood infection called sepsis or septic shock).
• severe, persistent or bloody diarrhoea (also with abdominal pain or fever) caused by bacteria called Clostridium difficile.
• chest pain or leg pain and swelling, particularly in the calf or shin (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 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 growths. If you notice any changes in your skin 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 on the right side of the abdomen, fever, nausea and vomiting. Seek immediate medical advice if you notice any of these symptoms.
• widespread rash, high fever, 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 you experience any of these symptoms, stop taking pomalidomide immediately and contact your doctor or seek immediate medical help. See also section 2.

If any of the above serious side effects occur, stop taking Pomalidomide Olpha and seek
immediate medical advice – immediate treatment may be necessary.

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).
• 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 sugar in the blood.
• Fast and irregular heartbeat (atrial fibrillation).
• Loss of appetite.
• Constipation, diarrhoea or nausea.
• Vomiting.
• Abdominal pain.
• Lack of energy.
• Difficulty falling asleep or staying asleep.
• Dizziness, tremor.
• Muscle cramps, muscle weakness.
• Bone pain, back pain.
• Numbness, tingling or burning sensation in 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 when passing urine or the need to pass urine more frequently.

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

• Falls.
• Bleeding inside 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 (paraesthesia).
• Sensation of spinning in the head, making it difficult to maintain proper standing posture and normal movement.
• Swelling due to fluid accumulation.
• Hives (urticaria).
• 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 susceptibility to bleeding and bruising. The patient may feel tired, weak, short of breath and more prone 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, general 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 phosphates 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 skeletal muscle weakness.
• High levels of potassium in the blood, which may cause irregular heart rhythm.
• Low levels of sodium in the blood, 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 stools, dark 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 the available data):

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

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 side effects helps provide more information on the safety of this medicine.
Side effects can 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 and carton after: EXP or Expiry date (EXP). The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Medicines must not be disposed of via the sewage system or in household waste. Unused medicine remaining after treatment should be returned to a pharmacy, which will accept it. This will help 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 (E 1520), black iron dioxide (E 172), potassium hydroxide (E525) and concentrated ammonia solution.

Pomalidomide Olpha, 1 mg, hard capsules

• Each capsule contains 1 mg of pomalidomide.
• The capsule shell contains: titanium dioxide (E 171) and gelatin.

Pomalidomide Olpha, 2 mg, hard capsules

• Each capsule contains 2 mg of pomalidomide.
• The capsule shell contains: titanium dioxide (E 171), gelatin, red iron oxide (E 172), yellow iron oxide (E 172), black iron oxide (E 172).

Pomalidomide Olpha, 3 mg, hard capsules

• Each capsule contains 3 mg of pomalidomide.
• The capsule shell contains: titanium dioxide (E 171), gelatin, red iron oxide (E 172).

Pomalidomide Olpha, 4 mg, hard capsules

• Each capsule contains 4 mg of pomalidomide.
• The capsule shell contains: titanium dioxide (E 171) 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 light 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 light 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 light 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 light yellow to yellowish, free from physical defects.
The capsules are packed in PVC/Aluminium/OPA/Aluminium 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 Member States of the European Economic Area under the following names:
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