Medicine guide

Pomalidomide Krka

·

  • Prescription status not stated
  • Cancer treatments and immune-system medicines
Active substance
Pomalidomide
Made by
Krka, d.d., Novo mesto

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

What it is for

Pomalidomide Krka is either used with:

  • What Pomalidomide Krka is Pomalidomide Krka contains the active substance ‘pomalidomide’. This medicine is related to thalidomide and belongs to a group of medicines which affect the immune system (the body’s natural defences).
  • What Pomalidomide Krka is used for Pomalidomide Krka is used to treat adults with a type of cancer called ‘multiple myeloma’.
  • - two other medicines - called ‘bortezomib’ (a type of chemotherapy medicine) and ‘dexamethasone’ (an anti-inflammatory medicine) in people who have had at least one other treatment - including lenalidomide.
  • Or
  • - one other medicine - called ‘dexamethasone’ in people whose myeloma has become worse, despite having at least two other treatments - including lenalidomide and bortezomib.
  • What is multiple myeloma Multiple myeloma is a type of cancer which affects a certain type of white blood cell (called the ‘plasma cell’). These cells grow out of control and accumulate in the bone marrow. This results in damage to the bones and kidneys.
  • Multiple myeloma generally cannot be cured. However, treatment can reduce the signs and symptoms of the disease, or make them disappear for a period of time. When this happens, it is called ‘response’.
  • How Pomalidomide Krka works Pomalidomide Krka works in a number of different ways:
  • - by stopping the myeloma cells developing
  • - by stimulating the immune system to attack the cancer cells
  • - by stopping the formation of blood vessels supplying the cancer cells.
  • The benefit of using Pomalidomide Krka with bortezomib and dexamethasone When Pomalidomide Krka is used with bortezomib and dexamethasone, in people who have had at least one other treatment, it can stop multiple myeloma getting worse:
  • - On average, pomalidomide when used with bortezomib and dexamethasone stopped multiple myeloma from coming back for up to 11 months - compared with 7 months for those patients who only used bortezomib and dexamethasone.
  • The benefit of using Pomalidomide Krka with dexamethasone When Pomalidomide Krka is used with dexamethasone, in people who have had at least two other treatments, it can stop multiple myeloma getting worse:
  • - On average, pomalidomide when used with dexamethasone stopped multiple myeloma from coming back for up to 4 months - compared with 2 months for those patients who used only dexamethasone.

From the package leaflet in EMA’s product information, p. 55–56 · 2026-09-03

How to take it

These directions are for this exact strength and form. Another one is different.

  • Pomalidomide Krka must be given to you by a doctor with experience in treating multiple myeloma.
  • Always take your medicines exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.
  • When to take Pomalidomide Krka with other medicines Pomalidomide Krka with bortezomib and dexamethasone
  • See the leaflets that come with bortezomib and dexamethasone for further information on their use and effects.
  • Pomalidomide Krka, bortezomib and dexamethasone are taken in ‘treatment cycles’. Each cycle lasts 21 days (3 weeks).
  • Look at the chart below to see what to take on each day of the 3-week cycle:
  • Each day, look down the chart and find the correct day to see which medicines to take.
  • Some days, you take all 3 medicines, some days just 2 or 1 medicines, and some days none at all.
  • POM: Pomalidomide Krka; BOR: Bortezomib; DEX: Dexamethasone Cycle 1 to 8 Cycle 9 and onwards Medicine name Medicine name Day POM BOR DEX Day POM BOR DEX 1 √ √ √ 1 √ √ √ 2 √ √ 2 √ √ 3 √ 3 √ 4 √ √ √ 4 √ 5 √ √ 5 √ 6 √ 6 √ 7 √ 7 √ 8 √ √ √ 8 √ √ √ 9 √ √ 9 √ √ 10 √ 10 √ 11 √ √ √ 11 √ 12 √ √ 12 √ 13 √ 13 √ 14 √ 14 √ 15 15 16 16 17 17 18 18 19 19 20 20 21 21
  • After completing each 3-week cycle, start a new one.
  • Pomalidomide Krka with dexamethasone only
  • See the leaflet that comes with dexamethasone for further information on its use and effects.
  • Pomalidomide Krka and dexamethasone are taken in ‘treatment cycles’. Each cycle lasts 28 days (4 weeks).
  • Look at the chart below to see what to take on each day of the 4-week cycle:
  • Each day, look down the chart and find the correct day to see which medicines to take.
  • Some days, you take both medicines, some days just 1 medicine, and some days none at all.
  • POM: Pomalidomide Krka; DEX: Dexamethasone Medicine name Day POM DEX 1 √ √ 2 √ 3 √ 4 √ 5 √ 6 √ 7 √ 8 √ √ 9 √ 10 √ 11 √ 12 √ 13 √ 14 √ 15 √ √ 16 √ 17 √ 18 √ 19 √ 20 √ 21 √ 22 √
  • After completing each 4-week cycle, start a new one.
  • How much Pomalidomide Krka to take with other medicines Pomalidomide Krka with bortezomib and dexamethasone
  • The recommended starting dose of Pomalidomide Krka is 4 mg per day.
  • The recommended starting dose of bortezomib will be worked out by your doctor and based on your height and weight (1.3 mg/m body surface area).
  • The recommended starting dose of dexamethasone is 20 mg per day. However, if you are over 75, the recommended starting dose is 10 mg per day.
  • Pomalidomide Krka with dexamethasone only
  • The recommended dose of Pomalidomide Krka is 4 mg per day.
  • The recommended starting dose of dexamethasone is 40 mg per day. However, if you are over 75, the recommended starting dose is 20 mg per day.
  • Your doctor may need to reduce the dose of Pomalidomide Krka, bortezomib or dexamethasone or stop one or more of these medicines based on the results of your blood tests, your general condition, other medicines you may be taking (e.g. ciprofloxacin, enoxacin and fluvoxamine) and if you experience side effects (especially rash or swelling) from treatment.
  • If you suffer from liver or kidney problems your doctor will check your condition very carefully whilst you are receiving this medicine.
  • How to take Pomalidomide Krka
  • Do not break, open or chew the capsules. If powder from a broken capsule makes 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 or capsule. Gloves should then be removed carefully to prevent skin exposure, placed in a sealable plastic polyethylene bag and disposed of in accordance with local requirements. Hands should then be washed thoroughly with soap and water. Women who are pregnant or suspect they may be pregnant should not handle the blister or capsule.
  • Swallow the capsules whole, preferably with water.
  • You can take the capsules either with or without food.
  • Take your capsules at about the same time each day.
  • Taking this medicine Do not try to push the capsules from the blister.
  • To remove the capsule from the blister:
  • 1. Hold the blister at the edges and gently tear along the perforations to separate one blister cell from the rest.
  • 2. Pull up the edge of the foil and peel the foil off completely.
  • 3. Tip the capsule out onto your hand.
  • 4. Swallow the capsule whole, preferably with water.
  • Your doctor will advise you of how and when to take Pomalidomide Krka if you have kidney problems and are receiving dialysis treatment.
  • Duration of the treatment with Pomalidomide Krka You should continue the cycles of treatment until your doctor tells you to stop.
  • If you take more Pomalidomide Krka than you should If you take more Pomalidomide Krka than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.
  • If you forget to take Pomalidomide Krka If you forget to take Pomalidomide Krka on a day when you should, take your next capsule as normal the next day. Do not increase the number of capsules you take to make up for not taking Pomalidomide Krka the previous day.
  • If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

From the package leaflet in EMA’s product information, p. 58–61.

Warnings and precautions

  • Talk to your doctor, pharmacist or nurse before taking Pomalidomide Krka if:
  • you have ever had blood clots in the past. During the treatment with Pomalidomide Krka you have an increased risk of getting blood clots in your veins and arteries. Your doctor may recommend you take additional treatments (e.g. warfarin) or lower the dose of Pomalidomide Krka to reduce the chance that you get blood clots.
  • you have ever had an allergic reaction such as rash, itching, swelling, feeling dizzy or trouble breathing while taking related medicines called ‘thalidomide’ or ‘lenalidomide’.
  • you have had a heart attack, have heart failure, have difficulty breathing, or if you smoke, have high blood pressure or high cholesterol levels.
  • you have a high total amount of tumour throughout the body, including your bone marrow. This could lead to a condition where the tumours break down and cause unusual levels of chemicals in the blood which can lead to kidney failure. You may also experience an uneven heartbeat.
  • This condition is called tumour lysis syndrome.
  • you have or have had neuropathy (nerve damage causing tingling or pain in your hands or feet).
  • you have or have ever had hepatitis B infection. Treatment with Pomalidomide Krka may cause the hepatitis B virus to become active again in patients who carry the virus, resulting in a recurrence of the infection. Your doctor should check whether you have ever had hepatitis B infection.
  • you experience or have experienced in the past a combination of any of the following symptoms: rash on face or extended rash, red skin, high fever, flu-like symptoms, enlarged lymph nodes (signs of 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 important to note that patients with multiple myeloma treated with pomalidomide may develop additional types of cancer, therefore your doctor should carefully evaluate the benefit and risk when you are prescribed this medicine.
  • At any time during or after your treatment, tell your doctor or nurse immediately if you: experience blurred, loss of or double vision, difficulty speaking, weakness in an arm or a leg, a change in the way you walk or problems with your balance, persistent numbness, decreased sensation or loss of sensation, memory loss or confusion. These may all be symptoms of a serious and potentially fatal brain condition known as progressive multifocal leukoencephalopathy (PML). If you had these symptoms prior to treatment with Pomalidomide Krka, tell your doctor about any change in these symptoms.
  • At the end of the treatment you should return all unused capsules to the pharmacist.
  • Pregnancy, contraception and breast-feeding – information for women and men The following must be followed as stated in the Pomalidomide Krka Pregnancy Prevention Programme. Women and men taking Pomalidomide Krka must not become pregnant or father a child.
  • This is because pomalidomide is expected to harm the unborn baby. You and your partner should use effective methods of contraception while taking this medicine.
  • Women Do not take Pomalidomide Krka if you are pregnant, think you may be pregnant or are planning to become pregnant. This is because this medicine is expected to harm the unborn baby. Before starting the treatment, you should tell your doctor if you are able to become pregnant, even if you think this is unlikely.
  • If you are able to become pregnant:
  • you must use effective methods of contraception for at least 4 weeks before starting treatment, for the whole time you are taking treatment, and until at least 4 weeks after stopping treatment.
  • Talk to your doctor about the best method of contraception for you.
  • each time your doctor writes a prescription for you, he will ensure you understand the necessary measures that have to be taken to prevent pregnancy.
  • your doctor will arrange pregnancy tests before treatment, at least every 4 weeks during treatment, and at least 4 weeks after the treatment has finished.
  • If you become pregnant despite the prevention measures:
  • you must stop the treatment immediately and talk to your doctor straight away.
  • Breast-feeding It is not known if Pomalidomide Krka passes into human breast milk. Tell your doctor if you are breast-feeding or intend to breast-feed. Your doctor will advise if you should stop or continue breast- feeding.
  • Men Pomalidomide Krka passes into human semen.
  • If your partner is pregnant or able to become pregnant, you must use condoms for the whole time you are taking treatment and for 7 days after the end of treatment.
  • If your partner becomes pregnant while you are taking Pomalidomide Krka, tell your doctor straight away. Your partner should also tell her doctor straight away.
  • You should not donate semen or sperm during treatment and for 7 days after the end of treatment.
  • Blood donation and blood tests You should not donate blood during treatment and for 7 days after the end of treatment.
  • Before and during the treatment with Pomalidomide Krka you will have regular blood tests. This is because your medicine may cause a fall in the number of blood cells that help fight infection (white cells) and in the number of cells that help to stop bleeding (platelets).
  • Your doctor should ask you to have a blood test:
  • before treatment
  • every week for the first 8 weeks of treatment
  • at least every month after that for as long as you are taking Pomalidomide Krka.
  • As a result of these tests, your doctor may change your dose of Pomalidomide Krka or stop your treatment. The doctor may also change the dose or stop the medicine because of your general health.
  • Children and adolescents Pomalidomide Krka is not recommended for use in children and young people under 18 years.

From the package leaflet in EMA’s product information, p. 56–58.

Other medicines

  • Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This is because Pomalidomide Krka can affect the way some other medicines work. Also some other medicines can affect the way Pomalidomide Krka works.
  • In particular, tell your doctor, pharmacist or nurse before taking Pomalidomide Krka if you are taking any of the following medicines:
  • some antifungals such as ketaconazole
  • some antibiotics (for example ciprofloxacin, enoxacin)
  • certain antidepressants such as fluvoxamine.

From the package leaflet in EMA’s product information, p. 58.

Driving and using machines

  • Some people feel tired, dizzy, faint, confused or less alert when taking Pomalidomide Krka. If this happens to you, do not drive or operate tools or machinery.
  • Pomalidomide Krka contains sodium and isomalt Pomalidomide Krka contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially “sodium-free”.
  • Pomalidomide Krka contains isomalt. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

From the package leaflet in EMA’s product information, p. 58.

Side effects

  • Like all medicines, this medicine can cause side effects, although not everybody gets them.
  • Serious side effects Stop taking Pomalidomide Krka and see a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:
  • Fever, chills, sore throat, cough, mouth ulcers or any other signs of infection (due to less white blood cells, which fight infection).
  • Bleeding or bruising without a cause, including nosebleeds and bleeding from the bowels or stomach (due to effects on blood cells called ‘platelets’).
  • Rapid breathing, rapid pulse, fever and chills, passing very little to no urine, nausea and vomiting, confusion, unconsciousness (due to infection of blood 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 leg pain and swelling, especially in your lower leg or calves (caused by blood clots).
  • Shortness of breath (from serious chest infection, inflammation of the lung, heart failure or blood clot).
  • Swelling of face, lips, tongue and throat, which may cause difficulty breathing (due to serious types of allergic reaction called angioedema and anaphylactic reaction).
  • Certain types of skin cancer (squamous cell carcinoma and basal cell carcinoma), which can cause changes in the appearance of your skin or growths on your skin. If you notice any changes to your skin whilst taking Pomalidomide Krka, tell your doctor as soon as possible.
  • Recurrence of hepatitis B infection, which can cause yellowing of the skin and eyes, dark brown-coloured urine, right-sided abdominal pain, fever and feeling nauseous or being sick.
  • Tell your doctor straightaway if you notice any of these symptoms.
  • Widespread rash, high body temperature, enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome, Toxic Epidermal Necrolysis or Stevens-Johnson Syndrome). Stop using pomalidomide if you develop these symptoms and contact your doctor or seek medical attention immediately. See also section 2.
  • Stop taking Pomalidomide Krka and see a doctor straight away if you notice any of the serious side effects listed above – you may need urgent medical treatment.
  • Other side effects Very common (may affect more than 1 in 10 people):
  • Shortness of breath (dyspnoea).
  • Infections of the lungs (pneumonia and bronchitis).
  • Infections of the nose, sinuses and throat, caused by bacteria or viruses.
  • Flu-like symptoms (influenza).
  • Low red blood cells, which may cause anaemia leading to tiredness and weakness.
  • Low blood levels of potassium (hypokalaemia), which may cause weakness, muscle cramps, muscle aches, palpitations, tingling or numbness, dyspnoea, mood changes.
  • High blood levels of sugar.
  • A fast and irregular heartbeat (atrial fibrillation).
  • Loss of appetite.
  • Constipation, diarrhoea or nausea.
  • Being sick (vomiting).
  • Abdominal pain.
  • Lack of energy.
  • Difficulty in falling asleep or staying asleep.
  • Dizziness, tremor.
  • Muscle spasm, muscle weakness.
  • Bone pain, back pain.
  • Numbness, tingling or burning sensation to the skin, pains in hands or feet (peripheral sensory neuropathy).
  • Swelling of the body, including swelling of the arms or legs.
  • Rashes.
  • Urinary tract infection, which may cause a burning sensation when passing urine, or a need to pass urine more often.
  • Common (may affect up to 1 in 10 people):
  • Fall.
  • Bleeding within the skull.
  • Decreased ability to move or feel (sensation) in your hands, arms, feet and legs because of nerve damage (peripheral sensorimotor neuropathy).
  • Numbness, itching, and a feeling of pins and needles on your skin (paraesthesia).
  • A spinning feeling in your head, making it difficult to stand up and move normally.
  • Swelling caused by fluid.
  • Hives (urticaria).
  • Itchy skin.
  • Shingles.
  • Heart attack (chest pain spreading to the arms, neck, jaw, feeling sweaty and breathless, feeling sick or vomiting).
  • Chest pain, chest infection.
  • Increased blood pressure.
  • A fall in the number of red and white blood cells and platelets at the same time (pancytopenia), which will make you more prone to bleeding and bruising. You may feel tired and weak, and short of breath and you are also more likely to get infections.
  • Decreased number of lymphocytes (one type of white blood cells) often caused by infection (lymphopenia).
  • Low blood levels of magnesium (hypomagnesaemia), which may cause tiredness, generalised weakness, muscle cramps, irritability and may result in low blood levels of calcium (hypocalcaemia), which may cause numbness and, or tingling of hands, feet, or lips, muscle cramps, muscle weakness, light-headedness, confusion.
  • Low blood level of phosphate (hypophosphataemia), which may cause muscle weakness and irritability or confusion.
  • High blood level of calcium (hypercalcaemia), which may cause slowing reflexes and skeletal muscle weaknesses.
  • High blood levels of potassium, which may cause abnormal heart rhythm.
  • Low blood levels of sodium, which may cause tiredness and confusion, muscle twitching, fits (epileptic seizures) or coma.
  • High blood levels of uric acid, which may cause a form of arthritis called gout.
  • Low blood pressure, which may cause dizziness or fainting.
  • Sore or dry mouth.
  • Changes in the way things taste.
  • Swollen abdomen.
  • Feeling confused.
  • Feeling down (depressed mood).
  • Loss of consciousness, fainting.
  • Clouding of your eye (cataract).
  • Damage to the kidney.
  • Inability to pass urine.
  • Abnormal liver test.
  • Pain in the pelvis.
  • Weight loss.
  • Uncommon (may affect up to 1 in 100 people):
  • Stroke.
  • Inflammation of the liver (hepatitis) which can cause itchy skin, yellowing of the skin and the whites of the eyes (jaundice), pale coloured stools, dark coloured urine and abdominal pain.
  • The breakdown of cancer cells resulting in the release of toxic compounds into the bloodstream (tumour lysis syndrome). This can result in kidney problems.
  • Underactive thyroid gland, which may cause symptoms such as tiredness, lethargy, muscle weakness, slow heart rate, 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 get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

From the package leaflet in EMA’s product information, p. 61–64.

How to store it

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of that month.
  • This medicine does not require any special temperature storage conditions. Store in the original package in order to protect from moisture.
  • Do not throw away any medicines via wastewater or household waste. Any unused medicine should be returned to your pharmacist at the end of treatment. These measures will help protect the environment.

From the package leaflet in EMA’s product information, p. 64.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

United StatesNo exact match for this strength and form

BulgariaNo exact match for this strength and form

SpainNo exact match for this strength and form

FranceNo exact match for this strength and form

CanadaNo exact match for this strength and form

NetherlandsNo exact match for this strength and form

SwitzerlandNo exact match for this strength and form

Details

Made byKrka, d.d., Novo mesto
Active substancePomalidomide
Used inCancer treatments and immune-system medicines
ClassificationL04AX06 · Cancer treatments and immune-system medicines
GenericYes — a generic medicine, according to the register
Authorised on2024-07-24
Last updated by the regulator2026-09-03
EMA product numberEMEA/H/C/006314

Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician

Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.