Prospect: information for the patient

Pomalidomide Krka 1 mg hard capsules

Pomalidomide Krka 2 mg hard capsules

Pomalidomide Krka 3 mg hard capsules

Pomalidomide Krka 4 mg hard capsules

pomalidomide

Read this prospect carefully before starting to take this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.

Pomalidomide Krka

Pomalidomide Krka contains the active ingredient “pomalidomide”. This medicine is related to talidomide and belongs to a group of medicines that affect the immune system (the body's natural defenses).

What Pomalidomide Krka is used for

Pomalidomide Krka is used to treat adults with a type of cancer called “multiple myeloma”.

Pomalidomide Krka is used with:

• two other medicinescalled “bortezomib” (a type of chemotherapy medicine) and “dexamethasone” (an anti-inflammatory medicine) in people who have received at least one other treatment, including lenalidomide.

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• Another medicinecalled “dexamethasone” in people who have experienced a worsening of their multiple myeloma, despite having received at least two other types of treatments, including the medicines lenalidomide and bortezomib.

What is multiple myeloma

Multiple myeloma is a type of cancer that affects a specific type of white blood cells (called “plasma cells”). These cells grow uncontrollably and accumulate in the bone marrow, damaging the bones and kidneys.

Multiple myeloma generally does not have a cure. However, treatment can reduce the symptoms and signs of the disease or make them disappear for a period of time. When this occurs, it is referred to as “response”.

How Pomalidomide Krka works

Pomalidomide Krka acts in several ways:

• stops the development of multiple myeloma cells;
• stimulates the immune system to attack cancer cells;
• stops the formation of blood vessels that feed cancer cells.

Benefit of using Pomalidomide Krka with bortezomib and dexamethasone

If Pomalidomide Krka is used with bortezomib and dexamethasone in people who have received at least one other treatment, the progression of multiple myeloma can be stopped:

• Generally, the combination of pomalidomide with bortezomib and dexamethasone prevented the recurrence of multiple myeloma for a period of up to 11 months compared to the 7 months observed in patients taking only bortezomib and dexamethasone.

Benefit of using Pomalidomide Krka with dexamethasone

If Pomalidomide Krka is used with dexamethasone in people who have received at least two other treatments, the progression of multiple myeloma can be stopped:

• Generally, the combination of pomalidomide and dexamethasone prevented the recurrence of multiple myeloma for a period of up to 4 months compared to the 2 months observed in patients taking dexamethasone only.

Do not take Pomalidomida Krka:

• if you are pregnant, think you may be pregnant, or intend to become pregnant, as it is expected to be harmful to the fetus.Pomalidomida Krka is expected to be harmful to the fetus.. (Men and women taking this medication should read the section “Pregnancy, contraception, and breastfeeding – information for women and men” below);
• if you can become pregnant, unless you are taking all necessary measures to avoid pregnancy (see “Pregnancy, contraception, and breastfeeding – information for women and men”). If you can become pregnant, your doctor will note on each prescription that all necessary measures have been taken and will provide you with this confirmation;
• if you are allergic to pomalidomida or any of the other components of this medication (listed in section 6). If you think you may be allergic, consult your doctor.

If you are unsure whether any of these situations described applies to you, consult your doctor, pharmacist, or nurse before starting to take Pomalidomida Krka.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Pomalidomida Krka if:

• you have ever had blood clots in the past. During treatment with Pomalidomida Krka, you have a higher risk of developing blood clots in your veins or arteries. Your doctor may recommend additional treatments (e.g., warfarin) or reduce your dose of Pomalidomida Krka to have fewer chances of developing blood clots;
• you have ever had an allergic reaction, such as skin rash, itching, swelling, dizziness, or respiratory problems while taking related medications called “thalidomide” or “lenalidomide”;
• you have had a heart attack, have heart failure, have difficulty breathing, or, if you are a smoker, have high blood pressure or high cholesterol levels;
• you have a high total tumor burden in the body, including the bone marrow. This could lead to a disease in which tumors break down and produce unusual levels of chemical substances in the blood that, in turn, may cause kidney failure. You may also experience irregular heartbeats. This disease is called tumor lysis syndrome;
• you suffer or have suffered neuropathy (neurological damage that causes tingling or pain in your feet or hands);
• you have or have had a hepatitis B virus infection. Treatment with Pomalidomida Krka may reactivate the hepatitis B virus in patients who are carriers of the virus, leading to the reappearance of the infection. Your doctor should check if you have ever had a hepatitis B virus infection;
• you experience or have experienced in the past a combination of any of the following symptoms: facial or generalized rash, skin redness, high fever, flu-like symptoms, swollen lymph nodes (symptoms of a severe skin reaction called drug reaction with eosinophilia and systemic symptoms or DRESS syndrome or Stevens-Johnson syndrome). See also section 4 “Possible side effects”).

It is essential to note that patients with multiple myeloma treated with pomalidomida may develop other types of cancer, so your doctor should carefully evaluate the benefits and risks of prescribing this medication.

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 an arm or leg, a change in the way you walk or balance problems, persistent numbness, decreased sensitivity, or loss of sensitivity, memory loss, or confusion. All of these may be symptoms of a severe and potentially fatal brain disease called multifocal progressive leukoencephalopathy (LMP). If you had any of these symptoms before starting treatment with Pomalidomida Krka, inform your doctor if you notice any change in these symptoms;

After treatment, you must return all unused capsules to the pharmacist.

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

You must follow the following instructions as part of the Pomalidomida Krka Pregnancy Prevention Program. Men and women taking Pomalidomida Krka should not conceive children or become pregnant. The reason is that pomalidomida is expected to be harmful to the fetus. You and your partner must use effective contraceptive methods while taking this medication.

Women

Do not take Pomalidomida Krka if you are pregnant, think you may be pregnant, or intend to become pregnant. The reason is that this medication is expected to be harmful to the fetus. Before starting treatment, you must inform your doctor if there is a possibility that you may become pregnant, even if you think this is unlikely.

If you can become pregnant:

• you must use effective contraceptive methods from at least 4 weeks before starting treatment, during the entire time you are taking the treatment, and until at least 4 weeks after finishing it. Your doctor will advise you on the most suitable contraceptive methods;
• each time your doctor prescribes a prescription, they will ensure that you understand the necessary measures to be taken to prevent pregnancy;
• your doctor will schedule pregnancy tests before treatment, at least every 4 weeks during treatment, and at least 4 weeks after finishing treatment.

If, despite preventive measures, you become pregnant:

• you must stop treatment immediately and inform your doctor immediately.

Breastfeeding

The passage of Pomalidomida Krka into human breast milk is unknown. Inform your doctor if you are breastfeeding or intend to breastfeed. Your doctor will advise you whether you can continue or must stop breastfeeding.

Men

Pomalidomida Krka passes into human semen.

• If your partner is pregnant or can become pregnant, you must use condoms during the entire time you are taking the treatment and for 7 days after finishing it.
• If your partner becomes pregnant while you are taking pomalidomida, inform your doctor immediately. Your partner should also inform their doctor immediately.

You must not donate semen or sperm during treatment and for 7 days after finishing it.

Blood donation and blood tests

You must not donate blood during treatment and for 7 days after finishing it. Before starting treatment with Pomalidomida Krka and during treatment, you will have periodic blood tests. This is because your medication may cause a decrease in the number of white blood cells that help fight infections and the number of platelets that help stop bleeding.

Your doctor will ask you to have a blood test:

• before treatment;
• every week during the first 8 weeks of treatment;
• at least once a month while you continue to take Pomalidomida Krka.

Your doctor may adjust the dose of Pomalidomida Krka or stop your treatment based on the results of these tests. Your doctor may also adjust the dose or stop this medication due to your overall health status.

Children and adolescents

The use of Pomalidomida Krka is not recommended in children and adolescents under 18 years of age.

Other medications and Pomalidomida Krka

Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medication. This is because Pomalidomida Krka may affect how other medications work. Additionally, some medications may affect how Pomalidomida Krka works.

Particularly, inform your doctor, pharmacist, or nurse before taking Pomalidomida Krka if you are taking any of the following medications:

• some antifungals such as ketoconazole;
• some antibiotics (e.g., ciprofloxacin, enoxacin);
• some antidepressants such as fluvoxamine.

Driving and using machines

Some people experience fatigue, dizziness, confusion, or decreased alertness while taking Pomalidomida Krka. If this happens to you, do not drive or use tools or machinery.

Pomalidomida Krka contains sodium and isomaltose

This medication contains less than 1 mmol of sodium (23 mg) per capsule; it is essentially “sodium-free”.

Pomalidomida Krka contains isomaltose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Pomalidomide Krka should be administered by a doctor with experience in the treatment of multiple myeloma.

Follow exactly the medication administration instructions indicated by your doctor.

In case of doubt, consult your doctor, pharmacist or nurse.

When to take Pomalidomide Krka with other medications

Pomalidomide Krka in combination with bortezomib and dexamethasone

• Consult the prospectus attached to bortezomib and dexamethasone for additional information on their use and effects.
• Pomalidomide Krka, bortezomib and dexamethasone are taken in treatment cycles. Each cycle lasts 21 days (3 weeks).
• Observe the following graph to consult what you should take each day of the 3-week cycle:

• Each day observe the graph and identify the correct day to see what medications you should take.
• Some days you will take all three medications, other days you will take only 1 or 2 medications, and other days you will take none of them.

POM:Pomalidomide Krka;BOR:bortezomib;DEX:dexamethasone

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

Pomalidomide Krka only with dexamethasone

• Consult the prospectus attached to dexamethasone for additional information on its use and effects.
• Pomalidomide Krka and dexamethasone are taken in treatment cycles. Each cycle lasts 28 days (4 weeks).
• Observe the following graph to consult what you should take each day of the 4-week cycle:

• Each day observe the graph and identify the correct day to see what medications you should take.
• Some days you will take both medications, other days you will take only 1 medication, and other days you will take none of them.

POM:Pomalidomide Krka;DEX:dexamethasone

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

How much Pomalidomide Krka to take with other medications

Pomalidomide Krka with bortezomib and dexamethasone

• The initial recommended dose of Pomalidomide Krka is 4 mg per day.
• The initial recommended dose of bortezomib will be calculated by your doctor based on your height and weight (1.3 mg/m2of body surface area).
• The initial recommended dose of dexamethasone is 20 mg per day. However, if you are over 75 years old, the initial recommended dose is 10 mg per day.

Pomalidomide Krka only with dexamethasone

• The recommended dose of Pomalidomide Krka is 4 mg once a day.
• The initial recommended dose of dexamethasone is 40 mg per day. However, if you are over 75 years old, the initial recommended dose is 20 mg per day.

Your doctor may need to reduce the dose of Pomalidomide Krka, bortezomib or dexamethasone, or interrupt one or more of these medications based on your blood test results and overall condition, if you are taking other medications (e.g., ciprofloxacin, enoxacin and fluvoxamine) and if you experience adverse effects (especially skin rash or swelling) as a result of treatment.

If you have liver or kidney problems, your doctor will closely monitor your condition while you receive this medication.

How to take Pomalidomide Krka

• Do not break, open or chew the capsules. If the powder from a broken capsule comes into contact with your skin, wash the skin immediately and thoroughly with water and soap.
• Healthcare professionals, caregivers and family members should wear disposable gloves when handling the blister pack or capsule. After that, they should carefully remove the gloves to avoid skin exposure, put them in a plastic bag and dispose of them according to local requirements. Then, they should wash their hands thoroughly with water and soap. Pregnant women or those who suspect they may be pregnant should not handle the blister pack or capsule.
• Swallow the capsules whole, preferably with water.
• You can take the capsules with or without food.
• You should take the capsules approximately at the same time each day.

How to take this medication

Do not try to remove the capsules from the blister pack.

To remove the capsule from the blister pack:

1. Hold the blister pack by the edges and gently pull along the perforations to separate one cell from the rest.
2. Pull the edge of the sheet upwards and completely detach it.
3. Tip the capsule onto your hand.
4. Swallow the capsule whole, preferably with water.

Your doctor will advise you on how and when to take Pomalidomide Krka if you have kidney problems and are receiving treatment with dialysis.

Treatment duration with Pomalidomide Krka

You should continue the treatment cycles 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, inform your doctor or go to the hospital immediately.

Bring the medication packaging with you.

If you forget to take Pomalidomide Krka

If you forget to take Pomalidomide Krka on the day you should, take the next capsule the next day at the usual time. Do not take more capsules to make up for the missed dose of Pomalidomide Krka the previous day.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

Severe side effects

If you experience any of the following severe side effects, stop taking Pomalidomida Krka and seek medical attention immediately, as you may need emergency medical treatment:

• Fever, chills, sore throat, cough, mouth ulcers, or any other sign of infection (due to a decrease in white blood cells that fight infection).
• Bleeding or bruising without apparent cause, including nosebleeds and gastrointestinal or intestinal bleeding (due to the effects on blood cells called platelets).
• Fast breathing, rapid pulse, fever, and chills, reduced or absent urination, nausea, and vomiting, confusion, and loss of consciousness (due to a blood infection called sepsis or septic shock).
• Severe, persistent, or bloody diarrhea (possibly accompanied by stomach pain or fever) caused by the bacteriaClostridium difficile.
• Chest or leg pain and swelling, especially in the lower leg or calf (produced by blood clots).
• Difficulty breathing (due to a severe chest infection, lung inflammation, heart failure, or blood clots).
• Swelling of the face, lips, tongue, and throat, which can cause difficulty breathing (due to severe allergic reactions called angioedema and anaphylaxis).
• Certain types of skin cancer (squamous cell carcinoma and basal cell carcinoma), which can cause changes in skin appearance or skin bumps. If you notice changes in skin appearance while taking Pomalidomida Krka, report them to your doctor as soon as possible.
• Recurrence of hepatitis B infection, which can cause yellowing of the skin and eyes, dark brown urine, right-sided abdominal pain, fever, nausea, or discomfort. Inform your doctor immediately if you notice any of these symptoms.
• Generalized rash, high body temperature, enlarged lymph nodes, and effects on other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome or drug hypersensitivity syndrome, toxic epidermal necrolysis, or Stevens-Johnson syndrome). Stop taking pomalidomida if you experience these symptoms and contact your doctor or seek medical attention immediately. See section 2.

If you experience any of the following severe side effects,stop taking Pomalidomida Krka and seek medical attention immediately, as you may need emergency medical treatment.

Other side effects

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

• Difficulty breathing (dyspnea).
• Pneumonia and bronchitis.
• Nasal, sinus, and throat infections caused by bacteria or viruses.
• Flu-like symptoms.
• Low red blood cell count, which can cause anemia leading to fatigue and weakness.
• Low potassium levels in the blood (hypokalemia), which can cause weakness, muscle cramps, and pains, palpitations, numbness, or tingling, shortness of breath, and mood changes.
• High blood sugar levels.
• Irregular and rapid heartbeat (atrial fibrillation).
• Loss of appetite.
• Constipation, diarrhea, or nausea.
• Vomiting.
• Abdominal pain
• Lack of energy.
• Difficulty falling or staying asleep.
• Dizziness, tremor.
• Muscle spasms, muscle weakness.
• Bone pain, back pain.
• Numbness, tingling, or prickling sensation in the skin, hand or foot pain (peripheral sensory neuropathy).
• Generalized swelling, including swelling of arms and legs.
• Skin rash.
• Urinary tract infections, which can cause a burning sensation while urinating or the need to urinate more frequently.

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

• Falling.
• Internal bleeding in the skull.
• Reduced ability to move or feel (sensitivity) in the hands, feet, and legs due to neurological damage (peripheral sensory-motor neuropathy).
• Numbness, itching, or tingling in the skin (paresthesia).
• Sensation of spinning, which makes it difficult to stand and move normally.
• Swelling caused by fluid retention.
• Hives (urticaria).
• Itching skin.
• Herpes zoster.
• Heart attack (chest pain that radiates to the arms, neck, and jaw, sweating, difficulty breathing, nausea, or vomiting).
• Chest pain, chest infection.
• Increased blood pressure.
• Simultaneous reduction in the number of red and white blood cells and platelets (pancytopenia) that makes you more prone to bleeding and bruising. You may feel tired and weak, and have difficulty breathing. You will also be more susceptible to infections.
• Decreased lymphocyte count (a type of white blood cell) often caused by an infection (lymphopenia).
• Low magnesium levels in the blood (hypomagnesemia), which can cause fatigue, generalized weakness, muscle cramps, and irritability, and can cause low
• calcium levels in the blood (hypocalcemia), which can cause numbness, tingling, or prickling sensation in the hands, feet, or lips, muscle cramps, muscle weakness, drowsiness, confusion.
• Low phosphate levels in the blood (hypophosphatemia), which can cause muscle weakness, irritability, or confusion.
• High calcium levels in the blood (hypercalcemia), which can slow down reflexes and cause muscle weakness in skeletal muscles.
• High potassium levels in the blood, which can cause abnormal heart rhythm.
• Low sodium levels in the blood, which can cause fatigue and confusion, muscle contractions, seizures, or coma.
• High uric acid levels in the blood, which can cause a type of arthritis called gout.
• Low blood pressure, which can cause dizziness or fainting.
• Oral pain or dryness.
• Changes in the taste of things.
• Swollen abdomen.
• Confusion.
• Feeling down (depressed mood).
• Loss of consciousness, fainting.
• Eye opacity (cataract).
• Kidney damage.
• Inability to urinate.
• Abnormal liver function test results.
• Pelvic pain.
• Weight loss.

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

• Stroke.
• Liver inflammation (hepatitis) that can cause skin itching, yellowing of the skin and eyes (jaundice), light-colored stools, dark-colored urine, and abdominal pain.
• The breakdown of cancer cells results in the release of toxic compounds into the bloodstream (tumor lysis syndrome). This can lead to kidney problems.
• Underactive thyroid gland, which can cause symptoms such as fatigue, lethargy, muscle weakness, slow heart rate, and weight gain.

Unknown frequency(cannot be estimated from available data):

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

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational reporting system included in theAppendix V.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature. Store in the original packaging to protect it from moisture.

Medicines should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. This way, you will help protect the environment.

Pomalidomide Krka Composition

• The active ingredient is pomalidomide
• The other components contained in the capsule are: isomaltose, crospovidone (type A), low-substituted hydroxypropylcellulose and sodium stearate fumarate.

Pomalidomide Krka 1 mg hard capsules EFG

• Each hard capsule contains 1 mg of pomalidomide
• The other components of the capsule coating are: gelatin, titanium dioxide (E171), yellow iron oxide (E172), indigo carmine (E132) and printing ink (shellac, black iron oxide (E172), potassium hydroxide).

Pomalidomide Krka 2 mg hard capsules EFG

• Each hard capsule contains 2 mg of pomalidomide
• The other components of the capsule coating are: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), indigo carmine (E132) and printing ink (shellac, titanium dioxide (E171), potassium hydroxide).

Pomalidomide Krka 3 mg hard capsules EFG

• Each hard capsule contains 3 mg of pomalidomide
• The other components of the capsule coating are: gelatin, titanium dioxide (E171), yellow iron oxide (E172), indigo carmine (E132) and printing ink (shellac, titanium dioxide (E171), potassium hydroxide).

Pomalidomide Krka 4 mg hard capsules EFG

• Each hard capsule contains 4 mg of pomalidomide
• The other components of the capsule coating are: gelatin, titanium dioxide (E171), indigo carmine (E132) and printing ink (shellac, titanium dioxide (E171), potassium hydroxide).

See section 2 “Pomalidomide Krka contains sodium and isomaltose”

Appearance of the product and contents of the pack

Pomalidomide Krka 1 mg hard capsules EFG (capsules):

Hard gelatin capsules, size 2. Capsule length: 17.3 ± 0.5 mm. The capsule body is yellowish to yellowish-brown with a black mark 1. The capsule cap is blue. The capsule contents are a yellowish to yellow powder.

Pomalidomide Krka 2 mg hard capsules EFG (capsules):

Hard gelatin capsules, size 2. Capsule length: 17.3 ± 0.5 mm. The capsule body is orange to orange-brown with a white mark 2. The capsule cap is blue. The capsule contents are a yellowish to yellow powder.

Pomalidomide Krka 3 mg hard capsules EFG (capsules):

Hard gelatin capsules, size 2. Capsule length: 17.3 ± 0.5 mm. The capsule body is blue-green with a white mark 3. The capsule cap is blue. The capsule contents are a yellowish to yellow powder.

Pomalidomide Krka 4 mg hard capsules EFG (capsules):

Hard gelatin capsules, size 2. Capsule length: 17.3 ± 0.5 mm. The capsule body is light blue with a white mark 4. The capsule cap is blue. The capsule contents are a yellowish to yellow powder.

Pomalidomide Krka is available in boxes containing 14 x 1 or 21 x 1 hard capsules in perforated unit dose blisters with a self-adhesive closure, child-resistant (calendar pack).

Only some pack sizes may be marketed.

Marketing authorisation holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer responsible

KRKA – FARMA d.o.o., V. Holjevca 20/E, 10450 Jastrebarsko, Croatia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of the leaflet

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.