POMALIDOMIDE KRKA 1 mg HARD CAPSULES

Introduction

Package Leaflet: 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 all of this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

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

What is Pomalidomide Krka

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

What is Pomalidomide Krka 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 had their myeloma get worse despite receiving 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 cell (called “plasma cells”). These cells grow out of control and accumulate in the bone marrow, damaging the bones and kidneys.

Multiple myeloma usually 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 a “response”.

How Pomalidomide Krka works

Pomalidomide Krka works in several ways:

• stops the growth of 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 Teva is used with bortezomib and dexamethasone in people who have received at least one other treatment, it can delay the progression of multiple myeloma:

• On average, the combination of pomalidomide with bortezomib and dexamethasone prevented the return of multiple myeloma for up to 11 months compared to 7 months in patients who took only bortezomib and dexamethasone.

Benefit of using Pomalidomide Krka with dexamethasone

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

• On average, the combination of pomalidomide and dexamethasone prevented the return of multiple myeloma for up to 4 months compared to 2 months in patients who took dexamethasone alone.

2. What you need to know before you take Pomalidomide Krka

Do not take Pomalidomide Krka:

• if you are pregnant, think you may be pregnant, or plan to become pregnant, as Pomalidomide Krka is expected to be harmful to the fetus. (Men and women taking this medicine should read the section “Pregnancy, contraception, and breastfeeding – information for men and women” below);
• if you can become pregnant, unless you are using effective contraception (see “Pregnancy, contraception, and breastfeeding – information for men and women”);
• if you are allergic to pomalidomide or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, talk to your doctor.

If you are not sure if any of these situations apply to you, talk to your doctor, pharmacist, or nurse before taking Pomalidomide Krka.

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 treatment with Pomalidomide 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 Pomalidomide Krka to reduce the risk of blood clots;
• you have ever had an allergic reaction, such as skin rash, itching, swelling, dizziness, or breathing problems while taking related medicines 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 tumor burden in your body, including the bone marrow. This could lead to a condition where tumors break down and produce abnormal levels of chemicals in the blood, which can cause kidney failure. You may also experience irregular heartbeats. This condition is called tumor lysis syndrome;
• you have or have had neuropathy (nerve damage that causes tingling or pain in your feet or hands);
• you have or have had a hepatitis B virus infection. Treatment with Pomalidomide Krka may reactivate the hepatitis B virus in patients who are carriers of the virus, leading to the infection coming back (recurrence). 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: rash on face or generalized, 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 hypersensitivity syndrome, toxic epidermal necrolysis, or Stevens-Johnson syndrome). See also section 4 “Possible side effects”.

It is important to note that patients with multiple myeloma treated with pomalidomide may develop other types of cancer, so your doctor should carefully weigh the benefits and risks when prescribing this medicine.

If, at any time during or after treatment, you experience:

Inform your doctor or nurse immediately if you experience blurred vision, loss of vision, or double vision, difficulty speaking, weakness in one arm or leg, a change in the way you walk, or balance problems, numbness, decreased sensitivity, or loss of sensitivity, memory loss, or confusion. These may be symptoms of a serious and potentially life-threatening brain disease called progressive multifocal leukoencephalopathy (PML). If you had any of these symptoms before starting treatment with Pomalidomide Krka, tell your doctor if you notice any change in these symptoms.

At the end of treatment, you must return all unused capsules to the pharmacist.

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

You must follow the instructions in the Pomalidomide Krka Pregnancy Prevention Program. Men and women taking Pomalidomide Krka must not father a child or become pregnant. The reason is that pomalidomide is expected to be harmful to the fetus. You and your partner must use effective contraception while taking this medicine.

Women

Do not take Pomalidomide Krka if you are pregnant, think you may be pregnant, or plan to become pregnant. The reason is that this medicine is expected to be harmful to the fetus. Before starting treatment, you must tell 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 contraception from at least 4 weeks before starting treatment, during treatment, and until at least 4 weeks after stopping treatment. Your doctor will advise you on the most suitable contraceptive methods;
• each time your doctor prescribes a prescription, they will ensure that you have understood the necessary measures to prevent pregnancy;
• your doctor will schedule pregnancy tests before treatment, at least every 4 weeks during treatment, and at least 4 weeks after stopping treatment.

If, despite preventive measures, you become pregnant:

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

Breastfeeding

It is not known whether Pomalidomide Krka passes into human breast milk. Inform your doctor if you are breastfeeding or plan to breastfeed. Your doctor will advise you whether you can continue breastfeeding or should stop.

Men

Pomalidomide Krka passes into human semen.

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

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

Blood donation and blood tests

You must not donate blood during treatment and for 7 days after stopping treatment. Before starting treatment with Pomalidomide Krka and during treatment, you will have regular blood tests. This is because your medicine may cause a decrease in the number of blood cells that help fight infections (white blood cells) and the number of cells that help stop bleeding (platelets).

Your doctor will ask you to have a blood test:

• before treatment;
• every week for the first 8 weeks of treatment;
• at least once a month while you are taking Pomalidomide Krka.

Your doctor may adjust the dose of Pomalidomide Krka or stop treatment, depending on the results of these tests. Your doctor may also adjust the dose or stop this medicine due to your overall health.

Children and adolescents

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

Other medicines and Pomalidomide Krka

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. This is because Pomalidomide Krka may affect the way other medicines work. Also, some medicines may 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:

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

Driving and using machines

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

Pomalidomide Krka contains sodium and isomaltose

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

Pomalidomide Krka contains isomaltose. If your doctor has told you that you have an intolerance to certain sugars, talk to them before taking this medicine.

3. How to take Pomalidomida Teva

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

Follow the medication administration instructions indicated by your doctor exactly.

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

When to take Pomalidomida Krka with other medications

Pomalidomida Krka in combination with bortezomib and dexamethasone

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

• Each day, observe the graph and identify the correct day to see which medications you should take.
• Some days you will take all 3 medications, other days only 1 or 2 medications, and other days none of them.

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

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

Pomalidomida Krka alone with dexamethasone

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

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

POM:Pomalidomida Krka; DEX:dexamethasone

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

How much Pomalidomida Krka to take with other medications

Pomalidomida Krka with bortezomib and dexamethasone

• The recommended initial dose of Pomalidomida Krka is 4 mg per day.
• The recommended initial dose of bortezomib will be calculated by your doctor based on your height and weight (1.3 mg/m2 of body surface area).
• The recommended initial dose of dexamethasone is 20 mg per day. However, if you are over 75 years of age, the recommended initial dose is 10 mg per day.

Pomalidomida Krka alone with dexamethasone

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

Your doctor may need to reduce the dose of Pomalidomida Krka, bortezomib, or dexamethasone, or interrupt one or more of these medications based on the results of your blood tests and your 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 carefully monitor your condition while you are taking this medication.

How to take Pomalidomida Krka

• Do not break, open, or chew the capsules. If the powder from a broken capsule comes into contact with the 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 or capsule. Afterwards, they should carefully remove the gloves to avoid skin exposure, place them in a sealable polyethylene 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 or capsule.
• Swallow the capsules whole, preferably with water.
• You can take the capsules with or without food.
• You should take the capsules at approximately the same time each day.

How to take this medication

Do not attempt to remove the capsules from the blister.

To remove the capsule from the blister:

1. Hold the blister by the edges and gently tear along the perforations to separate one cell of the blister from the rest.
2. Pull the edge of the foil upwards and completely peel it off.
3. Turn the capsule over onto your hand.
4. Swallow the capsule whole, preferably with water.

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

Duration of treatment with Pomalidomida Krka

You should continue the treatment cycles until your doctor tells you to stop the treatment.

If you take more Pomalidomida Krka than you should

If you take more Pomalidomida Krka than you should, inform your doctor or go to the hospital immediately.

Bring the medication packaging with you.

If you forget to take Pomalidomida Krka

If you forget to take Pomalidomida 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 Pomalidomida Krka the previous day.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Severe side effects

If you experience any of the following severe side effects, stop treatment with Pomalidomida Krka and go to a doctor immediately, as you may need urgent 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 intestinal or stomach bleeding (due to the effects on blood cells called "platelets").
• Rapid breathing, rapid heartbeat, fever, and chills, reduced ability to urinate, nausea, and vomiting, confusion, loss of consciousness (due to a blood infection called sepsis or septic shock).
• Severe diarrhea, persistent or bloody (possibly accompanied by stomach pain or fever) caused by the bacteria Clostridium difficile.
• Chest pain or leg swelling, especially in the lower leg or calf (caused 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 anaphylactic reaction).
• Certain types of skin cancer (squamous cell carcinoma and basal cell carcinoma), which can cause changes in the appearance of the skin or lumps on the skin. If you notice changes in the appearance of your skin while taking Pomalidomida Krka, inform your doctor as soon as possible.
• Recurrence of hepatitis B virus infection, which can cause yellowing of the skin and eyes, dark urine, abdominal pain on the right side, fever, nausea, or discomfort. Inform your doctor immediately if you notice any of these symptoms.
• Widespread rash, high body temperature, swollen lymph nodes, and effects on other organs of the body (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome, toxic epidermal necrolysis, or Stevens-Johnson syndrome). Stop taking pomalidomide if you experience these symptoms and contact your doctor or go to the doctor immediately. See also section 2.

If you experience any of the following severe side effects, stop treatment with Pomalidomida Krka and go to a doctor immediately, as you may need urgent medical treatment.

Other side effects

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

• Difficulty breathing (dyspnea).
• Lung infection (pneumonia and bronchitis).
• Infections in the nose, sinuses, and throat caused by bacteria or viruses.
• Flu-like symptoms (flu).
• 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, cramps, and muscle pain, palpitations, tingling or numbness, shortness of breath, and mood changes.
• High blood sugar levels.
• Fast and irregular heartbeat (atrial fibrillation).
• Lack 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, pain in hands or feet (peripheral sensory neuropathy).
• Generalized swelling, including swelling of arms and legs.
• Skin rash.
• Urinary tract infection, which can cause a burning sensation when urinating or the need to urinate more frequently.

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

• Fall.
• Bleeding inside the skull.
• Decreased ability to move or feel (sensitivity) in hands, feet, and legs due to nerve damage (peripheral sensorimotor neuropathy).
• Numbness, itching, or tingling in the skin (paresthesia).
• Feeling of dizziness, which can make it difficult to stand and move normally.
• Swelling caused by fluid retention.
• Hives (urticaria).
• Itching of the skin.
• Shingles.
• Heart attack (chest pain that spreads to the arms, neck, and jaw, sweating, difficulty breathing, feeling of nausea or vomiting).
• Chest pain, chest infection.
• Increased blood pressure.
• A decrease in the number of red and white blood cells and platelets at the same time (pancytopenia), which can make you more prone to bleeding and bruising. You may feel tired and weak, as well as have difficulty breathing. You will also be more susceptible to infections.
• A decrease in the number of lymphocytes (a type of white blood cell) often caused by an infection (lymphopenia).
• Low magnesium levels in the blood (hypomagnesemia), which can cause fatigue, weakness, muscle cramps, and irritability, and can also cause low calcium levels in the blood (hypocalcemia), leading to numbness or tingling in hands, feet, or lips, muscle cramps, muscle weakness, dizziness, and 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 weakness of the skeletal muscles.
• High potassium levels in the blood, which can cause an abnormal heart rhythm.
• Low sodium levels in the blood, which can cause fatigue and confusion, muscle contractions, seizures (epileptic convulsions), 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.
• Pain or dryness in the mouth.
• Changes in taste.
• Swollen abdomen.
• Confusion.
• Feeling depressed (depressive mood).
• Loss of consciousness, fainting.
• Clouding of the eye (cataract).
• Kidney damage.
• Inability to urinate.
• Abnormal results in liver function tests.
• Pelvic pain.
• Weight loss.

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

• Stroke.
• Liver inflammation (hepatitis) that can cause itching of the skin, yellowing of the skin and the white part of the eyes (jaundice), light-colored stools, dark urine, and abdominal pain.
• The breakdown of tumor cells results in the release of toxic compounds into the bloodstream (tumor lysis syndrome). It can lead to kidney problems.
• Underactive thyroid gland, which can 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 solid organ transplants (such as heart or liver).

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this prospectus. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Pomalidomida Krka

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

Do not use this medication after the expiration date stated 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.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Packaging Contents and Additional Information

Pomalidomide Krka Composition

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

Pomalidomide Krka 1 mg hard capsules EFG

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

Pomalidomide Krka 2 mg hard capsules EFG

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

Pomalidomide Krka 3 mg hard capsules EFG

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

Pomalidomide Krka 4 mg hard capsules EFG

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

See section 2 "Pomalidomide Krka contains sodium and isomaltose"

Product Appearance and Packaging Contents

Pomalidomide Krka 1 mg hard capsules EFG (capsules):

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

Pomalidomide Krka 2 mg hard capsules EFG (capsules):

Hard gelatin capsules, size 2. Capsule length: 17.3±0.5 mm. The body of the capsule is orange to brownish-orange in color with a white mark 2. The capsule cap is blue. The capsule contents are a light yellow to yellow powder.

Pomalidomide Krka 3 mg hard capsules EFG (capsules):

Hard gelatin capsules, size 2. Capsule length: 17.3±0.5 mm. The body of the capsule is greenish-blue in color with a white mark 3. The capsule cap is blue. The capsule contents are a light yellow to yellow powder.

Pomalidomide Krka 4 mg hard capsules EFG (capsules):

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

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

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

Manufacturer

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

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

You can request more information about this medicinal product by contacting the local representative of the marketing authorisation holder:

Date of last revision of this leaflet

Other sources of information

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