POMALIDOMIDE ACCORD 3 mg HARD CAPSULES

Introduction

Package Leaflet:information for the patient

Pomalidomida Accord 1 mg hard capsules

Pomalidomida Accord 2 mg hard capsules

Pomalidomida Accord 3 mg hard capsules

Pomalidomida Accord 4 mg hard capsules

pomalidomide

It is expected that Pomalidomida Accord will cause severe birth defects and may cause fetal death.

• Do not take this medicine if you are pregnant or think you may be pregnant.
• You must follow the contraceptive measures described in this package leaflet.

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

1. What is Pomalidomida Accord and what is it used for

What is Pomalidomida Accord

Pomalidomida Accord 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 Pomalidomida Accord used for

Pomalidomida Accord is used to treat adults with a type of cancer called "multiple myeloma".

Pomalidomida Accord is used with:

• Other two 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 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 cell (called "plasma cells"). These cells grow out of control and accumulate in the bone marrow, damaging the bones and kidneys.

Multiple myeloma usually has no cure. 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 Pomalidomida Accord works

Pomalidomida Accord 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 Pomalidomida Accord with bortezomib and dexamethasone

If Pomalidomida Accord is used with bortezomib and dexamethasone in people who have received at least one other treatment, it can stop the progression of multiple myeloma:

• Usually, the combination of Pomalidomida Accord 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 Pomalidomida Accord with dexamethasone

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

• Usually, the combination of Pomalidomida Accord 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 Pomalidomida Accord

Do not takePomalidomida Accord:

• if you are pregnant, think you may be pregnant, or plan to become pregnant, as it is expected that Pomalidomida Accord will 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 taking all necessary measures to avoid pregnancy (see "Pregnancy, contraception, and breastfeeding – information for men and women"). If you can become pregnant, your doctor will confirm that all necessary measures have been taken and provide you with this confirmation each time a prescription is issued;
• 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 Pomalidomida Accord.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting Pomalidomida Accord if:

• you have ever had blood clots in the past. During treatment with Pomalidomida Accord, 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 Accord to reduce the risk of blood clots;
• you have ever had an allergic reaction, such as a skin rash, itching, swelling, dizziness, or breathing problems while taking medicines related to "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 your body, including the bone marrow. This could lead to a condition in which 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 suffer from or have suffered from 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 Pomalidomida Accord may reactivate the hepatitis B virus in patients who are carriers of the virus, leading to the infection returning (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 the 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 [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 other types of cancer, so your doctor should carefully evaluate the benefits and risks when prescribing this medicine.

At any time during or after treatment, tell your doctor or nurse immediately if you:

experience blurred vision, loss of vision, or double vision, difficulty speaking, weakness in one arm or one leg, a change in the way you walk, or balance problems, persistent 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 Pomalidomida Accord, 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 below, which are part of the Pomalidomida Accord Pregnancy Prevention Program.

Men and women taking Pomalidomida Accord 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 contraceptive methods while taking this medicine.

Women

Do not take Pomalidomida Accord 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 any chance you may become pregnant, even if you think it is unlikely.

If you can become pregnant:

• you must use effective contraceptive methods 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 confirm 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 Pomalidomida Accord passes into human breast milk. Tell your doctor if you are breastfeeding or plan to breastfeed. Your doctor will advise you whether you can continue breastfeeding or should stop.

Men

Pomalidomida Accord 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 Pomalidomida Accord, tell your doctor immediately. Your partner should also tell 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 Pomalidomida Accord 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 during the first 8 weeks of treatment;
• at least once a month while you are taking Pomalidomida Accord.

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

Children and adolescents

Pomalidomida Accord is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Pomalidomida Accord

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

In particular, tell your doctor, pharmacist, or nurse before taking Pomalidomida Accord 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 Pomalidomida Accord. If this happens to you, do not drive or use tools or machinery.

Pomalidomida Accord contains sodium

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

3. How to take Pomalidomida Accord

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

Follow the medication administration instructions exactly as indicated by your doctor. In case of doubt, consult your doctor, pharmacist, or nurse.

When to take Pomalidomida Accord with other medications

Pomalidomida Accord in combination with bortezomib and dexamethasone

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

• Each day, observe the chart 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 Accord; BOR:bortezomib; DEX:dexamethasone

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

Pomalidomida Accord alone with dexamethasone

Consult the package insert that comes with dexamethasone for additional information on its use and effects.

• Pomalidomida Accord and dexamethasone are taken in treatment cycles. Each cycle lasts 28 days (4 weeks).

• Observe the following chart to see what you should take each day of the 4-week cycle:

• Each day, observe the chart 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 Accord; DEX:dexamethasone

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

How much Pomalidomida Accord to take with other medications

Pomalidomida Accord with bortezomib and dexamethasone

• The recommended initial dose of Pomalidomida Accord 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 old, the recommended initial dose is 10 mg per day.

Pomalidomida Accord alone with dexamethasone

• The recommended dose of Pomalidomida Accord is 4 mg once a day.

The recommended initial dose of dexamethasone is 40 mg per day. However, if you are over 75 years old, the recommended initial dose is 20 mg per day.

Your doctor may need to reduce the dose of Pomalidomida Accord, 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 are taking this medication.

How to take Pomalidomida Accord

• 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 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 well 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 Pomalidomida Accord at approximately the same time each day.

To remove the capsule from the blister, press only one end of the capsule to make it come out through the foil. Do not press in the center of the capsule, as it may break.

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

Duration of treatment with Pomalidomida Accord

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

If you take more Pomalidomida Accord than you should

If you take more Pomalidomida Accord than you should, inform your doctor or go to the hospital immediately. Bring the medication package with you.

If you forget to take Pomalidomida Accord

If you forget to take Pomalidomida Accord 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 Accord 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 Accord 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 effects on blood cells called "platelets").
• Rapid breathing, rapid heartbeat, fever, and chills, decreased ability to urinate, nausea, and vomiting, confusion, 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 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, pneumonia, 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 Accord, 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 pomalidomida 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 Accord 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, tremors.
• Muscle spasms, muscle weakness.
• Bone pain, back pain.
• Numbness, tingling, or burning sensation in the skin, pain in hands or feet (peripheral sensory neuropathy).
• Generalized swelling, including swelling of arms and legs.

• Skin rashes.

• 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):

• Falls.
• Bleeding inside the skull.
• Decreased ability to move or feel (sensitivity) in hands, feet, and legs due to nerve damage (peripheral sensorimotor neuropathy).
• Numbness, tingling, or burning sensation 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.
• Herpes zoster.
• Heart attack (chest pain that spreads to the arms, neck, and jaw, feeling of sweating and 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) 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.
• Bloated abdomen.
• Confusion.
• Feeling depressed (depressive mood).
• Loss of consciousness, fainting.
• Clouding of the eye (cataract).
• Kidney damage.
• Inability to urinate.
• Abnormal liver function test results.
• 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 it is a possible side effect not listed in this package insert. 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 Accord

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 blister and carton after CAD/EXP. The expiry date is the last day of the month indicated.

It does not require special storage conditions.

Do not use Pomalidomida Accord if you notice visible signs of deterioration or signs of tampering with the medicine.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Pomalidomida Accord

• The active ingredient is pomalidomide.
• The other ingredients are microcrystalline cellulose, maltodextrin, and sodium stearyl fumarate.

Pomalidomida Accord 1 mg hard capsule:

• Each capsule contains 1 mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E171), yellow iron oxide (E172), and red iron oxide (E172).
• The printing ink contains: shellac, titanium dioxide (E171), and propylene glycol (E1520).

Pomalidomida Accord 2 mg hard capsule:

• Each capsule contains 2 mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E171), yellow iron oxide (E172), and red iron oxide (E172).
• The printing ink contains: shellac, titanium dioxide (E171), and propylene glycol (E1520).

Pomalidomida Accord 3 mg hard capsule:

• Each capsule contains 3 mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E171), indigo carmine (E132), yellow iron oxide (E172), and red iron oxide (E172).
• The printing ink contains: shellac, titanium dioxide (E171), and propylene glycol (E1520).

Pomalidomida Accord 4 mg hard capsule:

• Each capsule contains 4 mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), indigo carmine (E132), and erythrosine (E127).
• The printing ink contains: shellac, titanium dioxide (E171), and propylene glycol (E1520).

Appearance of Pomalidomida Accord and Package Contents

Pomalidomida Accord 1 mg hard capsules: hard gelatin capsule, with a yellow body and a red cap, and "PLM 1" marked in white ink on the body of the capsule.

Pomalidomida Accord 2 mg hard capsules: hard gelatin capsule, with an orange body and a red cap, and "PLM 2" marked in white ink on the body of the capsule.

Pomalidomida Accord 3 mg hard capsules: hard gelatin capsule, with a turquoise body and a red cap, and "PLM 3" marked in white ink on the body of the capsule.

Pomalidomida Accord 4 mg hard capsules: hard gelatin capsule, with a dark blue body and a red cap, and "PLM 4" marked in white ink on the body of the capsule.

Pomalidomida Accord comes in blister packs of 7, 14, or 21 capsules, or in perforated unit-dose blisters of 7 x 1, 14 x 1, or 21 x 1 capsules. Only some pack sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n,

Edifici Est, 6a Planta,

08039 Barcelona,

Spain

Manufacturer

Synthon Hispania S.L.

Castello, 1

Polígono Las Salinas

08830 Sant Boi de Llobregat, Spain

Synthon B.V.

Microweg 22

6545 CM Nijmegen, Netherlands

Accord Healthcare Polska Sp. z.o.o.

ul.Lutomierska 50,

95-200, Pabianice, Poland

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

AT / BE / BG / CY / CZ / DE / DK / EE / ES / FI / FR / HR / HU / IE / IS / IT / LT / LV / LX / MT / NL / NO / PL / PT / RO / SE / SI / SK

Accord Healthcare S.L.U.

Tel: +34 93 301 00 64

EL

Win Medica Α.Ε.

Tel: +30 210 74 88 821

Date of the last revision of this leaflet: July 2024

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu. There are also links to other websites on rare diseases and orphan medicines.