Label:information for the patient

Pomalidomida Accord 1mg hard capsules

Pomalidomida Accord 2mg hard capsules

Pomalidomida Accord 3mg hard capsules

Pomalidomida Accord 4mg hard capsules

pomalidomida

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

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

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others who 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 are not listed in this label. See section4.

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

2.What you need to know before starting to take Pomalidomida Accord

3.How to take Pomalidomida Accord

4.Possible adverse effects

5.Storage of Pomalidomida Accord

6.Contents of the package and additional information

Pomalidomida Accord

Pomalidomida Accord contains the active ingredient “pomalidomida”.This medication is related to talidomida and belongs to a group of medications that affect the immune system (the body's natural defenses).

What is Pomalidomida Accord used for

Pomalidomida Accord is usedto treat adults with a type of cancer called “multiple myeloma”.

Pomalidomida Accord is used with:

• Other two medicationscalled “bortezomib” (a type of chemotherapy medication) and “dexametasona” (an anti-inflammatory medication) in people who have received at least another treatment, including lenalidomida.

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• Another medicationcalled “dexametasona”in people who have suffered a worsening of their myeloma, despite having received at least two other types of treatments, including the medications lenalidomida and bortezomib.

What is multiple myeloma

Multiple myeloma is a type of cancer that affects a specific type of white blood cells (called “plasmatic 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 Pomalidomida Accord works

Pomalidomida Accord acts in several ways:

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

Benefit of using Pomalidomida Accord withbortezomib anddexametasona

If Pomalidomida Accord is used withbortezomib anddexametasonain people who have received at least another treatment, the progression of multiple myeloma can be stopped:

• Generally, the combination of Pomalidomida Accord withbortezomiband dexametasona prevented the recurrence of multiple myeloma for a period of up to 11months compared to the 7months observed in patients who took onlybortezomib anddexametasona.

Benefit of using Pomalidomida Accord with dexametasona

If Pomalidomida Accord is used with dexametasonain people who have received at least two other treatments,the progression of multiple myeloma can be stopped:

• Generally, the combination of Pomalidomida Accord and dexametasona prevented the recurrence of multiple myeloma for a period of up to 4months compared to the 2months observed in patients who took dexametasona only.

Do not takePomalidomida Accord:

• if you are pregnant, think you may be pregnant, or intend to become pregnant, asPomalidomida Accord 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 prevent 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 section6). 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 taking Pomalidomida Accord.

Warnings and precautions

Consult your doctor, pharmacist, or nursebefore starting to take 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 Pomalidomida Accord dose 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 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, can cause kidney failure. You may also experience irregular heartbeats. This disease is called tumor lysis syndrome;
• you suffer or have suffered neuropathy (nerve damage that causes tingling or pain in your feet or hands);
• you have or have had 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 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, enlarged 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, double vision, difficulty speaking, weakness in an arm or leg, a change in gait or balance problems, persistent numbness, decreased sensitivity, or loss of sensitivity, memory loss, or confusion. All of these can be symptoms of a severe and potentially fatal brain disease called progressive multifocal leukoencephalopathy (PML). If you had any of these symptoms before starting treatment with Pomalidomida Accord, inform 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 following instructions as part of the Pomalidomida Accord Pregnancy Prevention Program.

Men and women taking Pomalidomida Accord 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 Accord 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 4weeks before starting treatment, during the entire treatment period, and until at least 4weeks after completing treatment. 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 prevent pregnancy;

• your doctor will schedule pregnancy tests before treatment, at least every 4weeks during treatment, and at least 4weeks after completing treatment.

If, despite preventive measures, you become pregnant:

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

Breastfeeding

The passage of Pomalidomida Accord 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 Accord passes into human semen.

• If your partner is pregnant or can become pregnant, you must use condoms during the entire treatment period and for 7days after completing treatment.
• If your partner becomes pregnant while you are taking Pomalidomida Accord, inform your doctor immediately.Your partner must also inform their doctor immediately.

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

Blood donation and blood tests

You must not donate blood during treatment and for 7days after completing treatment.

Before starting treatment with Pomalidomida Accord 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 in 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 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 medication due to your overall health status.

Children and adolescents

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

Other medications and Pomalidomida Accord

Inform your doctor, pharmacist, or nurseif you are taking, have taken recently, or may need to take any other medication. This is because Pomalidomida Accord may affectthe way other medications work.Additionally, some medications may affect the wayPomalidomida Accord works.

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

• someantifungalssuch 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 Accord. If this happens to you, do not drive or use tools or machinery.

Pomalidomida Accord contains sodium

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

Pomalidomide Accord 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 Accord with other medications

Pomalidomide Accord in combination withbortezomib and dexamethasone

• Consult the prospectus attached to bortezomib and dexamethasone for additional information on its use and effects.
• Pomalidomide Accord, 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 3 medications, other days you will take only 1 or 2 medications, and other days you will take none of them.

• POM:Pomalidomide Accord;BOR: bortezomib;DEX: dexamethasone

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

Pomalidomide Accord alone with dexamethasone

Consult the prospectus attached to dexamethasone for additional information on its use and effects.

• Pomalidomide Accord 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 Accord;DEX: dexamethasone

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

How much Pomalidomide Accord to take with other medications

Pomalidomide Accord with bortezomib and dexamethasone

• The initial recommended dose of Pomalidomide Accord 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/m2 of 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 Accord alone with dexamethasone

• The recommended dose of Pomalidomide Accord 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 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 Pomalidomide 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 abundantly with water and soap.
• Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister pack or capsule. Afterward, carefully remove the gloves to avoid skin exposure, place them in a plastic bag, and dispose of them according to local requirements. Then, wash your 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 Pomalidomide Accord approximately at the same time every day.

To remove the capsule from the blister pack, press only one end of the capsule to push it 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 Pomalidomide Accord if you have kidney problems and are receiving dialysis treatment.

Duration of treatment with Pomalidomide Accord

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

If you take more Pomalidomide Accord than you should

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

If you forget to take Pomalidomide Accord

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

If you have any other questions about using 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 Accord 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 Accord, report it to your doctor as soon as possible.
• Recurrence of hepatitis B virus 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 Accord 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 (influenza).
• 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 (peripheral sensory neuropathy).
• Generalized swelling, including swelling of arms and legs.

• Skin rashes.

• 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):

• Falls.
• Internal bleeding in the brain.
• Reduced ability to move or feel (sensitivity) in the hands, feet, and legs due to nerve damage (peripheral sensory-motor neuropathy).
• Numbness, itching, or tingling sensation in the skin (paresthesia).
• Sensation of dizziness, which makes it difficult to stand and move normally.
• Swelling caused by fluid retention.
• Hives (urticaria).
• Itching sensation in the 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.
• High blood pressure.
• Simultaneous reduction in the number of red and white blood cells and platelets (pancytopenia), making 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.
• Mouth or tongue dryness.
• Changes in taste.
• Abdominal swelling.
• Confusion.
• Feeling down (depressed mood).
• Loss of consciousness, fainting.
• Cataracts.
• 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 tumor 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 directlythrough 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 blister pack and the box after CAD/EXP. The expiration date is the last day of the month indicated.

It does not require special storage conditions.

Do not use Pomalidomida Accord if you observe visible signs of deterioration or signs of improper handling of the medication.

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

Pomalidomide Accord Composition

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

Pomalidomide Accord 1mg hard capsule:

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

Pomalidomide Accord 2mg hard capsule:

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

Pomalidomide Accord 3mg hard capsule:

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

Pomalidomide Accord 4mg hard capsule:

• Each hard capsule contains 4mg 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 ink used for printing contains: shellac, titanium dioxide (E171), and propylene glycol (E1520).

Appearance of Pomalidomide Accord and contents of the pack

Pomalidomide Accord 1mg hard capsules: hard gelatin capsule, yellow body and red cap with “PLM 1” printed in white ink on the body of the capsule.

Pomalidomide Accord 2mg hard capsules:hard gelatin capsule, orange body and red cap with “PLM 2” printed in white ink on the body of the capsule.

Pomalidomide Accord 3mg hard capsules: hard gelatin capsule, turquoise body and red cap with “PLM 3” printed in white ink on the body of the capsule.

Pomalidomide Accord 4mg hard capsules:hard gelatin capsule, dark blue body and red cap with “PLM 4” printed in white ink on the body of the capsule.

Pomalidomide Accord is available in blister packs of 7,14 or 21hard capsules or in perforated unit dose blister packs of 7 x 1, 14 x 1 or 21 x 1 hard 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, 6aPlanta,

08039 Barcelona,

Spain

Responsible Person

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

For further information about this medicinal product, please contact 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 MedicaΑ.Ε.

Τηλ: +30 210 74 88 821

Last update of this leaflet: July 2024

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.There are also links to other websites on rare diseases and orphan medicinal products.