Pomalidomide Abdi

Package leaflet: Information for the patient

Pomalidomide Abdi 1 mg hard capsules, 2 mg hard capsules, 3 mg hard capsules, 4 mg hard capsules

pomalidomide
Generic medicine
Pomalidomide Abdi is expected to cause birth defects and may result in fetal death.

• Do not take this medicine if you are pregnant or may become pregnant.
• Follow the advice on contraceptive methods described in this leaflet.

Please read all of this leaflet carefully before you start taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

What Pomalidomide Abdi is
Pomalidomide Abdi contains the active substance "pomalidomide". This medicine is related to
thalidomide and belongs to a group of medicines that act on the immune system (the body's natural
defences).

What Pomalidomide Abdi is used for
Pomalidomide Abdi is used to treat adults with a type of cancer called "multiple myeloma".

Pomalidomide Abdi is used in combination with:

• two other medicines, called "bortezomib" (a type of chemotherapy medicine) and "dexamethasone" (an anti-inflammatory medicine), in patients who have received at least one prior therapy including lenalidomide.

Or

• one other medicine, called "dexamethasone", in patients whose myeloma has worsened despite at least two prior therapies including lenalidomide and bortezomib.

What is multiple myeloma
Multiple myeloma is a type of cancer that affects a certain type of white blood cells (called "plasma cells"). These cells grow uncontrollably and accumulate in the bone marrow. This leads to damage to the bones and kidneys.
Multiple myeloma is generally incurable. However, treatment can reduce or eliminate signs and symptoms of the disease for a certain period of time. When this occurs, it is referred to as a "response".

How Pomalidomide Abdi works
Pomalidomide Abdi works in several ways:

• by stopping the growth of myeloma cells
• by stimulating the immune system to attack cancer cells
• by inhibiting the formation of blood vessels that supply tumour cells.

The benefit of using Pomalidomide Abdi with bortezomib and dexamethasone
When Pomalidomide Abdi is used together with bortezomib and dexamethasone in patients who have received at least one prior therapy, it can prevent multiple myeloma from worsening:

• On average, Pomalidomide Abdi used with bortezomib and dexamethasone prevented the return of multiple myeloma for up to 11 months, compared to 7 months in patients treated with bortezomib and dexamethasone alone.

The benefit of using Pomalidomide Abdi with dexamethasone
When Pomalidomide Abdi is used together with dexamethasone in patients who have received at least two prior therapies, it can prevent multiple myeloma from worsening:

• On average, Pomalidomide Abdi used with dexamethasone prevented the return of multiple myeloma for up to 4 months, compared to 2 months in patients treated with dexamethasone alone.

2. What you need to know before taking Pomalidomide Abdi

Do not take Pomalidomide Abdi

• If you are pregnant or think you might be pregnant, or if you are planning a pregnancy, because Pomalidomide Abdi is expected to be harmful to the unborn baby. (Men and women taking this medicine should read the section “Pregnancy, contraception and breastfeeding – information for women and men” below.)
• If there is any chance you may become pregnant unless you follow all necessary measures to avoid pregnancy (see “Pregnancy, contraception and breastfeeding – information for women and men”). If there is any chance you may become pregnant, your doctor will record at each prescription that the necessary precautions have been taken and will provide you with confirmation of this.
• If you are allergic to pomalidomide or any of the other ingredients of this medicine (listed in section 6).

If you are unsure whether any of the above conditions apply to you, consult your doctor,
pharmacist, or nurse before taking Pomalidomide Abdi.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Pomalidomide Abdi if:

• you have previously had episodes of blood clots. During treatment with Pomalidomide Abdi, there is an increased risk of blood clots forming in the veins (thrombosis) and arteries. Your doctor may recommend additional treatments (e.g. warfarin) or reduce your dose of Pomalidomide Abdi to reduce the likelihood of blood clots;
• you have previously had an allergic reaction, such as rash, itching, swelling, dizziness, or difficulty breathing, during treatment with related medicines called “thalidomide” or “lenalidomide”;
• you have had a heart attack, have heart failure, have breathing difficulties, or if you smoke,

have high blood pressure or high cholesterol levels;

• you have a high tumour burden throughout your body, including in the bone marrow. This could lead to a condition in which tumours break down and cause abnormal levels of chemicals in the blood, potentially leading to kidney failure. You may also experience an irregular heartbeat. This condition is called tumour lysis syndrome;
• you have or have previously had neuropathy (nerve damage causing tingling or pain in the hands or feet);
• you have or have previously had hepatitis B infection. Treatment with Pomalidomide Abdi may cause reactivation of the hepatitis B virus in patients who carry this virus, leading to a recurrence of infection. Your doctor must check whether you have ever had hepatitis B infection;
• you have or have previously had any combination of the following symptoms: rash on the face or more widespread, skin redness, high fever, flu-like symptoms, swollen lymph nodes (these are signs of a serious skin reaction called drug reaction with eosinophilia and systemic symptoms (DRESS), or drug hypersensitivity syndrome, toxic epidermal necrolysis (TEN), or Stevens-Johnson syndrome (SJS); see also section 4 “Possible side effects”);

It is important to note that patients with multiple myeloma treated with pomalidomide may develop
other types of cancer; therefore, your doctor must carefully evaluate the benefits and risks when
prescribing this medicine.
At any time during or after treatment, 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, changes in the way
you walk or problems with balance, persistent numbness, reduced sensation or loss of sensation,
memory loss or confusion. These may be symptoms of a serious brain disease that can be fatal, known as
progressive multifocal leukoencephalopathy (PML). If you had these symptoms before starting treatment
with Pomalidomide Abdi, inform your doctor of any changes in these symptoms.
At the end of treatment, you must return all unused capsules to the pharmacist.
Pregnancy, contraception and breastfeeding – information for women and men
The following instructions must be followed as outlined in the Pomalidomide Abdi Pregnancy Prevention Programme.
Women and men taking Pomalidomide Abdi must not attempt to become pregnant or conceive a child, because pomalidomide is expected to be harmful to the unborn baby. You and your partner must use effective contraception during treatment with this medicine.
Women
Do not take Pomalidomide Abdi if you are pregnant, suspect you may be pregnant, or are planning a
pregnancy, because this medicine is expected to be harmful to the unborn baby. Before starting
treatment, you must inform your doctor if there is any chance you could become pregnant, even if you think it is unlikely.
If there is any chance you could become pregnant:

• you must use effective contraceptive methods for at least 4 weeks before starting treatment, throughout the duration of treatment, and for at least 4 weeks after stopping treatment. Consult your doctor about the most suitable contraceptive method for you.
• At each prescription, your doctor will ensure that you understand the necessary measures to prevent pregnancy.
• Your doctor will arrange pregnancy tests before treatment, at least every 4 weeks during treatment, and at least 4 weeks after treatment ends.

If you become pregnant despite preventive measures:

• you must stop treatment immediately and contact your doctor right away.

Breastfeeding
It is not known whether Pomalidomide Abdi passes into breast milk. Inform your doctor if you are
breastfeeding or intend to breastfeed. Your doctor will advise you whether to stop or continue
breastfeeding.
Men
Pomalidomide Abdi passes into human semen.

• If your partner is pregnant or there is any chance she may become pregnant, you must use condoms throughout the duration of treatment and for 7 days after stopping treatment.
• If your partner becomes pregnant while you are being treated with Pomalidomide Abdi, inform your doctor immediately. Your partner must also inform her doctor immediately. You must not donate semen or sperm during treatment and for 7 days after treatment ends.

Blood donation and blood tests
You must not donate blood during treatment and for 7 days after treatment ends.
Before and during treatment with Pomalidomide Abdi, you will undergo regular blood tests because this medicine can cause a reduction in blood cells that fight infections (white blood cells) and cells that stop bleeding (platelets).
Your doctor will ask you to have blood tests:

• before starting treatment
• weekly for the first 8 weeks of treatment
• at least once a month thereafter, for the entire duration of treatment with Pomalidomide Abdi.

Based on the results of these tests, your doctor may adjust the dose of Pomalidomide Abdi or stop treatment. Your doctor may also adjust the dose or stop treatment based on your overall health status.
Children and adolescents
Pomalidomide Abdi is not recommended for use in children and adolescents under 18 years of age.
Other medicines and Pomalidomide Abdi
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. This is because Pomalidomide Abdi may affect the action of other medicines, and other medicines may affect the action of Pomalidomide Abdi.
In particular, inform your doctor, pharmacist, or nurse before taking Pomalidomide Abdi
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 may experience fatigue, dizziness, faintness, confusion, or reduced alertness when taking Pomalidomide Abdi. If this occurs, do not drive or operate tools or machinery.
Pomalidomide Abdi contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. essentially “sodium-free”.
Pomalidomide Abdi contains an azo dye
This medicine contains Brilliant Black PN (E151). This may cause allergic reactions.

3. How to take Pomalidomide Abdi

Pomalidomide Abdi must be prescribed and administered by a physician experienced in the treatment of multiple myeloma.
Always follow your doctor's instructions exactly. If you have any doubts, consult your doctor, pharmacist, or nurse.

When to take Pomalidomide Abdi with other medicines
Pomalidomide Abdi with bortezomib and dexamethasone

• Read the package leaflet for bortezomib and dexamethasone for more information about their use and effects.
• Pomalidomide Abdi, bortezomib, and dexamethasone are taken in "treatment cycles". Each cycle lasts 21 days (3 weeks).
• Refer to the table below to see which medicines to take each day during the 3-week cycle:
  o Each day, check the chart and find the correct day to determine which medicines to take.
  o On some days, you will take all three medicines; on other days, only two or one medicine; and on some days, no medicine at all.

POM: Pomalidomide Abdi; BOR: Bortezomib; DEX: Dexamethasone
Cycles 1 to 8 From Cycle 9 onwards
Medicine name Medicine name
Day POM BOR DEX Day POM BOR DEX
1 √ √ √ 1 √ √ √
2 √ √ 2 √ √
3 √ 3 √
4 √ √ √ 4 √
5 √ √ 5 √
6 √ 6 √
7 √ 7 √
8 √ √ √ 8 √ √ √
9 √ √ 9 √ √
10 √ 10 √
11 √ √ √ 11 √
12 √ √ 12 √
13 √ 13 √
14 √ 14 √
15 15
16 16
17 17
18 18
19 19
20 20
21 21

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

Pomalidomide Abdi with dexamethasone alone

• Read the package leaflet for dexamethasone for more information about its use and effects.
• Pomalidomide Abdi and dexamethasone are taken in treatment cycles. Each cycle lasts 28 days (4 weeks).
• Refer to the table below to see which medicines to take each day during the 4-week cycle:
  o Each day, check the chart and find the correct day to determine which medicines to take.
  o On some days, you will take both medicines; on other days, only one medicine; and on some days, no medicine at all.

POM: Pomalidomide Abdi; DEX: Dexamethasone
Medicine
name
Day POM DEX
1 √ √
2 √
3 √
4 √
5 √
6 √
7 √
8 √ √
9 √
10 √
11 √
12 √
13 √
14 √
15 √ √
16 √
17 √
18 √
19 √
20 √
21 √
22 √

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

Dose of Pomalidomide Abdi to be taken with other medicines
Pomalidomide Abdi with bortezomib and dexamethasone

• The recommended starting dose of Pomalidomide Abdi is 4 mg once daily.
• The recommended starting dose of bortezomib will be determined by your doctor based on your height and weight (1.3 mg/m² of body surface area).
• The recommended starting dose of dexamethasone:
  • For adults: 20 mg per day.
  • For elderly patients over 75 years of age: 10 mg per day.

Pomalidomide Abdi with dexamethasone alone

• The recommended starting dose of Pomalidomide Abdi is 4 mg once daily.
• The recommended starting dose of dexamethasone:
  • For adults: 40 mg per day.
  • For elderly patients over 75 years of age: 20 mg per day.

Your doctor may need to reduce the dose of Pomalidomide Abdi, bortezomib, or dexamethasone, or discontinue one or more of these medicines based on blood test results, your general condition, other medicines you may be taking (e.g. ciprofloxacin, enoxacin, and fluvoxamine), and if any adverse effects occur (particularly rash or swelling) due to treatment.

If you have liver or kidney problems, your doctor will monitor your condition very closely during treatment with this medicine.

How to take Pomalidomide Abdi

• 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 soap and water.
• Healthcare providers, caregivers, and family members should wear disposable gloves when handling the blister pack or capsule. Gloves should then be carefully removed to avoid skin exposure, placed in a sealed polyethylene bag, and disposed of according to local regulations. Hands should then be washed thoroughly with soap and water. Pregnant women or women who suspect they may be pregnant must not handle the blister pack or capsule.
• Swallow the capsules whole, preferably with water.
• The capsules may be taken with or without food.
• Take the capsules at approximately the same time each day.

To remove the capsule from the blister, press on one side of the capsule, pushing it through the aluminum foil. Do not press on the center of the capsule, as this may cause it to break.

Your doctor will inform you how and when to take Pomalidomide Abdi if you have kidney problems and are undergoing dialysis.

Duration of treatment with Pomalidomide Abdi
You must continue the treatment cycles until your doctor tells you to stop.

If you take more Pomalidomide Abdi than you should
If you take more Pomalidomide Abdi than prescribed, contact your doctor or go to hospital immediately. Bring the medicine packaging with you.

If you forget to take Pomalidomide Abdi
If you forget to take Pomalidomide Abdi on the prescribed day, take the next capsule as usual the following day. Do not increase the number of capsules taken to make up for the missed dose.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Serious side effects

Stop taking Pomalidomide Abdi and contact your doctor immediately if you experience any of the following serious side effects – urgent medical treatment may be required:

• Fever, chills, sore throat, cough, mouth ulcers, or any other sign of infection (due to a reduced number of white blood cells that fight infections).
• Bleeding or bruising without reason, including nosebleeds and bleeding from the intestine or stomach (due to effects on blood cells called "platelets").
• Rapid breathing, rapid pulse, fever and chills, little or no urination, nausea and vomiting, confusion, unconsciousness (due to a blood infection called sepsis or septic shock).
• Severe, persistent or bloody diarrhoea (possibly with stomach pain or fever) caused by bacteria called Clostridium difficile.
• Chest pain or pain and swelling in the legs, especially in the lower leg or calf (caused by blood clots).
• Shortness of breath (due to severe chest infection, lung inflammation, heart failure or blood clot).
• Swelling of the face, lips, tongue and throat, which may 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 may cause changes in the skin's appearance or skin growths. If you notice any skin changes during treatment with Pomalidomide Abdi, inform your doctor as soon as possible.
• Reactivation of hepatitis B infection, which may cause yellowing of the skin and eyes, dark brown urine, right-sided abdominal pain, fever, nausea or vomiting. Inform your doctor immediately if you notice any of these symptoms.
• Widespread rash, high body temperature, swollen lymph nodes and involvement of other organs (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 these symptoms occur and contact your doctor or seek immediate medical help. See also section 2.

Stop taking Pomalidomide Abdi and contact your doctor immediately if any of the above serious side effects occur – urgent medical treatment may be required.

Other side effects

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

• Shortness of breath (dyspnoea).
• Lung infections (pneumonia and bronchitis).
• Infections of the nose, sinuses and throat caused by bacteria or viruses.
• Flu-like symptoms (influenza).
• Low number of red blood cells, which may cause anaemia leading to tiredness and weakness.
• Low levels of potassium in the blood (hypokalaemia), which may cause weakness, muscle cramps, muscle pain, palpitations, tingling or numbness, shortness of breath, mood changes.
• High levels of sugar in the blood.
• Fast and irregular heartbeat (atrial fibrillation).
• Decreased appetite.
• Constipation, diarrhoea or nausea.
• Vomiting.
• Abdominal pain.
• Lack of energy.
• Difficulty falling asleep or staying asleep.
• Dizziness, tremor.
• Muscle spasms, muscle weakness.
• Bone pain, back pain.
• Numbness, tingling or burning sensation on the skin, pain in hands or feet (peripheral sensory neuropathy).
• Swelling of the body, including arms and legs.
• Skin rashes.
• Urinary tract infection, which may cause a burning sensation when urinating or the need to urinate more frequently.

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

• Falls.
• Bleeding within the skull.
• Reduced ability to move or feel sensations in the hands, arms, feet and legs due to nerve system damage (peripheral sensory-motor neuropathy).
• Numbness, itching and pins-and-needles sensation on the skin (paraesthesia).
• Dizziness, with difficulty standing up and moving normally.
• Swelling due to fluid retention.
• Hives.
• Itching.
• Herpes zoster (shingles).
• Heart attack (chest pain spreading to arms, neck, jaw, sweating, shortness of breath, nausea or vomiting).
• Chest pain, chest infection.
• Increased blood pressure.
• Simultaneous reduction in red blood cells, white blood cells and platelets (pancytopenia), increasing the risk of bleeding and bruising. You may feel tired, weak and breathless, and you may be more likely to develop infections.
• Reduced number of lymphocytes (a type of white blood cells), often caused by infection (lymphopenia).
• Low levels of magnesium in the blood (hypomagnesaemia), which may cause fatigue, generalised weakness, muscle cramps, irritability, and may lead to low levels of calcium in the blood (hypocalcaemia), possibly causing numbness and/or tingling in hands, feet or lips, muscle cramps, muscle weakness, dizziness, confusion.
• Low levels of phosphate in the blood (hypophosphataemia), which may cause muscle weakness, irritability or confusion.
• High levels of calcium in the blood (hypercalcaemia), which may cause slowed reflexes and weakness of skeletal muscles.
• High levels of potassium in the blood, which may cause an abnormal heart rhythm.
• Low levels of sodium in the blood, which may cause tiredness and confusion, muscle spasms, seizures or coma.
• High levels of uric acid in the blood, which may cause a form of arthritis called gout.
• Low blood pressure, which may cause dizziness or fainting.
• Painful or dry mouth.
• Altered sense of taste.
• Abdominal pain, bloated abdomen.
• Feeling confused.
• Feeling low in mood (depressed mood).
• Loss of consciousness, fainting.
• Blurred vision (cataract).
• Kidney damage.
• Inability to urinate.
• Abnormalities in liver function tests.
• Pelvic pain.
• Weight loss.

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

• Stroke.
• Inflammation of the liver (hepatitis), which may cause itching, yellowing of the skin and whites of the eyes (jaundice), pale stools, dark urine and abdominal pain.
• Breakdown of tumour cells, causing the release of toxic substances into the bloodstream (tumour lysis syndrome). This may cause kidney problems.
• Underactive thyroid gland, which may cause symptoms such as fatigue, lethargy, muscle weakness, slow heartbeat and weight gain.

Not known (frequency cannot be estimated from available data):

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

Reporting of side effects

If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pomalidomide Abdi

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 on the carton after
Exp./EXP. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not use Pomalidomide Abdi if you notice any damage or signs of tampering with the medicine packaging.
Do not dispose of any medicine via wastewater or household waste. Unused medicine must be returned to the pharmacist at the end of treatment. This will help protect the environment.

6. Package Contents and Other Information

What Pomalidomide Abdi Contains

• The active substance is pomalidomide.

Pomalidomide Abdi 1 mg hard capsule:

• Each capsule contains 1 mg of pomalidomide.
• The capsule shell contains: mannitol (E421), sodium croscarmellose, sodium stearyl fumarate, gelatin, titanium dioxide (E171), yellow iron oxide (E172), and brilliant black PN (E151).

Pomalidomide Abdi 2 mg hard capsule:

• Each capsule contains 2 mg of pomalidomide.
• The capsule shell contains: mannitol (E421), sodium croscarmellose, sodium stearyl fumarate, gelatin, titanium dioxide (E171), yellow iron oxide (E172), brilliant black PN (E151), and red iron oxide (E172).

Pomalidomide Abdi 3 mg hard capsule:

• Each capsule contains 3 mg of pomalidomide.
• The capsule shell contains: mannitol (E421), sodium croscarmellose, sodium stearyl fumarate, gelatin, titanium dioxide (E171), yellow iron oxide (E172), brilliant black PN (E151), and brilliant blue FCF & FD&C Blue No. 1 (E133).

Pomalidomide Abdi 4 mg hard capsule:

• Each capsule contains 4 mg of pomalidomide.
• The capsule shell contains: mannitol (E421), sodium croscarmellose, sodium stearyl fumarate, gelatin, titanium dioxide (E171), yellow iron oxide (E172), brilliant black PN (E151), and patent blue V (E131).

Description of the Appearance of Pomalidomide Abdi and Contents of the Pack
Pomalidomide Abdi 1 mg hard capsules are rigid gelatin capsules with an overall length of approximately 17.5 mm and an outer diameter of 6.2 mm, featuring a dark blue opaque cap and an ivory opaque body, containing yellow to yellowish powder.
Pomalidomide Abdi 2 mg hard capsules are rigid gelatin capsules with an overall length of approximately 17.5 mm and an outer diameter of 6.2 mm, featuring a dark blue opaque cap and a light orange opaque body, containing yellow to yellowish powder.
Pomalidomide Abdi 3 mg hard capsules are rigid gelatin capsules with an overall length of approximately 17.5 mm and an outer diameter of 6.2 mm, featuring a dark blue opaque cap and a light green opaque body, containing yellow to yellowish powder.
Pomalidomide Abdi 4 mg hard capsules are rigid gelatin capsules with an overall length of approximately 17.5 mm and an outer diameter of 6.2 mm, featuring a dark blue opaque cap and a light blue opaque body, containing yellow to yellowish powder.
Each pack contains 14 or 21 capsules. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Abdi Farma GmbH
Donnersbergstraße 4
64646 Heppenheim
Germany

Manufacturer
Interpharma Services Ltd.
43A Cherni Vrach Blvd.
1407 Sofia
Bulgaria
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola PLA3000
Malta
Abdi Farma GmbH
Donnersbergstraße 1
64646 Heppenheim
Germany

This medicinal product is authorized in the European Economic Area Member States under the following names: