Pomalidomide Aurobindo

Package leaflet: Information for the user

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

Generic medicine
Pomalidomide Aurobindo 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 because 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 other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

Pomalidomide Aurobindo 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 defenses).
What Pomalidomide Aurobindo is used for
Pomalidomide Aurobindo is used in the treatment of adults with a type of cancer called "multiple myeloma".
Pomalidomide Aurobindo 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 other therapy including lenalidomide; or
• one other medicine, called "dexamethasone", in patients whose myeloma has worsened despite at least two previous 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 of the bones and kidneys.
Multiple myeloma is generally incurable. However, treatment can reduce the signs and symptoms of the disease or make them disappear for a certain period of time. When this occurs, it is referred to as a "response".
How Pomalidomide Aurobindo works
Pomalidomide Aurobindo works in several ways:

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

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

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

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

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

2. What you need to know before taking Pomalidomide Aurobindo

Do not take Pomalidomide Aurobindo

• If you are pregnant, think you may be pregnant, or are planning a pregnancy, because Pomalidomide Aurobindo is expected to harm the unborn baby (men and women taking this medicine must read the section “Pregnancy, contraception and breastfeeding – information for women and men” below).
• If there is any chance you could 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 of becoming 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 to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, consult your doctor.

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

• You have previously had blood clots. There is an increased risk of developing blood clots in the veins (thrombosis) and arteries during treatment with Pomalidomide Aurobindo. Your doctor may recommend additional treatments (e.g., warfarin) or reduce your dose of Pomalidomide Aurobindo to lower the risk 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 the body, including in the bone marrow. This may 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 develop 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 Aurobindo may cause reactivation of the hepatitis B virus in patients who carry the virus, leading to a recurrence of the 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: facial or widespread rash, 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 before
prescribing this medicine.
At any time during or after treatment, inform your doctor or nurse immediately if you experience
blurred vision, loss of vision, double vision, difficulty speaking, weakness in one arm or leg, changes in
walking or balance, persistent numbness, reduced sensation, loss of sensation, memory loss, or
confusion. These may be symptoms of a serious and potentially fatal brain disease known as
progressive multifocal leukoencephalopathy (PML). If you had these symptoms before starting
treatment with Pomalidomide Aurobindo, 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 specified in the Pomalidomide Aurobindo Pregnancy Prevention Programme.
Women and men taking Pomalidomide Aurobindo must not become pregnant or father a child, because pomalidomide is expected to harm the unborn baby. You and your partner must use effective contraception during treatment with this medicine.
Women
Do not take Pomalidomide Aurobindo if you are pregnant, suspect you may be pregnant, or are planning a pregnancy, because this medicine is expected to harm 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 entire treatment period, 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 confirm 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 Aurobindo passes into breast milk. Inform your doctor if you are breastfeeding or plan to breastfeed. Your doctor will advise you whether to stop or continue breastfeeding.
Men
Pomalidomide Aurobindo passes into human seminal fluid.

• If your partner is pregnant or there is any chance she could become pregnant, you must use condoms throughout the entire treatment period and for 7 days after stopping treatment.
• If your partner becomes pregnant during treatment with Pomalidomide Aurobindo, 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 stopping treatment.
Blood donation and blood tests
You must not donate blood during treatment and for 7 days after stopping treatment.
Before and during treatment with Pomalidomide Aurobindo, you will have regular blood tests because this medicine may cause a reduction in blood cells that fight infections (white blood cells) and in 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 Aurobindo.

Based on the results of these tests, your doctor may adjust the dose of Pomalidomide Aurobindo or stop treatment. Your doctor may also adjust the dose or stop treatment based on your overall health status.
Children and adolescents
The use of Pomalidomide Aurobindo is not recommended in children and adolescents under 18 years of age.
Other medicines and Pomalidomide Aurobindo
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. This is because Pomalidomide Aurobindo may affect the action of other medicines and other medicines may affect the action of Pomalidomide Aurobindo.
In particular, inform your doctor, pharmacist, or nurse before taking Pomalidomide Aurobindo if you are taking any of the following medicines:

• certain antifungal medicines, 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 Aurobindo. If this occurs, do not drive or operate tools or machinery.
Pomalidomide Aurobindo contains sodium, maltitol and isomaltitol
Sodium:
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially ‘sodium-free’.
Maltitol and isomaltitol:
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

3. How to take Pomalidomide Aurobindo

Pomalidomide Aurobindo must be prescribed and administered by a physician experienced in the treatment of multiple myeloma.
Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor, pharmacist, or nurse.

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

• Read the package leaflet for bortezomib and dexamethasone for further information on their use and possible effects.
• Pomalidomide Aurobindo, 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:
  • Each day, check the chart to identify the correct day and determine which medicines to take.
  • On some days, you will take all three medicines; on other days, only two or one medicine; and on certain days, no medicines at all.

POM: Pomalidomide Aurobindo; BOR: Bortezomib; DEX: Dexamethasone
Cycle 1 to 8 Cycle 9 onwards

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

Pomalidomide Aurobindo with dexamethasone alone

• Refer to the dexamethasone package leaflet for more information on its use and effects.
• Pomalidomide Aurobindo and dexamethasone are taken in treatment cycles. Each cycle lasts 28 days (4 weeks).
• Consult the following table to know what to take each day of the 4-week cycle:
  o Each day, check the chart and find the correct day to know which medicines to take.
  o On some days you will take both medicines, on some days only one medicine, and on other days no medicine.

POM: Pomalidomide Aurobindo; DEX: Dexamethasone

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

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

• The recommended starting dose of Pomalidomide Aurobindo 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/m^2 of body surface area).
• The recommended starting dose of dexamethasone is 20 mg daily. However, if you are over 75 years of age, the recommended starting dose is 10 mg daily.

Pomalidomide Aurobindo with dexamethasone alone

• The recommended starting dose of Pomalidomide Aurobindo is 4 mg once daily.
• The recommended starting dose of dexamethasone is 40 mg daily. However, if you are over 75 years of age, the recommended starting dose is 20 mg daily.

Your doctor may need to reduce the dose of Pomalidomide Aurobindo, 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 adverse effects (particularly rash or swelling) occur 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 Aurobindo

• 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 only of the capsule, pushing it through the aluminum foil. Do not press in the center of the capsule, as this may cause it to break.

Your doctor will inform you how and when to take Pomalidomide Aurobindo if you have kidney problems
and are undergoing dialysis.
Duration of treatment with Pomalidomide Aurobindo
You must continue the treatment cycles until your doctor tells you to stop.
If you take more Pomalidomide Aurobindo than you should
If you take more Pomalidomide Aurobindo than prescribed, consult your doctor or go to hospital
immediately. Take the medicine package with you.
If you forget to take Pomalidomide Aurobindo
If you forget to take Pomalidomide Aurobindo on the prescribed day, take the next capsule as usual the following day. Do not increase the number of capsules you take to make up for the missed dose of Pomalidomide Aurobindo the previous day.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Serious side effects

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

• Fever, chills, sore throat, cough, mouth ulcers, or any other sign of infection (due to a lower number of white blood cells, which 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 types of 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 appearance of the skin or skin growths. If you notice any skin changes during treatment with Pomalidomide Aurobindo, inform your doctor as soon as possible.
• Reactivation of hepatitis B infection, which may cause yellowing of the skin and eyes, dark brown urine, abdominal pain on the right side, fever, and 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 you experience these symptoms and contact your doctor or seek immediate medical help. See also section 2.

Stop taking Pomalidomide Aurobindo and contact your doctor immediately if you experience any of the serious side effects listed above – urgent medical treatment may be needed.

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).
• Loss of 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 swelling of the 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 damage to the nervous system (peripheral sensory-motor neuropathy).
• Numbness, itching, and sensations of pins and needles on the skin (paraesthesia).
• Feeling of dizziness, with difficulty standing up and moving normally.
• Swelling caused by fluid accumulation.
• Hives.
• Itching of the skin.
• Herpes zoster (shingles).
• Heart attack (chest pain spreading to the arms, neck, jaw, sweating, shortness of breath, nausea or vomiting).
• Chest pain, chest infection.
• Increased blood pressure.
• Simultaneous reduction in the number of red blood cells, white blood cells, and platelets (pancytopenia), making you more prone to 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 cell), 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 the 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.
• Swollen 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.
• Increased alanine aminotransferase.

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.
• Basal cell carcinoma.

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 the website: 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 Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP.".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use Pomalidomide Aurobindo if you notice 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 Aurobindo contains

• The active substance is pomalidomide. Each hard capsule contains 1 mg of pomalidomide. Each hard capsule contains 2 mg of pomalidomide. Each hard capsule contains 3 mg of pomalidomide. Each hard capsule contains 4 mg of pomalidomide.

The other components are: Maltitol, isomaltitol, crospovidone and sodium stearilfumarate.
Capsule cap: Indigo carmine (E 132) (for 1 mg, 2 mg, 3 mg), titanium dioxide (E171), gelatin, red iron oxide (E172) (for 4 mg).
Capsule body: Titanium dioxide (E171), gelatin, indigo carmine (E 132) (for 3 mg), red iron oxide (E172) (for 2 mg and 4 mg), yellow iron oxide (E172) (for 1 mg, 2 mg and 3 mg).
Printing ink (black and white): Shellac, black iron oxide (for 4 mg), potassium hydroxide, titanium dioxide (E171) (for 1 mg, 2 mg and 3 mg).

Description of the appearance of Pomalidomide Aurobindo and package contents
Pomalidomide Aurobindo 1 mg hard capsules
Yellow powder contained in a size 3 hard gelatin capsule, with an opaque dark blue cap and an opaque yellow body, printed with "P1" in white ink on the cap; smooth body.

Pomalidomide Aurobindo 2 mg hard capsules
Yellow powder contained in a size 1 hard gelatin capsule, with an opaque dark blue cap and an opaque orange body, printed with "P2" in white ink on the cap; smooth body.

Pomalidomide Aurobindo 3 mg hard capsules
Yellow powder contained in a size 1 hard gelatin capsule, with an opaque dark blue cap and an opaque green body, printed with "P3" in white ink on the cap; smooth body.

Pomalidomide Aurobindo 4 mg hard capsules
Yellow powder contained in a size 0 hard gelatin capsule, with an opaque red cap and an opaque red body, printed with "P4" in black ink on the cap; smooth body.

Pomalidomide Aurobindo hard capsules are available in blister packs containing 14 and 21 hard capsules, and in perforated unit-dose divisible blister packs containing 14x1 and 21x1 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Eugia Pharma (Malta) Ltd
Vault 14, Level 2, Valletta Waterfront,
Floriana FRN 1914
Malta

Manufacturers
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000
Malta

Generis Farmacêutica SA
Rua João de Deus, 19,
2700-487 Amadora
Portugal

Arrow Generiques
26 Avenue Tony Garnier
69007 Lyon
France

This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium: Pomalidomide Eugia 1 mg, 2 mg, 3 mg, 4 mg harde capsules / gélules / Hartkapseln
Luxembourg: Pomalidomide Eugia 1 mg, 2 mg, 3 mg, 4 mg gélules / Hartkapseln
France: Pomalidomide Eugia 1 mg, 2 mg, 3 mg, 4 mg gélule
Germany: Pomalomid Puren 1 mg, 2 mg, 3 mg, 4 mg, Hartkapseln
Italy: Pomalidomide Aurobindo
Netherlands: Pomalidomide Eugia 1 mg, 2 mg, 3 mg, 4 mg, harde capsules
Poland: Pomalidomide Eugia
Portugal: Pomalidomida Eugia
Spain: Pomalidomida Eugia 3 mg, 4 mg cápsulas duras EFG