Pomalidomide Ever Pharma

Package leaflet: Information for the patient

Pomalidomide EVER PHARMA 1 mg hard capsules, 2 mg hard capsules, 3 mg hard capsules, 4 mg hard capsules

pomalidomide
Equivalent medicine
Pomalidomide EVER PHARMA 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 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 you, because it may be harmful to them.
• 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 EVER PHARMA is and what it is used for
2. What you need to know before taking Pomalidomide EVER PHARMA
3. How to take Pomalidomide EVER PHARMA
4. Possible side effects
5. How to store Pomalidomide EVER PHARMA
6. Contents of the pack and other information

1. What Pomalidomide EVER PHARMA is and what it is used for

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

Pomalidomide EVER PHARMA is used in combination with:

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

Or

• another 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 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 EVER PHARMA works
Pomalidomide EVER PHARMA 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 nutrients to cancer cells.

The benefit of using Pomalidomide EVER PHARMA together with bortezomib and dexamethasone
When Pomalidomide EVER PHARMA 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 EVER PHARMA used with bortezomib and dexamethasone delayed the recurrence 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 EVER PHARMA together with dexamethasone
When Pomalidomide EVER PHARMA 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 EVER PHARMA used with dexamethasone delayed the recurrence of multiple myeloma for up to 4 months, compared to 2 months in patients treated with dexamethasone alone.

2. What you should know before taking Pomalidomide EVER PHARMA

Do not take Pomalidomide EVER PHARMA

• If you are pregnant or think you may be pregnant, or if you are planning a pregnancy, because Pomalidomide EVER PHARMA is expected to be harmful to the fetus. (Men and women taking this medicine should read the section “Pregnancy, contraception and breastfeeding – information for women and men” below.)
• If there is any possibility that 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 possibility of becoming pregnant, at each prescription your doctor will record that the necessary precautions have been taken and will provide you with confirmation.
• If you are allergic to pomalidomide or to any of the other ingredients of this medicine (listed in section 6). If you think you are 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 EVER PHARMA.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Pomalidomide EVER PHARMA if:

• You have previously experienced blood clots. During treatment with Pomalidomide EVER PHARMA, there is an increased risk of blood clots forming in the veins (thrombi) and arteries. Your doctor may recommend additional treatments (e.g. warfarin) or reduce the dose of Pomalidomide EVER PHARMA to lower the risk of blood clots.
• You have previously had an allergic reaction, such as rash, itching, swelling, dizziness, or difficulty breathing, while taking 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 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 EVER PHARMA may cause reactivation of the hepatitis B virus in patients carrying this virus, leading to recurrence of the infection. Your doctor must check whether you have ever had a 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 benefit and risk 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 EVER PHARMA, 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 indicated in the Pomalidomide EVER PHARMA Pregnancy Prevention Programme.
Women and men taking Pomalidomide EVER PHARMA must not become pregnant or father a child, because pomalidomide is expected to be harmful to the fetus. You and your partner must use effective contraceptive measures during treatment with this medicine.
Women
Do not take Pomalidomide EVER PHARMA if you are pregnant, suspect you may be pregnant, or are planning a pregnancy, because this medicine is expected to be harmful to the fetus. Before starting treatment, you must inform your doctor if there is any possibility that you could become pregnant, even if you think it is unlikely.
If there is any possibility of becoming 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 EVER PHARMA 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 EVER PHARMA passes into human seminal fluid.

• If your partner is pregnant or there is a possibility she may become pregnant, you must use condoms throughout the duration of treatment and for 7 days after treatment ends.
• If your partner becomes pregnant during treatment with Pomalidomide EVER PHARMA, 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 EVER PHARMA, you will undergo regular blood tests because this medicine may 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 treatment starts
• Weekly for the first 8 weeks of treatment
• At least once a month thereafter, throughout the duration of treatment with Pomalidomide EVER PHARMA.

Based on the results of these tests, your doctor may adjust the dose of Pomalidomide EVER PHARMA 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 EVER PHARMA is not recommended in children and adolescents under 18 years of age.
Other medicines and Pomalidomide EVER PHARMA
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. This is because Pomalidomide EVER PHARMA may affect the action of other medicines, and other medicines may affect the action of Pomalidomide EVER PHARMA.
In particular, inform your doctor, pharmacist, or nurse before taking Pomalidomide EVER PHARMA 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 use of machines
Some people may experience fatigue, dizziness, fainting, confusion, or reduced alertness when taking Pomalidomide EVER PHARMA. If this occurs, do not drive vehicles or operate tools or machinery.
Pomalidomide EVER PHARMA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.
Pomalidomide EVER PHARMA contains lactose
Pomalidomide EVER PHARMA contains lactose monohydrate. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Pomalidomide EVER PHARMA

Pomalidomide EVER PHARMA 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 EVER PHARMA with other medicines
Pomalidomide EVER PHARMA with bortezomib and dexamethasone

• Read the package leaflet of bortezomib and dexamethasone for further information on their use and effects.
• Pomalidomide EVER PHARMA, bortezomib, and dexamethasone are taken in "treatment cycles". Each cycle lasts 21 days (3 weeks).
• Refer to the table below to know 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 some days only two or one medicine, and on other days no medicine at all.
  POM: Pomalidomide; BOR: Bortezomib; DEX: Dexamethasone

Cycles 1 to 8

4. Possible side effects

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

Serious side effects
Stop taking Pomalidomide EVER PHARMA 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 reduced numbers of white blood cells, which fight infections).
• Bleeding or bruising without reason, including nosebleeds and intestinal or stomach bleeding (due to effects on blood cells called "platelets").
• Rapid breathing, fast pulse, fever and chills, little or no urination, nausea and vomiting, confusion, loss of consciousness (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 appearance of the skin or skin growths. If you notice any skin changes during treatment with Pomalidomide EVER PHARMA, inform your doctor as soon as possible.
• Reactivation of hepatitis B infection, which may cause yellowing of the skin and eyes, dark brown urine, pain in the right side of the abdomen, 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 you experience these symptoms and contact your doctor or seek immediate medical help. See also section 2.

Stop taking Pomalidomide EVER PHARMA and contact your doctor immediately if you experience any of the serious side effects listed above: urgent medical treatment may be required.

Other side effects

Very common side effects (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 blood sugar levels.
• 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 spasm, 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 side effects (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).
• Sensation of dizziness, with difficulty standing up or moving normally.
• Swelling due to fluid accumulation.
• Hives.
• Itching.
• Shingles (herpes zoster).
• 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, breathless, and be more prone to infections.
• Reduced number of lymphocytes (a type of white blood cell), often due to infection (lymphopenia).
• Low levels of magnesium in the blood (hypomagnesaemia), which may cause tiredness, generalised weakness, muscle cramps, irritability, and may lead to low calcium levels 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 skeletal muscle weakness.
• High levels of potassium in the blood, which may cause 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.
• Bloating of the 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 side effects (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, leading to 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 tiredness, lethargy, muscle weakness, slow heartbeat, and weight gain.

Unknown frequency side effects (frequency cannot be estimated from available data):

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

Reporting of side effects
If you experience any side effect, including those 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.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Pomalidomide EVER PHARMA

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 pack and carton after
Exp. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not use Pomalidomide EVER PHARMA if you notice any damage or signs of tampering with the
medicine packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Pomalidomide EVER PHARMA contains

• The active substance is pomalidomide.
• The other ingredients are lactose monohydrate, crospovidone (E1202), povidone (E1201), sodium lauryl sulfate, and sodium stearyl fumarate (E485).

Pomalidomide EVER PHARMA 1 mg hard capsules:

• Each hard capsule contains 1 mg of pomalidomide.
• The capsule shell contains: gelatin (E441), titanium dioxide (E171), brilliant blue FCF (E133), and yellow iron oxide (E172).
• The printing ink contains: shellac (E904), propylene glycol (E1520), concentrated ammonia solution (E527), black iron oxide (E172), and potassium hydroxide (E525).

Pomalidomide EVER PHARMA 2 mg hard capsules:

• Each hard capsule contains 2 mg of pomalidomide.
• The capsule shell contains: gelatin (E441), titanium dioxide (E171), brilliant blue FCF (E133), yellow iron oxide (E172), and red iron oxide (E172).
• The printing ink contains: shellac (E904), propylene glycol (E1520), concentrated ammonia solution (E527), black iron oxide (E172), and potassium hydroxide (E525).

Pomalidomide EVER PHARMA 3 mg hard capsules:

• Each hard capsule contains 3 mg of pomalidomide.
• The capsule shell contains: gelatin (E441), titanium dioxide (E171), brilliant blue FCF (E133), and yellow iron oxide (E172).
• The printing ink contains: shellac (E904), propylene glycol (E1520), concentrated ammonia solution (E527), black iron oxide (E172), and potassium hydroxide (E525).

Pomalidomide EVER PHARMA 4 mg hard capsules:

• Each hard capsule contains 4 mg of pomalidomide.
• The capsule shell contains: gelatin (E441), titanium dioxide (E171), and brilliant blue FCF (E133).
• The printing ink contains: shellac (E904), propylene glycol (E1520), concentrated ammonia solution (E527), black iron oxide (E172), and potassium hydroxide (E525).

Description of the appearance of Pomalidomide EVER PHARMA and contents of the pack
Pomalidomide EVER PHARMA 1 mg hard capsules: Hard gelatin capsule (14.3 mm in length), with opaque blue cap and opaque yellow body, marked with “T” on the cap and “1” on the body.
Pomalidomide EVER PHARMA 2 mg hard capsules: Hard gelatin capsule (18.0 mm in length), with opaque blue cap and opaque orange body, marked with “T” on the cap and “2” on the body.
Pomalidomide EVER PHARMA 3 mg hard capsules: Hard gelatin capsule (18.0 mm in length), with opaque blue cap and opaque green body, marked with “T” on the cap and “3” on the body.
Pomalidomide EVER PHARMA 4 mg hard capsules: Hard gelatin capsule (18.0 mm in length), with opaque blue cap and opaque light blue body, marked with “T” on the cap and “4” on the body.
The capsules are packaged in unit-dose, whole and divisible blisters made of PVC/PE/PVDC-Aluminum and in unit-dose, whole and divisible blisters made of PVC/PCTFE/PVC-Aluminum.
Pack sizes:
1 mg: 21 capsules
2 mg: 21 capsules
3 mg: 14 capsules
4 mg: 21 capsules
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Ever Pharma Italia S.r.l.
Via Riccardo Gigante 4
00143 Rome
Italy
Manufacturer
Actavis Group PTC ehf.,
Dalshraun 1
IS-220 Hafnarfjordur,
Iceland
Balkanpharma Dupnitsa
AD, Samokovsko
Shosse 3, 2600
Dupnitsa, Bulgaria
Merckle GmbH, Graf-
Arco-Str. 3, 89079 Ulm,
Germany

This medicinal product is authorised in the European Economic Area countries under the
following names:
IT: Pomalidomide EVER PHARMA