Pomalidomide Accord: detailed information

Package leaflet: Information for the patient

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

Pomalidomide
Pomalidomide Accord 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 their symptoms are the same as yours, as 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

What Pomalidomide Accord is and what it is used for
What you need to know before taking Pomalidomide Accord
How to take Pomalidomide Accord
Possible side effects
How to store Pomalidomide Accord
Contents of the pack and other information

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

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

one other medicine, called "dexamethasone", in patients whose myeloma has worsened despite at least two previous therapies containing 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 causes damage to 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 Accord works
Pomalidomide Accord 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 Accord together with bortezomib and dexamethasone
When Pomalidomide Accord 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 Accord used with bortezomib and dexamethasone delayed the return 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 Accord together with dexamethasone
When Pomalidomide Accord 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 Accord used with dexamethasone delayed the return of multiple myeloma for up to 4 months, compared to 2 months for patients treated with dexamethasone alone.

2. What you should know before taking Pomalidomide Accord

Do not take Pomalidomide Accord

If you are pregnant or think you may be pregnant, or if you are planning a pregnancy, because Pomalidomide Accord is expected to be harmful to 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 possibility that 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 possibility that you could 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 to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, consult your doctor for advice.

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

you have previously had episodes of blood clots. During treatment with Pomalidomide Accord, there is an increased risk of developing blood clots in the veins (thrombi) and arteries. Your doctor may recommend additional treatments (e.g. warfarin) or reduce the dose of Pomalidomide Accord 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 could lead to a condition in which tumours break down and cause abnormally high levels of

chemical substances in the blood, which may lead to kidney failure. An irregular heartbeat may also occur.
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 Accord 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 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 when
prescribing this medicine.
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 one arm or leg, changes in the way
you walk, balance problems, persistent numbness, reduced sensation, 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 treatment with
Pomalidomide Accord, 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 Accord Pregnancy Prevention Programme.
Men and women taking Pomalidomide Accord 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 contraceptive measures during treatment with this medicine.
Women
Do not take Pomalidomide Accord 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 possibility that you could become pregnant, even
if you think it is unlikely.
If there is any possibility that you could become pregnant:

you must use effective contraceptive methods for at least 4 weeks before starting treatment, throughout the entire 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 taking preventive measures:

you must stop treatment immediately and contact your doctor right away

Breastfeeding
It is not known whether Pomalidomide Accord 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 Accord passes into human seminal fluid.

If your partner is pregnant or there is any possibility she could become pregnant, you must use condoms throughout the entire duration of treatment and for 7 days after treatment ends.
If your partner becomes pregnant during treatment with Pomalidomide Accord, 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 Accord, you will undergo 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 Accord.

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

certain antifungals, such as ketoconazole
certain antibiotics (e.g. ciprofloxacin, enoxacin)
certain antidepressants, such as fluvoxamine.

Driving and using machines
Some people may experience fatigue, dizziness, faintness, confusion, or reduced alertness when taking
Pomalidomide Accord. If this occurs, do not drive and do not operate tools or machinery.
Pomalidomide Accord contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. essentially ‘sodium-free’.

3. How to take Pomalidomide Accord

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

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

Read the package leaflet of bortezomib and dexamethasone for more information on their use and effects.
Pomalidomide Accord, 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 of 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 one or two medicines; and on some days, no medicine at all.
POM: Pomalidomide Accord; BOR: Bortezomib; DEX: Dexamethasone

Cycles 1 to 8 From Cycle 9 onwards
Medicine name

4. Possible side effects

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

Serious side effects
Stop taking Pomalidomide Accord 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 lower number of white blood cells, which fight infections).
Bleeding or bruising without cause, 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 appearance of the skin or skin growths. If you notice any skin changes during treatment with Pomalidomide Accord, 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 Accord 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 blood sugar levels.
Rapid and irregular heartbeat (atrial fibrillation).
Reduced 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 swelling of 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 prickling or pins-and-needles sensation on the skin (paraesthesia).
Sensation of dizziness, with difficulty standing up and moving normally.
Swelling due to fluid accumulation.
Hives.
Itching.
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), increasing the risk of bleeding and bruising. You may feel tired, weak and breathless and 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 tiredness, general 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 skeletal muscle weakness.
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.
Bloating.
Feeling confused.
Feeling low in mood (depressed mood).
Loss of consciousness, fainting.
Blurred vision (cataract).
Kidney damage.
Inability to urinate.
Abnormal 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, 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.

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 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 listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pomalidomide Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and 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 Accord if you notice damage or signs of tampering with the medicine packaging.
Do not dispose of medicines via wastewater or household waste. Unused medicines should be returned to the pharmacist at the end of treatment. This will help protect the environment.

6. Package contents and other information

What Pomalidomide Accord contains

The active substance is pomalidomide.
The other ingredients are microcrystalline cellulose, maltodextrin and sodium stearil fumarate.

Pomalidomide Accord 1 mg hard capsules:

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

Pomalidomide Accord 2 mg hard capsules:

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

Pomalidomide Accord 3 mg hard capsules:

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

Pomalidomide Accord 4 mg hard capsules:

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

Description of the appearance of Pomalidomide Accord and contents of the pack
Pomalidomide Accord 1 mg hard capsules: hard gelatin capsule with yellow body and red cap, printed with "PLM 1" in white ink on the body of the capsule.
Pomalidomide Accord 2 mg hard capsules: hard gelatin capsule with orange body and red cap, printed with "PLM 2" in white ink on the body of the capsule.
Pomalidomide Accord 3 mg hard capsules: hard gelatin capsule with turquoise body and red cap, printed with "PLM 3" in white ink on the body of the capsule.
Pomalidomide Accord 4 mg hard capsules: hard gelatin capsule with dark blue body and red cap, printed with "PLM 4" in white ink on the body of the capsule.
Pomalidomide Accord is available in blisters of 7, 14 or 21 capsules or in perforated, divisible blisters for single doses of 7 x 1, 14 x 1 or 21 x 1 capsules. Not all pack sizes may be marketed.

Marketing Authorization Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est, 6th Floor,
08039 Barcelona,
Spain

Manufacturers
Synthon Hispania S.L.
Castello, 1
Poligono 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 on 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 Medica Α.Ε.
Tel: +30 210 74 88 821

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu. Links to other websites on rare diseases and their therapeutic treatments are also provided.