Patient Information Leaflet

Imnovid 1 mg Hard Capsules

Imnovid 2 mg Hard Capsules

Imnovid 3 mg Hard Capsules

Imnovid 4 mg Hard Capsules

pomalidomida

This medicine is subject to additional monitoring. This will help speed up the detection of any new information about its safety. You can contribute by reporting any side effects you may experience. The final part of section 4 includes information on how to report these side effects.

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

• Keep this leaflet, as you may need to refer to it again.
• If you have any questions, consult 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, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist or nurse,
• even if they are not listed in this leaflet. See section 4.

What is Imnovid

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

What Imnovid is used for

Imnovid is used to treat adults with a type of cancer called “multiple myeloma”.

Imnovid is used with:

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

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

What is multiple myeloma

Multiple myeloma is a type of cancer that affects a specific type of white blood cells (called “plasma cells”). These cells grow uncontrollably and accumulate in the bone marrow, damaging the bones and kidneys.

Multiple myeloma generally does not have a cure. However, treatment can reduce the symptoms and signs of the disease or make them disappear for a period of time. When this occurs, it is referred to as “response”.

How Imnovid works

Imnovid acts in several ways:

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

Benefit of using Imnovid with bortezomib and dexamethasone

If Imnovid is used with bortezomib and dexamethasone in people who have received at least one other treatment, the progression of multiple myeloma can be stopped:

• Generally, the combination of Imnovid with bortezomib and dexamethasone prevented the recurrence of multiple myeloma for a period of up to 11months compared to the 7months observed in patients taking only bortezomib and dexamethasone.

Benefit of using Imnovid with dexamethasone

If Imnovid is used with dexamethasone in people who have received at least two other treatments, the progression of multiple myeloma can be stopped:

• Generally, the combination of Imnovid and dexamethasone prevented the recurrence of multiple myeloma for a period of up to 4months compared to the 2months observed in patients taking dexamethasone only.

Do not take Imnovid:

• if you are pregnant, think you may be pregnant, or intend to become pregnant, as it is expected that Imnovid may be harmful to the fetus.Imnovid is expected to be harmful to the fetus.. (Men and women taking this medication should read the section “Pregnancy, contraception, and breastfeeding – information for women and men” below);
• if you can become pregnant, unless you are taking all necessary measures to prevent pregnancy (see “Pregnancy, contraception, and breastfeeding – information for women and men”). If you can become pregnant, your doctor will note on each prescription that all necessary measures have been taken and will provide you with this confirmation;
• if you are allergic to pomalidomide or any of the other components of this medication (listed in section6). If you think you may be allergic, consult your doctor.

If you are unsure whether any of these situations apply to you, consult your doctor, pharmacist, or nurse before taking Imnovid.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting Imnovid if:

• you have ever had blood clots in the past. During treatment with Imnovid, you have a higher risk of developing blood clots in your veins or arteries. Your doctor may recommend additional treatments (e.g., warfarin) or reduce your Imnovid dose to reduce the risk of blood clots;
• you have ever had an allergic reaction, such as skin rash, itching, swelling, dizziness, or respiratory problems while taking related medications called “thalidomide” or “lenalidomide”;
• you have had a heart attack, have heart failure, have difficulty breathing, or, if you are a smoker, have high blood pressure or high cholesterol levels;
• you have a high total tumor burden in the body, including the bone marrow. This could lead to a condition in which tumors break down and produce unusual levels of chemicals in the blood that, in turn, can cause kidney failure. You may also experience irregular heartbeats. This condition is called tumor lysis syndrome;
• you suffer or have suffered neuropathy (nerve damage that causes tingling or pain in your feet or hands);
• you have or have had hepatitis B virus infection. Imnovid treatment can reactivate the hepatitis B virus in patients who are carriers of the virus, leading to the reappearance of the infection. Your doctor should check if you have ever had a hepatitis B virus infection.
• you experience or have experienced in the past a combination of any of the following symptoms: facial or generalized rash, skin redness, high fever, flu-like symptoms, enlarged lymph nodes (symptoms of a severe skin reaction called drug reaction with eosinophilia and systemic symptoms, or DRESS syndrome, or Stevens-Johnson syndrome). See also section4 “Possible side effects”).

It is essential to note that patients with multiple myeloma treated with pomalidomide may develop other types of cancer, so your doctor should carefully evaluate the benefits and risks of prescribing this medication.

At any time during or after treatment, immediately inform your doctor or nurse if you experience:

blurred vision, loss of vision, double vision, difficulty speaking, weakness in an arm or leg, a change in the way you walk or balance problems, persistent numbness, decreased sensitivity, or loss of sensitivity, memory loss, or confusion. All of these can be symptoms of a severe and potentially life-threatening brain disease called multifocal progressive leukoencephalopathy (LMP). If you had any of these symptoms before starting treatment with Imnovid, inform your doctor if you notice any change in these symptoms.

After completing treatment, return all unused capsules to the pharmacist.

Pregnancy, contraception, and breastfeeding: information for men and women

You must follow the following instructions as part of the Imnovid Pregnancy Prevention Program.

Men and women taking Imnovid should not conceive or become pregnant. The reason is that pomalidomide is expected to be harmful to the fetus. You and your partner must use effective contraceptive methods while taking this medication.

Women

Do not take Imnovid if you are pregnant, think you may be pregnant, or intend to become pregnant. The reason is that this medication is expected to be harmful to the fetus. Before starting treatment, inform your doctor if there is a possibility that you may become pregnant, even if you think this is unlikely.

If you can become pregnant:

• you must use effective contraceptive methods from at least 4 weeks before starting treatment, during the entire treatment period, and for at least 4 weeks after completing treatment. Your doctor will advise you on the most suitable contraceptive methods;
• each time your doctor prescribes a prescription, they will ensure that you understand the necessary measures to prevent pregnancy;
• your doctor will schedule pregnancy tests before treatment, at least every 4 weeks during treatment, and at least 4 weeks after completing treatment.

If, despite preventive measures, you become pregnant:

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

Breastfeeding

The safety of Imnovid in human breastfeeding is unknown. Inform your doctor if you are breastfeeding or intend to breastfeed. Your doctor will advise you on whether you can continue or should stop breastfeeding.

Men

Imnovid passes into human semen.

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

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

Blood donation and blood tests

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

Before starting treatment with Imnovid and during treatment, you will have periodic blood tests. This is because your medication can cause a decrease in the number of white blood cells that help fight infections and the number of platelets that help stop bleeding.

Your doctor will ask you to have a blood test:

• before treatment;
• every week during the first 8 weeks of treatment;
• at least once a month while you continue taking Imnovid.

Your doctor may adjust your Imnovid dose or discontinue treatment based on the results of these tests. Your doctor may also adjust your dose or discontinue this medication due to your overall health status.

Children and adolescents

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

Other medications and Imnovid

Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medication. This is because Imnovid can affect how other medications work. Additionally, some medications can affect how Imnovid works.

Specifically, inform your doctor, pharmacist, or nurse before taking Imnovid if you are taking any of the following medications:

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

Driving and operating machinery

Some people experience fatigue, dizziness, confusion, or decreased alertness while taking Imnovid. If this happens to you, do not drive or operate tools or machinery.

Imnovid contains sodium

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

Imnovid should be administered by a doctor with experience in the treatment of multiple myeloma.

Follow exactly the medication administration instructions indicated by your doctor. If in doubt, consult your doctor, pharmacist, or nurse.

When to take Imnovid with other medications

Imnovid in combination with bortezomib and dexamethasone

• Consult the prospectus attached to bortezomib and dexamethasone for additional information on their use and effects.
• Imnovid, bortezomib, and dexamethasone are taken in treatment cycles. Each cycle lasts 21 days (3 weeks).
• Observe the following graph to consult what you should take each day of the 3-week cycle:
• • Each day observe the graph and identify the correct day to see what medications you should take.
  • Some days you will take all 3 medications, other days you will take only 1 or 2 medications, and other days you will take none of them.

IMN:Imnovid;BOR: bortezomib;DEX: dexamethasone

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

Imnovid only with dexamethasone

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

• Imnovid and dexamethasone are taken in treatment cycles. Each cycle lasts 28 days (4 weeks).
• Observe the following graph to consult what you should take each day of the 4-week cycle:
• • Each day observe the graph and identify the correct day to see what medications you should take.
  • Some days you will take both medications, other days you will take only 1 medication, and other days you will take none of them.

IMN:Imnovid;DEX: dexamethasone

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

How much Imnovid to take with other medications

Imnovid with bortezomib and dexamethasone

• The initial recommended dose of Imnovid is 4 mg per day.
• The initial recommended dose of bortezomib will be calculated by your doctor based on your height and weight (1.3 mg/m2 of body surface area).
• The initial recommended dose of dexamethasone is 20 mg per day. However, if you are over 75 years old, the initial recommended dose is 10 mg per day.

Imnovid only with dexamethasone

• The recommended dose of Imnovid is 4 mg once a day.

• The initial recommended dose of dexamethasone is 40 mg per day. However, if you are over 75 years old, the initial recommended dose is 20 mg per day.

Your doctor may need to reduce the dose of Imnovid, bortezomib, or dexamethasone, or discontinue one or more of these medications based on your blood test results and overall condition, if you are taking other medications (e.g., ciprofloxacin, enoxacin, and fluvoxamine), and if you experience adverse effects (especially skin rash or swelling) as a result of treatment.

If you have liver or kidney problems, your doctor will closely monitor your condition while you are taking this medication.

How to take Imnovid

• Do not break, open, or chew the capsules. If the powder from a broken capsule comes into contact with your skin, wash the skin immediately and thoroughly with water and soap.
• Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister pack or capsule. Afterward, carefully remove the gloves, place them in a plastic bag, and dispose of them according to local regulations. Then, wash your hands thoroughly with water and soap. Pregnant women or those who suspect they may be pregnant should not handle the blister pack or capsule.
• Swallow the capsules whole, preferably with water.
• You can take the capsules with or without food.
• Take the capsules approximately at the same time each day.

To remove the capsule from the blister pack, press only one end of the capsule to push it through the foil. Do not press in the center of the capsule, as it may break.

Your doctor will advise you on how and when to take Imnovid if you have kidney problems and are receiving dialysis treatment.

Duration of Imnovid treatment

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

If you take more Imnovid than you should

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

If you forget to take Imnovid

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

If you have any other questions about using this medication, ask your doctor or pharmacist.

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

Severe side effects

If you experience any of the following severe side effects, stop taking Imnovid and seek medical attention immediately, as you may need emergency medical treatment:

• Fever, chills, sore throat, cough, mouth ulcers, or any other sign of infection (due to a decrease in white blood cells that fight infection).
• Bleeding or bruising without apparent cause, including nosebleeds and gastrointestinal or stomach bleeding (due to the effects on blood cells called platelets).
• Fast breathing, rapid pulse, fever, and chills, reduced or absent urination, nausea, and vomiting, confusion, and loss of consciousness (due to a blood infection called sepsis or septic shock).
• Severe, persistent, or bloody diarrhea (possibly accompanied by stomach pain or fever) caused by the bacteriaClostridium difficile.
• Chest or leg pain and swelling, especially in the lower leg or calf (produced by blood clots).
• Difficulty breathing (due to a severe chest infection, lung inflammation, heart failure, or blood clots).
• Swelling of the face, lips, tongue, and throat, which can cause difficulty breathing (due to severe allergic reactions called angioedema and anaphylaxis).
• Certain types of skin cancer (squamous cell carcinoma and basal cell carcinoma), which can cause changes in skin appearance or skin bumps. If you notice changes in skin appearance while taking Imnovid, report them to your doctor as soon as possible.
• Recurrence of hepatitis B virus infection, which can cause yellowing of the skin and eyes, dark brown urine, right-sided abdominal pain, fever, nausea, or discomfort. Inform your doctor immediately if you notice any of these symptoms.
• Generalized rash, high body temperature, enlarged lymph nodes, and effects on other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome or drug hypersensitivity syndrome, toxic epidermal necrolysis, or Stevens-Johnson syndrome). Stop taking pomalidomida if you experience these symptoms and contact your doctor or seek medical attention immediately. See section 2.

If you experience any of the following severe side effects,stop taking Imnovid and seek medical attention immediately, as you may need emergency medical treatment.

Other side effects

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

• Difficulty breathing (dyspnea).
• Pneumonia and bronchitis.
• Upper respiratory tract infections caused by bacteria or viruses.
• Flu-like symptoms.
• Low red blood cell count, which can cause anemia leading to fatigue and weakness.
• Low potassium levels in the blood (hypokalemia), which can cause weakness, muscle cramps, and pains, palpitations, numbness or tingling, dyspnea, and mood changes.
• High blood sugar levels.
• Irregular and rapid heartbeat (atrial fibrillation).
• Loss of appetite.
• Constipation, diarrhea, or nausea.
• Vomiting.
• Abdominal pain.
• Lack of energy.
• Difficulty falling or staying asleep.
• Dizziness, tremor.
• Muscle spasms, muscle weakness.
• Bone pain, back pain.
• Numbness, tingling, or prickling sensation in the skin, hand or foot pain (peripheral sensory neuropathy).
• Generalized swelling, including swelling of arms and legs.
• Rashes.
• Urinary tract infections, which can cause a burning sensation while urinating or the need to urinate more frequently.

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

• Falling.
• Internal bleeding in the skull.
• Reduced ability to move or feel (sensitivity) in the hands, feet, and legs due to nerve damage (peripheral sensory-motor neuropathy).
• Numbness, tingling, or prickling sensation in the skin (paresthesia).
• Sensation of spinning, which makes it difficult to stand and move normally.
• Swelling caused by fluid retention.
• Hives (urticaria).
• Itching skin.
• Herpes zoster.
• Heart attack (chest pain that radiates to the arms, neck, and jaw, sweating, difficulty breathing, nausea, or vomiting).
• Chest pain, chest infection.
• High blood pressure.
• Simultaneous reduction in the number of red and white blood cells and platelets (pancytopenia), which makes you more prone to bleeding and bruising. You may feel tired and weak, and have difficulty breathing. You will also be more susceptible to infections.
• Decreased lymphocyte count (a type of white blood cell) often caused by an infection (lymphopenia).
• Low magnesium levels in the blood (hypomagnesemia), which can cause fatigue, generalized weakness, muscle cramps, and irritability, and can cause low calcium levels in the blood (hypocalcemia), which can cause numbness or tingling in the hands, feet, or lips, muscle cramps, muscle weakness, drowsiness, confusion.
• Low phosphate levels in the blood (hypophosphatemia), which can cause muscle weakness, irritability, or confusion.
• High calcium levels in the blood (hypercalcemia), which can slow down reflexes and cause muscle weakness in skeletal muscles.
• High potassium levels in the blood, which can cause abnormal heart rhythm.
• Low sodium levels in the blood, which can cause fatigue and confusion, muscle contractions, seizures, or coma.
• High uric acid levels in the blood, which can cause a type of arthritis called gout.
• Low blood pressure, which can cause dizziness or fainting.
• Mouth or tongue pain.
• Changes in the taste of things.
• Swollen abdomen.
• Confusion.
• Feeling down (depressed mood).
• Loss of consciousness, fainting.
• Eye opacity (cataract).
• Kidney damage.
• Inability to urinate.
• Abnormal liver function test results.
• Pelvic pain.
• Weight loss.

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

• Stroke.
• Liver inflammation (hepatitis) that can cause skin itching, yellowing of the skin and eyes (jaundice), pale stools, dark brown urine, and abdominal pain.
• The breakdown of tumor cells results in the release of toxic compounds into the bloodstream (tumor lysis syndrome). This can lead to kidney problems.
• Underactive thyroid gland, which can cause symptoms such as fatigue, lethargy, muscle weakness, slow heart rate, and weight gain.

Frequency not known(cannot be estimated from available data):

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

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendixV. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and the box after CAD/EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

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

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

Composition of Imnovid

• The active ingredient is pomalidomide.
• The other components are mannitol (E421), pregelatinized starch, and sodium fumarate stearate.

Imnovid 1mg hard capsule:

• Each capsule contains 1mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E171), indigotin (E132), yellow iron oxide (E172), and white and black ink.
• The printing ink contains: shellac, titanium dioxide (E171), simeticona, propylene glycol (E1520), and ammonium hydroxide (E527) (white ink) and shellac, black iron oxide (E172), propylene glycol (E1520), and ammonium hydroxide (E527) (black ink).

Imnovid 2mg hard capsule:

• Each capsule contains 2mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E171), indigotin (E132), yellow iron oxide (E172), erythrosine (E127), and white ink.
• The printing ink contains: white ink - shellac, titanium dioxide (E171), simeticona, propylene glycol (E1520), and ammonium hydroxide (E527).

Imnovid 3mg hard capsule:

• Each capsule contains 3mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E171), indigotin (E132), yellow iron oxide (E172), and white ink.
• The printing ink contains: white ink - shellac, titanium dioxide (E171), simeticona, propylene glycol (E1520), and ammonium hydroxide (E527).

Imnovid 4mg hard capsule:

• Each capsule contains 4mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E171), indigotin (E132), brilliant blue FCF (E133), and white ink.
• The printing ink contains: white ink - shellac, titanium dioxide (E171), simeticona, propylene glycol (E1520), and ammonium hydroxide (E527).

Appearance of Imnovid and contents of the pack

Imnovid 1mg hard capsules: opaque dark blue cap and opaque yellow body with the imprint “POML 1mg”.

Imnovid 2mg hard capsules: opaque dark blue cap and opaque orange body with the imprint “POML 2mg”.

Imnovid 3mg hard capsules: opaque dark blue cap and opaque green body with the imprint “POML 3mg”.

Imnovid 4mg hard capsules: opaque dark blue cap and opaque blue body with the imprint “POML 4mg”.

Each pack contains 14 or 21capsules. Only some pack sizes may be marketed.

Marketing Authorisation Holder

Bristol‑MyersSquibbPharmaEEIG

Plaza 254

Blanchardstown Corporate Park 2

Dublin 15, D15 T867

Irlanda

Responsible Person

Celgene Distribution B.V.

Orteliuslaan 1000

3528 BD Utrecht

Países Bajos

For further information about this medicinal product, please contact the representative of the marketing authorisation holder in your country:

Last update of this leaflet:Other sources of information

Detailed information about this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu. There are also links to other websites on rare diseases and orphan medicines.

You can access detailed and updated information about this medicinal product by scanning the QR code included in the outer packaging with your smartphone. You can also access this information on the following internet address:www.imnovid-eu-pil.com.