1 mg, 2 mg, 3 mg, 4 mg hard capsules
pomalidomide
1. What Imnovid is and what it is used for
What Imnovid is
Imnovid contains the active substance pomalidomide. This drug is related to the substance thalidomide and belongs to a group of drugs that affect the immune system (the body’s natural defenses).
What Imnovid is used for
Imnovid is used to treat adults with multiple myeloma .
Imnovid is used with either:
- two other medicines , called bortezomib (a type of cytotoxic drug ) and dexamethasone (an anti-inflammatory drug), to people who have received at least one other treatment, including lenalidomide.
Or
- another drug , called dexamethasone, for people whose myeloma has worsened, even though they have received at least two other treatments, including lenalidomide and bortezomib.
What multiple myeloma is
Multiple myeloma is a form of cancer that affects a certain type of white blood cell (called plasma cells). These cells multiply uncontrollably and accumulate in the bone marrow . This can lead to damage to the skeleton and kidneys.
Multiple myeloma can generally not be cured. However, treatment can reduce the signs and symptoms of the disease, or make them disappear for a while. When this occurs, it is called that the treatment gives “answers”.
How Imnovid works
Imnovid operates in a number of different ways:
- by inhibiting the development of myeloma cells
- by stimulating the immune system to attack the cancer cells
- by preventing the formation of blood vessels that supply the cancer cells.
The benefit of using Imnovid with bortezomib and dexamethasone
When Imnovid is used in combination with bortezomib and dexamethasone, in people who have received at least one other treatment, it may prevent multiple myeloma from getting worse:
- Imnovid used with bortezomib and dexamethasone, on average, prevented multiple myeloma from recurring for up to 11 months – compared with 7 months for patients treated with bortezomib and dexamethasone alone.
The benefit of using Imnovid with dexamethasone
When Imnovid is used in combination with dexamethasone, in people who have received at least two other treatments, it can prevent multiple myeloma from getting worse:
- Imnovid used with dexamethasone prevented, on average, multiple myeloma from recurring for up to 4 months compared to 2 months for patients treated with dexamethasone alone.
2. What you need to know before you take Imnovid
Do not take Imnovid:
- if you are pregnant, think you may be pregnant or are planning to have a baby, as Imnovid is expected to harm your fetus . Women and men taking this medicine should read the section “Pregnancy, contraception and breast-feeding – information for women and men” below.
- if you could become pregnant and do not take all the necessary measures to prevent getting pregnant (see “Pregnancy, contraception and breast-feeding – information for women and men”). If you could become pregnant, your doctor will note at each prescription that the necessary steps have been taken and will give you this confirmation.
- if you are allergic to pomalidomide or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, ask your doctor for advice.
If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before taking Imnovid.
Warnings and cautions
Talk to your doctor, pharmacist or nurse before taking Imnovid
- if you have ever had a blood clot. During treatment with Imnovid increases the risk of developing blood clots in your veins and arteries you. The doctor may recommend further treatment (such as warfarin ) or lower the dose of Imnovid to reduce the chance that you’ll get blood clots.
- if you have ever had an allergic reaction , such as rash, itching , swelling, dizziness or difficulty breathing, when you have taken similar medicines called thalidomide or lenalidomide.
- if you have had a heart attack, have heart failure , have difficulty breathing or if you smoke, have high blood pressure or high cholesterol levels.
- if you have a large total amount of tumor you throughout the body, including in the bone marrow one. This can lead to a condition in which the tumors break down, which gives rise to an abnormally high level of chemicals in the body, which in turn can lead to kidney failure . You may also experience uneven heartbeat. This condition is called tumor lysis syndrome.
- if you have or have had neuropathy (nerve damage that causes you to get cramps or pain in your hands or feet).
- if you have or have ever had hepatitis B infection . Treatment with Imnovid may cause the hepatitis B virus to become active again in patients carrying the virus , resulting in a recurrence of infection . Your doctor should check if you have ever had a hepatitis B infection .
- if you experience or have ever experienced a combination of any of the following symptoms: facial rash or widespread rash, red skin, high fever, flu-like symptoms , enlarged lymph nodes (these are signs of a severe skin reaction called a drug reaction with eosinophilia and systemic symptoms (DRESS) or hypersensitivity syndrome to drugs, 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 should carefully assess the benefit and risk when prescribing this medicine.
Tell a doctor or nurse immediately if you experience any of the following during vision or after-treatment: blurred vision, loss of vision or double vision, difficulty speaking, weakness in one arm or leg, change in gait or problems with balance, persistent numbness, impaired feeling or lost feeling, memory loss or confusion. All of these symptoms can indicate a serious and potentially life-threatening brain disease called progressive multifocal leukoencephalopathy (PML). If you have had these symptoms before treatment with Imnovid, tell your doctor if the symptoms change in any way.
At the end of the treatment, you must return all remaining capsules to the pharmacy.
Pregnancy, contraception and breastfeeding – information for women and men
The following must be followed as indicated in the pregnancy prevention program for Imnovid. Women and men taking Imnovid must not become pregnant or have children, as pomalidomide is expected to harm the fetus. You and your partner must use effective contraception during treatment with this medicine.
Women
Do not take Imnovid if you are pregnant, think you may be pregnant or are planning to have a baby, as this medicine is expected to harm your fetus. Before starting treatment, you must tell your doctor if you may become pregnant, even if you think it is unlikely.
If you could get pregnant
- you must use effective contraception for at least 4 weeks before starting treatment, during the entire treatment period and for at least 4 weeks after the end of treatment. Talk to your doctor about appropriate contraceptive methods.
- With each prescription, your doctor will make sure you understand the steps that need to be taken to prevent pregnancy.
- your doctor will arrange for you to undergo pregnancy tests before treatment, at least every 4 weeks during treatment and at least 4 weeks after the end of treatment.
If you become pregnant despite using contraception:
- You must stop treatment immediately and inform your doctor immediately.
Breast-feeding
It is not known if Imnovid passes into breast milk. Tell your doctor if you are breast-feeding or planning to breast-feed. Your doctor may advise you to stop or continue breast-feeding.
Men
Imnovid passes into semen in humans.
- If your partner is pregnant or may become pregnant, you must use a condom throughout the treatment period and for 7 days after the end of the treatment.
- If your partner becomes pregnant while taking Imnovid, tell your doctor immediately. It is recommended that your partner also contact their doctor immediately.
You must not donate semen or semen during the treatment and for 7 days after the end of the treatment.
Blood donation and blood tests
You should not donate blood during the treatment and for 7 days after the treatment has ended.
Before and during treatment with Imnovid, you will be given regular blood tests as the medicine may reduce the number of blood cells that help fight infections ( white blood cells ) and the number of blood cells that help stop bleeding ( platelets ).
Your doctor will ask you to provide a blood sample:
- before treatment
- every week for the first 8 weeks of treatment
- then at least once a month as long as you take Imnovid.
Depending on the results of the blood tests, your doctor may change the dose of Imnovid or stop the treatment. Your doctor may also change your dose or discontinue treatment due to your general condition.
Children and young people
Imnovid is not recommended for use in children and adolescents under 18 years of age.
Other medicines and Imnovid
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This is because Imnovid may affect the effect of other medicines. In addition, some other medicines may affect the way Imnovid works.
In particular, you should tell your doctor, pharmacist or nurse before taking Imnovid if you are taking any of the following medicines:
- certain antifungal drugs such as ketoconazole
- certain antibiotics (eg ciprofloxacin , enoxacin)
- certain antidepressants such as fluvoxamine.
Driving and using machines
Some people may feel tired, dizzy, weak, confused or lethargic after taking Imnovid. If this happens to you, do not drive or use any tools or machines.
Imnovid contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per capsule, and is therefore considered to be almost ‘sodium-free’.
3. How to take Imnovid
Only a doctor who has experience in the treatment of multiple myeloma can prescribe Imnovid to you.
Always take your medicine exactly as your doctor has told you. If you are not sure, talk to your doctor, pharmacist or nurse.
When to take Imnovid with other medicines
Imnovid with bortezomib and dexamethasone
- Read the package leaflets that come with bortezomib and dexamethasone for more information on their use and effects.
- Imnovid, bortezomib and dexamethasone are taken during treatment cycles. Each cycle is 21 days (3 weeks) long.
- Look at the chart below to see what to take each day of the 3-week cycle:
- Every day, look at the chart and find the right day to see which medications to take.
- Some days you take all 3 drugs, some days only 2 or 1 drug and some days nothing at all.
- IMN: Imnovid; BOR : Bortezomib; DEX : Dexamethasone
| Cycle 1 to 8 | Cycle 9 and beyond | ||||||
| Drug name | Drug name | ||||||
| Day | IMN | BOR | DEX | Day | IMN | BOR | DEX |
| 1 | √ | √ | √ | 1 | √ | √ | √ |
| 2 | √ | √ | 2 | √ | √ | ||
| 3 | √ | 3 | √ | ||||
| 4 | √ | √ | √ | 4 | √ | ||
| 5 | √ | √ | 5 | √ | |||
| 6 | √ | 6 | √ | ||||
| 7 | √ | 7 | √ | ||||
| 8 | √ | √ | √ | 8 | √ | √ | √ |
| 9 | √ | √ | 9 | √ | √ | ||
| 10 | √ | 10 | √ | ||||
| 11 | √ | √ | √ | 11 | √ | ||
| 12 | √ | √ | 12 | √ | |||
| 13 | √ | 13 | √ | ||||
| 14 | √ | 14 | √ | ||||
| 15 | 15 | ||||||
| 16 | 16 | ||||||
| 17 | 17 | ||||||
| 18 | 18 | ||||||
| 19 | 19 | ||||||
| 20 | 20 | ||||||
| 21 | 21 |
- After completing each 3-week cycle, start with a new one.
Imnovid with dexamethasone alone.
- Read the package leaflet for dexamethasone for more information on the use and effects of that medicine.
Imnovid and dexamethasone are taken during treatment cycles. Each cycle is 28 days (4 weeks) long.
- Look at the chart below to see what you should take each day of the 4-week cycle:
- Every day, look at the chart and find the right day to see which medications to take.
- Some days you take both drugs, some days only 1 drug and some days nothing at all.
- IMN: Imnovid; DEX : Dexamethasone
| Drug name | ||
| Day | IMN | DEX |
| 1 | √ | √ |
| 2 | √ | |
| 3 | √ | |
| 4 | √ | |
| 5 | √ | |
| 6 | √ | |
| 7 | √ | |
| 8 | √ | √ |
| 9 | √ | |
| 10 | √ | |
| 11 | √ | |
| 12 | √ | |
| 13 | √ | |
| 14 | √ | |
| 15 | √ | √ |
| 16 | √ | |
| 17 | √ | |
| 18 | √ | |
| 19 | √ | |
| 20 | √ | |
| 21 | √ | |
| 22 | √ | |
| 23 | ||
| 24 | ||
| 25 | ||
| 28 | ||
| 27 | ||
| 28 |
- After completing each 4-week cycle, start with a new one.
How much Imnovid to take with other medicines
Imnovid with bortezomib and dexamethasone
- The recommended starting dose of Imnovid is 4 mg daily.
- The recommended starting dose of bortezomib will be calculated by your doctor and is based on your height and weight (1.3 mg / m 2 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.
Imnovid with dexamethasone alone
The recommended dose of Imnovid is 4 mg 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 Imnovid, bortezomib or dexamethasone or stop treatment for one or more of these medicines, based on the results of your blood tests, your general condition, any other medicines you may be taking (eg ciprofloxacin , enoxacin and fluvoxamine) and if you get any side effects from the treatment (especially rash or swelling).
If you suffer from liver or kidney problems, your doctor will check your condition very carefully while you are being treated with this medicine.
How to take Imnovid
- The capsules must not be crushed, opened or chewed. If powder from a broken capsule with Imnovid comes in contact with the skin, wash the area immediately with soap and water.
- Healthcare professionals, carers and family members should use disposable gloves when handling the blister or capsule. The gloves should then be carefully removed to prevent contact with the skin, placed in a resealable plastic bag made of polyethylene and disposed of in accordance with local regulations. Then wash your hands thoroughly with soap and water. Women who are pregnant or suspect they may be pregnant should not handle the blister or capsule.
- Swallow the capsules whole, preferably with water.
- You can take the capsules with or without food.
- Take Imnovid at about the same time each day.
When removing the capsule from the blister, press only one end of it so that it slides out through the foil. Do not press in the middle of the capsule, as this may cause it to break.
Your doctor will advise you on how and when to take Imnovid if you have kidney problems and receive dialysis treatment.
Duration of treatment with Imnovid
You should continue with the treatment cycles until your doctor tells you to stop.
If you take more Imnovid than you should
If you take more Imnovid than you should, contact a doctor immediately or go to a hospital. Take the medicine pack with you.
If you forget to take Imnovid
If you forget to take Imnovid at the usual time, take the next capsule as usual the following day. Do not take more capsules to compensate for missed dose .
If you have any further questions on the use of this product, ask 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 are
Stop taking Imnovid and see a doctor straight away if you notice any of the following serious side effects . You may need urgent medical attention.
- Fever, chills, sore throat, cough, cold sores or other symptoms of infection (due to fewer white blood cells fighting the infection )
- Bleeding or bruising without injury, including nosebleeds and bleeding from the intestines or stomach (due to effects on blood cells called platelets )
- Rapid breathing, rapid pulse , fever and chills, urinating very little or not at all, nausea and vomiting, confusion, unconsciousness (due to infection in the blood called sepsis or septic shock )
- Severe, persistent or bloody diarrhea (possibly with stomach pain and fever) caused by a bacterium called Clostridium difficile
- Chest or leg pain and swelling, especially of the lower legs or calves (caused by blood clots)
- Shortness of breath (due to severe respiratory infection, pneumonia , heart failure or blood clot)
- Swelling of the face, lips, tongue and throat, which can cause breathing difficulties (due to severe types of allergic reaction called angioedema and anaphylactic reaction )
- Certain types of skin cancer ( squamous cell carcinoma and basal cell carcinoma), which can cause changes in the appearance of the skin or growths on the skin. Talk to your doctor as soon as possible if you notice any changes in your skin while taking Imnovid.
- Recurrent hepatitis B infection , which can cause yellowing of the skin and eyes, dark brown urine, right-sided abdominal pain, fever and nausea and malaise. Talk to your doctor immediately if you experience any of these symptoms.
- Widespread rash, high body temperature, enlarged lymph nodes and effects on other organs in the body (drug reaction with eosinophilia and systemic symptoms also known as DRESS or drug hypersensitivity syndrome, toxic epidermal necrolysis or Stevens-Johnson syndrome ). If you get such symptoms, stop taking pomalidomide and contact your doctor immediately or seek medical attention. See also section 2.
Stop taking Imnovid and see a doctor straight away if you notice any of the above serious side effects . You may need urgent medical attention.
Other side effects ar
Very common (may affect more than 1 in 10 people):
- Shortness of breath ( dyspnoea )
- Infection in the lungs ( pneumonia and bronchitis )
- Infection in the nose, sinuses and throat, caused by bacteria or viruses
- Low number of red blood cells which can lead to anemia ( anemia ), which in turn leads to fatigue and weakness
- Low levels of potassium in the blood ( hypokalaemia ), which can cause weakness, muscle cramps, muscle aches, palpitations, tingling or numbness, shortness of breath, mood swings
- High levels of blood sugar
- Decreased appetite
- Constipation, diarrhea or nausea
- Vomiting
- Lack of energy
- Difficulty falling asleep or sleeping
- Dizziness, tremor
- Muscle cramps or muscle weakness
- Skeletal pain, back pain
- Numbness, tingling or burning sensation in the skin, pain in the hands or feet ( peripheral sensory neuropathy )
- Swelling in the body, including arms and legs
Common (may affect up to 1 in 10 people):
- Case
- Bleeding in the head
- Decreased mobility or sensation in your hands, arms, feet and legs due to nerve damage ( peripheral sensorimotor neuropathy )
- Numbness, itching and a tingling sensation in the skin ( paresthesia )
- A tingling sensation in the head that makes it difficult to stand up and move normally
- Swelling caused by fluid
- Hives ( urticaria )
- Rash
- Itching of the skin
- Shingles
- Rapid and irregular heartbeat ( atrial fibrillation )
- Myocardial infarction (chest pain that spreads to arms, neck or jaw, you may feel sweaty and short of breath, feel sick or vomit)
- Chest pain, breast infection
- High blood pressure
- A decrease in the number of red and white blood cells and platelets at the same time (pancytopenia), which makes you more likely to bleed and get bruises. You may feel tired, weak and short of breath and it is also easier for you to get an infection
- Decreased 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, generalized weakness, muscle cramps, irritability and may result in low levels of calcium in the blood ( hypocalcaemia ), which may cause numbness and / or tingling in the hands, feet or lips, muscle cramps, muscle weakness, intoxication, confusion
- Low levels of phosphate in the blood ( hypophosphatemia ), which can cause muscle weakness and irritability or confusion
- High levels of calcium in the blood ( hypercalcemia ), which can cause slower reflexes and weaknesses in the skeletal muscles
- High levels of potassium in the blood which can cause abnormal heart rhythm
- Low levels of sodium in the blood which can cause fatigue and confusion, muscle twitching, seizures (epileptic seizures) and coma
- High levels of uric acid in the blood which can cause a form of arthritis called gout
- Low blood pressure , which can cause dizziness or fainting
- Flu- like symptoms ( flu )
- Sore or dry mouth
- Taste changes
- Stomach ache, swollen abdomen
- Feeling of confusion
- Depression
- Loss of consciousness, fainting
- Cloud lens (cataract, cataract )
- Kidney damage
- Inability to urinate
- Abnormal liver test
- Urinary tract infection, which may cause a burning sensation when urinating or a need to urinate more often
- Pelvic pain
- Weight loss
Uncommon (may affect up to 1 in 100 people):
- stroke
- inflammation of the liver ( hepatitis ) which can cause itching of the skin, yellowing of the skin and whites of the eyes (jaundice), light stools, dark urine and abdominal pain
- the breakdown of cancer cells leads to the release of toxic substances in the blood (tumor lysis syndrome). This can lead to kidney problems.
- underactive thyroid gland that can cause symptoms such as fatigue, listlessness, muscle weakness, slow heart rate, weight gain.
Has been reported (occurs in an unknown number of users):
- Widespread rash, high body temperature, enlarged lymph nodes and effects on other organs (drug side effect with eosinophilia and systemic symptoms, also called DRESS or hypersensitivity syndrome to drugs, toxic epidermal necrolysis or Stevens-Johnson syndrome ). If you get such symptoms, stop taking pomalidomide and contact your doctor immediately or seek medical attention. See also section 2.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Imnovid
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 carton after “EXP”.
The expiration date is the last day of the specified month.
No special storage instructions.
Do not use this medicine if the packaging is damaged or appears to have been tampered with.
Medicines should not be disposed of via wastewater or household waste. Leftover medicine must be returned to the pharmacy after treatment has ended. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is pomalidomide.
- The other ingredients are: mannitol (E421), starch , pregelatinized, and sodium stearyl fumarate.
Imnovid 1 mg hard capsules:
- Each capsule contains 1 mg of pomalidomide.
- The capsule cover contains: gelatin, titanium dioxide (E171), indigotine (E132), yellow iron oxide (E172) and white and black ink.
- The printing ink contains: shellac, titanium dioxide (E171), simethicone, 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 2 mg hard capsules:
- Each capsule contains 2 mg of pomalidomide.
- The capsule cover contains: gelatin, titanium dioxide (E171), indigotine (E132), yellow iron oxide (E172), erythrosine (E127) and white ink.
- The ink contains: white ink – shellac, titanium dioxide (E171), simethicone, propylene glycol (E1520) and ammonium hydroxide (E527).
Imnovid 3 mg hard capsules:
- Each capsule contains 3 mg of pomalidomide.
- The capsule cover contains: gelatin, titanium dioxide (E171), indigotine (E132), yellow iron oxide (E172) and white ink.
- The ink contains: white ink – shellac, titanium dioxide (E171), simethicone, propylene glycol (E1520) and ammonium hydroxide (E527).
Imnovid 4 mg hard capsules:
- Each capsule contains 4 mg of pomalidomide.
- The capsule cover contains: gelatin, titanium dioxide (E171), indigotine (E132), brilliant blue FCF (E133) and white ink.
- The ink contains: white ink – shellac, titanium dioxide (E171), simethicone, propylene glycol (E1520) and ammonium hydroxide (E527).
What the medicine looks like and contents of the pack
Imnovid 1 mg hard capsules: opaque with a dark blue top and a yellow bottom, marked with “POML 1 mg”.
Imnovid 2 mg hard capsules: opaque with dark blue top and orange bottom, marked with “POML 2 mg”.
Imnovid 3 mg hard capsules: opaque with dark blue top and green bottom, marked with “POML 3 mg”.
Imnovid 4 mg hard capsules: opaque with dark blue top and blue bottom, marked with “POML 4 mg”.
Each carton contains 14 or 21 capsules. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Bristol ‑ Myers Squibb Pharma EEIG
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland
Manufacturer
Celgene Distribution BV
Winthontlaan 6 N
3526 KV Utrecht
Netherlands