Lenalidomide IPI contains the active substance 'lenalidomide'. This medicine belongs to a group of medicines which affect how your immune system works.
1. Dosage:
- 10 mg
- 25 mg
2. What Lenalidomide is and what is it used for:
Lenalidomide IPI contains the active substance lenalidomide. This medicine belongs to a group of medicines which affect how your immune system works.
Lenalidomide IPI is used in adults for:
- Multiple myeloma.
- Myelodysplastic syndromes
- Mantle cell lymphoma
- Follicular lymphoma
Lenalidomide IPI works by affecting the body's immune system and directly attacking the cancer. It works in several different ways:
- By stopping the cancer cells from developing.
- By stopping blood vessels growing in the cancer.
- By stimulating part of the immune system to attack the cancer cells.
3. What you need to know before you take Lenalidomide IPI:
You must read the package leaflet of all medicinal products to be taken in combination with Lenalidomide IPI before starting treatment with Lenalidomide IPI.
Do not take Lenalidomide IPI:
- If you are pregnant, think you may be pregnant or are planning to become pregnant, as Lenalidomide IPI is expected to be harmful to an unborn child.
- If you can become pregnant unless you follow all the necessary measures to prevent you from becoming pregnant. If you can become pregnant, your doctor will record with each prescription that the necessary measures have been taken and provide you with this confirmation.
- If you are allergic to lenalidomide 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.
4. Warnings and Precautions:
Talk to your doctor before taking Lenalidomide IPI if:
- You have had blood clots in the past you have an increased risk of developing blood clots in the veins and arteries during treatment.
- You have any signs of an infection, such as a cough or fever.
- You have or have ever had a previous viral infection, particularly: hepatitis B infection, varicella zoster, or HIV. Treatment with Lenalidomide IPI may cause the virus to become active again, in patients who carry the virus. This results in a recurrence of the infection. Your doctor should check whether you have ever had a hepatitis B infection.
- You have kidney problems - your doctor may adjust your dose of Lenalidomide IPI.
- You have had a heart attack, have ever had a blood clot, or if you smoke, have high blood pressure, or high cholesterol levels.
- You have had an allergic reaction while taking thalidomide such as rash, itching, swelling, dizziness, or trouble breathing.
- You have experienced in the past a combination of any of the following symptoms: widespread rash, red skin, or high body temperature. Flu-like symptoms, liver enzyme elevations, blood abnormalities, and enlarged lymph nodes are signs of a severe skin reaction called Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome.
At any time during or after your treatment, tell your doctor or immediately if you:
- Experience blurred, loss of or double vision, difficulty speaking, weakness in an arm or a leg, a change in the way you walk, problems with your balance, persistent numbness, decreased sensation or loss of sensation, and memory loss or confusion. These may all be symptoms of a serious and potentially fatal brain condition known as progressive multifocal leukoencephalopathy (PML).
- Experience shortness of breath, tiredness, dizziness, pain in the chest, a faster heartbeat, or swelling in the legs or ankles. These may be symptoms of a serious condition known as pulmonary hypertension.
Tests and Checks: Before and during the treatment with Lenalidomide IPI you will have regular blood tests. This is because Lenalidomide IPI may cause a fall in the blood cells that help fight infection and help the blood clot. Your doctor will ask you to have a blood test:
- Before the treatment.
- Every week for the first 8 weeks of the treatment.
- Then at least every month after that. You may be evaluated for signs of cardiopulmonary problems before and during the treatment with lenalidomide. For patients with MDS taking Lenalidomide IPI: If you have MDS, you may be more likely to get a more advanced condition called acute myeloid leukaemia (AML). In addition, it is not known how Lenalidomide IPI affects the chances of getting AML. Your doctor may therefore do tests to check for signs which may better predict the likelihood of you getting AML during your treatment with Lenalidomide IPI.
For patients with MCL taking Lenalidomide IPI, your doctor will ask you to have a blood test:
- Before the treatment.
- Every week for the first 8 weeks (2 cycles) of the treatment.
- Then every 2 weeks in cycles 3 and 4.
- After this, it will happen at the start of each cycle and,
- At least every month.
For patients with FL taking Lenalidomide IPI: Your doctor will ask you to have a blood test:
- Before the treatment.
- Every week for the first 3 weeks (1 cycle) of treatment.
- Then every 2 weeks in cycles 2 to 4.
- After this, it will happen at the start of each cycle and,
- At least every month.
Your doctor may check if you have a high total amount of tumours throughout the body, including your condition where the tumours break down and cause unusual levels of chemicals in the blood which can lead to kidney failure. Your doctor may check you for changes to your skin such as red spots or rashes.
Your doctor may adjust your dose of Lenalidomide IPI or stop your treatment based on the results of your blood tests and your general condition. If you are newly diagnosed, your doctor may also assess your treatment based on your age and other conditions you already have.
Blood Donations: You should not donate blood during treatment and for at least 7 days after the end of treatment.
Children and Adolescents: Lenalidomide IPI is not recommended for use in children and adolescents under 18 years.
Elderly and People with Kidney Problems: If you are aged 75 years or older or have moderate to severe kidney problems, the doctor will check you carefully before starting treatment.
Other Medicines and Lenalidomide IPI: Tell your doctor if you are taking or have recently taken any other medicines.
Pregnancy, Breast-feeding, and Contraception:
For women taking Lenalidomide IPI:
- You must not take Lenalidomide IPI if you are pregnant.
- You must not become pregnant while taking Lenalidomide IPI.
- If you do become pregnant during your treatment with Lenalidomide IPI, you must stop the treatment and inform your doctor immediately.
- You must not breastfeed when taking Lenalidomide IPI.
For men taking Lenalidomide IPI:
- If your partner becomes pregnant while you are taking Lenalidomide IPI, you should inform your doctor immediately. It is recommended that your partner seek medical advice.
- You must also use effective methods of contraception.
Contraception: For women taking Lenalidomide IPI: Before starting the treatment, ask your doctor if you can become pregnant, even if you think this is unlikely.
- If you can become pregnant you will have pregnancy tests under the supervision of your doctor (before every treatment, at least every 4 weeks during treatment, and at least 4 weeks after the treatment has finished) except where it has been confirmed that the fallopian tubes have been severed and sealed, to stop eggs from reaching the uterus (tubal sterilisation).
- You must use effective methods of contraception for at least 4 weeks before starting treatment, during treatment, and until at least 4 weeks after stopping treatment.
For men taking Lenalidomide IPI: Lenalidomide IPI passes into human semen. If your female partner is pregnant or able to become pregnant, and she does not use effective methods of contraception, you must use condoms during treatment and for at least 7 days after the end of treatment, even if you have had a vasectomy.
Driving and Using Machines: Do not drive or operate machines if you feel dizzy, tired, sleepy, or have vertigo or blurred vision after taking Lenalidomide IPI.
Lenalidomide IPI Contains Lactose.
5. How much Lenalidomide to take:
Before you start the treatment, your doctor will tell you:
- How much Lenalidomide IPI should you take.
- How many medicines should you take in combination with Lenalidomide IPI, if any.
- On what days of your treatment cycle to take each medicine.
6. How and when to take lenalidomide IPI:
- Swallow the capsules whole, preferably with water.
- Do not break, open, or chew the capsules. If powder from a broken Lenalidomide IPI capsule makes contact with the skin, wash the skin immediately and thoroughly with soap and water.
- Wear disposable gloves when handling the blister or capsule.
- Gloves should then be removed carefully to prevent skin exposure, placed in a sealable plastic polyethene bag and disposed of following local requirements. Hands should then be washed thoroughly with soap and water. Women who are pregnant or suspect they may be pregnant should not handle the blister or capsule.
- The capsules can be taken either with or without food.
- You should take Lenalidomide IPI at about the same time on the scheduled days.
Taking this medicine: To remove the capsule from the blister:
- Press only one end of the capsule out to push it through the foil.
- Do not put pressure on the centre of the capsule, as this can cause it to break.
Duration of the treatment with Lenalidomide IPI:
Lenalidomide IPI is taken in treatment cycles, each cycle lasting 21 to 28 days. You should continue the cycles of treatment until your doctor tells you to stop.
If you take more Lenalidomide IPI than you should: If you take more Lenalidomide IPI than you should, tell your doctor immediately.
If you forget to take Lenalidomide IPI:
If you forget to take Lenalidomide IPI at your regular time, and:
- Less than 12 hours have passed, take your capsule immediately.
- More than 12 hours have passed, do not take your capsule. Take your next capsule at the usual time.
7.Indication and Dose:
Lenalidomide IPI must be given to you by healthcare professionals with experience in treating multiple myeloma, MDS, MCL, or FL.
- When Lenalidomide IPI is used to treat multiple myeloma in patients who cannot have a bone marrow transplant or have had other treatments before, it is taken with other medicines.
- When Lenalidomide IPI is used to treat multiple myeloma patients who have had a bone marrow transplant or to treat patients with MDS or MCL, it is taken alone.
- When Lenalidomide IPI is used to treat follicular lymphoma, it is taken with another medicine called 'rituximab".
Always take Lenalidomide IPI exactly as your doctor has told you.
Indications and dose indications: Newly diagnosed multiple myeloma in patients who have undergone autologous stem cell transplantation.
-By mouth
-Adult 10 mg once daily for 28 consecutive days of repeated 28-day cycles; increased if tolerated to 15 mg once daily, after 3 cycles, for dose Adjustments due to side effects. Consult product literature
Newly diagnosed multiple myeloma in patients not eligible for transplant (in combination with dexamethasone), Multiple Myeloma in patients who have received at least one prior therapy (in combination with dexamethasone).
-By mouth
-Adult: 25 mg once daily for 21 consecutive days of repeated 28-day cycles, for doses of dexamethasone, and dose adjustments due to side-effects consult product literature.
Newly diagnosed multiple myeloma in patients not eligible for transplant in combination with melphalan and prednisone).
-By mouth
-Adult 10 mg once daily for 21 consecutive days of repeated 28-day cycles for up to 9 cycles, patients who complete 9 cycles or are intolerant to combination therapy should continue treatment with lenalidomide as monotherapy, for doses of melphalan and prednisone, and dose adjustments due to side-effects.
Newly diagnosed multiple myeloma in patients not eligible for transplant (in combination with bortezomib and dexamethasone).
- By mouth
-Adult: 25 mg once daily for 14 consecutive days of repeated 21-day cycles for up to 8 cycles, followed by 25 mg once daily for 21 consecutive days of repeated 28-day cycles (in combination with dexamethasone), for doses of bortezomib and dexamethasone, and dose adjustments due to side-effects.
Myelodysplastic syndromes.
- By mouth
- Adult: 10 mg once daily for 21 consecutive days of repeated 28-day cycles.
Mantle cell lymphoma.
- By mouth
Adult 25 mg once daily for 21 consecutive days of repeated 28-day cycles.
Follicular lymphoma (in combination with rituximab).
- By mouth
-Adult: 20 mg once daily for 21 consecutive days of repeated 28-day cycles for up to 12 cycles.
8. Possible Side effects:
Stop taking Lenalidomide IPI and see a doctor straight away if you notice any of the following serious side effects, you may need urgent medical treatment:
- Hives, rashes, swelling of eyes, mouth or face, difficulty breathing, or itching.
- A serious allergic reaction that may begin as a rash in one area but spread with extensive loss of skin over the whole body.
- Widespread rash, high body temperature, liver enzyme elevations, blood abnormalities, enlarged lymph nodes, and other body organs involvement.
Tell your doctor straight away if you notice any of the following serious side effects:
- Fever, chills, sore throat, cough, mouth ulcers or any other symptoms of infection including within the bloodstream.
- Bleeding or bruising in the absence of injury.
- Chest pain or leg pain.
- Shortness of breath.
- Bone pain, muscle weakness, confusion or tiredness that might be due to high levels of calcium in the blood.
Lenalidomide IPI may reduce the number of white blood cells that fight infection and also the blood cells which help the blood to clot which may lead to bleeding disorders such as nosebleeds and bruising Lenalidomide IPI may also cause blood clots in the veins (thrombosis).
Other side effects: It is important to note that a small number of patients may develop additional types of cancer, and this risk may be increased with Lenalidomide IPI treatment. Therefore, your doctor should carefully evaluate the benefits and risks when you are prescribed Lenalidomide IPI.
Very common side effects (May affect more than 1 in 10 people):
- A fall in the number of red blood cells which may cause anemia leading to tiredness and weakness.
- Rashes, itching.
- Muscle cramps, muscle weakness, muscle pain, muscle aches, bone pain, joint pain, back pain, or pain in the extremities.
- Generalized swelling including swelling of your arms and legs.
- Weakness, tiredness.
- Fever and flu-like symptoms including fever, muscle ache, headache, earache, cough and chills.
- Numbness, tingling or burning sensation to the skin, pains in hands or feet, dizziness, or tremors.
- Decreased appetite, change in the way things taste.
- Increase in pain, tumour size or redness around the tumour.
- Weight loss.
- Constipation, diarrhoea, nausea, vomiting, stomach pain, and heartburn.
- Low levels of potassium or calcium and/or sodium in the blood.
- Thyroid functioning less than it should be.
- Leg pain, chest pain or shortness of breath.
- Infections of all types, including infection of the sinuses that surround the nose, infection of the hung and the upper respiratory tract.
- Shortness of breath.
- Blurred vision.
- Clouding of your eye.
- Kidney problems which include kidneys not working properly or not being able to maintain normal function.
- Abnormal liver test results.
- Increase in liver test results.
- Changes to a protein in the blood that can cause swelling of the arteries.
- Increases in your blood sugar levels.
- Decreases in your blood sugar levels.
- Headache.
- Nosebleed.
- Dry skin.
- Depression, mood change, or difficulty sleeping.
- Cough.
- A fall in blood pressure.
- A vague feeling of bodily discomfort. Feeling bad.
- Sore inflamed mouth, dry mouth.
- Dehydration.
Common side effects (May affect up to 1 in 10 people):
- Destruction of red blood cells.
- Certain types of skin tumours.
- Bleeding of the gums, stomach, or bowels.
- Increased blood pressure.
- Slow, fast, or irregular heartbeat.
- Increase in the amount of a substance which results from normal and abnormal breakdown of red blood cells.
- An increase in a type of protein that indicates inflammation in the body.
- Darkening of your skin, discolouration of your skin resulting from bleeding. underneath, typically caused by bruising, swelling of skin filled with blood, or bruise - Increase in uric acid in the blood.
- Skin eruptions, redness of skin, cracking, flaking or peeling skin, or hives.
- Increased sweating and night sweats.
- Difficulty swallowing, sore throat, and difficulty with voice quality, or voice changes.
- Runny nose.
- Production of much more or much less urine than usual or the inability to control when to urinate.
- Passing blood in the urine.
- Shortness of breath especially when lying down.
- Difficulty getting an erection.
- Stroke, fainting, vertigo, or temporary loss of consciousness.
- Chest pain spreading to the arms, neck, jaw, back or stomach, feeling sweaty and breathless, feeling sick or vomiting, which may be symptoms of a heart attack.
- Muscle weakness, lack of energy.
- Neck pain, chest pain.
- Chills.
- Joint swelling.
- Bile flow from the liver is slowed or blocked.
- Low levels of phosphate or magnesium in the blood.
- Difficulty speaking.
- Liver injury.
- Impaired balance, difficulty moving.
- Deafness, ringing in the ears.
- Nerve pain, unpleasant abnormal sensation, especially to touch.
- An excess of iron in the body.
- Thirst.
- Confusion.
- Toothache.
- Fall, which may result in injury.
Uncommon side effects (May affect up to 1 in 100 people):
- Bleeding within the skull, a circulatory problem.
- Loss of vision.
- Loss of sex drive.
- Passing large amounts of urine with bone pain and weakness, which may be symptoms of a kidney disorder.
- Yellow pigmentation to the skin, mucus membrane or eyes, pale-coloured stools, dark-coloured urine, skin itch, rash, pain or swelling of the stomach
- these may be symptoms of injury to the liver.
- Stomach pain, bloating, or diarrhoea, which may be symptoms of inflammation in the large intestine.
- Damage to the cells of the kidney.
- Changes to the colour of your skin and sensitivity to sunlight.
- Tumor lysis syndrome, metabolic complications that can occur during the treatment of cancer and sometimes even without treatment. These complications are caused by the breakdown products of dying cancer cells and may include the following changes to blood chemistry, high potassium, phosphorus, uric acid, and low calcium consequently leading to changes in kidney function, heartbeat, seizures, and sometimes death.
- Increase in blood pressure within blood vessels that supply the lungs.
Not known side effects (Frequency cannot be estimated from the available data):
- Sudden or mild but worsening pain in the upper stomach and/or back, which remains for a few days, possibly accompanied by nausea, vomiting, fever and a rapid pulse.
- Wheezing, shortness of breath, or a dry cough.
- Rare cases of muscle breakdown, which can lead to kidney problems have been observed, some of them when Lenalidomide IPI is administered with a statin.
- A condition affecting the skin caused by inflammation of small blood vessels, along with pain in the joints and fever.
- Breakdown of the wall of the stomach or gut. This may lead to a very serious infection. Tell your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in your stool, or changes in bowel habits.
- Viral infections, including herpes zoster and recurrence of hepatitis B infection.
- Rejection of solid organ transplant.
© Copyrights 2025. All rights reserved. Designed by 