How does Revlimid® work?
Revlimid is a pill that you take by mouth to treat a type of blood cancer called multiple myeloma. It belongs to a group of medicines called IMiDs, which help your immune system fight the cancer cells. Revlimid is made by Bristol Myers Squibb.
Revlimid is similar to another medicine called Thalomid, but it works better and has fewer side effects. Some of the side effects that Thalomid can cause are feeling very sleepy, having trouble going to the bathroom, and having pain or tingling in your nerves.
Revlimid can also treat some other diseases that affect your blood cells (myelodysplastic syndrome and mantle cell lymphoma).
What does REVLIMID® (lenalidomide) do?
REVLIMID® (lenalidomide) is a medicine that you need a doctor’s prescription for. It is used to treat adults who have a type of blood cancer called multiple myeloma (MM). It can be used with another medicine called dexamethasone, or by itself after you have had a stem cell transplant that uses your own stem cells. REVLIMID should not be given to people who have another type of blood cancer called CLL, unless they are in a special research study. We don’t know if REVLIMID is safe and works well for children.
REVLIMID can get into your semen:
If you are a male, even if you had a surgery to prevent pregnancy, you must always use a rubber or man-made condom when you have s_x with a female who is pregnant or who can get pregnant while you are taking REVLIMID, when you stop taking REVLIMID for some time, and for up to 4 weeks after you stop taking REVLIMID.
Do not have s_x without a condom with a female who is or may get pregnant. Tell your doctor if you do have s_x without a condom with a female who is or may get pregnant.
Do not give your semen to anyone while you are taking REVLIMID, when you stop taking REVLIMID for some time, and for up to 4 weeks after you stop taking REVLIMID. If a female gets pregnant with your semen, the baby may be exposed to REVLIMID and may have birth defects.
Men: If your female partner gets pregnant, you should call your doctor right away.
Low white blood cells (neutropenia) and low platelets (thrombocytopenia). REVLIMID makes most people have low white blood cells and low platelets. You may need a blood transfusion or certain medicines if your blood counts get too low. Your doctor should check your blood counts often, especially during the first few months of treatment with REVLIMID, and then at least once a month. Tell your doctor if you have any bleeding or bruising during treatment with REVLIMID.
Blood clots. People who take REVLIMID have more chances of getting blood clots in the arteries, veins, and lungs. This risk is even higher for people with multiple myeloma who take the medicine dexamethasone with REVLIMID. Heart attacks and strokes also happen more often in people who take REVLIMID with dexamethasone. To lower this increased risk, most people who take REVLIMID will also take a medicine to prevent blood clots.
Before taking REVLIMID, tell your doctor:
if you have had a blood clot before;
if you have high blood pressure, smoke, or if you have been told you have a high level of fat in your blood (hyperlipidemia); and about all the medicines you take. Some other medicines can also make your risk for blood clots higher
Call your doctor or get medical help right away if you have any of the following during treatment with REVLIMID:
Signs or symptoms of a blood clot in the lung, arm, or leg may include: trouble breathing, chest pain, or arm or leg swelling
Signs or symptoms of a heart attack may include: chest pain that may spread to the arms, neck, jaw, back, or stomach area (abdomen), feeling sweaty, trouble breathing, feeling sick or throwing up
Signs or symptoms of stroke may include: sudden numbness or weakness, especially on one side of the body, severe headache or confusion, or problems with vision, speech, or balance
Before you start using lenalidomide and every time you get more of it, read the Medication Guide that your pharmacist gives you. If you don’t understand something, ask your doctor or pharmacist.
Take this medicine by mouth with or without food as your doctor tells you, usually once a day. Drink water and swallow this medicine whole. For some conditions, your doctor may tell you to take this medicine in cycles (once a day for 21 days, then stop for 7 days). The amount of medicine you take depends on your health, how well the medicine works for you, and your lab test results. Make sure to follow your doctor’s instructions carefully.
Do not open, chew, or break the capsules, or touch them more than you need to. If any of the powder from the capsule gets on your skin, wash the area with soap and water.
This drug can go through the skin and lungs and may hurt a baby that is not born yet, so women who are pregnant or who may get pregnant should not touch this medicine or breathe the dust from broken capsules. Everyone should wash their hands well after touching this drug.
Use this medicine regularly to get the most benefit from it. Remember to take it at the same time every day.
Do not take more of this drug or use it more often or for longer than your doctor tells you to. Your health will not get better faster, and you may have more side effects.
Lenalidomide is a medicine that can help some people with blood problems or cancer. But some people may be allergic to it or to a similar medicine called thalidomide. This medicine may also have other things in it (like lactose) that can cause problems for some people. Ask your pharmacist if you have any questions about this.
Before you start taking lenalidomide, tell your doctor or pharmacist about your health history. For example, tell them if you have problems with your kidneys, liver, thyroid, or immune system. Tell them if you ever had chicken pox, shingles, or hepatitis B. Tell them if you ever had an organ transplant.
Lenalidomide can make you feel dizzy. Do not drink alcohol or use marijuana (cannabis) while taking this medicine. They can make you feel more dizzy. Do not drive, use machines, or do anything that needs you to be alert until you know how this medicine affects you.
Lenalidomide can also make it easier for you to get sick from infections or make them worse. Stay away from people who are sick with things that can spread easily (like chickenpox, COVID-19, measles, or flu). Tell your doctor if you have been around someone who is sick or if you have any signs of infection.
Tell your doctor or nurse that you are taking lenalidomide before you get any shots or vaccines. Do not get any live vaccines (like the flu spray) while taking this medicine.
Be careful not to hurt yourself while taking lenalidomide. Use things like razors and nail cutters carefully. Avoid doing things like playing sports that can cause injuries.
Do not give blood or sperm while taking lenalidomide and for 4 weeks after stopping it.
Older people may have more side effects from this medicine.
This medicine can be very bad for unborn babies. Women who are pregnant or who may get pregnant should not touch this medicine or breathe in the dust from broken capsules. If you are pregnant or think you might be pregnant, stop taking lenalidomide and tell your doctor right away. If you are a man and have s_x with a woman who is or may get pregnant, or if you think your partner may be pregnant, tell both of your doctors right away.
It is not known if lenalidomide goes into breast milk. Do not breast-feed while taking this medicine because it may harm your baby. Talk to your doctor before breast-feeding.
Talk to your pharmacist or doctor if you have any more questions.”
Some drugs can affect how other drugs work or make you more likely to have bad side effects. This paper does not list all the drug interactions that can happen. Keep track of all the things you take (like prescribed drugs, over-the-counter drugs, and natural products) and show it to your doctor and pharmacist. Do not begin, end, or change the amount of any drugs you take without your doctor’s okay.
REVLIMID and dexamethasone are used together to treat adults with a type of blood cancer called multiple myeloma (MM).
REVLIMID is also used to prevent MM from coming back after a stem cell transplant.
1.2 Myelodysplastic Syndromes
REVLIMID is used to treat adults with a type of blood disorder called myelodysplastic syndromes (MDS) that causes low blood counts and needs frequent blood transfusions. REVLIMID is for patients with a specific genetic change in their MDS cells.
1.3 Mantle Cell Lymphoma
REVLIMID is used to treat adults with a type of lymphoma called mantle cell lymphoma (MCL) that has come back or gotten worse after two previous treatments, one of which included bortezomib.
1.4 Follicular Lymphoma
REVLIMID and a rituximab product are used together to treat adults with a type of lymphoma called follicular lymphoma (FL) that has been treated before.
1.5 Marginal Zone Lymphoma
REVLIMID and a rituximab product are used together to treat adults with a type of lymphoma called marginal zone lymphoma (MZL) that has been treated before.
1.6 Limitations of Use
REVLIMID is not approved and not recommended for treating patients with CLL unless they are in clinical trials.
4.1 Pregnancy
REVLIMID can harm an unborn baby if a woman takes it while she is pregnant. Some baby monkeys had problems with their limbs when their mothers got lenalidomide during the time their organs were forming. This happened with any amount of lenalidomide. Because of this monkey study, and because lenalidomide is similar to thalidomide, a drug that causes birth defects in humans, lenalidomide should not be used by women who are pregnant [see BOXED WARNING]. If a woman uses this drug during pregnancy or gets pregnant while using this drug, she should be told about the possible danger to her baby [see WARNINGS AND PRECAUTIONS (5.1, 5.2), USE IN SPECIAL POPULATIONS (8.1, 8.3)].
4.2 Severe Hypersensitivity Reactions
REVLIMID should not be used by patients who have had very bad allergic reactions (e.g., swelling, Stevens-Johnson syndrome, toxic epidermal necrolysis) to lenalidomide
Revlimid is a drug that helps people with some kinds of cancer and blood problems. It works on the cells in the bone marrow, where blood cells are made.
Revlimid can be used for these conditions:
– Multiple myeloma: This is when plasma cells, a kind of white blood cell, grow out of control and cause problems in the bones and organs. Revlimid can be used for adults who have had a special treatment called stem cell transplant, where they get new cells from someone else to replace their own bone marrow cells. It can also be used for adults who have not had this treatment before, or who have had other treatments before. Revlimid is given with other drugs like dexamethasone, bortezomib, melphalan or prednisone.
– Myelodysplastic syndromes: This is when the bone marrow does not make enough red blood cells, which carry oxygen in the body. People with this problem need to get blood from other people to feel better. Revlimid can be used for people who have a change in their genes (called deletion 5q) that causes this problem, and who do not get better with other treatments.
– Mantle cell lymphoma and follicular lymphoma: These are cancers of B lymphocytes, another kind of white blood cell that fights infections. Revlimid can be used for adults whose cancer has come back or has not gone away with other treatments. In follicular lymphoma, it is given with another drug called rituximab.
Revlimid has lenalidomide as its main ingredient.”
The most common problems that people have with Revlimid when they use it for multiple myeloma are: chest infection, sore nose and throat, cough, upset stomach, nose and throat infection, feeling tired, low number of neutrophils (a kind of white blood cell that fights infections), hard stools, loose stools, muscle pain, low number of red blood cells, low number of platelets (cells that help the blood to clot), skin rash, back pain, trouble sleeping, not feeling hungry, fever, swollen arms and legs because of too much water in the body, low number of white blood cells, feeling weak, nerve damage in the hands and feet and low amount of calcium in the blood.
The most common problems that people have with Revlimid when they use it for myelodysplastic syndromes are low number of neutrophils, low number of platelets, loose stools, hard stools, feeling sick, itching, skin rash, feeling tired and muscle twitching.
The most common problems that people have with Revlimid when they use it for mantle cell lymphoma are low number of neutrophils, low number of red blood cells, loose stools, feeling tired, hard stools, fever and skin rash.
The most common problems that people have with Revlimid when they use it for follicular lymphoma are low number of neutrophils, low number of white blood cells, loose stools, hard stools, feeling tired and cough.
The most serious problems that people can have with Revlimid are: low number of neutrophils, blood clots in the veins that can go to the lungs and cause breathing problems or death, lung infections including pneumonia, low blood pressure, losing too much water from the body, kidney failure, low number of neutrophils with fever, loose stools and low number of red blood cells.
Lenalidomide can hurt the baby in the womb. So Revlimid should not be used by women who are pregnant. It should also not be used by women who can get pregnant unless they make sure that they are not pregnant before taking the drug and that they do not get pregnant while taking the drug or soon after stopping it.”
The maker of Revlimid will send a note and learning kits to doctors and nurses, and booklets for patients, telling them that the medicine can hurt the baby before it is born and showing them the steps they need to follow for the medicine to be used safely. It will also give cards to patients about the safety actions patients should do.
The maker has also started a plan to prevent pregnancy in each country and will get information on how the medicine is used for other things than what it is approved for. The boxes that have Revlimid capsules also have a warning saying that lenalidomide can hurt the baby before it is born.
Also, the maker will do a study in patients with blood problems to get more safety information, and a safety study in patients with new blood cancer who cannot have a transplant.
Advice and tips for doctors, nurses and patients to use Revlimid safely and effectively have also been added in the summary of the medicine and the paper inside the box.
Lenalidomide is a drug that is similar to thalidomide, which can cause serious problems in the limbs of unborn babies. Thalidomide is known to harm human babies very badly if taken during pregnancy. It can cause death or deformity of the baby. Women who can get pregnant must have 2 negative pregnancy tests before they start taking REVLIMID. They must also use 2 ways of preventing pregnancy or not have s_x with men during and for 4 weeks after taking REVLIMID. To prevent harm to unborn babies, REVLIMID is only given through a special program, the Lenalidomide REMS program.
You can find more information about the Lenalidomide REMS program at www.lenalidomiderems.com or by calling this free number 1-888-423-5436.
Blood Problems (Low White Blood Cells and Platelets)
REVLIMID can cause low levels of white blood cells and platelets in your blood. White blood cells help fight infections and platelets help stop bleeding. Most patients with del 5q MDS (a type of blood cancer) had to change their dose or stop taking REVLIMID for a while because of these problems. More than half of them had to do it twice. Severe blood problems were seen in 80% of patients in the study. Patients with del 5q MDS should have their blood counts checked every week for the first 2 months of treatment and at least once a month after that. Patients may need to change their dose or stop taking REVLIMID. Patients may need to get blood transfusions or injections to help their blood cells.
Blood Clots in Veins and Arteries
REVLIMID can increase the risk of blood clots in the veins (DVT) and lungs (PE), as well as the risk of heart attack and stroke in patients with MM (another type of blood cancer) who were treated with REVLIMID and dexamethasone (a steroid). Watch for and tell patients about signs and symptoms of blood clots. Tell patients to get medical help right away if they have trouble breathing, chest pain, or swelling in their arms or legs. It is recommended to use medicines or devices to prevent blood clots and the choice should be based on how likely the patient is to get a blood clot.”
