Risk of severe life-threatening birth defects caused by lenalidomide:
For all patients:
Lenalidomide must not be taken by patients who are pregnant or who may become pregnant. There is a high risk that lenalidomide will cause severe birth defects (problems that are present at birth) or death of the unborn baby.
A program called REVLIMID REMSTM has been set up to make sure that pregnant women do not take lenalidomide and that women do not become pregnant while taking lenalidomide. All patients, including women who cannot become pregnant and men, can get lenalidomide only if they are registered with REVLIMID REMS, have a prescription from a doctor who is registered with REVLIMID REMS, and fill the prescription at a pharmacy that is registered with REVLIMID REMS.
You will receive information about the risks of taking lenalidomide and must sign an informed consent sheet stating that you understand this information before you can receive the medication. If you are younger than 18 years of age, a parent or guardian must sign the consent sheet and agree to make sure you meet these requirements. You will need to see your doctor during your treatment to talk about your condition and the side effects you are experiencing or to have pregnancy tests as recommended by the program. You may need to complete a confidential survey at the beginning of your treatment and at certain times during your treatment to be sure that you have received and understand this information and that you can follow the instructions to prevent serious risks to unborn babies.
Tell your doctor if you do not understand everything you were told about lenalidomide and the REVLIMID REMS program and how to use the birth control methods discussed with your doctor, or if you do not think you will be able to keep appointments.
Do not donate blood while you are taking lenalidomide, during any breaks in your treatment, and for 4 weeks after your final dose.
Do not share lenalidomide with anyone else, even someone who has the same symptoms that you have.
For female patients:
If you can become pregnant, you will need to meet certain requirements during your treatment with lenalidomide. You must use two acceptable forms of birth control for 4 weeks before you begin taking lenalidomide, during your treatment, including at times when your doctor tells you to temporarily stop taking lenalidomide, and for 4 weeks after your final dose. Your doctor will tell you which forms of birth control are acceptable and will give you written information about birth control. You must use these two forms of birth control at all times unless you can guarantee that you will not have any sexual contact with a male for 4 weeks before your treatment, during your treatment, during any interruptions in your treatment, and for 4 weeks after your final dose.
If you choose to take lenalidomide, it is your responsibility to avoid pregnancy for 4 weeks before, during, and for 4 weeks after your final dose. You must understand that any form of birth control can fail. Therefore, it is very important to decrease the risk of accidental pregnancy by using two forms of birth control. Tell your doctor if you do not understand everything you were told about birth control or you do not think that you will be able to use two forms of birth control at all times.
You must have two negative pregnancy tests before you can begin to take lenalidomide. You will also need to be tested for pregnancy in a laboratory at certain times during your treatment. Your doctor will tell you when and where to have these tests.
Stop taking lenalidomide and call your doctor right away if you think you are pregnant, you miss a menstrual period, you have unusual menstrual bleeding, or you have sex without using two forms of birth control. If you become pregnant during your treatment or within 30 days after your treatment, your doctor will contact the REVLIMID REMS program, the manufacturer of lenalidomide, and the Food and Drug Administration (FDA). You will also talk with a doctor who specializes in problems during pregnancy who can help you make choices that are best for you and your baby. Information about your health and your baby’s health will be used to help doctors learn more about the effects of lenalidomide on unborn babies.
For male patients:
Lenalidomide is present in your semen when you take this medication. You must always use a latex condom, even if you have had a vasectomy (surgery that prevents a man from causing a pregnancy), every time you have sexual contact with a female who is pregnant or able to become pregnant while you are taking lenalidomide, during any breaks in your treatment, and for 4 weeks after your final dose. Tell your doctor if you have sexual contact with a female without using a condom or if your partner thinks she may be pregnant during your treatment with lenalidomide.
Do not donate sperm while you are taking lenalidomide, during any breaks in your treatment, and for 4 weeks after your final dose.
Other risks of taking lenalidomide:
Lenalidomide may cause a decrease in the number of certain types of blood cells in your body. Your doctor will order laboratory tests regularly during your treatment to see how much the number of blood cells has decreased. Your doctor may decrease your dose, interrupt your treatment, or treat you with other medications or treatments if the decrease in your blood cells is severe. If you experience any of the following symptoms, tell your doctor immediately: sore throat, fever, chills, and other signs of infection; easy bruising or bleeding; bleeding gums; or nosebleeds.
If you are taking lenalidomide with dexamethasone to treat multiple myeloma, there is an increased risk that you will develop a blood clot in your leg that may move through the bloodstream to your lungs, or have a heart attack or a stroke. Your doctor may prescribe other medication to be taken along with lenalidomide to decrease this risk. Tell your doctor if you smoke, if you have ever had a serious blood clot, and if you have or have ever had high blood pressure or a high level of fat in your blood.
Also tell your doctor about all the medications you are taking because certain medications may increase the risk that you will develop a blood clot while taking lenalidomide with dexamethasone including darbepoetin (Aranesp), epoetin alfa (Epogen, Procrit), and medications containing estrogen such as hormone replacement therapy or hormonal contraceptives (birth control pills, patches, rings, implants, or injections). If you experience any of the following symptoms, tell your doctor immediately: shortness of breath; chest pain that may spread to the arms, neck, back, jaw, or stomach; cough; redness or swelling in an arm or leg; sweating; nausea; vomiting; sudden weakness or numbness, especially on one side of the body; headache; confusion; or difficulty with vision, speech, or balance.
Lenalidomide (brand name- Revlimid) is useful to treat a certain type of myelodysplastic syndrome (a group of conditions in which the bone marrow produces blood cells that are misshapen and does not produce enough healthy blood cells). Lenalidomide along with dexamethasone treats people with multiple myeloma (a type of cancer of the bone marrow). It also treats people with multiple myeloma after a hematopoietic stem-cell transplant.
Lenalidomide also treats people with mantle cell lymphoma who have been treated with bortezomib (Velcade) and at least one other medication. Avoid using it in people with chronic lymphocytic leukemia unless they are participating in a clinical trial.
Lenalidomide falls in a class of medications called immunomodulatory agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells in the bone marrow.
Let us walk you through the key things you need to know about Lenalidomide.
How should I take lenalidomide (Revlimid)?
Lenalidomide comes as a capsule to take by mouth. It is usually taken with or without food once daily. Take lenalidomide at around the same time of day every day that you take it. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take lenalidomide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the capsules whole with plenty of water; do not break, chew, or open them. Handle the capsules as little as possible. Your Doctor may need to interrupt your treatment or reduce your dose if you experience certain side effects. Be sure to tell your doctor how you feel during your lenalidomide treatment.
Do not stop taking Lenalidomide without talking to your doctor. You can help them by tracking your side effects in Ankr.
What are the side effects of lenalidomide?
Common side effects
- diarrhea (loose stools)
- abdominal pain (bellyache)
- appetite loss (anorexia)
- abnormal weight loss
- change in ability to taste
- pain or burning of the tongue, mouth, or throat
- decreased sense of touch
- burning or tingling in the hands or feet
- difficulty falling asleep or staying asleep
- joint, muscle, bone, or back pain
- dry skin
- abnormal hair growth in women
- uncontrollable shaking of a part of the body
- decrease in sexual desire or ability
Serious side effects
- swelling of the face, throat, tongue, lips, eyes, arms, hands, feet, ankles, or lower legs
- difficulty breathing or swallowing
- fast, slow, pounding, or irregular heartbeat
- skin pain
- blistering, peeling, or shedding skin
- swollen glands in the neck
- muscle cramps
- pain in the upper right part of the stomach
- yellowing of the skin or eyes
- dark colored urine
- bloody, cloudy, or painful urination
- increased or decreased urination
- painful, frequent, or urgent urination
Lenalidomide may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online or by phone (1-800-332-1088).
What special precautions should I follow?
Before taking lenalidomide (Revlimid)
- tell your doctor about your allergies
- tell your doctor about other intakes
- tell your doctor if you have or have ever had any disease, symptom, or treatment
- also tell your doctor if you have ever taken thalidomide (Thalomid) and developed a rash during your treatment.
While you are on lenalidomide (Revlimid)
- if you or your partner become pregnant while receiving lenalidomide, call your doctor. It may harm the fetus.
- tell your doctor if you are breastfeeding or are planning to breastfeed. You should not breastfeed while you are taking lenalidomide.
I forgot a dose. What should I do?
If it has been less than 12 hours since you were scheduled to take the dose, take the missed dose as soon as you remember it. If it has been more than 12 hours, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
In case of an emergency/overdose
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.
Symptoms of overdose may include the following:
How should I safely storae and dispose of lenalidomide?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Return any medication that is outdated or no longer needed to your doctor, the pharmacy that gave you the medication, or the manufacturer.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
Last Revised -06/15/2023, FDA updated- 04/15/2019, SG
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