Lenalidomide is a drug that is very similar to thalidomide, which is known to cause severe birth defects or death in unborn babies. If lenalidomide is taken during pregnancy, it may also cause severe birth defects or death in unborn babies. Therefore, this drug must never be used during pregnancy nor by women who could become pregnant while using this drug. Women must have two negative pregnancy tests before starting lenalidomide, the first 10-14 days before the first dose and the second within 24 hours before the first dose. Women must also continue to have pregnancy tests regularly during treatment (see also Notes section).
To receive this medication, all doctors, pharmacists, and patients must understand, agree to, and carefully follow the requirements of the Revlimid REMS Program (formerly known as the RevAssist program) developed by the U.S. Food and Drug Administration. These requirements apply in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.
If lenalidomide is used in a child between ages 12 to 18 years, a parent or legal guardian must also read the educational material and agree to carefully follow the requirements of the Revlimid REMS program.
Men or women who use this medication must use two reliable forms of birth control. For males, this means using a latex condom along with other effective birth control used by the female partner. If pregnancy does occur during treatment, stop this medication and contact your doctor immediately. (See also Precautions section.)
Lenalidomide may benefit you by helping increase the number of functioning red blood cells. However, it may also increase your risk of developing serious bone marrow problems such as low white blood cell counts or low platelet counts. Seek immediate medical attention if you develop the following symptoms: persistent fever, persistent sore throat, easy bleeding/bruising. Most patients will experience these effects, which will require your doctor to stop and restart lenalidomide or decrease your dose.
Lenalidomide may rarely cause blood clots (such as pulmonary embolism, stroke, heart attack, deep vein thrombosis). You may be at increased risk for blood clots if you smoke, or have a history of blood clots, or if you are immobile (such as on very long plane flights or being bedridden). If you use estrogen-containing products, these may also increase your risk. To lower your risk, your doctor may prescribe an additional medication. Before using lenalidomide, if you have any of these conditions report them to your doctor or pharmacist. Get medical help right away if any of these side effects occur: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headaches, slurred speech, weakness on one side of the body, sudden vision changes.Who should not take lenalidomide?
This medication is used to treat anemia in patients with certain blood/bone marrow disorders (myelodysplastic syndromes-MDS). These patients do not have enough properly working red blood cells and often require blood transfusions to reverse their anemia. Lenalidomide may lessen the need for blood transfusions. This medication may also be used to treat certain cancers (multiple myeloma, mantle cell lymphoma-MCL).
Lenalidomide is not recommended for the treatment of a certain type of cancer (chronic lymphocytic leukemia) because of the increased risk of serious heart-related side effects and death. If you have this type of cancer, talk to your doctor about the risks of using this medication.
Lenalidomide is a type of drug known as an immunomodulator. It is believed to work by decreasing the immune system's response, thereby lowering the number of working red blood cells that are destroyed naturally by the body.
This medication must be used only within the Revlimid REMS guidelines in order to avoid possible exposure of an unborn baby to the drug. Consult your doctor or pharmacist.
Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking lenalidomide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Before starting therapy, women of childbearing age should have two negative pregnancy tests before taking the drug. (See Warning section.)
Take this medication by mouth with or without food as directed by your doctor, usually once daily. Swallow this medication whole with water. Dosage is based on your medical condition, response to therapy, and laboratory test results. Be sure to follow your doctor's directions carefully.
Do not open, chew, or break the capsules, or handle them any more than needed. If any of the powder from the capsule gets on your skin, wash the area with soap and water.
Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from broken capsules. All people should wash their hands thoroughly after handling this drug.
Use this medication regularly in order to get the most benefit from it. Remember to take it at the same time each day.
Inform your doctor if your condition persists or worsens.
See also Warning section.
Diarrhea, tiredness, dry skin, constipation, nausea, stomach pain, vomiting, dry mouth, unpleasant taste, loss of appetite, headache, or trouble sleeping may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: mental/mood changes, pounding heartbeat, shaking (tremor), swelling ankles/feet/hands.
People with multiple myeloma who are treated with this medication may rarely get other cancers (such as acute leukemia, tumors). Consult your doctor for more details.
Lenalidomide sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, drink plenty of fluids unless your doctor directs you otherwise. Also, your doctor may prescribe an additional medication. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), pink/bloody urine, change in the amount of urine, painful urination, muscle spasms/weakness.
People taking lenalidomide for MCL sometimes have worsening of their MCL symptoms (tumor flare reaction). If you have tender/swollen lymph nodes, fever, pain, or rash, contact your doctor immediately.
Lenalidomide may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting/loss of appetite, stomach/abdominal pain, yellowing eyes/skin.
Lenalidomide can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, tell your doctor immediately if you develop any rash.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
See also Warning section.
Before taking lenalidomide, tell your doctor or pharmacist if you are allergic to it; or to thalidomide; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, high blood pressure, high cholesterol.
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
Lenalidomide can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.
Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).
To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.
Older adults may be more sensitive to the side effects of this drug, especially kidney problems, blood clots in the veins or lungs, irregular heartbeat.
Because lenalidomide can cause severe birth defects or death to an unborn baby, several precautions are noted below.
Do not donate blood while using lenalidomide and for 4 weeks after stopping this drug.
Males - This medication passes into semen. Therefore, while using lenalidomide and for 4 weeks after stopping the medication, do not donate sperm, and always use a latex condom when having sexual intercourse with a woman of childbearing age, even if you have had a vasectomy.
Use two forms of effective birth control together for at least 4 weeks before beginning lenalidomide treatment, during lenalidomide treatment, and for 4 weeks after stopping lenalidomide, or avoid intercourse completely during this period. Reliable birth control is necessary even if you have been unable to get pregnant in the past. Consult your doctor for more information about the right forms of birth control to use during this therapy.
Immediately tell your doctor if your period is late or if you have abnormal vaginal (menstrual) bleeding.
Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from broken capsules.
Lenalidomide must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. Even a single dose of lenalidomide taken during pregnancy can cause severe birth defects. If pregnancy does occur during treatment, this drug must be stopped immediately.
It is not known whether this drug passes into breast milk. Because of the potential for serious reactions in nursing infants, breast-feeding is not recommended while using lenalidomide.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some products that may interact with this drug include: other drugs which can harm the liver (such as acetaminophen).
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Do not share this medication with others.
Laboratory and/or medical tests (including complete blood counts, kidney/liver/thyroid function) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
Test for pregnancy before treatment, and weekly during the first 4 weeks of treatment. If you have regular periods, then test every 4 weeks thereafter. If you have irregular periods, you should test every 2 weeks thereafter.
If you miss a dose, take it as soon as you remember if it is less than 12 hours after the time you would usually take it. If more than 12 hours have passed, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised September 2014. Copyright(c) 2014 First Databank, Inc.
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