"Today the U.S. Food and Drug Administration granted approval for Empliciti (elotuzumab) in combination with two other therapies to treat people with multiple myeloma who have received one to three prior medications.
Multiple myeloma is a fo"...
Revlimid Consumer (continued)
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.
Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.
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, lymphoma). 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.
Read the Revlimid (lenalidomide) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: 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.
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