Lenalidomide (Revlimid®)

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About This Drug

Lenalidomide is used to treat cancer. It is given orally (by mouth).

Possible Side Effects

  • Bone marrow depression. This is a decrease in the number of white blood cells, red blood cells, and platelets. This may raise your risk of infection, make you tired and weak (fatigue), and raise your risk of bleeding
  • Fever
  • Tiredness and weakness
  • Feeling dizzy
  • Trouble sleeping
  • Upper respiratory infection, bronchitis
  • Inflammation of the nasal passages and throat
  • Trouble breathing
  • Cough
  • Nausea
  • Decreased appetite (decreased hunger)
  • Loose bowel movements (diarrhea)
  • Constipation (unable to move bowels)
  • Inflammation of your stomach and/or intestines
  • Pain in your abdomen
  • Pain in your joints
  • Swelling of your legs, ankles and/or feet
  • Muscle cramps/spasms
  • Back pain
  • Rash and itching
  • Tremor

Note: Each of the side effects above was reported in 15% or greater of patients treated with lenalidomide. Not all possible side effects are included above.

Warnings and Precautions

  • Blood clots and events such as stroke and heart attack.A blood clot in your leg may cause your leg to swell, appear red and warm, and/or cause pain. A blood clot in your lungs may cause trouble breathing, pain when breathing, and/or chest pain.
  • Severe bone marrow depression
  • Changes in your liver function, which may cause liver failure and be life-threatening
  • Tumor lysis syndrome: This drug may act on the cancer cells very quickly. This may affect how your kidneys work and can be life-threatening.
  • Changes in your thyroid function
  • Severe allergic skin reaction which may be life-threatening. You may develop blisters on your skin that are filled with fluid or a severe red rash all over your body that may be painful.
  • This drug may raise your risk of getting a second cancer
  • You may develop a syndrome called tumor flare reaction. You may have painful lymph nodes, enlarged spleen, fever and a rash.
  • This drug may make it more difficult to collect your stem cells if an autologous stem cell transplant is part of your treatment plan.
  • There is a rare increased risk of death in patients with chronic lymphocytic leukemia and a risk of early death (dying sooner) in patient with mantle cell lymphoma

Note: Some of the side effects above are very rare. If you have concerns and/or questions, please discuss them with your medical team.

Important Information

  • You will need to sign up for a special program called Revlimid® REMS when you start taking this drug. Your nurse will help you get started.
  • Do not donate blood during your treatment and for 4 weeks after your treatment.
  • For males only, do not donate sperm during your treatment and for 4 weeks after your treatment because this drug is present in semen and may badly harm a baby.

How to Take Your Medication

  • Swallow the medicine whole with water, with or without food daily.Do not chew, break, or open it.
  • Take this medicine at the same time each day
  • Missed dose: If you miss a dose, take it as soon as you think about it ONLY if it has been less than 12 hours since your regular time. If it has been more than 12 hours, skip the missed dose and contact your physician. Take your next dose at the regular time. Do not take 2 doses at the same time and do not double up on the next dose.
  • If you vomit a dose, take your next dose at the regular time.
  • Handling: Wash your hands after handling your medicine, your caretakers should not handle your medicine with bare hands and should wear latex gloves.
  • If you get any of the content of a broken capsules on your skin, you should wash the area of the skin well with soap and water right away. Call your doctor if you get a skin reaction
  • This drug may be present in the saliva, tears, sweat, urine, stool, vomit, semen, and vaginal secretions. Talk to your doctor and/or your nurse about the necessary precautions to take during this time.
  • Storage: Store this medicine in the original container at room temperature. Discuss with your nurse or your doctor how to dispose of unused medicine

Treating Side Effects

  • Manage tiredness by pacing your activities for the day.
  • Be sure to include periods of rest between energy-draining activities.
  • To decrease infection, wash your hands regularly.
  • Avoid close contact with people who have a cold, the flu, or other infections.
  • Take your temperature as your doctor or nurse tells you, and whenever you feel like you may have a fever.
  • To help decrease bleeding, use a soft toothbrush. Check with your nurse before using dental floss.
  • Be very careful when using knives or tools.
  • Use an electric shaver instead of a razor.
  • Ask your doctor or nurse about medicines that are available to help stop or lessen constipation.
  • If you are not able to move your bowels, check with your doctor or nurse before you use enemas, laxatives, or suppositories.
  • Drink plenty of fluids (a minimum of eight glasses per day is recommended).
  • If you throw up or have loose bowel movements, you should drink more fluids so that you do not become dehydrated (lack water in the body from losing too much fluid).
  • If you get diarrhea, eat low-fiber foods that are high in protein and calories and avoid foods that can irritate your digestive tracts or lead to cramping.
  • Ask your nurse or doctor about medicine that can lessen or stop your diarrhea.
  • To help with nausea and vomiting, eat small, frequent meals instead of three large meals a day. Choose foods and drinks that are at room temperature. Ask your nurse or doctor about other helpful tips and medicine that is available to help or stop lessen these symptoms.
  • To help with decreased appetite, eat small, frequent meals.
  • Eat high caloric food such as pudding, ice cream, yogurt and milkshakes.
  • If you get a rash, do not put anything on it unless your doctor or nurse says you may. Keep the area around the rash clean and dry. Ask your doctor for medicine if your rash bothers you.
  • Keeping your pain under control is important to your well-being. Please tell your doctor or nurse if you are experiencing pain.
  • If you are having trouble sleeping, talk to your nurse or doctor on tips to help you sleep better.

Food and Drug Interactions

  • There are no known interactions of lenalidomide with food.
  • Check with your doctor or pharmacist about all other prescription medicines and dietary supplements you are taking before starting this medicine as there are known drug interactions with lenalidomide. Also, check with your doctor or pharmacist before starting any new prescription or over-the-counter medicines, or dietary supplement to make sure that there are no interactions.

When to Call the Doctor

Call your doctor or nurse if you have any of these symptoms and/or any new or unusual symptoms:

  • Fever of 100.5 F (38 C) or higher
  • Chills
  • Fatigue that interferes with your daily activities
  • Feeling dizzy or lightheaded
  • Easy bleeding or bruising
  • Your leg or arm is swollen, red, warm and/or painful
  • Painful lymph nodes
  • Wheezing and/or trouble breathing
  • Chest pain or symptoms of a heart attack. Most heart attacks involve pain in the center of the chest that lasts more than a few minutes. The pain may go away and come back. It can feel like pressure, squeezing, fullness, or pain. Sometimes pain is felt in one or both arms, the back, neck, jaw, or stomach. If any of these symptoms last 2 minutes, call 911.
  • Symptoms of a stroke such as sudden numbness or weakness of your face, arm, or leg, mostly on one side of your body; sudden confusion, trouble speaking or understanding; sudden trouble seeing in one or both eyes; sudden trouble walking, feeling dizzy, loss of balance or coordination; or sudden, bad headache with no known cause.If you have any of these symptoms for 2 minutes, call 911.
  • Wheezing or trouble breathing
  • You cough up yellow, green, or bloody mucus
  • Feeling that your heart is beating in a fast or not normal way (palpitations)
  • Nausea that stops you from eating or drinking and/or is not relieved by prescribed medicines
  • Throwing up more than 3 times a day
  • Loose bowel movements (diarrhea) 4 times a day or loose bowel movements with lack of strength or a feeling of being dizzy
  • No bowel movement in 3 days or when you feel uncomfortable
  • Pain in your abdomen that does not go away
  • Weight gain of 5 pounds in one week (fluid retention)
  • Unexplained weight gain
  • Lasting loss of appetite or rapid weight loss of five pounds in a week
  • Pain that does not go away, or is not relieved by prescribed medicines
  • Flu-like symptoms: fever, headache, muscle and joint aches, and fatigue (low energy, feeling weak)
  • A new rash or a rash that is not relieved by prescribed medicines
  • Signs of possible liver problems: dark urine, pale bowel movements, bad stomach pain, feeling very tired and weak, unusual itching, or yellowing of the eyes or skin
  • Signs of tumor lysis: Confusion or agitation, decreased urine, nausea/vomiting, diarrhea, muscle cramping, numbness and/or tingling, seizures.
  • If you think you may be pregnant or may have impregnated your partner

Reproduction Warnings

  • Pregnancy warning: This drug can have harmful effects on the unborn baby. Women of child- bearing potential should use 2 effective methods of birth control, one of which, must be a highly effective method of birth control, beginning 4 weeks before treatment starts, during your cancer treatment, including dose interruptions, and for at least 4 weeks after treatment. A highly effective method of birth control includes tubal ligation, intra-uterine device (IUD), hormonal (birth control pills, injections, patch and/or implants) or a partner’s vasectomy. Let your doctor know right away if you think you may be pregnant
  • Two negative pregnancy tests are required in women of child-bearing potential prior to starting treatment.
  • You will need to have routine pregnancy tests while you are taking this drug.
  • Men with female partners of child-bearing potential should use effective methods of birth control during your cancer treatment and for at least 4 weeks after your cancer treatment. You should always wear a condom even if you have undergone a successful vasectomy. Let your doctor know right away if you think you may have impregnated your partner.
  • Breastfeeding warning: Women should not breast feed during treatment because this drug could enter the breast milk and cause harm to a breast feeding baby.
  • Fertility warning: Human fertility studies have not been done with this drug. Talk with your doctor or nurse if you plan to have children.Ask for information on sperm or egg banking.

Revised February 2018

This information is intended to provide helpful health information to the general public and is not to be used in place of any medical, health, psychological, or any other kind of personal professional services. The information herein does not cover all possible uses, actions, precautions, side effects, or interactions of the medicines mentioned, nor is the information intended as medical advice for individual problems or for making an evaluation as to the risks and benefits of taking a particular medication. The dose, method of administration and contraindications for any administered medication should be confirmed before use. UPMC specifically disclaims all responsibility for any liability, loss or risk, personal or otherwise, which is incurred as a consequence, directly or indirectly, of the use and application of any medication mentioned herein.