Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Incidence not known
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
It is very important that your doctor check your progress closely while you are using this medicine to see if it is working properly and to allow for a change in the dose. Blood tests may be needed to check for any unwanted effects.
Your doctor will want to see you every 4 weeks for pregnancy tests if you have a regular menstrual cycle, and every 2 weeks if you have an irregular cycle.
Call your doctor or 1-888-688-2528 for emergency contraception information if you think you are pregnant or, for males, if you think that your sexual partner may be pregnant.
Seek medical attention if you develop any shortness of breath, chest pain, or arm or leg swelling.
Do not breastfeed while you are using this medicine.
This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using this medicine.
Lenalidomide may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount; joint pain, stiffness, or swelling; lower back, side, or stomach pain; a rapid weight gain; swelling of the feet or lower legs; or unusual tiredness or weakness.
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking this medicine without checking with your doctor first.
It is very important that you understand the requirements of the RevAssist® program, and become familiar with the RevAssist® educational materials and Patient Medication Guide. Direct any questions to your doctor or pharmacist before starting lenalidomide therapy. .
You should take the necessary precautions to avoid pregnancy while taking lenalidomide. Use one highly effective form of birth control plus an additional effective form of birth control at the same time, if abstinence is not the chosen method. Begin this 4 weeks before starting lenalidomide and continue it for 4 weeks after stopping the medication.
There is a telephone survey and patient registry that you must participate in while taking lenalidomide. Ask your doctor or pharmacist if you have any questions about what you need to do.
Swallow the capsule whole, do not break, chew, or open it.
It is important that you have blood tests at regular intervals. Keep all appointments with your doctor for the tests.
It is important that you have pregnancy tests at regular intervals.
Male patients, even those who have had a vasectomy, must use a latex condom during sexual contact with a female patient.
Male patients: Do not donate semen or sperm while taking lenalidomide.
Do not donate blood while taking lenalidomide.
You should not share this medication with anyone, even if someone else has similar symptoms.
The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of lenalidomide in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lenalidomide in the elderly.
|All Trimesters||X||Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
Lenalidomide is used to treat anemia (low red blood cells) in patients with a certain type of myelodysplastic syndrome (MDS) called 5q MDS. Patients with this type of MDS may have very low red blood cell counts and require blood transfusions.
Lenalidomide is also used in combination with dexamathasone to treat multiple myeloma (plasma cell cancer) in patients who have received at least one prior therapy.
This medicine is available only under a special restricted distribution program called RevAssist® program.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, lenalidomide is used in certain patients with the following medical condition: