LENALIDOMIDE (Systemic)?
Some commonly used brand names are:
In the U.S.?
? Not commercially available in Canada.
Category
- Antianemic
- antiangiogenesis agent
- immunomodulator
Description
Lenalidomide (le-na-LID-oh-mide ) isa medicine used to treat anemia in patients with a certain type of myelodysplasticsyndrome (MDS) called 5q MDS. Patients with this type of MDS may have lowred blood cell counts that require blood transfusions.
This medicine is available only with your doctor's prescription, in thefollowing dosage forms:
Before Using This Medicine
In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For lenalidomide, thefollowing should be considered:
Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to lenalidomide. Also tell your doctor and pharmacistif you are allergic to any other substances, such as foods, preservatives,or dyes.
Pregnancy?Lenalidomide must not be used during pregnancy.It has been shown to cause serious birth defects in humans. Before takingthis medicine, make sure your doctor knows if you are pregnant or if you maybecome pregnant.
Breast-feeding?It is not known whether lenalidomide passes intobreast milk. However, lenalidomide is not recommended during breast-feeding,because it may cause unwanted effects in nursing infants.
Children?Studies on this medicine have been done only inadult patients, and there is no specific information comparing use of lenalidomidein children with use in other age groups.
Older adults?This medicine has been tested and has not beenshown to cause different side effects or problems in older people than itdoes in younger adults.
Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your health careprofessional if you are taking any other prescription or nonprescription (over-the-counter[OTC]) medicine.
Other medical problems?The presence of other medicalproblems may affect the use of lenalidomide. Make sure you tell your doctorif you have any other medical problems, especially:
- Kidney disease?May increase the amount of lenalidomide in yourbody and increase the risk of side effects
- Liver disease?Use cautionas studies have not been done.
- Multiple myeloma?May increase your risk for serious side effects
Proper Use of This Medicine
It is very important that you become educated and counseled on the requirementsof the RevAssist program, and familiar with the RevAssist educationalmaterials, Patient Medication Guide, and directing any questions to a physicianor pharmacist prior to starting lenalidomide therapy.
You should take the necessary precautions to avoidpregnancy while taking lenalidomide. Using one highly effective formof birth control plus an additional effective form of birth control at thesame time, if abstinence is not the chosen method. Starting 4 weeks beforestarting lenalidomide and for 4 weeks after stopping the medication.
There is a telephone survey and patient registry thatyou must participate in while taking lenalidomide. Ask your doctoror pharmacist if you have any questions about what you need to do.
Swallow whole, do not break, chew, or open the capsule.
The importance of having laboratory test on blood.
It is important that you have pregnancy tests at regularintervals.
Male patients, even those who have had a vasectomy, must use a latex condomduring sexual contact with a female patient.
Do not donate blood while taking lenalidomide.
You should not share this medication with anyone,even someone with similar symptoms.
For male patients: Do not donate semen or sperm whiletaking lenalidomide.
Dosing?The dose of lenalidomide will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe average doses of lenalidomide. If your dose is different,do not change it unless your doctor tells you to do so.
The number of capsules that you take depends on the strength of the medicine.
- For oral dosage form (capsules):
- For treating anemia in patients with myelodysplastic syndrome:
- Adults?Oral, 10 milligrams daily, taken with water . Dosingis continued or adjusted based upon clinical and laboratory findings.
- Children?Use and dose must be determined by your doctor.
Missed dose?If you miss a dose of this medicine, take itas soon as possible. However, if it is almost time for your next dose, skipthe missed dose and go back to your regular dosing schedule. Do not doubledoses.
Storage?To store this medicine:
- Keep out of the reach of children.
- Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
- Do not keep outdated medicine or medicine no longer needed. Ask yourhealth care professional how you should dispose of any medicine you do notuse. Be sure that any discarded medicine is out of the reach of children.
Precautions While Using This Medicine
Your doctor will want to see you every 4 weeks for pregnancytesting if you have a regular menstrual cycle and every 2 weeks if you havean irregular cycle..
Call your doctor or 1-888-688-2528 for emergency contraceptioninformation if you for any reason think you are pregnant or, for males, ifyou think that your sexual partner may be pregnant.
Seek medical attention if you develop any shortnessof breath, chest pain, or arm or leg swelling.
Side Effects of This Medicine
Along with its needed effects, a medicinemay cause some unwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.
Otherside effects may occur that usually do not need medical attention. These sideeffects may go away during treatment as your body adjusts to the medicine.However, check with your doctor if any of the following side effects continueor are bothersome.
More Common
Abnormal or decreased touch sensation; back pain; bloody nose; body aches or pain; blurred vision; bruising; burning, numbness, tingling,or painful sensations; burning while urinating; change in taste; constipation; contusion; cough producing mucus; depressed mood; diarrhea; difficulty having a bowel movement (stool); difficulty in moving; discouragement; drowsiness; dry skin and hair; dryness or soreness of throat; earcongestion; fast, irregular, pounding, or racingheartbeat or pulse; feeling sad or empty; feeling unusually cold; flushing, rednessof skin; hair loss; headache; hoarseness or husky voice; irritability; itching, pain, redness, swelling, tenderness, warmth on skin; itching skin; lack or loss of strength; large, flat,blue or purplish patches in the skin; loose stools; loss of appetite; lossof interest or pleasure; loss of taste; loss of voice; muscle aching; muscle pain or stiffness; muscle spasms; nasal congestion; nervousness; night sweats; pain; pain in arms or legs; pain in joints; pain or tenderness around eyes and cheekbones; pounding in the ears; rash; runny nose; seizures; shivering; sleeplessness; slow or fast heartbeat; sneezing; stomach pain; stuffy or runny nose; sweating increased; swelling; swelling of hands, ankles,feet, or lower legs; swollen joints; [tetany] or twitching; tiredness; trembling; ; trouble concentrating; trouble sleeping; trouble in swallowing; troubled breathing with exertion; tender, swollen glands in neck; unableto sleep; unsteadiness or awkwardness; unusually warm skin; upper abdominalpain; voice changes; vomiting; weakness in arms, hands, legs, or feet; weight gain; weight loss
Other side effectsnot listed above may also occur in some patients. If you notice any othereffects, check with your doctor.
Developed: 02/17/2006
