Revlimid (lenalidomide) affects the immune system. It promotes immune responses to help slow tumor growth. Revlimid is used to treat multiple myeloma (bone marrow cancer), either in combination with another medicine or after stem cell transplant.
Revlimid is also used to treat anemia (a lack of red blood cells) in patients with myelodysplastic syndrome caused by an abnormal chromosome. This disorder is also called deletion 5q MDS, because part of chromosome 5 is missing. In people with this disorder, the bone marrow does not produce enough healthy blood cells.
Revlimid (also called lenalidomide) is an oral cancer drug that is used for the treatment of multiple myeloma. It is part of a class of drugs called Immunomodulatory drugs or IMiDs. IMiDs work against cancer cells partly by impacting the functioning of the immune system.
Revlimid is chemically related to Thalomid (thalidomide, Celgene), another IMiD, but has been found to be more potent in the laboratory and has different side effects. For example, significant sleepiness, constipation and painful nerve problems (neuropathy), common side effects of Thalomid, are seen much less frequently with Revlimid.
In addition to multiple myeloma, Revlimid is also used to treat other diseases (myelodysplastic syndrome or MDS, and mantle cell lymphoma).
Revlimid is also used to treat mantle cell lymphoma (a rare cancer of the lymph nodes), after other medications have been tried without success.
Revlimid should not be used for chronic lymphocytic leukemia (CLL) unless you are in a controlled medical study. Lenalidomide can increase the risk of death from serious heart problems in people with CLL.
This medicine is available only from a certified pharmacy under a special program called Revlimid REMS. Your doctor must be registered in the program in order to prescribe lenalidomide for you. You must be registered in the program and sign documents stating that you understand the dangers of this medication and that you agree to use birth control measures as required by the program.
How is Revlimid used in multiple myeloma?
Revlimid is used throughout all stages of multiple myeloma.
The combination of Revlimid (lenalidomide, Celgene) and dexamethasone, also called Revlimid-dex, is approved by the FDA for the treatment of patients with multiple myeloma. Revlimid-dex has been shown to be effective in both newly diagnosed myeloma and in disease that has relapsed or become refractory to current therapies.
Revlimid has also been shown to extend remission and survival time when used as maintenance therapy following high-dose chemotherapy and stem cell transplantation.
Further, Revlimid is also being studied in combination with other myeloma drugs as well as other new drugs in development.
What types of patients can benefit from Revlimid-dex?
Revlimid-dex has been shown to be effective in a wide range of patients including:
- Newly diagnosed/untreated myeloma and relapsed or refractory myeloma
- Older patients (>65 years old) as well as younger patients
- Patients whose disease has certain high-risk features
- Patients who previously received Thalomid® (thalidomide, Celgene), although efficacy is slightly reduced
- Patients who have received several prior therapies (heavily-pretreated)
- One study showed that some of these patients responded for a long period of time (4 or more years)
- Patients who previously received high dose chemotherapy and stem-cell transplant
- Patients with reduced kidney function (renal impairment)
- In one study, 78% of patients with moderate to severe renal impairment showed improved renal function within 4 months of treatment.
How does Revlimid work?
Revlimid works in multiple ways to slow or kill myeloma cells, although the exact way in which it works is not completely understood. It directly affects the tumor cells. It is also known to affect the blood vessels and other substances surrounding a tumor (known as the tumor microenvironment) which help to feed the cancer cell’s growth.
Recently it has been shown in studies the Multiple Myeloma Research Consortium (MMRC) helped to fund that Revlimid and other IMiDs bind a protein in myeloma cells called cereblon. This binding triggers myeloma cell death. In some studies higher levels of cereblon are associated with better outcomes after treatment.
Never use Revlimid if you are pregnant. Even one dose of lenalidomide can cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking this medicine at the time of conception or during pregnancy.
Use birth control to prevent pregnancy, whether you are a man or a woman. For women: Use two forms of birth control beginning 4 weeks before you start taking Revlimid and ending 4 weeks after you stop taking it. For men: Use a condom to prevent pregnancy during your treatment, and for up to 4 weeks after your treatment ends.
Revlimid may cause blood clots. Stop using this medicine and call your doctor at once if you have symptoms such as sudden numbness, severe headache, problems with vision or speech, chest pain, shortness of breath, coughing up blood, or swelling in your arm or leg.
Revlimid can lower blood cells that help your body fight infections and help your blood to clot. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, chills, body aches). You will need frequent blood tests while you are taking Revlimid.
What are Revlimid side effects?
Revlimid® (lenalidomide, Celgene) can have a variety of side effects depending on the patient’s health history as well as the stage of their multiple myeloma. Most side effects of Revlimid-dex can be managed.
The most common side effects of Revlimid-dex seen in large clinical studies are:
- Gastrointestinal effects (diarrhea, constipation, or nausea)
- Fatigue or loss of strength
- Low red blood cell or white blood cell counts
- Swelling in the arms and legs (peripheral edema)
- Muscle cramps
- Back pain
The most common severe side effects of Revlimid-dex seen in large clinical studies are:
- Low white blood cell, red blood cell, or platelet counts
- Blood clots
Due to the possibility of low blood counts, patients taking Revlimid-dex will have their blood counts checked weekly during the first 2 cycles, every other week during cycle 3, and monthly afterward.
Because Revlimid-dex can increase the risk of blood clots in the legs and lungs, patients taking Revlimid-dex also receive a blood thinner (anticoagulant) such as aspirin or heparin. The choice of agent will be tailored to the patient based on their individual risk factors.
Other serious side effects that have been seen with Revlimid-dex include heart attack and stroke, liver failure, and allergic reactions, including severe skin reactions.
Women who are pregnant or who plan to become pregnant must not take Revlimid. This precaution is due to its similarity to Thalomid (thalidomide, Celgene), and some signs of birth defects in animals. A program called RevlimidREMSTM has been created to prevent exposure to Revlimid during pregnancy. Patients must register and meet all the conditions of the program in order to take Revlimid.
How are side effects of Revlimid-dex managed?
Management of side effects depends on the type and severity of the problem. Some side effects such as mild or moderate diarrhea can be managed with additional medications.
More serious side effects may require you to stop Revlimid-dex either temporarily or permanently. In many cases, Revlimid-dex is stopped temporarily, until the side effect improves, and then re-started at a lower dose. Studies have shown that Revlimid-dex is still effective at lower doses.
Does Revlimid cause second cancers?
There have been reports of new second cancers (also called second primary malignancies or SPMs) developing in a small number of myeloma patients who received Revlimid therapy in clinical studies. In all of these studies Revlimid was used in combination with melphalan chemotherapy. The types of second cancers seen include MDS (myelodysplastic syndrome, a form of preleukemia) and AML (acute myelogenous leukemia).
There have been very few additional second cancers in other studies with Revlimid where melphalan was not part of the treatment. Overall, the information available to date indicates that therapy with Revlimid significantly decreases the risk of myeloma disease progression. Hence, some doctors believe that the benefits of Revlimid therapy may outweigh any potential risk of second cancers.
What are the possible side effects of lenalidomide (Revlimid)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
Call your doctor at once if you have any of these serious side effects:
- chest pain, sudden shortness of breath, coughing up blood;
- pain or swelling in your arm, thigh, or calf;
- easy bruising, unusual bleeding or weakness;
- fever, chills, body aches, flu symptoms;
- lower back pain, blood in your…
heck with your doctor immediately if any of the following side effects occur while taking lenalidomide:
- Black, tarry stools
- bleeding gums
- blood in the urine or stools
- chest pain
- decreased urine
- difficult or labored breathing
- dry mouth
- increased thirst
- irregular heartbeat
- loss of appetite
- lower back or side pain
- mood changes
- muscle pain or cramps
- nausea or vomiting
- numbness or tingling in the hands, feet, or lips
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swollen glands
- tightness in the chest
- unusual bleeding or bruising
- unusual tiredness or weakness
- Chest discomfort
- difficulty with speaking
- double vision
- inability to move the arms, legs, or facial muscles
- inability to speak
- pain or discomfort in the arms, jaw, back or neck
- slow speech
Incidence not known
- blistering, peeling, or loosening of the skin
- clay-colored stools
- dark-colored urine
- depressed mood
- difficulty having a bowel movement (stool)
- dizziness or lightheadedness
- dry skin and hair
- fast heartbeat
- feeling cold
- general feeling of tiredness or weakness
- hair loss
- hoarseness or husky voice
- itching or rash
- joint pain, stiffness, or swelling
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- muscle cramps and stiffness
- pain, redness, or swelling in the arm or leg
- red skin lesions, often with a purple center
- red, irritated eyes
- sensitivity to heat
- slowed heartbeat
- stomach pain, continuing
- sudden shortness of breath or troubled breathing
- swelling of the feet or lower legs
- trouble sleeping
- unpleasant breath odor
- vomiting of blood
- weight gain or loss
- yellow eyes or skin
REVLIMID is a thalidomide analogue and is contraindicated for use during pregnancy. Thalidomide is a known human teratogen that causes life-threatening human birth defects or embryo-fetal death [see Use In Specific Populations]. An embryo-fetal development study in monkeys indicates that lenalidomide produced malformations in the offspring of female monkeys who received the drug during pregnancy, similar to birth defects observed in humans following exposure to thalidomide during pregnancy.
Females Of Reproductive Potential
Females of reproductive potential must avoid pregnancy for at least 4 weeks before beginning REVLIMID therapy, during therapy, during dose interruptions and for at least 4 weeks after completing therapy.
Females must commit either to abstain continuously from heterosexual sexual intercourse or to use two methods of reliable birth control, beginning 4 weeks prior to initiating treatment with REVLIMID, during therapy, during dose interruptions and continuing for 4 weeks following discontinuation of REVLIMID therapy.
Two negative pregnancy tests must be obtained prior to initiating therapy. The first test should be performed within 10-14 days and the second test within 24 hours prior to prescribing REVLIMID therapy and then weekly during the first month, then monthly thereafter in females with regular menstrual cycles or every 2 weeks in females with irregular menstrual cycles [see Use In Specific Populations].
Lenalidomide is present in the semen of patients receiving the drug. Therefore, males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking REVLIMID and for up to 4 weeks after discontinuing REVLIMID, even if they have undergone a successful vasectomy. Male patients taking REVLIMID must not donate sperm [see Use In Specific Populations].
Patients must not donate blood during treatment with REVLIMID and for 4 weeks following discontinuation of the drug because the blood might be given to a pregnant female patient whose fetus must not be exposed to REVLIMID.
Revlimid Rems Program
Because of the embryo-fetal risk [see Embryo-Fetal Toxicity], REVLIMID is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS), the REVLIMID REMS program.
Required components of the Revlimid Rems program include the following:
- Prescribers must be certified with the REVLIMID REMS program by enrolling and complying with the REMS requirements.
- Patients must sign a Patient-Physician agreement form and comply with the REMS requirements. In particular, female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements [see Use In Specific Populations] and males must comply with contraception requirements [see Use In Specific Populations].
- Pharmacies must be certified with the REVLIMID REMS program, must only dispense to patients who are authorized to receive REVLIMID and comply with REMS requirements.
When digoxin was co-administered with multiple doses of REVLIMID (10 mg/day) the digoxin Cmax and AUCinf were increased by 14%. Periodic monitoring of digoxin plasma levels, in accordance with clinical judgment and based on standard clinical practice in patients receiving this medication, is recommended during administration of REVLIMID.
Concomitant Therapies That May Increase The Risk Of Thrombosis
Erythropoietic agents, or other agents that may increase the risk of thrombosis, such as estrogen containing therapies, should be used with caution after making a benefit-risk assessment in patients receiving.
Co-administration of multiple doses of REVLIMID (10 mg/day) with a single dose of warfarin (25 mg) had no effect on the pharmacokinetics of lenalidomide or R- and S-warfarin. Expected changes in laboratory assessments of PT and INR were observed after warfarin administration, but these changes were not affected by concomitant REVLIMID administration. It is not known whether there is an interaction between dexamethasone and warfarin. Close monitoring of PT and INR is recommended in patients with MM taking concomitant warfarin.
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