Site Map | Prescribing Information | Patient Medication Guide | Contact Us
Revlimid
Resize TextIncrease Text SizeDecrease Text Size
HomeWhat is RevlimidRevAssistImportant Risk InformationHow To Take Revlimid Understanding Side EffectsPatient Support CoordinatorAbout MDS Patient Medication Guide

Learn More
Link to MM Site
Link to HCP Site

How to Take REVLIMID®

REVLIMID® dosing
What you should avoid while taking REVLIMID®
How should I store and handle REVLIMID®?

REVLIMID® must be taken in accordance with the RevAssist® program and you must agree to comply with the requirements of the RevAssist® program.

Take REVLIMID® (lenalidomide) exactly as prescribed by your healthcare professional.

REVLIMID® may cause birth defects or death to an unborn baby if taken during pregnancy. Do not take REVLIMID® if you are pregnant or plan on becoming pregnant.

Female patients must not get pregnant.
Female patients who are pregnant or who plan to become pregnant must not take REVLIMID®. Female patients who can get pregnant will get regular pregnancy testing. Female patients who can become pregnant must agree to use 2 separate forms of effective birth control at the same time, 4 weeks before, while taking, and for 4 weeks after stopping REVLIMID®.

It is not known if REVLIMID® passes into semen.
Male patients, including those who have had a vasectomy, must use a latex condom during any sexual contact with a pregnant female or a female that can become pregnant while taking REVLIMID® and for 4 weeks after stopping REVLIMID®.

If you get pregnant while taking REVLIMID®, stop taking it right away and call your healthcare professional. Female partners of males taking REVLIMID® should call their healthcare professional right away if they get pregnant. Healthcare professionals and patients should report all cases of pregnancy to:
  • FDA MedWatch at 1-800-FDA-1088, and
  • Celgene Corporation at 1-888-423-5436

REVLIMID® dosing

You will only get a 28-day supply of REVLIMID® at one time. This is to make sure you follow the RevAssist® program.

5mg 10mg 16mg 25mg
(Not Actual Size) (Not Actual Size) (Not Actual Size) (Not Actual Size)

REVLIMID® comes in 4 capsule strengths: 5 mg, 10 mg, 15 mg, and
25 mg.

Always take your medicine exactly as directed by your healthcare professional.

  • REVLIMID® is taken once a day, every day, for 21 days; you will then take a break for 7 days before starting again.
  • Swallow REVLIMID® capsules whole with water once a day.
  • Do not break, chew, or open your capsules.
  • REVLIMID® may be taken with or without food.
  • If you miss a dose of REVLIMID®, take it as soon as you remember, if you remember on the day you missed the dose.
  • If you miss taking your dose for the entire day, go back to taking your regular dose the next day. Do not take 2 doses at the same time.
  • If you take too much REVLIMID®, or overdose, call your healthcare professional or poison control center right away.
  • Talk to your healthcare professional if you have questions about taking REVLIMID®.

Your healthcare professional will schedule regular blood tests while you’re taking REVLIMID®. Your healthcare professional may adjust your dose of REVLIMID® or interrupt your treatment based on the results of your blood tests and on your general condition.

What you should avoid while taking REVLIMID®

  • DO NOT get pregnant while taking REVLIMID® and for 4 weeks after stopping REVLIMID®.
    • Female patients who can get pregnant will get regular pregnancy testing.
      • Get a pregnancy test weekly for 4 weeks.
      • Thereafter, the patient must have a pregnancy test every 4 weeks if she has a regular menstrual cycle or every 2 weeks if her cycles are irregular.
    • Female patients who can become pregnant must agree to use 2 separate forms of effective birth control at the same time, 4 weeks before, while taking, and for 4 weeks after stopping REVLIMID®.
    • Male patients, even those who have had a vasectomy, must agree to use a latex condom during sexual contact with a pregnant female or a female who can become pregnant. This is required during REVLIMID® treatment and for 4 weeks after stopping therapy.
  • REVLIMID® is only for you. DO NOT share REVLIMID® with other people. It may cause birth defects and other serious problems.
  • DO NOT give blood while you take REVLIMID® and for 4 weeks after stopping REVLIMID®. If someone who is pregnant gets your donated blood, her baby may be exposed to REVLIMID® and may be born with birth defects.
  • Male patients should NOT donate sperm while taking REVLIMID® and for 4 weeks after stopping REVLIMID®. If a female who is trying to become pregnant gets your sperm, her baby may be exposed to REVLIMID® and may be born with
    birth defects.

How should I store and handle REVLIMID®?

  • Use REVLIMID® only as prescribed by your healthcare professional.
  • REVLIMID® should be stored at room temperature, about 77°F (25°C), and within a range of 59°-86°F (15°-30°C).
  • As with all medicines, REVLIMID® should be kept out of the reach of children.
  • Do not break, chew, or open your capsules.
  • REVLIMID® is only for you. Do not share REVLIMID® with other people. It may cause birth defects and other serious problems.

REVLIMID® (lenalidomide) in combination with dexamethasone is indicated for the treatment of multiple myeloma patients who have received at least one prior therapy.
REVLIMID® (lenalidomide) is indicated for patients with transfusion-dependent anemia due to Low- or Intermediate-1–risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

Important Safety Information


REVLIMID® (lenalidomide) in combination with dexamethasone is indicated for the treatment of multiple myeloma patients who have received at least one prior therapy.
REVLIMID® (lenalidomide) is indicated for patients with transfusion-dependent anemia due to Low- or Intermediate-1–risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

Important Safety Information


ADDITIONAL WARNINGS: HEMATOLOGIC TOXICITY

Multiple Myeloma
  • In the pooled multiple myeloma studies, Grade 3 and 4 hematologic toxicities were more frequent in patients treated with the combination of REVLIMID® (lenalidomide) and dexamethasone than in patients treated with dexamethasone alone

  • Patients on therapy should have their complete blood counts monitored every 2 weeks for the first 12 weeks and then monthly thereafter

  • Patients may require dose interruption and/or dose reduction
    •

CONTRAINDICATIONS:

Pregnancy Category X:
  • Lenalidomide is contraindicated in pregnant women and women capable of becoming pregnant. When there is no alternative, females of childbearing potential may be treated with lenalidomide provided adequate precautions are taken to avoid pregnancy

Hypersensitivity:
  • REVLIMID® (lenalidomide) is contraindicated in any patients who have demonstrated hypersensitivity to the drug or its components
PRECAUTIONS:

Angioedema, Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis:
  • Angioedema and serious dermatologic reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported. These events can be fatal. Patients with a prior history of Grade 4 rash associated with thalidomide treatment should not receive REVLIMID® (lenalidomide). REVLIMID® (lenalidomide) interruption or discontinuation should be considered for Grade 2-3 skin rash. REVLIMID® (lenalidomide) must be discontinued for angioedema, Grade 4 rash, exfoliative or bullous rash, or if SJS or TEN is suspected, and should not be resumed following discontinuation for these reactions

Tumor Lysis Syndrome:
  • Lenalidomide has antineoplastic activity and therefore the complications of tumor lysis syndrome may occur. The patients at risk of tumor lysis syndrome are those with high tumor burden prior to treatment. These patients should be monitored closely and appropriate precautions taken

Renal impairment:
  • Since lenalidomide is primarily excreted unchanged by the kidney, adjustments to the starting dose of REVLIMID® (lenalidomide) are recommended to provide appropriate drug exposure in patients with moderate or severe (CLcr < 60 mL/min) renal impairment and in patients on dialysis

  • Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it would be prudent to monitor renal function

Nursing mothers: It is not known whether REVLIMID® (lenalidomide) is excreted in human milk.
  • Because of the potential for adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother
ADVERSE REACTIONS:

Multiple Myeloma
  • In the REVLIMID® (lenalidomide)/dexamethasone treatment group, 151 patients (45%) underwent at least one dose interruption with or without a dose reduction of REVLIMID® (lenalidomide) compared to 21% in the placebo/dexamethasone treatment group

  • Of these patients who had one dose interruption with or without a dose reduction, 50% in the REVLIMID® (lenalidomide)/dexamethasone treatment group underwent at least one additional dose interruption with or without a dose reduction compared to 21% in the placebo/dexamethasone treatment group

  • Most adverse events and Grade 3/4 adverse events were more frequent in MM patients who received the combination of REVLIMID® (lenalidomide)/dexamethasone compared to placebo/dexamethasone
Other adverse events reported in multiple myeloma patients (REVLIMID® (lenalidomide)/dexamethasone vs dexamethasone/placebo): constipation (39% vs 19%), fatigue (38% vs 37%), insomnia (32% vs 37%), muscle cramp (30% vs 21%), diarrhea (29% vs 25%), neutropenia (28% vs 5%), anemia (24% vs 17%), asthenia (23% vs 25%), pyrexia (23% vs 19%), nausea (22% vs 19%), headache (21% vs 21%), peripheral edema (21% vs 19%), dizziness (21% vs 15%), dyspnea (20% vs 15%), tremor (20% vs 7%), decreased weight (18% vs 14%), thrombocytopenia (17% vs 10%), rash (16% vs 8%), back pain (15% vs 14%), hyperglycemia (15% vs 14%), and muscle weakness (15% vs 15%).

Myelodysplastic Syndromes
  • Thrombocytopenia (61.5%; 91/148) and neutropenia (58.8%; 87/148) were the most frequently reported adverse events observed in the del 5q MDS population

Other adverse reactions reported in del 5q MDS patients (REVLIMID® (lenalidomide)): diarrhea (49%), pruritus (42%), rash (36%), fatigue (31%), constipation (24%), nausea (24%), nasopharyngitis (23%), arthralgia (22%), pyrexia (21%), back pain (21%), peripheral edema (20%), cough (20%), dizziness (20%), headache (20%), muscle cramp (18%), dyspnea (17%), and pharyngitis (16%).

DOSAGE AND ADMINISTRATION:
  • Dosing is continued or modified based upon clinical and laboratory findings. Dosing modifications are recommended to manage Grade 3 or 4 neutropenia or thrombocytopenia or other Grade 3 or 4 toxicity judged to be related to REVLIMID® (lenalidomide)

  • For other Grade 3 or 4 toxicities judged to be related to REVLIMID® (lenalidomide), hold treatment and restart at next lower dose level when toxicity has resolved to less than or equal to Grade 2
Please see full Prescribing Information, including Boxed WARNINGS, CONTRAINDICATIONS, PRECAUTIONS, and ADVERSE REACTIONS.
www.Celgene.com
Celgene Patient Support® is a registered trademark
of Celgene Corporation.
© 2010 Celgene Corporation, www.celgene.com .
This website is intended for residents of the United States only.
Privacy Policy| Terms of Use
  Important Safety Information RevAssist
Medwatch