Lenalidomide: Difference between revisions
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{{DrugProjectFormSinglePage | {{DrugProjectFormSinglePage | ||
|authorTag={{RB}} | |authorTag={{RB}} | ||
|genericName=Lenalidomide | |||
|aOrAn=a | |aOrAn=a | ||
|drugClass= Immune Modulator | |||
|indicationType=treatment | |||
|indication=Multiple myeloma(MM), Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS), Mantle cell lymphoma (MCL) | |||
|hasBlackBoxWarning=Yes | |hasBlackBoxWarning=Yes | ||
|adverseReactions= | |adverseReactions=fatigue, neutropenia, constipation, diarrhea, muscle cramp, anemia, pyrexia, peripheral edema, nausea, back pain, upper respiratory tract infection, dyspnea, dizziness, thrombocytopenia, tremor and rash | ||
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span> | |blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span> | ||
|blackBoxWarningBody= | |blackBoxWarningBody=====EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, AND VENOUS AND ARTERIAL THROMBOEMBOLISM==== | ||
=====Embryo-Fetal Toxicity===== | |||
* | * Do not use REVLIMID during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting REVLIMID® treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after REVLIMID treatment, and Medication Guide. To avoid embryo-fetal exposure to lenalidomide, REVLIMID is only available through a restricted distribution program, the REVLIMID REMS™ program (formerly known as the “RevAssist®” program). | ||
Information about the REVLIMID REMS™ program is available at www.celgeneriskmanagement.com or by calling the manufacturer’s toll-free number 1-888-423-5436. | |||
=====Hematologic Toxicity (Neutropenia and Thrombocytopenia)===== | |||
* REVLIMID can cause significant neutropenia and thrombocytopenia. Eighty percent of patients with del 5q myelodysplastic syndromes had to have a dose delay/reduction during the major study. Thirty-four percent of patients had to have a second dose delay/reduction. Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled in the study. Patients on therapy for del 5q myelodysplastic syndromes should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or reduction. Patients may require use of blood product support and/or growth factors. | |||
=====Venous and Arterial Thromboembolism===== | |||
|fdaLIADAdult====== | * REVLIMID has demonstrated a significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as risk of myocardial infarction and stroke in patients with multiple myeloma who were treated with REVLIMID and dexamethasone therapy. Monitor for and advise patients about signs and symptoms of thromboembolism. Advise patients to seek immediate medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. Thromboprophylaxis is recommended and the choice of regimen should be based on an assessment of the patient’s underlying risks. | ||
|fdaLIADAdult=====Indications==== | |||
* | =====Multiple Myeloma===== | ||
* REVLIMID in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma (MM) who have received at least one prior therapy. | |||
=====Myelodysplastic Syndromes===== | |||
* REVLIMID is indicated for the treatment of 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. | |||
===== | =====Mantle Cell Lymphoma===== | ||
* REVLIMID is indicated for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. | |||
* | =====Limitations of Use===== | ||
* REVLIMID is not indicated and is not recommended for the treatment of patients with CLL outside of controlled clinical trials | |||
====Dosage==== | |||
=====Multiple Myeloma===== | |||
===== | * The recommended starting dose of REVLIMID is 25 mg once daily on Days 1-21 of repeated 28-day cycles. The recommended dose of dexamethasone is 40 mg once daily on Days 1-4, 9-12, and 17-20 of each 28-day cycle for the first 4 cycles of therapy and then 40 mg once daily orally on Days 1-4 every 28 days. Treatment is continued or modified based upon clinical and laboratory findings. | ||
======Dose Adjustments for Hematologic Toxicities During Multiple Myeloma Treatment====== | |||
* | * Dose modification guidelines, as summarized below, are recommended to manage Grade 3 or 4 neutropenia or thrombocytopenia or other Grade 3 or 4 toxicity judged to be related to REVLIMID. | ||
=======Platelet counts======= | |||
=======Thrombocytopenia in MM======= | |||
: [[File:Lenalidomide Dose Adjustment.png|none|500px]] | |||
===== | =======Absolute Neutrophil counts (ANC)======= | ||
=======Neutropenia in MM======= | |||
: [[File:Lenalidomide Dose adjustment 2.png|none|500px]] | |||
=======Other Grade 3 / 4 Toxicities in MM======= | |||
: | * For other Grade 3/4 toxicities judged to be related to REVLIMID, hold treatment and restart at the physician's discretion at next lower dose level when toxicity has resolved to ≤ Grade 2. | ||
|offLabelAdultGuideSupport======Condition1===== | |offLabelAdultGuideSupport======Condition1===== | ||
Revision as of 14:45, 19 January 2015
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]
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Black Box Warning
ConditionName:
See full prescribing information for complete Boxed Warning.
====EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, AND VENOUS AND ARTERIAL THROMBOEMBOLISM====
Embryo-Fetal Toxicity
Information about the REVLIMID REMS™ program is available at www.celgeneriskmanagement.com or by calling the manufacturer’s toll-free number 1-888-423-5436. Hematologic Toxicity (Neutropenia and Thrombocytopenia)
Venous and Arterial Thromboembolism
|
Overview
Lenalidomide is a Immune Modulator that is FDA approved for the treatment of Multiple myeloma(MM), Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS), Mantle cell lymphoma (MCL). There is a Black Box Warning for this drug as shown here. Common adverse reactions include fatigue, neutropenia, constipation, diarrhea, muscle cramp, anemia, pyrexia, peripheral edema, nausea, back pain, upper respiratory tract infection, dyspnea, dizziness, thrombocytopenia, tremor and rash.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
Multiple Myeloma
- REVLIMID in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma (MM) who have received at least one prior therapy.
Myelodysplastic Syndromes
- REVLIMID is indicated for the treatment of 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.
Mantle Cell Lymphoma
- REVLIMID is indicated for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
Limitations of Use
- REVLIMID is not indicated and is not recommended for the treatment of patients with CLL outside of controlled clinical trials
Dosage
Multiple Myeloma
- The recommended starting dose of REVLIMID is 25 mg once daily on Days 1-21 of repeated 28-day cycles. The recommended dose of dexamethasone is 40 mg once daily on Days 1-4, 9-12, and 17-20 of each 28-day cycle for the first 4 cycles of therapy and then 40 mg once daily orally on Days 1-4 every 28 days. Treatment is continued or modified based upon clinical and laboratory findings.
Dose Adjustments for Hematologic Toxicities During Multiple Myeloma Treatment
- Dose modification guidelines, as summarized below, are recommended to manage Grade 3 or 4 neutropenia or thrombocytopenia or other Grade 3 or 4 toxicity judged to be related to REVLIMID.
=Platelet counts=
=Thrombocytopenia in MM=
=Absolute Neutrophil counts (ANC)=
=Neutropenia in MM=
=Other Grade 3 / 4 Toxicities in MM=
- For other Grade 3/4 toxicities judged to be related to REVLIMID, hold treatment and restart at the physician's discretion at next lower dose level when toxicity has resolved to ≤ Grade 2.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1
- Developed by:
- Class of Recommendation:
- Strength of Evidence:
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Lenalidomide in adult patients.
Non–Guideline-Supported Use
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Lenalidomide in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Lenalidomide in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
- Developed by:
- Class of Recommendation:
- Strength of Evidence:
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Lenalidomide in pediatric patients.
Non–Guideline-Supported Use
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Lenalidomide in pediatric patients.
Contraindications
- Condition1
Warnings
ConditionName:
See full prescribing information for complete Boxed Warning.
====EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, AND VENOUS AND ARTERIAL THROMBOEMBOLISM====
Embryo-Fetal Toxicity
Information about the REVLIMID REMS™ program is available at www.celgeneriskmanagement.com or by calling the manufacturer’s toll-free number 1-888-423-5436. Hematologic Toxicity (Neutropenia and Thrombocytopenia)
Venous and Arterial Thromboembolism
|
- Description
Precautions
- Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Lenalidomide in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Lenalidomide in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Drug Interactions
- Drug
- Description
Use in Specific Populations
Pregnancy
- Pregnancy Category
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Lenalidomide in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Lenalidomide during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Lenalidomide with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Lenalidomide with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Lenalidomide with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Lenalidomide with respect to specific gender populations.
Race
There is no FDA guidance on the use of Lenalidomide with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Lenalidomide in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Lenalidomide in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Lenalidomide in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Lenalidomide in patients who are immunocompromised.
Administration and Monitoring
Administration
- Oral
- Intravenous
Monitoring
There is limited information regarding Monitoring of Lenalidomide in the drug label.
- Description
IV Compatibility
There is limited information regarding IV Compatibility of Lenalidomide in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
- Description
Management
- Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Lenalidomide in the drug label.
Pharmacology
There is limited information regarding Lenalidomide Pharmacology in the drug label.
Mechanism of Action
Structure
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Lenalidomide in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Lenalidomide in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Lenalidomide in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Lenalidomide in the drug label.
How Supplied
Storage
There is limited information regarding Lenalidomide Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Lenalidomide |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Lenalidomide |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Patient Counseling Information of Lenalidomide in the drug label.
Precautions with Alcohol
- Alcohol-Lenalidomide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- ®[1]
Look-Alike Drug Names
- A® — B®[2]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
- ↑ Empty citation (help)
- ↑ "http://www.ismp.org". External link in
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(help)
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