Lenalidomide: Difference between revisions
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|genericName=Lenalidomide | |genericName=Lenalidomide | ||
|aOrAn=a | |aOrAn=a | ||
|drugClass=Immune Modulator | |drugClass= Immune Modulator | ||
|indicationType=treatment | |indicationType=treatment | ||
|indication=Multiple myeloma(MM), Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS), Mantle cell lymphoma (MCL) | |indication=Multiple myeloma(MM), Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS), Mantle cell lymphoma (MCL) | ||
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=======Other Grade 3 / 4 Toxicities 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. | * 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=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients. | |||
|offLabelAdultGuideSupport= | |||
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients. | |||
<!--Non–Guideline-Supported Use (Adult)--> | <!--Non–Guideline-Supported Use (Adult)--> | ||
|offLabelAdultNoGuideSupport====== | |offLabelAdultNoGuideSupport=* Chronic lymphoid leukemia, Relapsed or refractory<ref name="pmid18334676">{{cite journal| author=Ferrajoli A, Lee BN, Schlette EJ, O'Brien SM, Gao H, Wen S et al.| title=Lenalidomide induces complete and partial remissions in patients with relapsed and refractory chronic lymphocytic leukemia. | journal=Blood | year= 2008 | volume= 111 | issue= 11 | pages= 5291-7 | pmid=18334676 | doi=10.1182/blood-2007-12-130120 | pmc=PMC4082321 | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=18334676 }} </ref><ref name="pmid17088571">{{cite journal| author=Chanan-Khan A, Miller KC, Musial L, Lawrence D, Padmanabhan S, Takeshita K et al.| title=Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia: results of a phase II study. | journal=J Clin Oncol | year= 2006 | volume= 24 | issue= 34 | pages= 5343-9 | pmid=17088571 | doi=10.1200/JCO.2005.05.0401 | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=17088571 }} </ref> | ||
* Multiple myeloma, In combination with dexamethasone, first-line therapy<ref name="pmid20876454">{{cite journal| author=Zonder JA, Crowley J, Hussein MA, Bolejack V, Moore DF, Whittenberger BF et al.| title=Lenalidomide and high-dose dexamethasone compared with dexamethasone as initial therapy for multiple myeloma: a randomized Southwest Oncology Group trial (S0232). | journal=Blood | year= 2010 | volume= 116 | issue= 26 | pages= 5838-41 | pmid=20876454 | doi=10.1182/blood-2010-08-303487 | pmc=PMC3031379 | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=20876454 }} </ref><ref name="pmid25184863">{{cite journal| author=Benboubker L, Dimopoulos MA, Dispenzieri A, Catalano J, Belch AR, Cavo M et al.| title=Lenalidomide and dexamethasone in transplant-ineligible patients with myeloma. | journal=N Engl J Med | year= 2014 | volume= 371 | issue= 10 | pages= 906-17 | pmid=25184863 | doi=10.1056/NEJMoa1402551 | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=25184863 }} </ref> | |||
* Myelofibrosis<ref name="pmid21622644">{{cite journal| author=Jabbour E, Thomas D, Kantarjian H, Zhou L, Pierce S, Cortes J et al.| title=Comparison of thalidomide and lenalidomide as therapy for myelofibrosis. | journal=Blood | year= 2011 | volume= 118 | issue= 4 | pages= 899-902 | pmid=21622644 | doi=10.1182/blood-2010-12-325589 | pmc=PMC4186644 | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=21622644 }} </ref> | |||
* Non-Hodgkin's lymphoma, Aggressive disease, relapsed or refractory<ref name="pmid18606983">{{cite journal| author=Wiernik PH, Lossos IS, Tuscano JM, Justice G, Vose JM, Cole CE et al.| title=Lenalidomide monotherapy in relapsed or refractory aggressive non-Hodgkin's lymphoma. | journal=J Clin Oncol | year= 2008 | volume= 26 | issue= 30 | pages= 4952-7 | pmid=18606983 | doi=10.1200/JCO.2007.15.3429 | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=18606983 }} </ref> | |||
: | |fdaLIADPed=There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients. | ||
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There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients. | |||
<!--Off-Label Use and Dosage (Pediatric)--> | <!--Off-Label Use and Dosage (Pediatric)--> | ||
<!--Guideline-Supported Use (Pediatric)--> | <!--Guideline-Supported Use (Pediatric)--> | ||
|offLabelPedGuideSupport= | |offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | ||
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | |||
<!--Non–Guideline-Supported Use (Pediatric)--> | <!--Non–Guideline-Supported Use (Pediatric)--> | ||
|offLabelPedNoGuideSupport= | |offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | ||
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | |||
<!--Contraindications--> | <!--Contraindications--> |
Revision as of 16:36, 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]
Disclaimer
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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
There is limited information regarding Off-Label Guideline-Supported Use of Lenalidomide in adult patients.
Non–Guideline-Supported Use
- Chronic lymphoid leukemia, Relapsed or refractory[1][2]
- Multiple myeloma, In combination with dexamethasone, first-line therapy[3][4]
- Myelofibrosis[5]
- Non-Hodgkin's lymphoma, Aggressive disease, relapsed or refractory[6]
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Lenalidomide in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Lenalidomide in pediatric patients.
Non–Guideline-Supported Use
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
- ®[7]
Look-Alike Drug Names
- A® — B®[8]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
- ↑ Ferrajoli A, Lee BN, Schlette EJ, O'Brien SM, Gao H, Wen S; et al. (2008). "Lenalidomide induces complete and partial remissions in patients with relapsed and refractory chronic lymphocytic leukemia". Blood. 111 (11): 5291–7. doi:10.1182/blood-2007-12-130120. PMC 4082321. PMID 18334676.
- ↑ Chanan-Khan A, Miller KC, Musial L, Lawrence D, Padmanabhan S, Takeshita K; et al. (2006). "Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia: results of a phase II study". J Clin Oncol. 24 (34): 5343–9. doi:10.1200/JCO.2005.05.0401. PMID 17088571.
- ↑ Zonder JA, Crowley J, Hussein MA, Bolejack V, Moore DF, Whittenberger BF; et al. (2010). "Lenalidomide and high-dose dexamethasone compared with dexamethasone as initial therapy for multiple myeloma: a randomized Southwest Oncology Group trial (S0232)". Blood. 116 (26): 5838–41. doi:10.1182/blood-2010-08-303487. PMC 3031379. PMID 20876454.
- ↑ Benboubker L, Dimopoulos MA, Dispenzieri A, Catalano J, Belch AR, Cavo M; et al. (2014). "Lenalidomide and dexamethasone in transplant-ineligible patients with myeloma". N Engl J Med. 371 (10): 906–17. doi:10.1056/NEJMoa1402551. PMID 25184863.
- ↑ Jabbour E, Thomas D, Kantarjian H, Zhou L, Pierce S, Cortes J; et al. (2011). "Comparison of thalidomide and lenalidomide as therapy for myelofibrosis". Blood. 118 (4): 899–902. doi:10.1182/blood-2010-12-325589. PMC 4186644. PMID 21622644.
- ↑ Wiernik PH, Lossos IS, Tuscano JM, Justice G, Vose JM, Cole CE; et al. (2008). "Lenalidomide monotherapy in relapsed or refractory aggressive non-Hodgkin's lymphoma". J Clin Oncol. 26 (30): 4952–7. doi:10.1200/JCO.2007.15.3429. PMID 18606983.
- ↑ Empty citation (help)
- ↑ "http://www.ismp.org". External link in
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