Carfilzomib: Difference between revisions

Jump to navigation Jump to search
VisualWikitext
(Created page with "__NOTOC__ {{chembox | UNII_Ref = {{fdacite|correct|FDA}} | UNII = 72X6E3J5AR | verifiedrevid = 437155960 | ImageFile = Carfilzomib.svg | ImageSize = 200px | ImageAlt = | IUP...")
 
No edit summary
Line 1: Line 1:
__NOTOC__
{{DrugProjectFormSinglePage
{{chembox
|authorTag=
| UNII_Ref = {{fdacite|correct|FDA}}
 
| UNII = 72X6E3J5AR
{{VP}}
| verifiedrevid = 437155960
 
| ImageFile = Carfilzomib.svg
<!--Overview-->
| ImageSize = 200px
 
| ImageAlt =
|genericName=
| IUPACName = (''S'')-4-Methyl-''N''-((''S'')-1-(((''S'')-4-methyl-1-((''R'')-2-methyloxiran-2-yl)-1-oxopentan-2-yl)amino)-1-oxo-3-phenylpropan-2-yl)-2-((''S'')-2-(2-morpholinoacetamido)-4-phenylbutanamido)pentanamide
 
| IUPACName_hidden = yes
 
| OtherNames = PX-171-007
 
| Section1 = {{Chembox Identifiers
|aOrAn=
|  CASNo = 868540-17-4
 
| PubChem =
a
| ChEBI_Ref = {{ebicite|correct|EBI}}
 
| ChEBI = 65347
|drugClass=
| ChEMBL_Ref = {{ebicite|correct|EBI}}
 
| ChEMBL = 451887
proteasome inhibitor
|  PubChem = 11556711
 
|  ChemSpiderID = 9731489
|indication=
| KEGG_Ref = {{keggcite|correct|kegg}}
 
| KEGG = D08880
[[multiple myeloma]]
|  SMILES = O=C(N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)[C@@]1(OC1)C)CC(C)C)Cc2ccccc2)CC(C)C)CCc3ccccc3)CN4CCOCC4
 
|  InChI = 1/C40H57N5O7/c1-27(2)22-32(36(47)40(5)26-52-40)42-39(50)34(24-30-14-10-7-11-15-30)44-38(49)33(23-28(3)4)43-37(48)31(17-16-29-12-8-6-9-13-29)41-35(46)25-45-18-20-51-21-19-45/h6-15,27-28,31-34H,16-26H2,1-5H3,(H,41,46)(H,42,50)(H,43,48)(H,44,49)/t31-,32-,33-,34-,40+/m0/s1
|hasBlackBoxWarning=
|  InChIKey = BLMPQMFVWMYDKT-NZTKNTHTBE
 
|  StdInChI = 1S/C40H57N5O7/c1-27(2)22-32(36(47)40(5)26-52-40)42-39(50)34(24-30-14-10-7-11-15-30)44-38(49)33(23-28(3)4)43-37(48)31(17-16-29-12-8-6-9-13-29)41-35(46)25-45-18-20-51-21-19-45/h6-15,27-28,31-34H,16-26H2,1-5H3,(H,41,46)(H,42,50)(H,43,48)(H,44,49)/t31-,32-,33-,34-,40+/m0/s1
|adverseReactions=
| StdInChIKey = BLMPQMFVWMYDKT-NZTKNTHTSA-N}}
 
| Section2 = {{Chembox Properties
[[fatigue]], [[anemia]], [[nausea]], [[thrombocytopenia]], [[dyspnea]], [[diarrhea]], and [[pyrexia]]
| C=40 | H=57 | N=5 | O=7
 
| Appearance =
<!--Black Box Warning-->
| Density =
 
| MeltingPt =
|blackBoxWarningTitle=
|  BoilingPt =
Title
|  Solubility = }}
 
| Section3 = {{Chembox Hazards
|blackBoxWarningBody=
| MainHazards =
<i><span style="color:#FF0000;">ConditionName: </span></i>
|  FlashPt =
 
| Autoignition = }}
* Content
}}
 
{{SI}}
<!--Adult Indications and Dosage-->
{{CMG}}
 
==Overview==
<!--FDA-Labeled Indications and Dosage (Adult)-->
 
|fdaLIADAdult=
 
=====Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
* Dosing Information
 
:* Dosage
 
=====Condition3=====
 
* Dosing Information
 
:* Dosage
 
=====Condition4=====
 
* Dosing Information
 
:* Dosage
 
<!--Off-Label Use and Dosage (Adult)-->
 
<!--Guideline-Supported Use (Adult)-->
 
|offLabelAdultGuideSupport=
 
=====Condition1=====
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
<!--Non–Guideline-Supported Use (Adult)-->
 
|offLabelAdultNoGuideSupport=
 
=====Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
<!--Pediatric Indications and Dosage-->
 
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
 
|fdaLIADPed=
 
=====Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Off-Label Use and Dosage (Pediatric)-->
 
<!--Guideline-Supported Use (Pediatric)-->
 
|offLabelPedGuideSupport=
 
=====Condition1=====
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Non–Guideline-Supported Use (Pediatric)-->
 
|offLabelPedNoGuideSupport=
 
=====Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Contraindications-->
 
|contraindications=
 
* Condition1
 
<!--Warnings-->
 
|warnings=
 
* Description
 
====Precautions====
 
* Description
 
<!--Adverse Reactions-->
 
<!--Clinical Trials Experience-->
 
|clinicalTrials=
 
There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} 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-->
 
|postmarketing=
 
There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} 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-->
 
|drugInteractions=
 
* Drug
:* Description
 
<!--Use in Specific Populations-->
 
|useInPregnancyFDA=
* '''Pregnancy Category'''
 
|useInPregnancyAUS=
* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
 
|useInLaborDelivery=
There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
 
|useInNursing=
There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
 
|useInPed=
There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
 
|useInGeri=
There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
 
|useInGender=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
 
|useInRace=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
 
|useInRenalImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
 
|useInHepaticImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
 
|useInReproPotential=
There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
 
|useInImmunocomp=
There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
 
<!--Administration and Monitoring-->
 
|administration=
 
* Oral
 
* Intravenous
 
|monitoring=
 
There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
 
* Description
 
<!--IV Compatibility-->
 
|IVCompat=
 
There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
 
<!--Overdosage-->
 
|overdose=
 
===Acute Overdose===
 
====Signs and Symptoms====
 
* Description
 
====Management====
 
* Description
 
===Chronic Overdose===
 
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
 
<!--Pharmacology-->
 
<!--Drug box 2-->
 
|drugBox=
 
 
 
<!--Mechanism of Action-->
 
|mechAction=
 
*
 
<!--Structure-->
 
|structure=
 
*
 
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
<!--Pharmacodynamics-->
 
|PD=
 
There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
 
<!--Pharmacokinetics-->
 
|PK=
 
There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
 
<!--Nonclinical Toxicology-->
 
|nonClinToxic=
 
There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
 
<!--Clinical Studies-->
 
|clinicalStudies=
 
There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
 
<!--How Supplied-->
 
|howSupplied=
 
*
 
<!--Patient Counseling Information-->
 
|fdaPatientInfo=
 
There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
 
<!--Precautions with Alcohol-->
 
|alcohol=
 
* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
 
<!--Brand Names-->
 
|brandNames=


'''Carfilzomib''' (CFZ) is a [[tetrapeptide]] [[epoxyketone]] and a selective [[proteasome inhibitor]].  It is an [[Structural analog|analog]] of [[epoxomicin]].<ref name=dd>[http://www.cancer.gov/drugdictionary/?CdrID=459751 Carfilzomib], NCI Drug Dictionary</ref>
* ®<ref>{{Cite web | title = | url = }}</ref>


==Discovery, early development and regulatory approval==
<!--Look-Alike Drug Names-->


Carfilzomib is derived from epoxomicin, a natural product that was shown by the laboratory of Craig Crews at Yale University to inhibit the proteasome.<ref>{{cite journal|last=Meng|first=L|coauthors=Mohan, R., Kwok, B.H., Elofsson, M., Sin, N., Crews, C.M.|title=Epoxomicin, a potent and selective proteasome inhibitor, exhibits in vivo antiinflammatory activity|journal=Proc Natl Acad Sci USA|year=1999|volume=96|issue=18|pages=10403–8|pmid=10468620}}</ref> The Crews laboratory subsequently invented a more specific derivative of epoxomicin named YU101,<ref>{{cite journal|last=Myung|first=J|coauthors=Kim, K.B., Lindsten, K., Dantuma, N.P., Crews, C.M.|title=Lack of proteasome active site allostery as revealed by subunit-specific inhibitors|journal=Mol Cell|year=2001|volume=7|issue=2|pages=411–20|pmid=11239469}}</ref> which was licensed to [[Proteolix, Inc.]]. Scientists at Proteolix modified YU101 to create carfilzomib, which they advanced to multiple Phase 1 and 2 [[clinical trials]], including a pivotal [[Phase 2 clinical trial]] designed to seek [[accelerated approval]]. Clinical trials for carfilzomib continue under [[Onyx Pharmaceuticals]], which acquired Proteolix in 2009. In January 2011, the [[fda|U.S. FDA]] granted carfilzomib [[FDA Fast Track Development Program|fast-track status]], allowing Onyx to initiate a rolling submission of its new drug application for carfilzomib.<ref>{{cite news|url= http://www.bizjournals.com/sanfrancisco/news/2011/01/31/onyx-multiple-myeloma-drug-wins.html|title=Onyx multiple myeloma drug wins FDA fast-track status|publisher=San Francisco Business Times|date=2011-01-31|accessdate=2011-09-01}}</ref> In December 2011, the FDA granted Onyx standard review designation, 
|lookAlike=
<ref name=dd1>{{cite web|url= http://www.myelomabeacon.com/news/2011/12/11/beacon-breaking-news-carfilzomib-to-get-standard-not-priority-fda-review/ | title=Beacon Breaking News – Carfilzomib to Get Standard, Not Priority, FDA Review | publisher=The Myeloma Beacon  | accessdate=2012-02-27}}</ref><ref>{{cite web|url=http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm#compare | title= Fast Track, Accelerated Approval and Priority Review; Accelerating Availability of New Drugs for Patients with Serious Diseases | publisher=FDA | accessdate=2012-02-27}}</ref> for its new drug application submission based on the 003-A1 study, an open-label, single-arm Phase 2b trial. The trial evaluated 266 heavily-pretreated patients with relapsed and refractory multiple myeloma who had received at least two prior therapies, including bortezomib and either thalidomide or [[lenalidomide]].<ref>{{cite web|http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=102&abstractID=81812 | title= PX-171-003-A1, an open-label, single-arm, phase (Ph) II study of carfilzomib (CFZ) in patients (pts) with relapsed and refractory multiple myeloma (R/R MM): Long-term follow-up and subgroup analysis | publisher=ASCO 2009 | accessdate=2012-02-27}}</ref> Carfilzomib was approved by the FDA for use in patients with relapsed and refractory multiple myeloma on 20 July 2012.<ref>{{cite web|title=FDA approves Kyprolis for some patients with multiple myeloma|url=http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312920.htm|publisher=U.S. Food and Drug Administration}}</ref>  Onyx expects to launch the drug in the U.S. on 1 August 2012.  When it launches, it will cost $10,000 per 28-day cycle, making it the most expensive FDA-approved drug for multiple myeloma.<ref>{{cite web|title=FDA Approves Kyprolis (Carfilzomib) For Relapsed And Refractory Multiple Myeloma | url=http://www.myelomabeacon.com/news/2012/07/20/fda-approves-kyprolis-carfilzomib-for-relapsed-and-refractory-multiple-myeloma/ | publisher=The Myeloma Beacon | accessdate=2012-07-20}}</ref>


==Mechanism==
* A® — B®<ref name="www.ismp.org">{{Cite web  | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>
Carfilzomib irreversibly binds to and inhibits the [[chymotrypsin]]-like activity of the [[20S proteasome]], an enzyme that degrades unwanted cellular proteins. Inhibition of proteasome-mediated proteolysis results in a build-up of polyubiquinated proteins, which may cause cell cycle arrest, [[apoptosis]], and inhibition of tumor growth.<ref name=dd/>


==Clinical trials==
<!--Drug Shortage Status-->
A phase 2 trial for [[multiple myeloma]] showed promising results.<ref>[http://www.dddmag.com/news-Onyx-Says-Carfilzomib-Results-Promising-72710.aspx Onyx Says Carfilzomib Results Promising], ''Drug Discovery & Development'', July 27, 2010</ref><ref>"Phase II results of Study PX-171-007: A phase Ib/II study of carfilzomib (CFZ), a selective proteasome inhibitor, in patients with selected advanced metastatic solid tumors" - ASCO 2009; Abstract 3515.</ref>


A single-arm, phase 2 trial of carfilzomib in patients with relapsed and refractory multiple myeloma showed that single-agent carfilzomib had durable responses in 36 percent of the 257 patients evaluated.<ref>{{cite news|url=http://www.bizjournals.com/sanfrancisco/blog/2011/06/asco-cancer-genentech-avastin.html|title=ASCO Showcasing Bay Area Cancer Therapies|publisher=San Francisco Business Times|date=2011-06-02 |accessdate=2011-09-01}}</ref><ref name="ASCO 2011; Abstract 8027">{{cite web|url= http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=102&abstractID=81812|title=PX-171-003-A1, an open-label, single-arm, phase (Ph) II study of carfilzomib (CFZ) in patients (pts) with relapsed and refractory multiple myeloma (R/R MM): Long-term follow-up and subgroup analysis|publisher= ASCO 2011; Abstract 8027|year=2011|accessdate=2011-09-01}}</ref>
|drugShortage=
}}


In another phase 2 trial of patients with relapsed and/or refractory multiple myeloma, carfilzomib in combination with lenalidomide and dexamethasone demonstrated an overall response rate of 78 percent. Researchers found carfilzomib could be administered over a period of 14–23 months with no new or overlapping toxicities.<ref name="ASCO 2011; Abstract 8027"/><ref>{{cite news|url=http://www.asco.org/ascov2/Meetings/Abstracts?&vmview=abst_detail_view&confID=102&abstractID=82679|title=Interim results from PX-171-006, a phase (Ph) II multicenter dose-expansion study of carfilzomib (CFZ), lenalidomide (LEN), and low-dose dexamethasone (loDex) in relapsed and/or refractory multiple myeloma (R/R MM)|publisher= ASCO 2011; Abstract 8025|year=2011|accessdate=2011-09-01}}</ref>
<!--Pill Image-->


In a phase 2 trial, carfilzomib had a 53 percent overall response rate among patients with relapsed and/or refractory multiple myeloma who had not previously received [[bortezomib]]. This study also found prolonged carfilzomib treatment is well-tolerated with approximately 22 percent of patients continuing treatment beyond one year.<ref>{{cite news|url= http://www.asco.org/ascov2/Meetings/Abstracts?&vmview=abst_detail_view&confID=102&abstractID=77577|title=The effect of carfilzomib (CFZ) in patients (Pts) with bortezomib (BTZ)-naive relapsed or refractory multiple myeloma (MM): Updated results from the PX-171-004 study|publisher= ASCO 2011; Abstract 8026|year=2011|accessdate=2011-09-01}}</ref>
{{PillImage
|fileName=No image.jpg|This image is provided by the National Library of Medicine.
|drugName=
|NDC=
|drugAuthor=
|ingredients=
|pillImprint=
|dosageValue=
|dosageUnit=
|pillColor=
|pillShape=
|pillSize=
|pillScore=
}}


In phase 2 trials of carfilzomib, the most common grade 3 or higher treatment-emergent adverse events were [[thrombocytopenia]], anemia, lymphoenia, neutropenia, pneumonia, fatigue and hyponatremia.<ref>{{cite web|url= http://www.onclive.com/publications/obtn/2010/December-2010/ASH-2010-Carfilzomib-Shrinks-Tumors-in-More-Than-One-Third-of-Pretreated-Myeloma-Patients |title= Siegel DS, Martin T, Wang, M, et al. Results of PX-171- 003-A1, an open-label, single-arm, phase 2 study of carfilzomib in patients with relapsed and refractory multiple myeloma. Presented at: 52nd ASH Annual Meeting and Exposition; December 4-7, 2010; Orlando, Florida.|publisher=OncLive.com|date=2011-03-09 |accessdate=2011-09-01}}</ref>
<!--Label Display Image-->


A phase 3 trial comparing carfilzomib, lenalidomide and dexamethasone versus lenalidomide and dexamethasone in patients with relapsed multiple myeloma is ongoing.<ref>{{cite web|url= http://clinicaltrials.gov/ct2/show/NCT01080391|title= Phase 3 Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) Versus Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma |publisher=ClinicalTrials.gov|date=2011-08-04|accessdate=2011-09-01}}</ref>
{{LabelImage
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
}}


In a frontline phase 1/2 study, the combination of carfilzomib, lenalidomide, and low-dose dexamethasone was highly active and well tolerated, permitting the use of full doses for an extended time in newly-diagnosed multiple myeloma patients, with limited need for dose modification. Responses were rapid and improved over time, reaching 100% very good partial response.<ref>{{cite web|url=http://ash.confex.com/ash/2011/webprogram/Paper39029.html | title=Final Results of a Frontline Phase 1/2 Study of Carfilzomib Lenalidomide, and Low-Dose Dexamethasone (CRd) in Multiple Myeloma (MM) | publisher=ASH 20111; Abstract 631 | accessdate=2012-02-27}}</ref>
{{LabelImage
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
}}


==References==
<!--Category-->
{{reflist|2}}


[[Category:Epoxides]]
[[Category:Drug]]
[[Category:Morpholines]]
[[Category:Proteasome inhibitors]]

Revision as of 20:24, 23 January 2015

Carfilzomib
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Vignesh Ponnusamy, M.B.B.S. [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Overview

Carfilzomib is a proteasome inhibitor that is FDA approved for the {{{indicationType}}} of multiple myeloma. Common adverse reactions include fatigue, anemia, nausea, thrombocytopenia, dyspnea, diarrhea, and pyrexia.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1
  • Dosing Information
  • Dosage
Condition2
  • Dosing Information
  • Dosage
Condition3
  • Dosing Information
  • Dosage
Condition4
  • Dosing Information
  • Dosage

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 Carfilzomib in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Carfilzomib 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 Carfilzomib 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 Carfilzomib in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Carfilzomib in pediatric patients.

Contraindications

  • Condition1

Warnings

  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Carfilzomib 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 Carfilzomib 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 (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Carfilzomib in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Carfilzomib during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Carfilzomib with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Carfilzomib with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Carfilzomib with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Carfilzomib with respect to specific gender populations.

Race

There is no FDA guidance on the use of Carfilzomib with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Carfilzomib in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Carfilzomib in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Carfilzomib in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Carfilzomib in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Carfilzomib in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Carfilzomib in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Carfilzomib in the drug label.

Pharmacology

There is limited information regarding Carfilzomib Pharmacology in the drug label.

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Carfilzomib in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Carfilzomib in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Carfilzomib in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Carfilzomib in the drug label.

How Supplied

Storage

There is limited information regarding Carfilzomib Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Carfilzomib |?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::Carfilzomib |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Carfilzomib in the drug label.

Precautions with Alcohol

  • Alcohol-Carfilzomib interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)


{{#subobject: 

 |Page Name=Carfilzomib
 |Pill Name=No image.jpg
 |Drug Name=
 |Pill Ingred=|+sep=;
 |Pill Imprint=
 |Pill Dosage=
 |Pill Color=|+sep=;
 |Pill Shape=
 |Pill Size (mm)=
 |Pill Scoring=
 |Pill Image=
 |Drug Author=
 |NDC=

}}


{{#subobject: 

 |Label Page=Carfilzomib
 |Label Name=Carfilzomib11.png

}}


{{#subobject: 

 |Label Page=Carfilzomib
 |Label Name=Carfilzomib11.png

}}

Retrieved from "https://www.wikidoc.org/index.php?title=Carfilzomib&oldid=1059340"