Drug Report: KYPROLIS (CARFILZOMIB)
Primary Suspect Reports: 8 Total Reports: 48 FDA AERS Reports from 11/01/1997 to 08/27/2012
Drug Description :

Kyprolis (carfilzomib) is an injectable proteasome inhibitor. It is indicated for treatment of multiple myeloma in patients who have had at least two previous therapies and have shown disease progression within 60 days of their last medication therapy. Kyprolis is marketed by Onyx Pharms and was FDA approved on July 20, 2012.

From 11/01/1997 to 08/27/2012, there have been 8 reports of a serious adverse event where KYPROLIS was identified as the primary suspect drug causing that event. During that time period, the top three adverse events reported in cases where KYPROLIS was identified as the primary suspect drug were: Hypoxia, Dyspnoea and Acute Coronary Syndrome.

Drug Safety Monitor News :

06/22/2012 - Onyx Pharmaceuticals’ Kyprolis Receives Positive Vote from FDA Advisory Committee
06/19/2012 - FDA Advisory Committee To Discuss Recommending Approval For Kyprolis

Other Names : Generic Name : Report Info:

CARFILZOMIB

Average Age: 66 Years
Gender: 57% M, 43% F
Average Duration of Treatment: 131 Days

FDA Listed Names (4) : How to read this section Manufacturer: Common Conditions:

Carfilzomib
Infusion (form) Carfilzomib 45 Mg
Infusion (form) Carfilzomib Unk
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N/A

MULTIPLE MYELOMA
DIFFUSE LARGE B-CELL LYMPHOMA
MYELOMA RECURRENCE

KYPROLIS Adverse Event Timeline
Top KYPROLIS Adverse Events/Side Effects How to read this section
How to read this section
Side Effects
MedDRA Preferred Terms
KYPROLIS Primary Suspect Reports KYPROLIS Total Reports ROR Score
How to read this section
PRR Score
How to read this section
Compare Top Drugs
Dyspnoea 2 (25%) 4 (8%) Premium Feature Premium Feature
Hypoxia 2 (25%) 3 (6%) Premium Feature Premium Feature
Acute Coronary Syndrome 1 (13%) 1 (2%) Premium Feature Premium Feature
Atelectasis 1 (13%) 2 (4%) Premium Feature Premium Feature
Cardiac Arrest 1 (13%) 1 (2%) Premium Feature Premium Feature
Cardiac Failure Congestive 1 (13%) 1 (2%) Premium Feature Premium Feature
Cardiomegaly 1 (13%) 2 (4%) Premium Feature Premium Feature
Chest Pain 1 (13%) 1 (2%) Premium Feature Premium Feature
Cholelithiasis 1 (13%) 1 (2%) Premium Feature Premium Feature
Condition Aggravated 1 (13%) 2 (4%) Premium Feature Premium Feature
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Reported Report Outcomes for KYPROLIS Adverse Events
Report Outcomes KYPROLIS Primary Suspect
(# of Reports)
(11/01/1997 to 08/27/2012)
KYPROLIS Total
(# of Reports)
(11/01/1997 to 08/27/2012)
Hospitalization - Initial or Prolonged 7 (88%) 33 (69%)
Death 2 (25%) 11 (23%)
Most Recent KYPROLIS Report Reviews/FDA Reports (Primary Suspect)
Report Date Age Gender Conditions Adverse Events Outcome
08/08/2012 53 YR M Multiple Myeloma
Hypoxia
Hospitalization - Initial or Prolonged
07/06/2012 68 YR F Multiple Myeloma
Cardiac Arrest
Pulseless Electrical Activity
Pneumonia

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Death
04/27/2012 Not Stated M Acute Myeloid Leukaemia
Respiratory Failure
Death
Hospitalization - Initial or Prolonged
01/11/2012 77 YR F Multiple Myeloma
Condition Aggravated
Cardiomegaly
Cardiac Failure Congestive

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Hospitalization - Initial or Prolonged
01/10/2012 78 YR M Acute Myeloid Leukaemia
Head Injury
Subdural Haematoma
Fall

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Hospitalization - Initial or Prolonged
12/27/2011 58 YR M Mantle Cell Lymphoma Recurrent
Dyspnoea
Hospitalization - Initial or Prolonged
12/01/2011 65 YR M Waldenstrom's Macroglobulinaemia
Epigastric Discomfort
Gallbladder Polyp
Nephrolithiasis

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Hospitalization - Initial or Prolonged
11/18/2011 58 YR M Mantle Cell Lymphoma
Dyspnoea
Hospitalization - Initial or Prolonged

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