Drug Safety Information for JAKAFI (Ruxolitinib phosphate)

FDA Safety-related Labeling Changes for JAKAFI (RUXOLITINIB PHOSPHATE) Rx Drug: Safety Information Link

Required post-approval safety study:

Conduct a trial to provide evidence sufficient to characterize the long-term safety of ruxolitinib in the treatment of patients with polycythemia vera who do not have splenomegaly and who have had an inadequate response to or are intolerant of hydroxyurea. Submit the complete final report and data showing long-term safety with 5 years of follow-up from a randomized controlled trial comparing ruxolitinib vs best available therapy. In the safety analysis, include the long-term effects of treatment with ruxolitinib on hematocrit. Due Date: 2022-05-31

Required post-approval safety study:

Long-term safety follow-up in patients with myelofibrosis and lower baseline thrombocytopenia who are receiving longer term treatment with Jakafi. This longer term safety analysis may be based on further followup of ongoing trials or you may propose an alternative strategy to provide this information. Due Date: 2021-09-30

Original FDA Drug Approval Date for JAKAFI: 2011-11-16

Adverse Drug Reactions for JAKAFI* (Ruxolitinib phosphate)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with JAKAFI
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Death	754
2	Platelet count decreased	405
3	Anaemia	400
4	Fatigue	386
5	Haemoglobin decreased	375
6	Diarrhoea	256
7	Dizziness	231
8	Headache	230
9	Pneumonia	216
10	Dyspnoea	210
11	Asthenia	187
12	Weight increased	185
13	Splenomegaly	182
14	Thrombocytopenia	163
15	Pyrexia	161
16	Nausea	155
17	Contusion	153
18	Hospitalisation	153
19	Malaise	146
20	Drug dose omission	143

* This side effect also appears in "Top 10 Side Effects of JAKAFI " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking JAKAFI
(associated with FDA Medwatch/FAERS Reports)

	Reason	# of FDA Reports
1	Myelofibrosis	10500
2	Polycythaemia vera	719
3	Myeloproliferative disorder	323
4	Product used for unknown indication	245
5	Splenomegaly	216
6	Myelodysplastic syndrome	156
7	Essential thrombocythaemia	87
8	Blood disorder	58
9	Chronic myeloid leukaemia	49
10	Off label use	46

*Also a top-10 reason in AskaPatient Review Summary.

Types of Adverse Events for JAKAFI

Total Reports Filed with FDA: 14574

Number of FDA Adverse Event Reports by Patient Age for JAKAFI

Total Reports Filed with FDA: 14574*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Ruxolitinib phosphate (Jakafi)

Charts are based on 14574 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.