Kineret anakinra: A Review of Safety Data Postmarketing Surveillance

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Kineret (anakinra)A Review of Safety
DataPostmarketing Surveillance

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Serious Infectious Episodes Postmarketing
Experience

• Serious infection 20 cases reported
• Time to onset ranged from 122 months after drug
  initiation
• Pneumonia 8 serious cases reported, 2 of which
  were fatal
• Cellulitis/musculoskeletal infections 7 serious
  cases reported, all of which resolved
• Urinary tract infections 2 serious cases
  reported
• One patient developed a pleural effusion with M.
  fortuitum infection
• Abdominal infections 3 serious cases reported
• Reporting rate of serious infections
• 20/10,568 patients 0.2 per 100 treated patients

Periodic Safety Update Report 1 for
IL-1ra/anakinra (Kineret). Amgen Inc. Thousand
Oaks, Calif.
Postmarketing data as of 13 May 2002
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Hypersensitivity ReactionsPostmarketing
Experience

• Potential cases were identified by a broad list
  of codes
• Most frequently reported reactions rash,
  dyspnoea, hypersensitivity
• Spontaneous reports 21 cases, 7 of which were
  serious (2 of which likely due to other causes)
• Time to onset of the 5 serious cases ranged from
  15 minutes to 43 days
• none of the patients were hospitalised
• Reporting rate of hypersensitivity reactions
• 21/10,568 patients 0.2 per 100 treated patients
• Pattern and frequency of observed
  hypersensitivity reports are in line with
  clinical trial data

Periodic Safety Update Report 1 for
IL-1ra/anakinra (Kineret). Amgen Inc. Thousand
Oaks, Calif.
Postmarketing data as of 13 May 2002
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Kineret Injection Site Reactions Postmarketing
Experience

• 10,100 patients
• 1,784 reports 1,356 (78) concerning ISRs

• Call center (US)

• Spontaneous cases

• 100 reports 52 (52) concerning ISRs

• Serious ISRs

• One serious ISR on the thigh, with systemic
  symptoms (hypotension and tachycardia) 1 week
  after discontinuation of Kineret

• Pattern, time to onset, and resolution and
  distribution of ISRs are compatible with data
  generated from clinical trials

• Appearance

Periodic Safety Update Report 1 for
IL-1ra/anakinra (Kineret). Amgen Inc. Thousand
Oaks, Calif.
Postmarketing data as of 13 May 2002