Proven Safety & Tolerability

Octagam 10% has an established tolerability profile1-3

Drug-related adverse reactions experienced by >5% of subjects

ReactionsNo. of Subjects (% of Subjects [n=116])
Headache29 (25)
Pyrexia17 (15)
Heart Rate Increased13 (11)

Investigators judged 129 (54%) of the temporally associated (“infusional“) adverse reactions (ARs) in 62 patients to be at least possibly related to the infusion of octagam 10%.

  • The most serious AR observed with octagam 10% treatment during the clinical trial was a headache
  • The most common drug-related ARs reported in >5% of the subjects during a clinical trial were headache, fever, and increased heart rate (see table)

ARs in >5% subjects during and within 72 hours after the end of 2-days treatment cycle

ReactionsNo. of Subjects (% of Subjects [n=116])
Headache35 (30)
Heart Rate Increased25 (22)
Pyrexia20 (17)
Heart Rate Decreased18 (16)
Hypertension7 (6)

Review the recommended dosing, administration and usage of octagam 10%

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References:
  1. Octapharma, Data on File. 2014.
  2. Octagam 10% Full Prescribing Information. Hoboken, NJ: Octapharma USA Inc; rev May 2018.
  3. Robak T, Mainau C, Pyringer B, et al. Efficacy and safety of a new intravenous immunoglobulin 10% formulation (Octagam 10%) in patients with immune thrombocytopenia. Hematology. 2010;15(5):351-359.