Exposure to Maxifer has been documented in 231 patients undergoing chronic hemodialysis in the previously mentioned clinical trials and in 1,051 patients undergoing hemodialysis in 2 post-marketing safety studies. About 1,600 hemodialysis patients treated with Maxifer have been reported in the medical literature.
The safety of Maxifer has been documented in 3 efficacy studies (A, B and C previously described) and 2 post-marketing studies involving a total of 1,282 patients. In the first post-marketing safety study, 665 chronic hemodialysis patients were treated with Maxifer doses of 100 mg at each dialysis session for up to 10 consecutive dialysis sessions for their iron deficiency or on a weekly basis for 10 weeks for maintenance of iron stores. Serious adverse events and drug-related nonserious adverse events were collected. In the second post-marketing safety study, 386 hemodialysis patients were exposed to a single dose of Maxifer (100 mg IV by slow injection over 2 min or 200 mg IV by slow injection over 5 min). The mean age of patients enrolled in the 2 post-marketing safety studies was 59 years, with a range of 20-93 years. Males made up 60% of the population. The ethnicity of the patients enrolled in the 2 studies included Blacks (44%), Caucasians (41%), Asians (3%), Hispanics (11%) and others (1%).
Adverse Events Observed in Studies A, B and C: Adverse reactions, whether or not related to Maxifer administration, reported by >5% of treated patients from a total of 231 patients in the 3 studies are as follows: Hypotension (36%), cramps/leg cramps (23%), nausea, headache, vomiting and diarrhea.
Adverse events, whether or not related to Maxifer administration, reported by >1% of treated patients from a total of 231 patients in the 3 studies are categorized as follows by body system either by investigator term or by COSTART terminology and ranked in order of decreasing frequency within each body system. Some of these symptoms may be seen in patients with chronic renal failure or on hemodialysis not receiving iron IV.
Body as a Whole: Headache, fever, pain, asthenia, feeling unwell, malaise and accidental injury.
General and Cardiovascular Disorders: Hypotension, chest pain, hypertension, hypervolemia.
Gastrointestinal System Disorders: Nausea, vomiting, abdominal pain, elevated liver enzymes, diarrhea.
Central and Peripheral Nervous System: Dizziness.
Musculoskeletal System: Cramps/leg cramps, musculoskeletal pain.
Respiratory System: Dyspnea, pneumonia, cough.
Skin and Appendages: Pruritus, application site reaction.
Adverse Events Observed in Two Post-Marketing Safety Studies: In the 2 post-marketing safety studies, 665 patients received multiple doses of Maxifer and 386 patients received a single dose of Maxifer. In the multiple dose study, 72% of the patients received up to 10 doses, 27% received between 11-30 doses and 1% received 40-50 doses of Maxifer; only serious adverse events and nonserious adverse events considered by the investigators to be drug-related were collected.
Adverse events reported by >1% of 1,051 treated patients are as follows: Congestive heart failure, sepsis and taste perversion.
Hypersensitivity Reactions: See Warnings and Precautions.
In studies A, B and C and 2 post-marketing safety studies, several patients experienced mild or moderate hypersensitivity reactions presenting with wheezing, dyspnea, hypotension, rashes or pruritus.
No serious or life-threatening hypersensitivity reactions associated with Maxifer administration were observed in these studies. From the post-marketing spontaneous reporting system, there were 83 reports of anaphylactoid reactions including patients who experienced serious or life-threatening reactions (anaphylactic shock, loss of consciousness or collapse, bronchospasm with dyspnea or convulsion) associated with Maxifer administration between 1992 and 2002 based on estimated use in >2 million patients.
One hundred thirty (11%) of the 1151 patients evaluated in the 4 US trials had prior other iron IV therapy and were reported to be intolerant (defined as precluding further use of that iron product). When these patients were treated with Maxifer, there were no occurrences of adverse events that precluded further use of Maxifer.