Venofer Side Effects, and Drug Interactions - Iron Sucrose

Venofer Side Effects, and Drug Interactions - Iron Sucrose

SIDE EFFECTS

Exposure to Venofer® has been documented in 231 patients undergoing chronic hemodialysis in the above mentioned clinical trials and in 1,051 patients undergoing hemodialysis in two post-marketing safety studies. About 1,600 hemodialysis patients treated with Venofer^® have been reported in the medical literature.

The safety of VenoferÒ has been documented in three efficacy studies (A, B, and C previously described) and two post-marketing studies involving a total of 1282 patients.

In the first post-marketing safety study, 665 chronic hemodialysis patients were treated with Venofer^Ò doses of 100mg 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 non-serious adverse events were collected. In the second post-marketing safety study, 386 hemodialysis patients were exposed to a single dose of Venofer^Ò (100mg IV by slow injection over 2 minutes or 200mg IV by slow injection over 5 minutes). The mean age of patients enrolled into the two 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 two studies included Blacks (44%), Caucasians (41%), Asians (3%), Hispanics (11%) and others (1%).

Adverse reactions, whether or not related to Venofer^® administration, reported by >5% of treated patients from a total of 231 patients in the three studies are as follows: hypotension (36%), cramps/leg cramps (23%), nausea, headache, vomiting, and diarrhea.

Adverse events, whether or not related to Venofer^® administration, reported by >1% of treated patients from a total of 231 patients in the three studies are categorized below 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 intravenous iron.

Body as a Whole: headache, fever, pain, asthenia, unwell, malaise, accidental injury.

Cardiovascular Disorders, General: hypotension, chest pain, hypertension, hypervolemia.

Gastrointestinal System Disorders: nausea, vomiting, abdominal pain, elevated liver enzymes.

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.

In the two post-marketing safety studies, 665 of patients received multiple doses of Venofer^®, and 386 patients received a single dose of Venofer^®. In the multiple dose study, 72% of the patients received up to 10 doses, 27% received between 11-30 doses and 1% received 40 to 50 doses of Venofer^®; only serious adverse events and non-serious adverse events considered by the investigators to be drug related were collected.

Adverse events reported by >1% of 1051 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 two 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 Venofer 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 Venofer® administration between 1992 and 2002 based on estimated use in more than 2 million patients.

One hundred thirty (11%) of the 1,151 patients evaluated in the 4 U.S. trials had prior other intravenous iron therapy and were reported to be intolerant (defined as precluding further use of that iron product). When these patients were treated with Venofer^® there were no occurrences of adverse events that precluded further use of Venofer^®.

Venofer^® (iron sucrose injection, USP) should not be administered concomitantly with oral iron preparations since the absorption of oral iron is reduced.