Adverse Events observed in all treated populations

The frequency of adverse events associated with the use of Venofer® has been documented in six randomized clinical trials involving 231 hemodialysis dependent, 139 non-dialysis dependent and 75 peritoneal dialysis dependent-CKD patients; and in two post-marketing safety studies involving 1,051 hemodialysis dependent-CKD patients for a total of 1,496 patients. In addition, over 2,000 patients treated with Venofer® have been reported in the medical literature.

Treatment-emergent adverse events reported by ≥ 2% of treated patients in the randomized clinical trials, whether or not related to Venofer® administration, are listed by indication in Table 2.

Table 2. Most Common Treatment-Emergent Adverse Events Reported in ≥ 2% of Patients By Clinical Indication (Multidose Safety Population)

Treatment-emergent adverse events reported in ≥ 2% of patients by dose group are shown in Table 3.

Table 3. Most Common Treatment-Emergent Adverse Events Reported in ≥ 2% of Patients by Dose Group (Multidose Safety Population)

Drug related adverse events reported by ≥ 2% of Venofer® treated patients are shown by dose group in Table 4.

Table 4. Most Common Adverse Events Related to Study Drug Reported in ≥ 2% of Patients by Dose Group (Multidose Safety Population)

Adverse Events Observed in Hemodialysis Dependent-Chronic Kidney Disease (HDD-CKD) Patients

Adverse reactions, whether or not related to Venofer® (iron sucrose injection, USP) administration, reported by > 5% of treated patients from a total of 231 patients in HDD-CKD Studies A, B, and C were as follows: hypotension (39.4%), muscle cramps (29.4%), nausea (14.7%), headache (12.6%), graft complications (9.5%), vomiting (9.1%), dizziness (6.5%), hypertension (6.5%), chest pain (6.1%), and diarrhea (5.2%).

In the first post-marketing safety study, 665 chronic hemodialysis patients were treated with Venofer® 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. In this 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®. 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® (100 mg IV by slow injection over 2 minutes or 200 mg 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%), Hispanics (11%), Asians (3%), and others (1%). Adverse events reported by > 1% of 1,051 treated patients were: cardiac failure congestive, sepsis NOS and dysgeusia.

Adverse Events Observed in Non-Dialysis Dependent-Chronic Kidney Disease (NDD-CKD) Patients

In Study D of 182 treated NDD-CKD patients, 91 were exposed to Venofer®. Adverse events, whether or not related to Venofer® , reported by ≥ 5% of the Venofer® exposed patients were as follows: dysgeusia (7.7%), peripheral edema (7.7%), diarrhea (5.5%), constipation (5.5%), nausea (5.5%), dizziness (5.5%), and hypertension (5.5%). One serious related adverse reaction was reported (hypotension and shortness of breath not requiring hospitalization in a Venofer® patient). Two patients experienced possible hypersensitivity/allergic reactions (local edema/hypotension) during the study. Of the 5 patients who prematurely discontinued the treatment phase of the study due to adverse events (2 oral iron group and 3 Venofer® group), three Venofer® patients had events that were considered drug-related (hypotension, dyspnea and nausea).

In an additional study of Venofer® with varying erythropoietin doses in 96 treated NDD-CKD patients, adverse events, whether or not related to Venofer® reported by ≥ 5% of Venofer® exposed patients are as follows: diarrhea (16.5%), edema (16.5%), nausea (13.2%), vomiting (12.1%), arthralgia (7.7%), back pain (7.7%), headache (7.7%), hypertension (7.7%), dysgeusia (7.7%), dizziness (6.6%), extremity pain (5.5%), and injection site burning (5.5%). No patient experienced a hypersensitivity/allergic reaction during the study. Of the patients who prematurely discontinued the treatment phase of the study due to adverse events (2.1% oral iron group and 12.5% Venofer® group), only one patient (Venofer® group) had events that were considered drug-related (anxiety, headache, and nausea). Ninety-one (91) patients in this study were exposed to Venofer® either during the treatment or extended follow-up phase.

Adverse Events Observed in Peritoneal Dialysis Dependent-Chronic Kidney Disease (PDD-CKD) Patients

In Study E of 121 treated PDD-CKD patients, 75 patients were exposed to Venofer®. Adverse events, whether or not related to Venofer® reported by ≥ 5% of these patients are as follows: diarrhea, peritoneal infection, vomiting, hypertension, pharyngitis, peripheral edema and nausea.

In these 75 patients exposed to Venofer®, 9 patients experienced serious adverse events as follows: peritoneal infection (2 patients) and 1 patient each with cardiopulmonary arrest, myocardial infarction, upper respiratory infection NOS, anemia, gangrene, hypovolemia and tuberculosis. None of these events were considered drug-related. Two Venofer® patients experienced a moderate hypersensitivity/allergic reaction (rash or swelling/itching) during the study.

The only drug related adverse reaction to Venofer® administration reported by ≥ 2% of patients was diarrhea.

Three patients in the Venofer® study group discontinued study treatment due to adverse events (cardiopulmonary arrest, peritonitis and myocardial infarction, hypertension) which were considered to be not drug-related.

Hypersensitivity Reactions: See WARNINGS and PRECAUTIONS.

In clinical studies, several patients experienced hypersensitivity reactions presenting with wheezing, dyspnea, hypotension, rashes, or pruritus. Serious episodes of hypotension occurred in 2 patients treated with Venofer® at a dose of 500 mg.

The post-marketing spontaneous reporting system includes reports of patients who experienced serious or life-threatening reactions (anaphylactic shock, loss of consciousness or collapse, bronchospasm with dyspnea, or convulsion) associated with Venofer® administration.

One hundred thirty (11%) of the 1,151 patients evaluated in the 4 U.S. trials in HDD-CKD patients (studies A, B and the two post marketing studies) 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®.

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