Venofer

Friday, February 18, 2011

Pharmacy specifications

Dosage Form
Venofer® (iron sucrose injection, USP) is available in 5 mL single dose vials. Each 5
mL vial contains 100 mg (20 mg/mL) of elemental iron as iron sucrose in water for
injection. Venofer® contains no preservatives. Parenteral drug products should be
inspected visually for particulate matter and discoloration prior to infusion.1
Syringe Stability
Venofer® when diluted with 0.9% Sodium Chloride for Injection, USP at
concentrations ranging from 2 mg to 10 mg of elemental iron per mL, or undiluted
(20 mg elemental iron per mL) and stored in a plastic syringe, was found to be
physically and chemically stable for 48 hours at controlled room temperature
(25°C ± 2°C) and under refrigeration (4°C ± 2°C).142
IV Admixture Stability
Venofer®, when added to IV infusion bags (PVC) containing 0.9% Sodium Chloride
Injection, USP at concentrations ranging from 0.5 mg to 2 mg of
elemental iron per mL, has been found to be physically and chemically stable
for 48 hours at controlled room temperature (25°C ± 2°C) and under refrigeration
(4°C ± 2°C).142

Clinical efficacy and safety

Since Venofer® (iron sucrose injection, USP) was first approved in Switzerland in
1950, a large body of evidence in the form of study reports and publications has
been produced that demonstrates the safety and efficacy of intravenous iron
sucrose. The evaluation of clinical safety and efficacy of Venofer® is based on
results from more than 100 studies3-124 involving more than 7,000 subjects. More
than 5,000 patients were treated with Venofer®. These studies demonstrate the
effectiveness of Venofer® in the treatment of iron deficiency anemia, alone and in
combination with an erythropoietin. The incidence of serious adverse reactions is
low. Based on use in an estimated 4.6 million patients that received Venofer®
worldwide between 1992 and August 2005, only 108 hypersensitivity reactions have
been reported, including serious or life threatening reactions2. Venofer® is well tolerated
in the vast majority of patients, including those with a history of hypersensitivity
reactions to iron dextran and other parenteral iron preparations. Venofer® is easy
to administer either as a slow injection or as an infusion. A test dose is not required,
however, some physicians used a test dose at their discretion in two U.S. pivotal trials
in HDD-CKD patients.
Review of selected clinical trials in Chronic Kidney Disease
Study A Hemodialysis Patients (Charytan et al,12 Van Wyck et al136)
Study A was a multicenter, open-label, historically controlled study in 101
hemodialysis patients (77 patients with Venofer® treatment and 24 in the historical
control group) with iron deficiency anemia. Eligibility for Venofer® treatment
included patients undergoing chronic hemodialysis three times weekly,
receiving erythropoietin, hemoglobin concentration greater than 8.0 and less
than 11.0 g/dL for at least two consecutive weeks, transferrin saturation <
20%, and serum ferritin < 300 ng/mL. The erythropoietin dose was to be
held constant throughout the study. The protocol did not require administration
of a test dose; however, some patients received a test dose at the physician’s
discretion. Exclusion criteria included significant underlying disease,
asthma, active inflammatory disease, or serious bacterial or viral infection.
Venofer® 5 mL (one vial) containing 100 mg of elemental iron was administered
through the dialysis line at each dialysis session either as a slow injection
or a saline-diluted slow infusion for a total of 10 dialysis sessions with a
cumulative dose of 1000 mg elemental iron. A maximum of 3 vials of
Venofer® was administered per week. No additional iron preparations were
allowed until after the day 57 evaluation. The mean change in hemoglobin
from baseline to day 24 (end of treatment), day 36, and day 57 was
assessed.
• Four of the 77 patients (5%) had six adverse events believed to be
related to Venofer®, including diarrhea (2 patients), abdominal pain,
nausea, constipation, and taste perversion.
• No hypersensitivity reactions were seen, including in any of 10 patients
who had shown previous intolerance/allergy to iron dextran injection, USP.

The historical control population consisted of 24 patients similar to patients
treated with Venofer® (iron sucrose injection, USP) who were off intravenous
iron for at least 2 weeks and who had received erythropoietin therapy with
hematocrit averaging 31% to 36% for at least two months prior to study
entry.51 Patient age and serum ferritin level were similar between treatment
and historical control patients. The mean baseline hemoglobin and hematocrit
were higher, and the erythropoietin dose was lower in the historical control
population than in the Venofer®-treated population.
• Patients in the Venofer®-treated population showed a statistically
significantly greater increase in hemoglobin and hematocrit than
did patients in the historical control population.
– At the 2-week follow-up, patients in the Venofer®-treated population
showed a significantly (p<0.01) greater increase in hemoglobin
(1.3 g/dL) and hematocrit (3.6%) than did patients in the historical
control population (Hb, -0.6 g/dL, Hct, -1.2%).
– At the 5-week follow-up, Venofer®-treated patients showed a
significantly (p<0.05) greater increase in hemoglobin (1.2 g/dL)
than did patients in the historical control group (-0.1 g/dL).
– At the end of treatment, patients in the Venofer® -treated population
showed a significantly (p<0.01) greater increase in hemoglobin
(1.0 g/dL) and hematocrit (3.1%) than did patients in the historical
control group (Hb, -0.5 g/dL, Hct, -0.8%).
• Serum ferritin increased significantly (p=0.001) at endpoint of study from
baseline in the Venofer®-treated population (165.3 ng/mL) compared with
the historical control population (-27.6 ng/mL). Transferrin saturation also
increased significantly (p=0.0016) at endpoint of study from baseline in the
Venofer® treated population (8.8%) compared with the historical control
population (-5.1%).
The authors concluded that doses of 100 mg Venofer® (iron sucrose injection, USP)
given IV in 10 consecutive dialysis sessions for a total dose of 1,000 mg were effective
and safe in hemodialysis patients with iron deficiency anemia receiving supplemental
erythropoietin therapy and can be administered without a test dose.
Study B Hemodialysis Patients (Van Wyck et al13)
The safety and efficacy of Venofer® in hemodialysis patients who had
experienced intolerance to iron dextran were also examined in a singlearm,
two-period, open-label, multicenter study by Van Wyck et al. Sixteen
patients with Hb < 11g/dL and a history of mild reactions and 7 patients with
a history of severe anaphylactoid reactions to iron dextran were included.
Following an observation period, patients received 100 mg Venofer® either
by intravenous injection or infusion for 10 consecutive dialysis sessions over
3-4 weeks. A test dose was not required; however, some patients received a
16
test dose at the physician’s discretion. Since the study was primarily a safety
study, efficacy assessments were limited to changes from baseline to day 24
(end of treatment evaluation).
• There were no serious hypersensitivity reactions, no serious adverse
drug reactions, and no patients discontinued from the study
due to adverse drug reactions.
• Three mild adverse events considered related or possibly related
to iron sucrose were reported in 2 patients:
– Taste perversion (metallic taste, 1 patient twice)
– Pruritus (1 patient)
• Concomitant use of ACE inhibitors was present in 12 of 23
patients (52%).
• Mean hemoglobin increased from 10.4 g/dL to 11.5 g/dL
at day 24 (p<0.05, increase 11.0%).
• Mean hematocrit increased from 32.8% to 36.4% at day
24 (p<0.05, increase of 11.0%).
• MCV, MCHC, serum iron, TSAT, and serum ferritin also
increased significantly, and total iron binding capacity (TIBC)
decreased significantly.
The authors concluded that Venofer® (iron sucrose injection, USP) is safe and
effective in the management of anemia in hemodialysis patients receiving
supplemental erythropoietin sensitive to iron dextran and can be administered without
a test dose by IV push or infusion.
Study C Hemodialysis Patients (Van Zyl-Smit et al11)
A safety and efficacy study of Venofer® or the combination of Venofer® and
erythropoietin was performed in an open, single-arm, two-period, multicenter
study by Van Zyl-Smit et al in South Africa. One hundred thirty-one patients
were enrolled. All suffered from hemodialysis-associated anemia, were
undergoing maintenance hemodialysis (2 to 3 sessions per week), had an
Hb < 10.0 g/dL, serum transferrin saturation < 20%, and serum ferritin < 200
ng/mL. A first dose of 50 mg of Venofer® was administered at the first
hemodialysis session, followed by doses of 100 mg of iron during dialysis
3 times weekly until an individually calculated dose, based upon baseline
hemoglobin, and body weight, was administered. Patients were then followed
for an additional 4 weeks, in a no-treatment observation period.
17
The modified intent-to-treat population consisted of 130 patients. Mean
hematologic and iron parameters at baseline and following treatment with
Venofer® (iron sucrose injection, USP) are given below:
• Mean hemoglobin increased from 7.2 g/dL to 9.0 g/dL at
observation week two and 9.2 g/dL at observation week four
(p<0.0001, maximum increase of 28%).
• Mean hematocrit increased from 22.5% to 27.9% at observation
week two and 28.5% at observation week four (p<0.0001,
maximum increase of 27%).
• Mean serum ferritin increased from 65.1 ng/mL to 512.7 ng/mL at
observation week two and 440.2 ng/mL at observation week four
(p<0.0001, maximum increase of 687%).
• Mean serum transferrin saturation increased from 11.4% to
27.7% at observation week two and 27.6% at observation
week four (p<0.0001, maximum increase of 143%).
Adverse events (> 1%) that were reported to be possibly related to Venofer®
were hypotension (13%), nausea (3%), increased liver function test (2%),
pneumonia (2%), and vomiting (2%). Hypotension was also associated with
hemodialysis itself and occurred with similar frequency during the treatment
period and during the observation period when no iron was given.
The authors concluded that Venofer® was safe and effective in the treatment of
patients with hemodialysis-associated anemia.
18
Study D - Non-Dialysis Dependent CKD Patients (VanWyck et al)123
The safety and efficacy of Venofer® (iron sucrose injection, USP) in non-dialysis CKD
patients was examined in a randomized, open-label multicenter, active-controlled
study by Van Wyck et al. 182 patients were treated with oral iron (N=91) or Venofer®
(N=91) with or without an erythropoietin. Erythropoietin therapy was stable for 8
weeks prior to randomization. Patients with an average baseline Hg <11 g/dL, TSAT
< 25%, and ferritin < 300 ng/mL were randomized to receive either oral iron (325 mg
ferrous sulfate TID for 56 days) or Venofer® (200 mg IV over 2-5 minutes 5 times within
14 days or 500 mg IV infusion over 3.5-4 hours on Day 1 and Day 14). Sixty-one
patients received 280 doses of 200 mg iron sucrose, and 30 patients received 58
doses of iron sucrose 500 mg.
• A statistically greater proportion of Venofer® treated patients (44.3%) compared
to oral iron patients (28%) had a clinically significant response as
defined as an increase in hemoglobin > 1 g/dL at any time during the study.
(p=0.03)
• The mean increase in hemoglobin at Day 42 was greater in the Venofer®
treated patients (0.7 g/dL) compared to oral iron patients (0.4g/dL)
(p=0.0298)
• A greater proportion of Venofer® treated patients (39.2%) compared to oral
iron patients (1.2%) had a clinically significant response defined as an
increase in hemoglobin > 1 g/dL, and ferritin > 160 ng/mL at any time during
the study.(p<0.0001)
• Patients in the oral iron group, but not the Venofer® group, showed a statistically
significant rise in serum creatinine at study day 56/end of study (0.2
mg/dL, p<0.0013)
• Non-compliance was more common in the oral iron treatment group.
• No serious adverse drug events were seen in patients administered Venofer®
200 mg IV over 2-5 minutes, but drug related hypotension, including one
event considered serious, occurred in 2 females weighing less than 65 kg
after 500 mg doses were given over 4 hours.
• Among non-serious ADEs reported, GI complaints were seen most frequently
in both treatment groups, but the nature of GI complaints differed between
groups. Transient taste disturbance was the most prominent GI complaint
associated with Venofer® administration. Constipation, diarrhea, nausea,
vomiting and dyspepsia were associated with oral iron therapy. Headache,
myalgia, and hypotension were also associated with Venofer® administration.
The authors concluded that Venofer® administration of 1000 mg in divided
doses is superior to oral iron therapy in the management of NDD-CKD patients
with anemia and low iron indices. Venofer® therapy was safe, well tolerated and
more effective than oral iron treatment.

Study E - Peritoneal Dialysis Dependent CKD Patients (Singh et al)1,124
The safety and efficacy of Venofer® (iron sucrose injection, USP) in peritoneal dialysis
dependent-CKD patients receiving an erythropoietin was examined in a multicenter,
randomized, controlled trial by Singh et al. 126 patients were treated with an erythropoietin
and Venofer® (N=75), or an erythropoietin alone without iron supplementation.
Erythropoietic therapy was unchanged for 8 weeks prior to randomization and during
the study period. Patients with Hg < 11.5 g/dL, TSAT < 25 %, and ferritin < 500
ng/mL were randomized to receive either no iron (n=46) or Venofer® (300 mg diluted
in 250 mL 0.9% NaCl over 1.5 hours on Days 1 and 15 and 400 mg diluted in 250 mL
0.9% NaCl over 2.5 hours on Day 29) (n=75).
• Patients in the Venofer®/erythropoietin group had a greater mean hemoglobin
change from baseline to the highest hemoglobin value (1.3 g/dL)
(p<0.01)
• A greater proportion of patients treated with Venofer®/erythropoietin (59.1%)
had an increase in hemoglobin of > 1 g/dL at any time during the study
compared to patients who received erythropoietin alone (33.3%) (p < 0.05)
• There were no serious adverse events after Venofer® administration at
either dose level. 8 patients experienced at least 1 non-serious adverse
event thought to be related to study drug with GI complaints seen most frequently.
The authors concluded that Venofer® is an effective adjunct to erythropoietic
therapy in anemic patients with PDD-CKD. Administration of Venofer® as an
IV infusion of 300 mg over 1.5 hours or 400 mg over 2.5 hours is well tolerated
and provides a practical approach to correcting iron deficiency anemia
and replenishing iron stores.

Indications and dosage

Indications and dosage
Venofer® is indicated in the treatment of iron deficiency anemia in the following
patients:
• Non-dialysis dependent-chronic kidney disease (NDD-CKD) patients not
receiving an erythropoietin
• Non-dialysis dependent-chronic kidney disease (NDD-CKD) patients receiving
an erythropoietin
• Hemodialysis dependent chronic kidney disease (HDD-CKD) patients
receiving an erythropoietin
• Peritoneal dialysis dependent-chronic kidney disease (PDD-CKD) patients
receiving an erythropoietin
Venofer® is contraindicated in:
• Patients with evidence of iron overload.
• Patients with known hypersensitivity to iron sucrose or any of its inactive
components.
• Patients with anemia not caused by iron deficiency.

Usual Dosage
Most CKD patients will require a minimum cumulative repletion dose of 1,000 mg of
elemental iron to achieve a favorable hemoglobin response and to replenish iron
stores (ferritin, TSAT). Patients may continue to require therapy with Venofer® at
the lowest dose necessary to maintain target levels of hemoglobin, and laboratory
parameters of iron storage within acceptable limits.
• Hemodialysis Dependent Chronic-Kidney Disease Patients (HDDCKD):
Venofer® (iron sucrose injection, USP) may be administered undiluted
as a 100 mg slow intravenous injection over 2 to 5 minutes or as an
infusion of 100 mg, diluted in a maximum of 100 mL of 0.9% NaCl over a
period of at least 15 minutes per consecutive hemodialysis sessions for a
total cumulative dose of 1,000 mg.
• Non-Dialysis Dependent Chronic-Kidney Disease Patients (NDD-CKD):
Venofer® is administered as a total cumulative dose of 1,000 mg over a 14
day period as a 200 mg slow IV injection undiluted over 2 to 5 minutes on 5
different occasions within the 14 day period. There is limited experience
with administration of an infusion of 500 mg of Venofer®, diluted in a maximum
of 250 mL of 0.9% NaCl, over a period of 3.5-4 hours on day 1 and
day 14; hypotension occurred in 2 of 30 patients treated.
• Peritoneal Dialysis Dependent-Chronic Kidney Disease Patients (PDDCKD):
Venofer® is administered as a total cumulative dose of 1,000 mg in 3
divided doses, given by slow intravenous infusion, within a 28 day period: 2
infusions of 300 mg over 1.5 hours 14 days apart followed by one 400 mg
infusion over 2.5 hours 14 days later. The Venofer® dose should be diluted
in a maximum of 250mL of 0.9% NaCl.
Monitoring Parameters
• Patients receiving regular parenteral iron therapy require monitoring of
hematologic parameters and iron indices (Hb, Hct, TSAT, and ferritin).
• In order to prevent iron overload, serum iron values may be reliably
obtained 48 hrs. after IV iron sucrose dosing.

About Venofer

Venofer^® (iron sucrose injection, USP) is used intravenously to replenish body iron stores in patients with iron deficiency anemia. Venofer^® is indicated in the treatment of iron deficiency anemia in¹

Adult non-dialysis dependent-chronic kidney disease (NDD-CKD) patients receiving an erythropoietin
Adult non-dialysis dependent-chronic kidney disease (NDD-CKD) patients not receiving an erythropoietin
Adult hemodialysis dependent-chronic kidney disease (HDD-CKD) patients receiving an erythropoietin
Adult peritoneal dialysis dependent-chronic kidney disease (PDD-CKD) patients receiving an erythropoietin

Venofer^® is contraindicated in:

     Patients with evidence of iron overload
     Patients with know hypersensitivity to iron sucrose or any of its inactive components
     Patients with anemia not caused by iron deficiency

Non-dextran Formula
Venofer^® is a brown, sterile, aqueous complex of polynuclear iron (III)-hydroxide in sucrose containing 20 mg elemental iron per mL. It contains no dextran or modified dextran.

A Test Dose Is Not Required
Unlike iron dextran products, Venofer^® does not require a test dose prior to therapy. Staff vigilance when administering any intravenous iron product is recommended.

Over 50 Years of Worldwide Clinical Experience
More than 100 clinical studies and a long history of the use of iron sucrose injection worldwide have established the efficacy and safety of Venofer^® in patients with iron deficiency anemia from CKD.^2-125 Between 1992 and February 2010, over 12 million patients have been treated with more than 240 million units (100 mg equivalents) in more than 84 countries.²

Large Safety Database
A large safety database on Venofer^® (iron sucrose injection, USP) is available from clinical trial reports, publications, and post-marketing surveillance.

Data on the safety of Venofer^® have been collected since its introduction to the European market (Switzerland) in 1950 and during a modern clinical development program begun in 1992. Serious hypersensitivity reactions have occurred with Venofer^®.¹ See Important Safety Information below.

Flexible Administration
Venofer^® may be dosed in the office or outpatient setting. It may be administered either by undiluted IV push injection or IV infusion. This option gives healthcare providers the flexibility to deliver iron therapy in the most convenient way for the patient.

Convenient Single-dose Vials
Venofer^® is available in both 100 mg/5 mL and 200 mg/10 mL vials. Difficulties associated with glass ampules, such as breakage, splintering, and bodily injury to staff, are eliminated with these convenient single-dose vials. One 5-mL vial of Venofer^® provides 100 mg of iron as iron sucrose, the National Kidney Foundation-Kidney Dialysis Outcomes Quality Initiative (NKF-KDOQI)-recommended dose for a single dialysis session.¹²⁶ Each vial is barcoded with its National Drug Code (NDC) to help prevent medication errors.

For more complete information about Venofer^® (iron sucrose injection, USP) you may view and download the Formulary Monograph here.

*Based on IMS Health, IMS National Sales Perspective^® (July 2009) 2nd quarter 2009 results-dollar volume ($) and units (100 mg equivalents).

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IMPORTANT SAFETY INFORMATION: Venofer^® (iron sucrose injection, USP) is contraindicated in patients with evidence of iron overload, in patients with known hypersensitivity to Venofer® or any of its inactive components, and in patients with anemia not caused by iron deficiency. Serious hypersensitivity reactions have been reported in patients receiving Venofer®. In clinical studies, several patients experienced hypersensitivity reactions presenting with wheezing, dyspnea, hypotension, rashes, or pruritus. 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.
Hypotension has been reported frequently in non-dialysis dependent-CKD patients receiving IV iron. Hypotension following administration of Venofer® may be related to rate of administration and total dose delivered.
In a multi-dose efficacy study in non-dialysis dependent-CKD patients (N=91), the most frequent adverse events (≥5%) whether or not related to Venofer® administration, were taste disturbance (7.7%), peripheral edema (7.7%), diarrhea (5.5%), constipation (5.5%), nausea (5.5%), dizziness (5.5%), and hypertension (5.5%). 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%), taste disturbance (7.7%), dizziness (6.6%), extremity pain (5.5%), and injection site burning (5.5%).
In multi-dose efficacy studies in HDD-CKD patients (N=231), the most frequent adverse events (> 5%) whether or not related to Venofer® administration, were 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 post-marketing safety studies in HDD-CKD patients (N=1051), the most frequent adverse events reported (>1%), whether or not related to Venofer® administration, were congestive heart failure, sepsis, and taste disturbance. In the study of PDD-CKD patients (N=75), the most frequent adverse events, whether or not related to Venofer®, reported by ≥5% of these patients were diarrhea (8.0%), peritoneal infection (8.0%) vomiting (8.0%), hypertension (8.0%), pharyngitis (6.7%), peripheral edema (5.3%), and nausea (5.3%).

Anaemia Management

Iron plays a critical role in the transport of oxygen and oxidative metabolism. Two important iron-containing proteins involved in these processes are hemoglobin and myoglobin. If stores of iron within the body become depleted, several processes are affected including erythropoiesis. As iron deficiency progresses and requirements for erythropoiesis are not met anemia may occur.

Adapted from Jacinto et al.¹

Iron Deficiency Anemia and CKD
Chronic Kidney Disease (CKD) is a progressive disease that gradually impairs kidney function, usually over a period of years. It often progresses to end stage renal disease (ESRD), where the kidneys fail and renal replacement therapy such as dialysis or transplantation is required to sustain life. A significant complication of CKD is iron deficiency anemia, which develops early in the course of the disease and progresses with loss of renal function. Causes of iron deficiency in CKD patients include:

Use of ESAs
Restricted diets
Loss of blood (GI bleed, hemodialysis)

Functional Iron Deficiency vs Absolute Iron Deficiency
Functional iron deficiency is defined as a condition in which there is a failure to release iron rapidly enough to keep pace with the demands of the bone marrow for erythropoiesis, despite adequate total body iron stores. This condition is commonly associated with ESA usage:

Dramatic increase in RBC production, Hb, and Hct due to ESA
Iron uptake by erythroid cells is increased to meet demand of increased RBC production.
Reticuloendothelial cells are unable to release stores of iron fast enough to meet demand.
Despite adequate levels of stored iron (ferritin), insufficient iron is available for epoetin-stimulated RBC production.
Eventually iron deficiency erythropoiesis develops; the RBCs produced are small and have low Hb content.
In time, iron deficiency limits the response to epoetin therapy, and higher doses of epoetin are required to reach target Hb and Hct levels.

Absolute iron deficiency occurs when total body iron stores become depleted. The amount of stored iron is no longer adequate to meet the demands for erythropoiesis.

Lab Values to Differentiate Function and Absolute Iron Deficiency

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New Program

Program Overview
American Regent Inc., created the Venofer^® (iron sucrose injection, USP) Patient Assistance Program to help improve access to Venofer^® for adult CKD patients who lack health insurance and cannot afford therapy.

If a patient is eligible, American Regent will replace the Venofer^® provided free of charge while the patient is enrolled in the program.

American Regent reserves the right to modify or cancel the Program immediately with respect to any patient, or in its entirety, at any time.

Program Eligibility
To be eligible for the program, patients must completely lack health insurance and be ineligible for public insurance or financing. The patient must also be a US citizen, legal entrant in the United States, or permanent resident. Proof of citizenship or legal residency may also be required. Patients must also meet income and other criteria established by American Regent.

How to Apply
Providers may apply to the Program on behalf of their patients by following these steps.

Step 1: Provider submits patient application
A hospital, physician, or infusion center may apply to the Program on behalf of its patients. The provider submits a patient application for each patient, which is used to determine patient eligibility. A link to a copy of this form is provided below:

Patient Assistance Program Application (requires Adobe^® Reader^®)

The provider may also contact the Program at 800-282-7712 to apply by telephone. Program staff will ask the healthcare provider for the patient's insurance and financial information to determine whether the patient is likely to qualify.

(Note: All release of information is subject to patient authorization and consent.)

Step 2: Provider and patient are notified of enrollment status.
The provider and patient will receive notification by mail of the patient's enrollment or denial. If approved, the patient is eligible for replacement product during the enrollment period.

Step 3: Provider requests replacement Venofer^®
If the patient is approved, the provider submits a product replacement request for each patient at the end of each month. This form documents the amount of Venofer^® provided to the patient free of charge and must be signed by a physician. The provider will receive free replacement vials approximately 30 days after the product replacement request is received by the Program. A link to a copy of this form is provided below:

Patient Assistance Program Product Request (requires Adobe^® Reader^®)

Step 4: Provider reapplies if continued assistance is required
Providers may reapply on behalf of their patients by completing a new patient application or by calling the Program at the end of the patient's enrollment period. All Program forms should be sent to:

Venofer^® Patient Assistance Program
c/o InTeleCenter^™
PO Box 4280
Gaithersburg, MD 20885-4133
Fax: 240-632-3001

How to Contact the Program
Healthcare providers who would like to apply on behalf of their patients should call the Venofer^® Patient Assistance Program at 800-282-7712.

Program staff is available Monday through Friday between 9:00 AM and 5:00 PM, Eastern time. If you call at another time, please leave your name and telephone number, and program staff will return your call within one business day.

Or write to this address:

Venofer^® Patient Assistance Program
c/o InTeleCenter^™
PO Box 4280
Gaithersburg, MD 20885-4133

Adobe^® Reader^® is a registered trademark of Adobe Systems Incorporated.

Disclaimer: This web page is not intended to provide legal, medical, or other professional advice. This information is provided for reference only. American Regent, Inc. makes no representations or guarantees regarding the completeness or accuracy of the information in this guide and has no obligation to update this guide to reflect changes in laws that may affect reimbursement for Venofer^® (iron sucrose injection, USP). For assistance with legal or medical issues, you are urged to consult a qualified professional.

American Regent. Enriching the lives of anemia patients. ™

Reimbursement hotline

Venofer^® Reimbursement Hotline: 1-800-282-7712
FOR NON-DIALYSIS FACILITIES AND PROVIDERS ONLY

American Regent, Inc. has created a toll-free hotline to help physicians and other providers understand payer’s coverage and reimbursement policies for Venofer^® (iron sucrose injection, USP) and, when necessary, address reimbursement issues. Specifically, hotline Reimbursement Specialists assist with the following:

Insurance verifications. Help callers verify payer coverage and reimbursement policies for Venofer^® for specific patients with patient consent. Reimbursement specialists will determine patients’ benefits level and discuss potential billing options.
Billing assistance. Assist callers with filing claims and understanding the reimbursement policies for Venofer^®, including researching state-specific local codes.
Claims appeals. Support callers in appealing denied claims or inadequate reimbursement for Venofer^®.
Patient assistance. Screen individuals with no health insurance who are ineligible for public assistance for enrollment in a free product replacement program.

Instructions on Using the Reimbursement Hotline

Hours of operation are Monday through Friday from 9:00 AM to 5:00 PM, Eastern time. Call toll-free 800-282-7712
A Reimbursement Specialist answers most calls. There may be times when you need to leave a message that includes your name, telephone number, and a brief summary of your question or request. Calls are returned on the same day, or within one business day whenever possible
During your call, you will be asked to provide the following information:
- Name and telephone number(s) of the patient's primary and secondary third-party payer(s)
- Patient's name, date of birth, policy holder's name, and policy number(s)
- Your reimbursement questions

Patient information will be kept strictly confidential at all times

The Reimbursement Specialist will either provide you with the information you request or will contact the insurer for clarification. The Reimbursement Specialist will call you back with the information you requested.

There is no limit to the number of times you call or the number of cases you may discuss with the Reimbursement Specialist, and there is no charge for this service.

Every attempt is made to provide accurate, up-to-date information. The Venofer^® Reimbursement Hotline cannot guarantee successful reimbursement.

For more details about coverage and reimbursement, call the Venofer^® Reimbursement Hotline at 800-282-7712, Monday through Friday, 9:00 AM to 5:00 PM, Eastern time.

For Customer Service or Professional Services Departments, call 800-645-1706.

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Venofer

Friday, February 18, 2011

Pharmacy specifications

Clinical efficacy and safety

Indications and dosage

About Venofer

Venofer iron sucrose injection, USP. Reinvigorating anemia management

Anaemia Management

Venofer iron sucrose injection, USP. Reinvigorating anemia management

New Program

Venofer iron sucrose injection, USP. Reinvigorating anemia management

Reimbursement hotline

Venofer iron sucrose injection, USP. Reinvigorating anemia management