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.
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%).
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.
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Venofer iron sucrose injection, USP. Reinvigorating anemia management
American Regent. Enriching the lives of anemia patients. ™
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%).
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