This information is intended for U.S. healthcare professionals and/or healthcare professionals involved in healthcare reimbursement only.
Financial Assistance
- Assistance of up to $500 per dose
- Enrollment is valid for 2 courses of treatment per 12-month period
Register your office by calling AR Assist 1-877-448-4766
- AR Assist will provide you with a login for injectafercopay.com
- Registration only needs to be completed once
Before administering Injectafer, enroll your patient
- Login here (you can also enroll the patient at 1-877-448-4766)
- Enter required patient information
- For each patient, you’ll receive a 16-digit code for a virtual copay assistance card upon approval
After treatment, log in and submit EOB form
- Login here
- Submit the Explanation of Benefits (EOB) form for the Injectafer treatment
- There are 3 ways to send the EOB form†:
- Best way to submit EOBs and manage all patients
OR
Fax to 1-888-257-4673
OR
Morristown, NJ 07962
- It usually takes 2-3 days for EOB to be approved
- Then, funds will be uploaded onto the virtual 16-digit debit card
*The Injectafer Savings Program is only available for patients aged 1 year or older who are commercially insured. Please see full Terms and Conditions.
†When forms are uploaded to injectafercopay.com, the process may potentially be expedited. For patients who wish to directly submit their EOB form, please direct them to fax or mail the form to the Injectafer Savings Program.
Injectafer Savings Program Terms and Conditions
- This offer is valid for commercially insured patients. Uninsured and cash-paying patients are NOT eligible for this Program.
- Depending on insurance coverage, eligible patients may pay no more than $50 per dose for up to four doses per calendar year. There is a maximum savings limit of $500 per dose, with an overall program limit of $2,000 per calendar year. Check with your pharmacist or healthcare provider for your co-pay discount. Patient out-of-pocket expense may vary.
- This offer is not valid for patients enrolled in Medicare Part B or Medicare Part D, Medicaid, or other federal or state healthcare programs, or private indemnity or HMO insurance plans that reimburse you for the entire cost of your prescription drugs. Patients may not use this card if they are Medicare-eligible and enrolled in an employer-sponsored health plan or medical or prescription drug benefit program for retirees.
- An explanation of benefits (EOB) statement must be faxed, uploaded in the portal, or mailed in prior to transacting on the account numbers for co-pay assistance.
- Offer is invalid for claims or transactions more than 180 days from the date on the EOB.
- Patients will be automatically re-enrolled in the next calendar year. If there is no copay claim activity for 18 months, the enrollment will be canceled.
- American Regent, Inc. reserves the right to rescind, revoke or amend this offer without notice. Offer good only in the USA, including Puerto Rico, at participating pharmacies or healthcare providers.
- Void if prohibited by law, taxed, or restricted.
- This account number is not transferable. The selling, purchasing, trading, or counterfeiting of this account number is prohibited by law.
- This account number is not insurance.
- By redeeming this account number, you acknowledge that you are an eligible patient and that you understand and agree to comply with the terms and conditions of this offer.
- Qualified patients receiving Injectafer will be allowed a 180-day retroactive enrollment period from the date of EOB (eligibility of benefit form) to receive benefits under the program rules.
Q :
What is the
Injectafer Savings
Program?
A :
The Injectafer
Savings Program
helps patients being
treated with
Injectafer with
their prescription
out-of-pocket
responsibility.
Q :
Is the Injectafer
Savings Program only
valid on Injectafer
prescriptions?
A :
Yes, the program can
only be used toward
a patient's
prescription
out-of-pocket
responsibility for
the Injectafer
medication.
Q :
How much can a
patient save?
A :
The program
helps with up to
$500 per dose. A
patient can save a
maximum benefit of
up to $1000 per
course of treatment.
Enrollment is valid
for 2 courses
of
treatment per
12-month period.
Q :
Which patients are
eligible to
participate?
A :
Commercially insured
patients are
eligible to enroll.
Cash-paying patients
and patients with
drug coverage under
any federally funded
healthcare
program,
including but
not limited to
Medicare, Medicaid,
TRICARE, or other
state-funded
programs
(collectively FHCP),
will be ineligible
to participate.
Q :
If I recommend
additional therapy
with Injectafer, can
my patient still use
the program?
A :
Yes, if you
recommend additional
treatment with
Injectafer, the
program will help
cover your patient’s
prescription
out-of-pocket
responsibility. The
offer is valid for 2
courses of an
Injectafer
prescription. An
explanation of
benefits statement
must be faxed,
uploaded in the
portal, or mailed in
prior to transacting
on the account
numbers for
assistance. One
enrollment is
allowed per 12-month
period.
Q :
How does the
Injectafer Savings
Program work?
:A:An
interested patient
can visit
the Savings
Program
website and
enroll in the
program or you can
enroll the patient
on their behalf.
Following
confirmation of
eligibility, an
Injectafer Savings
Program virtual
debit card number
will be issued to
the patient; that
number is then given
to the patient's
healthcare provider.
The Savings Program
requires that once
the patient receives
each dose, an
explanation of
benefits or itemized
statement from his
or her healthcare
provider be sent to
the program via fax,
mail, or the upload
tool. The program
fax number is
1-888-257-4673. Once
this information is
received, the claims
department will load
funds to the virtual
card within 2-3
business days.
Q :
Is proof of purchase
necessary?
: A:
Yes.
After each dose, you
and your patient
will receive an
explanation of
benefits form from
your patient's
insurance provider.
This document will
need to be sent to
the program to load
funds to the
patient's virtual
debit card. There
are 3 ways to send
the EOB
form: 1. Upload
at
injectafercopay.com
(this is the best
way to submit EOBs
and manage all
patients); 2. Fax
to
1-888-257-4673; 3. Mail
to Injectafer
Savings Program, PO Box 2355
Morristown, NJ 07962
Q :
What
happens if an
explanation of
benefits is not sent
in?
A :
The funds will not
be available to the
patient until this
documentation is
submitted.
Q :
What do I do if my
practice cannot
process credit or
debit cards?
A :
In situations where
a dispensing entity
does not accept
debit or credit card
payments, the
program will provide
reimbursement for
the patient's
eligible
out-of-pocket
expense in
accordance with the
program via paper
check upon receiving
a receipt of the
incurred
out-of-pocket
expense for
Injectafer. To do
this, you will need
a check request
form. (The best
place to get the
form is online at
injectafercopay.com
or, alternately, by
calling
1-877-448-4766.) If
your office requires
a 3-digit security
code for processing,
please call us at
1-877-448-4766.
Q :
What if I administer
Injectafer before my
patient has enrolled
in the Savings
Program?
A :
Qualified patients
receiving Injectafer
will be allowed a
120-day retroactive
enrollment period to
receive benefits
under the program
rules.
American Regent, Inc., makes no representation or guarantee concerning coverage or reimbursement for any service or item. A completed form includes signatures from both the physician and the patient. Before submitting, please ensure all required information is provided.
- Meet 500% or less of Federal Poverty Level for household income
- Lack health insurance completely or be commercially underinsured
- Be a resident of the United States or Puerto Rico
- Download the Patient Enrollment Form and Product Request Form then fax both forms to 1-833-471-9988 (preferred method for fastest support)
- Call 1-877-448-4766
- Submit the Patient Enrollment Form before the patient’s infusion and confirm enrollment
- Plan at least 8 days in advance. In most cases, if you submit the Product Request Form by EOD Wednesday, the product will be shipped overnight on the following Wednesday. (Holidays and weather may cause delays.)
*Patients enrolled between
October 1 and December 31 are enrolled
through the following calendar year.
†The company reserves the right
to modify or cancel the program immediately
with respect to any patient, or in its
entirety, at any time.
American Regent, Inc., makes no representation or guarantee concerning coverage or reimbursement for any service or item. A completed form includes signatures from both the physician and the patient. Before submitting, please ensure all required information is provided.
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
Symptomatic Hypophosphatemia
Symptomatic hypophosphatemia with serious outcomes including osteomalacia and fractures requiring clinical intervention has been reported in patients treated with Injectafer in the post-marketing setting. These cases have occurred mostly after repeated exposure to Injectafer in patients with no reported history of renal impairment. However, symptomatic hypophosphatemia has been reported after one dose. Possible risk factors for hypophosphatemia include a history of gastrointestinal disorders associated with malabsorption of fat-soluble vitamins or phosphate, inflammatory bowel disease, concurrent or prior use of medications that affect proximal renal tubular function, hyperparathyroidism, vitamin D deficiency, malnutrition, and hereditary hemorrhagic telangiectasia (HHT or Osler-Weber-Rendu syndrome). In most cases, hypophosphatemia resolved within three months.
Correct pre-existing hypophosphatemia prior to initiating therapy with Injectafer. Monitor serum phosphate levels in patients at risk for chronic low serum phosphate. Check serum phosphate levels prior to a repeat course of treatment in patients at risk for low serum phosphate and in any patient who receives a second course of therapy within three months. Treat hypophosphatemia as medically indicated.
Hypersensitivity Reactions
Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Injectafer. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Injectafer administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Injectafer when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. In clinical trials, serious anaphylactic/anaphylactoid reactions were reported in 0.1% (2/1775) of subjects receiving Injectafer. Other serious or severe adverse reactions potentially associated with hypersensitivity which included, but were not limited to, pruritus, rash, urticaria, wheezing, or hypotension were reported in 1.5% (26/1775) of these subjects.
Hypertension
In clinical studies, hypertension was reported in 4% (67/1775) of subjects in clinical trials 1 and 2. Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed in 6% (106/1775) of subjects in these two clinical trials. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor patients for signs and symptoms of hypertension following each Injectafer administration.
Laboratory Test Alterations
In the 24 hours following administration of Injectafer, laboratory assays may overestimate serum iron and transferrin bound iron by also measuring the iron in Injectafer.
ADVERSE REACTIONS
Adults
In two randomized clinical studies [Studies 1 and 2], a total of 1775 patients were exposed to Injectafer, 15 mg/kg of body weight, up to a maximum single dose of 750 mg of iron on two occasions, separated by at least 7 days, up to a cumulative dose of 1500 mg of iron. Adverse reactions reported by >2% of Injectafer-treated patients were nausea (7.2%); hypertension (4%); flushing (4%); injection site reactions (3%); erythema (3%); hypophosphatemia (2.1%); and dizziness (2.1%).
Pediatric
The safety of Injectafer in pediatric patients was evaluated in Study 3. Study 3 was a randomized, active-controlled study in which 40 patients (1 to 12 years of age: 10 patients, 12 to 17 years of age: 30 patients) received Injectafer 15 mg/kg to a maximum single dose of 750 mg (whichever was smaller) on Days 0 and 7 for a maximum total dose of 1500 mg; 38 patients evaluable for safety in the control arm received an age-dependent formulation of oral ferrous sulfate for 28 days. The median age of patients who received Injectafer was 14.5 years (range, 1-17); 83% were female; 88% White and 13% Black. The most common adverse reactions (≥4%) were hypophosphatemia (13%), injection site reactions (8%), rash (8%), headache (5%), and vomiting (5%).
Patients with Iron Deficiency and Heart Failure
The safety of Injectafer was evaluated in adult patients with iron deficiency and heart failure in randomized controlled trials FAIR-HF (NCT00520780), CONFIRM-HF (NCT01453608) and AFFIRM-AHF (NCT02937454) in which 1016 patients received Injectafer versus 857 received placebo. The overall safety profile of Injectafer was consistent across the studied indications.
Post-Marketing Experience
The following adverse reactions have been identified during post approval use of Injectafer. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following adverse reactions have been reported from the post-marketing spontaneous reports with Injectafer: cardiac disorders : tachycardia; general disorders and administration site conditions : chest discomfort, chills, pyrexia; metabolism and nutrition disorders : hypophosphatemia; musculoskeletal and connective tissue disorders : arthralgia, back pain, hypophosphatemic osteomalacia; nervous system disorders : syncope; respiratory, thoracic and mediastinal disorders : dyspnea; skin and subcutaneous tissue disorders : angioedema, erythema, pruritus, urticaria; pregnancy: fetal bradycardia.
USE IN SPECIFIC POPULATIONS
Pregnancy – Fetal/Neonatal Adverse Reactions
Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with parenteral iron products (such as Injectafer) which may cause fetal bradycardia, especially during the second and third trimester.
You are encouraged to report Adverse Drug Events to American Regent, Inc. at 1-800-734-9236 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.
INDICATIONS
Injectafer and the Injectafer logo, Venofer and the Venofer logo are registered trademarks of Vifor (International) Inc., Switzerland. American Regent, the American Regent logo, AR Assist and the AR Assist logo are registered trademarks of American Regent, Inc. All rights reserved.
Injectafer and Venofer are manufactured under license from Vifor (International) Inc., Switzerland.
PP-VE-US-0137 (v3.0)