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How to Acquire AVEED®
for Your Patients
This guide provides helpful how-to information about:
• Becoming an AVEED® prescriber
• Ordering AVEED®
• Locating billing and coding information for your AVEED® order
• Navigating reimbursement and insurance
• Providing savings to your AVEED® patients
INDICATION AND IMPORTANT SAFETY
INFORMATION
WARNING: SERIOUS PULMONARY OIL MICROEMBOLISM
(POME) REACTIONS AND ANAPHYLAXIS
•S
erious POME reactions, involving urge to cough,
dyspnea, throat tightening, chest pain, dizziness, and
syncope; and episodes of anaphylaxis, including
life-threatening reactions, have been reported to occur
during or immediately after the administration of
testosterone undecanoate injection. These reactions
can occur after any injection of testosterone
undecanoate during the course of therapy, including
after the first dose.
•F
ollowing each injection of AVEED®, observe patients in
the healthcare setting for 30 minutes in order to provide
appropriate medical treatment in the event of serious
POME reactions or anaphylaxis.
•B
ecause of the risks of serious POME reactions and
anaphylaxis, AVEED® is available only through a restricted
program under a Risk Evaluation and Mitigation Strategy
(REMS) called the AVEED® REMS Program.
INDICATIONS AND USAGE
AVEED® is indicated for testosterone replacement
therapy in adult males for conditions associated with
a deficiency or absence of endogenous testosterone.
• Primary hypogonadism (congenital or acquired):
testicular failure due to cryptochordism, bilateral torsion,
orchitis, vanishing testis syndrome, orchiectomy,
Klinefelter’s syndrome, chemotherapy, or toxic damage
from alcohol or heavy metals. These men usually have
low serum testosterone concentrations and
gonadotropins (follicle-stimulating hormone [FSH],
luteinizing hormone [LH]) above the normal range.
•H
ypogonadotropic hypogonadism (congenital or
acquired): idiopathic gonadotropin or luteinizing
hormone-releasing hormone (LHRH) deficiency or
pituitary-hypothalamic injury from tumors, trauma,
or radiation. These men have low testosterone serum
concentrations but have gonadotropins in the normal
or low range.
AVEED® should only be used in patients who require
testosterone replacement therapy and in whom the
benefits of the product outweigh the serious risks
of pulmonary oil microembolism and anaphylaxis.
Limitations of use:
•S
afety and efficacy of AVEED® in males less than
18 years old have not been established.
Please see full Important Safety Information on pages 9-11 and accompanying full Prescribing Information,
including Boxed Warning.
AVEED® Provider Enrollment Program
Why Is Enrollment Required?
The AVEED® Provider Enrollment Program is required by the FDA. The program is designed to train
all healthcare professionals who prescribe and/or administer AVEED® about the risk of immediate
post-injection reactions, specifically pulmonary oil microembolism (POME) and anaphylaxis.
Among 3,556 patients in worldwide clinical trials1:
• 9 POME events occurred in 8 patients
• 2 events of anaphylaxis occurred
Program Requirements
Healthcare settings must
be certified in the AVEED®
REMS* Program to be able
to order AVEED®. One
representative needs to
enroll per healthcare
setting (the “Authorized
Representative”).
Prescribing Healthcare
Providers must be
certified in the AVEED®
REMS Program to be able
to prescribe AVEED®.
Non-prescribing
Healthcare Providers
who will administer
AVEED® to patients
must be trained on
the AVEED® REMS
Education Program for
Healthcare Providers.
*Risk Evaluation and Mitigation Strategy
For further information and to enroll in the AVEED® Provider Enrollment
Program, please visit the AVEED® Provider Enrollment Program website
at AveedREMS.com or call 1-855-755-0494 to request materials.
IMPORTANT SAFETY INFORMATION (CONT)
WARNINGS AND PRECAUTIONS
• Serious Pulmonary Oil Microembolism (POME) Reactions and Anaphylaxis
Serious POME reactions, involving cough, urge to cough, dyspnea, hyperhidrosis, throat tightening,
chest pain, dizziness, and syncope, have been reported to occur during or immediately after the injection
of intramuscular testosterone undecanoate 1000 mg (4 mL). The majority of these events lasted a few
minutes and resolved with supportive measures; however, some lasted up to several hours and some
required emergency care and/or hospitalization. To minimize the risk of intravascular injection of
AVEED®, care should be taken to inject the preparation deeply into the gluteal muscle, being sure to
follow the recommended procedure for intramuscular administration.
2
• AVEED® Risk Evaluation and Mitigation Strategy (REMS) Program
AVEED® is available only through a restricted program called the AVEED® REMS Program because of the risk
of serious POME and anaphylaxis.
Notable requirements of the AVEED® REMS Program include the following:
• Healthcare providers who prescribe AVEED® must be certified with the REMS Program before ordering or
dispensing AVEED®.
• Healthcare settings must be certified with the REMS Program and have healthcare providers who are
certified before ordering or dispensing AVEED®. Healthcare settings must have on-site access to equipment
and personnel trained to manage serious POME and anaphylaxis.
Further information is available at www.AveedREMS.com or call 1-855-755-0494.
Steps for Healthcare Setting Enrollment
1
Get started at AveedREMS.com
2
Review Training Materials
3
Complete Enrollment Process
4
Implementation
Designate an Authorized Representative. This may be a prescribing or non-prescribing HCP,
practice manager, or any responsible individual in a healthcare setting.
Review the AVEED® REMS Education Program for Healthcare Settings, including
Prescribing Information.
Complete and sign the Healthcare Setting Enrollment Form. This enrollment must
be renewed every 2 years.
Implement the necessary staff training and processes to comply with the AVEED® REMS
Program requirements.
Steps for Healthcare Provider Enrollment
1
Ensure that Your Healthcare Setting Is Enrolled
2
Get Started at AveedREMS.com
3
Review Training Materials
4
Complete Knowledge Assessment and Submit Enrollment Form
Healthcare Providers can begin the process to becoming certified to prescribe AVEED® by
creating an account with the AVEED® Provider Enrollment Program at AveedREMS.com.
After creating an account, Healthcare Providers will be able to access and review the AVEED®
REMS Education Program for Healthcare Providers, including Prescribing Information.
Successfully complete the 10-question Knowledge Assessment, then sign and submit the
one-time Healthcare Provider Enrollment Form to begin prescribing AVEED®.
IMPORTANT SAFETY INFORMATION (CONT)
• Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer - Patients with BPH
treated with androgens are at an increased risk of worsening of signs and symptoms of BPH. Monitor patients
with BPH for worsening signs and symptoms. Patients treated with androgens may be at an increased risk for
prostate cancer. Evaluate patients for prostate cancer prior to initiating and during treatment with androgens.
• Polycythemia - Increases in hematocrit, reflective of increases in red blood cell mass, may require
discontinuation of testosterone. Check hematocrit prior to initiating testosterone treatment. It would be
appropriate to re-evaluate the hematocrit 3 to 6 months after starting testosterone treatment, and then
annually. If hematocrit becomes elevated, stop therapy until hematocrit decreases to an acceptable level.
An increase in red blood cell mass may increase the risk of thromboembolic events.
Please see full Important Safety Information on pages 9-11 and accompanying full Prescribing
Information, including Boxed Warning.
3
– Reimbursement Hotline
A Helpful Resource for Navigating Insurance, Acquiring AVEED®, Reimbursement, and More
myAVEED is your one-stop source for product support. With myAVEED, healthcare professionals call just
one phone number for assistance with:
• Contacting patient health plan to verify
benefit coverage and eligibility
• Ordering and processing Specialty
Pharmacy prescriptions
• Ordering AVEED® for your patients
• Managing prior authorizations
• Reimbursement support
• Determining eligibility and enrollment
in the AVEED® Patient Savings Program
• Questions about coding AVEED® on
health plan claims
Get Started With myAVEED
• In order to access the support provided by myAVEED, please
contact a hotline representative at 1-855-myAVEED (692-8333)
• To initiate a benefits investigation or a prescription via
Specialty Pharmacy, complete and fax a Benefits Investigation
and Enrollment Form and a Patient Authorization Form to
1-877-488-6701
•T
o determine patient eligibility for the AVEED® Patient Savings
Program, have the patient sign the Patient Savings portion of
the Patient Authorization Form and fax it along with the
Benefits Investigation and Enrollment Form
FAX A BENEFITS
INVESTIGATION AND
ENROLLMENT FORM TO
1-877-488-6701
OR CALL FOR ASSISTANCE
1-855-myAVEED (692-8333)
8 am to 8 pm EST
• Forms are available through your sales representative or by
visiting AveedUSA.com/PrescriberResources
IMPORTANT SAFETY INFORMATION (CONT)
4
•V
enous thromboembolism (VTE) - There have been postmarketing reports of venous thromboembolic events,
including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone products,
such as AVEED®. Evaluate patients who report symptoms of pain, edema, warmth and erythema in the lower
extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic
event is suspected, discontinue treatment with AVEED® and initiate appropriate workup and management.
•U
se in Women - Due to lack of controlled evaluations in women and potential virilizing effects, AVEED® is
not indicated for use in women.
•P
otential for Adverse Effects on Spermatogenesis - With large doses of exogenous androgens, including
AVEED®, spermatogenesis may be suppressed through feedback inhibition of pituitary follicle-stimulating
hormone (FSH) which could possibly lead to adverse effects on semen parameters including sperm count.
•H
epatic Adverse Effects - Prolonged use of high doses of orally active 17-alpha-alkyl androgens (e.g.,
methyltestosterone) has been associated with serious hepatic adverse effects (peliosis hepatis, hepatic
neoplasms, cholestatic hepatitis, and jaundice). Peliosis hepatis can be a life-threatening or fatal
complication. Long-term therapy with intramuscular testosterone enanthate, which elevates blood levels
for prolonged periods, has produced multiple hepatic adenomas. AVEED® is not known to produce these
adverse effects. Nonetheless, patients should be instructed to report any signs or symptoms of hepatic
dysfunction (e.g., jaundice). If these occur, promptly discontinue AVEED® while the cause is evaluated.
Ordering AVEED®
Choose Buy-and-Bill or Specialty Pharmacy
Depending on your preferences, and your patient’s health plans, you may order AVEED® via one of these
two methods:
1
uy-and-Bill: Buy AVEED® exclusively through one of the Specialty Distributors listed below and
B
bill it to the patient or patient’s health plan along with professional services. Collect copay/coinsurance
from the patient.
Buy-and-Bill Distributors
2
Besse Medical
Cardinal Specialty
888-252-5585
Acute Care: 866-476-1340
Urology: 866-300-3838
www.besse.com
specialtyonlinecardinalhealth.com
McKesson Specialty
Smith Medical Partners
855-477-9800
800-292-9653
https://mscs.mckesson.com
www.smpspecialty.com
Specialty Pharmacy: Getting started via Specialty Pharmacy is as easy as completing and faxing a
Benefits Investigation and Enrollment Form to myAVEED at 1-877-488-6701. With the help of myAVEED,
you can acquire AVEED® exclusively through a Specialty Pharmacy Provider, which bills the patient or
patient’s health plan directly, then delivers the medication after payment is received. In this scenario,
you only bill for your professional services. The prescription will be sent to a certified healthcare setting,
such as your office or hospital.
To order via Specialty Pharmacy, fax a Benefits Investigation and
Enrollment Form to 1-877-488-6701, or call 1-855-myAVEED (692-8333)
IMPORTANT SAFETY INFORMATION (CONT)
• Edema - Androgens, including AVEED®, may promote retention of sodium and water. Edema with or
without congestive heart failure may be a serious complication in patients with preexisting cardiac, renal,
or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required.
•G
ynecomastia - Gynecomastia occasionally develops and occasionally persists in patients being treated
for hypogonadism.
•S
leep Apnea - The treatment of hypogonadal men with testosterone products may potentiate sleep apnea
in some patients, especially those with risk factors such as obesity or chronic lung diseases.
• Lipids - Changes in serum lipid profile may require dose adjustment of lipid lowering drugs or
discontinuation of testosterone therapy.
•H
ypercalcemia - Androgens, including AVEED®, should be used with caution in cancer patients at risk of
hypercalcemia (and associated hypercalciuria). Regular monitoring of serum calcium concentrations is
recommended in these patients.
Please see full Important Safety Information on pages 9-11 and accompanying full Prescribing
Information, including Boxed Warning.
5
AVEED® Patient Savings Program
$0 Copay on Your Patient’s
First 2 Injections
…and No More Than $30 Copay for Each Additional Injection*
Eligible patients pay $0 copay on their first 2 injections with the AVEED® Patient Savings Program.*
The program will pay up to a maximum reimbursement of $165 for each of their first 2 AVEED® injections—
PLUS, up to a maximum reimbursement of $135 for each injection thereafter. If their total out of pocket
expense exceeds these amounts, they are responsible for the additional amounts.
Some restrictions apply.† Offer not valid for prescriptions that may be reimbursed under a federal or state
healthcare program, including Medicare, Medicaid, or any other federal or state healthcare programs.
AveedUSA.com
IMPORTANT SAFETY INFORMATION (CONT)
•D
ecreased Thyroxine-binding Globulin - Androgens, including AVEED®, may decrease concentrations
of thyroxine-binding globulin, resulting in decreased total T4 serum concentrations and increased resin
uptake of T3 and T4. Free thyroid hormone concentrations remain unchanged, however, and there is no
clinical evidence of thyroid dysfunction.
•L
aboratory Monitoring - Monitor prostatic specific antigen (PSA), hemoglobin, hematocrit, and lipid
concentrations at the start of treatment and periodically thereafter.
ADVERSE REACTIONS
AVEED® was evaluated in an 84-week clinical study using a dose regimen of 750 mg (3 mL) at initiation, at
4 weeks, and every 10 weeks thereafter in 153 hypogonadal men. The most commonly reported adverse
reactions (≥2%) were: acne, injection site pain, prostate specific antigen increased, hypogonadism, estradiol
increased, fatigue, irritability, hemoglobin increased, insomnia, and mood swings.
In the 84-week clinical trial, 7 patients (4.6%) discontinued treatment because of adverse reactions. Adverse
reactions leading to discontinuation included: hematocrit increased, estradiol increased, prostatic specific
antigen increased, prostate cancer, mood swings, prostatic dysplasia, acne, and deep vein thrombosis.
6
Here’s how patients receive the rebate
If you choose the Buy-and-Bill method:
If your patient is insured, copay will need to be
collected by your practice. Your patient can
then submit a rebate form, along with their
Explanation of Benefits and the bill indicating
the amount the patient paid for AVEED®, to have
the rebate mailed to them. Rebate forms are
available from your Sales Representative or
through AveedUSA.com/PatientSavings.
Eligible patients paying cash can also receive
a rebate of up to $165.
If you choose to order via Specialty
Pharmacy with processing by myAVEED:
Patients will automatically be evaluated for copay
savings eligibility, and the savings will be applied
through the order, reducing the cost, once the
signed Patient Authorization Form has been
submitted. To get started, please contact a hotline
representative at 1-855-myAVEED (692-8333), or
complete and fax a Benefits Investigation and
Enrollment Form to 1-877-488-6701.
Download forms at AveedUSA.com/PhysicianResources
or contact your AVEED® sales representative.
*On the first 2 AVEED® injections, maximum savings is $165 per use. On subsequent injections, patient pays the first $30 of copay. Program
pays up to a maximum of $135 per use. Patient is responsible for any balance remaining, and for reporting receipt of this coupon benefit to
any insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the coupon, as may be
required. Patient and prescriber agree not to seek reimbursement for all or any part of the benefit received by the patient through this offer.
Terms and Conditions: Offer good only in the USA and void where prohibited or otherwise restricted by law. Offer is valid for patients with
private insurance or paying cash. Offer not valid for prescriptions that may be reimbursed under a federal or state healthcare program,
including Medicare, Medicaid, or any other federal or state healthcare programs, including any state medical pharmaceutical assistance
programs. If there are any questions, please call 1-800-381-2638.
†
Limitations apply, Endo Pharmaceuticals reserves the right to rescind, revoke, or amend this program without notice.
Patient is responsible for reporting receipt of program rewards to any private insurer that pays for or reimburses any part of the
prescriptions filled with this program.
Offer expires on 3/1/2015.
IMPORTANT SAFETY INFORMATION (CONT)
•P
ostmarketing Experience
Pulmonary Oil Microembolism (POME) and Anaphylaxis
Serious pulmonary oil microembolism (POME) reactions, involving cough, urge to cough, dyspnea,
hyperhidrosis, throat tightening, chest pain, dizziness, and syncope, have been reported to occur during or
immediately after the injection of intramuscular testosterone undecanoate 1000 mg (4 mL) in post-approval
use outside the United States.
In addition to serious POME reactions, episodes of anaphylaxis, including life-threatening reactions, have also
been reported to occur following the injection of intramuscular testosterone undecanoate in post-approval
use outside of the United States.
Please see full Important Safety Information on pages 9-11 and accompanying full Prescribing
Information, including Boxed Warning.
7
AVEED® Coding Information
Commonly Used Codes for AVEED®
Product Code (HCPCS)
J3490
Unclassified drugs
Unclassified drugs product code can be used for AVEED® until a specific AVEED® code
has been issued.
National Drug Code (NDC)
67979-511-43
(10-digit)
67979-0511-43
(11-digit)
AVEED® 750 mg/3 mL (250 mg/mL)
The 11-digit billing format is an electronic transaction standard required by many
health plans that require NDC codes for billing. Check with the health plan for the
requirements specific to your patient.
Diagnosis Code (ICD-9-CM)
257.2
Testicular dysfunction (other testicular hypofunction) – includes
testicular hypogonadism
CPT Code (Intramuscular Injection of AVEED®)
96372
8
Therapeutic, prophylactic, or diagnostic injection (specify
substance or drug); subcutaneous or intramuscular
INDICATION AND IMPORTANT SAFETY
INFORMATION
WARNING: SERIOUS PULMONARY OIL MICROEMBOLISM
(POME) REACTIONS AND ANAPHYLAXIS
•S
erious POME reactions, involving urge to cough,
dyspnea, throat tightening, chest pain, dizziness, and
syncope; and episodes of anaphylaxis, including
life-threatening reactions, have been reported to
occur during or immediately after the administration
of testosterone undecanoate injection. These
reactions can occur after any injection of testosterone
undecanoate during the course of therapy, including
after the first dose.
•F
ollowing each injection of AVEED®, observe
patients in the healthcare setting for 30 minutes in
order to provide appropriate medical treatment in
the event of serious POME reactions or anaphylaxis.
•B
ecause of the risks of serious POME reactions and
anaphylaxis, AVEED® is available only through a restricted
program under a Risk Evaluation and Mitigation Strategy
(REMS) called the AVEED® REMS Program.
INDICATIONS AND USAGE
AVEED® is indicated for testosterone replacement
therapy in adult males for conditions associated with
a deficiency or absence of endogenous testosterone.
• Primary hypogonadism (congenital or acquired):
testicular failure due to cryptochordism, bilateral
torsion, orchitis, vanishing testis syndrome,
orchiectomy, Klinefelter’s syndrome,
chemotherapy, or toxic damage from alcohol or
heavy metals. These men usually have low serum
testosterone concentrations and gonadotropins
(follicle-stimulating hormone [FSH], luteinizing
hormone [LH]) above the normal range.
• Hypogonadotropic hypogonadism (congenital or
acquired): idiopathic gonadotropin or luteinizing
hormone-releasing hormone (LHRH) deficiency or
pituitary-hypothalamic injury from tumors,
trauma, or radiation. These men have low
testosterone serum concentrations but have
gonadotropins in the normal or low range.
AVEED® should only be used in patients who require
testosterone replacement therapy and in whom the
benefits of the product outweigh the serious risks of
pulmonary oil microembolism and anaphylaxis.
Limitations of use:
• Safety and efficacy of AVEED® in males less than
18 years old have not been established.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
• Men with carcinoma of the breast or known or
suspected carcinoma of the prostate.
•W
omen who are or may become pregnant, or who
are breastfeeding. Testosterone can cause fetal
harm when administered to a pregnant woman.
AVEED® may cause serious adverse reactions in
nursing infants. Exposure of a fetus or nursing
infant to androgens may result in varying degrees
of virilization.
•M
en with known hypersensitivity to AVEED® or any
of its ingredients (testosterone undecanoate,
refined castor oil, benzyl benzoate).
WARNINGS AND PRECAUTIONS
• Serious Pulmonary Oil Microembolism (POME)
Reactions and Anaphylaxis
Serious POME reactions, involving cough, urge to
cough, dyspnea, hyperhidrosis, throat tightening,
chest pain, dizziness, and syncope, have been
reported to occur during or immediately after the
injection of intramuscular testosterone
undecanoate 1000 mg (4 mL). The majority of
these events lasted a few minutes and resolved
with supportive measures; however, some lasted
up to several hours and some required emergency
care and/or hospitalization. To minimize the risk
of intravascular injection of AVEED®, care should
be taken to inject the preparation deeply into the
gluteal muscle, being sure to follow the recommended
procedure for intramuscular administration.
In addition to serious POME reactions, episodes of
anaphylaxis, including life-threatening reactions, have
also been reported to occur following the injection of
intramuscular testosterone undecanoate.
Both serious POME reactions and anaphylaxis can
occur after any injection of testosterone undecanoate
during the course of therapy, including after the first
Please see additional full Important Safety Information on pages 10-11 and accompanying full Prescribing
Information, including Boxed Warning.
9
IMPORTANT SAFETY INFORMATION (CONT)
dose. Patients with suspected hypersensitivity reactions
to AVEED® should not be re-treated with AVEED®.
Following each injection of AVEED®, observe patients
in the healthcare setting for 30 minutes in order to
provide appropriate medical treatment in the event
of serious POME reactions and anaphylaxis.
•A
VEED® Risk Evaluation and Mitigation Strategy
(REMS) Program
AVEED® is available only through a restricted program
called the AVEED® REMS Program because of the risk
of serious POME and anaphylaxis.
Notable requirements of the AVEED® REMS Program
include the following:
•H
ealthcare providers who prescribe AVEED® must
be certified with the REMS Program before
ordering or dispensing AVEED®.
•H
ealthcare settings must be certified with the
REMS Program and have healthcare providers
who are certified before ordering or dispensing
AVEED®. Healthcare settings must have on-site
access to equipment and personnel trained to
manage serious POME and anaphylaxis.
Further information is available at www.AveedREMS.com
or call 1-855-755-0494.
•W
orsening of Benign Prostatic Hyperplasia (BPH)
and Potential Risk of Prostate Cancer - Patients with
BPH treated with androgens are at an increased risk
of worsening of signs and symptoms of BPH. Monitor
patients with BPH for worsening signs and
symptoms.Patients treated with androgens may be at
an increased risk for prostate cancer. Evaluate
patients for prostate cancer prior to initiating and
during treatment with androgens.
•P
olycythemia - Increases in hematocrit, reflective
of increases in red blood cell mass, may require
discontinuation of testosterone. Check hematocrit
prior to initiating testosterone treatment. It would
be appropriate to re-evaluate the hematocrit 3 to 6
months after starting testosterone treatment, and
then annually. If hematocrit becomes elevated, stop
therapy until hematocrit decreases to an acceptable
level. An increase in red blood cell mass may
increase the risk of thromboembolic events.
•V
enous thromboembolism (VTE) - There have been
postmarketing reports of venous thromboembolic
events, including deep vein thrombosis (DVT) and
10
pulmonary embolism (PE), in patients using
testosterone products, such as AVEED®. Evaluate
patients who report symptoms of pain, edema,
warmth and erythema in the lower extremity for
DVT and those who present with acute shortness of
breath for PE. If a venous thromboembolic event is
suspected, discontinue treatment with AVEED® and
initiate appropriate workup and management.
•U
se in Women - Due to lack of controlled
evaluations in women and potential virilizing
effects, AVEED® is not indicated for use in women.
• Potential for Adverse Effects on Spermatogenesis
- With large doses of exogenous androgens, including
AVEED®, spermatogenesis may be suppressed through
feedback inhibition of pituitary follicle-stimulating
hormone (FSH) which could possibly lead to adverse
effects on semen parameters including sperm count.
•H
epatic Adverse Effects - Prolonged use of high doses
of orally active 17-alpha-alkyl androgens (e.g.,
methyltestosterone) has been associated with serious
hepatic adverse effects (peliosis hepatis, hepatic
neoplasms, cholestatic hepatitis, and jaundice). Peliosis
hepatis can be a life-threatening or fatal complication.
Long-term therapy with intramuscular testosterone
enanthate, which elevates blood levels for prolonged
periods, has produced multiple hepatic adenomas.
AVEED® is not known to produce these adverse effects.
Nonetheless, patients should be instructed to report
any signs or symptoms of hepatic dysfunction (e.g.,
jaundice). If these occur, promptly discontinue AVEED®
while the cause is evaluated.
•E
dema - Androgens, including AVEED®, may promote
retention of sodium and water. Edema with or without
congestive heart failure may be a serious complication
in patients with preexisting cardiac, renal, or hepatic
disease. In addition to discontinuation of the drug,
diuretic therapy may be required.
• Gynecomastia - Gynecomastia occasionally
develops and occasionally persists in patients being
treated for hypogonadism.
•S
leep Apnea - The treatment of hypogonadal men with
testosterone products may potentiate sleep apnea in
some patients, especially those with risk factors such
as obesity or chronic lung diseases.
•L
ipids - Changes in serum lipid profile may require dose
adjustment of lipid lowering drugs or discontinuation of
testosterone therapy.
IMPORTANT SAFETY INFORMATION (CONT)
•H
ypercalcemia - Androgens, including AVEED®,
should be used with caution in cancer patients at risk
of hypercalcemia (and associated hypercalciuria).
Regular monitoring of serum calcium concentrations
is recommended in these patients.
•D
ecreased Thyroxine-binding Globulin - Androgens,
including AVEED®, may decrease concentrations of
thyroxine-binding globulin, resulting in decreased
total T4 serum concentrations and increased resin
uptake of T3 and T4. Free thyroid hormone
concentrations remain unchanged, however, and
there is no clinical evidence of thyroid dysfunction.
•L
aboratory Monitoring - Monitor prostatic specific
antigen (PSA), hemoglobin, hematocrit, and lipid
concentrations at the start of treatment and
periodically thereafter.
ADVERSE REACTIONS
AVEED® was evaluated in an 84-week clinical study
using a dose regimen of 750 mg (3 mL) at initiation,
at 4 weeks, and every 10 weeks thereafter in 153
hypogonadal men. The most commonly reported
adverse reactions (≥2%) were: acne, injection site
pain, prostate specific antigen increased,
hypogonadism, estradiol increased, fatigue,
irritability, hemoglobin increased, insomnia,
and mood swings.
DRUG INTERACTIONS
• I nsulin - Changes in insulin sensitivity or glycemic
control may occur in patients treated with
androgens. In diabetic patients, the metabolic
effects of androgens may decrease blood glucose
and, therefore, may necessitate a decrease in the
dose of anti-diabetic medication.
•O
ral Anticoagulants - Changes in anticoagulant
activity may be seen with androgens, therefore more
frequent monitoring of international normalized
ratio (INR) and prothrombin time are recommended
in patients taking warfarin, especially at the
initiation and termination of androgen therapy.
•C
orticosteroids - The concurrent use of
testosterone with corticosteroids may result in
increased fluid retention and requires careful
monitoring, particularly in patients with cardiac,
renal or hepatic disease.
USE IN SPECIFIC POPULATIONS
•G
eriatric Use - There have not been sufficient
numbers of geriatric patients in controlled clinical
studies with AVEED® to determine whether efficacy
or safety in those over 65 years of age differs from
younger subjects. There are insufficient long-term
safety data in geriatric patients to assess the
potential risks of cardiovascular disease and
prostate cancer.
In the 84-week clinical trial, 7 patients (4.6%) discontinued
treatment because of adverse reactions. Adverse
reactions leading to discontinuation included: hematocrit
increased, estradiol increased, prostatic specific antigen
increased, prostate cancer, mood swings, prostatic
dysplasia, acne, and deep vein thrombosis.
DRUG ABUSE
•P
ostmarketing Experience
Pulmonary Oil Microembolism (POME) and Anaphylaxis
Serious pulmonary oil microembolism (POME)
reactions, involving cough, urge to cough, dyspnea,
hyperhidrosis, throat tightening, chest pain, dizziness,
and syncope, have been reported to occur during or
immediately after the injection of intramuscular
testosterone undecanoate 1000 mg (4 mL) in postapproval use outside the United States.
Please see accompanying full Prescribing
Information, including Boxed Warning.
AVEED® contains testosterone undecanoate, a Schedule
III controlled substance in the Controlled Substances
Act. Anabolic steroids, such as testosterone, are abused.
Abuse is often associated with adverse physical and
psychological effects.
In addition to serious POME reactions, episodes of
anaphylaxis, including life-threatening reactions,
have also been reported to occur following the
injection of intramuscular testosterone undecanoate
in post-approval use outside of the United States.
11
To learn how you can become a certified AVEED® prescriber,
call 1-855-755-0494, or go to AveedREMS.com.
For questions about acquiring AVEED®, billing and reimbursement
related information, or how to provide savings for your patients, call
1-855-myAVEED (692-8333), anytime between 8 am and 8 pm EST.
To learn more and to download forms, visit AveedUSA.com.
INDICATION AND IMPORTANT SAFETY
INFORMATION
WARNING: SERIOUS PULMONARY OIL MICROEMBOLISM
(POME) REACTIONS AND ANAPHYLAXIS
•S
erious POME reactions, involving urge to cough,
dyspnea, throat tightening, chest pain, dizziness, and
syncope; and episodes of anaphylaxis, including
life-threatening reactions, have been reported to occur
during or immediately after the administration of
testosterone undecanoate injection. These reactions
can occur after any injection of testosterone
undecanoate during the course of therapy, including
after the first dose.
•F
ollowing each injection of AVEED®, observe patients in
the healthcare setting for 30 minutes in order to provide
appropriate medical treatment in the event of serious
POME reactions or anaphylaxis.
•B
ecause of the risks of serious POME reactions and
anaphylaxis, AVEED® is available only through a restricted
program under a Risk Evaluation and Mitigation Strategy
(REMS) called the AVEED® REMS Program.
INDICATIONS AND USAGE
AVEED® is indicated for testosterone replacement
therapy in adult males for conditions associated with
a deficiency or absence of endogenous testosterone.
• Primary hypogonadism (congenital or acquired):
testicular failure due to cryptochordism, bilateral torsion,
orchitis, vanishing testis syndrome, orchiectomy,
Klinefelter’s syndrome, chemotherapy, or toxic damage
from alcohol or heavy metals. These men usually have
low serum testosterone concentrations and
gonadotropins (follicle-stimulating hormone [FSH],
luteinizing hormone [LH]) above the normal range.
•H
ypogonadotropic hypogonadism (congenital or
acquired): idiopathic gonadotropin or luteinizing
hormone-releasing hormone (LHRH) deficiency or
pituitary-hypothalamic injury from tumors, trauma,
or radiation. These men have low testosterone serum
concentrations but have gonadotropins in the normal
or low range.
AVEED® should only be used in patients who require
testosterone replacement therapy and in whom the
benefits of the product outweigh the serious risks
of pulmonary oil microembolism and anaphylaxis.
Limitations of use:
•S
afety and efficacy of AVEED® in males less than
18 years old have not been established.
Please see full Important Safety Information on pages 9-11 and accompanying full Prescribing Information,
including Boxed Warning.
REFERENCE: 1. AVEED® (Prescribing Information). Malvern, PA: Endo Pharmaceuticals Inc; 2014.
Rx Only
AVEED® is a U.S. registered trademark of Endo Pharmaceuticals Inc.
© 2014 Endo Pharmaceuticals Inc. All Rights Reserved. Malvern, PA 19355
AV-03047a(1)/July 2014 www.AveedUSA.com 1-800-462-ENDO (3636)