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Fertility
Fact Sheet
Infertility is not uncommon. Recent estimates
indicate infertility affects one in eight couples, or
7.3 million men and women in the US. Infertility is
defined as the inability to achieve pregnancy after
one year of regular, unprotected intercourse (six
months if the woman is over 35). While infertility
can be an emotionally uncertain and frustrating
journey, it may be successfully treated. Many
patients who complete treatment for infertility
ultimately succeed in having a child.
EMD Serono is the only company to offer a FSH
portfolio of multiple presentations including
multi-dose vial, single-dose vial and pen options.
For more information, please visit Fertility LifeLines™
at www.fertilitylifelines.com or call 1-866-LETS-TRY
(1-866-538-7879).
These products should only be prescribed by
physicians specializing in fertility or reproductive
health. Patients prescribed the above products
should be monitored carefully by a trained fertility
specialist.
Marketed Products
Gonal-f® (follitropin alfa for injection)
Gonal-f® is a recombinant human follicle
stimulating hormone (r-hFSH) prescribed to
supplement or replace naturally occurring FSH,
one of the primary hormones used in the treatment
of infertility.
Gonal-F® (follitropin alfa for injection)
Indication:
Women: Gonal-f® (follitropin alfa for injection),
Gonal-f® RFF (follitropin alfa for injection), and
Gonal-f® RFF Pen (follitropin alfa injection) are
indicated for (1) the induction of ovulation and
pregnancy in the anovulatory infertile patient in
whom the cause of infertility is functional and
not due to primary ovarian failure and (2) for the
development of multiple follicles in the ovulatory
patient participating in an Assisted Reproductive
Technology (ART) program.
Men: Gonal-f® is also indicated for the induction
of spermatogenesis in men with primary and
secondary hypogonadotropic hypogonadism in
whom the cause of infertility is not due to primary
testicular failure.
The Gonal-f® RFF* Pen (follitropin alfa injection),
is the only prefilled and ready-to-use multidose FSH in the US. It was designed specifically
for the treatment of infertility to allow patients
to accurately deliver a precise daily dose of
medication.
Important Safety Information
These products should be prescribed only by
physicians specializing in fertility or reproductive
health. Use of Gonal-f®, Gonal-f® RFF, or
Gonal-f® RFF Pen by women can result in
multiple births.
EMD Serono offers recombinant versions of two
hormones used in the treatment of infertility:
Gonal-f® (follitropin alfa for injection) and
Ovidrel® PreFilled Syringe (choriogonadotropin alfa
injection). Rounding out EMD Serono’s portfolio of
fertility treatments is Cetrotide® (cetrorelix acetate
for injection).
Contact
Kristen LaVerghetta
781-681-2065
[email protected]
EMD Serono, Inc. is a subsidiary
of Merck KGaA, Darmstadt, Germany.
www.emdserono.com
www.facebook.com/myemdserono
Prescribers and patients should familiarize themselves
with product and risk information before using. For
more information on EMD Serono’s products, patient
support services, and full prescribing information,
visit emdserono.com.
* Revised Formulation Female
Last updated April 2013 | page 1
120525-103538
As a leader in fertility health, EMD Serono, Inc. is
dedicated to providing therapies and devices that
help treat infertility.
Fact Sheet fertility
Lindsay
EMD Serono, Fertility Patient
Gonal-f® (follitropin alfa for injection),
Gonal-f® RFF (follitropin alfa for injection), and
Gonal-f® RFF Pen (follitropin alfa injection) are
potent gonadotropins capable of causing mild
to severe adverse reactions, including Ovarian
Hyperstimulation Syndrome (OHSS) in women with
or without pulmonary or vascular complications.
Gonal-f®, Gonal-f® RFF, and Gonal-f® RFF Pen
are contraindicated in women and men who
exhibit prior hypersensitivity to recombinant
FSH preparations or one of their excipients, high
levels of FSH indicating primary gonadal failure,
uncontrolled thyroid or adrenal dysfunction, sex
hormone–dependent tumors of the reproductive
tract and accessory organs, and an organic
intracranial lesion such as a pituitary tumor.
Additionally, Gonal-f®, Gonal-f® RFF, or
Gonal-f® Pen should not be given to women
with abnormal uterine bleeding, presence or
enlargement of an ovarian cyst of undetermined
origin or to women who are pregnant or nursing.
The most common side effects reported in women
using Gonal-f®, Gonal-f® RFF, or Gonal-f® RFF
Pen include headache, abdominal pain, enlarged
abdomen, ovarian cysts, nausea, and upper
respiratory infections. Men using Gonal-f® have
commonly reported acne, breast pain and growth,
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and fatigue. Injection site reactions have been
reported.
This information is not intended to replace
discussions with your doctor. For additional
information about the risks of Gonal-f® (follitropin
alfa for injection), Gonal-f® RFF (follitropin alfa for
injection), and Gonal-f® RFF Pen (follitropin alfa
injection), see the Prescribing Information.
Ovidrel® PreFilled Syringe (choriogonadotropin
alfa injection)
Ovidrel® PreFilled Syringe is a ready-to-inject liquid
infertility treatment and the only available recombinant version of human chorionic gonadotropin
(hCG). Human chorionic gonadotropin is one of the
gonadotropins used in the treatment of infertility. Ovidrel® PreFilled Syringe is the first and only
recombinant hCG in the world.
Essentially equivalent in structure to naturally
occurring hCG, Ovidrel® PreFilled Syringe is used in
infertility treatment cycles to help follicles mature
and to trigger the actual release of mature eggs
from a woman’s ovaries following treatment with
products containing human follicle stimulating
hormone such as Gonal-f®.
Fact Sheet fertility
Ovidrel® prefilled syringe (choriogonadotropin
alfa injection) Indication:
Ovidrel® PreFilled Syringe is indicated for the
induction of final follicular maturation and
early luteinization in infertile women who have
undergone pituitary desensitization and who
have been appropriately pretreated with follicle
stimulating hormones as part of an ART program
such as in vitro fertilization and embryo transfer.
Ovidrel® PreFilled Syringe is also indicated for
the induction of ovulation (OI) and pregnancy in
anovulatory infertile patients in whom the cause
of infertility is functional and not due to primary
ovarian failure.
Important Safety Information
Ovidrel® Prefilled Syringe should only be used
by physicians who are thoroughly familiar with
infertility problems and their management.
Ovidrel® PreFilled Syringe is a potent gonadotropic
substance capable of causing Ovarian
Hyperstimulation Syndrome (OHSS) in women with
or without pulmonary or vascular complications.
Ovidrel® Prefilled Syringe is contraindicated
in women who exhibit prior sensitivity to hCG
preparations or their ingredients, primary ovarian
failure, uncontrolled thyroid or adrenal dysfunction
and pregnancy. Women who are nursing
should also not use Ovidrel® Prefilled Syringe
(choriogonadotropin alfa injection). The most
common side effects in women using Ovidrel®
Prefilled Syringe include abdominal pain, injection
site reactions, nausea and vomiting. Reports
of multiple births have been associated with
Ovidrel® Prefilled Syringe treatment. For additional
information about Ovidrel® Prefilled Syringe, see
the Prescribing Information.
Cetrotide® (cetrorelix acetate for injection)
Cetrotide® is a gonadotropin-releasing hormone
(GnRH) antagonist used to control hormone
responses, which impact the development of eggs.
Specifically, Cetrotide® helps delay a hormonal
event known as the LH (luteinizing hormone) surge,
which can result in premature ovulation. Cetrotide®
works by directly blocking the trigger effect of
GnRH, which controls the secretion of LH. This
blocking action is designed to stop a possible LH
surge before it begins, allowing eggs to reach the
level of development needed for fertilization.
Cetrotide® (cetrorelix acetate for injection)
Indication
Cetrotide® is indicated for the inhibition of
premature LH surges in women undergoing
controlled ovarian stimulation.
Important Safety Information
Cetrotide® should only be prescribed by doctors
specializing in infertility or reproductive health.
Cetrotide® can cause serious side effects including
ovarian hyperstimulation syndrome (OHSS), with
or without blood vessel and lung complications,
and multiple births. Cetrotide® should not be
used in women who, are allergic to cetrorelix
acetate, mannitol or exogenous peptide hormones
(medicines similar to Cetrotide®), who have kidney
disease, are pregnant or think they are pregnant, or
are breast-feeding. Mild and short-lasting injection
reactions like reddening, itching and swelling
at the injection sites have occurred in women
using Cetrotide®. Nausea and headache have also
been reported. For additional information about
Cetrotide®, see the Prescribing Information.
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Fact Sheet fertility
Fertility LifeLines™
Fertility LifeLines™ is a free and confidential
educational service offering customized
information and support to patients at every
stage of their journey. It is available via the Web
at www.FertilityLifeLines.com or by calling tollfree 1-866-LETS-TRY (1-866-538-7879). Fertility
LifeLines provides general infertility information,
insurance/benefits assistance, local Fertility
Specialist referral, EMD Serono product support,
and support through compassionate listening to
help put the patient journey into perspective, and
to provide information about additional support
and resources. For more information, please visit
www.fertilitylifelines.com.
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