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OVIDREL

 * Generic Name: choriogonadotropin alfa injection
 * Brand Name: Ovidrel
 * Drug Class: Ovulation Stimulators, Gonadotropins

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 11/15/2022

home drugs a-z list ovidrel (choriogonadotropin alfa injection) drug

   
   
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DRUG SUMMARY

WHAT IS OVIDREL?

Ovidrel (choriogonadotropin alfa) Injection is the hormone (hCG) that causes the
growth and release of a mature egg (ovulation) used to treat certain fertility
problems in women. Ovidrel is usually used in combination with another hormone
(FSH) that helps cause healthy ovaries to produce eggs.

WHAT ARE SIDE EFFECTS OF OVIDREL?

Ovidrel may cause serious side effects including:

 * pain, warmth, redness, numbness or tingling in your arm or leg,
 * confusion,
 * extreme dizziness, and
 * severe headache

Specific to women:

 * severe pelvic pain,
 * swelling of the hands or legs,
 * stomach pain and swelling,
 * shortness of breath,
 * weight gain,
 * diarrhea,
 * nausea,
 * vomiting, and
 * urinating less than normal

Common side effects of Ovidrel include:

 * nausea
 * vomiting
 * mild abdominal pain/swelling
 * headache
 * restlessness
 * irritability
 * water weight gain
 * depression
 * breast tenderness or swelling
 * injection site reactions (pain, bruising, redness, swelling, or irritation)

Tell the doctor if you have any side effect that bothers you or that does not go
away.

Seek medical care or call 911 at once if you have the following serious side
effects:

 * Serious eye symptoms such as sudden vision loss, blurred vision, tunnel
   vision, eye pain or swelling, or seeing halos around lights;
 * Serious heart symptoms such as fast, irregular, or pounding heartbeats;
   fluttering in your chest; shortness of breath; and sudden dizziness,
   lightheartedness, or passing out;
 * Severe headache, confusion, slurred speech, arm or leg weakness, trouble
   walking, loss of coordination, feeling unsteady, very stiff muscles, high
   fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur.
Check with your physician for additional information about side effects.

DOSAGE FOR OVIDREL

Ovidrel PreFilled Syringe comes in a 250 µg dose which is administered one day
following the last dose of the follicle stimulating agent.

WHAT DRUGS, SUBSTANCES, OR SUPPLEMENTS INTERACT WITH OVIDREL?

Ovidrel may interact with gonadorelin. Tell your doctor all medications and
supplements you use.

OVIDREL DURING PREGNANCY AND BREASTFEEDING

If you become pregnant or think you may be pregnant after treatment with
Ovidrel, stop using this medication and tell your doctor. This drug must not be
used during pregnancy because it may harm a fetus. It is unknown if this
medication passes into breast milk. Consult your doctor before breastfeeding.

ADDITIONAL INFORMATION

Our Ovidrel (choriogonadotropin alfa) Side Effects Drug Center provides a
comprehensive view of available drug information on the potential side effects
when taking this medication.


FDA DRUG INFORMATION

 * Drug Description
 * Indications
 * Dosage
 * Side Effects & Drug Interactions
 * Warnings
 * Precautions
 * Overdose & Contraindications
 * Clinical Pharmacology
 * Medication Guide


DESCRIPTION FOR OVIDREL

Ovidrel® PreFilled Syringe (choriogonadotropin alfa injection) is a sterile
liquid preparation of choriogonadotropin alfa (recombinant human Chorionic
Gonadotropin, r-hCG). Choriogonadotropin alfa is a water soluble glycoprotein
consisting of two non-covalently linked subunits - designated α and β -
consisting of 92 and 145 amino acid residues, respectively, with carbohydrate
moieties linked to ASN-52 and ASN-78 (on alpha subunit) and ASN-13, ASN-30,
SER-121, SER-127, SER-132 and SER- 138 (on beta subunit). The primary structure
of the α - chain of r-hCG is identical to that of the α - chain of hCG, FSH and
LH. The glycoform pattern of the α - subunit of r-hCG is closely comparable to
urinary derived hCG (u-hCG), the differences mainly being due to the branching
and sialylation extent of the oligosaccharides. The β - chain has both O- and
N-glycosylation sites and its structure and glycosylation pattern are also very
similar to that of u-hCG.

The production process involves expansion of genetically modified Chinese
Hamster Ovary (CHO) cells from an extensively characterized cell bank into large
scale cell culture processing. Choriogonadotropin alfa is secreted by the CHO
cells directly into the cell culture medium that is then purified using a series
of chromatographic steps. This process yields a product with a high level of
purity and consistent product characteristics including glycoforms and
biological activity. The biological activity of choriogonadotropin alfa is
determined using the seminal vesicle weight gain test in male rats described in
the “Chorionic Gonadotrophins” monograph of the European Pharmacopoeia. The in
vivo biological activity of choriogonadotropin alfa has been calibrated against
the third international reference preparation IS75/587 for chorionic
gonadotropin.

Ovidrel® PreFilled Syringe is a sterile, liquid intended for subcutaneous (SC)
injection. Each Ovidrel® PreFilled Syringe is filled with 0.515 mL containing
257.5 μg of choriogonadotropin alfa, 28.1 mg mannitol, 505 μg 85% O-phosphoric
acid, 103 μg L-methionine, 51.5 μg Poloxamer 188, Sodium Hydroxide (for pH
adjustment), and Water for Injection to deliver 250 μg of choriogonadotropin
alfa in 0.5 mL. The pH of the solution is 6.5 to 7.5.

Therapeutic Class: Infertility




USES FOR OVIDREL

Ovidrel® PreFilled Syringe (choriogonadotropin alfa injection) 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
Assisted Reproductive Technology (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.

SELECTION OF PATIENTS

 1. Before treatment with gonadotropins is instituted, a thorough gynecologic
    and endocrinologic evaluation must be performed. This should include an
    assessment of pelvic anatomy. Patients with tubal obstruction should receive
    Ovidrel® PreFilled Syringe only if enrolled in an in vitro fertilization
    program.
 2. Primary ovarian failure should be excluded by the determination of
    gonadotropin levels.
 3. Appropriate evaluation should be performed to exclude pregnancy.
 4. Patients in later reproductive life have a greater predisposition to
    endometrial carcinoma as well as a higher incidence of anovulatory
    disorders. A thorough diagnostic evaluation should always be performed in
    patients who demonstrate abnormal uterine bleeding or other signs of
    endometrial abnormalities before starting FSH and Ovidrel® PreFilled Syringe
    therapy.
 5. Evaluation of the partner's fertility potential should be included in the
    initial evaluation.


DOSAGE FOR OVIDREL

For Subcutaneous Use Only

INFERTILE WOMEN UNDERGOING ASSISTED REPRODUCTIVE TECHNOLOGIES (ART)

Ovidrel® PreFilled Syringe 250 μg should be administered one day following the
last dose of the follicle stimulating agent. Ovidrel® PreFilled Syringe should
not be administered until adequate follicular development is indicated by serum
estradiol and vaginal ultrasonography. Administration should be withheld in
situations where there is an excessive ovarian response, as evidenced by
clinically significant ovarian enlargement or excessive estradiol production.

INFERTILE WOMEN UNDERGOING OVULATION INDUCTION (OI)

Ovidrel® PreFilled Syringe should not be administered until adequate follicular
development is indicated by serum estradiol and vaginal ultrasonography.

Ovidrel® PreFilled Syringe 250 μg should be administered one day following the
last dose of the follicle stimulating agent.

Ovidrel® PreFilled Syringe administration should be withheld in situations where
there is an excessive ovarian response, as evidenced by multiple follicular
development, clinically significant ovarian enlargement or excessive estradiol
production.

DIRECTIONS FOR ADMINISTRATION OF OVIDREL® PREFILLED SYRINGE

Ovidrel® PreFilled Syringe is intended for a single subcutaneous injection. Any
unused material should be discarded.

Ovidrel® PreFilled Syringe may be self-administered by the patient. Follow the
directions below for injecting Ovidrel® PreFilled Syringe.

Step 1: Wash your hands thoroughly with soap and water.

Step 2: Carefully clean the injection site.

Make yourself comfortable by sitting or lying down. Carefully clean the
injection site on the stomach with an alcohol wipe and allow it to air-dry.

Step 3: Administer your injection.

Carefully remove the needle cap from the syringe. Do not touch the needle or
allow the needle to touch any surface. Inject the prescribed dose as directed by
your doctor, nurse or pharmacist.







Step 4: Gently withdraw the needle.

Discard the needle and syringe into your safety container. Place gauze over the
injection site. If any bleeding occurs, apply gentle pressure. If bleeding does
not stop within a few minutes, place a clean piece of gauze over the injection
site and cover it with an adhesive bandage.







Step 5: Storage and clean up.

Remember that your injection materials must be kept sterile and cannot be
reused.


HOW SUPPLIED

Ovidrel® PreFilled Syringe (choriogonadotropin alfa injection) is supplied in a
sterile, liquid single dose pre-filled 1 mL syringe. Each Ovidrel® PreFilled
Syringe is filled with 0.515 mL containing 257.5 μg of choriogonadotropin alfa,
28.1 mg mannitol, 505 μg 85% O-phosphoric acid, 103 μg Lmethionine, 51.5 μg
Poloxamer 188, Sodium Hydroxide (for pH adjustment), and Water for Injection to
deliver 250 μg of choriogonadotropin alfa in 0.5 mL.

The following package combination is available:

1 pre-filled syringe containing 250 μg Ovidrel® PreFilled Syringe NDC
44087-1150-1

STORAGE

The Ovidrel® PreFilled Syringe must be stored refrigerated between 2-8°C
(36-46°F) before being dispensed to the patient. Patients should store the
pre-filled syringe refrigerated to allow the product to be used until the expiry
date shown on the syringe or carton. The Ovidrel® PreFilled Syringe may be
stored by the patient for no more than 30 days at room temperature (up to 25°C
(77°F) but must be used within those 30 days.

Protect from light.

Store in original package. Discard unused material.

Manufactured For: EMD Serono, Inc. Rockland, MA 02370. Revised: Nov 2017




SIDE EFFECTS FOR OVIDREL

(see WARNINGS)

The safety of Ovidrel® was examined in four clinical studies that treated 752
patients of whom 335 received Ovidrel® 250 μg following follicular recruitment
with gonadotropins. When patients enrolled in four clinical studies (3 in ART
and one in OI) were injected subcutaneously with either Ovidrel® or an approved
urinary-derived hCG, 14.6 % (49 of 335 patients) in the Ovidrel® 250 μg group
experienced application site disorders compared to 28% (92 of 328 patients) in
the approved u-Hcg group. Adverse events reported for Ovidrel® 250 μg occurring
in at least 2% of patients (regardless of causality) are listed in Table 9 for
the 3 ART studies and in Table 10 for the single OI study.

Table 9: Incidence of Adverse Events of r-hCG in ART (Studies 7648, 7927, 9073)


Body System Ovidrel® 250 μg
(n=236) Preferred Term Incidence Rate % (n) At Least One Adverse Event 33.1%
(78) Application Site Disorders 14.0% (33) Injection Site Pain 7.6% (18)
Injection Site Bruising 4.7% (11) Gastro-Intestinal System Disorders 8.5% (20)
Abdominal Pain 4.2% (10) Nausea 3.4% ( 8) Vomiting 2.5% ( 6) Secondary Terms
(PostOperative Pain) 4.7% (11) Post-Operative Pain 4.7% (11)



Adverse events not listed in Table 9 that occurred in less than 2% of patients
treated with Ovidrel® 250 μg whether or not considered causally related to
Ovidrel® , included: injection site inflammation and reaction, flatulence,
diarrhea, hiccup, ectopic pregnancy, breast pain, intermenstrual bleeding,
vaginal hemorrhage, cervical lesion, leukorrhea, ovarian hyperstimulation,
uterine disorders, vaginitis, vaginal discomfort, body pain, back pain, fever,
dizziness, headache, hot flashes, malaise, paraesthesias, rash, emotional
lability, insomnia, upper respiratory tract infection, cough, dysuria, urinary
tract infection, urinary incontinence, albuminuria, cardiac arrhythmia, genital
moniliasis, genital herpes, leukocytosis, heart murmur and cervical carcinoma.

Table 10: Incidence of Adverse Events of r-hCG in Ovulation Induction (Study
8209)


Body System Ovidrel® 250 μg
(n=99) Preferred Term Incidence Rate % (n) At Least One Adverse Event 26.2% (26)
Application Site Disorders 16.2% (16) Injection site pain 8.1% (8) Injection
site inflammation 2.0% (2) Injection site bruising 3.0% (3) Injection site
reaction 3.0% (3) Reproductive Disorders, Female 7.1% (7) Ovarian cyst 3.0% (3)
Ovarian hyperstimulation 3.0% (3) Gastro-Intestinal System Disorders 4.0% (4)
Abdominal pain 3.0% (3)



Additional adverse events not listed in Table 10 that occurred in less than 2%
of patients treated with Ovidrel® 250 μg, whether or not considered causally
related to Ovidrel® , included: breast pain, flatulence, abdominal enlargement,
pharyngitis, upper respiratory tract infection, hyperglycemia and pruritis.

The following medical events have been reported subsequent to pregnancies
resulting from hCG therapy in controlled clinical studies:

 1. Spontaneous Abortion
 2. Ectopic Pregnancy
 3. Premature Labor
 4. Postpartum Fever
 5. Congenital Abnormalities

Of 125 clinical pregnancies reported following treatment with FSH and Ovidrel®
250 μg or 500 μg, three were associated with a congenital anomaly of the fetus
or newborn. Among patients receiving Ovidrel® 250 μg, cranial malformation was
detected in the fetus of one woman and a chromosomal abnormality (47, XXX) in
another. These events were judged by the investigators to be of unlikely or
unknown relation to treatment. These three events represent an incidence of
major congenital malformations of 2.4%, which is consistent with the reported
rate for pregnancies resulting from natural or assisted conception. In a woman
who received Ovidrel® 500 μg, one birth in a set of triplets was associated with
Down's syndrome and atrial septal defect. This event was considered to be
unrelated to the study drug.

The following adverse reactions have been previously reported during menotropin
therapy:

 1. Pulmonary and vascular complications (see “WARNINGS”)
 2. Adnexal torsion (as a complication of ovarian enlargement)
 3. Mild to moderate ovarian enlargement
 4. Hemoperitoneum

There have been infrequent reports of ovarian neoplasms, both benign and
malignant, in women who have undergone multiple drug regimens for ovulation
induction; however, a causal relationship has not been established.

POST-MARKETING EXPERIENCE

In addition to adverse events reported from clinical trials, the following
events have been reported during post-marketing use of Ovidrel®. Therefore,
these events were reported from a population of uncertain size, the frequency or
causal relationship to Ovidrel® cannot be reliably determined.

 * Cases of allergic reactions, including anaphylactic reactions and mild
   reversible skin rashes have been reported in patients treated with Ovidrel®
   since market introduction. The causal relationship is unknown.
 * Thromboembolic events both in association with, and separate from, the
   Ovarian Hyperstimulation Syndrome (see “WARNINGS”)


DRUG INTERACTIONS FOR OVIDREL

No Information provided


WARNINGS FOR OVIDREL

Gonadotropins, including Ovidrel® PreFilled Syringe (choriogonado-tropin alfa
injection), should only be used by physicians who are thoroughly familiar with
infertility problems and their management. Like other hCG products, Ovidrel®
PreFilled Syringe is a potent gonadotropic substance capable of causing Ovarian
Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular
complications. The risks of gonadoptropin treatment should be considered for
women with risk factors of thromboembolic events such as prior medical or family
history. Gonadotropin therapy requires a certain time commitment by physicians
and supportive health professionals, and requires the availability of
appropriate monitoring facilities (see “PRECAUTIONS /Laboratory Tests”). Safe
and effective induction of ovulation and use of Ovidrel® PreFilled Syringe in
women requires monitoring of ovarian response with serum estradiol and
transvaginal ultrasound on a regular basis.

OVERSTIMULATION OF THE OVARY FOLLOWING HCG THERAPY

OVARIAN ENLARGEMENT

Mild to moderate uncomplicated ovarian enlargement which may be accompanied by
abdominal distention and/or abdominal pain may occur in patients treated with
FSH and hCG, and generally regresses without treatment within two or three
weeks. Careful monitoring of ovarian response can further minimize the risk of
overstimulation.

If the ovaries are abnormally enlarged on the last day of FSH therapy,
choriogonadotropin alfa should not be administered in this course of therapy.
This will reduce the risk of development of Ovarian Hyperstimulation Syndrome.

OVARIAN HYPERSTIMULATION SYNDROME (OHSS)

OHSS is a medical event distinct from uncomplicated ovarian enlargement. Severe
OHSS may progress rapidly (within 24 hours to several days) to become a serious
medical event. It is characterized by an apparent dramatic increase in vascular
permeability which can result in a rapid accumulation of fluid in the peritoneal
cavity, thorax, and potentially, the pericardium. The early warning signs of
development of OHSS are severe pelvic pain, nausea, vomiting, and weight gain.
The following symptomatology has been seen with cases of OHSS: abdominal pain,
abdominal distension, gastrointestinal symptoms including nausea, vomiting and
diarrhea, severe ovarian enlargement, weight gain, dyspnea, and oliguria.
Clinical evaluation may reveal hypovolemia, hemoconcentration, electrolyte
imbalances, ascites, hemoperitoneum, pleural effusions, hydrothorax, acute
pulmonary distress, and thromboembolic events (see “Pulmonary and Vascular
Complications ”). Transient liver function test abnormalities suggestive of
hepatic dysfunction, which may be accompanied by morphologic changes on liver
biopsy, have been reported in association with Ovarian Hyperstimulation Syndrome
(OHSS).

OHSS occurred in 4 of 236 (1.7 %) patients treated with Ovidrel® 250 μg during
clinical trials for ART and 3 of 99 (3.0%) patients treated in the OI trial.
OHSS occurred in 8 of 89 (9.0%) patients who received Ovidrel® 500 μg. Two
patients treated with Ovidrel® 500 μg developed severe OHSS. OHSS may be more
severe and more protracted if pregnancy occurs. OHSS develops rapidly;
therefore, patients should be followed for at least two weeks after hCG
administration. Most often,

OHSS occurs after treatment has been discontinued and reaches its maximum at
about seven to ten days following treatment. Usually, OHSS resolves
spontaneously with the onset of menses. If there is evidence that OHSS may be
developing prior to hCG administration (see “PRECAUTIONS /Laboratory Tests”),
the hCG must be withheld.

If severe OHSS occurs, treatment with gonadotropins must be stopped and the
patient should be hospitalized.

A physician experienced in the management of this syndrome, or who is
experienced in the management of fluid and electrolyte imbalances should be
consulted.

Multiple Births

As with other hCG products, reports of multiple births have been associated with
Ovidrel® treatment. In ART, the risk of multiple births correlates to the number
of embryos transferred. Multiple births occurred in 17 of 55 live deliveries
(30.9 %) experienced by women receiving Ovidrel® 250 μg in the ART studies. In
the ovulation induction clinical trial, 2 of 15 live deliveries (13.3%) were
associated with multiple births in women receiving Ovidrel® . The patient should
be advised of the potential risk of multiple births before starting treatment.

Pulmonary And Vascular Complications

As with other hCG products, a potential for the occurrence of arterial
thromboembolism exists.


PRECAUTIONS FOR OVIDREL

GENERAL

Careful attention should be given to the diagnosis of infertility in candidates
for hCG therapy. (see “INDICATIONS AND USAGE/ Selection of Patients ”). After
the exclusion of pre-existing conditions, elevations in ALT were found in 10
(3%) of 335 patients receiving Ovidrel® 250 μg, 9 (10%) of 89 patients receiving
Ovidrel® 500 μg and in 16 (4.8%) of 328 patients receiving urinary-derived hCG.
The elevations ranged up to 1.2 times the upper limit of normal. The clinical
significance of these findings is not known.

LABORATORY TESTS

In most instances, treatment of women with FSH results only in follicular
recruitment and development. In the absence of an endogenous LH surge, hCG is
given when monitoring of the patient indicates that sufficient follicular
development has occurred. This may be estimated by ultrasound alone or in
combination with measurement of serum estradiol levels. The combination of both
ultrasound and serum estradiol measurement are useful for monitoring the
development of follicles, for timing of the ovulatory trigger, as well as for
detecting ovarian enlargement and minimizing the risk of the Ovarian
Hyperstimulation Syndrome and multiple gestation. It is recommended that the
number of growing follicles be confirmed using ultrasonography because serum
estrogens do not give an indication of the size or number of follicles.

Human chorionic gonadotropins can crossreact in the radioimmunoassay of
gonadotropins, especially luteinizing hormone. Each individual laboratory should
establish the degree of crossreactivity with their gonadotropin assay.
Physicians should make the laboratory aware of patients on hCG if gonadotropin
levels are requested.

The clinical confirmation of ovulation, with the exception of pregnancy, is
obtained by direct and indirect indices of progesterone production. The indices
most generally used are as follows:

 1. A rise in basal body temperature
 2. Increase in serum progesterone and
 3. Menstruation following a shift in basal body temperature

When used in conjunction with the indices of progesterone production,
sonographic visualization of the ovaries will assist in determining if ovulation
has occurred. Sonographic evidence of ovulation may include the following:

 1. Fluid in the cul-de-sac
 2. Ovarian stigmata
 3. Collapsed follicle
 4. Secretory endometrium

Accurate interpretation of the indices of ovulation require a physician who is
experienced in the interpretation of these tests.

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

Long-term studies to evaluate the carcinogenic potential of Ovidrel® in animals
have not been performed. In vitro genotoxicity testing of Ovidrel® in bacteria
and mammalian cell lines, chromosome aberration assay in human lymphocytes and
in-vivo mouse micronucleus have shown no indication of genetic defects.

PREGNANCY

PREGNANCY CATEGORY X

Intrauterine death and impaired parturition were observed in pregnant rats given
a dose of urinary-hCG (500 IU) equivalent to three times the maximum human dose
of 10,000 USP, based on body surface area.

NURSING MOTHERS

It is not known whether this drug is excreted in human milk. Because many drugs
are excreted in human milk, caution should be exercised if hCG is administered
to a nursing woman.

PEDIATRIC PATIENTS

Safety and effectiveness in pediatric patients has not been established.

GERIATRIC PATIENTS

Safety and effectiveness in geriatric patients has not been established.


OVERDOSE INFORMATION FOR OVIDREL

No Information provided


CONTRAINDICATIONS FOR OVIDREL

Ovidrel® PreFilled Syringe (choriogonadotropin alfa injection) is
contraindicated in women who exhibit:

 1. Prior hypersensitivity to hCG preparations or one of their excipients.
 2. Primary ovarian failure.
 3. Uncontrolled thyroid or adrenal dysfunction.
 4. An uncontrolled organic intracranial lesion such as a pituitary tumor.
 5. Abnormal uterine bleeding of undetermined origin (see “Selection of
    Patients”).
 6. Ovarian cyst or enlargement of undetermined origin (see “Selection of
    Patients”).
 7. Sex hormone dependent tumors of the reproductive tract and accessory organs.
 8. Pregnancy.


CLINICAL PHARMACOLOGY FOR OVIDREL

The physicochemical, immunological, and biological activities of recombinant hCG
are comparable to those of placental and human pregnancy urine-derived hCG.
Choriogonadotropin alfa stimulates late follicular maturation and resumption of
oocyte meiosis, and initiates rupture of the pre-ovulatory ovarian follicle.
Choriogonadotropin alfa, the active component of Ovidrel® PreFilled Syringe , is
an analogue of Luteinizing Hormone (LH) and binds to the LH/hCG receptor of the
granulosa and theca cells of the ovary to effect these changes in the absence of
an endogenous LH surge. In pregnancy, hCG, secreted by the placenta, maintains
the viability of the corpus luteum to provide the continued secretion of
estrogen and progesterone necessary to support the first trimester of pregnancy.
Ovidrel® PreFilled Syringe is administered when monitoring of the patient
indicates that sufficient follicular development has occurred in response to FSH
treatment for ovulation induction.

PHARMACOKINETICS

When given by intravenous administration, the pharmacokinetic profile of
Ovidrel® followed a biexponential model and was linear over a range of 25 μg to
1000 μg. Pharmacokinetic parameter estimates following SC administration of
Ovidrel® 250 μg to females are presented in Table 1.

Table 1: Pharmacokinetic Parameters (mean ± SD) of r-hCG after Single-Dose
Adminis tration of Ovidrel® in Healthy Female Volunteers


  Ovidrel® 250 pg SC Cmax (IU/L) 121 ± 44 tmax (h)* 24 (12-24) AUC (h•IU/L)
7701±2101 t½(h) 29 ± 6 F 0.4 ± 0.1 Cmax : peak concentration (above baseline), t
max: time of Cmax, AUC: total area under the curve, t ½ :elimination half-life,
F: bioavailability
*median (range)



ABSORPTION

Following subcutaneous administration of Ovidrel® 250 μg, maximum serum
concentration (121 ± 44 IU/L) is reached after approximately 12 to 24 hours. The
mean absolute bioavailability of Ovidrel® following a single subcutaneous
injection to healthy female volunteers is about 40%.

DISTRIBUTION

Following intravenous administration of Ovidrel® 250 μg to healthy
down-regulated female volunteers, the serum profile of hCG is described by a
two-compartment model with an initial half-life of 4.5 ± 0.5 hours. The volume
of the central compartment is 3.0 ± 0.5 L and the steady state volume of
distribution is 5.9 ± 1.0 L.

METABOLISM/EXCRETION

Following subcutaneous administration of Ovidrel® , hCG is eliminated from the
body with a mean terminal half-life of about 29 ± 6 hours. After intravenous
administration of Ovidrel® 250 μg to healthy down-regulated females, the mean
terminal half-life is 26.5 ± 2.5 hours and the total body clearance is 0.29 ±
0.04 L/h. One-tenth of the dose is excreted in the urine.

PHARMACODYNAMICS

In female subjects on oral contraception after an initial latency period,
Ovidrel® induced a clear increase in androstenedione serum levels by 24 hours
after dosing. Pharmacodynamic studies in females determined that the
relationship of Ovidrel® pharmacokinetics to pharmacologic effect of Ovidrel®
are complex and vary with the pharmacodynamic marker examined. In general
pharmacologic effects are not proportional to exposure and in some cases appear
to be near maximal at a 250 μg dose.

POPULATION PHARMACOKINETICS AND PHARMACODYNAMICS

In patients undergoing in-vitro fertilization/embryo transfer given Ovidrel®
subcutaneously to trigger ovulation, the results of a population PK/PD analysis
generally supported the data obtained in healthy subjects. Pharmacokinetic
parameters for Ovidrel® include a median elimination half-life of 29.2 hours,
median apparent clearance (Cl/F) of 0.51 L/hr and median apparent volume of
distribution (V/F) of 21.4 L.

BIOEQUIVALENCE OF FORMULATIONS

Ovidrel® PreFilled Syringe (choriogonadotropin alfa injection) has been
determined to be bioequivalent to Ovidrel® (choriogonadotropin alfa for
injection) based on the statistical evaluation of AUC and Cmax. A summary of the
Ovidrel® PreFilled Syringe pharmacokinetic parameters is presented in Table 2.

Table 2: Summary of Ovidrel® PreFilled Syringe Pharmacokinetic Parameters


Parameter Cmax (mIU/mL) AUClast (mIU•h/mL) AUC (mIU•h/mL) AUC extrapolated (%)
tmax (h) Mean (Min-Max) 125 (68.0-294) 10050 (5646- 14850) 10350 (5800- 15100)
2.85 (1.08-6.27) 20.0 (9.00- 48.0) Abbreviations are: Cmax: peak concentration
(above baseline); tmax: time of Cmax



SPECIAL POPULATIONS

Safety, efficacy, and pharmacokinetics of Ovidrel® PreFilled Syringe in patients
with renal or hepatic insufficiency have not been established.

DRUG-DRUG INTERACTIONS

No drug-drug interaction studies have been conducted. Administration of Ovidrel®
PreFilled Syringe may interfere with the interpretation of pregnancy tests. (see
PRECAUTIONS.)

CLINICAL STUDIES

The safety and efficacy of Ovidrel® have been examined in three well-controlled
studies in women; two studies for assisted reproductive technologies (ART) and
one study for ovulation induction (OI).

ASSISTED REPRODUCTIVE TECHNOLOGIES (ART)

The safety and efficacy of Ovidrel® 250 μg and Ovidrel® 500 μg administered
subcutaneously versus 10,000 USP Units of an approved urinary-derived hCG
product administered intramuscularly were assessed in a randomized, open-label,
multicenter study in infertile women undergoing in vitro fertilization and
embryo transfer (Study 7927). The study was conducted in 20 U.S. centers.

The primary efficacy parameter in this single-cycle study was the number of
oocytes retrieved. 297 patients entered the study, of whom 94 were randomized to
receive Ovidrel® 250 μg. The number of oocytes retrieved was similar for the
Ovidrel® and urinary-derived hCG (10,000 USP Units) treatment groups. The
efficacy of Ovidrel® 250 μg and Ovidrel® 500 μg were both found to be clinically
and statistically equivalent to that of the approved urinary-derived hCG product
and to each other. The efficacy results for the patients who received Ovidrel®
250 μg are summarized in Table 3.

Table 3: Efficacy Outcomes of r-hCG in ART (Study 7927)


Parameter Ovidrel® 250 μg
(n = 94) Mean number of oocytes retrieved per patient 13.60 Mean number of
mature oocytes retrieved per patient 7.6 Mean number of 2 PN fertilized oocytes
per patient 7.2 Mean number of 2 PN or cleaved embryos per patient 7.6
Implantation rate per embryo transferred (%) 18.7 Mean mid-luteal serum
progesterone levels (nmol/L*) 423 Clinical pregnancy rate per initiated
treatment cycle (%)† 35.1 Clinical pregnancy rate per transfer (%)† 36.3 *nmol/L
÷ 3.18 = ng/mL
†Clinical pregnancy was defined as a pregnancy during which a fetal sac (with or
without heartbeat activity) was detected by ultrasound on day 35-4 2 after Hcg
administration)



For the 33 patients who achieved a clinical pregnancy with Ovidrel® 250 μg, the
outcomes of the pregnancies are presented in Table 4.

Table 4: Pregnancy Outcomes of r-hCG in ART (Study 7927)


Parameter Ovidrel® 250 μg
(n = 33) Clinical pregnancies not reaching term 4 (12.1%) Live births 29 (87.9%)
Singleton 20 (69.0%) Multiple birth 9 (31.0%)



The safety and efficacy of Ovidrel® 250 μg administered subcutaneously versus
5,000 IU of an approved urinary-derived hCG product administered subcutaneously
were assessed in a second, randomized, multicenter study in infertile women
undergoing in vitro fertilization and embryo transfer (Study 7648). This
double-blinded study was conducted in nine centers in Europe and Israel.

The primary efficacy parameter in this single-cycle study was the number of
oocytes retrieved per patient. 205 patients entered the study, of whom 97
received Ovidrel® 250 μg. The efficacy of Ovidrel® 250 μg was found to be
clinically and statistically equivalent to that of the approved urinaryderived
hCG product. The results for the 97 patients who received Ovidrel® 250 μg are
summarized in Table 5.

Table 5: Efficacy Outcomes of r-hCG in ART (Study 7648)


Parameter Ovidrel® 250 μg
(n = 97) Mean number of oocytes retrieved per patient 10.6 Mean number of mature
oocytes retrieved per patient 10.1 Mean number of 2 PN fertilized oocytes per
patient 5.7 Mean number of 2 PN or cleaved embryos per patient 5.1 Implantation
rate per embryo transferred (%) 17.4 Mean mid-luteal serum progesterone levels
(nmol/L)* 394 Clinical pregnancy rate per initiated treatment cycle (%)† 33
Clinical pregnancy rate per transfer (%)† 37.6 *nmol/L ÷ 3.18 = ng/mL
†Clinical pregnancy was defined as a pregnancy during which a fetal sac (with or
without heartbeat activity) was detected by ultrasound on day 35-4 2 after hCG
administration)



For the 32 patients who achieved a clinical pregnancy with Ovidrel® 250 μg, the
outcomes of the pregnancies are presented in Table 6.

Table 6: Pregnancy Outcomes of r-hCG in ART (Study 7648)


Parameter Ovidrel® 250μg
(n = 32) Clinical Pregnancies not reaching term 6 (18.8%) Live births 26 (81.2%)
Singleton 18 (69.2%) Multiple birth 8 (30.8%)



OVULATION INDUCTION (OI)

The safety and efficacy of Ovidrel® 250 μg administered subcutaneously versus
5,000 IU of an approved urinary-derived hCG product administered intramuscularly
were assessed in a double-blind, randomized, multicenter study in anovulatory
infertile women (Study 8209) which was conducted in 19 centers in Australia,
Canada, Europe and Israel.

The primary efficacy parameter in this single-cycle study was the patient
ovulation rate. 242 patients entered the study, of whom 99 received Ovidrel® 250
μg. The efficacy of Ovidrel® 250 μg was found to be clinically and statistically
equivalent to that of the approved urinary-derived hCG product. The results of
those patients who received Ovidrel® 250 μg are summarized in Table 7.

Table 7: Efficacy Outcomes of r-hCG in OI (Study 8209)


Parameter Ovidrel® 250 μg
(n = 99) Ovulation Rate 91 (91.9%) Clinical Pregnancy Rate* 22 (22%) *Clinical
pregnancy was defined as a pregnancy during which a fetal sac (with or without
heartbeat activity) was detected by ultrasound on day 35-4 2 after hCG
administration.



For the 22 patients who had a clinical pregnancy with Ovidrel® 250 μg, the
outcome of the pregnancy is presented in Table 8.

Table 8: Pregnancy Outcomes of r-hCG in OI (Study 8209)


Parameter Ovidrel® 250 μg
(n = 22) Clinical Pregnancies not reaching term 7 (31.8%) Live births 15 (68.2%)
Singleton 13 (86.7%) Multiple birth 2 (13.3%)




PATIENT INFORMATION FOR OVIDREL

Prior to therapy with hCG, patients should be informed of the duration of
treatment and monitoring of their condition that will be required. The risks of
ovarian hyperstimulation syndrome and multiple births in women (see WARNINGS)
and other possible adverse reactions (see “ADVERSE REACTIONS”) should also be
discussed.


FROM

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