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 Choriogonadotropin Alpha 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. Choriogonadotropin Alpha PreFilled Syringe is administered when monitoring of the patient indicates that sufficient follicular development has occurred in response to FSH treatment for ovulation induction.

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. Choriogonadotropin alfa 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:

• 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 Choriogonadotropin Alfa PreFilled Syringe only if enrolled in an in vitro fertilization program.
• Primary ovarian failure should be excluded by the determination of gonadotropin levels.
• Appropriate evaluation should be performed to exclude pregnancy.
• 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 Choriogonadotropin Alfa PreFilled Syringe therapy.
• Evaluation of the partner's fertility potential should be included in the initial evaluation.

Infertile Women Undergoing Assisted Reproductive Technologies (ART): Choriogonadotropin Alfa PreFilled Syringe 250 μg should be administered one day following the last dose of the follicle stimulating agent. Choriogonadotropin Alfa PreFilled Syringe should not be administered until adequate follicular development is indicated by serum estradioland 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): Choriogonadotropin Alfa PreFilled Syringe should not be administered until adequate follicular development is indicated by serum estradiol and vaginal ultrasonography. Choriogonadotropin Alfa PreFilled Syringe 250 μg should be administered one day following the last dose of the follicle stimulating agent. Choriogonadotropin Alfa 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.

Administration

For Subcutaneous Use Only. Directions For Administration Of Choriogonadotropin Alfa Prefilled Syringe is intended for a single subcutaneous injection. Any unused material should be discarded. Choriogonadotropin Alfa PreFilled Syringe may be self-administered by the patient. Follow the directions below for injecting Choriogonadotropin Alfa 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.

Choriogonadotropin Alpha PreFilled Syringe is contraindicated in women who exhibit:

• Prior hypersensitivity to hCG preparations or one of their excipients.
• Primary ovarian failure.
• Uncontrolled thyroid or adrenal dysfunction.
• An uncontrolled organic intracranial lesion such as a pituitary tumor.
• Abnormal uterine bleeding of undetermined origin 
• Ovarian cyst or enlargement of undetermined origin
• Sex hormone dependent tumors of the reproductive tract and accessoryorgans.
• Pregnancy.

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 murmurand cervical carcinoma.

Gonadotropins, including Choriogonadotropin Alpha 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, Choriogonadotropin Alpha PreFilled Syringe is a potent gonadotropic substance capable of causing OvarianHyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascularcomplications. 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. Safe and effective induction of ovulation and use of Choriogonadotropin Alpha PreFilled Syringe in women requires monitoring of ovarian response with serum estradiol and transvaginal ultrasound on a regular basis.

Use in Special Populations

Pediatric Patients: Safety and effectiveness in pediatric patients has not been established.

Geriatric Patients: Safety and effectiveness in geriatric patients has not been established.

Pregnancy & Lactation

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, 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.