Choriogonadotropin alfa injection is used to trigger final follicular maturation and early luteinization in infertile women who have undergone pituitary desensitization and 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. It is also indicated for inducing ovulation and supporting pregnancy in anovulatory infertile women where infertility is due to functional causes and not primary ovarian failure.

Selection Of Patients:

• Prior to initiating gonadotropin therapy, a comprehensive gynecological and endocrine assessment should be carried out, including evaluation of pelvic anatomy. Patients with tubal obstruction should receive Choriogonadotropin Alfa Prefilled Syringe only if they are enrolled in an in vitro fertilization program.
• Primary ovarian failure should be ruled out by assessing gonadotropin levels.
• Pregnancy must be excluded before starting treatment.
• Women in later reproductive age have a higher risk of endometrial carcinoma and ovulatory disorders; therefore, careful diagnostic evaluation is necessary in patients with abnormal uterine bleeding or suspected endometrial abnormalities before initiating FSH and Choriogonadotropin Alfa therapy.
• Assessment of the male partner’s fertility status should be included in the initial evaluation.
• Use medicines only as advised by a registered physician

The physicochemical, immunological, and biological properties of recombinant hCG are comparable to those of naturally occurring placental or urine-derived human chorionic gonadotropin. Choriogonadotropin alfa promotes final follicular maturation, resumption of oocyte meiosis, and rupture of the pre-ovulatory follicle. As an analogue of luteinizing hormone (LH), it binds to LH/hCG receptors located on granulosa and theca cells in the ovary, thereby triggering ovulation and enhancing endogenous LH activity. During pregnancy, hCG produced by the placenta supports the corpus luteum, ensuring continued secretion of estrogen and progesterone required for maintaining early pregnancy. Choriogonadotropin Alfa Prefilled Syringe is administered when adequate follicular development has been achieved following FSH stimulation, in order to induce ovulation.

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 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): 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.

Drug & other interactions: No clinically meaningful drug interactions have been reported with hCG therapy. After administration, Ovidrel (choriogonadotropin alfa) may interfere with laboratory tests measuring serum or urinary hCG for up to 10 days, potentially causing false-positive pregnancy results. Mild thyroid stimulation may also occur during therapy, though its clinical significance remains uncertain.

Choriogonadotropin Alfa Prefilled Syringe should not be used in women with:

• Known hypersensitivity to hCG preparations or any of their components
• Primary ovarian failure
• Uncontrolled thyroid or adrenal disorders
• Uncontrolled intracranial lesions (e.g., pituitary tumors)
• Unexplained abnormal uterine bleeding
• Ovarian cysts or enlargement of unknown origin
• Hormone-dependent tumors of reproductive organs or accessory tissues
• Pregnancy

Possible adverse effects include injection site reactions, abdominal bloating, diarrhea, hiccups, ectopic pregnancy, breast pain, irregular menstrual bleeding, vaginal bleeding, cervical abnormalities, leukorrhea, ovarian hyperstimulation, uterine disorders, vaginitis, vaginal discomfort, body and back pain, fever, dizziness, headache, hot flushes, fatigue, tingling sensations, skin rash, mood changes, insomnia, upper respiratory tract infections, cough, painful urination, urinary tract infection, urinary incontinence, albuminuria, cardiac arrhythmia, genital fungal infection, genital herpes, leukocytosis, heart murmur, and cervical carcinoma.

Pregnancy: Animal studies have shown intrauterine death and impaired delivery in rats given high doses of urinary hCG.

Nursing Mothers: It is not known whether this drug is excreted in human breast milk. As many drugs are excreted in milk, caution should be taken when administered to breastfeeding women.

Gonadotropins, including Choriogonadotropin Alfa Prefilled Syringe, should be used only under the supervision of physicians experienced in infertility treatment. It is a potent gonadotropic agent that may cause Ovarian Hyperstimulation Syndrome (OHSS), with or without respiratory or vascular complications. Careful consideration is required in patients with risk factors for thromboembolic events (e.g., personal or family history).

Gonadotropin therapy requires appropriate monitoring, including regular assessment of ovarian response using serum estradiol levels and transvaginal ultrasound. Safe and effective ovulation induction depends on proper clinical supervision and monitoring.

Pediatric Patients: Safety and efficacy have not been established.

Geriatric Patients: Safety and efficacy have not been established.

Female sex hormones

The prefilled syringe should be stored in a refrigerator at 2–8°C before dispensing. After dispensing, it may be kept at room temperature (up to 25°C) for a maximum of 30 days, after which it should be discarded if unused. Protect from light and store in the original packaging.