Ovidrel Drug Information

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.

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. Figure 1 Figure 2

(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. Table 9: Incidence of Adverse Events of r-hCG in ART Studies 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) 3.0% 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: Spontaneous Abortion Ectopic Pregnancy Premature Labor Postpartum Fever 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: Pulmonary and vascular complications (see " Warnings " ) Adnexal torsion (as a complication of ovarian enlargement) Mild to moderate ovarian enlargement 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 ")

Pregnancy 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.

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

Ovidrel ® PreFilled Syringe (choriogonadotropin alfa injection) 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 (see " Selection of Patients " ). Ovarian cyst or enlargement of undetermined origin (see " Selection of Patients " ).

Sex hormone dependent tumors of the reproductive tract and accessory organs. Pregnancy.