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Ovidrel

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Ovidrel

Warnings
Precautions

WARNINGS

Gonadotropins, including Ovidrel® (choriogonadotropin alfa injection) PreFilled Syringe (choriogonadotropin alfa injection), should only be used by physicians who are thoroughly familiar with infertility problems and their management. Like other hCG products, Ovidrel® (choriogonadotropin alfa injection) 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 gonadotropin 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® (choriogonadotropin alfa injection) 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® (choriogonadotropin alfa injection) 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® (choriogonadotropin alfa injection) 500 µg. Two patients treated with Ovidrel® (choriogonadotropin alfa injection) 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® (choriogonadotropin alfa injection) 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® (choriogonadotropin alfa injection) 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® (choriogonadotropin alfa injection) . 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

General

Careful attention should be given to the diagnosis of infertility in candidates for hCG therapy. (see INDICATIONS/Selection of Patients). After the exclusion of pre-existing conditions, elevations in ALT were found in 10 (3%) of 335 patients receiving Ovidrel® (choriogonadotropin alfa injection) 250 µg, 9 (10%) of 89 patients receiving Ovidrel® (choriogonadotropin alfa injection) 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® (choriogonadotropin alfa injection) in animals have not been performed. In-vitro genotoxicity testing of Ovidrel® (choriogonadotropin alfa injection) 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.

Last reviewed on RxList: 6/25/2010
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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