Ovidrel Injection
Choriogonadotropin Alfa
250 mcg/0.5 ml
Janata Pharma
| Pack size | 0.5 ml |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 2383.00 AED |
Indications
Ovidrel Injection is used for:
Anovulatory infertility, Adjunct to IVF procedures and other assisted conception techniques, Induction of Ovulation & Pregnancy
Adult Dose
Induction of Ovulation & Pregnancy
250 mcg SC one day following the last dose of follicle-stimulating agent; use only after adequate follicular development has been determined;
hold treatment if there is an excessive ovarian response
Child Dose
Renal Dose
Administration
Contra Indications
Hypersensitivity to component
Primary ovarian failure
Uncontrolled thyroid or adrenal dysfunction
Uncontrolled organic intracranial lesion such as pituitary tumor
Undiagnosed abnormal uterine bleeding
Ovarian cyst or enlargement of undetermined origin
Sex hormone dependent tumor of reproductive tract and accessory organs
Pregnancy
Precautions
Potent gonadotropic substance capable of causing ovarian hyperstimulation syndrome (OHSS) in women with or without pulmonary or vascular complications
Withhold where clinically significant ovarian enlargement or excessive estradiol production to reduce risk of ovarian hyperstimulation syndrome
Safe and effective induction of ovulation and use of prefilled syringe in women requires monitoring of ovarian response with serum estradiol and transvaginal ultrasound on a regular basis
Ovarian hyperstimulation syndrome is characterized by mild to moderate ovarian enlargement may occur, accompanied by abdominal distension and/or abdominal pain; usually regresses without treatment in 2-3 wk; may progress rapidly to a serious medical event characterized by dramatic increase in vascular permeability, which may result in rapid fluid accumulation in peritoneal cavity, thorax and/or pericardium
Potential for arterial thromboembolism
Risk of enlargement of preexisting ovarian cysts or rupture of ovarian cysts with resultant hemoperitoneum
If ovaries are abnormally enlarged on last day of FSH therapy, choriogonadotropin alfa should not be administered in this course of therapy; this will reduce risk of development of ovarian hyperstimulation syndrome
Early warning signs of development of OHSS are severe pelvic pain, nausea, vomiting, and weight gain; symptomatology seen with cases of OHSS include 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
Transient liver function test abnormalities suggestive of hepatic dysfunction, which may be accompanied by morphologic changes on liver biopsy, reported in association with ovarian hyperstimulation syndrome
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 onset of menses; if there is evidence that OHSS may be developing prior to hCG administration hCG must be withheld
If severe OHSS occurs, treatment with gonadotropins must be stopped and patient should be hospitalized;a physician experienced in management of this syndrome, or who is experienced in management of fluid and electrolyte imbalances should be consulted
As with other hCG products, reports of multiple births have been associated with treatment; in ART, the risk of multiple births correlates to number of embryos transferred; multiple births were experienced by 30.9% of women receiving 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 therapy; the patient should be advised of potential risk of multiple births before starting treatment
Combination of both ultrasound and serum estradiol measurement are useful for monitoring development of follicles, for timing of ovulatory trigger, as well as for detecting ovarian enlargement and minimizing risk of ovarian hyperstimulation syndrome and multiple gestation; recommended that number of growing follicles be confirmed using ultrasonography because serum estrogens do not give an indication of size or number of follicles
Pregnancy-Lactation
Pregnancy
Intrauterine death and impaired parturition observed in pregnant rats given a dose of urinary-hCG (500 IU) equivalent to three times maximum human dose of 10,000 USP, based on body surface area
Lactation
Not known whether this drug is excreted in human milk; because many drugs are excreted in human milk, exercise caution if hCG administered to a nursing woman
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed child from therapy or from underlying maternal condition
Interactions
Adverse Effects
Side effects of Choriogonadotropin Alfa :
1-10%
Ovarian cyst (3%),Ovarian hyperstimulation (2-3%),Abdominal pain (3-4%),Nausea (3%),Vomiting (3%),Injection site inflammation (<2%)
<1%
Breast pain,Cervical lesion,Cough,Albuminuria,Back pain,Breast pain,Cardiac arrhythmia,Dizziness,Emotional lability,Genial herpes,Hyperglycemia,Pruritus,Urinary tract infection,Vaginal hemorrhage,Vaginitis
Mechanism of Action
Choriogonadotropin alfa is a recombinant form of chorionic gonadotrophin. Its effects mimic those of leuteinizing hormone, which triggers ovulation and formation of the corpus luteum in women and stimulates the production of testosterone by the testes in men.
Produced by recombinant DNA techniques: human chorionic gonadotropin; stimulates late follicular maturation & resumption of oocyte meiosis & initiates rupture of pre-ovulatory ovarian follicle
Note
Ovidrel 250 mcg/0.5 ml Injection manufactured by Janata Pharma. Its generic name is Choriogonadotropin Alfa. Ovidrel is availble in Bangladesh.
Farmaco BD drug index information on Ovidrel Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.