Choriogonadotropin alfa
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
CONTRAINDICATIONS Prior hypersensitivity reactions to human gonadotropins, including hCG, or any of the excipients (see ADVERSE REACTIONS ). High serum FSH, indicating primary gonadal failure in women. Presence of uncontrolled non-gonadal endocrinopathies (e.g., thyroid, adrenal, or pituitary disorders). Tumors of the hypothalamus or pituitary gland and ovary, breast, or uterus in females and breast or prostate in males.
The early warning signs of the development of OHSS are severe pelvic pain, nausea, vomiting, and weight gain. Abdominal pain, abdominal distension, gastrointestinal symptoms including nausea, vomiting and diarrhea, severe ovarian enlargement, weight gain, dyspnea, and oliguria have been reported with OHSS. Clinical evaluation may reveal hypovolemia, hemoconcentration, electrolyte imbalances, ascites, hemoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and thromboembolic reactions.
Preparation and administration
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Selected cases of hypogonadotropic hypogonadism in males. 500 to 1000 USP units 3 times a week for 3 weeks, followed by the same dose twice a week for 3 weeks. 4000 USP units 3 times weekly for 6 to 9 months, following which the dosage may be reduced to 2000 USP units 3 times weekly for an additional 3 months. Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure and who has been appropriately treated with gonadotropins. (See also prescribing information for gonadotropins for dosage and administration for that drug product .) 5000 to 10,000 USP units 1 day following the last dose of gonadotropins. (A dosage of 10,000 USP units is recommended in the labeling for gonadotropins.) Directions for Reconstitution Withdraw sterile air from vial with lyophilized powder and inject into vial with solvent.
Remove 1 to 10 mL of solvent and add to vial with lyophilized powder; agitate gently until powder is completely dissolved in solution. Do not shake. PREGNYL is a white, dry powder / cake. The solvent is a clear and colorless aqueous solution. Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit.
If there is a discoloration or particulates, do not use. IMPORTANT: IF NEEDED, THE RECONSTITUTED SOLUTION IS STABLE FOR 60 DAYS WHEN REFRIGERATED. DO NOT FREEZE. USE THE RECONSTITUTED SOLUTION WITHIN 60 DAYS OF RECONSTITUTION. IF THE RECONSTITUTED SOLUTION IS NO LONGER NEEDED, DISCARD UNUSED PORTION.
Contraindications
Prior hypersensitivity reactions to human gonadotropins, including hCG, or any of the excipients (see ADVERSE REACTIONS ). High serum FSH, indicating primary gonadal failure in women. Presence of uncontrolled non-gonadal endocrinopathies (e.g., thyroid, adrenal, or pituitary disorders). Tumors of the hypothalamus or pituitary gland and ovary, breast, or uterus in females and breast or prostate in males. Malformations of the reproductive organs incompatible with pregnancy. Fibroid tumors of the uterus incompatible with pregnancy. Abnormal vaginal bleeding of undetermined origin.
Pregnancy and lactation
Pregnancy
Pregnancy PREGNYL is not indicated in pregnancy. PREGNYL may be used for luteal phase support, but is discontinued upon confirmation of pregnancy. There are no data on the use of hCG in pregnancy. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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