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|Follitropin Beta |
Drugs search, click the first letter of a drug name: | A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z | 1 | 2 | 3 | 4 | 5 | 6 | 8 | 9 Home Follitropin BetaPronouncation: (fole-lih-TROE-pin BAY-tah)Class: Ovulation stimulant Trade Names: Trade Names: Mechanism of ActionPharmacologyStimulates ovarian follicular growth in women who do not have primary ovarian failure. PharmacokineticsAbsorptionSubcutaneous routeBioavailability is 77.8%, AUC is 455.6 units•hr/L, and C max is 5.4 units/L. IM routeBioavailability is 76.4%, AUC is 445.7 units•hr/L, and C max is 6.86 units/L. DistributionVd is 8 L. EliminationMean t ½ is about 26.9 to 43.9 hr and is dose dependent. Indications and UsageFor development of multiple follicles in ovulatory patients participating in an assisted reproductive technology (ART) program; for induction of ovulation and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not caused by primary ovarian failure. ContraindicationsPrior hypersensitivity to recombinant human follicle-stimulating hormone products; high circulating FSH level (indicating primary ovarian failure); uncontrolled thyroid or adrenal dysfunction; tumor of the ovary, breast, uterus, hypothalamus, or pituitary gland; pregnancy; heavy or irregular vaginal bleeding of undetermined origin; ovarian cysts or enlargement not caused by polycystic ovary syndrome; hypersensitivity to streptomycin or neomycin. Dosage and AdministrationFollicle Stimulation (ART)Adults Follistim AQ IM/Subcutaneous 150 to 225 units/day for at least first 4 days of treatment, then adjust dose upon patient"s ovarian response. Daily maintenance dosages ranging from 75 to 300 units for 6 to 12 days is usually sufficient, although longer treatment may be necessary. However, in low or poor responders, maintenance doses of 375 to 600 units have been administered (max, 600 units/day). The final maturation of the follicles is induced by administering human chorionic gonadotropin (hCG) at a dose of 5,000 to 10,000 units. If the ovaries are abnormally enlarged on the last day, hCG must be withheld. Follistim AQ CartridgeSubcutaneous 150 to 225 units or lower/day for at least first 5 days of treatment, then adjust dose upon patient"s ovarian response (max, 450 units). If prescriber generally uses an initial dose of 150 to 225 units of lyophilized gonadotropin, then a lower starting dose should be considered (eg, 50 units instead of 75 units, 125 units instead of 150 units, 175 units instead of 225 units). A lower maintenance dose also should be considered (eg, 250 units instead of 300 units, 300 units instead of 375 units, 375 units instead of 450 units). The final maturation of the follicles is induced by administering hCG at a dose of 5,000 to 10,000 units. If the ovaries are abnormally enlarged on the last day, hCG must be withheld. Ovulation InductionAdults Follistim AQ IM/Subcutaneous There are various treatment protocols. In studies using a gradually increasing dosing scheme, treatment was initiated with 75 units/day for up to 14 days, then the dose was increased by 37.5 units at weekly intervals until follicular growth or serum estradiol levels indicate an adequate response (max, 300 units). Continue treatment until ultrasonic visualization or serum estradiol determinations indicate pre-ovulatory conditions at least those of normal individuals followed by hCG, 5,000 to 10,000 units. If the ovaries are abnormally enlarged on the last day, hCG must be withheld during this course of treatment. Follistim AQ CartridgeSubcutaneous Initiate treatment with 75 units or lower/day for at least the first 7 days. If prescriber generally uses an initial dose of 75 units of lyophilized gonadotropin, then a lower starting dose of Follistim AQ Cartridge should be considered (eg, 50 units instead of 75 units). Dose then is increased 25 or 50 units at weekly intervals, based upon patient response (max, 175 units). Continue treatment until follicular growth or serum estradiol levels indicate pre-ovulatory conditions at least those of normal individuals followed by hCG, 5,000 to 10,000 units. If the ovaries are abnormally enlarged on the last day, hCG must be withheld during this course of treatment. General Advice
Storage/StabilityStore in refrigerator (36° to 46°F) until dispensed. May be stored by patient in refrigerator until expiration date, or at or below 77°F for 3 mo or until expiration date, whichever occurs first. Once cartridge has been pierced by a needle, cartridges can only be stored for max of 28 days at 36° to 77°F. Protect all products from light and freezing. Drug InteractionsNone well documented. Laboratory Test InteractionsNone well documented. Adverse ReactionsCardiovascularTachycardia, vascular complications (eg, arterial occlusion, cerebral vascular occlusion, pulmonary embolism, pulmonary infarction, venous thrombophlebitis). CNSDizziness, headache (5%). DermatologicBody rash, dry skin, erythema, hair loss, hives. GIAbdominal discomfort, abdominal pain, lower abdominal discomfort (28%); flatulence (27%); nausea (17%); abdomen enlarged (8%); constipation (5%); ovarian cyst (3%). GenitourinaryAbdominal pain/gynecological (25%); breast pain (15%); miscarriage (11%); ovarian hyperstimulation syndrome (9%); ovarian pain (5%); ectopic pregnancy (3%); vaginal hemorrhage (2%); breast tenderness, ovarian neoplasm (benign and malignant). LocalInjection site pain (10%). RespiratoryUpper respiratory tract infection (5%); dyspnea, pulmonary complications (eg, acute respiratory distress syndrome, atelectasis), tachypnea. MiscellaneousBack pain (7%); sinusitis (5%); adnexal torsion, febrile reactions, flu-like symptoms (including fever, chills, musculoskeletal aches, joint pains, nausea, headache, malaise), hemoperitoneum. Precautions
PregnancyCategory X . LactationUndetermined. ChildrenSafety and efficacy not established. Multiple birthsMay occur. Ovarian enlargementTo minimize hazards associated with abnormal ovarian enlargement, use lowest effective dose. Ovarian hyperstimulation syndromeMay occur. Warning signs include pelvic pain, nausea, vomiting, abdominal distention, weight gain, oliguria. May progress within 24 hr to several days to become a serious medical event. Pulmonary complicationsSerious pulmonary conditions (eg, acute respiratory distress syndrome, atelectasis) have been reported. Vascular complicationsIntravascular thrombosis may occur, resulting in intravascular thrombosis and embolism, which can reduce blood flow to vital organs (resulting in pulmonary infarction or stroke) or extremities (resulting in loss of limbs). OverdosageSymptomsMultiple gestations, ovarian hyperstimulation syndrome. Patient Information
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