Follitropin alfa
Follitropin alfa (Gonal-F)
Follitropin alfa
(fol-ih-
TROH-pin
AL-fah)
Pregnancy Category: X
Gonal-F
(Rx)
Follitropin beta
Follitropin beta (Follistim)
Follitropin beta
(fol-ih-
TROH-pin
BAY-tah)
Pregnancy Category: X
Follistim
(Rx)
Classification:
Ovarian stimulant, gonadotropin
Action/Kinetics:
Both products are human FSH prepared by recombinant DNA technology. When given with HCG, products stimulate ovarian follicular growth in women who do not have primary ovarian failure. Steady state plasma levels reached within 4 to 5 days. Increased body weight or body mass index (BMI) results in a decrease in rate of absorption. Increased risk of multiple births.
Uses:
Induction of ovulation and pregnancy in anovulatory infertile clients where cause of infertility is functional. To stimulate development of multiple follicles in ovulatory clients undergoing in-vitro fertilization.
Contraindications:
Use in primary ovarian failure; uncontrolled thyroid or adrenal dysfunction; in presence of any cause of infertility other than anovulation; tumor of ovary, breast, uterus, hypothalamus, or pituitary gland; abnormal vaginal bleeding of undetermined origin; ovarian cysts or enlargement not due to polycystic ovary syndrome; pregnancy; use in children; hypersensitivity to products.
Special Concerns:
Use with caution during lactation.
Side Effects:
CV: Intravascular thrombosis and embolism causing venous thrombophlebitis,
pulmonary embolism pulmonary infarction, stroke, arterial occlusion (leading to loss of limb).
Pulmonary: Atelectasis, ARDS, exacerbation of asthma.
Ovarian hyperstimulation syndrome: Ovarian enlargement, abdominal pain/distention, N&V;, diarrhea, dyspnea, oliguria, ascites, pleural effusion, hypovolemia, electrolyte imbalance, hemoperitoneum, thromboembolic events.
Hypersensitivity: Febrile reaction, chills, musculoskeletal aches, joint pains, malaise, headache, fatigue.
GI: N&V;, diarrhea, abdominal cramps, bloating.
Dermatologic: Dry skin, body rash, hair loss, hives.
Miscellaneous: Ovarian cysts, pain, swelling, headache, irritation at site of injection, breast tenderness.
How Supplied:
Follitropin alfa:
Powder for injection: 75 IU, 150. IU; Follitropin beta:
Powder for injection: 75 IU
Dosage
Follitropin Alfa
?SC only
Ovulation induction.
Initial, first cycle: 75 IU/day. An incremental adjustment up to 37.5 IU may be considered after 14 days; further increases can be made, if needed, every 7 days. To complete follicular development and effect ovulation in absence of an endogenous LH surge, give 5,000 units of HCG 1 day after last dose of follitropin alfa. Withold HCG if serum estradiol is greater than 2,000 pg/mL. Base initial dose in subsequent cycles on response in the preceding cycle. Doses greater than 300 IU/day are not recommended routinely. As in initial cycle, HCG at a dose of 5,000 is given 1 day after last dose of follitropin alfa.
Follicle stimulation.
Initiate on day 2 or 3 of the follicular phase at a dose of 150 IU/day, until sufficient follicular development is achieved. Usually, therapy does not exceed 10 days. In those undergoing in vitro fertilization whose endogenous gonadotropin levels are suppressed, initiate follitropin alfa at a dose of 225 IU/day. Consider dosage adjustments after 5 days based on client response; adjust subsequent dosage every 3 to 4 days and by less than 75 to 150 IU additional drug at each adjustment, not to exceed 450 IU/day. Once follicular development is achieved, give HCG, 5,000-10,000 units, to cause final follicular maturation in preparation for oocyte retrieval.
Follitropin Beta
?SC, IM
Ovulation induction.
Use stepwise, gradually increasing dosage regimen.
Initial: 75 IU/day for up to 14 days; increase by 37.5 IU at weekly intervals until follicular growth or serum estradiol levels indicate response. Maximum daily dose: 300 IU. Treat until ultrasonic visualization or serum estradiol levels indicate pre-ovulatory conditions greater than or equal to normal values. Then, give HCG 5,000-10,000 IU.
Follicle stimulation.
Initial: 150-225 IU for first 4 days of treatment. Dose may be adjusted based on ovarian response. Daily maintenance doses from 75-300 IU (however, doses from 375-600 IU have been used) for 6 to 12 days are usually sufficient. Maximum daily dose: 600 IU. When sufficient number of follicles of adequate size are present, induce final maturation by giving HCG, 5,000-10,000 IU. Oocyte retrieval is undertaken 34-36 hr later. |