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Repronex

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Repronex

Repronex

CLINICAL PHARMACOLOGY

Menotropins administered for 7 to 12 days produces ovarian follicular growth in women who do not have primary ovarian failure. Treatment with menotropins in most instances results only in follicular growth and maturation. When sufficient follicular maturation has occurred, hCG must be given to induce ovulation.

Pharmacokinetics

Single doses of 300 IU menotropins (Menogon®, Ferring's European formulation) were administered subcutaneously (SC) and intramuscularly (IM) in a 2-period crossover study to 16 healthy female subjects while their endogenous FSH and LH were being suppressed. Serum FSH concentrations were determined. Based on the ratio of FSH Cmax and AUCo-oc, SC and IM administration of menotropins are not bioequivalent. Compared to IM administration, the SC administration of menotropins results in an increase of FSH Cmax and AUCo-oc by 35 and 20%, respectively.

Based on two subjects who received either the highest SC or IM Repronex® (menotropins for injection) dose, FSH pharmacokinetics (PK) appears to be linear up to 450 IU menotropins. The mean accumulation factors for FSH upon six doses of SC or IM 150 to 450 IU/day Repronex® (menotropins for injection) are 1.6 and 1.4, respectively. Upon six doses of SC or IM 150 IU/day Repronex® (menotropins for injection) , the observed serum FSH concentrations range from 1.7 to 15.9 mIU/mL and 0.5 to 10.1 mIU/mL, respectively. The FSH pharmacokinetic parameters from population modeling for these two studies are in Table 1.

Table 1. FSH Pharmacokinetic Parameters Upon Menotropins Administration

Single Dose Multiple Dose
FSH Parameter SC IM SC IM
Ka(h-1) 0.128 (42.1) 0.117 (21.3) 0.076 (46.3) 0.064 (63.2)
C1/F (L/h) 0.770 (17.1) 0.94 (6.9) 1.11 (39.5) 1.44 (43.5)
V/F (L) 39.37 (14.1) 57.68 (11.4) 23.09 (8.3) 23.5 (2.5)
mean (CV%)
Menogon® (Ferring's European formulation of menotropins)
Repronex® (menotropins for injection)

Serum LH concentrations upon multiple dose SC or IM Repronex® (menotropins for injection) are low and variable. No recognizable trend in the increase in serum LH concentrations from SC or IM 150 to 450 IU/day Repronex® (menotropins for injection) doses was observed. After the 6th dose of SC or IM 150 IU/day Repronex® (menotropins for injection) , the range of baseline-corrected serum LH concentrations is 0 to 3.2 mIU/mL for both routes of administration.

Absorption

The geometric mean of FSH Cmax and AUCo-oc upon single dose SC administration of menotropins is 5.62 mIU/mL and 385.2 mIU-h/mL, respectively; the corresponding geometric median of FSH tmax is 12 hours. The geometric mean of FSH Cmax and AUCo-oc upon single dose IM administration of menotropins is 4.15 mIU/mL and 320.1 mIU-h/mL, respectively; the corresponding geometric median of FSH tmax is 18 hours.

Distribution

Human tissue or organ distribution of FSH and LH have not been studied for Repronex® (menotropins for injection) .

Metabolism

Metabolism of FSH and LH have not been studied for Repronex® (menotropins for injection) in humans.

Excretion

The mean elimination half-lives of FSH upon single dose SC and IM administration of menotropins are 53.7 and 59.2 hours, respectively.

Pediatric Populations

Repronex® (menotropins for injection) is not used in pediatric populations.

Geriatric Populations

Repronex® (menotropins for injection) is not used in geriatric populations.

Special Populations

The safety and efficacy of Repronex® (menotropins for injection) in renal and hepatic insufficiency have not been studied.

Drug Interactions

No drug/drug interaction studies have been conducted for Repronex® (menotropins for injection) in humans.

Clinical Studies

Efficacy results from a clinical trial in in vitro fertilization (IVF) patients and a clinical trial in ovulation induction (OI) in anovulatory and oligovulatory patients are summarized in Tables 2 and 3 respectively. Both studies were multicenter, active control, randomized, parallel group designs. In addition, all patients in both studies underwent pituitary suppression with a GnRH agonist before starting treatment with Repronex® (menotropins for injection) or the control therapy. The IVF study evaluated 186 patients (125 patients received Repronex® (menotropins for injection) ). The patients treated with Repronex® (menotropins for injection) received 225 IU Repronex® (menotropins for injection) daily for 5 days. This was followed by individual titration of the dose from 75 to 450 IU daily based on ultrasound and estradiol (E2) levels. The total duration of dosing did not exceed 12 days. The OI study evaluated 108 patients (72 patients received Repronex® (menotropins for injection) ). The patients treated with Repronex® (menotropins for injection) received 150 IU Repronex® (menotropins for injection) daily for 5 days. This was followed by individual titration of the dose from 75 to 450 IU daily based on ultrasound and estradiol (E2) levels. The total duration of dosing did not exceed 12 days.

Table 2. Efficacy Outcomes by Treatment Group for IVF (one cycle of treatment)

Parameter Repronex® IM
N=65
Repronex® SC
N=60
Total oocytes Retrieved 13.6 12.7
Mature oocytes Retrieved 9.4 8.6
Pts. w/oocyte Retrieval (%) 61(93.8) 55 (91.7)
Pts. w/Embryo Transfer (%) 58(89.2) 51(85.0)
Pts. w/Chemical Pregnancy (%) 31(47.7) 35(58.3)
Pts. w/Clinical Pregnancy (%) 25(38.5) 30(50.0)
Pts. w/Continuing Pregnancy (%) 24(36.9)1 29(48.3)2
Pts. w/Live Births (%) 22(33.8)3 25(41.7)4
1. Continuing pregnancies included 14 single, 7 twins, and 3 triplet pregnancies.
2. Continuing pregnancies included 14 single, 9 twins, 3 triplets, and 3 quadruplet pregnancies.
3. Total of 34 live births. One spontaneous abortion. The follow-up data is not available for one patient.
4. Total of 39 live births. Two spontaneous abortions. The follow-up data is not available for two patients.

Table 3. Efficacy Outcomes by Treatment Groups in Ovulation Induction (one cycle of treatment)

Parameter Repronex® IM
N=36
Repronex® SC
N=36
Ovulation (%) 23 (63.9) 25 (69.4)
Received hCG (%) 25 (69.4) 27 (75.0)
Mean Peak Serum E2 (SD) 1158.5 (742.3) 1452.6* (1270.6)
Chemical Pregnancy (%) 4 (11.1) 11 (30.6)
Clinical Pregnancy (%) 4 (11.1) 6 (16.7)
Continuing Pregnancy (%) 4 (11.1)1 6 (16.7)2
Pts. w/Live Births (%) 4(11.1)3 4(11.1)4
* Fisher's Exact/Chi-Squared Tests -significant for Repronex® (menotropins for injection) SC vs. Repronex® (menotropins for injection) IM
1. Continuing pregnancies included 2 single and 2 triplet pregnancies.
2. Continuing pregnancies included 3 single, 1 twin and 2 quadruplet pregnancies.
3. Total 6 live births
4. Total of 6 live births. One spontaneous abortion. The follow-up data is not available for one patient.

Last reviewed on RxList: 10/9/2008
This monograph has been modified to include the generic and brand name in many instances.

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