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Bravelle

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Bravelle

Bravelle

CLINICAL PHARMACOLOGY

Mechanism Of Action

BRAVELLE® administered for 7 to 12 days produces ovarian follicular growth in women who do not have primary ovarian failure. Treatment with BRAVELLE® 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 225 International Units and multiple daily doses (7 days) of 150 International Units of BRAVELLE® were administered to healthy volunteer female subjects while their endogenous FSH was suppressed. Sixteen subjects received BRAVELLE® subcutaneously and 12 received the drug intramuscularly. Serum FSH concentrations were determined. Based on the steady state ratio of FSH C max and AUC, subcutaneous and intramuscular administration of BRAVELLE® were not bioequivalent. Multiple doses of BRAVELLE® intramuscular resulted in C max and AUC of 77.7% and 81.8% compared to multiple doses of BRAVELLE® subcutaneous. The FSH pharmacokinetic parameters for single and multiple dose BRAVELLE®, administered subcutaneously and intramuscularly are in Table 3.

Table 3: FSH Pharmacokinetic Parameters (Mean ± SD) Following BRAVELLE® Administration

PK Parameters Single Dose (225 IU) Multiple Dose X 7 (150 IU)
Subcutaneous Intramuscular Subcutaneous Intramuscular
Cmax (mIU/mL) 6.0 (1.7) 8.8 (4.5) 14.8 (2.9) 11.5 (2.9)
Tmax (hrs) 20.5 (7.7) 17.4 (12.2) 9.6 (2.1) 11.3 (8.4)
AUC obs (mIU•hr/mL) 379 (111) 331 (179) 234.7 (77.0) 192.1 (52.3)
t½ (hrs) 31.8 37 20.6 15.2

Absorption

The subcutaneous route of administration trends toward greater bioavailability than the IM route for single and multiple doses of BRAVELLE® .

Distribution

Human tissue or organ distribution of FSH has not been studied for BRAVELLE® .

Metabolism

Metabolism of FSH has not been studied for BRAVELLE® in humans.

Elimination

The mean elimination half-lives of FSH for subcutaneous and intramuscular single dosing are 31.8 and 37 hours, respectively. However, following multiple dosing (X 7 days) they are 20.6 and 15.2 hours for SC and IM, respectively.

Clinical Studies

The efficacy of BRAVELLE® was examined in two clinical studies, one for in-vitro fertilization (IVF) and one for ovulation induction (OI).

Ovulation Induction

In the randomized, multi-center, active-controlled, ovulation induction study, women underwent pituitary suppression with a GnRH agonist before being randomized to subcutaneously administered BRAVELLE® , intramuscularly-administered BRAVELLE®, or a subcutaneously administered commercial recombinant FSH product. A total of 111 oligo-anovulatory women were randomized to both treatment arms, of which 72 received BRAVELLE®, starting at a dose of 150 International Units daily for 5 days. Subsequently each woman received individual titration of the BRAVELLE® dose from 75 to 450 International Units daily based on ultrasound and estradiol (E 2) levels. The total duration of dosing did not exceed 12 days. Results for the Intent-To-Treat Population are summarized in Table 4.

Table 4: Efficacy Outcome by Treatment Groups in Induction of Ovulation (one cycle of treatment) Study

Parameter BRAVELLE® Subcutaneous
N=35
BRAVELLE® Intramuscular
N=37
Ovulation (%) 24 (68.6) 26 (70.3)
Received hCG (%) 25 (71.4) 28 (75.7)
Mean Peak Serum E2 (pg/mL) (SD) 976.5 (680.6) 893.2 (815.2)
Chemical Pregnancy (%) 11 (31.4) 8 (21.6)
Clinical Pregnancy (%) 9 (25.7) 7 (18.9)
Continuing Pregnancy (%) 9 (25.7) 7 (18.9)
Pts. w/Live Births (%) 9 (25.7) 6 (16.2)

Assisted Reproductive Technologies [ART]

In the randomized, multi-center, active-controlled, IVF study, women underwent pituitary suppression with a GnRH agonist before being randomized to subcutaneously administered BRAVELLE® or a subcutaneously administered commercial recombinant FSH product. A total of 120 patients were randomized to both treatment arms, of which 60 received BRAVELLE®, starting at a dose of 225 International Units daily for 5 days. Subsequently each woman received individual titration of the dose from 75 to 450 International Units daily based on ultrasound and estradiol (E2) levels. The total duration of dosing did not exceed 12 days. Results are summarized in Table 5 for the Intent-To-Treat population.

Table 5: Efficacy Outcome for IVF (one cycle of treatment) Study

Parameter BRAVELLE® subcutaneous
n=60
Mean Total Oocytes Retrieved Per Patient (SD) 11.8 (6.3)
Mean Mature Oocytes Retrieved Per Patient (SD) 9.0 (5.7)
Patients with Oocyte Retrieval (%) 57 (95.0)
Patients with Embryo Transfer (%) 57 (95.0)
Patients with Chemical Pregnancy (%) 28 (46.6)
Patients with Clinical Pregnancy (%) 25 (41.7)
Patients with Continuing Pregnancy (%) 23 (38.3)

Last reviewed on RxList: 2/28/2014
This monograph has been modified to include the generic and brand name in many instances.

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