REPRONEX POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MENOTROPINS

Available from:

FERRING INC

ATC code:

G03GA02

INN (International Name):

HUMAN MENOPAUSAL GONADOTROPHIN

Dosage:

75UNIT

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

MENOTROPINS 75UNIT

Administration route:

INTRAMUSCULAR

Units in package:

2 ML

Prescription type:

Prescription

Therapeutic area:

GONADOTROPINS AND ANTIGONADOTROPINS

Product summary:

Active ingredient group (AIG) number: 0149345001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2019-04-23

Summary of Product characteristics

1
PRODUCT MONOGRAPH
Pr
REPRONEX
®
(Menotropins for Injection)
75 IU/Vial
(75 IU FSH, 75 IU LH)
For SC/IM Use Only
Gonadotropins for Infertility
Ferring Inc.
200 Yorkland Boulevard
Suite 500
North York, Ontario
M2J 5C1
CONTROL #: 197382
DATE OF APPROVAL: November 17, 2016
2
DESCRIPTION
Repronex (menotropins for injection) is a purified preparation of
gonadotropins
extracted from the urine of postmenopausal women. Human Chorionic
Gonadotropin
(hCG) a naturally occurring hormone in postmenopausal urine, is
detected in
Repronex. Each vial of Repronex contains 75 International Units (IU)
of follicle-
stimulating hormone (FSH) activity and 75 IU of luteinizing hormone
(LH) activity,
respectively, plus 20 mg lactose monohydrate in a sterile, lyophilized
form. The final
product may contain sodium phosphate buffer (sodium phosphate tribasic
and
phosphoric acid). Both FSH and LH are acidic and water soluble.
Repronex is
administered by subcutaneous or intramuscular injection.
3
ACTIONS AND CLINICAL PHARMACOLOGY
Repronex (menotropins for injection) administered for seven to twelve
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. In
order to effect ovulation, human chorionic gonadotropin (hCG) must be
given following the
administration of menotropins when clinical assessment of the patient
indicates that
sufficient follicular maturation has occurred.
(1,7)
In an early pharmacokinetic study including 16 healthy female
volunteers, 300 IU
menotropins were administered subcutaneously (SC) and intramuscularly
(IM) in a
crossover study, after patients endogenous FSH and LH were suppressed.
Measurements of serum FSH concentrations indicated that SC
administration leads to
higher values for both C
max
and AUC
(0 -

)
when
compared to IM injections.
The subcutaneous and intramuscular routes were not bioequivalent.
Compared to IM
administration, the SC administration of menotropins results in an
i