Recombinant FSH

Follitropin Beta
Recombinant human
follicle-stimulating hormone
for the treatment of infertility
The WHO defines three groups
of ovulatory disorders
WHO Group 1
Hypothalamic
pituitary failure
WHO Group 2
Hypothalamic
pituitary dysfunction
WHO Group 3
Ovarian failure
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FSH activity alone is
sufficient to allow normal
follicular growth and
maturation in most patients
Which gonadotropins
for which patients?
Patient group
1
st
line
therapy
2
nd
line
therapy
WHO Group 1 FSH and LH
WHO Group 2
Clomiphene
citrate
FSH alone
WHO Classification: for anovulatory patients
Puregon

(follitropin beta)
Recombinant follicle-stimulating hormone (rFSH)
Produced by CHO cells transfected with plasmids
carrying the 2-subunit genes that encode human FSH
1
For annovulation to induce development of single
follicle in preparation for OI/IUI procedures
For controlled ovarian stimulation (COS) to induce
development of multiple follicles in preparation for
IVF and other assisted reproductive technology
(ART) procedures
Used for 10 years to deliver 1 million children
2
ART, assisted reproductive technology; CHO, Chinese hamster ovary;
IVF, in vitro fertilization.
1. Olijve W, et al. Hum Reprod. 1996;2:371-382.
2. Gordon K, et al. RBM Onlne. 2006;13:313-314.
Characteristics of Puregon

99% pure FSH

High specific activity (~10,000 IU/mg protein)
Amino acid sequence identical to natural FSH
No contamination with urinary proteins
No LH activity
Indications (female)
Puregon

is indicated for the treatment of female

infertility
Anovulation (including PCOS) in women
unresponsive to treatment with clomiphene citrate
COS to induce development of follicles in
IVF/ET
ICSI
GIFT
ET, embryo transfer; ICSI, intracytoplasmic sperm injection; GIFT, gamete
intrafallopian transfer (rarely done); PCOS, polycystic ovary syndrome.
How Puregon

Is Administered
Intramuscular (IM) or subcutaneous (SC)
administration with traditional needle and syringe
Puregon

Formulations
Two other formulations of Puregon

are available:
Puregon

solution
Available in doses of 50 & 100 IU rFSH in 0.5 mL
of fluid
PUREGON | ORGALUTRAN | PREGNYL
PUREGON DELIVERS DEMONSTRATED ONGOING
PREGNANCY RATES AND CLINICAL TRIAL EFFICACY
IN THE ENGAGE TRIAL-THE WORLDS LARGEST
IVF/ICSI CLINICAL TRIAL
2
Puregon has delivered more than one million babies all
over the world
PUREGON | ORGALUTRAN | PREGNYL
Key clinical data: Engage and Xpect
Engage Xpect
750 women received Puregon

for
COS
442 women received Puregon for
COS
Ongoing pregnancy rates 38.1% Ongoing pregnancy rates 35.7%
Oocyte retrieval rate 12.5 per
attempt
Oocyte retrieval rate 12.1 per cycle
without OC
Ongoing pregnancy rate
irrespective of levels of
endogenous LH
OC pre-treatment did not affect
ovarian response but did reduce
pregnancy rates
PUREGON | ORGALUTRAN | PREGNYL
DEMONSTRATED EFFICACY IN A GnRH ANTAGONIST
PROTOCOL IN IVF/ICSI CLINICAL TRIALS
1-3
PUREGON | ORGALUTRAN | PREGNYL
No toxic or mutagenic effects have been
noted with Puregon

Tidak ada kematian yang

disebabkan obat
Tidak ada potensi
menyebabkan kanker
Tidak data toksisitas akut
pada manusia
Tidak dindikasikan untuk
dgunakan pd kehamilan
Pharmacokinetics
Elimination half-life of approximately 40 hours
Steady state after 4 doses over 4 days
Accumulation factor is 1.5 to 2.5 compared with
single dose.
Bioavailability after SC or IM administration is
75% to 80% compared with IV administration.
1. Non Kombinasi
Dosage recommendation
Menstrual
Cycle day
1 2 3 4 5 6 7 8 9 10 11 12 13 14
Puregon
Puregon 50 100 iu (1-2 amp)
Puregon 1-2 amp atau 2-3
amp diteruskan sampai
follicle >18 mm,
ketebalan endometrium
> 8 mm
Preg
nyl
5000
1-2
amp

Dosis awal yang di rekomendasikan adalah 50 iu, Penyesuaian dosis selanjutnya di naikkan
menjadi 100 150 iu (2-3 amp)
Keterangan
Dosis awal Puregon 50 iu (1 amp)*
Penyuntikan di mulai hari ke 3 mens hingga hari ke 8 mens (6 kali penyuntikan)
Pada hari ke 9 folikle di periksa :
Jika sudah ada folicle dominan (diameter 18 20 mm) berjumlah 1-3 dan ketebalan endometrium > 8 mm , maka Penyuntikan puregon
dihentikan dan langsung di suntikkan Pregnyl 5000 iu 1-2 amp
Jika belum ada maka penyuntikan puregon dilanjutkan dan dosis dapat ditingkatkan hingga mencapai ukuran yang optimum ( sampai
hari ke 13 mens)
Puregon dapat diberikan max sampai hari 16 mens
Coitus atau inseminasi dilakukan 36 40 jam setelah penyuntikkan Pregnyl 5000
Jika respon berlebihan, pengobatan dihentikan dan HCG di tunda, dosis yang lebih rendah direkomendasikan untuk pengobatan
pada siklus berikutnya
* Untuk pasien usia di atas 35 thun dosis awal adalah 100 iu (2amp)
* Untuk kasus PCO (Polycistis Ovary) sebaikanya diberikan dosis rendah (50 iu) dan diberikan dosis yang tetap/jangan dinaikkan.
Prosedur Penggunaan Puregon (Contoh pada OI)
Prosedur Penggunaan Puregon (Contoh pada OI)
1. Kombinasi
1 2 3 4 5 6 7 8 9 10 11 12 13 14
Clomiphene Citrat Puregon
50 100 iu
Puregon
50-100iu
Puregon
50-100iu
Pregnyl
5000iu
Keterangan
1. Pengobatan dimulai pada hari ke 3 mens dengan Clomiphene citrate (Dosis rekomendasi dokter)
2. Penyuntikan puregon pada hari ke 8, 10, dan 12 (50-100 iu)
3. Penyuntikan pregnyl 5000 iu pada hari ke 14 mens
4. Coitus dilakukan 36 40 jam setelah penyuntikkan pregnyl.
Contraindication & Warnings
Monitoring
Essential for all gonadotropins therapy
To increase treatment success
To reduce the risk of OHSS
Monitoring:
Ultrasound scan
Assay of estradiol level
Urinary FSH Products / urofollitropin
Kekurangan urinary FSH adalah:
Kemurnian FSH yang berbeda-beda; konsistensi dari
batch ke batch yang rendah bila dibandingkan dengan
Puregon
Proporsi isoform FSH yang berbeda-beda23
Sumber donor yang berbeda, dengan jumlah donor yang
besar
Resiko kontaminasi dengan obat atau metabolit obat
Kemungkinan resiko transmisi penyakit yang berasal dari
produk urin tersebut
Memerlukan rekonstitusi dengan berbagai langkah
Hasil studi klinis efikasi dari
Puregon pada ovulation induction
Produk Gonadotropin Lain
Schering-Plough/MSD
hCG (Pregnyl

)
has a biologic effect
similar to hLH
promotes ovulation
induction of infertility due
to anovulation or impaired
follicle-ripening
1500 IU & 5000 IU dose
Subcutan inj adm
Orgalutran

Ganirelix Acetate
Orgalutran

(Ganirelix Acetate Injection):

Therapeutic Indication
Orgalutran

(ganirelix acetate injection) is

indicated for the prevention of premature LH
surges in women undergoing controlled
ovarian stimulation for assisted reproduction
techniques.
LH, luteinizing hormone.