Follitropin beta

Therapeutic indications

Follitropin beta is indicated for:

Anovulation

Population group: women, only adults (18 - 65 years old)

Anovulation (including polycystic ovarian syndrome, PCOS) in women who have been unresponsive to treatment with clomifene citrate.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Controlled ovarian hyperstimulation

Population group: women, only adults (18 - 65 years old)

Controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs [e.g. in vitro fertilisation/embryo transfer (IVF/ET), gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)].

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Hypogonadotrophic hypogonadism

Population group: men, only adults (18 - 65 years old)

Deficient spermatogenesis due to hypogonadotrophic hypogonadism.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Contraindications

Follitropin beta is contraindicated in the following cases:

Tumours of the ovary, breast, uterus, testis, pituitary, hypothalamus

at least one of
Neoplasm of ovary
Neoplasm of breast
Neoplasm of uterus
Neoplasm of testis
Neoplasm of pituitary gland
Tumor of hypothalamus

Primary gonadal failure

Primary testicular failure

Undiagnosed vaginal bleeding

Observations of vaginal bleeding

Ovarian cysts, enlarged ovaries

at least one of
Ovarian cyst and additionally not Polycystic ovary

Ovarian enlargement

Malformations of the reproductive organs

Congenital malformation of uterus and cervix

Fibroid tumours of the uterus

Uterine leiomyoma

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Factors such as age, gender, and health history are evaluated to create a personalized medication regimen.

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Summary of Product Characteristics (SPC) 2020: PUREGON Solution for injection
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