Medicinal Products

BEMFOLA 150 IU / 025 ml

Generic drug of the therapeutic class: Endocrinology
active ingredients: Follitropin alfa
laboratory: Finox Biotech

Injectable solution
in pre-filled pen box of 1 ¼ mL pre-filled pen
All forms

Indication

In adult women

• Anovulation (including polycystic ovary disease, PCOS) in women who have not responded to clomiphene citrate therapy.

• Stimulation of multiple follicular growth in patients undergoing superovulation as part of assisted reproductive technologies (ART) such as in vitro fertilization (IVF), gamete intravenous transfer (IGT) and transfer intratubic zygote (TITZ).

• Follitropin alfa, in combination with a luteinizing hormone (LH) preparation, is recommended to stimulate follicular development in women with severe LH and FSH deficiency. In clinical trials, these patients were defined by a plasma endogenous LH level <1.2 IU / l.

In adult men

• Follitropin alfa is indicated to stimulate spermatogenesis in men with hypogonadotropic hypogonadism, congenital or acquired, in association with human choriogonadotropin (hCG).

Dosage BEMFOLA 150 IU / 025 ml solution for injection in a pre-filled pen 1 pack of 1 ml pre-filled pen

In adult women

• Anovulation (including polycystic ovary disease, PCOS) in women who have not responded to clomiphene citrate therapy.

• Stimulation of multiple follicular growth in patients undergoing superovulation as part of assisted reproductive technologies (ART) such as in vitro fertilization (IVF), gamete intravenous transfer (IGT) and transfer intratubic zygote (TITZ).

• Follitropin alfa, in combination with a luteinizing hormone (LH) preparation, is recommended to stimulate follicular development in women with severe LH and FSH deficiency. In clinical trials, these patients were defined by a plasma endogenous LH level <1.2 IU / l.

In adult men

• Follitropin alfa is indicated to stimulate spermatogenesis in men with hypogonadotropic hypogonadism, congenital or acquired, in association with human choriogonadotropin (hCG).

Against indications

• hypersensitivity to the active substance, follitropin alfa (FSH) or to any of the excipients listed under Composition

• hypothalamic or pituitary tumor

• ovarian hypertrophy or ovarian cyst not due to polycystic ovary syndrome

• gynecological bleeding of unknown etiology

• ovarian, uterine or breast carcinoma.

Follitropin alfa can not be used if an effective response can not be obtained, for example:

• primary ovarian failure

• malformation of the genitals incompatible with pregnancy

• uterine fibroid incompatible with pregnancy

• primary testicular insufficiency.

Bemfola side effects

The most frequently reported adverse reactions are: headache, ovarian cysts, and local reactions at the injection site (eg, pain, erythema, hematoma, edema, and / or irritation at the injection site).

A mild to moderate ovarian hyperstimulation syndrome (OHSS) has been reported frequently and should be considered an intrinsic risk to stimulation. The intensity of the SHO is uncommon (see section Warnings and precautions for use ).

Very rarely, thromboembolic events can occur, often associated with severe OHSS (see Warnings and Precautions section ).

The terms used below to express the frequency of adverse reactions are as follows:

Very common (≥1 / 10) Common (≥1 / 100, <1/10) Uncommon (≥1 / 1000, <1/100) Rare (≥1 / 10, 000, <1/1000) Very rare ( <1/10 000)

Treatment in women

Immune system disorders

Very rare: mild to severe hypersensitivity reactions, including anaphylactic reactions and shock

Nervous system disorders

Very often: Headache

Vascular disorders

Very rare: Thromboembolic stroke, usually associated with severe OHSS (see Warnings and Precautions section )

Respiratory, thoracic and ediastinal disorders

Very rare: Exacerbation or worsening of asthma

Gastrointestinal disorders

Abnormal: Abdominal pain, abdominal distension, gastrointestinal disturbances, nausea, vomiting, diarrhea

Disorders of reproductive organs and breast

Very often: ovarian cysts

Fr equ: SHO of mild to moderate intensity (and associated symptomatology)

Low frequency: SHO of mild to moderate intensity (and associated symptomatology) (see Warnings and precautions for use section )

Rare: Complication of a severe SHO

General disorders and administration site abnormalities

Very common: Injection site reactions (including pain, erythema, hematoma, edema and / or irritation at the injection site)

Treatment in men

Immune system disorders

Very rare: mild to severe hypersensitivity reactions, including anaphylactic reactions and shock

Respiratory, thoracic and ediastinal disorders

Very rare: Exacerbation or worsening of asthma

Skin and subcutaneous tissue disorders

Fr equent: Acne

Disorders of reproductive organs and breast

Fr equent: Gynecomastia, varicocele

General disorders and administration site abnormalities

Very common: Injection site reactions (including pain, erythema, hematoma, edema and / or irritation at the injection site)

investigations

Fr equent: Weight gain

Disclaimer of suspected adverse reactions

The statement of suspected side effects after approval of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals report any suspected adverse reactions via the national reporting system - see Annex V.

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