Follitropin Alfa

Registered South African indications:

• Infertility

Contraindications

• Hypersensitivity to the active ingredient or to any of its excipients
• Tumours of the hypothalamus or pituitary gland
• Ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome
• Gynaecological haemorrhage of unknown aetiology
• Ovarian, uterine or mammary carcinoma

Follitropin alfa must not be used when an effective response cannot be obtained, such as:

• Primary ovarian failure
• Malformations of sexual organs incompatible with pregnancy
• Fibroid tumours incompatible with pregnancy
• Primary testicular insufficiency 

Cautions

• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Personal or family history of porphyria
• Hypothyroidism
• Adrenocortical deficiency
• Hyperprolactinaemia
• History of follipian tube disease
• Personal or family history of thromboembolic disease
• Risk factors for thromboembolic disease

Forms avail. in SA and covered in this monograph: inj

Women undergoing ovarian stimulation for multiple follicular development prior to assisted reproductive technologies

• SC: 150-225 IU, on day 2 or 3 of the cycle; Treatment continued until adequate follicular development is achieved; Max: 450 IU/24hrs

Not indicated for use in children

Pregnancy

• Not indicated for use

Breastfeeding

• Caution, not recommended

Renal Impairment 

• Caution; no information available

Hepatic Impairment

•  Caution; no information available

Elderly

• Caution; no information available

Central Nervous System Disorders

• Headache

Cardiovascular Disorders

• Thromboembolism

Respiratory Disorders

• Exacerbation or aggravation of asthma

Gastrointestinal Disorders

• Abdominal pain 
• Abdominal distension 
• Abdominal discomfort 
• Nausea and vomiting
• Diarrhoea

Endocrine and Metabolic Disorders

• Ovarian cysts
• Ovarian hyperstimulation syndrome
• Gynaecomastia 
• Varicocele

Skin and Subcutaneous Tissue Disorders

• Injection site reactions
• Acne

Immune, Blood and Lymphatic System Disorders

•  Hypersensitivity reactions

• Clomifene
• Gonadotropin releasing hormone agonist or antagonist

• Signs and symptoms of ovarian hyperstimulation syndrome

Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor induces follicular growth.

Injection (per vial) 75iu

• Gonal-F (Merck) originator

Injection (per 0.5ml) 300iu

• Gonal-F (Merck) originator

Injection (per 0.75ml) 450iu

• Gonal-F (Merck) originator

Injection (per 1.5ml) 900iu

• Gonal-F (Merck) originator

COMBINATION PREPARATIONS

Follitropin/ Lutropin alfa

Injection (per vial) 150iu/75iu

• Pergoveris (Merck) originator