ection 4.4).
Tabulated list of adverse reactions
The adverse reactions are ranked under heading of frequency using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Treatment in women
Table 1: Adverse reactions in women
System organ class
Frequency
Adverse reaction
Immune system disorders
Very rare
Mild to severe hypersensitivity reactions, including anaphylactic reactions and shock
Nervous system disorders
Very common
Headache
Vascular disorders
Very rare
Thromboembolism, (both in association with and separate from OHSS)
Respiratory, thoracic and mediastinal disorders
Very rare
Exacerbation or aggravation of asthma
Gastrointestinal disorders
Common:
Abdominal pain, abdominal distension, abdominal discomfort, nausea, vomiting, diarrhoea
Reproductive system and breast disorders
Very common
Ovarian cysts
Common
Mild or moderate OHSS (including associated symptomatology)
Uncommon
Severe OHSS (including associated symptomatology) (see section 4.4)
Rare
Complication of severe OHSS
General disorders and administration site conditions
Very common
Injection site reactions (e.g. pain, erythema, haematoma, swelling and/or irritation at the site of injection)
Treatment in men
Table 2: Adverse reactions in men
System organ class
Frequency
Adverse reaction
Immune system disorders
Very rare
Mild to severe hypersensitivity reactions, including anaphylactic reactions and shock
Respiratory, thoracic and mediastinal disorders
Very rare
Exacerbation or aggravation of asthma
Skin and subcutaneous tissue disorders
Common:
Acne
Reproductive system and breast disorders
Common
Gynaecomastia, varicocele
General disorders and administration site conditions
Very common
Injection site reactions (e.g. pain, erythema, haematoma, swelling and/or irritation at the site of injection)
Investigations
Common
Weight gain
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
4.9 Overdose
The effects of an overdose of follitropin alfa are unknown, nevertheless, there is a possibility that OHSS may occur (see section 4.4).
5. Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Sex hormones and modulators of the genital systems, gonadotropins, ATC code: G03GA05.
Ovaleap is a biosimilar medicinal product. Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Pharmacodynamic effects
In women, the most important effect resulting from parenteral administration of FSH is the development of mature Graafian follicles. In women with anovulation, the object of follitropin alfa therapy is to develop a single mature Graafian follicle from which the ovum |
