section 4.4), headache (4.0%), pelvic pain (2.9%), nausea (2.3%), fatigue (1.5%), and breast tenderness (1.3%).
Tabulated list of adverse reactions
The table below displays the main adverse reactions in women treated with Elonva in clinical trials and post-marketing surveillance according to system organ class and frequency; 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 available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
System organ class
Frequency
Adverse reaction
Immune system disorders
Not known
Hypersensitivity reactions, both local and generalised, including rash*
Psychiatric disorders
Uncommon
Mood swings
Nervous system disorders
Common
Headache
Uncommon
Dizziness
Vascular disorders
Uncommon
Hot flush
Gastrointestinal disorders
Common
Nausea
Uncommon
Abdominal distension, vomiting, diarrhoea, constipation
Musculoskeletal and connective tissue disorders
Uncommon
Back pain
Pregnancy, puerperium and perinatal conditions
Uncommon
Abortion spontaneous
Reproductive system and breast disorders
Common
OHSS, pelvic pain, pelvic discomfort, breast tenderness
Uncommon
Ovarian torsion, adnexa uteri pain, premature ovulation, breast pain
General disorders and administration site conditions
Common
Fatigue
Uncommon
Injection site haematoma, injection site pain, irritability
Investigations
Uncommon
Alanine aminotransferase increased, aspartate aminotransferase increased
Injury, poisoning and procedural complications
Uncommon
Procedural pain
*Adverse reactions were identified through post-marketing surveillance.
Description of selected adverse reactions
In addition, ectopic pregnancy and multiple gestations have been reported. These are considered to be related to ART or subsequent pregnancy.
In rare instances, thromboembolism has been associated with Elonva therapy as with other gonadotropins.
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 at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
More than one injection of Elonva within one treatment cycle or too high a dose of Elonva and/or (rec)FSH may increase the risk of OHSS. For measures to reduce the risk of OHSS see section 4.4.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: sex hormones and modulators of the genital system, gonadotropins,
ATC code: G03GA09
Mechanism of action
Corifollitropin alfa is designed as a sustained follicle stimulant with the same pharmacodynamic profile as (rec)FSH, but with a markedly prolonged duration of FSH activity. Due to its ability to initiate and sustain multiple follicular growth for an entire week, a single subcutaneous injection of the recommended dose of Elonva may replace the first seven injections of any daily (rec)FSH prep |
