Corifollitropin alfa interacts in the following cases:
There are limited data on the use of corifollitropin alfa in combination with a GnRH agonist. Results of a small uncontrolled study suggest a higher ovarian response than in combination with a GnRH antagonist. Therefore, the use of corifollitropin alfa is not recommended in combination with a GnRH agonist.
In case of inadvertent exposure to corifollitropin alfa during pregnancy, clinical data are not sufficient to exclude an adverse outcome of pregnancy. In animal studies reproductive toxicity has been observed. The use of corifollitropin alfa during pregnancy is not indicated.
The use of corifollitropin alfa during breast-feeding is not indicated.
In women corifollitropin alfa is used in the treatment of Controlled Ovarian Stimulation in combination with GnRH in ART programs.
In adolescent males (14 years and older), corifollitropin alfa is used in treatment of hypogonadotropic hypogonadism in combination with hCG. However, whether this treatment has effect on fertility is unknown.
No studies on the ability to drive and use machines have been performed. Corifollitropin alfa may cause dizziness. Women should be advised that if they feel dizzy, they should not drive or use machines.
The most frequently reported adverse reactions during treatment with corifollitropin alfa in clinical trials (N=2,397) are pelvic discomfort (6.0%), OHSS (4.3%), headache (4.0%), pelvic pain (2.9%), nausea (2.3%), fatigue (1.5%), and breast tenderness (1.3%).
The table below displays the main adverse reactions in women treated with corifollitropin alfa 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.
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 corifollitropin alfa therapy as with other gonadotropins.
The table below lists the adverse reactions with corifollitropin alfa reported in a clinical trial in adolescent males (17 patients dosed) according to system organ class and frequency: common (≥1/100 to <1/10).
| SOC | Frequency1 | Adverse reaction |
|---|---|---|
| Gastrointestinal disorders | Common | Vomiting |
| Vascular disorders | Common | Hot flush |
| General disorders and administration site conditions | Common | Injection site pain |
1 Adverse reactions that are reported only once are listed as common because a single report raises the frequency above 1%.
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