Cetrorelix

Chemical formula: C₇₀H₉₂ClN₁₇O₁₄  Molecular mass: 1,431.038 g/mol  PubChem compound: 25074887

Interactions

Cetrorelix interacts in the following cases:

Hepatic impairment

Cetrorelix has not been studied in patients with hepatic impairment and caution is therefore warranted.

Renal impairment

Cetrorelix has not been studied in patients with renal impairment and caution is therefore warranted. Cetrorelix is contraindicated in patients with severe renal impairment.

Fertility

Studies in animals have indicated that cetrorelix exerts a dose related influence on fertility, reproductive performance and pregnancy. No teratogenic effects occurred when the medicinal product was administered during the sensitive phase of gestation.

Ovarian Hyperstimulation Syndrome (OHSS)

During or following ovarian stimulation an ovarian hyperstimulation syndrome can occur. This event must be considered as an intrinsic risk of the stimulation procedure with gonadotropins

An OHSS should be treated symptomatically, e.g. with rest, intravenous electrolytes/colloids and heparin therapy.

Luteal phase support should be given according to the reproductive medical centre’s practice.

Allergic reactions

Cases of allergic/pseudoallergic reactions, including life-threatening anaphylaxis with the first dose have been reported.

Special care should be taken in women with signs and symptoms of active allergic conditions or known history of allergic predisposition. Treatment with cetrorelix is not advised in women with severe allergic conditions.

Pregnancy

Cetrorelix is not intended to be used during pregnancy.

Nursing mothers

Cetrorelix is not intended to be used during lactation.

Carcinogenesis, mutagenesis and fertility

Fertility

Studies in animals have indicated that cetrorelix exerts a dose related influence on fertility, reproductive performance and pregnancy. No teratogenic effects occurred when the medicinal product was administered during the sensitive phase of gestation.

Effects on ability to drive and use machines

Cetrorelix has no or negligible influence on the ability to drive and use machines.

Adverse reactions


Summary of the safety profile

The most commonly reported adverse reactions are local injection site reactions such as erythema, swelling and pruritus that are usually transient in nature and mild in intensity. In clinical trials, these effects were observed with a frequency of 9.4% following multiple injections of cetrorelix 0.25 mg.

Mild to moderate OHSS (WHO grade I or II) have been commonly reported and should be considered as an intrinsic risk of the stimulation procedure. Inversely, severe OHSS remains uncommon.

Uncommonly, cases of hypersensitivity reactions including pseudo-allergic/anaphylactoid reactions have been reported.

List of adverse reactions

The adverse reactions reported below are classified according to frequency of occurrence as follows: 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).

Immune system disorders

Uncommon: Systemic allergic/pseudo-allergic reactions including life-threatening anaphylaxis.

Nervous system disorders

Uncommon: Headache

Gastrointestinal disorders

Uncommon: Nausea

Reproductive system and breast disorders

Common: Mild to moderate OHSS (WHO grade I or II) can occur which is an intrinsic risk of the stimulation procedure.

Uncommon: Severe OHSS (WHO grade III)

General disorders and administration site conditions

Common: Local reactions at the injection site (e.g. erythema, swelling and pruritus).

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