Drug Class Description
LHRH antagonists.
Generic Name
Cetrorelix
Drug Description
Cetrotide 3 mg powder and solvent for solution for injection
Presentation
Powder and solvent for solution for injection.Appearance of the powder: white lyophilised pelletAppearance of the solvent: clear colourless solution.The pH of the reconstituted solution is 4.0 – 6.0.
Indications
Prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte pick-up and assisted reproductive techniques.In clinical trials Cetrotide 3 mg was used with human menopausal gonadotropin (HMG), however, limited experience with recombinant FSH suggested similar efficacy.
Adult Dosage
Cetrotide 3 mg should only be prescribed by a specialist experienced in this field.
Cetrotide 3 mg is for subcutaneous injection into the lower abdominal wall.
The first administration of Cetrotide should be performed under the supervision of a physician and under conditions where treatment of possible pseudo-allergic reactions is immediately available. The following injections may be self-administered as long as the patient is made aware of the signs and symptoms that may indicate hypersensitivity, the consequences of such a reaction and the need for immediate medical intervention. The contents of 1 vial (3 mg cetrorelix) are to be administered on day 7 of ovarian stimulation (approximately 132 to 144 hours after start of ovarian stimulation) with urinary or recombinant gonadotropins. Following the first administration, it is advised that the patient be kept under medical supervision for 30 minutes to ensure there is no allergic/pseudo-allergic reaction to the injection. Facilities for the treatment of such reactions should be immediately available.
If the follicle growth does not allow ovulation induction on the fifth day after injection of Cetrotide 3 mg, additionally 0.25 mg cetrorelix (Cetrotide 0.25 mg) should be administered once daily beginning 96 hours after the injection of Cetrotide 3 mg until the day of ovulation induction.
Child Dosage
Not applicable.
Elderly Dosage
Contraindicated after the menopause.
Contra Indications
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Hypersensitivity to the active substance or any structural analogue of GnRH, extrinsic peptide hormones or to any of the excipients.
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Pregnancy, and lactation.
-
Postmenopausal women.
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Patients with moderate and severe renal and hepatic impairment.
.
Special Precautions
Special care should be taken in women with signs and symptoms of active allergic conditions or known history of allergic predisposition. Treatment with Cetrotide is not advised in women with severe allergic conditions.
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 ovarian hyperstimulation syndrome 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.
There is limited experience up to now with the administration of Cetrotide 3 mg during a repeated ovarian stimulation procedure. Therefore Cetrotide 3 mg should be used in repeated cycles only after a careful risk/benefit eva luation.
Interactions
In vitro investigations have shown that interactions are unlikely with medications that are metabolised by cytochrome P450 or glucuronised or conjugated in some other way. However, interactions with commonly used medicinal products, including products that may induce histamine release in susceptible individuals, may occur.
Adverse Reactions
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Immune system disorders |
Rare ( 1/10,000, <1/1,000) |
Rare cases of hypersensitivity reactions including pseudo-allergic/anaphylactoid reactions have also been reported |
Nervous system disorders |
Uncommon ( 1/1,000, <1/100) |
Headache |
Gastrointestinal disorders |
Uncommon ( 1/1,000, <1/100) |
Nausea |
Reproductive system and
breast disorders |
Common ( 1/100, <1/10) |
Mild to moderate ovarian hyperstimulation syndrome (WHO grade I or II) can occur which is an intrinsic risk of the stimulation procedure |
|
Uncommon ( 1/1,000, <1/100) |
Severe ovarian hyperstimulation syndrome (WHO grade III) |
General disorders and administration site conditions |
Common ( 1/100, <1/10) |
Local reactions at the injection site (e.g. erythema, swelling and pruritus) have been reported. Usually they were transient in nature and mild intensity. The frequency as reported in clinical trials was 8.0%. |
Manufacturer
ASTA Medica
Drug Availability
(POM)
Updated
17 April 2009