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CETROTIDE is a brand name for Cetrorelix, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: CETROTIDE® (cetrorelix for injection) is indicated for the prevention of premature ovulation in patients undergoing controlled ovarian stimulation.
Verbatim from this product's HC label. Tap a section to expand.
1 Recommended Dose and Dosage Adjustment Ovarian stimulation therapy with gonadotropins (FSH, hMG) is started on cycle Day 2 or 3. The dose of gonadotropins should be adjusted according to individual response. The response should be primarily based on the number and size of the developing follicles as evidenced by ultrasound.
This may be more reliable than by the amount of circulating estradiol. 25 mg dose) as part of the multiple dose protocol during the early- to mid-follicular phase. 25 mg is administered on either stimulation day 5 (morning or evening) or day 6 (morning).
It is administered once daily at the same time each day at 24 hour intervals and continued daily until the day of hCG administration. When assessment by ultrasound shows a sufficient number of follicles of adequate size (≥17 mm in diameter), hCG is administered to induce ovulation and final maturation of the oocytes.
No hCG should be administered if the ovaries show an excessive response to the treatment with gonadotropins to reduce the chance of developing ovarian hyperstimulation syndrome (OHSS). 25 mg should be performed under the supervision of a physician and under conditions where treatment of possible allergic/pseudo-allergic reactions (including life-threatening anaphylaxis) is immediately available.
The subsequent injections may be self-administered after appropriate instructions by the doctor 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.
25 mg The reconstituted product is to be administered subcutaneously. Use immediately after reconstitution. As with all parenteral drug products, reconstituted solutions should be inspected visually for clarity, particulate matter, precipitate, discolouration and leakage prior to administration.
Solution showing haziness, particulate matter, precipitate, discolouration or leakage should not be used. Discard unused portions. 4 Missed Dose If you miss a dose of CETROTIDE (cetrorelix for injection) do not double dose. Discuss with your doctor when you should receive your next dose.
Check with your doctor if you have any questions about this.
1 Adverse Reaction Overview The safety of CETROTIDE (cetrorelix for injection) in 949 patients undergoing controlled ovarian stimulation in clinical studies was evaluated. Women were between 19 and 40 years of age (mean: 32). 0 % of them were Caucasian.
1 mg to 5 mg as either a single or multiple dose. 2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. 1 (10) Table 3 shows systemic adverse events from the beginning of CETROTIDE (cetrorelix for injection) treatment until confirmation of pregnancy by ultrasound in CETROTIDE (cetrorelix for injection) treated subjects undergoing COS (Controlled Ovarian Stimulation).
g. pain, redness, swelling pruritus, erythema, hematoma and/or irritation at the site of injection) have been commonly reported. Usually, they were of a transient nature and mild intensity. Uncommon cases of systematic allergic/pseudo-allergic reactions including life-threatening anaphylactoid reactions have been observed.
Two stillbirths were reported in Phase 3 studies of CETROTIDE (cetrorelix for injection). Ovarian Hyperstimulation Syndrome (OHSS) During or following controlled ovarian stimulation it is common for mild to moderate ovarian hyperstimulation syndrome (WHO grade I or II) to occur.
). In this potentially serious medical event, the ovaries are massively enlarged, and intravascular fluid volume shifts into the peritoneal space, resulting in hypovolemia, oliguria, hemoconcentration, and massive ascites. The syndrome can usually be avoided by closely monitoring the patient and withholding the hCG if ovarian response becomes excessive.
General CETROTIDE (cetrorelix for injection) should be prescribed by physicians who are experienced in fertility treatment. Before starting treatment with CETROTIDE (cetrorelix for injection), pregnancy must be excluded (see CONTRAINDICATIONS).
Prior to therapy with CETROTIDE (cetrorelix for injection), patients should be informed of the duration of treatment and monitoring procedures that will be required. The risk of possible adverse reactions should be discussed (see ADVERSE REACTIONS).
CETROTIDE (cetrorelix for injection) should not be prescribed if a patient is pregnant. If CETROTIDE (cetrorelix for injection) is prescribed to patients for self-administration, information for proper use is given in the Patient Insert (see CONSUMER INFORMATION).
25 mg cetrorelix (as cetrorelix acetate), Powder for Solution Mannitol Cetrotide® (cetrorelix acetate) Page 6 of 26 Carcinogenesis and Mutagenesis Long-term carcinogenicity studies in animals have not been performed with cetrorelix acetate.
Cetrorelix acetate was not genotoxic in vitro (Ames test, HPRT test, chromosome aberration test) or in vivo (chromosome aberration test, mouse micronucleus test). Cetrorelix acetate induced polyploidy in CHL-Chinese hamster lung fibroblasts, but not in V79-Chinese hamster lung fibroblasts, cultured peripheral human lymphocytes or in an in-vitro micronucleus test in the CHL-cell line.
Immune Caution is advised in patients with hypersensitivity to GnRH analogs. These patients should be carefully monitored after the first injection, where treatment of possible allergic/pseudo-allergic reactions (including life-threatening anaphylaxis) is immediately available.
Therefore, it is recommended that a physician supervises the first administration. Special care should be taken in women with signs and symptoms of active allergic conditions or known history of allergic predisposition. Treatment with CETROTIDE (cetrorelix for injection), is not advised in women with severe allergic conditions.
CETROTIDE (cetrorelix for injection) is contraindicated under the following conditions: Hypersensitivity to cetrorelix acetate, extrinsic peptide hormones, mannitol, or any component of the container. For a complete listing, see Dosage Forms, Strengths, Composition and Packaging.
Known hypersensitivity to GnRH or any other GnRH analogs. Known or suspected pregnancy, and lactation (see PRECAUTIONS). Moderate or severe impairment of hepatic or renal function.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Severe OHSS (WHO grade III) is uncommon. Congenital Anomalies Clinical follow-up studies of 316 newborns of women administered CETROTIDE (cetrorelix for injection) were reviewed. One infant of a set of twin neonates was found to have anencephaly at birth and died after four days.
The other twin was normal. Developmental findings from ongoing baby follow-up included a child with a ventricular septal defect and another child with bilateral congenital glaucoma. Four pregnancies that resulted in therapeutic abortion in Phase 2 and Phase 3 controlled ovarian stimulation studies had major anomalies (diaphragmatic hernia, trisomy 21, Klinefelter syndrome, polymalformation, and trisomy 18).
In three of these four cases, intracytoplasmic Cetrotide® (cetrorelix acetate) Page 9 of 26 sperm injection (ICSI) was the fertilization method employed; in the fourth case, in-vitro fertilization (IVF) was the method employed. The minor congenital anomalies reported include: supernumerary nipple, bilateral strabismus, imperforate hymen, congenital nevi, hemangiomata, and QT syndrome.
The causal relationship between the reported anomalies and CETROTIDE (cetrorelix for injection) is unknown. Multiple factors, genetic and others (including, but not limited to ICSI, IVF, gonadotropins, and progesterone) make causal attribution difficult to study.
Efficacy and safety (immunogenicity and/or sensitization) have not been extensively evaluated in women undergoing multiple treatment cycles with CETROTIDE (cetrorelix for injection). However, hypersensitivity, antibody formation, and acute anaphylactic reaction have been reported with GnRH analogs.
Therefore, special care should be taken upon using the drug in the same patient for more than one cycle.
Sexual Function/Reproduction Congenital Anomalies:
The prevalence of congenital anomalies after the use of assisted reproductive technologies (ART) with or without GnRH antagonists may be slightly higher than after spontaneous conceptions although it is unclear whether this is related to factors inherent to the couple's infertility or the ART procedures.
Ovarian Hyperstimulation Syndrome (OHSS):
During or following ovarian stimulation an ovarian hyperstimulation syndrome (OHSS) can occur. This event must be considered as an intrinsic risk of the stimulation procedure with gonadotropins. Protocols combining gonadotropins and GnRH antagonist have been found to be correlated with a shorter duration of stimulation and of lower dose of gonadotropins, lower estradiol level.
These findings may account for the reduction of the risk of OHSS, associated with the use of GnRH antagonists. 46 mg/kg cetrorelix acetate for 4 weeks resulted in complete infertility in female rats which was reversed 8 weeks after cessation of treatment.
1 Pregnant Women CETROTIDE (cetrorelix for injection) is contraindicated in pregnant women. When administered to rats for the first seven days of pregnancy, cetrorelix acetate did not affect the development of the implanted conceptus at doses up to 38 μg/kg (approximately 1 times the recommended human therapeutic dose based on body surface area).
However, a dose of 139 μg/kg (approximately 4 times the human dose) resulted in a resorption rate and a post- implantation loss of 100%. 4 times the human dose). In animals that maintained their pregnancy, there was no increase in the incidence of fetal abnormalities.
The fetal resorption observed in animals is a logical consequence of the alteration in hormonal levels effected by the antigonadotrophic properties of CETROTIDE (cetrorelix for injection), which could result in fetal loss in humans as well.
Therefore, this drug should not be used in pregnant women. 2 Breast-feeding It is not known whether CETROTIDE (cetrorelix for injection) is excreted in human milk. Because many drugs are excreted in human milk, and because the effects of CETROTIDE (cetrorelix for injection) on lactation and/or the breast-fed child have not been determined, CETROTIDE (cetrorelix for injection) is contraindicated for nursing mothers.