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Cetrotide
Overview
What is Cetrotide?
Cetrotide (cetrorelix acetate for injection) is a synthetic decapeptide with gonadotropin-releasing hormone (GnRH) antagonistic activity. Cetrorelix acetate is an analog of native GnRH with substitutions of amino acids at positions 1, 2, 3, 6, and 10. The molecular formula is Acetyl-D-3-(2´-naphtyl)-alanine-D-4-chlorophenylalanine-D-3-(3´-pyridyl)-alanine-L-serine-L-tyrosine-D-citruline-L-leucine-L-arginine-L-proline-D-alanine-amide, and the molecular weight is 1431.06, calculated as the anhydrous free base. The structural formula is as follows:
What does Cetrotide look like?
What are the available doses of Cetrotide?
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What should I talk to my health care provider before I take Cetrotide?
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How should I use Cetrotide?
Cetrotide (cetrorelix acetate for injection) is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation.
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. Cetrotide (cetrorelix acetate for injection) 0.25 mg may be administered subcutaneously once daily during the early- to mid-follicular phase.
Cetrotide 0.25 mg is administered on either stimulation day 5 (morning or evening) or day 6 (morning) and continued daily until the day of hCG administration.
When assessment by ultrasound shows a sufficient number of follicles of adequate size, 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).
What interacts with Cetrotide?
- Cetrotide (cetrorelix acetate for injection) is contraindicated under the following conditions:
- Hypersensitivity to cetrorelix acetate, extrinsic peptide hormones or mannitol.
- Known hypersensitivity to GnRH or any other GnRH analogs.
- Known or suspected pregnancy, and lactation (see ).
- Severe renal impairment
What are the warnings of Cetrotide?
Repeated large doses of vitamin K are not warranted in liver disease if the response to initial use of the vitamin is unsatisfactory. Failure to respond to vitamin K may indicate a congenital coagulation defect or that the condition being treated is unresponsive to vitamin K.
What are the precautions of Cetrotide?
General
Cases of hypersensitivity reactions, including anaphylactoid reactions with the first dose, have been reported during post-marketing surveillance (see ). A severe anaphylactic reaction associated with cough, rash, and hypotension, was observed in one patient after seven months of treatment with Cetrotide (10 mg/day) in a study for an indication unrelated to infertility.
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.
Information for Patients
Prior to therapy with Cetrotide (cetrorelix acetate 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 ). Cetrotide should not be prescribed if a patient is pregnant.
If Cetrotide is prescribed to patients for self-administration, information for proper use is given in the Patient Leaflet (see below).
Laboratory Tests
After the exclusion of preexisting conditions, enzyme elevations (ALT, AST, GGT, alkaline phosphatase) were found in 1-2% of patients receiving Cetrotide during controlled ovarian stimulation. The elevations ranged up to three times the upper limit of normal. The clinical significance of these findings was not determined.
During stimulation with human menopausal gonadotropin, Cetrotide had no notable effects on hormone levels aside from inhibition of LH surges.
Drug Interactions
No formal drug interaction studies have been performed with Cetrotide.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term carcinogenicity studies in animals have not been performed with cetrorelix acetate. Cetrorelix acetate was not genotoxic (Ames test, HPRT test, chromosome aberration test) or (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 micronucleus test in the CHL-cell line. Treatment with 0.46 mg/kg cetrorelix acetate for 4 weeks resulted in complete infertility in female rats which was reversed 8 weeks after cessation of treatment.
Pregnancy Category X
Nursing Mothers
It is not known whether Cetrotide is excreted in human milk. Because many drugs are excreted in human milk, and because the effects of Cetrotide on lactation and/or the breast-fed child have not been determined, Cetrotide should not be used by nursing mothers.
Geriatric Use
Cetrotide is not intended to be used in subjects aged 65 and over.
What are the side effects of Cetrotide?
The safety of Cetrotide (cetrorelix acetate 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). 94.0% of them were Caucasian. Cetrotide was given in doses ranging from 0.1 mg to 5 mg as either a single or multiple dose.
Table 3 shows systemic adverse events, reported in clinical studies without regard to causality, from the beginning of Cetrotide treatment until confirmation of pregnancy by ultrasound at an incidence ≥ 1% in Cetrotide treated subjects undergoing COS.
Local site reactions (e.g. redness, erythema, bruising, itching, swelling, and pruritus) were reported. Usually, they were of a transient nature, mild intensity and short duration. During post-marketing surveillance, cases of mild to moderate Ovarian Hyperstimulation syndrome and infrequent cases of hypersensitivity reactions including anaphylactoid reactions have been reported.
Two stillbirths were reported in Phase 3 studies of Cetrotide.
| (WHO preferred term) | CetrotideN=949% (n) |
|---|---|
| Ovarian Hyperstimulation Syndrome | 3.5 (33) |
| Nausea | 1.3 (12) |
| Headache | 1.1 (10) |
Congenital Anomalies
Clinical follow-up studies of 316 newborns of women administered Cetrotide 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 sperm injection (ICSI) was the fertilization method employed; in the fourth case, 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 is unknown. Multiple factors, genetic and others (including, but not limited to ICSI, IVF, gonadotropins, and progesterone) make causal attribution difficult to study.
What should I look out for while using Cetrotide?
Cetrotide (cetrorelix acetate for injection) is contraindicated under the following conditions:
Cetrotide (cetrorelix acetate for injection) should be prescribed by physicians who are experienced in fertility treatment. Before starting treatment with Cetrotide, pregnancy must be excluded (see and ).
What might happen if I take too much Cetrotide?
There have been no reports of overdosage with Cetrotide 0.25 mg or 3 mg in humans. Single doses up to 120 mg Cetrotide have been well tolerated in patients treated for other indications without signs of overdosage.
How should I store and handle Cetrotide?
Cetrotide (cetrorelix acetate for injection) 0.25 mg is available in a carton of one packaged tray (NDC 44087-1225-1).Each packaged tray contains: one glass vial containing 0.26 - 0.27 mg cetrorelix acetate (corresponding to 0.25 mg cetrorelix), one pre-filled glass syringe with 1 mL of Sterile Water for Injection, USP (pH 5-8), one 20 gauge needle (yellow) and one 27 gauge needle (grey).Cetrotide (cetrorelix acetate for injection) 0.25 mg is available in a carton of one packaged tray (NDC 44087-1225-1).Each packaged tray contains: one glass vial containing 0.26 - 0.27 mg cetrorelix acetate (corresponding to 0.25 mg cetrorelix), one pre-filled glass syringe with 1 mL of Sterile Water for Injection, USP (pH 5-8), one 20 gauge needle (yellow) and one 27 gauge needle (grey).
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The pharmacokinetic parameters of single and multiple doses of Cetrotide (cetrorelix acetate for injection) in adult healthy female subjects are summarized in Table 1.
Non-Clinical Toxicology
Cetrotide (cetrorelix acetate for injection) is contraindicated under the following conditions:Cetrotide (cetrorelix acetate for injection) should be prescribed by physicians who are experienced in fertility treatment. Before starting treatment with Cetrotide, pregnancy must be excluded (see and ).
No formal drug interaction studies have been performed with Cetrotide.
Cases of hypersensitivity reactions, including anaphylactoid reactions with the first dose, have been reported during post-marketing surveillance (see ). A severe anaphylactic reaction associated with cough, rash, and hypotension, was observed in one patient after seven months of treatment with Cetrotide (10 mg/day) in a study for an indication unrelated to infertility.
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.
The safety of Cetrotide (cetrorelix acetate 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). 94.0% of them were Caucasian. Cetrotide was given in doses ranging from 0.1 mg to 5 mg as either a single or multiple dose.
Table 3 shows systemic adverse events, reported in clinical studies without regard to causality, from the beginning of Cetrotide treatment until confirmation of pregnancy by ultrasound at an incidence ≥ 1% in Cetrotide treated subjects undergoing COS.
Local site reactions (e.g. redness, erythema, bruising, itching, swelling, and pruritus) were reported. Usually, they were of a transient nature, mild intensity and short duration. During post-marketing surveillance, cases of mild to moderate Ovarian Hyperstimulation syndrome and infrequent cases of hypersensitivity reactions including anaphylactoid reactions have been reported.
Two stillbirths were reported in Phase 3 studies of Cetrotide.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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