(set roe REL iks)
Controlled ovarian stimulation: Inhibits premature luteinizing hormone (LH) surges in women undergoing controlled ovarian stimulation.
Hypersensitivity to cetrorelix, extrinsic peptide hormones, gonadotropin releasing hormone (GnRH) or GnRH analogs, or any component of the formulation; severe renal impairment; pregnancy; breast-feeding.
Controlled ovarian stimulation in conjunction with gonadotropins (FSH, hMG): Female: SubQ:
Single-dose regimen: 3 mg given when serum estradiol levels show appropriate stimulation response, usually stimulation day 7 (range: days 5 to 9). If hCG is not administered within 4 days, continue cetrorelix at 0.25 mg/day until hCG is administered.
Multiple-dose regimen: 0.25 mg once daily the morning or evening of stimulation day 5, or morning of stimulation day 6; continue until hCG is administered.
Not intended for use in women ≥65 years of age
Mild to moderate impairment: There are no dosage adjustments provided in the manufacturers labeling (has not been studied).
Severe impairment: Use is contraindicated.
There are no dosage adjustments provided in the manufacturers labeling (has not been studied).
Administer by SubQ injection following proper aseptic technique procedures. Injections should be to the lower abdomen, preferably around the navel (but staying at least 1 inch from the navel). The injection site should be rotated daily.
Hazardous agent; use appropriate precautions for handling and disposal (NIOSH 2014 [group 3]).
0.25 mg vials: Store refrigerated at 2 ‚ °C to 8 ‚ °C (36 ‚ °F to 46 ‚ °F). Store in outer carton to protect from light.
3 mg vials: Store at 25 ‚ °C (77 ‚ °F); excursions permitted to 15 ‚ °C to 30 ‚ °C (59 ‚ °F to 86 ‚ °F).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Kit, Subcutaneous:
Cetrotide: 0.25 mg, 3 mg [DSC] [contains mannitol]
Indium 111 Capromab Pendetide: Antigonadotropic Agents may diminish the diagnostic effect of Indium 111 Capromab Pendetide. Avoid combination
Ultrasound to assess follicle size
1% to 10%:
Central nervous system: Headache (1%)
Endocrine & metabolic: Ovarian hyperstimulation syndrome (WHO grade II or III: 4%), increased gamma-glutamyl transferase ( ≤1% to 2%)
Gastrointestinal: Nausea (1%)
Hepatic: Increased serum alkaline phosphatase ( ≤1% to 2%), increased serum ALT ( ≤1% to 2%), increased serum AST ( ≤1% to 2%)
<1% (Limited to important or life-threatening): Anaphylaxis (includes cough, hypotension, skin rash), injection site reactions (bruising at injection site, erythema at injection site, injection site pruritus, local swelling)
Concerns related to adverse effects:
- Hypersensitivity: Hypersensitivity reactions, including severe anaphylactoid reactions, have been reported after initial dose and months after starting therapy; use with caution in patients with signs and symptoms of active allergic conditions or known history of allergic predisposition. Treatment is not recommended in patients with severe allergic conditions.
Special handling:
- Hazardous agent: Use appropriate precautions for handling and disposal (NIOSH 2014 [group 3]).
Other warnings/precautions:
- Experienced specialists: Should only be prescribed by fertility specialists.
X
Studies in animals or pregnant women have shown evidence of fetal abnormalities and use is contraindicated in women who are or may become pregnant. Resorption resulting in fetal loss would be expected if used in a pregnant woman. Exclude pregnancy before beginning treatment.
Competes with naturally-occurring GnRH for binding on receptors of the pituitary. This delays luteinizing hormone surge, preventing ovulation until the follicles are of adequate size.
Rapid
Vd: ~1 L/kg
Transformed by peptidases; cetrorelix and peptides (1-9), (1-7), (1-6), and (1-4) are found in the bile; peptide (1-4) is the predominant metabolite
Feces (5% to 10% as unchanged drug and metabolites); urine (2% to 4% as unchanged drug)
0.25 mg dose: 2 hours; 3 mg dose: 1 hour
1 to 2 hours
0.25 mg dose: 24 hours; 3 mg dose (single dose): 4 days
0.25 mg dose: 5 hours; 0.25 mg multiple doses: 20.6 hours; 3 mg dose: 62.8 hours
86%
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Have patient report immediately to prescriber dizziness, cough, or signs of ovarian hyperstimulation syndrome (severe abdominal pain or bloating; severe nausea, vomiting, or diarrhea; excessive weight gain; shortness of breath; or change in how much urine is passed) (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.