Adult Dosing

Prevention of premature ovulation

Single dose regimen

• Administer 3 mg SC when level of serum estradiol is indicative of an appropriate stimulation response, usually on stimulation day 7 (range day 5-9)
• Administer 0.25 mg SC qd until the day of hCG administration if hCG has not been administered within four days after injection of 3 mg SC

Multiple dose regimen

• Administer 0.25 mg qd SC on either stimulation day 5 (morning or evening) or day 6 (morning) and continue daily until the day of hCG administration

• Initiate ovarian stimulation therapy with gonadotropins on cycle Day 2 or 3
• Adjust dose of gonadotropins according to individual response
• Avoid hCG administration if the ovaries show an excessive response to the treatment with gonadotropins

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Inhibition of premature LH surge in women undergoing controlled ovarian stimulation

• Hypersensitivity to any of the ingredients of the product
• Hypersensitivity to peptide hormones
• Hypersensitivity to mannitol
• Hypersensitivity to GnRH or any other GnRH analogs
• Known or suspected pregnancy
• Lactation
• Severe renal impairment
• Primary ovarian failure

• N/A

Renal Dose Adjustment

• Severe renal impairment: Contraindicated

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Only physicians experienced in fertility treatment should prescribe this drug. Exclude pregnancy before initiating therapy
• Anaphylactic reaction associated with cough, rash, and hypotension may occur
• Take special care in women with signs and symptoms of active allergic conditions/history of allergic predisposition. Treatment with cetrorelix is not recommended in women with severe allergic conditions
• Perform pregnancy test at baseline

Cautions: Use cautiously in

• Allergic conditions
• Predisposition of allergy

Supplemental Patient Information

• Inform patients about the duration of treatment and required monitoring procedures before initiation of therapy
• Discuss possible risk of adverse reactions

Pregnancy Category:X

Breastfeeding: Unknown whether excreted in human milk. As many drugs are excreted in human milk, and effects on lactation and the breast-fed child is not evaluated cetrorelix should not be used by nursing mothers.

• REPRODUCTIVE: Fetal harm, fetal death, ovarian hyperstimulation syndrome
• LOCAL: Injection site reaction
• GI: Elevated LFTs, nausea
• MISC: Anaphylactoid reactions

• Gonadotropin-releasing hormone antagonist; binds to gonadotropin releasing hormone receptor and inhibits gonadotropin secretion, controls the release of LH and FSH in a dose-dependent manner
• Rapid absorption; Absolute bioavailability: 85%
• Metabolized by peptidases; CYP450: Unknown
• Excreted in urine (2.4% unchanged), bile (5-10%)
• Half life
• 5 hrs (single 0.25 mg dose)
• 20.6 hrs (multiple 0.25 mg dose)
• 62.8 hrs (single 3 mg dose)

US Trade Name(s)

• Cetrotide

US Availability

Cetrotide

• PWDR for INJ: 0.25 mg/mL
• PWDR for INJ: 3 mg/mL

Canadian Trade Name(s)

• Cetrotide

Canadian Availability

Cetrotide

• PWDR for INJ: 0.25 mg/mL
• PWDR for INJ: 3 mg/mL

UK Trade Name(s)

• Cetrotide

UK Availability

Cetrotide

• PWDR for INJ: 0.25 mg/mL
• PWDR for INJ: 3 mg/mL

Australian Trade Name(s)

• Cetrotide

Australian Availability

Cetrotide

• PWDR for INJ: 0.25 mg/mL

[Outline]

Obstetrics/Gynecology

GnRH Antagonist

Pricing data from www.DrugStore.com in U.S.A.

• Cetrotide 0.25 MG KIT [Box] (SERONO)
  1 mg = $145.99
  3 mg = $429.96
• Cetrotide 3 MG KIT [Box] (SERONO)
  1 mg = $693.02
  3 mg = $2026.87

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.