Cetrorelix

Cetrorelix
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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Overview

Cetrorelix is a Luteinizing Hormone Releasing Hormone Antagonist that is FDA approved for the treatment of inhibition of premature LH surges in women undergoing controlled ovarian stimulation. Common adverse reactions include Ovarian Hyperstimulation Syndrome, Nausea, Headache ..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• Cetrotide® (cetrorelix acetate for injection) is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation.

Dosage

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).

Administration Cetrotide® 0.25 mg can be administered by the patient herself after appropriate instructions by her doctor.

Directions for using Cetrotide® 0.25 mg with the enclosed needles and pre-filled syringe:

Wash hands thoroughly with soap and water. Flip off the plastic cover of the vial and wipe the aluminum ring and the rubber stopper with an alcohol swab. Twist the injection needle with the yellow mark (20 gauge) on the pre-filled syringe. Push the needle through the center of the rubber stopper of the vial and slowly inject the solvent into the vial. Leaving the syringe in the vial, gently swirl the vial until the solution is clear and without residues. Avoid forming bubbles. Draw the total contents of the vial into the syringe. If necessary, invert the vial and pull back the needle as far as needed to withdraw the entire contents of the vial. Replace the needle with the yellow mark by the injection needle with the grey mark (27 gauge). Invert the syringe and push the plunger until all air bubbles have been expelled. Choose an injection site in the lower abdominal area, preferably around, but staying at least one inch away from the navel. Choose a different injection site each day to minimize local irritation. Use the second alcohol swab to clean the skin at the injection site and allow alcohol to dry. Gently pinch up the skin surrounding the site of injection. Inject the prescribed dose as directed by your doctor, nurse or pharmacist. Use the syringe and needles only once. Dispose of the syringe and needles properly after use. If available, use a medical waste container for disposal.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Cetrorelix in adult patients.

Non–Guideline-Supported Use

• Uterine leiomyoma

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Cetrorelix in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Cetrorelix in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Cetrorelix in pediatric patients.

Contraindications

• 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 PRECAUTIONS). Severe renal impairment

Warnings

• 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

Precautions

General Cases of hypersensitivity reactions, including anaphylactoid reactions with the first dose, have been reported during post-marketing surveillance (see ADVERSE REACTIONS). 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 ADVERSE REACTIONS). 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.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Cetrorelix in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Cetrorelix in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• No formal drug interaction studies have been performed with Cetrotide®.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): X

• Cetrotide® 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 postimplantation loss of 100%. When administered from day 6 to near term to pregnant rats and rabbits, very early resorptions and total implantation losses were seen in rats at doses from 4.6 μg/kg (0.2 times the human dose) and in rabbits at doses from 6.8 μg/kg (0.4 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®, which could result in fetal loss in humans as well. Therefore, this drug should not be used in pregnant women.
Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Cetrorelix in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Cetrorelix during labor and delivery.

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.

Pediatric Use

There is no FDA guidance on the use of Cetrorelix with respect to pediatric patients.

Geriatic Use

• Cetrotide® is not intended to be used in subjects aged 65 and over.

Gender

There is no FDA guidance on the use of Cetrorelix with respect to specific gender populations.

Race

There is no FDA guidance on the use of Cetrorelix with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Cetrorelix in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Cetrorelix in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Cetrorelix in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Cetrorelix in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Cetrorelix in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Cetrorelix in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Cetrorelix in the drug label.

Pharmacology

There is limited information regarding Cetrorelix Pharmacology in the drug label.

Mechanism of Action

Structure

File:Cetrorelix01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Cetrorelix in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Cetrorelix in the drug label.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility 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. 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.

Clinical Studies

There is limited information regarding Clinical Studies of Cetrorelix in the drug label.

How Supplied

Storage

There is limited information regarding Cetrorelix Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

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 ADVERSE REACTIONS). 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

Precautions with Alcohol

• Alcohol-Cetrorelix interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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