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Cetrorelix: Drug information

Cetrorelix: Drug information
(For additional information see "Cetrorelix: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Cetrotide
Brand Names: Canada
  • Cetrotide
Pharmacologic Category
  • Gonadotropin Releasing Hormone Antagonist
Dosing: Adult
Controlled ovarian stimulation

Controlled ovarian stimulation: SUBQ: 0.25 mg once daily the morning or evening of ovarian stimulation day 5, or morning of ovarian stimulation day 6; continue 0.25 mg once daily until the day hCG is administered.

Dosing: Kidney Impairment: Adult

Mild to moderate impairment: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Severe impairment: Use is contraindicated.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults.

1% to 10%:

Gastrointestinal: Nausea (1%)

Genitourinary: Ovarian hyperstimulation syndrome (4%)

Hepatic: Increased liver enzymes (1% to 2%; including increased gamma-glutamyl transferase, increased serum alanine aminotransferase, increased serum alkaline phosphatase, increased serum aspartate aminotransferase)

Nervous system: Headache (1%)

Postmarketing:

Hypersensitivity: Anaphylaxis, hypersensitivity reaction, nonimmune anaphylaxis

Local: Injection-site reaction (including bruising at injection site, erythema at injection site, injection-site pruritus, swelling at injection site)

Contraindications

Hypersensitivity to cetrorelix, extrinsic peptide hormones, gonadotropin releasing hormone (GnRH) or other GnRH analogs, mannitol, or any component of the formulation; severe renal impairment; pregnancy; breastfeeding.

Canadian labeling: Additional contraindications (not in the US labeling): Moderate to severe hepatic function impairment; moderate renal function impairment.

Warnings/Precautions

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.

Other warnings/precautions:

• Experienced specialists: Should only be prescribed by fertility specialists.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Kit, Subcutaneous:

Cetrotide: 0.25 mg [contains mannitol]

Generic: 0.25 mg

Generic Equivalent Available: US

Yes

Pricing: US

Kit (Cetrorelix Acetate Subcutaneous)

0.25 mg (per each): $326.87

Kit (Cetrotide Subcutaneous)

0.25 mg (per each): $344.08

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Kit, Subcutaneous:

Cetrotide: 0.25 mg [contains mannitol]

Administration: Adult

SUBQ: 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 Drugs Handling Considerations

Hazardous agent (NIOSH 2016 [group 3]).

Use appropriate precautions for receiving, handling, administration, and disposal. Gloves (single) should be worn during receiving, unpacking, and placing in storage.

NIOSH recommends double gloving, a protective gown, ventilated engineering controls (a class II biological safety cabinet or a compounding aseptic containment isolator), and closed system transfer devices (CSTDs) if compounding. Double gloves and a protective gown are required during administration (NIOSH 2016). Assess risk to determine appropriate containment strategy (USP-NF 2017).

Use: Labeled Indications

Controlled ovarian stimulation: Inhibition of premature luteinizing hormone surges in patients undergoing controlled ovarian stimulation.

Medication Safety Issues
High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs that have a heightened risk of causing significant patient harm when used in error.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Flotufolastat F18: Androgen Deprivation Therapy Agents may diminish the diagnostic effect of Flotufolastat F18. Management: Androgen deprivation therapy (ADT) may result in changes in the uptake of flotufolastat F18 in prostate cancer. The impact of ADT on the performance of flotufolastat F18 is unknown, but use of alternative agents should be considered. Risk D: Consider therapy modification

Gallium Ga 68 PSMA-11: Androgen Deprivation Therapy Agents may diminish the therapeutic effect of Gallium Ga 68 PSMA-11. Management: Androgen deprivation therapy (ADT) may result in changes in the uptake of gallium Ga 68 PSMA-11 (gozetotide) in prostate cancer. The impact of ADT on the performance of gallium Ga 68 PSMA-11 is unknown, but use of alternative agents should be considered. Risk D: Consider therapy modification

Indium 111 Capromab Pendetide: Antigonadotropic Agents may diminish the diagnostic effect of Indium 111 Capromab Pendetide. Risk X: Avoid combination

Piflufolastat F18: Androgen Deprivation Therapy Agents may diminish the diagnostic effect of Piflufolastat F18. Management: Androgen deprivation therapy (ADT) may result in changes in the uptake of piflufolastat F18 in prostate cancer. The impact of ADT on the performance of piflufolastat F18 is unknown, but use of alternative agents should be considered. Risk D: Consider therapy modification

Reproductive Considerations

Evaluate pregnancy status before beginning treatment. Ovarian stimulation may be initiated with gonadotropins (FSH, hMG) on day 2 or 3 of a regular menstrual cycle followed by cetrorelix administered either on a specific day of the cycle, or when follicles reach an appropriate size (Al-Inany 2016).

Pregnancy Considerations

Based on data from animal reproduction studies, resorption resulting in fetal loss would be expected. Major congenital abnormalities have been reported following in utero exposure to cetrorelix; however, a causal link has not been determined.

Use is contraindicated in pregnant patients.

Breastfeeding Considerations

It is not known if cetrorelix is present in breast milk.

Use while breastfeeding is contraindicated.

Monitoring Parameters

Ultrasound to assess follicle size

Mechanism of Action

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.

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: Luteinizing hormone suppression 0.25 mg dose: ~2 hours.

Duration: Luteinizing hormone suppression 0.25 mg dose: 24 hours.

Absorption: Rapid.

Distribution: Vd: ~1 L/kg.

Protein binding: 86%.

Metabolism: 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.

Bioavailability: SUBQ: 85%.

Half-life elimination: 0.25 mg dose: 5 hours; 0.25 mg multiple doses: 20.6 hours.

Time to peak: 1 to 2 hours.

Excretion: Feces (5% to 10% as unchanged drug and metabolites); urine (2% to 4% as unchanged drug).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (HU) Hungary: Ceziboe;
  • (ID) Indonesia: Cetrotide;
  • (IN) India: Certifert | Ovucet;
  • (QA) Qatar: Cetrotide
  1. Al-Inany HG, Youssef MA, Ayeleke RO, Brown J, Lam WS, Broekmans FJ. Gonadotrophin-releasing hormone antagonists for assisted reproductive technology. Cochrane Database Syst Rev. 2016;4:CD001750. doi:10.1002/14651858.CD001750.pub4 [PubMed 27126581]
  2. Cetrotide (cetrorelix acetate) [prescribing information]. Rockland, MA: EMD Serono, Inc; May 2018.
  3. Cetrotide (cetrorelix acetate) [product monograph]. Mississauga, Ontario, Canada: EMD Serono; June 2019.
  4. Hazardous Drugs—Handling in Healthcare Settings. United States Pharmacopeia and National Formulary (USP 40-NF 35). Rockville, MD: United States Pharmacopeia Convention; 2017:83-102.
  5. US Department of Health and Human Services; Centers for Disease Control and Prevention; National Institute for Occupational Safety and Health. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2016. https://www.cdc.gov/niosh/docs/2016-161/default.html. Updated September 2016. Accessed October 5, 2016.
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