CETROTIDE

Generic Name/API: cetrorelix acetate for injection

Manufacturer: MERCK

Dosage Forms & Strength & Pack Size:
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, one 20 gauge needle (yellow) and one 27 gauge needle (grey).

Storage:
Store Cetrotide 0.25 mg refrigerated, 2-8°C (36-46°F). Store the packaged tray in the outer carton in order to protect from light.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

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

CONTRAINDICATIONS
Cetrotide (cetrorelix acetate for injection) is contraindicated under the following
conditions:
1. Hypersensitivity to cetrorelix acetate, extrinsic peptide hormones or mannitol.
2. Known hypersensitivity to GnRH or any other GnRH analogs.
3. Known or suspected pregnancy, and lactation (see PRECAUTIONS).
4. 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 (see CONTRAINDICATIONS and PRECAUTIONS).
Progesterone
Following initiation of Cetrotide® therapy
Morning values
Median with 5th – 95th percentiles
Mean ± standard deviation






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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.
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 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.
Pregnancy
(see CONTRAINDICATIONS)
Cetrotide is contraindicated in pregnant women.
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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.
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.

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