Cetrotide
cetrorelix acetate · KIT · EMD Serono, Inc.
Cetrotide is a kit containing cetrorelix acetate, taken subcutaneous. Manufactured by EMD Serono, Inc..
Key Facts
- Brand Name
- Cetrotide
- Generic Name
- cetrorelix acetate
- NDC Code (Product)
44087-1225- Manufacturer
- EMD Serono, Inc.
- Dosage Form
- KIT
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- NDA021197
- Marketing Start
- 08/11/2000
Recall History
EMD Serono, Inc.
Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Cetrotide ® (cetrorelix acetate for injection) is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation.
Dosage & Administration
DOSAGE AND ADMINISTRATION 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…
Warnings
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 ).
Contraindications
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
Drug Interactions
Drug Interactions No formal drug interaction studies have been performed with Cetrotide ® .
Adverse Reactions
ADVERSE REACTIONS The safety of Cetrotide ® (cetrorelix acetate for injection) in 949 patients undergoing controlled ovarian stimulation in clinical studies was evaluated. Women were between 19 and 40 years of age (mean: 32). 94.0% of them were Caucasian. Cetrotide ® was given in doses ranging from 0.1 mg to 5 mg as either a single or multiple dose. Table 3 shows systemic adverse events, reported in clinical studies without regard to causality, from the beginning of Cetrotide ® treatment until confirmation of pregnancy by ultrasound at an incidence ≥ 1% in Cetrotide ® treated subjects undergoing COS. Table 3: Adverse Events in ≥1% (WHO preferred term) Cetrotide ® N=949 % (n) Ovarian Hyperstimulation Syndrome Intensity moderate or severe, or WHO Grade II or III, respectively 3.5 (33) Nausea 1.3 (12) Headache 1.1 (10) Local site reactions (e.g. redness, erythema, bruising, itching, swelling, and pruritus) were reported. Usually, they were of a transient nature, mild intensity and short duration. During post-marketing surveillance, cases of mild to moderate Ovarian Hyperstimulation syndrome and cases of hypersensitivity reactions including anaphylactoid reactions have been reported. T…
Frequently Asked Questions
What is Cetrotide used for?
Cetrotide contains cetrorelix acetate. It is a kit taken subcutaneous. Consult your doctor for specific uses.
Is Cetrotide a controlled substance?
Cetrotide is not classified as a controlled substance by the DEA.
What is the generic name for Cetrotide?
The generic name for Cetrotide is cetrorelix acetate. There are 6 other brand versions of cetrorelix acetate.
What is the NDC code for Cetrotide ?
The NDC (National Drug Code) for Cetrotide is 44087-1225, listed by EMD Serono, Inc..