Cetrorelix injectable

Name: Cetrorelix injectable

Precautions

Before using cetrorelix, tell your doctor or pharmacist if you are allergic to it; or to other hormones (e.g., GnRH); or if you have any other allergies. This product may contain inactive ingredients (such as mannitol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: history of severe allergic reactions, kidney disease.This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately.It is not known whether this drug passes into breast milk. Breast-feeding while using this drug is not recommended because it may harm the nursing infant. Consult your doctor before breast-feeding.

What is the most important information I should know about cetrorelix?

You should not use cetrorelix if you have severe kidney disease, if you are pregnant or breast-feeding, or if you have ever had an allergic reaction to a medicine similar to cetrorelix (such as Lupron, Antagon, Zoladex, Synarel, Zoladex, or others).

How should I use cetrorelix?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Cetrorelix is injected under the skin. You may be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and syringes.

Cetrorelix is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

Your care provider will show you the best places on your body to inject cetrorelix. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

For best results, you will need to start using cetrorelix injections on a certain day of your cycle. Follow your doctor's dosing instructions about when to use this medicine, and at what time of day to give your injections.

As part of your fertility treatment, you will be treated with a second medicine called human chorionic gonadotropin (hCG). You will receive an hCG injection only on days when your ovaries are ready for controlled ovulation to occur.

You will need frequent ultrasound examinations to check your ovaries for signs of readiness for ovulation. This will help your doctor determine when to give your hCG injection.

Store cetrorelix in a refrigerator. Do not freeze. Keep the medicine in its original carton to protect it from light. Throw away any medicine not used before the expiration date on the medicine label.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

For Healthcare Professionals

Applies to cetrorelix: subcutaneous powder for injection

Endocrine

Common (1% to 10%): Mild to moderate ovarian hyperstimulation syndrome (OHSS) (WHO grade I or II)
Uncommon (0.1% to 1%): Severe ovarian hyperstimulation syndrome (WHO grade III)[Ref]

Gastrointestinal

Very common (10% or more): Nausea (12%)[Ref]

General

The most commonly reported side effects were local injection site reactions such as erythema, swelling, and pruritus that were usually transient in nature and mild in intensity.[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Systemic allergic/pseudo-allergic reactions including life-threatening anaphylaxis[Ref]

Local

Common (1% to 10%): Redness, erythema, bruising, itching, swelling, pruritus (at the injection site)[Ref]

Nervous system

Common (1% to 10%): Headache[Ref]

Some side effects of cetrorelix may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Dialysis

Data not available

Other Comments

Administration advice:
-Administer via subcutaneous injection into the lower abdominal wall
-The injection site should be varied daily
-The first administration should be performed under physician supervision; the patient should be kept under medical supervision for 30 minutes after the initial injection.
-Subsequent injections may be self-administered provided that the patient is appropriately counseled

Monitoring:
-Hypersensitivity reactions post-injection

Storage requirements:
-Vials should be refrigerated at 2 to 8 degrees Celsius and not frozen. Reconstituted product should be used immediately.

Reconstitution/preparation techniques:
-The manufacturer's product information should be consulted.

General:
-This drug should only be prescribed by or under the supervision of a specialist experienced with its use in the treatment of infertility.

Cetrorelix Pregnancy Warnings

Contraindicated AU TGA pregnancy category: D US FDA pregnancy category: X

If gonadotrophin releasing hormone antagonists are used during pregnancy, there is a theoretical risk of abortion. Animal studies have revealed evidence of increased resorption rate and implantation loss. There are no controlled data in human pregnancy. AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details. US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Cetrorelix Breastfeeding Warnings

Contraindicated Excreted into human milk: Unknown Excreted into animal milk: Unknown Comment: The effects in the nursing infant are unknown.

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