INDICATION AND IMPORTANT SAFETY INFORMATION

What is CETRORELIX ACETATE FOR INJECTION?
CETRORELIX ACETATE FOR INJECTION is a medication that prevents premature LH surges in women undergoing controlled ovarian stimulation during fertility treatment.

Who should not take CETRORELIX ACETATE FOR INJECTION?
CETRORELIX ACETATE FOR INJECTION should not be taken by people with 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.
4. Severe renal impairment.

What is the most important information I should know about CETRORELIX ACETATE FOR INJECTION?

• CETRORELIX ACETATE FOR INJECTION should be prescribed by physicians who are experienced in fertility treatment. Before starting treatment with CETRORELIX ACETATE FOR INJECTION, pregnancy must be excluded.
• Cases of hypersensitivity reactions, including anaphylactoid reactions with the first dose, have been reported during post-marketing surveillance. Special care should be taken in women with signs and symptoms of active allergic conditions or known history of allergic predisposition. Treatment with CETRORELIX ACETATE FOR INJECTION is not advised in women with severe allergic conditions.
• Use of CETRORELIX ACETATE FOR INJECTION could result in fetal loss. It should not be used in pregnant women.
• It is not known whether CETRORELIX ACETATE FOR INJECTION is excreted in human milk. Because the effects of CETRORELIX ACETATE FOR INJECTION on lactation and/or the breast-fed child have not been determined, CETRORELIX ACETATE FOR INJECTION should not be used by nursing mothers.
• CETRORELIX ACETATE FOR INJECTION is not intended to be used in people aged 65 and over.

How do I take CETRORELIX ACETATE FOR INJECTION?

You can administer CETRORELIX ACETATE FOR INJECTION 0.25 mg yourself after receiving appropriate instruction from your doctor. To use CETRORELIX ACETATE FOR INJECTION 0.25 mg with the enclosed needles and pre-filled syringe:

1. Wash hands thoroughly with soap and water.
2. Flip off the plastic cover of the vial and wipe the aluminum ring and the rubber stopper with an alcohol swab.
3. Twist the injection needle with the yellow mark (20 gauge) on the pre-filled syringe.
4. Push the needle through the center of the rubber stopper of the vial and slowly inject the solvent into the vial.
5. Leaving the syringe in the vial, gently swirl the vial until the solution is clear and without residues. Avoid forming bubbles.
6. 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.
7. Replace the needle with the yellow mark by the injection needle with the grey mark (27 gauge).
8. Invert the syringe and push the plunger until all air bubbles have been expelled.
9. 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 a 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.
10. Inject the prescribed dose as directed by your doctor, nurse, or pharmacist. Discard unused portion.
11. 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.

What are the possible side effects of CETRORELIX ACETATE FOR INJECTION?

• The most common adverse reactions occurring in ≥1% of people were ovarian hyperstimulation syndrome (3.5%), nausea (1.3%), and headache (1.1%).
• Some people also experience reactions at the injection site, including redness, erythema, bruising, itching, swelling, and pruritis. These reactions usually went away quickly, were not severe, and lasted only a short time.

You are encouraged to report negative side effects of prescription drugs. To report SUSPECTED ADVERSE REACTIONS, contact Apotex at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchM.

Please see full Prescribing Information.