Cetrotide® 0.25 mg
Active ingredient: cetrorelix acetate
Cetrotide® blocks the effects of a natural hormone,
called gonadotropin-releasing hormone (GnRH). GnRH controls the secretion of
another hormone, called luteinizing hormone (LH), which induces ovulation
during the menstrual cycle. During hormone treatment for ovarian stimulation,
premature ovulation may lead to eggs that are not suitable for fertilization.
Cetrotide® blocks such undesirable premature ovulation.
Cetrotide® is used to prevent premature ovulation during
controlled ovarian stimulation.
Do not use Cetrotide® if you
- have kidney disease
- are allergic to cetrorelix acetate, mannitol or exogenous
peptide hormones (medicines similar to Cetrotide®) or
- are pregnant, or think that you might be pregnant, or if
you are breast-feeding.
Consult your doctor before taking Cetrotide® if you have
had severe allergic reactions.
Ovarian stimulation therapy is started on cycle Day 2 or
3. Cetrotide® 0.25 mg is injected under the skin once daily , as directed by
your physician. When an ultrasound examination shows that you are ready,
another drug (hCG) is injected to induce ovulation.
How should you use Cetrotide®?
You may self-inject Cetrotide® after special instruction
from your doctor.
To fully benefit from Cetrotide®, please read carefully
and follow the instructions given below, unless your doctor advises you
Cetrotide® is for injection under the skin of the lower
abdominal area, preferably around, but staying at least one inch away from the
belly button. Choose a different injection site each day to minimize local
Dissolve Cetrotide® powder only with the water contained
in the pre-filled syringe. Do not use a Cetrotide® solution if it contains
particles or if it is not clear.
Before you inject Cetrotide® yourself, please read the
following instructions carefully:
Directions for using Cetrotide® 0.25 mg with
the enclosed needles and pre-filled syringe:
1. Wash your hands thoroughly with soap and water.
2. On a clean flat surface, lay out everything you need
(one vial of powder, one pre-filled syringe, one injection needle with a yellow
mark, one injection needle with a grey mark, and two alcohol wipes).
3. Flip off the plastic cover of the vial. Wipe the
aluminum ring and the rubber stopper with an alcohol wipe.
4. Take the injection needle with the yellow mark and
remove the wrapping. Take the pre-filled syringe and remove the cover. Twist
the needle on the syringe and remove the cover of the needle.
5. Push the needle through the center of the rubber
stopper of the vial. Inject the water into the vial by slowly pushing down on
the plunger o f the syringe.
6. Leave the syringe in the vial. Gently shake the vial
until the solution is clear and without residue. Avoid forming bubbles during
7. Draw the total contents of vial, pull back the needle
until the opening of the needle is the vial into the syringe. If liquid is left
in the vial, invert the just inside the stopper. If you look from the side
through the gap in the stopper, you can control the movement of the needle and
the liquid. It is important to withdraw the entire contents of the vial.
8. Detach the syringe from the needle and lay down the
syringe. Take the injection needle with the grey mark and remove its wrapping.
Twist the needle on the syringe and remove the cover of the needle.
9. Invert the syringe and push the plunger until all air
bubbles have been pushed out. Do not touch the needle or allow the needle to
touch any surface.
10. Choose an injection site in the lower abdominal area,
preferably around, but at least one inch away from the belly button. Choose a
different injection site each day to minimize local irritation. Take the second
alcohol wipe and clean the skin at the injection site and allow alcohol to dry.
Inject the prescribed dose as directed by your doctor, nurse or pharmacist.
11. Use the syringe and needles only once. Dispose of the
syringe and needles immediately after use (put the covers on the needles to
avoid injury). A medical waste container should be used of or disposal.
What do you do if you have used too much Cetrotide®?
Contact your doctor in case of overdosage immediately to
check whether an adjustment of the further ovarian stimulation procedure is
Possible Side Effects
Mild and short lasting reactions may occur at the
injection site like reddening, itching, and swelling. Nausea and headache have
also been reported.
Call your doctor if you have any side effect not
mentioned in this leaflet or if you are unsure about the effect of this
How is Cetrotide® to be stored?
Store Cetrotide® in a cool dry place protected from
excess moisture and heat.
Store Cetrotide® 0.25 mg in the refrigerator at 2-8°C
(36-46°F). Keep the packaged tray in the outer carton in order to protect it
How long may Cetrotide® be stored?
Do not use the Cetrotide® powder or the pre-filled
syringe after the expiration date, which is printed on the labels and on the
carton, and dispose of the vial and the syringe properly.
How long can you keep Cetrotide® after preparation of
The solution should be used immediately after
Store the medicine out of the reach of children.
If you suspect that you may have taken more than the
prescribed dose of this medicine, contact your doctor immediately. This
medicine was prescribed for your particular condition. Do not use it for
another condition or give the drug to others.
This leaflet provides a summary of the information about
Cetrotide®. Medicines are sometimes prescribed for uses other than those listed
in the Leaflet. If you have any questions or concerns, or want more information
about Cetrotide®, contact your doctor or pharmacist.
This Leaflet has been approved by the U.S. Food and Drug