DOSAGE AND ADMINISTRATION
Assisted Reproductive Technologies (ART)
A starting dose of 150 to 225 IU of Follistim® AQ (follitropin beta injection)
is recommended for at least the first four days of treatment. After this, the
dose may be adjusted for the individual patient based upon their ovarian response.
In clinical studies with patients who are responding, it was shown that daily
maintenance dosages ranging from 75 to 300 IU for six to twelve days are sufficient,
although longer treatment may be necessary. However, in patients that were low
or poor responders, maintenance doses of 375 to 600 IU were administered according
to individual response. This later category comprised approximately 10% of the
women evaluated during clinical studies. The maximum, individualized, daily
dose of Follistim®that has been used in clinical studies is 600 IU. When
a sufficient number of follicles of adequate size are present, the final maturation
of the follicles is induced by administering hCG ata dose of 5000 IU to 10,000
IU. Oocyte (egg) retrieval is performed 34 to 36 hours later. The administration
of hCG must be withheld in cases where the ovaries are abnormally enlarged on
the last day of Follistim® AQ (follitropin beta) therapy. This will reduce the chance of developing
In studies using Follistim®, a stepwise gradually increasing dosing scheme
was used. The starting dose was 75 IU of Follistim®for up to 14 days. The
dose was then increased by 37.5 IU of Follistim®at weekly intervals until
follicular growth and/or serum estradiol levels indicated an adequate response.
The maximum, individualized, daily dose of Follistim®that has been safely
used for ovulation induction patients during clinical trials is 300 IU. Treatment
should continue until ultrasonic visualizations and/or serum estradiol determinations
indicate pre-ovulatory conditions equivalent to or greater than those of the
normal individual followed by hCG, 5000 to 10,000 IU. If the ovaries are abnormally
enlarged on the last day with Follistim® AQ (follitropin beta) therapy, hCG must be withheld
during this course of treatment; this will reduce the chances of developing
During treatment with Follistim® AQ (follitropin beta) and during a two-week post-treatment
period, patients should be examined at least every other day for signs of excessive
ovarian stimulation. It is recommended that Follistim® AQ (follitropin beta) administration
be stopped if the ovaries become abnormally enlarged or abdominal pain occurs.
Most OHSS occurs after treatment has been discontinued and reaches its maximum
at about seven to ten days post-ovulation.
For ovulation induction, the couple should be encouraged to have intercourse
daily, beginning on the day prior to the administration of hCG and until ovulation
becomes apparent from the indices employed for the determination of progestational
activity (see PRECAUTIONS-Laboratory Tests).
Care should be taken to insure insemination. In the light of the foregoing indices
and parameters mentioned, it should become obvious that, unless a physician
is willing to devote considerable time to these patients and be familiar with
and conduct these necessary laboratory studies, he/she should not use Follistim® AQ (follitropin beta) .
Directions for using Follistim® AQ (follitropin beta)
- Please read these instructions carefully before using Follistim® AQ (follitropin beta) .
- Before you begin, check the liquid in the container. If the solution is
not clear and colorless or has particles in it, DO NOT USE. Please
consult your healthcare provider.
- Injecting cold drug is likely to cause discomfort. Therefore, it is recommended
you allow the drug to reach room temperature before taking the injection.
What you will need before giving yourself the injection
- Only use the syringe and needle(s) prescribed by your physician.
- Alcohol, cotton balls or alcohol pads/swabs, sterile gauze, antibacterial
soap and a special safety container to discard the used needles, and/or other
- A clean dry surface for preparation of your injection.
Instructions for use
Before using Follistim® AQ (follitropin beta injection) for the first
time, read these instructions carefully. Keep this leaflet in a safe place and
refer to it when questions arise.
1. Wash your hands thoroughly with antibacterial soap and water before starting.
2. Remove the flip-cap off of the vial and wipe the rubber stopper with an
3. Use a fresh alcohol swab to clean about two inches around the injection
site where the needle will be inserted, as explained by your healthcare provider
(See step 6 below).
Let the alcohol dry on your skin for at least one minute before injecting the
4. a. Attach a needle to the syringe. Carefully remove the cap from the needle
and pierce it through the rubber stopper of the vial.
b. Draw the volume of Follistim® AQ (follitropin beta) into the syringe as prescribed by your
5. Hold the syringe pointing upwards and gently tap the side to force any air
bubbles to the top; then squeeze the plunger gently until all the air has been
expelled and a drop of Follistim® AQ (follitropin beta) solution appears at the tip of the needle.
6. Follistim® AQ (follitropin beta) is designed to be injected SUBCUTANEOUSLY or INTRAMUSCULARLY.
Your healthcare provider will decide which type of injection is best foryou.
a. SUBCUTANEOUS INJECTION
Carefully follow your healthcare provider's instructions for administering
Follistim® AQ (follitropin beta) subcutaneously. The best place for SUBCUTANEOUS INJECTION
is in the area just below the belly button (navel) or in the upper thigh
Change your injection site a little with each injection to lower your chances
for skin reactions.
For SUBCUTANEOUS injection, pinch up a large area of skin between the
finger and thumb. The needle should be inserted at an angle of 90° to the
b. INTRAMUSCULAR INJECTION
Carefully follow your healthcare provider's instructions for administering
Follistim® AQ (follitropin beta) intramuscularly. You may consider asking another person for
assistance. The best site for INTRAMUSCULAR injection of Follistim® AQ (follitropin beta)
is the upper outer quadrant of the buttock muscle. Stretching the skin helps
the needle to go in more easily and pushes the tissue beneath the skin out of
the way. This helps the solution disperse correctly.
Relax the muscle first by shifting your weight to the leg opposite the muscle
to be injected. The needle for INTRAMUSCULAR injection should be fully
inserted to the hub of the needle, at an angle of 90°to the skin surface.
Pull back gently on the plunger. If the needle is correctly positioned it will
be difficult to draw the plunger back. Any blood drawn into the syringe means
the needle tip has penetrated a blood vessel. If this happens, remove the syringe,
cover the injection site with an alcohol swab and apply pressure. The site should
stop bleeding in a minute or two. Discard original needle and replace with a
new sterile needle. Repeat the above steps for intramuscular administration
at a different site.
7. Once the needle is properly placed, depress the plunger slowly and
steadily, sothe solution is correctly injected.
8. Pull the syringe out quickly and apply pressure to the site with an alcohol
swab. Gently massage the site—while still maintaining pressure—to help disperse
the Follistim® AQ (follitropin beta) solution and relieve any discomfort.
9. Use the syringe, needle, and Follistim® AQ (follitropin beta) vial only once and dispose
of them properly as instructed by your healthcare provider.
General information about Follistim® AQ (follitropin beta)
If you miss or forget a dose, do not double your next dose. Contact your health-care
provider for recommendations.
Do not mix Follistim® AQ (follitropin beta) with any other medicines in the same vial or in
the same syringe.
Follistim® AQ (follitropin beta injection) is supplied as a sterile aqueous
solution in the following concentrations and packaging:
Follistim® AQ (follitropin beta) Single-Use Vial 75 IU/0.5 mL
Box of 1 NDC 0052-0308-02
Follistim® AQ (follitropin beta) Single-Use Vial 150 IU/0.5 mL
Box of 1NDC 0052-0309-02
Store refrigerated, 2–8°C (36–46°F) until dispensed. Upon dispensing,
the product may be stored by the patient at 2–8°C (36–46°F) until the
expiration date, or at or below 25°C (77°F) for 3 months or until expiration
date, whichever occurs first. Protect from light, keep container in carton.
Do not freeze.
For more detail regarding the information contained in this
leaflet call 1-866-836-5633. www.follistim.com. Manufactured for Organon USA
Inc., Roseland, NJ 07068 by Organon (Ireland) Ltd. Swords, Co. Dublin, Ireland.
9/05. FDA revision date: 2/11/2005