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Follistim

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Follistim AQ

Indications
Dosage
How Supplied

INDICATIONS

Follistim® AQ (follitropin beta injection) is indicated for the development of multiple follicles in ovulatory patients participating in an Assisted Reproductive Technology (ART) program. Follistim® AQ (follitropin beta) is also indicated for the induction of ovulation and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure.

Selection of Patients

Before treatment with Follistim® AQ (follitropin beta) is instituted:

  1. A thorough gynecologic and endocrinologic evaluation of the patient must be performed. The evaluation should include a hysterosalpingogram (to rule out uterine and tubal pathology) and documentation of anovulation by means of reviewing a patient's history, performing a physical examination, determining serum hormonal levels as indicated, and optionally performing an endometri-al biopsy. Patients with tubal pathology should receive Follistim® AQ (follitropin beta) only if enrolled in an ART program.
  2. Primary ovarian failure should be excluded by the determination of circulating gonadotropin levels.
  3. Careful examination should be made to rule out early pregnancy.
  4. Evaluation of the partner's fertility potential should be included in the workup procedure.

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 OHSS.

Ovulation Induction

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 OHSS.

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)

Important notice

  • 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 supplies.
  • 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.

 Wash your hands thoroughly - Illustration

2. Remove the flip-cap off of the vial and wipe the rubber stopper with an alcohol swab.

Remove the flip-cap off of the vial - Illustration

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).

Use a fresh alcohol swab - Illustration

Let the alcohol dry on your skin for at least one minute before injecting the medicine.

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.

Attach a needle to the syringe - Illustration

b. Draw the volume of Follistim® AQ (follitropin beta) into the syringe as prescribed by your health-care provider.

Draw the volume of Follistim®AQ into the syringe - Illustration

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.

Hold the syringe pointing upwards and gently tap the side to force any air bubbles to the top - Illustration

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 (upper leg).

The best place for SUBCUTANEOUS INJECTION - Illustration

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 skin surface.

Pinch up a large area of skin between the finger and thumb - Illustration

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.

The best site for INTRAMUSCULAR injection - Illustration

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.

Injection should be fully inserted to the hub of the needle, at an angle of 90°to the skin surface - Illustration

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.

 

Pull the syringe out quickly and apply pressure to the site with an alcohol swab - Illustration

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.

HOW SUPPLIED

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

Storage

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

Last reviewed on RxList: 11/17/2008
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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