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Follistim (Follitropin Beta) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Follistim® (follitropin beta for injection) is indicated for the development of multiple follicles in ovulatory patients participating in an Assisted Reproductive Technology (ART) program. Follistim® 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® 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 endometrial biopsy. Patients with tubal pathology should receive Follistim® 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® (follitropin beta for 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 at a dose of 5,000 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® therapy; this will reduce the chance of developing OHSS.

Ovulation Induction

There are a variety of treatment protocols available for 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. The patient should be treated 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, 5,000 IU to 10,000 IU. If the ovaries are abnormally enlarged on the last day of Follistim® therapy, hCG must be withheld during this course of treatment; this will reduce the chances of developing OHSS.

During treatment with Follistim® 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® 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®.

Directions for using Follistim®

  1. Wash hands thoroughly with soap and water.
  2. Before injections, the septum tops of the vials should be wiped with an aseptic solution to prevent contamination of the contents.
  3. To prepare the Follistim® solution, inject 1 mL of Sterile Water for Injection, USP into the vial of Follistim®. DO NOT SHAKE, but gently swirl until the solution is clear. Generally, the Follistim® dissolves immediately. Check the liquid in the container. If it is not clear or has particles in it, DO NOT USE IT.
  4. For patients requiring a single injection from multiple vials of Follistim®, up to 4 vials can be reconstituted with 1 mL of Sterile Water for Injection, USP. This can be accomplished by reconstituting a single vial as described above (see step 3). Then draw the entire contents of the first vial into a syringe, and inject the contents into a second vial of lyophilized Follistim®. Gently swirl the second vial, as described above, once again checking to make sure the solution is clear and free of particles. This step can be repeated with 2 additional vials for a total of up to 4 vials of lyophilized Follistim® into 1 mL of diluent.
  5. Immediately ADMINISTER the reconstituted Follistim® either SUBCUTANEOUSLY or INTRAMUSCULARLY. Any unused reconstituted material should be discarded.
  6. Draw the reconstituted Follistim® into an empty, sterile syringe.
  7. 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 only Follistim® solution is left in the syringe.
  8. Follistim® only works if it is injected SUBCUTANEOUSLY or INTRAMUSCULARLY. The most convenient sites for SUBCUTANEOUS injection are either in the abdomen around the navel where there is a lot of loose skin and layers of fatty tissue or in the upper thigh. Pinch up a large area of skin between the finger and thumb. You should vary the injection site a little with each injection. The best site for INTRAMUSCULAR injection of Follistim® is the upper outer quadrant of the buttock muscle. This area contains a large volume of muscle with few blood vessels and major nerves. 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.
  9. The injection site should be swabbed with a disinfectant to remove any surface bacteria. Clean about two inches around the point where the needle will go in and let the disinfectant dry for at least one minute before proceeding.
  10. For SUBCUTANEOUS injection the needle should be inserted at the base of the pinched-up skin at an angle of 45˚ to the skin surface. The needle for INTRAMUSCULAR injection should be inserted right up to the hilt at an angle of 90˚ to the skin surface. Pushing in with a quick thrust causes the least discomfort.
  11. If the needle is correctly positioned it will be difficult to draw back on the plunger. Any blood drawn into the syringe means the needle tip has penetrated a vein or artery. If this happens, remove the syringe, cover the injection site with a swab containing disinfectant and apply pressure; the site should stop bleeding in a minute or two.
  12. Once the needle is properly placed, depress the plunger slowly and steadily, so the solution is correctly injected and the skin or muscle tissue is not damaged.
  13. Pull the syringe out quickly and apply pressure to the site with a swab containing disinfectant. A gentle massage of the site—while still maintaining pressure—helps disperse the Follistim® solution and relieve any discomfort.
  14. Use the disposable syringe only once and dispose of it properly.

HOW SUPPLIED

Follistim® (follitropin beta for injection) is supplied in a sterile, freeze-dried form, as a white to off-white cake or powder in vials containing 75 IU of FSH activity. The following package combinations are available:

  • 5 vials 75 IU Follistim® and 5 vials 5 mL Sterile Water for Injection, USP.
    NDC 0052-0306-31

Storage

Lyophilized powder may be stored refrigerated or at room temperature (2o-25oC/36o-77oF). Protect from light. Use immediately after reconstitution. Discard unused material.

Rx Only

Manufactured by
Organon Inc.
West Orange, NJ 07052
Diluent manufactured by
Luitpold Pharmaceuticals, Inc.
Shirley, NY 11967

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