Fertiline

Human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the - and - subunits. The - and - subunits have 92 and 111 amino acids

Fertiline® (Fertiline for injection) and hCG given in a sequential manner are indicated for the stimulation of follicular development and the induction of ovulation in patients with polycystic ovary syndrome, and infertility, who have failed to respond or conceive following adequate clomiphene citrate therapy.

Fertiline® (Fertiline for injection) and hCG may also be used to stimulate the development of multiple follicles in ovulatory patients undergoing Assisted Reproductive Technologies (ART) such as in vitro fertilization.

Selection of Patients

1. Before treatment with Fertiline® (Fertiline for injection) is instituted, a thorough gynecologic and endocrinologic evaluation must be performed. This should include an assessment of pelvic anatomy. Patients with tubal obstruction should receive Fertiline® (Fertiline for injection) only if enrolled in an in vitro fertilization program.

2. Primary ovarian failure should be excluded by the determination of gonadotropin levels.

3. Careful examination should be made to rule out the presence of early pregnancy.

4. Patients in late reproductive life have a greater predisposition to endometrial carcinoma as well as a higher incidence of anovulatory disorders. A thorough diagnostic examination should always be performed before starting Fertiline® (Fertiline for injection) therapy in such patients who demonstrate abnormal uterine bleeding or other signs of endometrial abnormalities.

5. Evaluation of the husbands fertility potential should be included in the workup.

Fertiline injection is used to treat infertility in women. Fertiline is a man-made hormone called follicle-stimulating hormone (FSH). FSH is produced in the body by the pituitary gland. FSH helps to develop eggs in the ovaries of women.

Fertiline will help develop and release eggs in women who have not been able to become pregnant because of problems with ovulation, and have already received a medicine to control their pituitary gland.

Fertiline is also used in women with healthy ovaries who are enrolled in a fertility program called assisted reproductive technology (ART). ART uses procedures such as in vitro fertilization (IVF). Fertiline is used together with human chorionic gonadotropin (hCG) in these procedures.

Fertiline is often used in women who have low levels of FSH and too-high levels of LH. Women with polycystic ovary syndrome usually have hormone levels such as this and are treated with Fertiline to make up for the low amounts of FSH. Many women being treated with Fertiline have already tried clomiphene (eg, Serophene) and have not been able to conceive yet. Fertiline may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).

Fertiline is available only with your doctor's prescription.

Dosage

Polycystic Ovary Syndrome: The dose of Fertiline® (Fertiline for injection) to stimulate development of the follicle must be individualized for each patient. The lowest dose consistent with the expectation of good results should be used. Over the course of treatment, doses of Fertiline® (Fertiline for injection) may range between 75 IU to 300 IU per day depending on the individual patient response. Fertiline® (Fertiline for injection) should be administered until adequate follicular development is indicated by serum estradiol and vaginal ultrasonography. A response is generally evident after 5 to 7 days. Subsequent monitoring intervals should be based on individual patient response.

It is recommended that the initial dose of the first cycle be 75 IU of Fertiline® (Fertiline for injection) per day, ADMINISTERED INTRAMUSCULARLY. An adjustment in dose may be considered after 5 to 7 days. An additional dose adjustment may also be considered based on individual patient response. The dose should not be increased more than twice in any cycle or by more than one ampule (75 IU) per adjustment. To complete follicular development and effect ovulation in the absence of an endogenous LH surge, hCG, 5,000 U to 10,000 U, should be given 1 day after the last dose of Fertiline® (Fertiline for injection). HCG should be withheld if the serum estradiol is greater than 2,000 pg/mL. If the ovaries are abnormally enlarged or abdominal pain occurs, Fertiline® (Fertiline for injection) treatment should be discontinued, hCG should not be administered, and the patient should be advised not to have intercourse; this will reduce the chance of development of the Ovarian Hyperstimulation Syndrome and, should spontaneous ovulation occur, reduce the chance of multiple gestation. A follow-up visit should be conducted in the luteal phase.

The initial dose administered in the subsequent cycles should be individualized for each patient based on her response in the preceding cycle. Doses larger than 300 IU of FSH per day are not routinely recommended. As in the initial cycle, 5,000 U to 10,000 U of hCG must be given 1 day after the last dose of Fertiline® (Fertiline for injection) to complete follicular development and induce ovulation. The precautions described above should be followed to minimize the chance of development of the Ovarian Hyperstimulation Syndrome.

The couple should be encouraged to have intercourse daily, beginning on the day prior to the administration of hCG until ovulation becomes apparent from the indices employed for the determination of progestational activity. Care should be taken to ensure insemination. In light of the 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 the necessary laboratory studies, he/she should not use Fertiline® (Fertiline for injection).

Assisted Reproductive Technologies: As in the treatment of patients with polycystic ovary syndrome, the dose of Fertiline® (Fertiline for injection) to stimulate development of the follicle must be individualized for each patient. For Assisted Reproductive Technologies, therapy with Fertiline® (Fertiline for injection) should be initiated in the early follicular phase (cycle day 2 or 3) at a dose of 150 IU per day, until sufficient follicular development is attained. In most cases, therapy should not exceed ten days.

Administration

Dissolve the contents of one ampule of Fertiline® (Fertiline for injection) in one to two mL of sterile saline and ADMINISTER INTRAMUSCULARLY immediately. Any unused reconstituted material should be discarded.

Parenteral drug products should be inspected visually, for particulate matter and discoloration prior to administration, whenever solution and container permit.

How supplied

Fertiline® (Fertiline for injection) is supplied in a sterile, lyophilized form as a white to off-white powder or pellet in ampules containing 75 IU or 150 IU FSH activity. The following package combinations are available:

- 1 ampule 75 IU Fertiline® (Fertiline for injection) and 1 ampule 2 mL Sodium Chloride Injection (USP), NDC 44087-6075-1

- 1 ampule 150 IU Fertiline® (Fertiline for injection) and 1 ampule 2 mL Sodium Chloride Injection (USP), NDC 44087-6150-1

- 10 ampules 75 lU Fertiline® (Fertiline for injection) and 10 ampules 2 mL Sodium Chloride Injection (USP), NDC 44087-6075-3

- 100 ampules 75 IU Fertiline® (Fertiline for injection) and 100 ampules 2 mL Sodium Chloride Injection (USP), NDC 44087-6075-4

Lyophilized powder may be stored refrigerated or at room temperature (3°-25°C/37°-77°F). Protect from light. Use immediately after reconstitution. Discard unused material.

Caution: Federal law prohibits dispensing without prescription.

See also:
What is the most important information I should know about Fertiline?

Fertiline® (Fertiline for injection) is contraindicated in women who exhibit:

1. High levels of FSH indicating primary ovarian failure.

2. Uncontrolled thyroid or adrenal dysfunction.

3. An organic intracranial lesion such as a pituitary tumor.

4. The presence of any cause of infertility other than anovulation, as stated in the Indications unless they are candidates for Assisted Reproductive Technologies.

5. Abnormal bleeding of undetermined origin.

6. Ovarian cysts or enlargement of undetermined origin.

7. Prior hypersensitivity to Fertiline.

Fertiline® (Fertiline for injection) is also contraindicated in women who are pregnant and may cause fetal harm when administered to a pregnant woman. There are limited human data on the effects of Fertiline® (Fertiline for injection) when administered during pregnancy.

Use Fertiline as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Fertiline is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Fertiline at home, carefully follow the injection procedures taught to you by your health care provider.
• To use Fertiline, first break open the diluent ampule by snapping it at the neck, keeping the dot on the ampule facing away from you. When breaking open ampules, you may use gauze, paper towels, or tissues to protect your fingers.
• Draw up the recommended amount of diluent into a syringe, then break open the ampule containing the powder (using the same technique as above), and add the diluent to the powder by slowly pushing in the plunger of the syringe. Gently roll the ampule between your fingers but do not shake. The solution should be clear and free of particles.
• Draw up the solution for injection. The ampule can be held at an angle or turned upside down to remove all the solution. Use a different syringe for this or switch needles just prior to injection. Needles with a higher gauge (25 and higher) are smaller and more comfortable to the patient. Be sure all air bubbles are tapped out of the syringe.
• Wipe the injection site with an alcohol swab, then insert the syringe through the skin in the appropriate injection site.
• After giving the injection, cover the injection site with a small bandage if necessary.
• If Fertiline contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Use immediately after mixing. Throw away any unused portion.
• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
• If you miss a dose of Fertiline, contact your doctor for instructions.

Ask your health care provider any questions you may have about how to use Fertiline.

Use: Labeled Indications

Multifollicular development during Assisted Reproductive Technologies: Development of multiple follicles with Assisted Reproductive Technologies (ART) in women who have previously received pituitary suppression.

Limitations of use: Prior to therapy, perform a complete gynecologic exam and endocrinologic evaluation and diagnose cause of fertility; exclude the possibility of pregnancy; evaluate the fertility status of the male partner; exclude women with primary ovarian failure

Ovulation induction: Ovulation induction in women who previously received GnRH agonist or antagonist for pituitary suppression.

Limitations of use: Prior to therapy, perform a complete gynecologic exam (including demonstration of tubal patency) and endocrinologic evaluation; exclude the possibility of pregnancy; evaluate the fertility status of the male partner; exclude a diagnosis of primary ovarian failure

See also:
What other drugs will affect Fertiline?

No clinically significant drug/drug or drug/food interactions have been reported during Fertiline (Fertiline for injection) ® therapy.

See also:
What are the possible side effects of Fertiline?

The following adverse reactions reported during Fertiline® (Fertiline for injection) therapy are listed in decreasing order of potential severity:

1. Pulmonary and vascular complications,

2. Ovarian Hyperstimulation Syndrome,

3. Adnexal torsion (as a complication of ovarian enlargement),

4. Mild to moderate ovarian enlargement,

5. Abdominal pain,

6. Sensitivity to Fertiline® (Fertiline for injection),

(Febrile reactions which may be accompanied by chills, musculoskeletal aches, joint pains, malaise, headache, and fatigue have occurred after the administration of Fertiline® (Fertiline for injection). It is not clear whether or not these were pyrogenic responses or possible allergic reactions.)

7. Ovarian cysts,

8. Gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal cramps, bloating),

9. Pain, rash, swelling, and/or irritation at the site of injection,

10. Breast tenderness,

11. Headache,

12. Dermatological symptoms (dry skin, body rash, hair loss, hives),

13. Hemoperitoneum has been reported during menotropins therapy and, therefore, may also occur during Fertiline® (Fertiline for injection) therapy.

14. There have been infrequent reports of ovarian neoplasms, both benign and malignant, in women who have undergone multiple drug regimens for ovulation induction; however, a causal relationship has not been established.

The following medical events have been reported subsequent to pregnancies resulting from Fertiline® (Fertiline for injection) therapy:

1. Ectopic pregnancy

2. Congenital abnormalities

(Three incidents of chromosomal abnormalities and four birth defects have been reported following Fertiline® (Fertiline for injection) -hCG or Fertiline® (Fertiline for injection), Pergonal® (menotropins for injection, USP) hCG therapy in clinical trials for stimulation prior to in vitro fertilization. The aborted pregnancies included one Trisomy 13, one Trisomy 18, and one fetus with multiple congenital anomalies (hydrocephaly, omphalocele, and meningocele). One meningocele, one external ear defect, one dislocated hip and ankle, and one dilated cardiomyopathy in presence of maternal Systemic Lupus Erythematosis were reported. None of these events was thought to be drug-related. The incidence does not exceed that found in the general population.)

Drug Abuse and Dependence

There have been no reports of abuse or dependence with Fertiline® (Fertiline for injection).