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Follitropin Beta

Pronunciation: fole-lih-TROE-pin BAY-tah
Class: Ovulation stimulant

Trade Names

Follistim AQ
- Injection 150 units per 0.5 mL
- Injection 75 units per 0.5 mL

Follistim AQ
- Cartridge 150 units per 0.21 mL
- Cartridge 300 units per 0.42 mL
- Cartridge 600 units per 0.78 mL
- Cartridge 900 units per 1.17 mL

Puregon (Canada)

Pharmacology

Stimulates ovarian follicular growth in women who do not have primary ovarian failure.

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Pharmacokinetics

Absorption

Subcutaneous route

Bioavailability is 77.8%, AUC is 455.6 units•h/L, and C max is 5.4 units/L.

IM route

Bioavailability is 76.4%, AUC is 445.7 units•h/L, and C max is 6.86 units/L.

Distribution

Vd is 8 L.

Elimination

Mean t ½ is about 26.9 to 43.9 h and is dose dependent.

Indications and Usage

For development of multiple follicles in ovulatory patients participating in an assisted reproductive technology (ART) program; for induction of ovulation and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not caused by primary ovarian failure.

Contraindications

Prior hypersensitivity to recombinant human follicle-stimulating hormone products; high circulating FSH level (indicating primary ovarian failure); uncontrolled thyroid or adrenal dysfunction; tumor of the ovary, breast, uterus, hypothalamus, or pituitary gland; pregnancy; heavy or irregular vaginal bleeding of undetermined origin; ovarian cysts or enlargement not caused by polycystic ovary syndrome; hypersensitivity to streptomycin or neomycin.

Dosage and Administration

Follicle Stimulation (ART)
Adults Follistim AQ

IM/Subcutaneous 150 to 225 units/day for at least first 4 days of treatment, then adjust dose upon patient's ovarian response. Daily maintenance dosages ranging from 75 to 300 units for 6 to 12 days is usually sufficient, although longer treatment may be necessary. However, in low or poor responders, maintenance doses of 375 to 600 units have been administered (max, 600 units/day). The final maturation of the follicles is induced by administering human chorionic gonadotropin (hCG) at a dose of 5,000 to 10,000 units. If the ovaries are abnormally enlarged on the last day, hCG must be withheld.

Follistim AQ Cartridge

Subcutaneous 150 to 225 units or lower/day for at least first 5 days of treatment, then adjust dose upon patient's ovarian response (max, 450 units). If prescriber generally uses an initial dose of 150 to 225 units of lyophilized gonadotropin, then a lower starting dose should be considered (eg, 50 units instead of 75 units, 125 units instead of 150 units, 175 units instead of 225 units). A lower maintenance dose also should be considered (eg, 250 units instead of 300 units, 300 units instead of 375 units, 375 units instead of 450 units). The final maturation of the follicles is induced by administering hCG at a dose of 5,000 to 10,000 units. If the ovaries are abnormally enlarged on the last day, hCG must be withheld.

Ovulation Induction
Adults Follistim AQ

IM/Subcutaneous There are various treatment protocols. In studies using a gradually increasing dosing scheme, treatment was initiated with 75 units/day for up to 14 days, then the dose was increased by 37.5 units at weekly intervals until follicular growth or serum estradiol levels indicate an adequate response (max, 300 units). Continue treatment until ultrasonic visualization or serum estradiol determinations indicate pre-ovulatory conditions at least those of normal individuals followed by hCG, 5,000 to 10,000 units. If the ovaries are abnormally enlarged on the last day, hCG must be withheld during this course of treatment.

Follistim AQ Cartridge

Subcutaneous Initiate treatment with 75 units or lower/day for at least the first 7 days. If prescriber generally uses an initial dose of 75 units of lyophilized gonadotropin, then a lower starting dose of Follistim AQ Cartridge should be considered (eg, 50 units instead of 75 units). Dose then is increased 25 or 50 units at weekly intervals, based upon patient response (max, 175 units). Continue treatment until follicular growth or serum estradiol levels indicate pre-ovulatory conditions at least those of normal individuals followed by hCG, 5,000 to 10,000 units. If the ovaries are abnormally enlarged on the last day, hCG must be withheld during this course of treatment.

General Advice

  • Allow refrigerated solution to reach room temperature before administering dose.
  • To minimize bleeding, do not rub site after injection.
  • Do not administer if solution is cloudy, discolored, or contains particulate matter.
  • Administer drug with patient sitting or lying down.
  • Rotate injection sites.
  • Aqueous solution
  • For subcutaneous or IM administration only. Not for intradermal, IV, or intra-arterial administration.
  • Follistim AQ and Follistim AQ Cartridge are not interchangeable on a unit-to-unit dose basis.
  • Discard any unused solution remaining in vial after withdrawing dose. Do not save for future use.
  • Cartridge
  • For subcutaneous administration only. Not for intradermal, IM, IV, or intra-arterial administration.
  • For administration using Follistim Pen only.
  • Insert cartridge into pen following directions in Instruction Booklet . Note gonadotropin content in cartridge (300 or 600 units).
  • Attach needle to pen prior to each injection. Needles are not to be reused.
  • Check for drug flow before dialing prescribed dose. Administer dose by depressing injection button for 5 sec.
  • Document administered dose and amount of medication remaining in syringe after each dose.

Storage/Stability

Store in refrigerator (36° to 46°F) until dispensed. May be stored by patient in refrigerator until expiration date, or at or below 77°F for 3 mo or until expiration date, whichever occurs first. Once cartridge has been pierced by a needle, cartridges can only be stored for max of 28 days at 36° to 77°F. Protect all products from light and freezing.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Tachycardia, vascular complications (eg, arterial occlusion, cerebral vascular occlusion, pulmonary embolism, pulmonary infarction, venous thrombophlebitis).

CNS

Dizziness, headache (5%).

Dermatologic

Body rash, dry skin, erythema, hair loss, hives.

GI

Abdominal discomfort, abdominal pain, lower abdominal discomfort (28%); flatulence (27%); nausea (17%); abdomen enlarged (8%); constipation (5%); ovarian cyst (3%).

Genitourinary

Abdominal pain/gynecological (25%); breast pain (15%); miscarriage (11%); ovarian hyperstimulation syndrome (9%); ovarian pain (5%); ectopic pregnancy (3%); vaginal hemorrhage (2%); breast tenderness, ovarian neoplasm (benign and malignant).

Local

Injection site pain (10%).

Respiratory

Upper respiratory tract infection (5%); dyspnea, pulmonary complications (eg, acute respiratory distress syndrome, atelectasis), tachypnea.

Miscellaneous

Back pain (7%); sinusitis (5%); adnexal torsion, febrile reactions, flu-like symptoms (including fever, chills, musculoskeletal aches, joint pains, nausea, headache, malaise), hemoperitoneum.

Precautions

Monitor

Examine patients at least every other day during, and for 2 wk following, treatment for signs of excessive ovarian stimulation (eg, abdominal pain or distension, diarrhea, dyspnea, nausea, oliguria, rapid weight gain, severe pelvic pain, vomiting). Monitor patient for signs and symptoms of thromboembolic events (eg, arterial occlusion, pulmonary embolism, pulmonary infarction, stroke, venous thrombophlebitis).


Pregnancy

Category X .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Multiple births

May occur.

Ovarian enlargement

To minimize hazards associated with abnormal ovarian enlargement, use lowest effective dose.

Ovarian hyperstimulation syndrome

May occur. Warning signs include pelvic pain, nausea, vomiting, abdominal distention, weight gain, oliguria. May progress within 24 h to several days to become a serious medical event.

Pulmonary complications

Serious pulmonary conditions (eg, acute respiratory distress syndrome, atelectasis) have been reported.

Vascular complications

Intravascular thrombosis may occur, resulting in intravascular thrombosis and embolism, which can reduce blood flow to vital organs (resulting in pulmonary infarction or stroke) or extremities (resulting in loss of limbs).

Overdosage

Symptoms

Multiple gestations, ovarian hyperstimulation syndrome.

Patient Information

  • Explain name, action, and potential side effects of the treatment regimen, including risk of multiple births. Review the treatment regimen, including duration of treatment and monitoring that will be required.
  • If patient will be administering at home, teach patient how to store, prepare, and administer the dose, and dispose of used equipment and supplies. Advise patient to review the patient information leaflet, which comes with the single-dose vials or, if using the aqueous cartridge, the Patient Information Booklet that comes with the cartridges, before starting therapy, and with each refill.
  • Advise patient that if medication has been stored in refrigerator to allow solution to warm to room temperature before administering dose.
  • Caution patient not to change the dose or stop taking unless advised by health care provider.
  • Caution patient that if a dose is missed not to double the dose to catch up. Advise patient to contact health care provider for further instructions.
  • Remind patient that drug is administered to promote follicular growth and egg production, and that hCG will need to be administered to induce ovulation.
  • Encourage women receiving drug for infertility to have intercourse daily, beginning on the day prior to administration of hCG and until ovulation has become apparent.
  • Warn patient that close monitoring for overstimulation of the ovary is required and to report any of the following immediately to health care provider: difficulty breathing, severe pelvic pain, nausea, vomiting, rapid weight gain, stomach pain or bloating, diarrhea, infrequent urination.
  • Advise patient to inform health care provider of any side effects, symptoms, or physical changes, or bothersome injection site reactions.

Copyright © 2009 Wolters Kluwer Health.

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