follitropin beta

follitropin beta

(foll-i-tro-pin) ,

Follistim AQ

(trade name)

Classification

Therapeutic: hormones
Pregnancy Category: X

Indications

Induction of ovulation and pregnancy in anovulatory infertile women whose infertility is not due to primary ovarian failure.Stimulation of multiple oocytes in ovulatory women undergoing assisted reproduction technology (ART).Pregnancy in normal ovulatory women undergoing controlled ovarian stimulation as part of an in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycle (Follistim AQ cartridge only).Induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism (HH) whose infertility is not due to primary testicular failure.

Action

Stimulates follicle recruitment, growth, and maturation (in women) and spermatogenesis (in men).

Therapeutic effects

Ovulation.
Improved production/harvest of oocytes in patients undergoing ART.
Pregnancy.
Spermatogenesis.

Pharmacokinetics

Absorption: Well absorbed following subcutaneous or intramuscular administration.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: 26.9–43.9 hr (dose-dependent).

Time/action profile

ROUTEONSETPEAKDURATION
Subcut (men or women)unknownunknownunknown

Contraindications/Precautions

Contraindicated in: Hypersensitivity to FSH or antibiotics, streptomycin or neomycin (may contain traces of these antibiotics); Abnormal vaginal bleeding; Risk factors for thromboembolism; Uncontrolled adrenal, thyroid, or pituitary dysfunction; Intracranial or hormone-dependent tumors; Ovarian cyst/enlargement not due to polycystic ovary syndrome; Primary ovarian or testicular failure; Obstetric / Lactation: Pregnancy or lactation.
Use Cautiously in: None noted.

Adverse Reactions/Side Effects

Central nervous system

  • dizziness
  • headache

Cardiovascular

  • thromboembolism (life-threatening)
  • tachycardia

Gastrointestinal

  • nausea (most frequent)
  • flatulence (most frequent)
  • constipation

Genitourinary

  • ovarian hyperstimulation syndrome (life-threatening)
  • abdominal/pelvic pain (most frequent)
  • dysmenorrhea
  • irregular bleeding
  • ovarian enlargement
  • ovarian neoplasm
  • ovarian torsion

Endocrinologic

  • breast pain/enlargement (most frequent)

Musculoskeletal

  • back pain

Respiratory

  • acute respiratory distress syndrome (life-threatening)
  • dyspnea
  • tachypnea
  • upper respiratory tract infection

Dermatologic

  • acne
  • rash

Local

  • injection site reactions (most frequent)

Miscellaneous

  • flu-like symptoms
  • multiple births

Interactions

Drug-Drug interaction

None significant.

Route/Dosage

Ovulation and Pregnancy Induction in Anovulatory Infertile Women (Follistim AQ Single-Use Vial)

Subcutaneous Intramuscular (Adults) 75 IU/day for up to 7 days, then ↑ by 25–50 IU at weekly intervals as needed by assessment (300 IU/day maximum); followed by hCG.

Ovarian and Pregnancy Induction in Anovulatory Infertile Women (Follistim AQ Cartridge)

Subcutaneous (Adults) 50 IU/day for up to 7 days, then ↑ by 25–50 IU at weekly intervals as needed by assessment (250 IU/day maximum); followed by hCG. A lower initial dose should be given if previous doses were administered using Follistim AQ single-use vials.

Assisted Reproduction Technologies (Follistim AQ Single-Use Vial)

Subcutaneous Intramuscular (Adults) 150–225 IU/day for at least the first 4 days of treatment; dose may be then adjusted based upon ovarian response (600 IU/day maximum); followed by hCG.

Pregnancy in Normal Ovulatory Women Undergoing IVF or ICSI (Follistim AQ Cartridge)

Subcutaneous (Adults) 200 IU daily for at least the first 7 days of treatment; dose may be then adjusted based upon ovarian response (500 IU/day maximum); followed by hCG.

Spermatogenesis Induction (Follistim AQ Single-Use Vial or Cartridge)

Subcutaneous (Adults) Pretreat with hCG prior to use of Follistim AQ; once normal serum testosterone levels achieved, give 450 IU/week (as 225 IU twice weekly or 150 IU 3 times weekly) with hCG; continue for at least 3–4 mo.

Availability

Injection (single-use vial): 75 IU/vial, 150 IU/vial
Injection (multi-dose cartridge): 175 IU/vial (delivers 150 IU), 350 IU/vial (delivers 300 IU), 650 IU/vial (delivers 600 IU), 975 IU/vial (delivers 900 IU)

Nursing implications

Nursing assessment

  • Monitor follicular maturation during therapy via ovarian ultrasound and serum estradiol levels.
  • Assess for ovarian enlargement (abdominal distention, abdominal pain). Usually regresses without treatment within 2–3 weeks.
  • Assess patient for signs of ovarian hyperstimulation syndrome (severe ovarian enlargement, abdominal pain and distention, nausea, vomiting, weight gain, diarrhea, dyspnea, oliguria). May be accompanied by ascites, pleural effusion, hypovolemia, electrolyte imbalance, hemoperitoneum, thromboembolic events.

Potential Nursing Diagnoses

Deficient knowledge, related to medication regimen (Patient/Family Teaching)

Implementation

  • When converting from single-use vial to cartridge, dose must be reduced by 18%. See manufacturer's recommendations for specific dose conversions.
  • Intramuscular: Subcutaneous: Follistim AQ single-use vial: Administer via subcutaneous or IM injection. Best place for subcutaneous injection is area below navel (belly button) or in upper thigh. Best place for IM injection is upper outer quadrant of buttock muscle. May be stored in refrigerator until expiration date or at room temperature for 3 mo or until expiration date, whichever occurs first. Protect from light.
  • Subcutaneous: Follistim AQ cartridge: Administer via subcutaneous injection. Remove protective cap on pen. Unscrew the entire pen body from cartridge holder. Place Follistim AQ Cartridge into cartridge holder (placing metal rimmed cap end first). Screw pen body onto cartridge holder. Screw cartridge holder into BD Micro-Fine Pen Needle. Best place for injection is area below navel (belly button) or in upper thigh. Unused cartridges may be stored in refrigerator until expiration date or at room temperature for 3 mo or until expiration date, whichever occurs first. Used cartridges may be stored in refrigerator or at room temperature for up to 28 days. Protect from light.

Patient/Family Teaching

  • Prior to initiation of therapy discuss with patient the duration of therapy, required monitoring, potential adverse reactions, and risk of multiple births.
  • Encourage couple to have intercourse daily, beginning on the day prior to administration of hCG until ovulation becomes apparent based on indices to determine progestational activity. Care should be taken to ensure insemination.
  • Advise patient to notify health care professional if worsening or strong abdominal pain occurs or if any side effect that is persistent or bothersome occurs.
  • Advise female patients to notify health care professional if breastfeeding.

Evaluation/Desired Outcomes

  • Successful pregnancy.

follitropin alfa/follitropin beta

an ovulation stimulant.
indications It is used to induce ovulation during assisted reproductive technologies such as in vitro fertilization.
contraindications Factors that prohibit its use include known hypersensitivity, pregnancy, undiagnosed vaginal bleeding, intracranial lesion, and ovarian cyst not caused by polycystic ovarian disease.
adverse effects Life-threatening effects are birth defects and spontaneous abortion. Other adverse effects include malaise, nausea, vomiting, constipation, increased appetite, abdominal pain, rash, dermatitis, urticaria, alopecia, polyuria, urinary frequency, multiple ovulation, and breast pain.

follitropin beta

A drug that stimulated the ovaries into producing eggs and is used to treat infertility. More recently, the drug has been found to be useful in the treatment of male infertility due to hypogonadotrophic hypogonadism. A brand name is Puregon.
References in periodicals archive ?
Dalteparin, darbepoetin, dasatinib, dexamethasone + neomycin sulphate + polymyxin B sulfate, epoetin beta, epoetin theta, epoetin zeta, erlotinib, estradiol + cyproterone, etoricoxib, everolimus, follitropin beta, formoterol + beclomethasone, fusidic + betamethasone, fusidic + hydrocortisone , goserelin, hydromorphone hydrochloride, ketorolac, levothyroxine + liothyronine, Linezolid, nadroparin, paliperidone palmitate, pazopanib, pegfilgrastim, piribedil, progesterone, prothipendyl, Reviparin, risperidone, sildenafil, sumatriptan, tinzaparin, tobramycin, tobramycin + dexamethasone, voriconazole.
The Follistim AQ Cartridge is designed to be used only with the Follistim Pen (TM), an innovative pen device that facilitates accurate delivery of individualized doses of pre-mixed follitropin beta injection, a highly effective and widely used prescription fertility medication made from state of the art recombinant DNA technology.
Follistim(R) AQ Cartridge administered with Follistim Pen(TM), delivers on average an 18 percent higher amount of follitropin beta compared to lyophilized preparations administered by a conventional syringe and needle.
Single-dose of investigational sustained follicle stimulant achieves similar efficacy to daily injections of follitropin beta given over a one week period in Phase III Study
Do not use PUREGON if you: -- are allergic (hypersensitive) to follitropin beta or any of the other ingredients of PUREGON -- have a tumour of the ovary, breast, uterus, testis, pituitary gland or hypothalamus -- are pregnant or breast-feeding -- have heavy or irregular vaginal bleeding where the cause is not known -- suffer from primary ovarian failure -- have ovarian cysts or enlarged ovaries not caused by polycystic ovarian disease (PCOD) -- have malformations of the sexual organs which make a normal pregnancy impossible -- have fibroids in the uterus which make a normal pregnancy impossible.
Follistim(R) AQ Cartridge administered with Follistim Pen(R) delivers on average an 18% higher amount of follitropin beta compared to lyophilized preparations administered with a conventional syringe and needle.
Follistim(R) AQ Cartridge is designed to be used only with the Follistim Pen(TM), an innovative pen device that facilitates accurate delivery of individualized doses of pre-mixed follitropin beta injection, a highly effective and widely used prescription fertility medication made from state of the art recombinant DNA technology.
Study outcomes in Bravelle(TM) SC Follitropin beta SC patients receiving hCG (n=57) (n=59) Oocytes retrieved 12.