follitropin alfa

(redirected from Gonal-F)

follitropin alfa

(foll-i-tro-pin) ,

Gonal-F

(trade name),

Gonal-F RFF

(trade name)

Classification

Therapeutic: hormones
Pregnancy Category: X

Indications

Induction of ovulation in anovulatory patients whose infertility is not due to primary ovarian failure (Gonal-F and Gonal-F RFF).Stimulation of multiple oocytes in ovulatory patients undergoing assisted reproduction technology (ART) (Gonal-F and Gonal-F RFF).Induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism whose infertility is not due to primary testicular failure (Gonal-F only).

Action

Stimulates follicle recruitment, growth and maturation.
Induces spermatogenesis.

Therapeutic effects

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

Pharmacokinetics

Absorption: Well absorbed following subcut administration.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: 24 hr.

Time/action profile

ROUTEONSETPEAKDURATION
Subcutunknownunknownunknown

Contraindications/Precautions

Contraindicated in: Hypersensitivity; Primary ovarian or testicular failure; Obstetric: PregnancyUncontrolled thyroid, adrenal, or pituitary dysfunction; Abnormal uterine bleeding; Intracranial or hormone-dependent tumors; Ovarian cyst/enlargement not due to polycystic ovarian syndrome.
Use Cautiously in: .

Adverse Reactions/Side Effects

Central nervous system

  • dizziness
  • headache

Cardiovascular

  • thromboembolic events (life-threatening)

Ear, Eye, Nose, Throat

  • pharyngitis
  • rhinitis

Gastrointestinal

  • constipation
  • diarrhea
  • dyspepsia
  • flatulence

Genitourinary

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

Dermatologic

  • acne

Endocrinologic

  • breast pain

Respiratory

  • cough

Local

  • injection site reactions

Miscellaneous

  • anaphylaxis (life-threatening)
  • flu-like symptoms
  • multiple births

Interactions

Drug-Drug interaction

Unknown.

Route/Dosage

Female infertility

Subcutaneous (Adults) 75 IU/day for 14 days, then increased by 37.5 IU at weekly intervals as needed by assessment (up to 300 IU/day); followed by hCG.

Assisted Reproduction Technologies

Subcutaneous (Adults) 150 IU/day starting on day 2 or 3 of cycle until follicles develop sufficiently; if needed may be increased by 75–150 IU/day every 3–5 days (not to exceed 10 days or 450 IU/day); followed by hCG.

Male Patients with Hypogonadotropic Hypogonadism (Gonal-F only)

Subcutaneous (Adults) After normal serum testosterone levels are achieved with hCG, Gonal–F can be initiated at 150 IU 3 times weekly (must be given with hCG). If azoospermia persists, dose can be increased up to 300 IU 3 times weekly; may be given for up to 18 mo.

Availability

Powder for injection: 75 IU/vial (Gonal-F RFF), 450 IU/vial (Gonal-F), 1050 IU/vial (Gonal-F)
Pre-filled multidose pen (Gonal-F RFF Redi-ject): 300 IU/pen, 450 IU/pen, 900 IU/pen

Nursing implications

Nursing assessment

  • Monitor follicular maturation during therapy via ovarian ultrasound and serum estradiol levels.
  • Assess patient for ovarian enlargement (abdominal distention, abdominal pain). Usually regresses without treatment within 2–3 wks.
  • For men, monitor serum testosterone levels and sperm counts. Prior to concomitant therapy with follitropin alfa and hCG, pretreatment with hCG alone is required to achieve normal serum testosterone levels. Pretreatment with hCG may require 3–6 mo. Serum testosterone levels should be normalized prior to initiation of therapy.
  • 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

  • Subcutaneous: Administer via subcut injection only. Vials:Dissolve the contents of each vial with sterile or bacteriostatic water for injection provided in accompanying pre-filled syringe. For single-dose vial, use immediately after reconstitution and discard unused solution. Multi-dose vials may be stored in refrigerator or at room temperature for up to 28 days. Dose from multi-dose vials should be administered with calibrated syringes provided by manufacturer. Protect all vials from light. Pre-filled pens:Pens should be at room temperature before using. Remove protective pen cap. Remove peel tab from outer needle cap on single-use disposable needle (provided in carton). Press threaded tip of pen into open end of outer needle cap and twist it clockwise until securely fixed. Remover outer needle cap (but don't throw away). Do not remove the inner needle cap at this time. Select prescribed dose by turning dosage dial to proper dose mark. Pull out injection button on pen as far as it will go. Remover inner needle cap on pen. Insert needle into abdominal skin at 90 degree angle and push injection button. Allow needle to remain in skin for at least 5 sec to ensure that full dose is injected. Remove needle. Replace outer needle cap onto needle. Remove needle by unscrewing pen counter-clockwise and dispose of in safety container. Replace protective pen cap. Unused pens may be stored in refrigerator until expiration date or at room temperature for up to 1 mo or until expiration date, whichever occurs first. Used pens may be stored in refrigerator or at room temperature for up to 28 days. Pens should be protected 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.

Evaluation/Desired Outcomes

  • Successful pregnancy.
  • Increased sperm count.

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.
References in periodicals archive ?
Viagra, Gonal-f and AndroGel are the major drugs in their respective drug classes, which are preferred majorly for treating different causes of infertility.
Some key branded products, such as Cetrotide, GONAL-f, Crinone, Ovidrel, Luveris, Pergoveris and Puregon, are going to face a severe threat from generics as they approach patent expiry between 2010 and 2015.
Some key branded products such as Cetrotide, GONAL-f, Crinone, Ovidrel, Luveris, Pergoveris and Puregon are going to face a severe threat from generics as they approach patent expiry between 2010 and 2015.
The ESPART Phase III multicenter, randomized, controlled, single-blind trial compares Pergoveris versus GONAL-f in patients who are classified as POR, as aligned with the outcomes of the 2011 Consensus Meeting of the European Society of Human Reproduction and Embryology (ESHRE).
Gonal-f RFF* Redi-ject(TM) (follitropin alfa injection) was approved for use by the FDA on October 17, 2013
Rest of the World Follicle Stimulating Hormone -- Gonal-f (follitropin alfa) -- Biosimilar Follitropin Alfa?
GONAL-f has been approved in 100 countries worldwide - among which 74 countries have approved GONAL-f prefilled pen - including Europe and the US with indications of stimulation of the growth of ovarian follicles and ovulation in women.
The Company has six recombinant products on the worldwide market: Gonal-F (R)(follitropin alfa for injection), Luveris (R)(lutropin alfa), Ovidrel(R)/Ovitrelle (R)(choriogonadotropin alfa for injection), Rebif (R)(interferon beta-1a), Serostim(R) (somatropin (rDNA origin) for injection) and Saizen(R) (somatropin (rDNA origin) for injection).
Of the 184 patients in the study, there were no multiple pregnancies with the MENOPUR(R) group while the incidence was 12 percent in the Gonal-f group.
GONAL-f is a recombinant follicle-stimulating hormone currently approved in Japan for the treatment of male infertility.
In a separate analysis of 184 women with World Health Organization (WHO) Group II anovulatory infertility who failed to ovulate or conceive on clomiphene citrate and were randomized to receive either MENOPUR(R) or Gonal-f treatment in a low-dose step-up protocol, results demonstrated that treatment with MENOPUR(R) is associated with equivalent ovulation and pregnancy rates compared with Gonal-f.
Now, Gonal-F Multi-Dose brings the added advantages of flexible dosing and a convenient one-step drug preparation process that produces a liquid for use over several days of treatment.