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GONAL-F PEN is a brand name for Follitropin Alfa, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: GONAL-f® (Follitropin alfa for Injection) is indicated for: • GONAL-f® is indicated for the stimulation of multiple follicular development in ovulatory patients undergoing Assisted Reproductive Technologies (ART) such as in vitro fertilization. To complete follicular maturation in the absence of an endogenous LH…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Treatment with GONAL-f® should be initiated under the supervision of a physician experienced in the treatment of fertility problems.
Selection of Patients:
GONAL-f® Pen Product Monograph Page 5 of 41 1. Before treatment with GONAL-f® is instituted, a thorough gynaecologic and endocrinologic evaluation must be performed. This should include an assessment of pelvic anatomy. 2. Primary ovarian failure should be excluded by the determination of gonadotropin levels.
3. Appropriate evaluation should be performed to exclude 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 evaluation should always be performed in patients who demonstrate abnormal uterine bleeding or other signs of endometrial abnormalities before starting GONAL-f® therapy.
5. Evaluation of the partner's fertility potential should be included in the initial evaluation. 2 Recommended Dose and Dosage Adjustment Health Canada has not authorized an indication for pediatric use. The dose of GONAL-f® to stimulate development of the follicle must be individualized for each patient and the particular indication.
To minimize the hazard associated with the occasional abnormal ovarian enlargement which may occur with GONAL-f® therapy, the lowest dose consistent with the expectation of good results should be used. GONAL-f® should be administered subcutaneously or intramuscularly until adequate follicular development is indicated by ultrasound alone or in combination with measurement of serum estradiol levels.
The dosage recommendations given for GONAL-f® are those in use for urinary FSH. Clinical assessment of GONAL-f® indicates that its daily doses, regimens of administration, and treatment monitoring procedures should not be different from those currently used for urinary FSH-containing preparations.
However, when these doses were used in a clinical study comparing GONAL-f® and urinary FSH, GONAL-f® was more effective than urinary FSH in terms of a lower total dose and a shorter treatment period needed to achieve pre-ovulatory conditions.
Over the course of treatment, doses may range between 75 to 450 IU depending on the indication and the individual patient response. To complete follicular development and effect ovulation in the absence of an endogenous LH surge, hCG is given when monitoring of the patient indicates that sufficient follicular development has occurred.
) and the risk of multiple births should also be discussed. Before starting treatment, the couple’s infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated. 44 mL disodium phosphate dihydrate, L- methionine, m-cresol, phosphoric acid, poloxamer 188, sodium dihydrogen phosphate monohydrate, sodium hydroxide, sucrose and water for injection GONAL-f® Pen Product Monograph Page 8 of 41 and appropriate specific treatment given.
During training of the patient for self-administration, special attention should be given to specific instructions for the use of the pen. Carcinogenesis and Mutagenesis Long-term studies in animals have not been performed to evaluate the carcinogenic potential of GONAL-f®.
(see 16 NON-CLINICAL TOXICOLOGY) There have been reports of ovarian and other reproductive system neoplasms, both benign and malignant, in women who have undergone multiple drug regimens for infertility treatment. It is not yet established whether or not treatment with gonadotropins increases the baseline risk of these tumours in infertile women.
Cardiovascular The following paragraph describes serious medical events reported following gonadotropin therapy. Thromboembolic events both in association with, and separate from Ovarian Hyperstimulation Syndrome have been reported.
Intravascular thrombosis and embolism can result in reduced blood flow to critical organs or the extremities. Sequelae of such events have included venous thrombophlebitis, pulmonary embolism, pulmonary infarction, myocardial infarction, cerebral vascular occlusion (ischemic stroke), and arterial occlusion resulting in loss of limb.
In rare cases, pulmonary complications and/or thromboembolic events have resulted in death. In women with recent or ongoing thromboembolic disease or women with generally recognised risk factors for thromboembolic events, such as personal or family history, treatment with gonadotropins may further increase the risk for aggravation or occurrence of such events.
), little is known concerning the consequences of acute overdosage with GONAL-f®. Apart from expected ovarian and endometrial effects, no acute toxicity was seen in animals given doses of r-hFSH up to1000-fold the human dose. For management of a suspected drug overdose, contact your regional poison control centre.
GONAL-f® Pen Product Monograph Page 7 of 41 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING GONAL-f® Pen is presented as solution for injection in 3 mL cartridge (Type I glass), with a plunger stopper (halobutyl rubber) and a rubber crimp cap (halobutyl rubber).
The cartridge is preassembled with the prefilled pen. GONAL-f® Pen is shatterproof per EN ISO 11608-1:2000 standards. 44 mL) Filled by Mass: 1 prefilled pen and 16 needles to be used with the pen for subcutaneous administration. There is no latex in the components of the prefilled pen.
Table 1 – Dosage Forms, Strengths, Composition and Packaging 7 WARNINGS AND PRECAUTIONS General Careful attention should be given to diagnosis in candidates for GONAL-f® therapy (see 44 DOSAGE AND ADMINISTRATION, Dosing Considerations, Selection of Patients).
GONAL-f® should only be used by physicians who are thoroughly familiar with infertility problems and their management. GONAL-f® is a potent gonadotropic substance capable of causing mild to severe adverse reactions. Gonadotropin therapy requires a certain time commitment by physicians and supportive health professionals, and requires the availability of appropriate monitoring facilities (see 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests).
Safe and effective use of GONAL-f® requires monitoring of ovarian response with ultrasound, alone or in combination with measurement of serum estradiol levels, on a regular basis. In patients with porphyria or a family history of porphyria GONAL-f® may increase the risk of an acute attack.
Follitropin alfa is contraindicated in women who exhibit: • High levels of Follicle Stimulating Hormone (FSH) indicating primary ovarian failure. • Uncontrolled thyroid or adrenal dysfunction. • An organic intracranial lesion such as a pituitary tumour or tumours of the hypothalamus.
• The presence of any cause of infertility other than anovulation, as stated in the 1 INDICATIONS section, unless the women are candidates for Assisted Reproductive Technologies. • Abnormal uterine bleeding of unknown aetiology (see 4 DOSAGE AND ADMINISTRAION, Dosing Considerations) • Ovarian cyst or enlargement of undetermined origin (see 4 DOSAGE AND ADMINISTRAION, Dosing Considerations)).
• Sex hormone dependent tumours of the reproductive organs and breasts. • Pregnancy/lactation • Hypersensitivity to or history of previous allergic reaction to follitropin alfa, FSH or to any of the excipients.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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If the ovaries are abnormally enlarged or significant abdominal pain occurs, GONAL-f® treatment should be discontinued, hCG should not be administered, and the patient should be advised to refrain from intercourse until resolution of the cycle; this will reduce the chances of development of the Ovarian Hyperstimulation Syndrome and, should spontaneous ovulation occur, reduce the chances of multiple gestation.
While individual dosing regimens will differ between patients, typical treatment regimens are presented below.
Assisted Reproductive Technologies:
In patients undergoing Assisted Reproductive Technologies (ART) whose endogenous gonadotropin levels are not suppressed, GONAL-f® should be initiated in the early follicular phase (cycle day 2 or 3) at a dose of 150 IU per day, administered subcutaneously.
Treatment should be continued until adequate follicular development is indicated as determined by either ultrasound alone or in combination with measurement of serum estradiol levels. 5-150 IU additionally at each adjustment. Treatment should be continued until adequate follicular development is indicated.
Once adequate follicular development is evident, hCG should be administered to induce final follicular maturation in preparation for oocyte retrieval. In patients undergoing ART, whose endogenous gonadotropin levels are suppressed indicating a GONAL-f® Pen Product Monograph Page 6 of 41 hypogonadotropic state, GONAL-f® should be initiated at a dose of 225 IU per day, administered subcutaneously or intramuscularly.
Treatment should be continued until adequate follicular development is indicated as determined by either ultrasound alone or in combination with measurement of serum estradiol levels. 5–150 IU additionally at each adjustment. Doses greater than 450 IU per day are not generally recommended.
As before, once adequate follicular development is evident, hCG should be administered to induce final follicular maturation in preparation for oocyte retrieval.
Ovulation Induction:
The majority of patients who require ovulation induction are patients with Polycystic Ovarian Syndrome (PCOS). Patients with PCOS tend to show a more rapid and exaggerated response to treatment. Therefore, in this patient population, particular care should be employed to ensure that patients are adequately monitored and that the lowest dose consistent with the expectation of good results is employed.
It is recommended that treatment of any patient be initiated at a dose of 75 IU GONAL- f per day, administered subcutaneously or intramuscularly. 5 IU may be considered after 14 days. Further dose increases of the same magnitude could be made, if necessary, every seven days.
Treatment duration should not exceed 35 days unless an estradiol rise indicates imminent follicular development. Once adequate follicular development is evident, hCG should be administered to induce final follicular maturation and effect ovulation.
The patient should attempt to have intercourse at a consistent frequency of at […]
In these women, the benefits of gonadotropin administration need to be weighed against the risks. It should be noted however, that pregnancy itself as well as OHSS also carries an increased risk of thrombo-embolic events. Dependence/Tolerance There have been no reports of abuse or dependence with GONAL-f®.
Driving and Operating Machinery No studies on the effects on the ability to drive and use machines have been performed.
Fertility Overstimulation of the Ovary During FSH Therapy Ovarian Enlargement:
Use of FSH therapy to stimulate follicular development may result in the recruitment of a number of follicles. This may result in mild to moderate uncomplicated ovarian enlargement which may be accompanied by abdominal distention and/or abdominal pain.
It is more commonly seen in women with polycystic ovarian syndrome. This degree of enlargement has been reported to occur in approximately 20% of those treated with urofollitropin and hCG, and generally regresses without treatment within two or three weeks.
To minimize the hazard associated with the occasional abnormal ovarian enlargement which may occur with GONAL-f® therapy, the lowest dose consistent with the expectation of good results should be used. Careful monitoring of ovarian response can further minimize the risk of ovarian enlargement.
If there is clinical evidence of excessive ovarian response (see 7 WARNINGS and PRECAUTIONS, Monitoring and Laboratory Tests), treatment should be discontinued and hCG should not be GONAL-f® Pen Product Monograph Page 9 of 41 administered.
This will reduce the chances of development of the Ovarian Hyperstimulation Syndrome (OHSS).
Ovarian Hyperstimulation Syndrome (OHSS):
OHSS is a medical event distinct from uncomplicated ovarian enlargement. OHSS may progress rapidly (within 24 hours to several days) to become a serious medical event. It is characterized by marked ovarian enlargement, high serum sex steroids and an apparent dramatic increase in vascular permeability which can result in an accumulation of fluid in the peritoneal, pleural and, rarely, in the pericardial cavities.
The early warning signs of development of OHSS are severe pelvic pain, nausea, vomiting, and weight gain. The following symptomatology has been seen with cases of mild manifestations of OHSS: abdominal pain, abdominal distention, and enlarged ovaries.
Moderate OHSS may additionally present nausea, vomiting, diarrhoea, ultrasound evidence of ascites and marked ovarian enlargement. Severe OHSS further includes symptoms such as severe ovarian enlargement, weight gain, dyspnea, or oliguria Clinical evaluation may reveal hypovolemia, hemoconcentration, electrolyte imbalances, ascites, pleural effusions, or acute pulmonary distress (see 7 WARNINGS AND PRECAUTIONS).
Rarely, severe OHSS may be complicated by ovarian torsion or thromboembolic events, such as pulmonary embolism, ischaemic stroke or myocardial infarction. Transient liver function test abnormalities suggestive of hepatic dysfunction, which may be accompanied by morphologic changes on liver biopsy, have been reported in association with the OHSS.
0% of patients treated with urofollitropin therapy in the initial clinical trials, in patients treated for anovulation due to polycystic ovarian syndrome. In these studies, prospective monitoring of ovarian response using serum estradiol determination or ultrasonographic visualizations was not routinely employed.
In the clinical trials in oligo-anovulatory infertile women treated with GONAL-f® in which both estradiol and ultrasound measurements were utilized to monitor follicular […]
Deterioration or a first appearance of this condition may require cessation of treatment. Prior to therapy with GONAL-f®, patients should be informed of the duration of treatment and monitoring of their condition that will be required.
Possible adverse reactions (see