Gonal-f

Gonal-f

follitropin alfa

Manufacturer:

Merck

Distributor:

Apex Pharma Marketing
Full Prescribing Info
Contents
Follitropin α.
Description
Vial: Each vial contains follitropin α*, 5.5 mcg and 77 mcg, equivalent to 75 IU, and 1050 IU, respectively.
Each mL of reconstituted solution contains 75 IU for Gonal-f 75 IU and 600 IU for Gonal-f 1050 IU.
Each vial also contains the following excipients: Powder: Sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, methionine, polysorbate 20, concentrated phosphoric acid and sodium hydroxide; and also methionine and polysorbate 20 for Gonal-f 75 IU. Solvent: Water for injections. Gonal-f 1050 IU also contains benzyl alcohol.
The pH of the reconstituted solution is 6.5-7.5.
Pre-Filled Pen: Each mL of the solution contains follitropin α, 600 IU (equivalent to 44 mcg). Each pre-filled multidose pen delivers follitropin α 300 IU (equivalent to 22 mcg), 450 IU (equivalent to 33 mcg) and 900 IU (equivalent to 66 mcg) in 0.5 mL, 0.75 mL and 1.5 mL, respectively.
Each pre-filled pen also contains the following excipients: Poloxamer 188, sucrose, methionine, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, m-cresol, concentrated phosphoric acid, sodium hydroxide and water for injections.
The pH of the solution is 6.7-7.3.
Sodium Content: Each vial/pre-filled pen contains >1 mmol sodium (2.3 mg)/dose ie, essentially "sodium free".
*Recombinant human follicle stimulating hormone (r-hFSH) produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
Action
Pharmacotherapeutic Group: Sex hormones and modulators of the genital systems, gonadotropins. ATC Code: G03GA05.
Pharmacology: Pharmacodynamics: In women, the most important effect resulting from parenteral administration of follicle stimulating hormone (FSH) is the development of mature Graafian follicles. In women with anovulation, the object of Gonal-f therapy is to develop a single mature Graafian follicle from which the ovum will be liberated after the administration of human chorionic gonadotropin (hCG).
Clinical Efficacy and Safety in Women: In clinical trials, patients with severe FSH and luteinising hormone (LH) deficiency were defined by an endogenous serum LH level <1.2 IU/L as measured in a central laboratory. However, it should be taken into account that there are variations between LH measurements performed in different laboratories.
In clinical studies comparing recombinant human follicle stimulating hormone (r-hFSH) and urinary FSH in assisted reproductive technologies (ART) (see Table 1) and in ovulation induction, Gonal-f was more potent than urinary FSH in terms of a lower total dose and a shorter treatment period needed to trigger follicular maturation.
In ART, Gonal-f at a lower total dose and shorter treatment period than urinary FSH, resulted in a higher number of oocytes retrieved when compared to urinary FSH. (See Table 1.)

Click on icon to see table/diagram/image

Differences between the 2 groups were statistically significant (p<0.05) for all criteria listed.
Pharmacokinetics: Following IV administration, follitropin α is distributed to the extracellular fluid space with an initial half-life (t½) of around 2 hrs and eliminated from the body with a terminal t½ of about 1 day. The steady state volume of distribution and total clearance are 10 L and 0.6 L/hr, respectively. One-eighth (1/8) of the follitropin α dose is excreted in the urine.
Following SC administration, the absolute bioavailability is about 70%. Following repeated administration, follitropin α accumulates 3-fold achieving a steady state within 3-4 days. In women whose endogenous gonadotropin secretion is suppressed, follitropin α has nevertheless been shown to effectively stimulate follicular development and steroidogenesis, despite unmeasurable LH levels.
Toxicology: Preclinical Safety Data: Nonclinical data reveal no special hazard for humans based on conventional studies of single- and repeated-dose toxicity and genotoxicity additional to that already stated in other sections.
In rabbits, the formulation (Gonal-f 1050 IU/1.75 mL vial) reconstituted with 0.9% benzyl alcohol and 0.9% benzyl alcohol alone, both resulted in a slight haemorrhage and subacute inflammation after single SC injection or mild inflammatory and degenerative changes after single IM injection respectively.
Impaired fertility has been reported in rats exposed to pharmacological doses of follitropin α (≥40 IU/kg/day) for extended periods, through reduced fecundity.
Given in high doses (≥5 IU/kg/day) follitropin α caused a decrease in the number of viable foetuses without being a teratogen and dystocia similar to that observed with urinary menopausal gonadotropin (hMG). However, since Gonal-f is not indicated in pregnancy, these data are of limited clinical relevance.
Indications/Uses
In Adult Women: Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomiphene citrate.
Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technology (ART) eg, in vitro fertilisation (IVF), gamete intrafallopian transfer and zygote intrafallopian transfer.
Dosage/Direction for Use
Treatment with Gonal-f should be initiated under the supervision of a physician experienced in the treatment of fertility disorders.
Pre-Filled Pen: Patients must be provided with the correct number of pens for their treatment course and educated to use the proper injection techniques.
The dose recommendations given for Gonal-f are those in use for urinary follicle stimulating hormone (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 medicinal products. It is advised to adhere to the recommended starting doses indicated as follows.
Comparative clinical studies have shown that on average patients require a lower cumulative dose and shorter treatment duration with Gonal-f compared with urinary FSH. Therefore, it is considered appropriate to give a lower total dose of Gonal-f than generally used for urinary FSH, not only in order to optimise follicular development but also to minimise the risk of unwanted ovarian hyperstimulation. (See Pharmacology: Pharmacodynamics under Actions.)
Bioequivalence has been demonstrated between equivalent doses of the monodose presentation and the multidose presentation of Gonal-f (pre-filled pen/vial 1050 IU/1.75 mL only).
The following table states the volume to be administered, to deliver the prescribed dose (Gonal-f 1050 IU/1.75 mL only): (See Table 2.)

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The next injection should be done at the same time the next day.
Women with Anovulation [Including Polycystic Ovarian Syndrome (PCOS)]: Gonal-f may be given as a course of daily injections. In menstruating women, treatment should commence within the first 7 days of the menstrual cycle.
A commonly used regimen commences at 75-150 IU FSH daily and is increased preferably by 37.5 or 75 IU at 7- or preferably 14-day intervals if necessary, to obtain an adequate but not excessive response. Treatment should be tailored to the individual patient's response as assessed by measuring follicle size by ultrasound and/or oestrogen secretion. The maximal daily dose is usually not higher than 225 IU FSH. If a patient fails to respond adequately after 4 weeks of treatment, that cycle should be abandoned and the patient should undergo further evaluation. After which, the patient may recommence treatment at a higher starting dose than in the abandoned cycle.
When an optimal response is obtained, a single injection of recombinant human choriogonadotropin α (r-hCG) 250 mcg or hGC 5000 up to 10,000 IU should be administered 24-48 hrs after the last Gonal-f injection. The patient is recommended to have coitus on the day of, and the day following hCG administration. Alternatively, intrauterine insemination (IUI) may be performed.
If an excessive response is obtained, treatment should be stopped and hCG withheld (see Precautions). Treatment should recommence in the next cycle at a dose lower than that of the previous cycle.
Women Undergoing Ovarian Stimulation for Multiple Follicular Development Prior to In Vitro Fertilisation (IVF) or Other Assisted Reproductive Technologies: A commonly used regimen for superovulation involves the administration of 150-225 IU of Gonal-f daily, commencing on days 2 or 3 of the cycle. Treatment is continued until adequate follicular development has been achieved (as assessed by monitoring of serum oestrogen concentrations and/or ultrasound examination), with the dose adjusted according to the patient's response, to usually not higher than 450 IU daily. In general, adequate follicular development is achieved on average by the 10th day of treatment (range 5-20 days).
A single injection of r-hCG 250 mcg or hCG 5000 up to 10,000 IU hCG is administered 24-48 hrs after the last Gonal-f injection to induce final follicular maturation.
Down-regulation with a gonadotropin-releasing hormone (GnRH) agonist or antagonist is now commonly used in order to suppress the endogenous luteinising hormone (LH) surge and to control tonic levels of LH. In a commonly used protocol, Gonal-f is started approximately 2 weeks after the start of agonist treatment, both being continued until adequate follicular development is achieved. For example, following 2 weeks of treatment with an agonist, Gonal-f 150-225 IU are administered for the first 7 days. The dose is then adjusted according to the ovarian response.
Overall experience with IVF indicates that in general, the treatment success rate remains stable during the first 4 attempts and gradually declines thereafter.
Special Populations: Renal or Hepatic Impairment: Safety, efficacy and pharmacokinetics of Gonal-f in patients with renal or hepatic impairment have not been established.
Children: There is no relevant use of Gonal-f in the paediatric population.
Elderly: There is no relevant use of Gonal-f in the elderly population. Safety and effectiveness of Gonal-f in elderly patients have not been established.
Administration: Vial: Gonal-f is intended for SC administration. The 1st injection of Gonal-f should be performed under direct medical supervision. Self-administration of Gonal-f should only be performed by patients who are well motivated, adequately trained and have access to expert advice. For instructions on the reconstitution and administration of Gonal-f powder and solvent for solution for injection (see Cautions for Usage).
Gonal-f pre-filled pen with multidose cartridge is intended for several injections, clear instructions should be provided to the patients to avoid misuse of the multidose presentation.
Due to a local reactivity to benzyl alcohol, the same site of injection should not be used on consecutive days. Individual reconstituted vials should be for single patient use only.
Overdosage
The effects of an overdose of Gonal-f are unknown, nevertheless, there is a possibility that ovarian hyperstimulation syndrome (OHSS) may occur (see Precautions).
Contraindications
Hypersensitivity to follitropin α, follicle stimulating hormone (FSH) or to any of the excipients of Gonal-f.
Tumours of the hypothalamus and pituitary gland; ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome (PCOS); gynaecological haemorrhages of unknown aetiology; ovarian, uterine or mammary carcinoma.
Gonal-f must not be used when an effective response cannot be obtained eg, primary ovarian failure; malformations of sexual organs incompatible with pregnancy; fibroid tumours of the uterus incompatible with pregnancy.
Use in lactation: Gonal-f is not indicated during lactation. During lactation, the secretion of prolactin can result in poor prognosis to ovarian stimulation.
Special Precautions
Gonal-f is a potent gonadotropic substance capable of causing mild to severe adverse reactions and should only be used by physicians who are thoroughly familiar with infertility problems and their management.
Gonadotropin therapy requires a certain time commitment by physicians and supportive health professionals, as well as the availability of appropriate monitoring facilities. In women, safe and effective use of Gonal-f calls for monitoring of ovarian response with ultrasound alone or preferably in combination with measurement of serum oestradiol levels on a regular basis. There may be a degree of interpatient variability in response to follicle stimulating hormone (FSH) administration with a poor response to FSH in some patients and exaggerated response in others. The lowest effective dose in relation to the treatment objective should be used.
Porphyria: Patients with porphyria or a family history of porphyria should be closely monitored during treatment with Gonal-f. Deterioration or a first appearance of this condition may require cessation of treatment.
Treatment in Women: Before starting treatment, the couple’s infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated. In particular, patients should be evaluated for hypothyroidism, adrenocortical deficiency, hyperprolactinemia and appropriate specific treatment given.
Patients undergoing stimulation of follicular growth, whether in the frame of treatment for anovulatory infertility or assisted reproductive technology (ART) procedures, may experience ovarian enlargement or develop hyperstimulation. Adherence to recommended Gonal-f dose and regimen of administration and careful monitoring of therapy will minimise the incidence of such events. For accurate interpretation of the indices of follicle development and maturation, the physician should be experienced in the interpretation of the relevant tests.
In clinical trials, an increase of the ovarian sensitivity to Gonal-f was shown when administered with lutropin α. If an FSH dose increase is deemed appropriate, dose adaptation should preferably be at 7- to 14-day intervals and preferably with 37.5-75 IU increments.
No direct comparison of Gonal-f/luteinising hormone (LH) versus hMG has been performed. Comparison with historical data suggests that the ovulation rate obtained with Gonal-f/LH is similar to that obtained with hMG.
Ovarian Hyperstimulation Syndrome (OHSS): A certain degree of ovarian enlargement is an expected effect of controlled ovarian stimulation. It is more commonly seen in women with polycystic ovarian syndrome (PCOS) and usually regresses without treatment.
In distinction to uncomplicated ovarian enlargement, OHSS is a condition that can manifest itself with increasing degrees of severity. It comprises marked ovarian enlargement, high serum sex steroids and an increase in vascular permeability which can result in an accumulation of fluid in the peritoneal, pleural and, rarely, in the pericardial cavities.
The following symptomatology may be observed in severe cases of OHSS: Abdominal pain and distension, severe ovarian enlargement, weight gain, dyspnoea, oliguria and gastrointestinal symptoms including nausea, vomiting and diarrhoea. Clinical evaluation may reveal hypovolaemia, haemoconcentration, electrolyte imbalances, ascites, haemoperitoneum, pleural effusions, hydrothorax or acute pulmonary distress. Very rarely, severe OHSS may be complicated by ovarian torsion or thromboembolic events eg, pulmonary embolism, ischaemic stroke or myocardial infarction.
Independent risk factors for developing OHSS include PCOS, high absolute or rapidly rising serum oestradiol levels (eg, >900 pg/mL or >3300 pmol/L in anovulation; >3000 pg/mL or >11,000 pmol/L in ART) and large number of developing ovarian follicles (eg, >3 follicles of ≥14 mm in diameter in anovulation; ≥20 follicles of ≥12 mm in diameter in ART), and large numbers of oocytes retrieved in ART cycles (vial only).
Adherence to recommended Gonal-f dosage and regimen of administration can minimise the risk of ovarian hyperstimulation (see Dosage & Administration and Adverse Reactions). Monitoring of stimulation cycles by ultrasound scans as well as oestradiol measurements are recommended to early identify risk factors.
There is evidence to suggest that hCG plays a key role in triggering OHSS and that the syndrome may be more severe and more protracted if pregnancy occurs. Therefore, if signs of ovarian hyperstimulation occur eg, serum oestradiol level >5500 pg/mL or >20,200 pmol/L and/or ≥40 follicles in total, it is recommended that hCG be withheld and the patient be advised to refrain from coitus or to use barrier contraceptive methods for at least 4 days. As OHSS may progress rapidly (within 24 hrs) or over several days to become a serious medical event. It most often occurs after hormonal treatment has been discontinued and reaches its maximum at about 7-10 days following treatment. Therefore, patients should be followed for at least 2 weeks after hCG administration.
In ART, aspiration of all follicles prior to ovulation may reduce the occurrence of hyperstimulation.
Mild or moderate OHSS usually resolves spontaneously. If severe OHSS occurs, it is recommended that gonadotropin treatment be stopped if still ongoing, and that the patient be hospitalised and appropriate therapy be started.
Multiple Pregnancy: In patients undergoing ovulation induction, the incidence of multiple pregnancy is increased compared with natural conception. The majority of multiple conceptions are twins. Multiple pregnancy, especially of high order, carries an increased risk of adverse maternal and perinatal outcomes.
To minimise the risk of multiple pregnancy, careful monitoring of ovarian response is recommended.
In patients undergoing ART procedures, the risk of multiple pregnancy is related mainly to the number of embryos replaced, their quality and the patient age.
The patients should be advised of the potential risk of multiple births before starting treatment.
Pregnancy Loss: The incidence of pregnancy loss by miscarriage or abortion is higher in patients undergoing stimulation of follicular growth for ovulation induction or ART than following natural conception.
Ectopic Pregnancy: Women with a history of tubal disease are at risk of ectopic pregnancy, whether the pregnancy is obtained by spontaneous conception or with fertility treatments. The prevalence of ectopic pregnancy after ART was reported to be higher than in the general population.
Reproductive System Neoplasms: 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 risk of these tumours in infertile women.
Congenital Malformation: The prevalence of congenital malformations after ART may be slightly higher than after spontaneous conceptions. This is thought to be due to differences in parental characteristics (eg, maternal age, sperm characteristics) and multiple pregnancies.
Thromboembolic Events: In women with recent or ongoing thromboembolic disease or women with generally recognised risk factors for thromboembolic events eg, personal or family history, treatment with gonadotropins may further increase the risk for aggravation or occurrence of such events. 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 carry an increased risk of thromboembolic events.
Effects on the Ability to Drive or Operate Machinery: Gonal-f is expected to have no or negligible influence on the ability to drive and use machines.
Impairment of Fertility: Gonal-f is indicated for use in infertility (see Indications).
Use in pregnancy: There is no indication for use of Gonal-f during pregnancy. Data on a limited number of exposed pregnancies (<300 pregnancy outcomes) indicate no malformative or feto/neonatal toxicity of follitropin α. No teratogenic effect has been observed in animal studies (see Toxicology: Preclinical Safety Study under Pharmacology under Actions).
In case of exposure during pregnancy, clinical data are not sufficient to exclude a teratogenic effect of Gonal-f.
Use In Pregnancy & Lactation
Use in pregnancy: There is no indication for use of Gonal-f during pregnancy. Data on a limited number of exposed pregnancies (<300 pregnancy outcomes) indicate no malformative or feto/neonatal toxicity of follitropin α. No teratogenic effect has been observed in animal studies (see Toxicology: Preclinical Safety Study under Pharmacology under Actions).
In case of exposure during pregnancy, clinical data are not sufficient to exclude a teratogenic effect of Gonal-f.
Use in lactation:
Gonal-f is not indicated during lactation. During lactation, the secretion of prolactin can result in poor prognosis to ovarian stimulation.
Adverse Reactions
The most commonly reported adverse reactions are headache, ovarian cysts and local injection site reactions (eg, pain, erythema, haematoma, swelling and/or irritation at the site of injection).
Mild or moderate ovarian hyperstimulation sydrome (OHSS) have been commonly reported and should be considered as an intrinsic risk of the stimulation procedure. Severe OHSS is uncommon (see Precautions).
Thromboembolism may occur very rarely, usually associated with severe OHSS (see Precautions).
The following definitions apply to the frequency terminology used hereafter: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000).
The following adverse reactions may be observed after administration of Gonal-f.
Treatment in Women: Immune System Disorders: Very Rare: Mild to severe hypersensitivity reactions including anaphylactic reactions and shock.
Respiratory, Thoracic and Mediastinal Disorders: Very Rare: Exacerbation or aggravation of asthma.
General Disorders and Administration Site Conditions: Very Common: Injection site reactions (eg, pain, erythema, haematoma, swelling and/or irritation at the site of injection).
Nervous System Disorders: Very Common: Headache.
Vascular Disorders: Very Rare: Thromboembolism, usually associated with severe OHSS (see Precautions).
Gastrointestinal Disorders: Common: Abdominal pain, distension and discomfort, nausea, vomiting, diarrhoea.
Reproductive System and Breast Disorders: Very Common: Ovarian cysts. Common: Mild or moderate OHSS (including associated symptomatology). Uncommon: Severe OHSS (including associated symptomatology) (see Precautions). Rare: Complication of severe OHSS.
Drug Interactions
Concomitant use of Gonal-f with other medicinal products used to stimulate ovulation [eg, human chorionic gonadotropin (hCG), clomiphene citrate] may potentiate the follicular response, whereas concurrent use of a GnRH agonist or antagonist to induce pituitary desensitisation may increase the dosage of Gonal-f needed to elicit an adequate ovarian response. No other clinically significant medicinal product interaction has been reported during Gonal-f therapy.
Vial 75 IU: Gonal-f must not be mixed with other medicinal products, in the same injection, except lutropin α for which studies have shown that co-administration does not significantly alter the activity, stability, pharmacokinetic nor pharmacodynamic properties of the active substances.
Incompatibilities: Vial: In the absence of compatibility studies, it must not be mixed with other medicinal products except those mentioned in Caution for Usage.
Pre-Filled Pen: Not applicable.
Caution For Usage
The pre-filled pen and reconstituted solution in vial should not be administered if it contains particles or is not clear.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
If Gonal-f to be is self-administered, the following instructions must be read carefully: Vial: Gonal-f 75 IU ang 1050 IU/1.75 mL must be reconstituted with the 1 mL and 2 mL solvent, respectively, provided before use.
Gonal-f 75 IU is for single use only. It may be co-reconstituted with lutropin α and co-administered as a single injection. In this case lutropin α should be reconstituted 1st and then used to reconstitute Gonal-f powder.
Gonal-f 1050 IU/1.75 mL must not be reconstituted with any other Gonal-f containers. The solvent pre-filled syringe provided should be used for reconstitution only and then disposed of in accordance with local requirements. A set of administration syringes graduated in FSH units is supplied in the Gonal-f multidose box. Alternatively, a 1 mL syringe, graduated in mL, with pre-fixed needle for SC administration could be used.
The injection is administered at the same time each day.
Instructions for Use and Handling: 1. Wash Hands and Find a Clean Area: It is important that the hands and the items used will be as clean as possible. A good place is a clean table or kitchen surface.
2. Assemble and Lay Out Everything that is Needed: The pre-filled syringe containing the solvent (the clear liquid), the vial containing Gonal-f (the white powder), and empty syringe for injection (Gonal-f 1050 IU/1.75 mL only). Not included in the pack: 2 alcohol swabs, 1 needle for reconstitution and a fine bore needle for SC injection (Gonal-f 75 IU only), a sharp container.
3. Preparing the Injection Solution: Remove the protective caps from the Gonal-f vial and from the solvent pre-filled syringe. Attach the needle for reconstitution to the pre-filled syringe and slowly inject all the solvent (1 mL and 2 mL for Gonal-f 75 IU and 1050 IU/1.75 mL, respectively) into the vial containing the powder. Swirl gently without removing the syringe. Do not shake.
After the powder has dissolved (which usually occurs immediately), check that the resulting solution is clear and does not contain any particles.
Gonal-f 75 IU: Turn the vial upside down and gently draw the solution back into the syringe by pulling the plunger.
Remove the syringe from the vial and set it down carefully. Do not touch the needle and do not allow the needle to touch any surface. (If >1 vial of Gonal-f have been prescribed, slowly re-inject the solution into another powder vial, until the prescribed number of powder vials have been dissolved in the solution. If lutropin α have been prescribed in addition to Gonal-f, the patient may also mix the 2 medicines as an alternative to injecting each product separately. After dissolving the lutropin α powder, draw the solution back into the syringe and re-inject it into the vial containing Gonal-f. Once the powder has dissolved, draw the solution back into the syringe. Inspect for particles as before, and do not use if the solution is not clear. Up to 3 containers of powder may be dissolved in 1 mL of solvent.)
Gonal-f 1050 IU: Remove the syringe from the vial and throw it away (put the protective cap to avoid injuries). This preparation contains several doses of Gonal-f. The patient will have to keep it several days and only draw the prescribed dose every day.
4. Preparing the Syringe for Injection: Gonal-f 75 IU: Change the needle for the fine bore needle.
Gonal-f 1050 IU: Take the syringe for injection and fill it with air by pulling the plunger to the correct dose in International Units (IU FSH). Insert the needle into the vial, turn the vial upside down and inject the air into the vial. Draw the prescribed dose of Gonal-f into the syringe for administration by pulling the plunger until it reaches the correct dose in IU FSH.
5. Removing Air Bubbles: If there are air bubbles in the syringe, hold the syringe with the needle pointing upwards and gently flick the syringe until all the air collects at the top. Push the plunger until the air bubbles are gone.
6. Injecting the Solution: Immediately inject the solution: The physician or nurse will have already advised as to where to inject (eg, tummy, front of thigh). To minimise skin irritation, select a different injection site each day. Clean the chosen skin area with an alcohol swab using a circular motion. Firmly pinch the skin together and insert the needle at a 45-90° angle using a dart-like motion. Inject under the skin by pushing gently the plunger, as taught. Do not inject directly into a vein. Take as much time needed to inject all the solution. Immediately withdraw the needle and clean the skin with an alcohol swab using a circular motion.
7. After the Injection: Dispose of All Used Items: Once the patient has finished the injection, immediately discard all needles used syringes and empty glass container safely, preferably in a sharp container.
Gonal-f 75 IU: Any unused solution must be discarded.
Gonal-f 1050 IU: Store the glass vial with the prepared solution in a safe place. The patient may still need the remaining dose. The prepared solution is for individual use only and must not be given to other patients. For further injections with the prepared solution, repeat steps 4 to 7.
Pre-Filled Pen: Always use Gonal-f exactly as the physician has instructed.
Gonal-f is intended to be given by injection just under the skin (subcutaneously). The pre-filled pen can be used for several injections.
Any unused solution must be discarded not later than 28 days after 1st opening. Gonal-f pre-filled pen is not designed to allow the cartridge to be removed.
Discard used needles immediately after injection.
Storage
Vial: Do not store above 25°C prior or after reconstitution. Do not freeze. Protect from light.
Shelf-Life: Vial: The reconstituted solution is stable for 28 days at or below 25°C.
Pre-filled Pen: Store in a refrigerator (2-8°C). Do not freeze.
Shelf-Life: Before opening and within its shelf-life, Gonal-f pre-filled pen may be removed from the refrigerator, without being refrigerated again, for up to 3 months at or below 25°C. Gonal pre-filled pen must be discarded if it has not been used after 3 months. Protect from light.
Once opened, Gonal-f pre-filled pen may be stored for a maximum of 28 days at or below 25°C. The patient should write on the Gonal-f pre-filled pen the day of the 1st use.
ATC Classification
G03GA05 - follitropin alfa ; Belongs to the class of gonadotropins. Used as ovulation stimulants.
Presentation/Packing
Inj [vial powder (white lyophilised pellet) and solvent (clear, colourless solution)] 75 IU (5.5 mcg) x 1's. 1050 IU/1.75 mL x 1's. Pre-filled pen (clear, colourless soln for inj) 300 IU/0.5 mL x 1's. 450 IU/0.75 mL x 1's. 900 IU/1.5 mL x 1's.
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