Gonal-f

Gonal-f

follitropin alfa

Manufacturer:

PT. Merck Tbk
Full Prescribing Info
Contents
Follitropin α (recombinant FSH).
Description
75 IU: Each vial contains 5.5 micrograms of follitropin alfa* equivalent to 75 IU. Each ml of the reconstituted solution contains 75 IU.
1,050 IU/1.75 mL: Each vial contains 77 micrograms of follitropin alfa* equivalent to 1050 IU. Each ml of the reconstituted solution contains 600 IU.
300 IU/0.5 mL: Each ml of the solution contains 600 IU of follitropin alfa*, (equivalent to 44 micrograms).
Each pre-filled multidose pen delivers 300 IU (equivalent to 22 micrograms) in 0.5 ml.
900 IU/1.5 mL: Each ml of the solution contains 600 IU of follitropin alfa*, (equivalent to 44 micrograms).
Each pre-filled multidose pen delivers 900 IU (equivalent to 66 micrograms) in 1.5 ml.
* 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 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 hCG.
Clinical efficacy and safety in women: In clinical trials, patients with severe FSH and 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 r-hFSH (follitropin alfa) and urinary FSH in ART (see table as follows) 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.)


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Differences between the 2 groups were statistically significant (p< 0.05) for all criteria listed.
Clinical efficacy and safety in men: In men deficient in FSH, GONAL-f administered concomitantly with hCG for at least 4 months induces spermatogenesis.
Pharmacokinetics: Following intravenous administration, follitropin alfa is distributed to the extracellular fluid space with an initial half-life of around 2 hours and eliminated from the body with a terminal half-life of about one day. The steady state volume of distribution and total clearance are 10 l and 0.6 l/h, respectively. One-eighth of the follitropin alfa dose is excreted in the urine.
Following subcutaneous administration, the absolute bioavailability is about 70 %. Following repeated administration, follitropin alfa accumulates 3-fold achieving a steady-state within 3-4 days. In women whose endogenous gonadotropin secretion is suppressed, follitropin alfa has nevertheless been shown to effectively stimulate follicular development and steroidogenesis, despite unmeasurable LH levels.
Pharmacokinetics in special populations: The pharmacokinetic data obtained from the Japanese studies were similar to those observed in the phase I studies performed with Caucasians.
Toxicology: Preclinical safety data: Non-clinical 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 of this package insert.
Impaired fertility has been reported in rats exposed to pharmacological doses of follitropin alfa (≥ 40 IU/kg/day) for extended periods, through reduced fecundity.
Given in high doses (≥ 5 IU/kg/day) follitropin alfa 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.
1,050 IU/1.75 mL: In rabbits, the formulation reconstituted with 0.9 % benzyl alcohol and 0.9 % benzyl alcohol alone, both resulted in a slight haemorrhage and subacute inflammation after single subcutaneous injection or mild inflammatory and degenerative changes after single intramuscular injection respectively.
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 technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer and zygote intra-fallopian transfer.
GONAL-f in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/l.
In adult men: GONAL-f is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human Chorionic Gonadotropin (hCG) therapy.
Dosage/Direction for Use
Treatment with GONAL-f should be initiated under the supervision of a physician experienced in the treatment of fertility disorders.
The dose 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 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.
300 IU/0.5 mL, 900 IU/1.5 mL and 1,050 IU/1.75 mL: Bioequivalence has been demonstrated between equivalent doses of the monodose presentation and the multidose presentation of GONAL-f.
1,050 IU/1.75 mL: The following table states the volume to be administered to deliver the prescribed dose: (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): 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 she may recommence treatment at a higher starting dose than in the abandoned cycle.
When an optimal response is obtained, a single injection of 250 micrograms recombinant human choriogonadotropin alfa (r-hCG) or 5,000 IU, up to 10,000 IU hCG should be administered 24-48 hours 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 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 tenth day of treatment (range 5 to 20 days).
A single injection of 250 micrograms r-hCG or 5,000 IU up to 10,000 IU hCG is administered 24-48 hours 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 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 two weeks of treatment with an agonist, 150-225 IU GONAL-f 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 four attempts and gradually declines thereafter.
Women with anovulation resulting from severe LH and FSH deficiency: In LH and FSH deficient women (hypogonadotrophic hypogonadism), the objective of GONAL-f therapy in association with lutropin alfa is to develop a single mature Graafian follicle from which the oocyte will be liberated after the administration of human chorionic gonadotropin (hCG). GONAL-f should begiven as a course of daily injections simultaneously with lutropin alfa. Since these patients are amenorrhoeic and have low endogenous oestrogen secretion, treatment can commence at any time.
A recommended regimen commences at 75 IU of lutropin alfa daily with 75-150 IU FSH. Treatment should be tailored to the individual patient's response as assessed by measuring follicle size by ultrasound and oestrogen response.
If an FSH dose increase is deemed appropriate, dose adaptation should preferably be after 7-14 day intervals and preferably by 37.5-75 IU increments. It may be acceptable to extend the duration of stimulation in any one cycle to up to 5 weeks.
When an optimal response is obtained, a single injection of 250 micrograms r-hCG or 5,000 IU up to 10,000 IU hCG should be administered 24-48 hours after the last GONAL-f and lutropin alfa injections. The patient is recommended to have coitus on the day of, and on the day following, hCG administration.
Alternatively, IUI may be performed.
Luteal phase support may be considered since lack of substances with luteotrophic activity (LH/hCG) after ovulation may lead to premature failure of the corpus luteum.
If an excessive response is obtained, treatment should be stopped and hCG withheld. Treatment should recommence in the next cycle at a dose of FSH lower than that of the previous cycle.
Men with hypogonadotrophic hypogonadism: GONAL-f should be given at a dose of 150 IU three times a week, concomitantly with hCG, for a minimum of 4 months. If after this period, the patient has not responded, the combination treatment may be continued; current clinical experience indicates that treatment for at least 18 months may be necessary to achieve spermatogenesis.
Special population: Elderly population: 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.
Renal or hepatic impairment: Safety, efficacy and pharmacokinetics of GONAL-f in patients with renal or hepatic impairment have not been established.
Paediatric population: There is no relevant use of GONAL-f in the paediatric population.
Method of administration: GONAL-f is intended for subcutaneous administration. The first 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.
75 IU: The injection site should be alternated daily.
1,050 IU/1.75 mL: As GONAL-f multidose 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.
300 IU/0.5 mL and 900 IU/1.5 mL: As 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.
Overdosage
The effects of an overdose of GONAL-f are unknown, nevertheless, there is a possibility that OHSS may occur (see Precautions).
Contraindications
Hypersensitivity to follitropin alfa or to any of the excipients.
Tumours of the hypothalamus or pituitary gland.
Ovarian enlargement or ovarian cyst not due topolycystic ovarian syndrome.
Gynaecological haemorrhages of unknown aetiology.
Ovarian, uterine or mammary carcinoma.
GONAL-f must not be used when an effective response cannot be obtained, such as: Primary ovarian failure.
Malformations of sexual organs incompatible with pregnancy.
Fibroid tumours of the uterus incompatible with pregnancy.
Primary testicular insufficiency.
Special Precautions
GONAL-f is a potent gonadotrophic 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 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 in both men and women.
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 as treatment for anovulatory infertility or 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 alfa. If an FSH dose increase is deemed appropriate, dose adaptation should preferably be at 7-14 day intervals and preferably with 37.5-75 IU increments.
No direct comparison of GONAL-f/LH versus human menopausal gonadotropin (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 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, abdominal 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 such as pulmonary embolism, ischaemic stroke or myocardial infarction.
Independent risk factors for developing OHSS include polycystic ovarian syndrome high absolute or rapidly rising serum oestradiol levels (e.g. > 900 pg/ml or > 3,300 pmol/l in anovulation; >3,000 pg/ml or > 11,000 pmol/l in ART) and large number of developing ovarian follicles (e.g. >3 follicles of ≥ 14 mm in diameter in anovulation; ≥ 20 follicles of ≥ 12 mm in diameter in ART).
Adherence to recommended GONAL-f dose 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 maybe more severe and more protracted if pregnancy occurs. Therefore, if signs of ovarian hyperstimulation occur such as serum oestradiol level > 5,500 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. OHSS may progress rapidly (within 24 hours) 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 seven to ten days following treatment. Therefore patients should be followed for at least two 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 treatment 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 (e.g. 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 thrombo-embolic events, such as 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 thrombo-embolic events.
Treatment in men: Elevated endogenous FSH levels are indicative of primary testicular failure. Such patients are unresponsive to GONAL-f/hCG therapy. GONAL-f should not be used when an effective response cannot be obtained.
Semen analysis is recommended 4 to 6 months after the beginning of treatment as part of the assessment of the response.
Sodium content: GONAL-f contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially "sodium-free".
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed.
Use In Pregnancy & Lactation
Pregnancy: There is no indication for use of GONAL-f during pregnancy. Data on a limited number of exposed pregnancies (less than 300 pregnancy outcomes) indicate no malformative or feto/neonatal toxicity of follitropin alfa.
No teratogenic effect has been observed in animal studies (see Pharmacology: Toxicology: Preclinical safety data under Actions).
In case of exposure during pregnancy, clinical data are not sufficient to exclude a teratogenic effect of GONAL-f.
Breastfeeding: GONAL-f is not indicated during breastfeeding. During lactation, the secretion of prolactin can result in a poor prognosis to ovarian stimulation.
Adverse Reactions
The most commonly reported adverse reactions are headache, ovarian cysts and local injection site reactions (e.g. pain, erythema, haematoma, swelling and/or irritation at the site of injection).
Mild or moderate ovarian hyperstimulation syndrome (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 (see Precautions).
The following definitions apply to the frequency terminology used hereafter: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥ 1/10,000 to < 1/1,000); Very rare (< 1/10,000).
Treatment in general: 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 (e.g. pain, erythema, haematoma, swelling and/or irritation at the site of injection).
Treatment in women: Nervous system disorders: Very common: Headache.
Vascular disorders: Very rare: Thromboembolism, (both in association with and separate from OHSS) (see Precautions).
Gastrointestinal disorders: Common: Abdominal pain, abdominal distension, abdominal 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.
Treatment in men: Skin and subcutaneous tissue disorders: Common: Acne.
Reproductive system and breast disorders: Common: Gynaecomastia, Varicocele.
Investigations: Common: Weight gain.
Drug Interactions
Applies only to single use presentation forms: GONAL-f must not be administered as a mixture with other medicinal products in the same injection, except lutropin alfa or combination of lutropin alfa and follitropin alfa for which studies have shown that co-administration dose not significantly alter the activity, stability, pharmacokinetics nor pharmacodynamic properties of the active substances.
Applies to all presentation forms: Concomitant use of GONAL-f with other medicinal products used to stimulate ovulation (e.g. hCG, clomiphene citrate) may potentiate the follicular response, whereas concurrent use of a GnRH agonist or antagonist to induce pituitary desensitisation may increase the dose of GONAL-f needed to elicit an adequate ovarian response. No other clinically significant medicinal product interaction has been reported during GONAL-f therapy.
Caution For Usage
Special precautions for disposal and other handling: 75 IU: For single use only.
GONAL-f must be reconstituted with the solvent before use.
GONAL-f may be co-reconstituted with lutropin alfa and co-administered as a single injection. In this case lutropin alfa should be reconstituted first and then used to reconstitute GONAL-f powder.
1,050 IU/1.75 mL: GONAL-f 1050 IU/1.75 ml (77 micrograms/1.75 ml) must be reconstituted with the 2 ml solvent provided before use.
GONAL-f 1050 IU/1.75 ml (77 micrograms/1.75 ml) preparation 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 subcutaneous administration could be used.
The reconstituted solution 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.
300 IU/0.5 mL and 900 IU/1.5 mL: The solution should not be administered if it contains particles or is not clear.
Any unused solution must be discarded not later than 28 days after first opening.
GONAL-f 300 IU/0.5 ml (22 micrograms/0.5 ml)/GONAL-f 900 IU/1.5 ml (66 micrograms/1.5 ml) is not designed to allow the cartridge to be removed. Discard used needles immediately after injection.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Incompatibilities: 75 IU and 1,050 IU/1.75 mL: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned previously.
300 IU/0.5 mL and 900 IU/1.5 mL: Not applicable.
Storage
Store in the original package, in order to protect from light.
75 IU: Do not store above 25°C.
1,050 IU/1.75 mL: Prior to or after reconstitution, do not store above 25°C. Do not freeze.
300 IU/0.5 mL and 900 IU/1.5 mL: Store in a refrigerator (2°C-8°C). Do not freeze.
Before opening and within its shelf life, the medicinal product may be removed from the refrigerator, without being refrigerated again, for up to 3 months at or below 25°C. The product must be discarded if it has not been used after 3 months.
Once opened, the medicinal product 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 first use.
Patient Counseling Information
IF YOU ADMINISTER GONAL-F TO YOURSELF, PLEASE READ THE FOLLOWING INSTRUCTIONS CAREFULLY: 75 IU: 1. Wash your hands and find a clean area: It is important that your hands and the items you use be as clean as possible.
A good place is a clean table or kitchen surface.
2. Get together everything you need and lay them out: 1 vial containing the solvent (the clear liquid); 1 vial containing GONAL-f (the white powder).
Not provided in the pack: 2 alcohol swabs, 1 empty syringe for injection, 1 needle for preparation, 1 fine bore needle for injection under the skin, 1 sharp container.
3. Preparing the solution: Remove the protective cap from the solvent vial.
Attach the needle for preparation to the empty syringe for injection.
Draw up some air into the syringe by pulling the plunger to approximately the 1 ml mark.
Insert the needle into the solvent vial and push the plunger to expel the air.
Turn the vial upside down and gently draw up all the solvent.
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 you have been prescribed more than one vial of GONAL-f, slowly re-inject the solution into another powder vial, until you have the prescribed number of powder vials dissolved in the solution. If you have been prescribed lutropin alfa in addition to GONAL-f, you may also mix the two medicines as an alternative to injecting each medicine separately. After dissolving the lutropin alfa 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, and do not use if the solution is not clear. Up to three containers of powder may be dissolved in 1 ml of solvent.)
4. Getting ready the syringe for injection: Change the needle for the fine bore needle.
Remove any air bubbles: If you see 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.
5. Injecting the dose: Immediately inject the solution: Your doctor or nurse will have already advised you where to inject (e.g. 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° to 90° angle using a dart-like motion.
Inject under the skin by pushing gently the plunger, as you were taught. Do not inject directly into a vein. Take as much time as you need to inject all the solution.
Immediately withdraw the needle and clean the skin with an alcohol swab using a circular motion.
6. After the injection: Dispose of all used items: Once you have finished your injection, immediately discard all needles and empty glass containers safely preferably in the sharp container. Any unused solution must be discarded.
1,050 IU/1.75 mL: 1. Wash your hands and find a clean area: It is important that your hands and the items you use be as clean as possible.
A good place is a clean table or kitchen surface.
2. Get together everything you need and lay them out: 2 alcohol swabs; The pre-filled syringe containing the solvent (the clear liquid); The vial containing GONAL-f (the white powder); An empty syringe for injection.
3. Preparing the solution: Remove the protective caps from the powder via land from the pre-filled syringe.
Take your pre-filled syringe, insert the needle into the powder vial and slowly inject all the solvent into the vial containing the powder.
Remove the syringe from the vial and throw it away (put the protective cap to avoid injuries).
This vial contains several doses of GONAL-f. You will have to keep it several days and only draw the prescribed dose every day.
4. Getting ready the syringe for injection: Swirl gently the vial of GONAL-f prepared in step 3, do not shake. Check that the solution is clear and does not contain any particles.
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 you see 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 dose: Immediately inject the solution:Your doctor or nurse will have already advised you where to inject (e.g. 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° to 90° angle using a dart-like motion.
Inject under the skin by pushing gently the plunger, as you were taught. Do not inject directly into a vein. Take as much time as you need 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: Once you have finished your injection, immediately discard the used syringes safely, preferably in a sharp container.
Store the glass vial with the prepared solution in a safe place. You may need it again. The prepared solution is for your use alone and must not be given to other patients.
For further injections with the prepared solution of GONAL-f, repeat steps 4. to 7. 300 IU/0.5 mL and 900 IU/1.5 mL: Before you start: 1. Wash your hands: It is important that your hands and the things you use to get your pen ready are as clean as possible.
2. Find a clean area: A good place is a clean table or kitchen surface.
3. Get together everything you need and lay them out: 2 alcohol swabs, the pre-filled pen, a needle.
Please note: The scale that can be seen through the liquid holder shows how much of the medicine is left in the pen. Do not use it to set the dose.
Getting a new pen ready for the first time: 1. Take off the pen cap.
2. Put on a needle: Take a new needle - only use the "single-use" needles supplied for the GONAL-f pre-filled pen.
Check that the peel-off seal on the outer needle cap is not damaged or loose. If it is damaged or loose, do not use the needle and get another. Throw away the unused needle with the outer needle cap still on, in your household rubbish.
Pull off the peel-off seal.
Hold the outer needle cap firmly.
Press the threaded tip of the pen into the outer needle cap and twist it clockwise.
Twist it until it is firmly fixed.
3. Getting the liquid in the pen ready for use (also called "priming" the pen): Set the dose arrow to 37.5 using the black dose selection dial - look for the small dot.
Pull out the injection button as far as it will go.
Take off the outer needle cap.
Then take off the inner needle cap and hold the pen with the needle pointing upwards.
Tap the liquid holder gently with your finger. This lets any air bubbles rise up towards the needle.
With the needle still pointing upwards, press the injection button fully. A drop of liquid will appear at the tip of the needle; this shows that your pen is ready for injection. This liquid at the needle tip is the "over-fill" from the pen.
If no liquid appears the first time, pull out the injection button as far as it will go and press the button again until a drop of liquid appears.
Setting the dose: 1. Set the dose you need by turning the black dose dial in either direction: Turn the dial until the arrow is pointing to the dose you need. The black dial lets you set the dose in steps of 37.5 IU. The smallest dose is 37.5 IU and the largest is 300 IU.
Important: carefully check the dose dial before moving on to the next step. This is because the dose cannot be changed after you have pulled out the injection button.
If you realise that you have set and loaded a wrong dose, do not inject it. Discard the wrong dose in the sink and set the dose again.
2. Once you have set your dose, load the dose by pulling the injection button out as far as it will go: Take care to pull the button straight and not to twist it out - twisting it might change the dose which you have set.
When the injection button is pulled out, the loaded dose is shown on the red dose control scale which appears. It is shown by the last mark (flat arrow).
Important: check the red dose control scale on the injection button to make sure that the full dose has been loaded.
If the loaded dose is lower than the set dose, then there was not enough medicine left in your pen for this dose. If this happens, follow the instructions given at the "More information about the red dose control scale" as follows.
If the same dose is required every time, then the dose arrow can be left pointing at the same position on the dose dial.
Injecting the dose: 1. Choose the place to give the injection: where your doctor or nurse has told you (e.g. tummy, front of thigh). To minimise skin irritation, select a different injection site each day.
2. Clean the skin where the injection is going by wiping with an alcohol swab.
3. Inject the dose as you were told by your doctor or nurse: Put the needle into the skin and press the injection button as far as it will go.
Check that the grey marker on the injection button is no longer visible. This confirms that the dose has been given. You must keep the needle in the skin with the injection button pressed down for at least 10 seconds. After 10 seconds, keep the injection button pressed down, and take the needle out of the skin.
After the injection: 1. Taking off the needle: Take off the needle after each injection. Hold the pen firmly by the liquid holder. Carefully put back the outer needle cap onto the needle. Then grip the outer needle cap and unscrew the needle - do this by turning anticlockwise. Throw away the used needle with outer needle cap on, in your household rubbish. Now put the pen cap back onto the pen.
2. Storing the pen: First take off the needle and put back on the pen cap - as described previously.
Then store the pen in a safe place. It is best to put it back into its original package.
When the pen is empty, throw it away in your household rubbish.
More information about the red dose control scale: When the pen is nearly empty, there may not be enough left for your last dose from that pen. The red dose control scale on the injection button is for you to check whether there is enough for your last dose from the pen. It can only be pulled out as far as the mark (flat arrow) showing the amount of medicine left in the pen.
If the loaded dose is not enough to complete your injection, you can do one of two things: Either inject the part dose - what is left in the pen. If you do this, write down straight away how much you have injected. Then give the rest of your dose from a new pen. Or throw away the pen and inject the full dose using a new pen.
ATC Classification
G03GA05 - follitropin alfa ; Belongs to the class of gonadotropins. Used as ovulation stimulants.
Presentation/Packing
Inj (white, lyophilised pellet in vial) 75 IU x 1's. Multidose (powd and solvent for soln for inj) 1,050 IU/1.75 mL x 1's. Pen (clear, colourless soln in pre-filled pen) 300 IU/0.5 mL x 1's. 900 IU/1.5 mL x 1's.
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