Gonal-F

Gonal-F

follitropin alfa

Manufacturer:

Merck

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Follitropin alfa.
Description
Follitropin alfa 600 IU/mL is equivalent to 44 mcg/mL.
Powder and Solvent for Solution for Injection: Each vial contains follitropin alfa 75 IU (equivalent 5.5 mcg) and 450 IU (equivalent to 33 mcg).
The pH of the solution is 6.5-7.5. Follitropin alfa is recombinant human follicle-stimulating hormone (r-FSH) produced in Chinese hamster ovary (CHO) cell by recombinant DNA technology.
Pre-filled pen: Each ml of the solution contains 600 IU of follitropin alfa*, (equivalent to 44 micrograms).
Each 300IU pre-filled multidose pen delivers 300 IU (equivalent to 22 micrograms) in 0.5 ml.
Each 450IU pre-filled multidose pen delivers 450 IU (equivalent to 33 micrograms) in 0.75 ml.
Each 900IU pre-filled multidose pen delivers 900 IU (equivalent to 66 micrograms) in 1.0 ml.
* recombinant human follicle stimulating hormone (r-hFSH) produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
The pH of the solution is 6.7-7.3.
Excipients/Inactive Ingredients: Pre-filled pen: Poloxamer 188, Sucrose, Methionine, Sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, m-Cresol, Concentrated phosphoric acid, Sodium hydroxide, Water for injections.
Action
Pharmacotherapeutic group: Sex hormones and modulators of 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.)

Click on icon to see table/diagram/image

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/hr, 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 gonadotrophin secretion is suppressed, follitropin alfa has nevertheless been shown to effectively stimulate follicular development and steroidogenesis, despite unmeasurable LH levels.
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 stated in other sections of this monograph.
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.
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.
Dosage/Direction for Use
Treatment with GONAL-f should be initiated under the supervision of a physician experienced in the treatment of fertility disorders.
Patients must be provided with the correct number of pens for their treatment course and educated to use the proper injection techniques.
Posology: 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 required 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 optimize 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.
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.
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: Powder and Solvent for Solution for Injection: Step 1: Mixing (reconstituting) the vial containing Gonal-F.
1. Wash the hands with soap and water.
2. Prepare a clean, flat surface for mixing the Gonal-F vials. Place alcohol wipes on the surface within easy reach.
3. Using the thumb, flip off the plastic cap of the Gonal-F vial(s).
4. Wipe the top of the vial stopper with an alcohol wipe.
5. Remove the wrapping from the mixing needle.
6. Carefully remove the protective cap off the pre-filled syringe labeled "sterile water for Injection, USP". Twist the mixing needle on the pre-filled syringe until it is tightened and remove the needle cap.
7. Position the needle of the syringe of water in a straight, upright position over the marked center circle of the rubber stopper on the vial of Gonal-F powder. Keep the needle at a 90° angle to the rubber stopper as inserted it through the center circle or it may be difficult to depress the plunger. Slowly inject the water into the vial by depressing the syringe plunger.
8. Leave the needle and syringe in the vial. Gently rotate the vial between the fingers until the powder is dissolved. Do not shake the vial. If bubbles appear, wait a few moments for the bubbles to settle. The liquid drug should be clear.
9. Draw the total contents of the vial into the syringe. If necessary, invert the vial and pull back the needle as far as needed to withdraw the entire contents of the vial. Remove the needle and syringe containing the solution from the vial.
10. If >1 vial of powder medication is to be dissolved repeat steps 3, 4 and 7-9. A new alcohol wipe should be used to clean each vial. Use the same needle and syringe now containing reconstituted solution to reconstitute the additional vial(s). (Discard any other unused syringes of water for injection.)
11. Gently pull the plunger back to allow a small air space. Carefully recap the needle. Twist off the mixing needle from the syringe and discard safely.
Step 2: Determining the dose on the injection syringe.
The physician will instruct a specific dose of Gonal-F to be taking.
Step 3: Preparing the dose.
12. Remove the wrapping from the injection needle. Twist the injection needle on the syringe and remove the needle cap.
13. Invert the syringe with the needle for injection facing up toward the ceiling, gently tap the syringe, and push the plunger until all air bubbles have been expelled. This step may need to be repeated if all air bubbles are not expelled. Slightly depress the plunger until a drop of liquid is released from the tip of the needle.
14. Recap the needle for injection while preparing the injection site. Carefully lay the syringe on a flat, clean surface. Do not touch the needle or allow the needle to touch any surface.
Now, it is ready to prepare for the injection.
Step 4: Injecting the dose.
The physician, nurse or pharmacist should provide the patient with injection training. Inject the prescribed dose as directed. Usual injection sites include the skin on the stomach, upper arm or upper leg. Change the injection location each day to minimize discomfort.
15. All needles should be disposed of in an appropriate needle disposal container as directed by the physician.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Pre-Filled Pen: 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.
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.
For instructions on the administration with the pre-filled pen, see HOW TO USE GONAL-f under Cautions for Usage.
Overdosage
The effects of an overdose of GONAL-f are unknown, nevertheless, there is a possibility that OHSS to may occur (see Precautions).
Contraindications
Hypersensitivity to the active substance follitropin alfa, FSH or to any of the excipients; tumours of the hypothalamus or pituitary gland; ovarian enlargement or ovarian cyst not due to polycystic 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.
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.
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, hyper-prolactinemia and appropriate specific treatment given.
Patients undergoing stimulation of follicular growth, whether as treatment for anovulatory infertility or for 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 gonadotrophin (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 event 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 measurement are recommended to early identity 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 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 method 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 discontinued 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 as 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 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 treatment regimens for infertility treatment. It is not yet established whether or not treatment with gonadotropins increases the risk of these tumors 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 thromboembolic 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 thromboembolic events.
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: GONAL-f is expected to have no or negligible influence on the ability to drive and use machines.
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.
Fertility: GONAL-f is indicated for use in infertility (see Indications/Uses).
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) has 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 women: Immune system disorders: Very rare: Mild to severe hypersensitivity reactions including anaphylactic reactions and shock.
Nervous system disorders: Very common: Headache.
Vascular disorders: Very rare: Thromboembolism (both in association and separate from OHSS) (see Precautions).
Respiratory, thoracic and mediastinal disorders: Very rare: Exacerbation or aggravation of asthma.
Gastrointestinal disorders: Common: Abdominal pain, abdominal distension, abdominal discomfort, nausea, vomiting, diarrhoea.
Reproductive system and breast disorders: Very common: Ovarian cysts.
Common: Mild to moderate OHSS (including associated symptomatology).
Uncommon: Severe OHSS (including associated symptomatology).
Rare: Complication of severe OHSS.
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).
Drug Interactions
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
Incompatibilities: Not applicable.
Special precautions for disposal and other handling: See the HOW TO USE GONAL-f as follows.
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) 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.
Pre-filled pen: HOW TO USE GONAL-f: Always use GONAL-f exactly as the doctor told. Check with the doctor or pharmacist if  not sure.
Using this medicine: GONAL-f is intended to be given by injection just under the skin (subcutaneously). The pre-filled pen can be used for several injections.
The first injection of GONAL-f should be given under supervision of the doctor.
The doctor or nurse will show how to use the GONAL-f pre-filled pen to inject the medicine.
If administering GONAL-f to oneself, please carefully read and follow the this section.
How much to use: The doctor will decide how much medicine to take and how often.
The doses described as follows are stated in International Units (IU) and millilitres (ml).
Women: If not ovulating and have irregular or no periods: GONAL-f is usually given every day.
If having irregular periods, start using GONAL-f within the first 7 days of the menstrual cycle. If not having periods start using the medicine on any convenient day.
The usual starting dose of GONAL-f is 75 to 150 IU (0.12 to 0.24 ml) each day.
The dose of GONAL-f may be increased every 7 or every 14 days by 37.5 to 75 IU, until getting the desired response.
The maximum daily dose of GONAL-f is usually not higher than 225 IU (0.36 ml).
When getting the desired response, patient will be given a single injection of 250 micrograms of "recombinant hCG" (r-hCG, an hCG made in a laboratory by a special DNA technique), or 5,000 to 10,000 IU of hCG, 24 to 48 hours after the last GONAL-f injection. The best time to have sex is on the day of the hCG injection and the day after.
If the doctor cannot see a desired response after 4 weeks, that treatment cycle with GONAL-f should be stopped. For the following treatment cycle, the doctor will give a higher starting dose of GONAL-f than before.
If the body responds too strongly, the treatment will be stopped and patient will not be given any hCG (see section 2, OHSS). For the following cycle, the doctor will give a lower dose of GONAL-f than before.
If there is a need to develop several eggs for collection prior to any assisted reproductive technology: The usual starting dose of GONAL-f is 150 to 225 IU (0.24 to 0.36 ml) each day, from day 2 or 3 of the treatment cycle.
GONAL-f dose may be increased, depending on the response. The maximum daily dose is 450 IU (0.72 ml).
Treatment is continued until the eggs have developed to a desired point. This usually takes about 10 days but can take any time between 5 and 20 days. The doctor will use blood tests and/or an ultrasound machine to check when this is.
When the eggs are ready, patient will be given a single injection of 250 micrograms "recombinant hCG" (r-hCG, an hCG made in a laboratory by a special recombinant DNA technique), or 5,000 IU to 10,000 IU of hCG, 24 to 48 hours after the last GONAL-f injection. This gets the eggs ready for collection.
In other cases, the doctor may first stop the patient from ovulating by using a gonadotropin-releasing hormone (GnRH) agonist or antagonist. Then GONAL-f is started approximately two weeks after start of agonist treatment. The GONAL-f and GnRH agonist are then both given until the follicles develop as desired. For example, after two weeks of GnRH agonist treatment, 150 to 225 IU GONAL-f is administered for 7 days. The dose is then adjusted according to the ovarian response. When GnRH antagonist is used, it is administered from the 5th or 6th day of GONAL-f treatment and continued until ovulation induction.
Storage
Powder and Solvent for Solution for Injection: Do not store above 25°C. Protect from light. After reconstitution, do not store above 25°C. Do not freeze.
Pre-filled pen: 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.
Store in the original package, in order to protect from light.
For in-use storage conditions: 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.
ATC Classification
G03GA05 - follitropin alfa ; Belongs to the class of gonadotropins. Used as ovulation stimulants.
Presentation/Packing
Powd for inj (multi-dose vial) 450 IU/0.75 mL x 1's. (vial) 75 IU/mL (5.5 mcg) x 1's. Pre-filled pen (clear colourless solution) 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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