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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.
