GONAL-F® (Follitropin Alfa [Rch]) Solution for Injection

GONAL-f® (follitropin alfa [rch]) solution for injection Consumer Medicine Information What is in this leaflet reproductive technologies (ART) • you have an unexplained such as in vitro fertilisation (IVF). ovarian cyst This leaflet answers some common In men • you have unexplained vaginal or questions about GONAL-f. GONAL-f is used in combination uterine bleeding It does not contain all the available with human chorionic • you have cancer of the ovaries, information. gonadotrophin (hCG) to stimulate uterus or breasts the production of sperm. It does not take the place of talking • your ovaries have failed to your doctor, nurse or pharmacist. Ask your doctor if you have any • you have fibroids in your uterus questions about why GONAL-f which would make pregnancy All medicines have risks and has been prescribed for you. impossible benefits. Your doctor has weighed Your doctor may have prescribed it For men the risks of you using GONAL-f for another reason. against the benefits it is expected to Do not use GONAL-f if: have for you. GONAL-f is available only on a • you have increased levels of doctor's prescription. If you have any concerns about gonadotrophins indicating using this medicine, ask your GONAL-f is not habit-forming. failure of the testes doctor, nurse or pharmacist. • your infertility is due to Keep this information with your disorders other than medicine. hypogonadotrophic You may need to read it again later. Before you are given hypogonadism (low levels of GONAL-f gonadotrophins) If you are not certain whether When you must not use these conditions apply to you, or What is GONAL-f used GONAL-f you are worried about anything on this list, tell your doctor. for Do not use GONAL-f if you have a history of allergy to any of the Do not give this medicine to a GONAL-f contains follitropin alfa, ingredients listed at the end of child or elderly person. which is similar to follicle this leaflet. Do not use this medicine after the stimulating hormone (FSH) found expiry date (month/year) on the Symptoms of an allergic reaction naturally in humans. packaging has passed, or if the may include: GONAL-f belongs to a class of packaging is torn or shows signs • shortness of breath of tampering. hormones called gonadotrophins. If your medicine has expired or is FSH is necessary for the growth and • wheezing or difficulty breathing damaged, return it to your development of egg cells (follicles) • swelling of the face, lips, tongue in women, and sperm production in or other parts of the body pharmacist / clinic for disposal. men. • rash, itching or hives on the If you are not sure whether you skin. should start using GONAL-f, talk In women to your doctor. GONAL-f can be used to bring Do not use GONAL-f if you have about the development of follicles tumours of the hypothalamus or pituitary gland. Before you start to use in women who are not ovulating GONAL-f and who have not responded to For women treatment with clomiphene citrate. Do not use GONAL-f if: Your doctor will assess you and your partner's fertility. This may GONAL-f is also used to stimulate • you are pregnant include tests for other medical the development of several follicles • you are breastfeeding conditions, which may interfere in women undergoing assisted • your ovaries are enlarged with your ability to become GONAL-f® Published by MIMS March 2020 1 pregnant. If necessary, other Compared to natural conception, the How GONAL-f is given medical conditions may be treated frequency of pregnancy loss is before starting infertility treatments higher in patients undergoing Follow all directions given to you including GONAL-f. treatments to stimulate follicle by your doctor, nurse or Tell your doctor if you have any growth for ovulation induction. pharmacist carefully. allergies to any foods, dyes, There may be a slightly increased They may differ from the preservatives or any other risk of birth defects in women using information contained in this leaflet. medicines. assisted reproductive technologies. Treatment with GONAL-f should Tell your doctor if you have or This may be due to increased be started under the supervision of a have had any of the following maternal age, genetic factors, specialist doctor experienced in medical conditions: multiple pregnancies or the fertility treatment. • disorders of the thyroid gland procedures. An effect of medicines GONAL-f is given as a course of • disorders of the adrenal glands used to induce ovulation has not daily injections. been excluded. • high prolactin levels in the You should have your injection at blood Tell your doctor if you or a family the same time each day. • porphyria or a family history of member have or have had signs of blood clots (e.g. pain, warmth, Do not use GONAL-f on anyone porphyria redness, numbness or tingling in else. For women the arm or leg). It is for your use only. Your doctor will assess if you have Treatment with GONAL-f and hCG any medical conditions which may increase the risk of blood clots How much to inject interfere with your ability to forming in your blood vessels. Your doctor will decide the correct become pregnant. Talk to your doctor about any dose of GONAL-f for you. Your Treatment with GONAL-f may concerns you may have before dose of GONAL-f may be adjusted increase your risk of developing a undergoing treatment or before depending on your individual you start using GONAL-f. condition called ovarian response to treatment. Please hyperstimulation syndrome For men consult your doctor if you are in any (OHSS). This is when the ovaries Elevated FSH blood levels are doubt. over-react to the hormonal indicative of testicular failure. Your The following is a guide to the treatment and become larger. doctor may ask you for a semen common dose. The most common symptom is analysis to assess your response to 1. Women who are not ovulating lower abdominal pain. During treatment. The common dose usually starts stimulation your doctor will Talk to your doctor about any at 75IU (5.46 microgram) daily. monitor your treatment by the use concerns you may have before The dose may be adjusted as of ultrasound and/or blood tests to you start using GONAL-f your treatment progresses. The help determine if you are likely to maximal daily dose is usually develop OHSS. If necessary your Taking other medicines not higher than 225 IU (16.5 doctor will delay or cancel your Tell your doctor if you are taking microgram). GONAL-f injection. You may also any other medicines, including: 2. Women undergoing assisted be advised to refrain from sexual • all prescription medicines reproductive technologies intercourse until the end of the The common dose usually starts cycle if this occurs. • any medicines, vitamins, herbal supplements or natural at 150 IU (10.92 microgram) Compared to natural conception, the therapies you buy without daily, commencing on day 2 or frequency of multiple pregnancies prescription from your 3 of the cycle. The dose may be and births is higher in patients pharmacy, supermarket, adjusted as your treatment receiving treatments that stimulate naturopath or health food progresses. The maximal daily follicle growth for ovulation shop dose is usually not higher than induction. The majority of these are 450 IU (32.76 microgram). Some medicines may be affected by twins. Your doctor will monitor GONAL-f or may affect how well it 3. Men with hypogonadotrophic your response to treatment to works. hypogonadism minimise the chance of multiple GONAL-f is commonly given pregnancies, because of the greater Your doctor has more information with hCG. The common dose risks they carry for mothers and on medicines to be careful with or usually starts at 150 IU (10.92 babies. avoid while using GONAL-f. microgram) three times a week. GONAL-f® Published by MIMS March 2020 2 How to inject If you forget to inject GONAL- • Stop using GONAL-f without f telling your doctor. GONAL-f is given as a • Change the dose unless your subcutaneous (under your skin) If you forget an injection or are not doctor tells you to. injection in the lower abdominal sure what to do, contact your doctor Changing your dose without area or thigh. or nurse immediately for advice. advising your doctor can GONAL-f is intended to be injected Do not inject a double dose on increase your risk of unwanted by you or your partner. any day. side effects or can prevent the Alternatively your doctor or a nurse Ask your doctor if you are not drug from working properly. may give you these injections. sure what to do or have trouble • Give this medicine to anyone remembering to inject your else, even if their symptoms If your doctor or nurse decides you medicine. can give the injections yourself, the seem similar to yours or if they have the same condition doctor or nurse will teach you the If you injected too much injection technique. as you. Immediately contact your doctor Do not self-inject until you are or the Poisons Information Things to be careful of sure of how to do it. Centre (In Australia telephone Read the Instructions for Use 131 126. In New Zealand Be careful driving or operating provided in the pack carefully telephone 0800 764 766) if you are machinery until you know how before commencing injections. concerned that you have given GONAL-f affects you. Your partner may be trained to give yourself too much or someone else the injection at home.

Load more