SAIZEN® Somatropin (Rmc), Recombinant Human Growth Hormone Consumer Medicine Information

SAIZEN® Somatropin (rmc), recombinant human growth hormone Consumer Medicine Information

What is in this leaflet SAIZEN contains somatropin, which  You have diabetic retinopathy, an is the same as natural human growth eye disease caused by This leaflet answers some common hormone, but is made in a laboratory. complications of diabetes. questions about SAIZEN. If you are unsure as to why you  You have an acute, critical It does not contain all of the available have been prescribed SAIZEN, ask illness, e.g. following major information. your doctor. surgery, or hospitalisation for an Your doctor may have prescribed it accident, or severe breathing It does not take the place of talking to disorders. your doctor, nurse or pharmacist. for another reason. SAIZEN should not be used for All medicines have benefits and SAIZEN is available only on a doctor's prescription. growth promotion in children if their risks. Your doctor has weighed the bones have stopped growing. risks of using SAIZEN against the benefits it is expected to have for In children with CRI, treatment with you. Saizen must be discontinued at the Before you use time of renal transplantation. If you have any concerns about using this medicine, ask your SAIZEN Do not use SAIZEN after the doctor, nurse or pharmacist. expiry date printed on the pack or When you must not use it if the packaging is torn or shows Keep this information with the signs of tampering. medicine. Do not use SAIZEN if you have an allergy to: If it has expired or is damaged, return You may need to read it again later. it to your pharmacist for disposal.  somatropin If you are not sure whether you any of the other ingredients listed  should start using this medicine, at the end of this leaflet. What SAIZEN is used talk to your doctor. for Some of the symptoms of an allergic reaction may include: Before you start to use it SAIZEN is used to treat:  shortness of breath Tell your doctor if you have or  Growth failure in children who  wheezing or difficulty breathing have had any of the following medical conditions: have a deficiency of natural  swelling of the face, lips, tongue human growth hormone. or other parts of the body  Any type of cancer  Growth failure in girls who have  rash, itching or hives on the skin.  Diabetes mellitus a genetic condition called gonadal Do not use SAIZEN if: Somatropin may cause blood dysgenesis, often referred to as sugar levels to increase. If you Turner Syndrome, which may  You currently have any type of active cancer. are diabetic, your doctor will cause short stature. monitor your treatment and may  Growth hormone deficiency in All cancer treatments must be change your treatment for adults. finished before starting treatment diabetes. with SAIZEN.  Growth disturbance (growth  Thyroid disorders  You have an active brain lesion, retardation) in pre-pubertal Your doctor may prescribe children with chronic renal e.g. brain injury, abscess or tumour. another hormone to take if you insufficiency (CRI). are found to have developed a lack of thyroid hormone.

SAIZEN® 1 If you have not told your doctor skin) injection, preferably in the  Brain disorders about any of the above, tell evening. him/her before you start using Your doctor, nurse or pharmacist will If you have other hormone SAIZEN. deficiencies due to a previous instruct and assist you in learning the brain condition, your doctor techniques for preparing the needs to correct these before medicine and for self-injection. starting treatment with SAIZEN. Taking other medicines If your doctor has prescribed During treatment with SAIZEN, Tell your doctor if you are taking SAIZEN solution for injection, the your doctor will make regular any other medicines, including: medicine is provided in a cartridge with a dedicated autoinjector device examinations to check that your  All prescription medicines (provided separately). The original brain disorder has not including any hormone autoinjector device provided with returned. replacement (e.g. oral oestrogen) your medicine can either be Your SAIZEN treatment may  All medicines, vitamins, herbal electronic or hand-operated. need to be stopped if your brain supplements or natural therapies Follow the Instructions for Use condition returns. that you buy without a provided with the device carefully.  Scoliosis prescription from your pharmacy, supermarket, naturopath or health Do not attempt self-injection until Your doctor needs to monitor for food shop. you are sure of how to do it. any signs of scoliosis as rapid growth in any child can cause Tell your doctor if you are taking Do not inject SAIZEN if it contains progression of scoliosis. corticosteroids. particles and is not clear. Corticosteroids are used to treat  Liver or Kidney disorders Where to inject several illnesses including asthma, Your doctor may need to adjust allergies and rheumatoid arthritis. The best areas for injection are loose your SAIZEN treatment if you Corticosteroids might stop SAIZEN and soft (flabby) skin away from have any pre-existing condition from working well. joints and nerves. with your liver or kidney. If you are not sure if you are Use a different injection site each Treatment with SAIZEN in children taking any of these medicines, ask time to lessen the risk of damage to with CRI should only be started after your doctor or pharmacist. the fat and tissues under the skin. growth disturbance has been confirmed over a period of one year Your doctor and pharmacist have Prepare the injection site or upon your doctors discretion (for more information on medicines to be according to the instructions given example not less than 6 months in careful with or to avoid while using by your doctor, nurse or older children). SAIZEN. pharmacist. Children with CRI should be Suitable injection sites are: examined and monitored regularly  Outside of the upper arm for evidence of bone disease. It is  Abdomen (stomach) uncertain whether the bone disease How to use SAIZEN and its complications are affected by  Upper outer buttocks SAIZEN therapy should be carried growth hormone therapy. Assessment  Outside of the thigh. of the hip should be obtained prior to out under the regular guidance of a doctor who is experienced in the Do not inject into any areas in initiating therapy and at regular which you feel lumps, firm knots, intervals upon discretion of your diagnosis and management of growth depressions or pain. Talk to your doctor. hormone disorders. doctor, nurse or pharmacist if you Follow all directions given to you Tell your doctor if you are experience anything unusual when by your doctor, nurse or pregnant or breastfeeding, or plan injecting. pharmacist carefully. to become pregnant or start breastfeeding. They may differ from the How much to inject information contained in this leaflet. Your doctor will discuss with you the Your doctor will determine your dose risks and benefits of using SAIZEN How to inject and how frequently you inject (3, 6 if you are pregnant or breastfeeding. or 7 times a week). This depends on Also tell your doctor if you have SAIZEN is intended for you to inject why you are being treated with allergies to any other medicines, yourself by subcutaneous (under the SAIZEN, and your body surface area foods, preservatives, or dyes. or body weight.

SAIZEN® 2 If you forget to inject it Do not stop using SAIZEN without Tell your doctor immediately if telling your doctor. you notice any of the following: If you forget a treatment, contact your doctor, nurse or pharmacist Do not change the dose unless your  Symptoms of an allergic reaction for advice. doctor tells you to. which may include: Do not take a double dose to make  shortness of breath up for the dose that you missed.  wheezing or difficulty If you have trouble remembering Side effects breathing your injection schedule, ask your  swelling of the face, lips, pharmacist or nurse for some tips. Tell your doctor as soon as possible tongue or other parts of the if you do not feel well while using body If you inject too much SAIZEN.  rash, itching or hives on the Immediately contact your doctor SAIZEN helps most people needing skin. or the Poisons Information Centre treatment with growth hormone but it  Unexplained limp or hip/knee (telephone 131 126 in Australia or may have unwanted side effects in pain. 0800 764 755 in New Zealand) if some people. All medicines can  Strong or recurrent headache you are concerned that you or have side effects. Sometimes they associated with nausea, vomiting anyone else may have used too are serious, most of the time they are or sight disturbances. much SAIZEN. not. You may need medical Tell your doctor if you notice If you feel shaky or lightheaded, treatment if you get some side anything else that is making you contact your doctor immediately. effects. feel unwell. Injecting too much SAIZEN can lead Tell your doctor if you experience Other side effects not listed above to changes in blood sugar levels. any of the following side effects and they worry you: may also occur in some patients. Some side effects may only be found  Pain, numbness, redness or when your doctor does tests from swelling at the injection site. time to time to check your progress. While you are using  Muscle or joint pain or swelling, Do not be alarmed by this list of SAIZEN stiffness or pins and needles. possible side effects.  Headache Things you must do You may not experience any of them. These side effects are more common Keep all of your doctor's in adult patients. They often appear appointments so that your progress at the start of treatment and are can be monitored. usually temporary. After using SAIZEN Your doctor will also do tests from  Increased thirst, increased need to time to time to check for side effects. pass urine, dry mouth or skin Storage Before starting any new medicine, (symptoms of high blood sugar Keep SAIZEN injection solution in tell your doctor and pharmacist levels). the original package, in a that you are using SAIZEN.  Extreme tiredness, lethargy, refrigerator where the Tell any other doctors, dentists, muscle weakness or cramps temperature is between 2°C to 8°C and pharmacists who treat you (symptoms of low levels of (Refrigerate. Do not freeze) and it that you are using SAIZEN. thyroid hormone). is not exposed to light. If you become pregnant while This can be tested by your doctor Do NOT store it in the freezer. using SAIZEN, tell your doctor and if necessary he/she will SAIZEN injection solution is immediately. prescribe appropriate treatment. intended for multiple use in one

 Shaking and/or light-headedness patient only. Things you must not do (symptoms of low blood sugar levels). After first injection, store at 2°C to Do not use SAIZEN to treat any 8°C (Refrigerate. Do not freeze) for other complaints unless your  Tingling, numbness, weakness, or a maximum of 28 days, of which up doctor tells you to. pain in the fingers or hand, or to 7 days can be at or below 25°C. pain in your arm between hand Do not give your medicine to Protect from light. After first anyone else, even if they have the and elbow (symptom of pressure injection use within 28 days and same condition as you. on nerve around your wrist). discard any leftovers.

SAIZEN® 3 SAIZEN cartridge must be used with  Sodium hydroxide an autoinjector device.  Citric acid-anhydrous The autoinjector containing a cartridge of SAIZEN must be Manufacturer/Supplier stored in the device storage box. Sponsor in Australia: Disposal Merck Healthcare Pty Ltd Suite 1, Level 1, Building B Discard all sharps into a disposal unit. 11 Talavera Road Sharps are objects or devices having Macquarie Park NSW 2113 sharp points or edges capable of cutting or piercing the skin. For SAIZEN education and support, Ask your doctor or pharmacist call connections for growth on 1800 what to do if you have any 724 936. SAIZEN that has expired or is left over from your treatment. Sponsor in New Zealand: Healthcare Logistics 58 Richard Pearse Drive Product description Airport Oaks, Auckland What it looks like For any questions about SAIZEN, SAIZEN injection solution call Merck Serono Australia Medical SAIZEN injection solution is Information on + 61 2 8977 4100. presented in cartridges for multiple injections in one patient only. Australian Registration SAIZEN injection solution is Numbers registered in three presentations: 6 SAIZEN 6 mg: AUST R 166475 mg (in 1.03 mL), 12 mg (in 1.5 mL) and 20 mg (in 2.5 mL). SAIZEN 12 mg: AUST R 166478 Each presentation is supplied in SAIZEN 20 mg: AUST R 166479. boxes of 1 cartridge. Your doctor will decide which presentation is This leaflet was prepared in suitable for you or your child. October 2019. Ingredients ® Registered trademark SAIZEN injection solution A015-1019 Active Ingredient: SAIZEN 6 mg contains somatropin (rmc) 6 mg in 1.03 mL (5.83 mg/mL) SAIZEN 12 mg contains somatropin (rmc) 12 mg in 1.5 mL (8.00 mg/mL) SAIZEN 20 mg contains somatropin (rmc) 20 mg in 2.5 mL (8.00 mg/mL) Other Ingredients:  Sucrose  Poloxamer  Phenol  Water for injections

SAIZEN® 4