Saizen Click Easy - Consumer Medicine Information
|Manufacture:||EMD Serono, Inc|
|Condition:||Adult Human Growth Hormone Deficiency, Chronic Renal Failure (Renal Failure), Pediatric Growth Hormone Deficiency, Prader-Willi Syndrome, Turner's Syndrome|
|Class:||Growth hormones, Hormones|
|Form:||Liquid solution, Subcutaneous (SC)|
|Ingredients:||somatropin, sucrose, phosphoric acid and sodium hydroxide.|
8.8 mg (8.0 mg/mL) click.easy, 8.8 mg (5.83 mg/mL) click.easy, 4 mg (1.5 mg/mL) click.easy
(Somatropin for injection)
About This Medication
What is Saizen
SAIZEN contains somatropin which is identical to growth hormone found naturally in humans but is made in laboratories.
What is Saizen Used For
SAIZEN is indicated for:
- the long term treatment of patients with growth failure due to inadequate secretion of growth hormone.
- the treatment of short stature in girls with gonadal dysgenesis (Turner's syndrome) when epiphyses are not closed.
- the treatment of growth failure in children due to Chronic Renal Failure.
- growth disturbance (current height Standard Deviation Score (SDS) < -2) in short children born small for gestational age (SGA) with a birth weight and/or length below -2 standard deviations (SD), who failed to show catch-up growth (Height Velocity SDS < 0 during the last year) by 2 years of age or later.
- replacement therapy in adult patients with acquired or idiopathic growth hormone deficiency (GHD) as diagnosed by a single dynamic test for growth hormone deficiency (peak GH ≤ 5 µg/L).
How Saizen Works
SAIZEN provides an external supply of human growth hormone for those patients lacking the ability to produce adequate amounts naturally. SAIZEN has many effects on growth and metabolism in patients undergoing therapy:
- stimulates linear growth (growth rate)
- measurable increase in growth (body length) from effects on cartilaginous growth areas of the long bones.
- cellular growth as demonstrated by an increase in the muscular, visceral and red cell mass
- effect on carbohydrate metabolism, including glucose tolerance and insulin levels
- effect on protein metabolism. SAIZEN is an anabolic agent that stimulates intracellular transport of amino acids, net retention of nitrogen and protein synthesis.
- lipid metabolism is also affected when intracellular lipolysis is stimulated, thus increasing the plasma concentration of free fatty acids and stimulating the oxidation of fatty acids.
- connective tissue metabolism is affected by stimulation the synthesis of chondroitin sulfate and collagen as well as the urinary excretion of hydroxyproline
- affects mineral metabolism by inducing the retention of phosphorus and potassium and to a lesser degree sodium.
- also increased are the intestinal absorption of calcium, renal tubular reabsorption of phosphorus with increased serum and inorganic phosphate.
How Long is Saizen Therapy
Length of time on SAIZEN therapy will vary for every patient. This should be discussed with the patient, parents and doctor throughout the therapy.
Treatment with SAIZEN for growth in children should be discontinued when the patient has reached satisfactory adult height, or the epiphyses (bones) are fused.
When Should Saizen not be Used
SAIZEN should not be used in the following cases:
- Acute critical illness with complications following cardiac surgery, abdominal surgery, multiple trauma or acute respiratory failure. Clinical studies demonstrated that high doses of another somatropin, were associated with a significantly increased morbidity and mortality in those patients.
- In patients with closed epiphyses, SAIZEN is ineffective for growth. Treatment with SAIZEN should be discontinued when the patient has reached satisfactory adult height, or the epiphyses are fused.
- In the presence of progression of an underlying intracranial tumour. An intracranial tumour should be inactive prior to instituting therapy, and SAIZEN should be discontinued if there is evidence of recurrent activity. Patients should be examined frequently for progression or recurrence of the underlying disease process.
- Patients known to be hypersensitive to somatropin and any of the excipients in powder for solution for injection or the diluent.
- Active neoplasia (either newly diagnosed or recurrent). Any pre-existing neoplasia should be inactive.
- Proliferative or preproliferative diabetic retinopathy.
- In patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment. Unless patients with Prader-Willi syndrome also have a diagnosis of growth hormone deficiency, SAIZEN is not indicated for long-term treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Will syndrome.
SAIZEN treatment should be discontinued in critically ill patients.
SAIZEN is not recommended for use during pregnancy and lactation.
In children with chronic renal disease, treatment with somatropin must be discontinued at the time of renal transplantation.
The Nonmedicinal Ingredients of Saizen
Sucrose, phosphoric acid and sodium hydroxide.
What Dosage Forms of Saizen are Available
SAIZEN comes as a powder in a vial along with a cartridge of diluent pre-assembled in a reconstitution device (click.easy). There are three presentations which are available:
- SAIZEN 8.8 mg with 1.10 mL of 0.3% metacresol in water for injection. Final concentration that will be injected is 8.0 mg/mL.
- SAIZEN 8.8 mg with 1.51 mL of 0.3% metacresol in water for injection. Final concentration that will be injected is 5.83 mg/mL.
- SAIZEN 4 mg with 2.66 mL of 0.3% metacresol in water for injection. Final concentration that will be injected is 1.5 mg/mL.
Note: SAIZEN is also available in 1.33 mg, 3.33 mg, 5 mg and 8.8 mg vials, each with vials of diluent, instead of cartridge and without the reconstitution device.
Warnings and Precautions
- SAIZEN therapy should be carried out under the regular guidance of a doctor who is experienced in the diagnosis and management of patients with growth hormone deficiency.
- Shortly after SAIZEN is given, the patient may feel shaky or light-headed due to low blood sugar levels. The feelings will quickly disappear. The patient’s blood sugar levels may then rise above normal 2-4 hours after administration. Since treatment with growth hormone (GH) can alter how your body handles sugar, the patient’s levels will be tested regularly by a health care professional.
- If the patient is diabetic or a member of the family has diabetes, the doctor will monitor closely the treatment with SAIZEN and may change the treatment for diabetes. The doctor may additionally prescribe another hormone if the patient is found to have developed a lack of thyroid hormone.
- If in the past the patient has had a condition affecting the brain e.g. a tumour, the doctor will examine the patient regularly to check that this has not come back again. Please note that there is no evidence to suggest that the use of SAIZEN increases the changes of such conditions coming back.
- If the patient suffers from a bad or recurrent headache, or from problems with eyesight and vomiting or feeling sick, contact your doctor immediately. Very rarely, a swelling of the brain may develop and the doctor may want to examine the patient’s eyes to look for any sign of this. In this case it may be necessary to stop the growth hormone treatment, although the treatment may be re-started at a later date. If the symptoms of brain swelling recur, treatment with SAIZEN should be discontinued.
- When the medicine is injected into the same place over a long time, it can cause damage to this area. It is therefore important to keep changing the injection site. The doctor or nurse can speak to you about which parts of the body should be used.
- Some children with growth hormone deficiency have developed leukemia, whether or not they have received treatment with growth hormone, and might be at a slightly higher risk of developing leukemia than non-growth hormone deficient children. No cause and effect relationship with growth hormone treatment have been proven.
- Hip problems may occur more commonly in children with hormone or kidney problems. If the patient has chronic renal failure (which can occur when kidneys are damaged) he or she should be examined periodically for evidence of bone disease. It is uncertain whether the bone disease in children with hormone or kidney problems is affected by growth hormone therapy. X-rays of the hip should be obtained prior to initiating therapy. If the patient develops a limp or complains of hip or knee pain while being treated with SAIZEN, notify your doctor.
- In children with chronic renal failure, treatment should be discontinued at the time of renal transplant.
- Small for Gestational Age (SGA) patients: SGA means small for gestational age. Gestational age is the time a baby is in its mother’s womb. SGA refers to a baby who is smaller than most babies of the same gestational age. Patients who are small for their gestational age have a greater chance of developing diabetes. It is important to have your fasting insulin and blood glucose levels checked before and during treatment with SAIZEN.
It is usually safe to take other medicines. However, if the patient is taking CORTICOSTEROIDS, it is necessary to tell the doctor or nurse. These medicines are used to treat several illnesses including asthma, allergies, kidney rejection and rheumatoid arthritis. These medicines might stop your growth treatment from working.
You should tell the doctor or nurse about all medicines that the patient is taking, even those obtained without a doctor’s prescription.
Proper Use of This Medication
SAIZEN should be injected preferably in the evening.
The dosage and administration schedule of SAIZEN will be adapted to the patient’s body weight by the doctor according to the following scheme:
- Growth failure due to inadequate endogenous growth hormone secretion: It is recommended that SAIZEN be administered subcutaneously at a dose of 0.2 mg/kg body weight per week. The dosage can be increased to 0.27 mg/kg per week if there is insufficient response to treatment.
- Growth failure in girls due to gonadal dysgenesis (Turner’s syndrome):It is recommended that SAIZEN be administered subcutaneously at a dose of 0.375 mg/kg body weight per week (optimal dosing 0.32 – 0.375 mg/kg/week). Concomitant therapy with non-androgenic anabolic steroids in patients with Turner’s syndrome can enhance the growth response.
- Growth failure in children with Chronic Renal Failure : It is recommended that SAIZEN be administered subcutaneously at a dose of 0.35 mg/kg body weight per week.
- Growth disturbance in short children born small for gestational age (SGA):
It is recommended that SAIZEN be administered subcutaneously at a dose of 0.47 mg/kg body weight/week.
- Adult Growth Hormone Deficiency:
It is recommended that SAIZEN be administered subcutaneously at a dose of 0.005 mg/kg/day at the start of therapy. This dose may be increased after 4 weeks to 0.01 mg/kg/day if well tolerated. The minimum effective dose should be used and dose requirements may decline with age.
Preparing Saizen For Administration
The product (powder in vial) must be reconstituted with the bacteriostatic diluent (0.3%(w/v) metacresol in water for injections) provided using the click.easy reconstitution device.
The reconstitution solution is intended for subcutaneous administration (under the skin) and should be clear with no particles. If the solution contains particles, it must not be injected.
Patients should be thoroughly instructed in the reconstitution procedures. For young children, the reconstitution process should be supervised by an adult.
For reconstitution of SAIZEN click.easy please read the following instruction carefully.
- Make sure the click.easy reconstitution device is complete by checking that the SAIZEN vial (a), the sterile transfer cannula (b), and the diluent cartridge (c) are present.
- Check that both the tamper evident seals on the vial container (d) and on the cap (e) are not broken. (picture of tamper evident seal magnified). Do not use the device if the tamper evident seal on the cap is broken, and return it to your pharmacist or doctor.
How to Reconstitute
- Wash your hands with soap and water.
- Find a clean area and lay out the elements needed for the preparation of the medication and the injection
- Place the click.easy reconstitution device vertically on a flat surface with the vial of powder at the bottom and the cap facing upward.
- Push firmly on the collar of the base until the vial container is completely inside the main body.
- Turn the cap clockwise until the green button (f) is visible. You will hear a ‘click’ (Note: the tamper evident seal on the cap is now broken).
- Holding the click.easy device on a flat surface, push the cap down very slowly and firmly until it will go no further to transfer the diluent from the cartridge into the vial.
- Check that all the diluent has been transferred into the vial. Dissolve the powder with the diluent by gently swirling the click.easy (Note: A fast transfer of the diluent or shaking will create more foam). Let the solution stand for 2-5 minutes until the powder is completely dissolved.
- Turn the click.easy upside down and pull the cap slowly downwards until the solution is completely drawn back into the cartridge. Check that no more than one or two drops of solution remain in the vial. If there are more than one or two drops of solution remaining in the vial, slowly push the cap up until some of the solution is back in the vial and gently tap the click.easy. Then draw the solution slowly again back into the cartridge. Remove any excess air that has been drawn into the cartridge by pushing slowly the cap up until no air is visible in the cartridge (Note: Avoid pulling the cap down too fast, as this will draw air into the cartridge).
- Turn the click.easy device sideways with fingers pushing on the cartridge grips, unscrew the cap all the way until it falls off (do NOT pull).
Important: Pulling off the cap (instead of unscrewing it) may break the device & waste the medication.
- Remove the cartridge containing the reconstituted solution for injection from the click.easy by continuing to hold it on its side, release the cartridge grips and gently pull the end of the cartridge out of the blue plastic container.
- Carefully peel off the outer label using the tab provided. Write the reconstitution date on the inner label for your records.
- Discard the click.easy safely in accordance with your local requirements. The cartridge containing the reconstituted solution of SAIZEN is now ready to be used with the one.click auto-injector, or easypod electromechanical auto-injector.
NOTE: For instructions on how to load the cartridge into the one.click auto-injector and inject the reconstituted solution of SAIZEN please read the instructions that have been provided at the end of this leaflet.
For instructions on how to load the cartridge into the easypod electromechanical auto-injector, please carefully read the corresponding instruction manual provided with the device.
NOTE: Injections should be given in different parts of your body. Do not use any areas in which you feel lumps, firm knots, depressions, or pain; talk to your doctor or health care professional about anything you find. Clean the skin at the injection site with soap and water.
NOTE: Although SAIZEN in the click.easy device is intended for the one.click auto-injector, SAIZEN, once reconstituted, can also be accessed with a conventional syringe for a subcutaneous injection.
What If a Dose is Missed or Too Much is Taken
If a dose is missed or too much SAIZEN injected it is important to tell your doctor as it may be necessary to change slightly the dose to make up for this. Injecting too much can lead to changes in blood sugar levels which could mean that the patient will feel shaky and light-headed. If this happens contact your doctor as soon as possible. If too much were taken over a period in time, this could cause an excessive growth of some bones to occur, particularly the hands, feet and jaw.
There have been no reports of the effects of acute overdose.
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Side Effects and What to Do About Them
As with any medicine, side effects can sometimes occur, however most people have no problems with their prescribed SAIZEN.
Sometimes, however, redness and itching may appear at the injection site. If this appears to be particularly troublesome, you should discuss this with your doctor.
SAIZEN may bring about insulin resistance. Insulin resistance means your body cannot make good use of the insulin it produces. This causes higher levels of glucose in your blood. Your doctor will need to check your blood glucose on a regular basis. It is also important to check blood glucose if you have diabetes or a family history of diabetes.
Intracranial hypertension is pressure within the skull that is too high. This may be a complication of SAIZEN (growth hormone therapy) . Call your doctor if you have a headache that does not go away or goes away and comes back, problems with your vision, a sick feeling in your stomach (nausea) or vomiting.
Very rarely a patient could develop antibodies to somatropin. These are usually not associated with any side effects and do not usually interfere with growth.
If the patient shows an unexplained limp, please contact your doctor or nurse.
If the patient suffers from these or any other unwanted effects, please inform your doctor or nurse.
This is not a complete list of side effects. If the patient experiences any unusual symptoms or side effects, you should report them to the doctor immediately. It is also wise to discuss the possibility of side effects with the doctor before beginning treatment.
How to Store Saizen Click.Easy
Unopened vials of SAIZEN are stable for 3 years from the time of manufacture.
Vials of SAIZEN pre-assembled in the click.easy reconstitution device should be stored in the original package at room temperature (25 °C or below).
SAIZEN 8.8 mg (5.83 mg/mL) click.easy should be stored at 2 oC to 8oC in the cartridge and should be used within 28 days.
SAIZEN 8.8 mg (8.0 mg/mL) click.easy and SAIZEN 4.0 mg (1.5 mg/mL) click.easy should be stored at 2 °C to 8 °C in the cartridge and should be used within 21 days.
Do not freeze.
It is important not to use the medicine:
- after the date shown on the vial label
- in case of apparent deterioration.
Keep out of reach of children.
Reporting Suspected Side Effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Postal Locator 0701D
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
SAIZEN 8.8 mg (8.0 mg/mL) click.easy, 8.8 mg (5.83 mg/mL) click.easy and 4 mg (1.5 mg/mL) click.easy cartridges can be used with the one.click auto-injector or the easypod auto-injector. If easypod instructions are required, please contact the Growth Support Program at 1-877-724-9361.
This document plus the full Product Monograph, prepared for health care professionals can be obtained from
EMD Serono, A Division of EMD Inc., Canada
2695 North Sheridan Way, Suite 200
Mississauga, Ontario, Canada
Growth Support Program: 1-877-724-9361