In people with growth hormone deficiency, Saizen® can replace the growth hormone that the body isn’t making on its own. In clinical studies, Saizen® has been shown to stimulate linear growth and protein synthesis. These effects are primarily mediated by IGF-1 produced in the liver and also locally, while others are primarily a consequence of the direct effects of somatropin, such as improved lipid metabolism.
In addition to tissue growth, other documented benefits of Saizen® include:

• Skeletal Growth
• Cell Growth
• Organ Growth
• Increased protein metabolism
• Improved carbohydrate metabolism
• Improved Lipid Metabolism
• Improved Mineral Metabolism – particularly resulting in an increase in bodily potassium and phosphorus levels
• Improved tissue metabolism – particularly an increase in collagen production

More common – According to the manufacturer, the most common side effects of Saizen® are:

• An injection site reaction such as pain, numbness, redness, and swelling
• Muscle and joint pain
• Tingling and numbness
• Unusual skin sensations
• Headache
• Adults also commonly report swelling associated with fluid retention especially in the legs, arms, and face

Less common – some of the potentially severe, though less common side effects of Saizen® include:

• Tumors or cancerous growths
• High blood sugar (hyperglycemia/diabetes) which can include symptoms of increased thirst and urination, tiredness, trouble concentrating and weight loss
• Headaches, changes in vision, nausea or vomiting which requires immediate medical attention
• Serious allergic reactions that require immediate medical attention.
• Hip and knee pain or a limp in children, which can be a sign that the thigh bone and hip joint may have slipped out of place
• Curvature of the spine or backbone in children (scoliosis)
• Pain and tenderness in the abdomen, which could be a sign of a problem with the pancreas

See your medication’s insert or Prescribing Information for a complete list of potential side-effects.

Your prescription for Saizen® will be tailored to best meet your particular goals and lifestyle. You will be carefully monitored over the course of your treatment with Saizen®, so any chance of side effects should be kept to a minimum. Tell your doctor if you are experiencing any of these or other side effects while taking Saizen®.

Overdose

Short-term overdosage of Saizen® could lead initially to hypoglycemia and subsequently to hyperglycemia. Moreover, overdose with Saizen® is likely to cause fluid retention. Long-term overdosage could result in signs and symptoms of gigantism and/or acromegaly consistent with the known effects of excess human growth hormone.

As with any medication, in case of accidental overdose, seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Keep Saizen® and all prescription medications out of the reach of children.

According to its manufacturer, Saizen® should not be used in children after the growth plates have closed.

Saizen® should not be used in children and adults with any of the following medical conditions because serious side effects can occur:

• A critical illness from surgery, serious injuries, or a severe breathing problem
• Prader-Willi syndrome patients who are severely overweight or have a history of breathing problems including sleep apnea
• Cancer or other tumors
• Allergies to growth hormone
• Eye problems caused by diabetes

Before accepting a prescription for Saizen®, tell your doctor:

• If you have or had cancer as a child. There is an increased risk of getting another tumor if you are a childhood cancer survivor.
• If you have diabetes, are at risk for getting diabetes, or have blood sugar levels that are higher than normal. New cases of type 2 diabetes have been reported in patients taking Saizen.
• If you are allergic to growth hormone, or other ingredients such as benzyl alcohol, sucrose, phosphoric acid, sodium hydroxide, or metacresol.
• If you are nursing, pregnant, or plan to become pregnant. It is not known if Saizen passes into your breast milk or could harm your unborn baby.

In addition, tell your healthcare provider about any medicines you are taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Saizen® may affect how other medicines work, and other medicines may affect how Saizen® works.

See your medication’s insert for a complete list of potential drug interactions.

How to Use

Saizen® is taken by injection only. The injection is subcutaneous, which means the medication is delivered into the fatty tissue that lies just below the skin. Saizen can be administered via needle and syringe or via one of several propriety injection devices, provided by the manufacturer.

To further assist with the Saizen® injection process, and the use of their easypod® or one.click® injection devices, the manufacturer has provided detailed instruction guides and how to videos on their website.

Dosage*

The daily dosage of Saizen® varies by your age, weight and the condition it is being prescribed for. According to the Prescribing Information provided by the National Institutes for Health, Saizen® should be administered subcutaneously as follows:

Pediatric GHD: 0.18 mg/kg/week, divided into equal doses given either on 3 alternate days, 6 times per week or daily

Adult GHD: Either a non-weight based or a weight based dosing regimen may be followed, with doses adjusted based on treatment response and IGF-1 concentrations

• Non-weight-based dosing: A starting dose of approximately 0.2 mg/day (range, 0.15-0.30 mg/day) may be used without consideration of body weight, and increased gradually every 1 to 2 months by increments of approximately 0.1 to 0.2 mg/day
• Weight-based dosing: The recommended initial dose is not more than 0.005 mg/kg/day; the dose may be increased as tolerated to not more than 0.01 mg/kg/day after 4 weeks

Injection sites should always be rotated to avoid lipoatrophy.

*Dosing information is provided for informational purposes only, and should not be construed as any kind of instructions for use. Consult your physician or pharmacist for guidance regarding your particular dose of Saizen®

Sources:
http://www.saizenus.com/
https://www.drugs.com/pro/saizen.html