Storage and Handling

Saizen® (somatropin) for injection is a growth hormone available by prescription only. Therefore, you should be aware of the proper way to handle and store Saizen® prior to use. Talk to your doctor about the potential benefits and risks associated with Saizen® growth hormone treatment.

Patients and caregivers who will administer Saizen® should receive appropriate training and instruction. Committed to supporting Saizen® patients, Connections for Growth® provides educational materials, growth hormone treatment information and device training. Learn more about patient services.

Storage and Handling

To keep you and your medication safe, it’s a good idea to follow these tips:

  • Keep Saizen® away from pets and children
  • Store Saizen® in a secure place to prevent damage or loss
  • Don’t leave Saizen® in a sun-warmed car; and if you’re in a location with a warm climate, make sure Saizen® doesn’t get warmer than 86°F/ 30°C
  • Keep Saizen® out of direct sunlight
  • Children should be supervised by an adult when self-administering Saizen®

Storage Before Reconstitution

Saizen® should be stored at room temperature (59°–86°F/15°–30°C). Expiration dates are stated on the labels.

Storage After Reconstitution

Saizen® 5 mg and 8.8 mg vials reconstituted with the Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol) provided should be stored under refrigeration (36°–46°F/2°–8°C) for up to 14 days.

Saizen® 8.8 mg click.easy® cartridge reconstituted with the Sterile Water for Injection, 0.3% (w/v) metacresol provided should be stored under refrigeration (36°–46°F/2°–8°C) for up to 21 days.

Avoid freezing reconstituted vials or cartridges of Saizen®.

Proper Disposal of Sharps Waste

Discard needles and pen devices safely in accordance with your local requirements. You can check with local waste disposal and regulatory agencies to see what options are available to you.

EMD Serono supports the proper disposal of medical sharps waste. California and Minnesota residents can download SHARPS disposal instructions by visiting EMD Serono.com.

Indication

What is SAIZEN® (somatropin) for injection?

Saizen is a prescription medicine that is used to treat growth hormone deficiency (GHD) in:

1- Children with growth failure who produce low amounts of growth hormone.
2- Adults with GHD that started as a child or as an adult.

Saizen is an injectable form of a protein called growth hormone that is produced by your body.

Important Risk Information

Who should not take SAIZEN?

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 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

What should patients tell their doctor before taking SAIZEN?

  • 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 taking any other medicines (both prescription or over the counter), vitamins, or supplements because these medicines may affect each other. Your doctor may need to adjust the dose of Saizen or other medicines you are taking
  • 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

Your doctor will perform certain tests before prescribing SAIZEN and will monitor progress during the course of treatment.

What are the most common side effects of SAIZEN reported in clinical trials in patients treated for GHD?

The most common side effects reported 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

Other less common but serious side effects of SAIZEN are:

  • 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

These are not all of the possible side effects. Let your doctor know about any side effects you may experience.

How should you administer SAIZEN?

Patients and caregivers should be trained by a healthcare professional on how to mix and inject Saizen prior to use. Children should always be supervised.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see the Prescribing Information for a complete list of SAIZEN Risk Information.