cool.click® 2 Provides 100% Needle-Free Delivery for Patients Who Don't Want to Use a Needle

cool.click® 2 provides needle-free delivery of Saizen® (somatropin) for injection for patients who do not want to use a needle. A spring mechanism is used to disperse Saizen® through the skin. cool.click® 2 incorporates an improved nozzle and a digital display for reading the dose compared to the original cool.click®.

cool.click® 2 is designed for use with Saizen® in 5 mg and 8.8 mg vials.

cool.click® 2 should only be used according to the instruction manual and only after proper training from a healthcare provider. For children, an adult should supervise the use of cool.click® 2.

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How to use cool.click®2

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IMPORTANT DEVICE RISK INFORMATION

cool.click® 2 should only be used according to the instruction manual and after proper training from a healthcare provider. Please reference the cool.click® 2 Instructions for Use. cool.click® 2 should not be used in patients and children who have low platelet count, bruise or bleed easily, or are taking anticoagulants (blood thinners), or any other medication/therapy that may contribute to excess bleeding or bruising. Hemophiliacs should not use this device. cool.click® 2 is not recommended for patients who do not have adequate subcutaneous tissue or normal hematopoietic function. Although infrequent, delivery-site reactions may occur. cool.click® 2 should not be used in patients for whom growth hormone is contraindicated. cool.click® 2 is available by prescription only.

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.