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 (rDNA origin) 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.

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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.

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 (rDNA origin) for injection]?

Saizen® [somatropin (rDNA origin) for injection] is a prescription medicine indicated for the treatment of growth hormone deficiency (GHD) in children and adults:

1- to increase growth rate in children with growth failure and who produce low amounts of growth hormone.
2- to replace growth hormone in adults because of either of a deficiency that started as a child or started as an adult due to of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; and has been confirmed using medical tests

As with any prescription medicine, your doctor will do a complete health evaluation prior to prescribing Saizen® and will monitor your progress and possible side effects during the course of treatment.

Important Risk Information including side effects

Who should not take Saizen®?

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 caused by certain types of heart or stomach surgery, serious injury or a sudden and severe breathing problem (respiratory failure)
  • cancer or other tumors
  • certain types of eye problems caused by diabetes
  • allergies to any of the ingredients in the medicine including benzyl alcohol
  • Prader-Willi syndrome who are severely overweight or have a history of breathing problems including sleep apnea

Saizen® should also not be used in children who have completed growth.

What should patients tell their doctor before taking Saizen®?

Patients should tell their doctor about their medical and family history, treatment use and past and existing medical conditions, such as but not limited to the following:

  • diabetes
  • cancer or any tumor
  • use of prescription and non prescription medicines, steroids, vitamins, and herbal supplements
  • allergies
  • pregnancy
  • nursing

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

CHILDREN ADULTS
  • local reactions at the injection site (such as pain, numbness, redness and swelling)
  • low levels of thyroid hormone (hypothyroidism)
  • low blood sugar
  • seizures or convulsions
  • worsening of skin psoriasis
  • swelling associated with fluid retention

 

  • local reactions at the injection site (such as pain, numbness, redness and swelling)
  • low levels of thyroid hormone (hypothyroidism)
  • pain in joints and muscle pain
  • swelling associated with fluid retention
  • tingling and numbness
  • unusual skin sensations
  • carpal tunnel syndrome
  • increased blood sugar (hyperglycemia)

Other possible side effects of Saizen® are:

  • return of tumor or cancerous growths
  • headaches, changes in vision, nausea or vomiting (these may be symptoms of raised pressure in the brain which requires immediate medical attention)
  • hip and knee pain or a limp that can be a sign of slipped capital femoral epiphysis
  • worsening of pre-existing curvature of the spine (scoliosis)
  • intense pain and tenderness in the abdomen as consequence of an inflammation of the pancreas (pancreatitis)
  • high blood sugar (hyperglycemia/diabetes)

Never share a Saizen® needle with another person, even if the needle is changed. Sharing of the pen between patients may pose a risk of transmission of infection. easypod® 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 easypod®.

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.

Click here for Full Prescribing Information