cool.click® 2 Instructions

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cool.click® 2 is a needle-free device for mixing and injecting Serostim® [somatropin (rDNA origin) for injection]. Your healthcare provider or nurse must teach you how to use cool.click® 2 correctly.

What is Needed for cool.click® 2 Injection

If you have questions about cool.click® 2 , talk to your healthcare provider or call the AXIS Center at 1-877-714-AXIS (2947).

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Important Risk Information and IndicationToggle Button

Important Risk Information

Before beginning treatment, patients should discuss with their clinician potential benefits and risks associated with Serostim® [somatropin (rDNA origin) for injection].

You should NOT take Serostim® if:

  • You are hospitalized with complications due to heart or abdominal surgery
  • You are hospitalized for serious injuries
  • You are hospitalized for respiratory failure
  • You have been diagnosed with diabetic retinopathy
  • You currently have cancer. Any cancer treatment should be completed before starting Serostim®
  • You are allergic to growth hormone products or any materials associated with the product

You should tell your clinician if:

  • You are pregnant or breastfeeding
  • You are currently taking any medications for HIV
  • You have a history of diabetes

The most common adverse reactions associated with Serostim® are:

  • Muscle aches
  • Joint pain
  • Swelling (particularly of the hands or feet)

These side effects were generally mild-to-moderate in severity, and were often managed by lowering the dose.1

High blood glucose (sugar levels) may occur in HIV-infected individuals for many reasons and has also been reported in Serostim® clinical studies. If you have a history of high blood glucose or have other risk factors for glucose intolerance, you should be monitored closely while on Serostim®. New onset type 2 diabetes or worsening of current diabetes has been reported with Serostim®. Patients have experienced complications of diabetes, some of which were serious and continued after stopping treatment with Serostim®.

What is Serostim®?

Serostim® is human growth hormone and is the only FDA-approved medicine clinically proven to significantly increase lean body mass and body weight, and improve physical endurance. You must be on antiretroviral therapy to be prescribed Serostim®.

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.

This information is not intended to replace discussions with your doctor. For additional information about Serostim® please consult the Prescribing Information and ask your doctor if Serostim® is right for you. You can also call the AXIS Center toll-free at 1-877-714-AXIS (2947). Serostim® is available by prescription only.

Please see Serostim® Prescribing Information available in English and Spanish

Reference:

  1. Moyle GJ, Daar ES, Gertner JM, et al. Growth hormone improves lean body mass, physical performance, and quality of life in subjects with HIV-associated weight loss or wasting on highly active antiretroviral therapy. J Acquir Immune Defic Syndr. 2004;35:367-375.

Indication

Serostim® [somatropin (rDNA origin) for injection] is indicated for the treatment of HIV patients with wasting or cachexia to increase lean body mass and body weight, and improve physical endurance. Concomitant antiretroviral therapy is necessary.