FlexPro® PenMate® designed for Norditropin® (somatropin [rDNA origin] injection) patients who dislike needles
PLAINSBORO, N.J., July 16, 2015 /PRNewswire/ -- Novo Nordisk announced today the U.S. Food and Drug Administration (FDA) approval of FlexPro® PenMate®, designed for users of Norditropin® FlexPro® 5 mg, 10 mg, and 15 mg pens who dislike needles and prefer them to be hidden during the injection process.
"Children and adolescents with growth hormone-related disorders are the primary users of Norditropin®, and some feel uneasy at the thought of having to inject their medicine," said Eddie Williams, senior vice president, Biopharmaceuticals, Novo Nordisk. "FlexPro® PenMate® was developed to hide the needle, demonstrating our commitment to keeping the patient at the center of everything we do."
FlexPro® PenMate® has been developed exclusively for use with the Norditropin® FlexPro® 5, 10, and 15 mg pens. It is a cylindrical attachment that is designed to conceal the needle so patients cannot see it being inserted into their skin during injection. The Norditropin® FlexPro® pen slides into FlexPro®PenMate® and twists into a locked position. The needle is then attached, and the injection process can begin. FlexPro® PenMate® features a large gripping surface so patients can firmly hold the pen during injection.
Norditropin® FlexPro® is the only prefilled growth hormone injection pen that can be stored outside of the refrigerator for up to 21 days after first usea.
Novo Nordisk expects to make FlexPro® PenMate® available in the United Statesin the latter half of this year. Visit www.norditropin.com for more information on Norditropin®.
aAll Norditropin® products must be refrigerated prior to first use. Do not freeze. After initial use, Norditropin® pens can either be stored outside of the refrigerator (up to 77 degrees F [25 degrees C]) for use within 3 weeks, or in the refrigerator (between 36 degrees F and 46 degrees F [2 degrees C and 8 degrees C]) for use within 4 weeks.
Indications and Usage
What is Norditropin® (somatropin [rDNA origin] injection)?
Norditropin® is a prescription medicine that contains human growth hormone and is used to treat:
- children who are not growing because of low or no growth hormone.
- children who are short (in stature) and who have Noonan syndrome or Turner syndrome.
- children who are short (in stature) because they were born small (small for gestational age-SGA) and have not caught-up in growth by age 2 to 4 years.
- adults who did not make enough growth hormone when they were children or when they became adults.
Important Safety Information
Who should not use Norditropin®?
Do not use Norditropin® if:
- you have a critical illness caused by certain types of heart or stomach surgery, trauma or breathing (respiratory) problems.
- you are a child with Prader-Willi syndrome who is severely obese or has breathing problems including sleep apnea.
- you have cancer or other tumors.
- your healthcare provider tells you that you have certain types of eye problems caused by diabetes.
- you are a child with closed bone growth plates (epiphyses).
- you are allergic to any of the ingredients in Norditropin®.
What should I tell my healthcare provider before I start Norditropin®?
Tell your healthcare provider if you:
- have diabetes, had cancer or any tumor, or have any other medical conditions.
- are pregnant or breastfeeding, or plan to become pregnant or breastfeed.
- take any prescription and non-prescription medicines, vitamins or herbal supplements. Norditropin® may affect how other medicines work, and other medicines may affect how Norditropin® works.
How should I use Norditropin®?
- Do not share your Norditropin® pen and needles with another person. You may give another person an infection or get an infection from them.