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January, 2008
Dear Colleague,
I am pleased to announce the most recent innovation in Nutropin AQ® [somatropin (rDNA origin) injection therapy from Genentech—the new Nutropin AQ Pen® 20 and the Nutropin AQ Pen® 20mg Cartridge. The new Nutropin AQ Pen 20 doses in increments of 0.2 mg liquid growth hormone (GH) up to a maximum dose of 8 mg. With the ability to deliver a higher concentration at a lower volume per injection, the Nutropin AQ Pen 20 gives your GH patients some real advantages:
- Lower volume per injection
- Fewer cartridge changes
- Larger doses given in a single injection
The Nutropin AQ Pen 20 retains all the simplicity, ease-of-use and safety features of the original Nutropin AQ Pen, now referred to as Nutropin AQ Pen® 10. The new, expanded Nutropin AQ Pen family delivers a wide range of doses so that most of your GH patients can start on the Nutropin AQ Pen and remain on it for the duration of their therapy.
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The Nutropin AQ pens and cartridges are color-coded for easy identification and use. Cartridge and device labeling and packaging provide distinct visual differences to enable health care professionals and patients to match the correct cartridge to the appropriate device.
Patients who are prescribed the Nutropin AQ Pen 10 should only use the Nutropin AQ Pen 10mg Cartridge (gold band with 10 on the label).
Patients who are prescribed the Nutropin AQ Pen 20 should only use the Nutropin AQ Pen 20mg Cartridge (purple band with 20 on the label).
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It is critical that you educate your patients to always check to make sure they are using their prescribed strength of Nutropin AQ Pen cartridge (10mg or 20mg) and the corresponding Nutropin AQ Pen. Patients should be instructed to ensure that they have the correct cartridge for the pen prescribed for them by:
- Checking the label text on the pen and cartridge (10mg or 20mg)
- Check the color band on the cartridge (gold for 10mg, purple for the 20mg)
The new labeling and packaging for the 20mg cartridge and device and the existing labeling and packaging for the Nutropin Pen 10mg cartridge and device are described in the patient instruction and educational materials. These materials also remind patients to match their cartridge to the appropriate device when inserting a new cartridge.
Please refer to the enclosed Nutropin AQ full prescribing information for additional safety considerations.
We encourage you to visit our web site at Nutropin.com for more information about the new Nutropin AQ Pen® 20mg Cartridge and how it can benefit your GH patients.
Sincerely,
Barbara Lippe, MD
Principle Medical Director
Genentech, Inc.
Enclosure
9010800
Indications
Pediatric Patients
Nutropin AQ and Nutropin are indicated for the long-term treatment of growth failure due to a lack of adequate endogenous GH secretion.
Nutropin AQ and Nutropin are also indicated for the treatment of growth failure associated with chronic renal insufficiency up to the time of renal transplantation. Nutropin AQ and Nutropin therapy should be used in conjunction with optimal management of chronic renal insufficiency.
Nutropin AQ and Nutropin are also indicated for the long-term treatment of short stature associated with Turner syndrome.
Nutropin AQ and Nutropin are also indicated for the long-term treatment of idiopathic short stature, also called non–growth hormone deficient short stature, defined by height SDS ≤-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, in pediatric patients whose epiphyses are not closed and for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means.
Adult Patients
Nutropin AQ and Nutropin are indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria:
Adult-Onset: Patients who have growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or
Childhood-Onset: Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.
In general, confirmation of the diagnosis of adult growth hormone deficiency in both groups usually requires an appropriate growth hormone stimulation test. However, confirmatory growth hormone stimulation testing may not be required in patients with congenital/genetic GH deficiency or multiple pituitary hormone deficiencies due to organic disease.
Important Safety Information
Growth hormone (GH) should not be used for growth promotion in pediatric patients with closed epiphyses.
GH should not be used in patients with active proliferative or severe non-proliferative diabetic retinopathy.
In general, GH should not be used in patients with active malignancy. Any pre-existing malignancy should be inactive and its treatment complete prior to instituting therapy with growth hormone.
GH therapy should be discontinued if there is evidence of recurring tumor activity. GH should not be used in patients with any evidence of progression or recurrence of an underlying intracranial tumor.
GH should not be used to treat patients with acute critical illness due to complications following open heart surgery, abdominal surgery, or multiple accidental trauma, or those with acute respiratory failure.
GH is contraindicated in patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment. Unless patients with Prader-Willi syndrome also have a diagnosis of GH deficiency, Nutropin AQ and Nutropin are not indicated for the long-term treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome.
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