EMD Serono, Inc. is the only pharmaceutical company in the world to have growth hormone approved for three clearly distinct
therapeutic indications, including
Saizen® [somatropin (rDNA origin) for injection] for growth hormone deficiency in children and adults,
Serostim® [somatropin (rDNA origin) for injection] for HIV-associated wasting, and
Zorbtive™ [somatropin (rDNA origin) for injection] for short bowel syndrome. (Through a promotional rights agreement with Emmaus Medical,
Zorbtive is detailed and promoted by Emmaus within the United States.)
EMD Serono is also the only company to offer a needle-free option for people with HIV-associated wasting. easypod™ is the
first and only electronic delivery device for use with Saizen® in the growth hormone therapeutic area. easypod was designed
with direct input from patients, caregivers and healthcare professionals to answer the need for a device that provided simple,
everyday use and to help provide an easy-to-use solution for healthcare professionals make more informed treatment decisions
for their patients.
Indications and Important Safety InformationSaizen®
Saizen® is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone.
It is also indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet the criteria
of adult onset or childhood onset.
Growth hormone therapy should not be initiated in patients with acute critical illness due to complications following open
heart or abdominal surgery, multiple accidental trauma or acute respiratory failure. Saizen® is contraindicated in patients
with a known hypersensitivity to growth hormone, diabetic retinopathy, acute critical illness in the presence of active malignancy,
and in patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment. Saizen® should be
used with caution in patients with insulin resistance, glucose intolerance, diabetes, hypothyroidism, intracranial hypertension
and in women who are pregnant or nursing. Although infrequent, delivery site reactions may occur. Saizen®, easypod®, click.easy®,
cool.click2® and one.click® are available by prescription only. Please refer to Full Prescribing Information below. Refer
to device instructions for use.
Serostim®
Serostim® [somatropin [rDNA origin) for injection] is indicated for the treatment of HIV-associated wasting or cachexia in
patients receiving antiretroviral therapy.
Growth hormone therapy should not be initiated in patients with acute critical illness due to complications following open
heart or abdominal surgery, multiple accidental trauma or acute respiratory failure. Serostim® should not be used in patients
with active cancer or in patients hospitalized in intensive care. Patients with a history of diabetes or related glucose intolerance
problems should be monitored closely during Serostim® treatment. Common side effects with Serostim® include joint pain and
swelling. These side effects can usually be managed with treatment or a change in Serostim® dose. See full prescribing information.
Zorbtive®
Growth hormone therapy should not be initiated in patients with acute critical illness due to complications following open
heart or abdominal surgery, multiple accidental trauma or acute respiratory failure. Zorbtive® [somatropin (rDNA origin)
for injection] is indicated for the treatment of Short Bowel Syndrome in patients receiving specialized nutritional support.
Zorbtive® therapy should be used in conjunction with optimal management of Short Bowel Syndrome. For more information on Zorbtive®
refer to full prescribing information. Patients should be instructed to read the Patient Information Leaflet accompanying
the product and talk to their doctor.