PARSIPPANY, N.J.–(BUSINESS WIRE)–Ferring Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved ZOMACTON (somatropin) for injection in four additional pediatric indications:
- Idiopathic short stature (ISS)
- Short stature associated with Turner syndrome
- Short stature born small for gestational age (SGA) with no catch-up growth by 2 to 4 years
- Short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency
ZOMACTON was previously approved to treat growth failure in pediatric patients due to inadequate secretion of endogenous growth hormone (GH) and replacement of endogenous GH in adults with GH deficiency. Along with these approvals, Ferring announced plans to launch the ZOMA-Jet 10 Needle-Free Delivery System for ZOMACTON in September.
It is estimated that around 3-5% of children in the United States have short stature, defined as a height below the 3rd percentile. Patients with short stature typically present with below average height in relation to their age, sex, racial group, or family.1 Today, the majority of treatments for these diseases involve needles. However, in a recent study, over 60% of children ages 6-17 expressed a fear of needles.2
“Parents struggle to deliver their child’s daily dose of growth hormone due to children’s fear and anxiety of needles,” said Teresa Tucker, Co-Founder and Patient Advocate of The MAGIC Foundation. “Parents and patients will welcome an option that is completely needle free.”
From September, ZOMACTON will be available to use with the ZOMA-Jet 10 Needle-Free Delivery System. ZOMA-Jet 10 will provide the only completely needle-free delivery option available for children being treated with growth hormone.
ZOMACTON is available by prescription in the U.S., offering both 5 and 10 milligram (mg) options. Ferring developed ZOMACTON and currently markets it in 47 countries globally.
“We are expanding the Ferring endocrinology portfolio with new indications and a delivery system to meet patient needs,” said Paul Navarre, CEO, Ferring Holding Inc. (US). “Many patients object to needles, no matter how small. Ferring will now offer the only completely needle-free option for treating these diseases.”
Consistent with the Ferring Philosophy that “People come first,” Ferring continues to offer its ZoGo support services to all ZOMACTON®patients, providers and caregivers. The ZoGo program has been in place since 2015. For more information, call 1-844-944-ZOGO (9646).
You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.FDA.gov/medwatch, or call 800.FDA.1088.
For full prescribing information, please visit: www.ferringusa.com/pi/zomacton
About Ferring Pharmaceuticals Inc.
Ferring Pharmaceuticals is a research-driven biopharmaceutical company devoted to identifying, developing and marketing innovative products in the fields of reproductive health, urology, gastroenterology, endocrinology, women’s health and orthopaedics. For more information, call 1-888-FERRING (1-888-337-7464); visit www.FerringUSA.com or www.ZOMACTON.com.
FERRING, the FERRING PHARMACEUTICALS logo, and ZOMACTON and ZOMA-Jet 10 are trademarks of Ferring B.V.
ZOMACTON is a recombinant human growth hormone indicated for the treatment of pediatric patients with:
- growth failure due to inadequate secretion of endogenous growth hormone (GH)
- short stature associated with Turner syndrome
- idiopathic short stature (ISS)
- short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency
- short stature born small for gestational age (SGA) with no catch-up growth by 2 to 4 years
ZOMACTON is also indicated for the replacement of endogenous GH in adults with GH deficiency.
Important Safety Information
ZOMACTON is contraindicated in patients with:
- Acute critical illness
- Pediatric patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment due to the risk of death.
- Active malignancy.
- Hypersensitivity to ZOMACTON, its excipients, or diluents.
- Active proliferative or severe non-proliferative diabetic retinopathy.
- Pediatric patients with closed epiphyses.
WARNINGS AND PRECAUTIONS
- Increased Risk of Neoplasm: Second neoplasms have occurred in childhood cancer survivors. Monitor patients with preexisting tumors for progression or recurrence.
- Glucose Intolerance and Diabetes Mellitus: ZOMACTON may decrease insulin sensitivity, particularly at higher doses. Monitor glucose levels periodically, especially in patients with existing diabetes mellitus or at risk for development.
- Intracranial Hypertension (IH): Has been reported usually within 8 weeks of initiation. Perform fundoscopic examinations prior to initiation and periodically thereafter. If papilledema occurs, stop treatment.
- Hypersensitivity: Serious hypersensitivity reactions may occur, seek prompt medical attention.
- Fluid Retention: May occur in adults and may be dose dependent.
- Hypoadrenalism: Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism.
- Hypothyroidism: Monitor thyroid function periodically as hypothyroidism may occur or worsen after initiation of somatropin.
- Slipped Capital Femoral Epiphysis in Pediatric Patients: May occur; evaluate patients with onset of a limp or hip/knee pain.
- Progression of Preexisting Scoliosis in Pediatric Patients: Monitor patients with scoliosis for progression.
- Pancreatitis: Has been reported; consider pancreatitis in patients with abdominal pain, especially pediatric patients.
- Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative: Serious and fatal adverse reactions can occur in neonates and infants treated with benzyl alcohol-preserved drugs, including the diluent for ZOMACTON 5 mg. If administering ZOMACTON 5 mg to infants, reconstitute with 0.9% sodium chloride injection.
Common adverse reactions reported include: upper respiratory infection, fever, pharyngitis, headache, otitis media, edema, arthralgia, paresthesia, myalgia, carpal tunnel syndrome, peripheral edema, flu syndrome, hypothyroidism, hyperglycemia, and impaired glucose tolerance.
- Glucocorticoids: Patients treated with glucocorticoids may require an increased dose.
- Pharmacologic Glucocorticoid Therapy and Supraphysysiologic Glucocorticoid Treatment: Adjust dosing in pediatric patients to avoid hypoadrenalism or an inhibitory effect on growth.
- Cytochrome P450-Metabolized Drugs: Monitor carefully if used with ZOMACTON as clearance may be altered.
- Oral Estrogen: Larger doses of ZOMACTON may be required.
- Insulin and/or Other Hypoglycemic Agents: Dose adjustment may be required.
USE IN SPECIFIC POPULATIONS
- Pregnancy and Lactation: If ZOMACTON 5 mg is needed, reconstitute with 0.9% sodium chloride injection or use the ZOMACTON® 10 mg benzyl alcohol-free formulation.
1 Argente J. Challenges in the Management of Short Stature. Horm Res Paediatr. 2016;85(1):2-10.
2 Orenius T, Mikola K, Ristolainen L. Fear of Injections and Needle Phobia Among Children and Adolescents: An Overview of Psychological, Behavioral, and Contextual Factors. SON