Ferring Introduces ZOMA-Jet® 10, a New Needle-Free Delivery System for Patients Treated with ZOMACTON® 10mg

Ferring Introduces ZOMA-Jet® 10, a New Needle-Free Delivery System for Patients Treated with ZOMACTON® 10mg

• ZOMA-Jet 10 is a new completely needle-free delivery option available for children and adults being treated with the growth hormone, ZOMACTON 10mg

• ZOMACTON (somatropin) for injection is approved for 5 pediatric and 1 adult indication                                                                  

Parsippany, NJ, US – September 27, 2018 – Ferring Pharmaceuticals (US) today announced the availability of the ZOMA-Jet 10 Needle-Free Delivery System for ZOMACTON. ZOMA-Jet 10 is a new completely needle-free delivery option available for children and adults being treated with the growth hormone, ZOMACTON 10mg.

It is estimated that around 3-5% of children in the United States have short stature, defined as a height below the third 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.

“Parents struggle to deliver their child’s growth hormone treatment 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.”

“We are expanding the Ferring endocrinology portfolio with a delivery system to meet patient needs,” said Paul Navarre, CEO, Ferring Pharmaceuticals (US). “Many patients object to needles, no matter how small. Ferring will now offer a completely needle-free option for treating these diseases.”

ZOMACTON is available by prescription in the U.S., offering both 5 and 10mg options.  Ferring developed ZOMACTON and currently markets it in 47 countries globally.

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).

About ZOMACTON

 Indications:

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

CONTRAINDICATIONS

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 5mg. If administering ZOMACTON 5mg to infants, reconstitute with 0.9% sodium chloride injection.

ADVERSE REACTIONS

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.

You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.FDA.gov/medwatch, or call 800.FDA.1088.

DRUG INTERACTIONS

• 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 5mg is needed, reconstitute with 0.9% sodium chloride injection or use the ZOMACTON 10mg benzyl alcohol-free formulation.

For full prescribing information, please visit: www.zomacton.com

References 

About Ferring Pharmaceuticals Inc. (US)

Ferring Pharmaceuticals (US) 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, ZOMACTON and ZOMA-Jet 10 are trademarks of Ferring B.V.

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For more information, please contact

Patrick Gorman                                                               
Director, External Communications
(862) 286-5035 (direct)

(973) 722-6335 (mobile)

patrick.gorman@ferring.com

ZN/2347/2018/US(1)

[1] Argente J. Challenges in the Management of Short Stature. Horm Res Paediatr. 2016;85(1):2-10.