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The COVID-19 pandemic has impacted life as we know it, including daily routines. But no matter the challenges, compliance to therapy remains a top priority for children living with central precocious puberty (CPP). Arbor Pharmaceuticals is committed to helping patients with CPP maintain their prescribed injection schedule.
We have implemented new measures to assist with the availability and delivery of Triptodur treatments. We do not anticipate any issues with the supply of Triptodur. Additionally, with the Triptodur Care Program assisting with patient therapy compliance and seamless customer service, we’re here to help ensure healthcare providers and families receive the access and guidance they need—when they need it.
View this step-by-step video for important instructions for the reconstitution and administration of Triptodur prior to injection.
If a Triptodur injection is scheduled it is important that the healthcare provider
receives education regarding the specific reconstitution and administration instructions prior
to the injection.
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to request in-service support (virtual or live) from an Arbor representative.
For additional guidance on how to safely reconstitute and administer Triptodur injections, review the Triptodur Administration Booklet.
TRIPTODUR is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP).
Initial Rise of Gonadotropins and Sex Steroid Levels - During the early phase of therapy, gonadotropins and sex steroids rise above baseline because of the initial stimulatory effect of the drug. Therefore, a transient increase in clinical signs and symptoms of puberty, including vaginal bleeding, may be observed during the first weeks of therapy or after subsequent doses.
Psychiatric Events - Psychiatric events have been reported in patients taking GnRH agonists. Postmarketing reports with this class of drugs include symptoms of emotional lability, such as crying, irritability, impatience, anger, and aggression. Monitor for development or worsening of psychiatric symptoms during treatment with TRIPTODUR.
Convulsions - Postmarketing reports of convulsions have been observed in patients receiving GnRH agonists, including triptorelin. These included patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and patients on concomitant medications that have been associated with convulsions such as bupropion and SSRIs. Convulsions have also been reported in patients in the absence of any of the conditions mentioned above.
Pseudotumor Cerebri (idiopathic intracranial hypertension) - has been reported in pediatric patients receiving GnRH agonists, including triptorelin. Monitor patients for signs and symptoms of pseudotumor cerebri, including headache, papilledema, blurred vision, diplopia, loss of vision, pain behind the eye or pain with eye movement, tinnitus, dizziness, and nausea.
In clinical trials for TRIPTODUR, the most common adverse reactions (≥4.5%) are injection site reactions, menstrual (vaginal) bleeding, hot flush, headache, cough, and infections (bronchitis, gastroenteritis, influenza, nasopharyngitis, otitis externa, pharyngitis, sinusitis, and upper respiratory tract infection).
To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
The Important Safety Information does not include all the information needed to use TRIPTODUR safely and effectively. For additional safety information, please consult the full Prescribing Information for TRIPTODUR.