New Formulation and Indication for Tekturna
November 14, 2017 – The U.S. FDA has approved a new formulation and new indication for Tekturna® (aliskiren), manufactured by Noden Pharma. Previously available as an oral tablet for use only in adults, Tekturna is now available as oral pellets, and indicated to treat patients at least six years of age and weighing a minimum of 20kg (approximately 44lbs) to manage high blood pressure. Tekturna is the only direct renin inhibitor approved by the FDA for use in the United States.
The American Academy of Pediatrics estimates that up to 25 million American children and adolescents have high blood pressure. The same number are believed to be at risk of developing the condition. Tekturna works by blocking renin, an enzyme responsible for regulating the body’s mean arterial blood pressure, from tightening blood vessels. This allows the vessels to open further, resulting in lower blood pressure. Recommended dosing with Tekturna is 75mg or 150mg once a day for patients who weigh between 20kg (44lbs) and 50kg (110lbs). For patients who weigh more than 50kg, recommended dosing is the same as for adults: 150mg or 300mg once per day. If needed, Tekturna pellets can be opened and mixed with small amounts of a soft food (ice cream or pudding) or a beverage (milk or water). The contents can also be swallowed alone after breaking open the pellet.
It is important to note that Tekturna® HCT (aliskiren/hydrochlorothiazide), which includes a diuretic, should not be used in pediatric patients.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.