Invega Trinza Approved for Three Month Dosage
May 19, 2015 – The U.S. Food and Drug Administration (FDA) approved Invega Trinza (paliperidone palmitate) extended-release injectable suspension used in the treatment of adult patients with schizophrenia. Administered by a healthcare provider, one Invega Trinza injection lasts for three months. Invega Trinza is manufactured by Janssen.
Invega is already available in two other dosage forms. Invega Sustenna (paliperidone palmitate), a once monthly injection is used to treat bipolar disorder as well as schizophrenia. Invega (paliperidone) extended-release tablets, originally approved in December 2006, are taken once a day. Invega has indications for schizophrenia and schizoaffective disorder treatment for patients who are 12 years old or older.
Invega Trinza is expected to be available by the end of the second quarter. However, patients will have to be treated with monthly Invega Sustenna injections for at least four months prior to starting Invega Trinza. All the Invega dose forms have a boxed warning indicating that they are not approved for use by elderly patients with psychoses related to dementia because they increase the risk of death.
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 regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular 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 a 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.