Rx Product News (October 2018)

MANUFACTURED BY: Agios Pharmaceuticals

INDICATION: Tibsovo (ivosidenib) has been approved to treat relapsed or refractory acute myeloid leukemia (R/R AML) in patients with an IDH1 gene mutation. Patients with AML who have the mutation in their blood or bone marrow through FDA-approved testing are eligible for treatment with Tibsovo. The medication inhibits the production of the IDH1 enzyme, making it the only approved treatment for or R/R AML with this mutation.

DOSAGE FORM: Tablets

FOR MORE INFORMATION: tibsovopro.com

MANUFACTURED BY: Sun Pharmaceuticals

INDICATION: The FDA has approved SunPharma’s Infugem (gemcitabine in 0.9% sodium chloride injection) to treat cancer in ready-to-administer (RTA) bags for intravenous injections. The cytotoxic drug uses a patented technology that eliminates the risks of compounding by allowing the compound to be mixed and sterilized in an RTA bag before reaching the prescriber.

DOSAGE FORM: Intravenous injection

FOR MORE INFORMATION: sunpharma.com/node/228538

AZEDRA

MANUFACTURED BY: Progenics Pharmaceuticals

INDICATION: Azedra (iobenguane I-131) is FDA approved to treat iobenguane scan-positive, unresectable, locally advanced, or metastatic pheochromocytoma or paraganglioma in patients 12 and older who require systemic anticancer treatment. Patients with the rare neuroendocrine cancer can experience tumor-related symptoms, such as high blood pressure. Azedra is clinically proven to reduce the need for antihypertensive drugs and, in some cases, tumor size.

DOSAGE FORM: Injection

FOR MORE INFORMATION: progenics.com/product-pipeline/azedra/

PERSERIS

MANUFACTURED BY: Indivior PLC

INDICATION: FDA officials have approved Perseris (risperidone), a once-monthly subcutaneous injection, to treat schizophrenia in adults. The extended-release delivery system creates a buildup of risperidone under the skin that provides treatment for 1 month. Perseris is the first long-acting extended-release suspension approved to treat schizophrenia.

DOSAGE FORM: Extended-release injectable suspension

FOR MORE INFORMATION: indiviormedia.com/#restoftext