CARY, N.C., August 21, 2020—Biologics by McKesson, an independent specialty pharmacy specializing in oncology and rare disease areas, has been selected by Taiho Oncology, Inc. as a specialty pharmacy provider for INQOVI® (decitabine and cedazuridine) tablets for the treatment of adults with intermediate and high-risk myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML), two blood malignancies.
INQOVI, approved by the U.S. Food and Drug Administration (FDA) on July 7, 2020, is a fixed-dose oral C-DEC (combination of decitabine and cedazuridine). The FDA granted this therapy orphan drug designation and approved INQOVI through its Priority Review process. By inhibiting cytidine deaminase in the gut and the liver, INQOVI enables the DNA hypomethylating agent, decitabine, to be taken orally for five days to reach systemic exposure levels that match those from five days’ worth of intravenous (IV) administration.
“This new oral therapy option can help patients with MDS and CMML avoid spending nearly a week each month getting IV decitabine,” said Allison Kinnarney, director of Clinical Programs for Biologics. “We’re excited to work with Taiho Oncology to deliver this essential treatment to patients.”
Biologics specialty pharmacy is committed to and recognized for its level of customer service as well as its innovative, high-touch and multidisciplinary patient-centric approach. Each team includes pharmacists with in-depth knowledge of therapies, experienced nurses, and financial counselors who are familiar with various financial assistance programs and organizations that help patients. This deeply-skilled care team works together to develop individualized care plans that address each patient’s unique clinical, financial and emotional needs and streamlines communication back to the treating provider, enabling high-quality care and differentiated outcomes. In addition, the Biologics team works closely with payers to ensure patients can access the specialty medications they need.
Physicians may submit prescriptions to Biologics via phone (800.850.4306), fax (800.823.4506) or eScribe. For electronic prescribing systems, physicians may search for Biologics within their EMR system.
About Biologics by McKesson
Biologics by McKesson is an independent specialty pharmacy with more than 25 years of experience connecting patients to life-changing medications in oncology and other rare and complex therapeutic areas. Built on the foundation of deep clinical expertise and a high-touch approach to patient care, Biologics delivers seamless access and personalized engagement, so patients get the most out of the care they receive. As a business within McKesson Corporation, Biologics harnesses unparalleled reach and connectivity across the healthcare system to connect the dots between payers, providers and biopharma, so together, they can deliver better care and outcomes for every patient.
INQOVI is indicated for treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.
Important Safety Information
Warnings and Precautions
Myelosuppression: Fatal and serious myelosuppression can occur with INQOVI. Based on laboratory values, new or worsening thrombocytopenia occurred in 82% of patients, with Grade 3 or 4 occurring in 76%. Neutropenia occurred in 73% of patients, with Grade 3 or 4 occurring in 71%. Anemia occurred in 71% of patients, with Grade 3 or 4 occurring in 55%. Febrile neutropenia occurred in 33% of patients, with Grade 3 or 4 occurring in 32%.
Fatal and serious infectious complications can occur with INQOVI. Pneumonia occurred in 21% of patients, with Grade 3 or 4 occurring in 15%. Sepsis occurred in 14% of patients, with Grade 3 or 4 occurring in 11%. Fatal pneumonia occurred in 1% of patients, fatal sepsis in 1%, and fatal septic shock in 1%.
Obtain complete blood cell counts prior to initiation of INQOVI, prior to each cycle, and as clinically indicated to monitor response and toxicity. Administer growth factors, and anti‑infective therapies for treatment or prophylaxis as appropriate. Delay the next cycle and resume at the same or reduced dose as recommended.
Embryo-Fetal Toxicity: INQOVI can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise patients to use effective contraception during treatment with INQOVI and for 6 months (females) or 3 months (males) after last dose.
Serious adverse reactions in >5% of patients included febrile neutropenia (30%), pneumonia (14%), and sepsis (13%). Fatal adverse reactions included sepsis (1%), septic shock (1%), pneumonia (1%), respiratory failure (1%), and one case each of cerebral hemorrhage and sudden death.
The most common adverse reactions (≥ 20%) were fatigue, constipation, hemorrhage, myalgia, mucositis, arthralgia, nausea, dyspnea, diarrhea, rash, dizziness, febrile neutropenia, edema, headache, cough, decreased appetite, upper respiratory tract infection, pneumonia, and transaminase increased. The most common Grade 3 or 4 laboratory abnormalities (>50%) were leukocytes decreased, platelet count decreased, neutrophil count decreased, and hemoglobin decreased.
Use in Specific Populations
Lactation: Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with INQOVI and for at least 2 weeks after the last dose.
Renal Impairment: No dosage modification of INQOVI is recommended for patients with mild or moderate renal impairment (creatinine clearance [CLcr] of 30 to 89 mL/min based on Cockcroft-Gault). Due to the potential for increased adverse reactions, monitor patients with moderate renal impairment (CLcr 30 to 59 mL/min) frequently for adverse reactions. INQOVI has not been studied in patients with severe renal impairment (CLcr 15 to 29 mL/min) or end-stage renal disease (ESRD: CLcr <15 mL/min).
Please see the accompanying Full Prescribing Information.
Claire Crye, Public Relations