On September 10, Hikma Pharmaceuticals PLC (Hikma), at London announced Azacitidine for Injection, 100 mg, the generic version of Vidaza, in the United States it would be seld through the US affiliate, Hikma Pharmaceuticals USA Inc.
This drug is usually used for Injection is indicated for treatment of patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).
$82 Million In The 12 Months
According to IQVIA (Quintiles and IMS Health) US sales of Azacitidine for Injection, 100 mg, were approximately $82 million in the 12 months ending July 2020. Today Hikma is the third largest US supplier of generic injectable medicines by volume, with a growing portfolio of over 100 products, one in every six injectable generic medicines used in US hospitals is a Hikma product.
According to the statistics there no accurate data, about how many people in the United States each year diagnosed with myelodysplastic syndromes (MDS). But, some estimates have put this number at about 10,000, while other estimates have been much higher.
Usually MDS isn’t common for people under age 50, and the risk increases as a person gets older. More often it is diagnosed in people in their 70s, and of course, the new cases diagnosed each year is likely increasing as the average age of the US population increases.
Side Effects And Warnings
Company set list of warnings for those who going to use the medicine or prescribe it:
- Azacitidine for Injection causes anemia, neutropenia and throm Monitor complete blood counts frequently for response and/or toxicity, at a minimum, prior to each dosing cycle.
- Azacitidine is potentially hepatotoxic in patients with severe pre-existing hepatic impairment, caution is needed in patients with liver diseases.
- Azacitidine is contraindicated in patients with advanced malignant hepatic tum.
- Safety and effectiveness of Azacitidine for Injection in patients with MDS and hepatic impairment have not been studied as these patients were excluded from the clinical trials.
- Toxicity ranging from elevated serum creatinine to renal failure and death have been reported in patients treated with intravenous azacitidine in combination with other chemotherapeutic agents.
- Renal tubular acidosis, defined developed in 5 patients with CML treated with azacitidine and etoposide.
- Patients with renal impairment may be at increased risk for renal toxicity.
- Azacitidine for Injection may cause fatal or serious tumor lysis syndrome, including in patients with Tumor lysis syndrome may occur despite concomitant use of allopurinol.
- Based on the mechanism of action and findings in animals, Azacitidine for Injection can cause fetal harm when administered to a pregnant woman.
- Advise females with reproductive potential to avoid pregnancy during treatment with Azacitidine for Injection.
“Hikma helps put better health within reach every day for millions of people in more than 50 countries around the world. For more than 40 years, we’ve been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across the United States (US), the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people’s lives,” – company concluded.