Avion Pharmaceuticals’ new gout prophylaxis product, GLOPERBA®, is the first and only liquid form of colchicine1,2
February 26, 2020
FDA-approved GLOPERBA (colchicine) is now available in pharmacies.
Avion Pharmaceuticals, LLC, a specialty pharmaceutical company, announced its gout prophylaxis product, GLOPERBA® (colchicine), is now commercially available in pharmacies across the United States. The FDA approved GLOPERBA 0.6 mg/5 mL on Jan. 30, 2019, but the drug has not been commercially available until now.
Gout is a debilitating form of arthritis affecting an estimated 8.7 million people in the United States. The disease is caused by elevated levels of uric acid crystals in the joints, which can trigger painful and debilitating inflammation. Gout can become a chronic condition if left untreated.
Physicians have long used colchicine to treat gout, but they are often required to adjust dosing or interrupt treatment to minimize the potential for side effects, especially in patients with liver or kidney disease, which are common comorbidities of gout. Prior to GLOPERBA, colchicine was only available in tablet and capsule forms, which can make dose adjustments difficult for patients. As a liquid oral solution, GLOPERBA allows physicians and patients to easily tailor dosing as needed.
“GLOPERBA brings a new level of flexibility and control to the management of gout with colchicine,” said Art Deas, CEO of Avion Pharmaceuticals. “Every gout patient is unique. As a liquid, GLOPERBA gives physicians the power to easily individualize treatment and titrate dosing based on their patients’ unique needs.”
GLOPERBA (NDC: 75854-801-01) is available at chain, independent, and specialty pharmacies. For more information, please visit GLOPERBA.com.
Please see full Prescribing Information for GLOPERBA.
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ML-0103 0220-01
ABOUT AVION
Avion Pharmaceuticals, LLC, is a specialty pharmaceutical company formed to develop and market a portfolio of innovative pharmaceutical products in the women’s heath therapeutic category. Avion Pharmaceuticals focuses on identifying opportunities to acquire and enhance the market potential of innovative, commercially available therapeutics and late-stage- development drugs to fulfill unmet medical needs. For additional information about Avion Pharmaceuticals, please contact the company at 678-325-5188.
INDICATION
GLOPERBA (colchicine) 0.6 mg oral solution is indicated for prophylaxis of gout flares in adults. The safety and effectiveness of GLOPERBA for acute treatment of gout flares during prophylaxis has not been studied.
GLOPERBA is not an analgesic medication and should not be used to treat pain from other causes.
IMPORTANT SAFETY INFORMATION FOR GLOPERBA (colchicine)
- Colchicine 0.6 mg oral solution is contraindicated in patients with renal or hepatic impairment who are currently prescribed drugs that inhibit both P-gp and CYP3A4. Combining these dual inhibitors with colchicine in patients with renal or hepatic impairment has resulted in life-threatening or fatal colchicine toxicity. Patients with both renal and hepatic impairment should not be given GLOPERBA.
- Fatal overdoses have been reported with colchicine in adults and children. Keep GLOPERBA out of the reach of children.
- Blood dyscrasias, such as myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, and aplastic anemia, have been reported with colchicine used in therapeutic doses.
- Monitor for toxicity and, if present, consider lowering the dose, temporary interruption, or discontinuation of colchicine.
- Neuromuscular toxicity and rhabdomyolysis may occur with chronic treatment with colchicine in therapeutic doses, especially in combination with other drugs known to cause this effect. Patients with impaired renal function and elderly patients (including those with normal renal and hepatic function) are at increased risk. Consider lowering the dose, temporary interruption, or discontinuation of GLOPERBA.
- The most commonly reported adverse reactions with colchicine are gastrointestinal symptoms, including diarrhea, nausea, vomiting, and abdominal pain.
You are encouraged to report negative side effects of prescription drugs to the FDA. To report suspected adverse reactions, visit www.fda.gov/medwatch or call 1-800-FDA-1088.
REFERENCES: 1. GLOPERBA [Package Insert]. Alpharetta, GA: Avion Pharmaceuticals, LLC; 2020. 2. US Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm. Revised January 17, 2020. Accessed February 5, 2020.