HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
GLOPERBA® safely and effectively. See full prescribing information for
GLOPERBA®.
GLOPERBA(colchicine) Oral Solution
Initial U.S. Approval: 1961
INDICATIONS AND USAGE
• GLOPERBA is indicated for prophylaxis of gout flares in adults.
Limitations of use:
The safety and effectiveness of GLOPERBA for acute treatment of gout flaresduring prophylaxis has not been studied. GLOPERBA is not an analgesicmedication and should not be used to treat pain from other causes.
DOSAGE AND ADMINISTRATION
0.6 mg (5 mL) once or twice daily. Maximum dose 1.2mg/day.
GLOPERBA is administered orally, without regard to meals。
DOSAGE FORMS AND STRENGTHS0.6mg/5mL oral solution
CONTRAINDICATIONS
• Patients with renal or hepatic impairment should not be given GLOPERBAin conjunction with drugs that inhibit both CYP3A4 and P-gp.
• Patients with both renal and hepatic impairment should not be givenGLOPERBA.
WARNINGS AND PRECAUTIONS
• Fatal overdoses have been reported with colchicine in adults and children.Keep GLOPERBA out of the reach of children.
• Blood dyscrasias: myelosuppression, leukopenia, granulocytopenia,thrombocytopenia and aplastic anemia have been reported.
• Monitor for toxicity and, if present, consider lowering the dose, temporaryinterruption or discontinuation of colchicine.
• Drug interaction with CYP3A4 and P-gp inhibitors: Co-administration ofcolchicine with dual CYP3A4 and P-gp inhibitors has resulted inlife-threatening interactions and death.
• Neuromuscular toxicity: Myotoxicity including rhabdomyolysis may occur,especially in combination with other drugs known to cause this effect.
Consider lowering the dose, temporary interruption or discontinuation ofGLOPERBA.
ADVERSE REACTIONS
• The most commonly reported adverse reactions with colchicine aregastrointestinal symptoms, including diarrhea, nausea, vomiting, andabdominal pain.
To report SUSPECTED ADVERSE REACTIONS, contact Romeg Therapeutics, LLC at (1-800-758-9702) or FDA at 1-800-FDA-1088(www.fda.gov/medwatch).
DRUG INTERACTIONS
• Co-administration of CYP3A4 or P-gp inhibitors or inhibitors of bothCYP3A4 and P-gp (e.g., clarithromycin or cyclosporine) have been reportedto lead to colchicine toxicity. The potential for drug-drug interactions mustbe considered prior to and during therapy.
• Concomitant use of GLOPERBA and inhibitors of both CYP3A4 and P-gpshould be avoided if possible. If co-administration with a CYP3A4 and P-gp inhibitor is required, the patients’ dose of colchicine may need to bereduced or interrupted, and the patient should be monitored carefully forcolchicine toxicity.
USE IN SPECIFIC POPULATIONS
• In the presence of renal or hepatic impairment, patients should be monitoredclosely and dose adjustment should be considered as necessary.
• Females and Males of Reproductive Potential: Advise males that GLOPERBA may rarely and transiently impair fertility.
• Geriatric Use: The recommended dose of colchicine should be based onrenal and hepatic function.
See 17 for PATIENT COUNSELING INFORMATION and Medication
Guide.
Revised: 1/2019
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FULL PRESCRIBING INFORMATION: CONTENTS
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