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Gloperba FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 26, 2019.

FDA Approved: Yes (First approved January 30, 2019)
Brand name: Gloperba
Generic name: colchicine
Dosage form: Oral Solution
Company: Romeg Therapeutics, LLC
Treatment for: Gout

Gloperba (colchicine) is an oral solution formulation of the approved drug colchicine indicated for prophylaxis of gout flares in adults.

Dosage and Administration
The dosage for Gloperba is 0.6 mg (5 mL) administered orally once or twice daily, with or without food. The maximum dose is 1.2 mg/day. Patients are advised to measure each dose with an accurate milliliter measuring device. A household teaspoon is not an accurate measuring device.

Gloperba should not be given to patients with renal or hepatic impairment in conjunction with drugs that inhibit both CYP3A4 and P-gp.
Gloperba should not be given to patients with both renal and hepatic impairment.

Warnings and Precautions

  • Fatal Overdose. Fatal overdoses, both accidental and intentional, have been reported in adults and children who have ingested colchicine. Gloperba must always be kept out of the reach of children.
  • Blood Dyscrasias. Patients should be aware that bone marrow depression with agranulocytosis, aplastic anemia and thrombocytopenia may occur with Gloperba.
  • Neuromuscular toxicity. Patients should be informed that muscle pain or weakness, tingling or numbness in fingers or toes may occur with Gloperba alone or when it is used with certain other drugs. Patients developing any of these signs or symptoms must discontinue treatment and seek medical evaluation immediately.
  • Drug and Food Interactions. Patients are advised that many drugs or other substances may interact with Gloperba and some interactions could be fatal. Patients should report to their healthcare provider all of the current medications they are taking and check with their healthcare provider before starting any new medications, including short-term medications such as antibiotics. Patients should also be advised to report the use of nonprescription medication or herbal products. Grapefruit and grapefruit juice may also interact and should not be consumed during Gloperba treatment.
  • Infertility. Males of reproductive potential are advised that Gloperba may rarely and transiently impair fertility.

Adverse Reactions
The most commonly reported adverse reactions with colchicine are gastrointestinal symptoms, including diarrhea, nausea, vomiting, and abdominal pain.

Development timeline for Gloperba

Feb 26, 2019Approval FDA Approves Gloperba (colchicine) for Prophylaxis of Adult Gout Flares

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.