Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying and controlled conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not predict the rates observed in a broader patient population in clinical practice.
In the LoDoCo2 trial, myalgia was reported for 21.2% of individuals randomized to colchicine and 18.5% of individuals randomized to matching placebo (hazard ratio 1.15, 95%CI 1.01-1.31).
6.2 Postmarketing Experience The following adverse reactions have been identified with colchicine.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or establish a causal relationship to drug exposure.
These most often occur with excessive accumulation or overdosage [see Overdosage (10)] .
Neuromuscular : myotoxicity, weakness, numbness, paresthesia, rhabdomyolysis.
Gastrointestinal : diarrhea, vomiting, abdominal cramping, abdominal pain.
Renal : acute renal impairment Dermatology : rashes and alopecia Hematological : thrombocytopenia, leukopenia, pancytopenia The common side-effects reported in published clinical studies and literature with the use of colchicine are gastrointestinal symptoms (diarrhea;
abdominal cramping) and myalgia ( 6 ).
To report SUSPECTED ADVERSE REACTIONS, contact AGEPHA Pharma FZ LLC at 1 (800) 963-0353 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
WARNINGS AND PRECAUTIONS 5.1 Blood Dyscrasias LODOCO can cause myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, and aplastic anemia, which can be life-threatening or fatal [see Adverse Reactions (6)] .
Gastrointestinal symptoms often are the first sign of colchicine toxicity, so new symptoms should prompt an evaluation for toxicity.
Concomitant use of drugs that reduce the metabolism of colchicine or the presence of hepatic or renal impairment increases the risk of developing blood dyscrasias.
Use of LODOCO in patients with pre-existing blood dyscrasias, renal failure (Creatinine clearance less than 15 mL/minute), or severe hepatic dysfunction, and concomitant use of strong CYP3A4 inhibitors or P-glycoprotein inhibitors is contraindicated [see Contraindications (4)] .
Concomitant use of moderate CYP3A4 inhibitors with LODOCO should be avoided in patients with risk factors for increased systemic exposure of colchicine.
Like all medications, Lodoco can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: