). Gastrointestinal Clostridium difficile-associated disease Clostridium difficile-associated disease (CDAD) has been reported with use of many antibacterial agents, including BAXDELA. CDAD may range in severity from mild diarrhea to fatal colitis.
It is important to consider this diagnosis in patients who present with diarrhea or symptoms of colitis, pseudomembranous colitis, toxic megacolon, or perforation of the colon subsequent to the administration of any antibacterial agent.
CDAD has been reported to occur over 2 months after the administration of antibacterial agents. Treatment with antibacterial agents may alter the normal flora of the colon and may permit overgrowth of Clostridium difficile. C. difficile produces toxins A and B, which contribute to the development of CDAD.
CDAD may cause significant morbidity and mortality. CDAD can be refractory to antimicrobial therapy. If the diagnosis of CDAD is suspected or confirmed, appropriate therapeutic measures should be initiated. Mild cases of CDAD usually respond to discontinuation of antibacterial agents not directed against Clostridium difficile.
In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial agent clinically effective against Clostridium difficile. Surgical evaluation should be instituted as clinically indicated since surgical intervention may be required in certain severe cases (see 8 ADVERSE REACTIONS).
Hematologic Patients with Glucose-6-phosphate Dehydrogenase Deficiency Patients with latent or actual defects in glucose-6-phosphate dehydrogenase activity may be prone to hemolytic reactions when treated with quinolone antibacterial agents.
Therefore, if BAXDELA has to be used in these patients, potential occurrence of hemolysis should be monitored. Immune Hypersensitivity Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving systemic therapy with quinolones, including delafloxacin.
These reactions often occurred following the first dose. Some reactions have be en accompanied by cardiovascular collapse, hypotension/shock, seizure, loss of consciousness, tingling, angioedema (including tongue, laryngeal, throat or facial edema/swelling), airway obstruction (including bronchospasm, shortness of breath, and acute re spiratory distress), dyspnea, BAXDELA / Delafloxacin Product Monograph Page 13 of 60 urticaria, itching, and other serious skin reactions.
Delafloxacin should be discontinued immediately at the first appearance of a skin rash or any other sign of hypersensitivity. Serious acute hypersensitivity reactions may require treatment with epinephrine and other resuscitative measures, including oxygen, intravenous fluids, antihistamines, corticosteroids, pressor, amines and airway management, as clinically indicated (see 8 ADVERSE REACTIONS).
Serious and sometimes fatal events, some due to hypersensitivity and some due to uncertain etiology, have rarely been reported in patients receiving systemic therapy with quinolones. These events may be severe, and generally occur following the administration of multiple doses.
, toxic epidermal necrolysis, Stevens-Johnson syndrome); vasculitis; arthralgia; myalgia; serum sickness; allergic pneumonitis; interstitial nephritis; acute renal insufficiency or failure; hepatitis, including acute hepatitis; jaundice; acute hepatic necrosis or failure; anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities.
The administration of BAXDELA should be discontinued immediately, at the first appearance of a skin rash or any other sign of hypersensitivity, and supportive measures instituted. Musculoskeletal Tendinitis and Tendon Rupture Rupture of the shoulder, hand and Achilles tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones.
BAXDELA should be discontinued if the patient experiences pain, inflammation or rupture of a tendon. Patients should rest and refrain from exercise until the diagnosis of tendinitis or tendon rupture has been confidently excluded. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over age 60 years of age, in patients taking corticosteroid drugs, and, in patients with kidney, heart, and lung transplants.
Factors, in addition to age and corticosteroid use, that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors.
Tendon rupture can occur during (within hours to weeks) or after completion of therapy; cases occurring up to several months after completion of therapy have been reported. BAXDELA should be discontinued immediately if the patient experiences pain, swelling, inflammation or rupture of a tendon.
Patients should be advised to rest at the first sign of tendinitis or tendon rupture, and to promptly contact their health professional regarding changing to a non-quinolone antimicrobial drug. BAXDELA should not be used in patients with a history of tendon disease/disorder related to previously quinolone treatment.
Myasthenia Gravis Fluoroquinolones have neuromuscular blocking activity and may exacerbate muscle weakness BAXDELA / Delafloxacin Product Monograph Page 14 of 60 in persons with myasthenia gravis. Post-marketing serious adverse reactions, including deaths and requirement for ventilator support, have been associated with fluoroquinolone use in persons with […]