Avelox® Product Safety

Avelox® (moxifloxacin) has been extensively investigated in over 18,000 patients in clinical trials and 134,000 patients in post-marketing surveillance studies. In addition, there is extensive clinical experience with Avelox® with over 134 million patients treated worldwide.

Table 1. Details adverse events that are commonly (>1/100, <1/10) reported during therapy with Avelox® 400mg in the clinical trials

Read full details of adverse events, including less common events

Contraindications

Avelox® is contraindicated in the following:

• Patients with hypersensitivity to moxifloxacin, other quinolones or to any of the excipients
• Patients who are pregnant or lactating
• Patients below 18 years of age

Warnings and Precautions

In some instances, hypersensitivity, allergic and anaphylactic reactions occurred after the first administration of Avelox® (In very rare instances anaphylactic reactions can progress to a life threatening shock ). Treatment should be discontinued and medical treatment provided, as required.

Both in preclinical investigations and in humans, changes in cardiac electrophysiology have been observed following exposure to Avelox®, in the form of QT prolongation. For reasons of drug safety, treatment with Avelox® should be avoided in:

• Patients with known prolongation of the QT interval
• Patients with uncorrected hypokalaemia
• Patients receiving class IA (e.g. quinidine, procainamide) or class III (e.g. amiodarone, sortalol) antiarrhythmic agents

Treatment with Avelox® should be used with caution in:

• Female and elderly patients who may be more susceptible to the effects of QTc-prolonging drugs
• Patients with liver cirrhosis as pre-existing QT prolongation cannot be excluded
• Patients receiving drugs that prolong the QT interval (e.g. cisapride, erythromycin, antipsychotics and tricyclic antidepressants)
• Patients with ongoing proarrhythmic conditions, such as significant bradycardia or acute myocardial ischemia
• Patients with CNS disorders which may predispose to seizures or lower the seizure threshold
• Patients with myasthenia gravis

As the magnitude of QT prolongation may increase with increasing concentrations of the drug, the recommended dose and infusion rate of IV Avelox® (400mg within 60 minutes) should not be exceeded.

Due to limited clinical data, Avelox® is contraindicated in patients with impaired liver function (Child Pugh C) and in patients with transaminases increase > 5-fold ULN.

Cases of fulminant hepatitis potentially leading to life-threatening liver failure (including fatal cases) have been reported. Patients should be advised to contact their doctor immediately prior to continuing treatment if symptoms relating to liver failure occur.

Cases of bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported with Avelox®. Patients should be advised to contact their doctor immediately prior to continuing treatment if skin and/or mucosal reactions occur.

Tendon inflammation and rupture may occur, particularly in the elderly and those on concurrent treatment with corticosteroids.

Moxifloxacin is not recommended for the treatment of MRSA infections. In case of a suspected or confirmed infection due to MRSA, treatment with an appropriate antibacterial agent should be started.

Interactions with Other Medicinal Products and Other Forms of Interaction

Concomitant ingestion of Avelox® with antacids, minerals and multi-vitamins may result in impaired absorption of Avelox® due to formation of chelate complexes with the multi-valent cations contained in these preparations, leading to lower-than-desired concentrations of Avelox® in the blood. Avelox® IV solution for infusion should be administered over a period of not less than 60 minutes by direct infusion or through a Y-type intravenous infusion set with compatible infusion solutions.

No interaction during concomitant treatment with warfarin on pharmacokinetics, prothrombin time and other coagulation parameters has been observed. However, cases of increased anticoagulant activity have been reported in patients receiving anticoagulants with antibiotics, including Avelox®. INR (International Normalised Ratio) monitoring should be performed and, if necessary, the oral anticoagulant dosage should be adjusted as appropriate.

The pharmacokinetics of digoxin are not significantly influenced by Avelox® and vice versa. After repeated dosing in healthy volunteers Avelox® increased the C_max of digoxin by approximately 30% at steady state without affecting AUC or trough levels.

For the following substances, absence of a clinically relevant interaction with Avelox® was proven: atenolol, ranitidine, calcium supplements, theophylline, per oral (PO) contraceptives, glibenclamide, itraconazole, digoxin, morphine, probenecid. No dose adjustment is necessary for these drugs.

Absorption of Avelox® was not altered by food intake (including dairy products). Avelox® can be taken independent from food intake.

*Contraindications may vary from country to country, please ensure you consult your local prescribing information before prescribing Avelox®.

For further information on using Avelox® in the management of bacterial infections, please consult your local country specific prescribing information.