Moxifloxacin (Page 5 of 10)

8.2 Lactation

Risk Summary

It is not known if moxifloxacin is present in human milk. Based on animal studies in rats, moxifloxacin may be excreted in human milk (see Data). When a drug is present in animal milk, it is likely that the drug will be present in human milk.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for moxifloxacin and any potential adverse effects on the breastfed child from moxifloxacin or from the underlying maternal condition.

Data

In lactating rats given a single oral dose of 4.59 mg/kg moxifloxacin (approximately 9 times less than the recommended human dose based on body surface area) 8 days postpartum, there was very low excretion of substance-related radioactivity into the milk, amounting to approximately 0.03% of the dose.

8.4 Pediatric Use

Effectiveness in pediatric patients and adolescents less than 18 years of age has not been established. Moxifloxacin causes arthropathy in juvenile animals. Limited information on the safety of moxifloxacin in 301 pediatric patients is available from the cIAI trial [see Boxed Warning, Warnings and Precautions (5.11) and Nonclinical Toxicology (13.2)].

Active Controlled Trial in Complicated Intra-Abdominal Infection (cIAI)

The safety and efficacy of moxifloxacin in pediatric patients for the treatment of cIAI has not been demonstrated.

Pediatric patients 3 months to <18 years of age (mean age of 12 ± 4 years) were enrolled in a single randomized, double-blind, active controlled trial in cIAI including appendicitis with perforation, abscesses and peritonitis.

Pediatric patients were randomized (2:1) to receive either moxifloxacin or comparator. This study enrolled 451 patients who received study medication, 301 treated with moxifloxacin, and 150 with comparator. Of the 301 pediatric patients treated with moxifloxacin, 15 were below the age of 6 years and 286 were between the ages of 6 to <18 years.

Patients received sequential intravenous/oral moxifloxacin or comparator (intravenous ertapenem followed by oral amoxicillin/clavulanate) for 5 to 14 days (mean duration was 9 days with a range of 1 to 24 days).

The overall adverse reaction profile in pediatric patients was comparable to that of adult patients. The most frequently occurring adverse reactions in pediatric patients treated with moxifloxacin were QT prolongation 9.3% (28/301), vomiting, 6.6% (20/301) diarrhea 3.7% (11/301), arthralgia 3% (9/301), and phlebitis 2.7% (8/301) (see Table 5). Discontinuation of study drug due to an adverse reaction was reported in 5.3% (16/301) of moxifloxacin-treated patients versus 1.3% (2/150) of comparator-treated patients. The adverse reaction profile of moxifloxacin or comparator was similar across all age groups studied.

Musculoskeletal adverse reactions were monitored and followed up to 5 years after the end of study treatment. The rates of musculoskeletal adverse reactions were 4.3% (13/301) in the moxifloxacin-treated group versus 3.3% (5/150) in the comparator-treated group. The majority of musculoskeletal adverse reactions were reported between 12 and 53 weeks after start of study treatment with complete resolution at the end of the study [see Warnings and Precautions (5.11) and Nonclinical Toxicology (13.2)].

Table 5 Incidence (%) of Selected Adverse Reactions in ≥2% of Pediatric Patients Treated with Moxifloxacin in cIAI Clinical Trial

System Organ Class Adverse Reactions Moxifloxacin N = 301 (%) Comparator N = 150 (%)
Gastrointestinal disorders Abdominal pain 8 (2.7) 3 (2.0)
Diarrhea 11 (3.7) 1 (0.7)
Vomiting 20 (6.6) 12 (8.0)
General disorders and administration site conditions Pyrexia 6 (2.0) 4 (2.7)
Investigations Aspartate aminotransferaseincreased 2 (0.7) 3 (2.0)
Electrocardiogram QTprolonged 28 (9.3) 4 (2.7)
Musculoskeletal and connective tissue disorders Arthralgia 9 (3.0) 2 (1.3)
Nervous system disorders Headache 6 (2.0) 2 (1.3)
Vascular disorders Phlebitis 8 (2.7) 0 (0)

Clinical response was assessed at the test-of-cure visit (28 to 42 days after end of treatment). The clinical response rates observed in the modified intent to treat population were 83.9% (208/248) for moxifloxacin and 95.5% (127/133) for comparator; see Table 6.

Table 6: Clinical Response Rates at 28 to 42 Days After End of Treatment in Pediatric Patients with cIAI

Moxifloxacin n (%) Comparator n (%) Difference2 (95% CI)
mITT Population1 N=248 N=133
Cure 208 (83.9) 127 (95.5) -12.2 (-17.9, -6.4)
Failure 17 (6.9) 3 (2.3)
Indeterminate 21 (8.5) 3 (2.3)
Missing 2 (0.8) 0

1 The modified intent-to-treat (mITT) population is defined as all subjects who were treated with at least one dose of study medication and who have at least one pre-treatment causative organism from the intra-abdominal site of infection or from blood cultures.

2 Difference in clinical cure rates (Moxifloxacin — Comparator) and 95% confidence intervals, presented as percentages, are based on stratified analysis by age group using Mantel-Haenszel methods.

8.5 Geriatric Use

Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as moxifloxacin. This risk is further increased in patients receiving concomitant corticosteroid therapy. Tendinitis or tendon rupture can involve the Achilles, hand, shoulder, or other tendon sites and can occur during or after completion of therapy; cases occurring up to several months after fluoroquinolone treatment have been reported. Caution should be used when prescribing moxifloxacin to elderly patients especially those on corticosteroids. Patients should be informed of this potential side effect and advised to discontinue moxifloxacin and contact their healthcare provider if any symptoms of tendinitis or tendon rupture occur [see Boxed Warning, Warnings and Precautions (5.2)]

Epidemiologic studies report an increased rate of aortic aneurysm and dissection within two months following use of fluoroquinolones, particularly in elderly patients [see Warnings and Precautions (5.9)].

In controlled multiple-dose clinical trials, 23% of patients receiving oral moxifloxacin were greater than or equal to 65 years of age and 9% were greater than or equal to 75 years of age. The clinical trial data demonstrate that there is no difference in the safety and efficacy of oral moxifloxacin in patients aged 65 or older compared to younger adults.

In trials of intravenous use, 42% of moxifloxacin patients were greater than or equal to 65 years of age, and 23% were greater than or equal to 75 years of age. The clinical trial data demonstrate that the safety of intravenous moxifloxacin in patients aged 65 or older was similar to that of comparator-treated patients. In general, elderly patients may be more susceptible to drug-associated effects of the QT interval. Therefore, moxifloxacin should be avoided in patients taking drugs that can result in prolongation of the QT interval (for example, class IA or class III antiarrhythmics) or in patients with risk factors for torsade de pointes (for example, known QT prolongation, uncorrected hypokalemia) [see Warnings and Precautions ( 5.6 ), Drug Interactions ( 7.5), and Clinical Pharmacology ( 12.3) ].

8.6 Renal Impairment

The pharmacokinetic parameters of moxifloxacin are not significantly altered in mild, moderate, severe, or end-stage renal disease. No dosage adjustment is necessary in patients with renal impairment, including those patients requiring hemodialysis (HD) or continuous ambulatory peritoneal dialysis (CAPD) [see Dosage and Administration ( 2), and Clinical Pharmacology ( 12.3).]

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