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warnings and cautions
5 WARNINGS AND PRECAUTIONS Acute renal failure: Cases of acute renal failure have been reported in patients with underlying renal disease who have received inappropriately high doses of FAMVIR for their level of renal function. Dosage reduction is recommended when administering FAMVIR to patients with renal impairment [see Dosage and Administration (2.3), Use in Specific Populations (8.6) ]. Acute renal failure: May occur in patients with underlying renal disease who receive higher than recommended doses of FAMVIR for their level of renal function. Reduce dosage in patients with renal impairment. ( 2.3 , 8.6 )
6 ADVERSE REACTIONS Acute renal failure is discussed in greater detail in other sections of the label [see Warnings and Precautions (5)]. The most common adverse events reported in at least 1 indication by >10% of adult patients treated with FAMVIR are headache and nausea. The most common adverse events reported in at least one indication by >10% of adult patients are headache and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience in Adult Patients Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Immunocompetent p atients: The safety of FAMVIR has been evaluated in active- and placebo-controlled clinical studies involving 816 FAMVIR-treated patients with herpes zoster (FAMVIR, 250 mg three times daily to 750 mg three times daily); 163 FAMVIR-treated patients with recurrent genital herpes (FAMVIR, 1000 mg twice daily); 1,197 patients with recurrent genital herpes treated with FAMVIR as suppressive therapy (125 mg once daily to 250 mg three times daily) of which 570 patients received FAMVIR (open-labeled and/or double-blind) for at least 10 months; and 447 FAMVIR-treated patients with herpes labialis (FAMVIR, 1500 mg once daily or 750 mg twice daily). Table 2 lists selected adverse events. Table 2 Selected Adverse Events (all grades and without regard to causality) Reported by ≥ 2% of Patients in Placebo-Controlled Famvir Trials* Incidence Herpes Zoster † Recurrent Genital Herpes ‡ Genital Herpes- Suppression § Herpes Labialis ‡ Famvir Placebo Famvir Placebo Famvir Placebo Famvir Placebo (n=273) (n=146) (n=163) (n=166) (n=458) (n=63) (n= 447 ) (n=254) Events % % % % % % % % Nervous System Headache 22.7 17.8 13.5 5.4 39.3 42.9 8.5 6.7 Paresthesia 2.6 0.0 0.0 0.0 0.9 0.0 0.0 0.0 Migraine 0.7 0.7 0.6 0.6 3.1 0.0 0.2 0.0 Gastrointestinal Nausea 12.5 11.6 2.5 3.6 7.2 9.5 2.2 3.9 Diarrhea 7.7 4.8 4.9 1.2 9.0 9.5 1.6 0.8 Vomiting 4.8 3.4 1.2 0.6 3.1 1.6 0.7 0.0 Flatulence 1.5 0.7 0.6 0.0 4.8 1.6 0.2 0.0 Abdominal Pain 1.1 3.4 0.0 1.2 7.9 7.9 0.2 0.4 Body as a Whole Fatigue 4.4 3.4 0.6 0.0 4.8 3.2 1.6 0.4 Skin and Appendages Pruritus 3.7 2.7 0.0 0.6 2.2 0.0 0.0 0.0 Rash 0.4 0.7 0.0 0.0 3.3 1.6 0.0 0.0 Reproductive (Female) Dysmenorrhea 0.0 0.7 1.8 0.6 7.6 6.3 0.4 0.0 * Patients may have entered into more than one clinical trial. † 7 days of treatment ‡ 1 day of treatment § daily treatment Table 3 lists selected laboratory abnormalities in genital herpes suppression trials. Table 3 Selected Laboratory Abnormalities in Genital Herpes Suppression Studies* Parameter Famvir (n = 660) † % Placebo (n = 210) † % Anemia (<0.8 x NRL) 0.1 0.0 Leukopenia (<0.75 x NRL) 1.3 0.9 Neutropenia (<0.8 x NRL) 3.2 1.5 AST (SGOT) (>2 x NRH) 2.3 1.2 ALT (SGPT) (>2 x NRH) 3.2 1.5 Total Bilirubin (>1.5 x NRH) 1.9 1.2 Serum Creatinine (>1.5 x NRH) 0.2 0.3 Amylase (>1.5 x NRH) 1.5 1.9 Lipase (>1.5 x NRH) 4.9 4.7 * Percentage of patients with laboratory abnormalities that were increased or decreased from baseline and were outside of specified ranges. † n values represent the minimum number of patients assessed for each laboratory parameter. NRH = Normal Range High. NRL = Normal Range Low. HIV-infected p atients : In HIV-infected patients, the most frequently reported adverse events for FAMVIR (500 mg twice daily; n=150) and acyclovir (400 mg, 5x/day; n=143), respectively, were headache (17% vs. 15%), nausea (11% vs. 13%), diarrhea (7% vs. 11%), vomiting (5% vs. 4%), fatigue (4% vs. 2%), and abdominal pain (3% vs. 6%). 6. 2 Postmarketing Experience The adverse events listed below have been reported during post-approval use of FAMVIR. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Blood and lymphatic system disorders: Thrombocytopenia Hepatobiliary disorders : Abnormal liver function tests, cholestatic jaundice Nervous system disorders : Dizziness, somnolence Psychiatric disorders : Confusion (including delirium, disorientation, and confusional state occurring predominantly in the elderly), hallucinations Skin and subcutaneous tissue disorders : Urticaria, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema (e.g. face, eyelid, periorbital, and pharyngeal edema.)