Home FDA labels f77d4f79-bf54-40dd-84c8-8b2cd1c2ebe4 Famciclovir openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
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Brand name Famciclovir
Generic name FAMCICLOVIR
Manufacturer Proficient Rx LP
Product type HUMAN PRESCRIPTION DRUG
SPL set ID 29b7ea8b-b976-45cb-9006-a27ba797b0fd
SPL ID f77d4f79-bf54-40dd-84c8-8b2cd1c2ebe4
Version 4
Effective date 2022-06-01
Source export date 2026-09-28
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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 famciclovir for their level of renal function. Dosage reduction is recommended when administering famciclovir 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 famciclovir for their level of renal function. Reduce dosage in patients with renal impairment. ( 2.3 , 8.6 )
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adverse reactions 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 famciclovir are headache and nausea. The most common adverse events reported in at least 1 indication by >10% of adult patients are headache and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 866-495-1995 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 patients: The safety of famciclovir has been evaluated in active- and placebo-controlled clinical studies involving 163 famciclovir-treated patients with recurrent genital herpes (Famciclovir, 1000 mg twice daily); 1,197 patients with recurrent genital herpes treated with famciclovir as suppressive therapy (125 mg once daily to 250 mg three times daily) of which 570 patients received famciclovir (open-labeled and/or double-blind) for at least 10 months; and 447 famciclovir-treated patients with herpes labialis (Famciclovir, 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 Famciclovir Trials* Incidence Events Recurrent Genital Herpes ‡ Genital Herpes- Suppression § Herpes Labialis ‡ Famciclovir (n=163) % Placebo (n=166) % Famciclovir (n=458) % Placebo (n=63) % Famciclovir (n=447) % Placebo (n=254) % Nervous System Headache 13.5 5.4 39.3 42.9 8.5 6.7 Paresthesia 0.0 0.0 0.9 0.0 0.0 0.0 Migraine 0.6 0.6 3.1 0.0 0.2 0.0 Gastrointestinal Nausea 2.5 3.6 7.2 9.5 2.2 3.9 Diarrhea 4.9 1.2 9.0 9.5 1.6 0.8 Vomiting 1.2 0.6 3.1 1.6 0.7 0.0 Flatulence 0.6 0.0 4.8 1.6 0.2 0.0 Abdominal Pain 0.0 1.2 7.9 7.9 0.2 0.4 Body as a Whole Fatigue 0.6 0.0 4.8 3.2 1.6 0.4 Skin and Appendages Pruritus 0.0 0.6 2.2 0.0 0.0 0.0 Incidence Events Recurrent Genital Herpes ‡ Genital Herpes- Suppression § Herpes Labialis ‡ Famciclovir (n=163) % Placebo (n=166) % Famciclovir (n=458) % Placebo (n=63) % Famciclovir (n=447) % Placebo (n=254) % Rash 0.0 0.0 3.3 1.6 0.0 0.0 Reproductive (Female) Dysmenorrhea 1.8 0.6 7.6 6.3 0.4 0.0 *Patients may have entered into more than one clinical trial. ‡ 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 Famciclovir (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 patients: In HIV-infected patients, the most frequently reported adverse events for famciclovir (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 postapproval use of famciclovir. 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 Immune system disorders: Anaphylactic shock, anaphylactic reaction Nervous system disorders: Dizziness, somnolence, seizure 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), hypersensitivity vasculitis Cardiac disorders: Palpitations
adverse reactions table <table cellpadding="0pt" cellspacing="0pt" width="100%"><col width="16%"/><col width="15%"/><col width="15%"/><col width="15%"/><col width="15%"/><col width="12%"/><col width="12%"/><tbody><tr><td align="center" colspan="7" styleCode="Rrule Botrule Lrule Toprule " valign="bottom"><paragraph><content styleCode="bold">Incidence</content> </paragraph></td></tr><tr><td align="center" rowspan="2" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph><content styleCode="bold">Events</content> </paragraph></td><td align="center" colspan="2" styleCode="Rrule Botrule " valign="middle"><paragraph><content styleCode="bold">Recurrent Genital Herpes<sup>‡</sup></content> </paragraph></td><td align="center" colspan="2" styleCode="Rrule Botrule " valign="middle"><paragraph><content styleCode="bold">Genital Herpes- Suppression<sup>§</sup></content> </paragraph></td><td align="center" colspan="2" styleCode="Rrule Botrule " valign="middle"><paragraph><content styleCode="bold">Herpes Labialis<sup>‡</sup></content> </paragraph></td></tr><tr><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">Famciclovir</content> <content styleCode="bold">(n=163)</content> <content styleCode="bold">%</content> </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph><content styleCode="bold">Placebo (n=166) %</content> </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph><content styleCode="bold">Famciclovir</content> <content styleCode="bold">(n=458)</content> <content styleCode="bold">%</content> </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph><content styleCode="bold">Placebo (n=63) </content> <content styleCode="bold">%</content> </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph><content styleCode="bold">Famciclovir</content> <content styleCode="bold">(n=447)</content> <content styleCode="bold">%</content> </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph><content styleCode="bold">Placebo (n=254)</content> <content styleCode="bold">%</content> </paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">Nervous </content> <content styleCode="bold">System</content> </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph> </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph> </paragraph></td><td align="center" colspan="2" styleCode="Rrule Botrule " valign="top"><paragraph> </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph> </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph> </paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Headache </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>13.5 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>5.4 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>39.3 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>42.9 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>8.5 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>6.7 </paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Paresthesia </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.0 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.0 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.9 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.0 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.0 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.0 </paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Migraine </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.6 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.6 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>3.1 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.0 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.2 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.0 </paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">Gastrointestinal</content> </paragraph></td><td styleCode="Rrule Botrule " valign="top"><paragraph> </paragraph></td><td styleCode="Rrule Botrule " valign="top"><paragraph> </paragraph></td><td styleCode="Rrule Botrule " valign="top"><paragraph> </paragraph></td><td styleCode="Rrule Botrule " valign="top"><paragraph> </paragraph></td><td styleCode="Rrule Botrule " valign="top"><paragraph> </paragraph></td><td styleCode="Rrule Botrule " valign="top"><paragraph> </paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Nausea </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>2.5 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>3.6 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>7.2 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>9.5 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>2.2 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>3.9 </paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Diarrhea </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>4.9 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>1.2 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>9.0 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>9.5 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>1.6 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.8 </paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Vomiting </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>1.2 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.6 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>3.1 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>1.6 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.7 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.0 </paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Flatulence </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.6 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.0 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>4.8 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>1.6 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.2 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.0 </paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Abdominal Pain </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.0 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>1.2 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>7.9 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>7.9 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.2 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.4 </paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold"> Body as a Whole</content> </paragraph></td><td styleCode="Rrule Botrule " valign="top"><paragraph> </paragraph></td><td styleCode="Rrule Botrule " valign="top"><paragraph> </paragraph></td><td styleCode="Rrule Botrule " valign="top"><paragraph> </paragraph></td><td styleCode="Rrule Botrule " valign="top"><paragraph> </paragraph></td><td styleCode="Rrule Botrule " valign="top"><paragraph> </paragraph></td><td styleCode="Rrule Botrule " valign="top"><paragraph> </paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Fatigue </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.6 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.0 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>4.8 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>3.2 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>1.6 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.4 </paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">Skin and </content> <content styleCode="bold">Appendages</content> </paragraph></td><td styleCode="Rrule Botrule " valign="top"><paragraph> </paragraph></td><td styleCode="Rrule Botrule " valign="top"><paragraph> </paragraph></td><td styleCode="Rrule Botrule " valign="top"><paragraph> </paragraph></td><td styleCode="Rrule Botrule " valign="top"><paragraph> </paragraph></td><td styleCode="Rrule Botrule " valign="top"><paragraph> </paragraph></td><td styleCode="Rrule Botrule " valign="top"><paragraph> </paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Pruritus </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.0 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.6 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>2.2 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.0 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.0 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.0 </paragraph></td></tr><tr><td align="center" colspan="7" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph><content styleCode="bold">Incidence </content> </paragraph></td></tr><tr><td align="center" rowspan="2" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph><content styleCode="bold">Events</content> </paragraph></td><td align="center" colspan="2" styleCode="Rrule Botrule " valign="middle"><paragraph><content styleCode="bold">Recurrent Genital Herpes<sup>‡</sup></content> </paragraph></td><td align="center" colspan="2" styleCode="Rrule Botrule " valign="middle"><paragraph><content styleCode="bold">Genital Herpes- Suppression<sup>§</sup></content> </paragraph></td><td align="center" colspan="2" styleCode="Rrule Botrule " valign="middle"><paragraph><content styleCode="bold">Herpes Labialis<sup>‡</sup></content> </paragraph></td></tr><tr><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">Famciclovir</content> <content styleCode="bold">(n=163)</content> <content styleCode="bold">%</content> </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph><content styleCode="bold">Placebo (n=166) %</content> </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph><content styleCode="bold">Famciclovir</content> <content styleCode="bold">(n=458)</content> <content styleCode="bold">%</content> </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph><content styleCode="bold">Placebo (n=63)</content> <content styleCode="bold">%</content> </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph><content styleCode="bold">Famciclovir</content> <content styleCode="bold">(n=447)</content> <content styleCode="bold">%</content> </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph><content styleCode="bold">Placebo (n=254)</content> <content styleCode="bold">%</content> </paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Rash </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.0 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.0 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>3.3 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>1.6 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.0 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.0 </paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">Reproductive</content> <content styleCode="bold"> (Female)</content> </paragraph></td><td styleCode="Rrule Botrule " valign="top"><paragraph> </paragraph></td><td styleCode="Rrule Botrule " valign="top"><paragraph> </paragraph></td><td styleCode="Rrule Botrule " valign="top"><paragraph> </paragraph></td><td styleCode="Rrule Botrule " valign="top"><paragraph> </paragraph></td><td styleCode="Rrule Botrule " valign="top"><paragraph> </paragraph></td><td styleCode="Rrule Botrule " valign="top"><paragraph> </paragraph></td></tr><tr><td styleCode="Rrule Botrule Lrule " valign="top"><paragraph>Dysmenorrhea </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>1.8 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.6 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>7.6 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>6.3 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.4 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.0 </paragraph></td></tr></tbody></table>
adverse reactions table <table cellpadding="0pt" cellspacing="0pt" width="100%"><col width="33%"/><col width="33%"/><col width="33%"/><tbody><tr><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph><content styleCode="bold">Parameter</content> </paragraph></td><td align="center" styleCode="Rrule Botrule Toprule " valign="top"><paragraph><content styleCode="bold">Famciclovir </content> <content styleCode="bold">(n = 660)<sup>†</sup></content> <content styleCode="bold">%</content> </paragraph></td><td align="center" styleCode="Rrule Botrule Toprule " valign="top"><paragraph><content styleCode="bold">Placebo</content> <content styleCode="bold">(n = 210)<sup>†</sup></content> <content styleCode="bold">%</content> </paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Anemia (<0.8 x NRL) </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.1 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.0 </paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Leukopenia (<0.75 x NRL) </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>1.3 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.9 </paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Neutropenia (<0.8 x NRL) </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>3.2 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>1.5 </paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>AST (SGOT) (>2 x NRH) </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>2.3 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>1.2 </paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>ALT (SGPT) (>2 x NRH) </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>3.2 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>1.5 </paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Total Bilirubin (>1.5 x NRH) </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>1.9 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>1.2 </paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Serum Creatinine (>1.5 x NRH) </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.2 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>0.3 </paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Amylase (>1.5 x NRH) </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>1.5 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>1.9 </paragraph></td></tr><tr><td styleCode="Rrule Botrule Lrule " valign="top"><paragraph>Lipase (>1.5 x NRH) </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>4.9 </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>4.7 </paragraph></td></tr></tbody></table>
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