ADVERSE REACTIONS
Immunocompetent Patients
The safety of Famvir® (famciclovir) has been evaluated in clinical studies involving 816 Famvir-treated patients with herpes zoster (Famvir, 250 mg t.i.d. to 750 mg t.i.d.); 163 Famvir-treated patients with recurrent genital herpes (Famvir, 1000 mg b.i.d.); 1,197 patients with recurrent genital herpes treated with Famvir as suppressive therapy (125 mg q.d. to 250 mg t.i.d.) 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 or 750 mg b.i.d.). Table 5 lists selected adverse events.
Table 5 Selected Adverse Events (all grades and without regard to causality) Reported by ≥2% of Patients in Placebo-controlled Famvir® (famciclovir) Trials* | | | Incidence | |
| | Herpes Zoster † | Recurrent
Genital Herpes ‡ | Genital Herpes-
Suppression § | Herpes Labialis ‡ |
| Event | Famvir ® | Placebo | Famvir ® | Placebo | Famvir ® | Placebo | Famvir ® | Placebo |
| | 500 mg | | 1 gram | | 250 mg | | 1500 mg | |
| | t.i.d* | | b.i.d* | | b.i.d* | | single dose* | |
| | (n=273) | (n=146) | (n=163) | (n=166) | (n=458) | (n=63) | (n=227) | (n=254) |
| | % | % | % | % | % | % | % | % |
| Nervous System |
| Headache | 22.7 | 17.8 | 13.5 | 5.4 | 39.3 | 42.9 | 9.7 | 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 | 0.0 | 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 | 1.8 | 0.8 |
| Vomiting | 4.8 | 3.4 | 1.2 | 0.6 | 3.1 | 1.6 | 0.0 | 0.0 |
| Flatulence | 1.5 | 0.7 | 0.6 | 0.0 | 4.8 | 1.6 | 0.0 | 0.0 |
| Abdominal Pain | 1.1 | 3.4 | 0.0 | 1.2 | 7.9 | 7.9 | 0.0 | 0.4 |
| Body as a Whole |
| Fatigue | 4.4 | 3.4 | 0.6 | 0.0 | 4.8 | 3.2 | 1.3 | 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 | 0.9 | 0.0 |
*Patients may have entered into more than one clinical trial.
† 7 days of treatment
‡ 1 day of treatment
§daily treatment
Table 6 lists selected laboratory abnormalities in genital herpes suppression trials.
Table 6 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 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 (16.7% vs. 15.4%), nausea (10.7% vs. 12.6%), diarrhea (6.7% vs. 10.5%), vomiting (4.7% vs. 3.5%), fatigue (4.0% vs. 2.1%), and abdominal pain (3.3% vs. 5.6%).
Post Marketing Experience
The following adverse events have been reported during post-approval use of Famvir: urticaria, serious skin reactions (e.g. erythema multiforme,Stevens-Johnson syndrome, toxic epidermal necrolysis), cholestatic jaundice, abnormal liver function tests, thrombocytopenia, hallucinations, dizziness, somnolence and confusion (including delirium, disorientation, confusional state, occurring predominantly in the elderly). Because these adverse events are reported voluntarily from a population of unknown size, estimates of frequency cannot be made.
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REPORTS OF SUSPECTED FAMVIR SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Famvir. The information is not vetted and should not be considered as verified clinical evidence.
Possible Famvir side effects / adverse reactions in 72 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2011-10-14
Patient: 72 year old female
Reactions: Loss of Consciousness
Suspect drug(s):
Famvir
Possible Famvir side effects / adverse reactions in 72 year old female
Reported by a individual with unspecified qualification from Japan on 2011-10-20
Patient: 72 year old female
Reactions: Blood Pressure Decreased, Loss of Consciousness
Suspect drug(s):
Famvir
Other drugs received by patient: Tramadol Hydrochloride/acetaminophen; Xyzal
Possible Famvir side effects / adverse reactions in 76 year old male
Reported by a pharmacist from Spain on 2011-10-25
Patient: 76 year old male
Reactions: Pneumonia, Agranulocytosis
Adverse event resulted in: hospitalization
Suspect drug(s):
Famvir
Dosage: unk
Administration route: Oral
Indication: Herpes Zoster
Start date: 2011-06-24
Mirtazapine
Dosage: 30 mg, qd
Administration route: Oral
Indication: Depression
Start date: 2011-06-20
End date: 2011-06-27
Other drugs received by patient: Omeprazole; Insulin; Sintrom; Plantaben; Fluoxetine
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