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adverse reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: • Thrombotic Thrombocytopenic Purpura/Hemolytic Uremic Syndrome [see Warnings and Precautions (5.1) ]. • Acute Renal Failure [see Warnings and Precautions (5.2) ] . • Central Nervous System Effects [see Warnings and Precautions (5.3) ] . The most common adverse reactions reported in at least one indication by > 10% of adult patients treated with valacyclovir and observed more frequently with valacyclovir compared to placebo are headache, nausea and abdominal pain. The only adverse reaction reported in > 10% of pediatric patients < 18 years of age was headache. • The most common adverse reactions reported in at least one indication by > 10% of adult patients treated with valacyclovir and more commonly than in patients treated with placebo are headache, nausea and abdominal pain. ( 6.1 ) • The only adverse reaction occurring in > 10% of pediatric patients < 18 years of age was headache. ( 6.2 )To report SUSPECTED ADVERSE REACTIONS, contact Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX) 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. Cold Sores (Herpes Labialis) In clinical studies for the treatment of cold sores, the adverse reactions reported by patients receiving valacyclovir 2 grams twice daily (n = 609) or placebo (n = 609) for one day, respectively, included headache (14%, 10%) and dizziness (2%, 1%). The frequencies of abnormal ALT (> 2 x ULN) were 1.8% for patients receiving valacyclovir compared with 0.8% for placebo. Other laboratory abnormalities (hemoglobin, white blood cells, alkaline phosphatase and serum creatinine) occurred with similar frequencies in the two groups. Genital Herpes Initial Episode In a clinical study for the treatment of initial episodes of genital herpes, the adverse reactions reported by ≥ 5% of patients receiving valacyclovir 1 gram twice daily for 10 days (n = 318) or oral acyclovir 200 mg 5 times daily for 10 days (n = 318), respectively, included headache (13%, 10%) and nausea (6%, 6%). For the incidence of laboratory abnormalities see Table 2 . Recurrent Episodes In three clinical studies for the episodic treatment of recurrent genital herpes, the adverse reactions reported by ≥ 5% of patients receiving valacyclovir 500 mg twice daily for 3 days (n = 402), valacyclovir 500 mg twice daily for 5 days (n = 1,136) or placebo (n = 259), respectively, included headache (16%, 11%, 14%) and nausea (5%, 4%, 5%). For the incidence of laboratory abnormalities see Table 2 . Suppressive Therapy Suppression of Recurrent Genital Herpes in Immunocompetent Adults In a clinical study for the suppression of recurrent genital herpes infections, the adverse reactions reported by patients receiving valacyclovir 1 gram once daily (n = 269), valacyclovir 500 mg once daily (n = 266), or placebo (n = 134), respectively, included headache (35%, 38%; 34%), nausea (11%, 11%, 8%), abdominal pain (11%, 9%, 6%), dysmenorrhea (8%, 5%, 4%), depression (7%, 5%, 5%), arthralgia (6%, 5%, 4%), vomiting (3%, 3%, 2%) and dizziness (4%, 2%, 1%). For the incidence of laboratory abnormalities see Table 2 . Suppression of Recurrent Genital Herpes in HIV-Infected Patients In HIV-infected patients, frequently reported adverse reactions for valacyclovir (500 mg twice daily; n = 194, median days on therapy = 172) and placebo (n = 99, median days on therapy = 59), respectively, included headache (13%, 8%), fatigue (8%, 5%) and rash (8%, 1%). Post-randomization laboratory abnormalities that were reported more frequently in valacyclovir subjects versus placebo included elevated alkaline phosphatase (4%, 2%), elevated ALT (14%, 10%), elevated AST (16%, 11%), decreased neutrophil counts (18%, 10%) and decreased platelet counts (3%, 0%), respectively. Reduction of Transmission In a clinical study for the reduction of transmission of genital herpes, the adverse reactions reported by patients receiving valacyclovir 500 mg once daily (n = 743) or placebo once daily (n = 741), respectively, included headache (29%, 26%), nasopharyngitis (16%, 15%) and upper respiratory tract infection (9%, 10%). Herpes Zoster In two clinical studies for the treatment of herpes zoster, the adverse reactions reported by patients receiving valacyclovir 1 gram 3 times daily for 7 to 14 days (n = 967) or placebo (n = 195), respectively, included nausea (15%, 8%), headache (14%, 12%), vomiting (6%, 3%), dizziness (3%, 2%) and abdominal pain (3%, 2%). For the incidence of laboratory abnormalities see Table 2. Table 2. Incidence (%) of Laboratory Abnormalities in Herpes Zoster and Genital Herpes Study Populations Laboratory Abnormality Herpes Zoster Genital Herpes Treatment Genital Herpes Suppression Valacyclovir 1 gram 3 times daily (n = 967) Placebo (n = 195) Valacyclovir 1 gram twice daily (n = 1,194) Valacyclovir 500 mg twice daily (n = 1,159) Placebo (n = 439) Valacyclovir 1 gram once daily (n = 269) Valacyclovir 500 mg once daily (n = 266) Placebo (n = 134) Hemoglobin (< 0.8 x LLN) 0.8% 0% 0.3% 0.2% 0% 0% 0.8% 0.8% White blood cells (< 0.75 x LLN) 1.3% 0.6% 0.7% 0.6% 0.2% 0.7% 0.8% 1.5% Platelet count (< 100,000/mm 3 ) 1% 1.2% 0.3% 0.1% 0.7% 0.4% 1.1% 1.5% AST (SGOT) (> 2 x ULN) 1% 0% 1% Data were not collected prospectively. 0.5% 4.1% 3.8% 3% Serum creatinine (> 1.5 x ULN) 0.2% 0% 0.7% 0% 0% 0% 0% 0% LLN = Lower limit of normal. ULN = Upper limit of normal. 6.2 Clinical Trials Experience in Pediatric Patients Sixty-five pediatric patients, 12 to < 18 years of age, received oral caplets for 1 to 2 days for treatment of cold sores. The frequency, intensity, and nature of clinical adverse reactions and laboratory abnormalities were similar to those seen in adults. Pediatric Patients 12 to < 18 Years of Age (Cold Sores) In clinical studies for the treatment of cold sores, the adverse reactions reported by adolescent patients receiving valacyclovir 2 grams twice daily for 1 day, or valacyclovir 2 grams twice daily for 1 day followed by 1 gram twice daily for 1 day (n = 65, across both dosing groups) or placebo (n = 30), respectively, included headache (17%, 3%) and nausea (8%, 0%). Labeling describing additional clinical trial adverse reactions in pediatric patients (ages of one month to ≤ 12 years) is approved for GlaxoSmithKline’s Valtrex ® Caplets. However, due to GlaxoSmithKline’s marketing exclusivity rights, a description of those adverse reactions is not approved for this valacyclovir hydrochloride tablet product. 6.3 Post-marketing Experience In addition to adverse events reported from clinical trials, the following events have been identified during post-marketing use of valacyclovir. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting or potential causal connection to valacyclovir. General: Facial edema, hypertension, tachycardia. Allergic: Acute hypersensitivity reactions including anaphylaxis, angioedema, dyspnea, pruritus, rash and urticaria [see Contraindications (4) ] . CNS Symptoms: Aggressive behavior; agitation; ataxia; coma; confusion; decreased consciousness; dysarthria; encephalopathy; mania; and psychosis, including auditory and visual hallucinations, seizures, tremors [see Warnings and Precautions (5.3) , Use in Specific Populations (8.5) , (8.6) ]. Eye: Visual abnormalities. Gastrointestinal: Diarrhea. Hepatobiliary Tract and Pancreas: Liver enzyme abnormalities, hepatitis. Renal: Renal failure, renal pain (may be associated with renal failure) [see Warnings and Precautions (5.2) , Use in Specific Populations (8.5) , (8.6) ] . Hematologic: Thrombocytopenia, aplastic anemia, leukocytoclastic vasculitis, TTP/HUS [see Warnings and Precautions (5.1) ] . Skin: Erythema multiforme, rashes including photosensitivity, alopecia.