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A SPIRIVA HandiHaler (tmtmnaim bromide inhalation powder) Spiriva HandiHaler (tiotropium bromide inhalation powder) FOR ORAL INHALATION ONLY Brief Summary of Prescribing Information INDICATIONS AND USAGE SPIRIVA HandiHaler (tiotropium bromide inhalation powder) is indicated for the long-term, once-daisy. maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD). including chronic bronchitis and emphysema CONTRAINDICATIONS SPIRIVA HandiHaler (tiotropium bromide inhalation powder) is contraindicated in patients with a history of hypersensitivity to atropine or its derivatives, includ ing ipratropium, or to any component of this product. WARNINGS SPIRIVA HanoiHaier (tiotropium bromide inhalation powder) is intended as a once-daiiy maintenance treatment for COPD and is not indicated for the initial treatment of acute episodes of bronchospasm. i.e.. rescue therapy Immediate hypersensitivity reactions, including angioeoema. may occur after administration of SPIRIVA. If such a reaction occurs, therapy with SPIRIVA should be stopped at once and alternative treatments should be considered. Inhaled medicines, includ ing SPIRIVA may cause parade* ca bronchospasm. If this occurs, treatment with SPIRIVA should be stopped ano other treatments considered. PRECAUTIONS General As an anbchohnergK drug. SPIRIVA (tiotropium bromide inhalation powder) may potentially worsen symptoms and s’gns associated with narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction and should be used with caution in patients with any of these conditions. As a predominantly renaHy excreted drug, patients with moderate to severe renal impairment (creatinin clearance of sSO ml/min) treated with SPIRIVA should be monitored closely (see CLINICAL PHARMACOLOGY. Pharmacokinetics, Special Populations. Renolby impotred Patterns) Information for Patients It is important for patients to understand how to correctly administer SPIRIVA capsules using the HandiHaler inhalation device (see Patient's Instructions for Use). SPIRIVA capsules should only be administered via the HandiHaler device and the HanchHaier device should not be.used for administering other medications. Capsules should always be stored in sealed blisters. Remove only one capsuie immedi ately before use. or its effectiveness may be recuced Additional capsules that are exposed to air (i.e. not intended for immediate use) should be discarded. Eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema may be signs of acute narrow-angle glaucoma. Should any of these signs and symptoms develop, consult a physiaan immediatefy. Miotic eye drops alone are not considered to be effective treatment. Care must be taker not to allow the powder to enter into the eyes as this may cause tturring of vision and puofi dilation. SPIRIVA HandiHaler is a once-daiiy maintenance bronchodilator and should not be used ♦or immediate •efcef of breathing problems. Le.. as a rescue medication Drug Interactions SPIRIVA has been used concomitantly with other drugs commonly used in COPD without increases n adverse drug reactions These include sympathomimetic bronchodnators. methyixanrvnes, and oral ano inhaled steroids. However, the co-admmistration of SPIRIVA with other anticholinergic-containing drugs (e.g.. pratropium) has not been studied and is therefore not recommended. Drug/Laboratory Test Interactions None known Carcinogenesis, Mutagenesis, Impairment of Fertility No evidence of tumorgemety was observed in a 104-week inhalation study in rats at botropium doses up to 0 059 mg/kg/day. in an 83-week inhalation study -.n female mice at doses up to 0.145 mg <g day. and in a 101-week inhalation study in male mice at ooses up to 0.002 mg/kg day. These doses correspond to 25. 35, and 0.5 times the Recommended Human Daily Dose (PJ-iDD) or a mg/m 2 oasis, respectively. Tnese dose multiples may be over-estimated due to difficul ties in measuring deposned Ooses in animal inhalation studies. Tiotropium bromide Demonstrated no evidence of mutagenicity or dastogenicitv in the following assays: the bacterial gene mutation assay, the VI9 Chinese hamster cell mutagen eses assay. We chromosomal aberration assays n human lymphocytes >n vitro and mouse micronudeus formation in vivo, and the unschedulec DNA synthesis in primary rat nepatocytes in vrtre assay. In rats, decreases in the number of corpora tutee arc the percentage of implants were noted at inhalation tiotropium doses of 0.078 mg/kc/day v greater (approximately 35 times the RHDD on a mg/m 2 basis) No such effect were observed at C. 009 mg/kg/day (approx:matety 4 times than the RHDD on a mg/m 4 basis). The fertility index, however, was not affected at inhalation doses up to 1.689 mg/kg/day (approximately 760 times the RHDD on a mg/m 2 basis). These dose multiples may be over-estimated due to difficulties in measuring deposttec doses in animal inhalation studies. Pregnancy Pregnancy Category C No evidence of structural alterations was observed ;n rats and rabb’ts at inhalation tiotropium doses of up to 1.471 and 0.007 mg/kg/day. respectively. These doses correspond tc approximately 660 and 6 times the recommended human daily dose (RHDD) on a mg/m* basis However. ;n rats, fetal resorption, litter loss, decreases ■r, t*»e number of bve pups at birth and the mean pup weights, and a delay in pup sexual maturation were observed at inhalation tiotropium doses of 20.078 mg/kg (approximately 35 times the RHDD on a mg/m* basis). In rabbits, an increase in post mplantatior «ss was observed at an inhalation dose of 0.4 mg/kg/day (approxi mately 360 times the RHDD on a mg/m* basis). Such effects were not observed at inhalation doses of 0.009 and up to 0.088 mg/kg/day in rats and rabbits, respectively. These doses correspond to approximately 4 and 80 times the RHDD on a mg/m* basis, respectively. These dose multiples may be over-estimated due to difficulties in measunng deposited doses m animal inhalation studies. There are no adequate and we«-controi«d studies in pregnant women. SPIRIVA should be used during pregnan cy omy ;f the potential benefit justifies the potential risk to the fetus Use in Labor and Delivery The safety anc effectiveness of SPIRIVA has not been studied during labor and delivery. Nursing Mothers Conical data from nursing women exposed to tiotropium are not available. Based on lactatmg rodent stud es, tiotropium is excreted into breast milk. It is not known whether rotropium is excreted in human milk, but because many drugs are excreted in human milk and g ; ven these findings in rats, caution should be exercised if SPIRIVA is administered to a nursing woman Pediatric Use SPIRIVA HandiHaler is approved for use in the maintenance treatment of broncho spasm associated with chronic obstructive pulmonary d ; sease. including chronic bronchitis and emphysema This d sease does not normally occur in children The safety and effectiveness SPIRIVA m pediatric patients have not been established. Geriatric Use Of the total number of patients who received SPIRIVA in the 1-year clinical trials 426 were <65 years. 375 were 65-74 years and 105 were *75 years of age Withm each age subgroup, there were no differences between the proportion of patients with adverse events in the SPIRIVA and the comparator groups for most events. Dry mouth increased with age in the SPIRIVA group (differences from placebo were 9.0%, 17.1%, and 16.2% in the aforementioned age subgroups). A higher frequency of constipation and urinary tract infections with increasing age was observed in the SPIRIVA group in the placebo-controlled studies. The differences from placebo for constipation were 0%. 1.8%. and 7.8% for each of the age groups. The differences from placebo for urinary tract infections were -0.6%. 4 6% and 4.5% No overall differences in effectiveness were observed among these groups Based on available data, no adjustment of SPIRIVA dosage in geriatric patients is warranted. ADVERSE REACTIONS Of the 2.663 patients in the four 1-year and two 6-month controlled clinical trials, 1.308 were treated with SPIRIVA (tiotropium bromide inhalation powder) at the recommended dose of 18 meg once a day. Patients with narrow angle glaucoma, or symptomatic prostatic hypertrophy or bladder outlet obstruction were excluded from these tnals The most commonly reported adverse drug reaction was dry mouth. Dry mouth was usually mild and often resolved during continued treatment. Other reactions reported in individual patients and consistent with possible anticholinergic effects included constipation, increased heart rate, blurred vision, glaucoma, urinary difficulty, and urinary retention. Four multicenter. 1-year, controlled studies evaluat ed SPIRIVA in patients with COPD. Table 1 shows all adverse events that occurred with a frequency of *3% in the SPIRIVA group in the 1-year placebo-controlled trials where the rates in the SPIRIVA group exceeded placebo by *l%. The frequency of corresponding events in the ipratropium-controlled trials is included for comparison. Table 1: Adverse Experience Incidence (% Patients) in One-Year-COPD Clinical Trials Body System (Event) PtaceboGontrotted Trials IpratropiumGontroMed Trials SPIRIVA Placebo SPIRIVA Ipratropium Body as a Whole Accidents 13 11 5 8 Chest Pain (non-specific) 7 5 5 2 Edema, Dependent 5 4 3 5 Gastrointestinal System Disorders Abdominal Pain 5 3 6 6 Constipation 4 2 1 1 Dry Mouth 16 3 12 6 Dyspepsia 6 5 1 1 Vomiting 4 2 12 Musculoskeletal System Myalgia 4 3 4 3 Resistance Mechanism Disorders Infection 4 3 1 3 Moniliasis 4 2 3 2 Respiratory System (upper) ” Epistaxis 4 2 1 1 Pharyngitis 9 7 7 3 Rhinitis 6 5 3 2 Sinusitis 11 (i 3 2 Upper Respiratory Trad Infection 41 37 43 35 Skin and Appendage Disorders ~ Rash 4 2 2 2 Urinary System Urinary Tract Infection 7 5 4 2 Arthritis. coughing, and influenza-like symptoms occurred at a rate of *3% in the SPIRIVA treatment group, but were <l% in excess of the placebo group. Other events that occurred in the SPIRIVA group at a frequency of 1-3% Tn the placebo-controlled trials where the rates exceeded that in the placebo group include: Body as 0 Whole: allergic reaction. i e g pain; Central and Peripheral Nervous System: dysphoma. paresthesia: Gastrointestinal System Disorders: gastrointestinal disorder not otherwise specified (NOS), gastroesophageal reflux, stomatitis (including ulcerative stomatitis); Metabolic ond Nutritional Disorders: hypercholesterolemia, hyperglyce mia; Musculoskeletal System Disorders: skeletal pain; Cardiac Events: angina pectoris (including aggravated angina pectoris); Psychiatric Disorder: depression; Infections: herpes zoster. Respiratory System Disorder (Upper): laryngitis; Vision Disorder. cataract In addition, among the adverse events observed in the clinical trials with an incidence of <l% were atrial fibrillation, supraventricular tachycardia, angioedema. and urinary retention. In the 1-year trials, the incidence of dry mouth, constipa tion. and urinary tract infection increased with age (see PRECAUTIONS. Geriatric Use). Two multicenter. 6-month, controlled studies evaluated SPIRIVA in patients wuh COPD. The adverse events and the incidence rates were similar to those seen in the 1-year controlled trials. The following adverse reactions have been identified during worldwide post-approval use of SPIRIVA dizziness, dysphagia, epistaxis. hoarseness, intestinal obstruction including ileus paralytic, intraocular pressure increased, oral candidiasis, palpitations, pruritus, tachycardia, throat irntation. and urticaria. DOSAGE AND ADMINISTRATION The recommended dosage of SPIRIVA HandiHaler (tiotropium bromide inhalation powder) is the inhalation of the contents of one SPIRIVA capsule, once-daily. with the HandiHaler inhalation device (see Patient's Instructions for Use). No dosage adjust ment is required for geriatric, hepaticaliy-impaired. or renally-impaired patients. However, patients with moderate to severe renal impairment given SPIRIVA should be monitored closely (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations and PRECAUTIONS). SPIRIVA capsules are for inhalation only and must not be swallowed. HOW SUPPLIED The following packages are available: carton containing 5 SPIRIVA capsules (1 unit-dose blister card) and 1 HandiHaler inhalation device (NDC 0597-0075-75) carton containing 30 SPIRIVA capsules (3 unit-dose blister cards) and 1 HandiHaler inhalation device (NDC 0597 0075-41) carton containing 90 SPIRIVA capsules (9 unit-dose blister cards) and 1 HandiHaler inhalation device (NDC 0597 0075-47) SV-BS (10-06) 65626/US/1 Rt only SPUOOO46B Copyrigtit ©2007. Boennnger Ingelheim Pharmaceuticals. Inc. All rights reserved. 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