10/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ........................................................................
4 1 INDICATIONS...................................................................................................................... 1 Pediatrics ........................................................................................................................
2 Geriatrics......................................................................................................................... 4 2 CONTRAINDICATIONS .........................................................................................................
4 4 DOSAGE AND ADMINISTRATION........................................................................................... 1 Dosing Considerations .......................................................................................................
2 Recommended Dose and Dosage Adjustment ....................................................................... 5 Missed Dose ....................................................................................................................
7 5 OVERDOSAGE..................................................................................................................... 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING...............................................
7 7 WARNINGS AND PRECAUTIONS............................................................................................ 1 Special Populations ...........................................................................................................
1 Pregnant Women ...................................................................................................... 2 Breast-feeding ........................................................................................................
3 Pediatrics ............................................................................................................... 4 Geriatrics ...............................................................................................................
10 8 ADVERSE REACTIONS ........................................................................................................ 1 Adverse Reaction Overview..............................................................................................
2 Clinical Trial Adverse Reactions ......................................................................................... 3 Less Common Clinical Trial Adverse Reactions.....................................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ... 13 9 DRUG INTERACTIONS ........................................................................................................ 1 Serious Drug Interactions.................................................................................................
2 Drug Interactions Overview.............................................................................................. 4 Drug-Drug Interactions ....................................................................................................
5 Drug-Food Interactions.................................................................................................... 6 Drug-Herb Interactions ....................................................................................................
7 Drug-Laboratory Test Interactions ..................................................................................... 20 10 CLINICAL PHARMACOLOGY ..............................................................................................
1 Mechanism of Action..................................................................................................... 2 Pharmacodynamics .......................................................................................................
3 Pharmacokinetics.......................................................................................................... 20 11 STORAGE, STABILITY AND DISPOSAL .................................................................................
22 12 SPECIAL HANDLING INSTRUCTIONS ................................................................................... 22 PART II: SCIENTIFIC INFORMATION ........................................................................................
23 13 PHARMACEUTICAL INFORMATION .................................................................................... 23 14 CLINICAL TRIALS..............................................................................................................
1 Clinical Trials by Indication ............................................................................................. 23 15 MICROBIOLOGY ..............................................................................................................
35 16 NON-CLINICAL TOXICOLOGY............................................................................................. 36 PATIENT MEDICATION INFORMATION ...................................................................................
40 ADEMPAS (Riociguat Tablets) Page 4 of 46 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Pulmonary Hypertension ADEMPAS (riociguat) is indicated for the treatment of: inoperable chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4) persistent or recurrent […]