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Riociguat

Embryo-Fetal Toxicity

  • Do not administer Adempas to a pregnant female because it may cause fetal harm [see Contraindications (4) and Use in Specific Populations (8.1)].
  • Females of reproductive potential: Exclude pregnancy before the start of treatment, monthly during treatment, and 1 month after stopping treatment. Prevent pregnancy during treatment and for one month after stopping treatment by using acceptable methods of contraception [see use in Special Populations (8.6)].
  • For all female patients, Adempas is available only through a restricted program called the Adempas Risk Evaluation and Mitigation Strategy (REMS) Program [see Warnings and Precautions (5.2)

Approved Risk Evaluation and Mitigation Strategies (REMS)

ADEMPAS (Riociguart) Tablets

Patient Counseling Information

Medication Guides

Patient Medication Guide

Package Inserts

Riociguat

Additional Information

Updated January 2016