Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: • Embryo-Fetal Toxicity [see Warnings and Precautions ( 5.1 )] • Hypotension [see Warnings and Precautions ( 5.3 )] • Bleeding [see Warnings and Precautions ( 5.4 )] Adverse reactions occurring more frequently (≥3%) on Adempas compared to placebo are headache, dyspepsia/gastritis, dizziness, nausea, diarrhea, hypotension, vomiting, anemia, gastroesophageal reflux, and constipation.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc.
at 1-888-842-2937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety data described below reflect exposure to Adempas in two, randomized, double blind, placebo-controlled trials in patients with inoperable or recurrent/persistent CTEPH (CHEST-1) and treatment naive or pre-treated PAH patients (PATENT-1).
The population (Adempas: n = 490;
Placebo: n = 214) was between the age of 18 and 80 years [see Clinical Studies ( 14.1 , 14.2 )].
The safety profile of Adempas in patients with inoperable or recurrent/persistent CTEPH (CHEST-1) and treatment naive or pre-treated PAH (PATENT-1) were similar.
Therefore, adverse drug reactions (ADRs) identified from the 12 and 16 week placebo-controlled trials for PAH and CTEPH respectively were pooled, and those occurring more frequently on Adempas than placebo (≥3%) are displayed in Table 1 below.
Most adverse reactions in Table 1 can be ascribed to the vasodilatory mechanism of action of Adempas.
5 WARNINGS AND PRECAUTIONS • Symptomatic hypotension ( 5.3 ) • Bleeding ( 5.4 ) • Pulmonary edema in patients with pulmonary veno-occlusive disease.
If confirmed, discontinue treatment ( 5.5 ) 5.1 Embryo-Fetal Toxicity Based on data from animal reproduction studies, Adempas may cause embryo-fetal toxicity when administered to a pregnant female and is contraindicated in females who are pregnant.
Advise females of reproductive potential of the potential risk to a fetus.
Obtain a pregnancy test before the start of treatment, monthly during treatment, and for one month after stopping treatment.
Advise females of reproductive potential to use effective contraception during treatment with ADEMPAS and for at least one month after the last dose [see Dosage and Administration ( 2.3 ) and Use in Specific Populations ( 8.1 , 8.3 )] .
Like all medications, Adempas can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: