Please note: Mfg. Restrictions.
PLEASE VISIT https://www.uptravihcp.com FOR ALL INFORMATION:
Also visit for info: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a7a23b87-f892-4e2c-8e2e-ebf841220f90
1 INDICATIONS AND USAGE
1.1 Pulmonary Arterial Hypertension - UPTRAVI is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and ...
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage - The recommended starting dose of UPTRAVI is 200 micrograms (mcg) given twice daily. Tolerability may be improved when taken with food [see ...
3 DOSAGE FORMS AND STRENGTHS
UPTRAVI is available in the following strengths: � 200 mcg [Light yellow tablet debossed with 2] � 400 mcg [Red tablet debossed with ...
4 CONTRAINDICATIONS
Concomitant use of strong inhibitors of CYP2C8 (e.g., gemfibrozil) [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].
5 WARNINGS AND PRECAUTIONS
5.1 Pulmonary Veno-Occlusive Disease (PVOD) Should signs of pulmonary edema occur, consider the possibility of associated PVOD. If confirmed, discontinue UPTRAVI ...
6 ADVERSE REACTIONS
6.1 Clinical Trial Experience - Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a ...
7 DRUG INTERACTIONS
7.1 CYP2C8 Inhibitors - Concomitant administration with gemfibrozil, a strong inhibitor of CYP2C8, doubled exposure to selexipag and increased exposure to the active ...
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy - Risk Summary There are no adequate and well-controlled studies with UPTRAVI in pregnant women. Animal reproduction studies ...
10 OVERDOSAGE
Isolated cases of overdose up to 3200 mcg were reported. Mild, transient nausea was the only reported consequence. In the event of overdose, supportive measures must be taken as required ...
11 DESCRIPTION
UPTRAVI (selexipag) is a selective non-prostanoid IP prostacyclin receptor agonist. The chemical name of selexipag is ...
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action - Selexipag is an oral prostacyclin receptor (IP receptor) agonist that is structurally distinct from prostacyclin. Selexipag is hydrolyzed ...
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis: In the 2-year carcinogenicity studies, chronic oral administration of ...
14 CLINICAL STUDIES
14.1 Pulmonary Arterial Hypertension - The effect of selexipag on progression of PAH was demonstrated in a multi-center, double-blind, placebo-controlled, parallel ...
16 HOW SUPPLIED/STORAGE AND HANDLING
UPTRAVI (selexipag) film-coated, round tablets are supplied in the following configurations: Strength (mcg ...
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Package Insert). Inform patients: what to do if they miss a dose - not to split ...
SPL UNCLASSIFIED SECTION
Manufactured for: Actelion Pharmaceuticals US, Inc. 5000 Shoreline Court, Ste. 200 - South San Francisco, CA 94080, USA - ACT20171016 - � 2017 Actelion Pharmaceuticals US, Inc. All rights .
