Selexipag 400 ug/1
Selexipag · TABLET, FILM COATED · Zydus Lifesciences Limited
Selexipag is a tablet, film coated containing selexipag at 400 ug/1, taken oral. Manufactured by Zydus Lifesciences Limited.
Key Facts
- Brand Name
- Selexipag
- Generic Name
- Selexipag
- NDC Code (Product)
70771-1794- Manufacturer
- Zydus Lifesciences Limited
- Strength
- 400 ug/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA214302
- Drug Class
- Prostacyclin Receptor Agonist [EPC]
- Marketing Start
- 02/14/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Selexipag tablets are a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH. ( 1.1 ) 1.1 Pulmonary Arterial Hypertension Selexipag tablets are indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH. Effectiveness of selexipag tablets was established in a long-term study in PAH patients with WHO Functional Class II-III symptoms. Patients had idiopathic and heritable PAH (58%), PAH associated with connective tissue disease (29%), PAH associated with congenital heart disease with repaired shunts (10%) [see Clinical Studies ( 14.1 )] .
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Selexipag tablets starting dose: 200 mcg twice daily. ( 2.1 ) Increase the dose by 200 mcg twice daily at weekly intervals to the highest tolerated dose up to 1,600 mcg twice daily. ( 2.1 ) Maintenance dose is determined by tolerability. ( 2.1 ) Moderate hepatic impairment: Starting dose 200 mcg once daily , increase the dose by 200 mcg once daily at weekly intervals to the highest tolerated dose up to 1,600 mcg. ( 2.5 ) 2.1 Recommended Dosage The recommended starting dosage of selexipag tablets is 200 micrograms (mcg) given twice daily. Tolerability may be improved when taken with food [see Clinical Pharmacology ( 12.3 )] . Increase the dose in increments of 200 mcg twice daily, usually at weekly intervals, to the highest tolerated dose up to 1,600 mcg twice daily. If a patient reaches a dose that cannot be tolerated, the dose should be reduced to the previous tolerated dose. Do not split, crush, or chew tablets. 2.4 Interruptions and Discontinuations If a dose of selexipag tablets is missed, patients should take a missed dose as soon as possible unless the next dose is within the next 6 hours. If treatment is missed for 3 days or more, restart selexipa…
Contraindications
4 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients. Concomitant use of strong inhibitors of CYP2C8 (e.g., gemfibrozil) [see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.3 )]. Concomitant use with strong CYP2C8 inhibitors. ( 4 , 7.1 , 12.3 ) Hypersensitivity to the active substance or to any of the excipients. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Moderate CYP2C8 inhibitors (e.g., clopidogrel, deferasirox and teriflunomide) increase exposure to the active metabolite of selexipag. Reduce the dosing of selexipag to once daily ( 2.6 , 7.1 , 12.3 ). CYP2C8 inducers (e.g., rifampin) decrease exposure to the active metabolite. Increase up to twice the dose of selexipag ( 7.2 , 12.3 ). 7.1 CYP2C8 Inhibitors Concomitant administration with gemfibrozil, a strong inhibitor of CYP2C8, doubled the exposure to selexipag and increased exposure to the active metabolite by approximately 11-fold. Concomitant administration of selexipag with strong inhibitors of CYP2C8 (e.g., gemfibrozil) is contraindicated [see Contraindications ( 4 ) and Clinical Pharmacology ( 12.3 )] . Concomitant administration of selexipag tablets with clopidogrel, a moderate inhibitor of CYP2C8, had no relevant effect on the exposure to selexipag and increased the exposure to the active metabolite by approximately 2.7-fold [see Clinical Pharmacology ( 12.3 )] . Reduce the dosing of selexipag to once daily in patients on a moderate CYP2C8 inhibitor [see Dosage and Administration ( 2.6 )] . 7.2 CYP2C8 Inducers Concomitant administration with an induce…
Adverse Reactions
6 ADVERSE REACTIONS Adverse reactions occurring more frequently (≥5%) on selexipag compared to placebo are headache, diarrhea, jaw pain, nausea, myalgia, vomiting, pain in extremity, and flushing. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial 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 of selexipag tablets has been evaluated in a long-term, placebo-controlled study enrolling 1,156 patients with symptomatic PAH (GRIPHON study) [see Clinical Studies ( 14 )] . The exposure to selexipag in this trial was up to 4.2 years with median duration of exposure of 1.4 years. Table 1 presents adverse reactions more frequent on selexipag tablets than on placebo by ≥3%. Table 1 Adverse Reactions Adverse Reaction Selexipag tablets N=575 Placebo N=577 Headache 65% 32% Diarrhea 42% 18% Jaw pain 26% 6% Nausea 33% 18% Myalgia 16% 6% Vomit…
Frequently Asked Questions
What is Selexipag used for?
Selexipag contains Selexipag. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Selexipag a controlled substance?
Selexipag is not classified as a controlled substance by the DEA.
What is the generic name for Selexipag?
The generic name for Selexipag is Selexipag. There are 7 other brand versions of Selexipag.
What is the NDC code for Selexipag 400 ug/1?
The NDC (National Drug Code) for Selexipag 400 ug/1 is 70771-1794, listed by Zydus Lifesciences Limited.