Selexipag TITRATION PACK Kit — NDC 70710-1653-7 (Billing 70710-1653-07)
This is a package of Selexipag TITRATION PACK Kit from Zydus Pharmaceuticals (USA) Inc., marketed since Feb 2025 and currently FDA-listed. It is this product's only package size.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
- RxCUI (RxNorm): 1729007
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Prostacyclin Receptor Agonist class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- Selexipag treats pulmonary arterial hypertension, a type of high blood pressure in the arteries of your lungs. It helps delay the disease getting worse and lowers the chance you'll...
- Tablets are taken by mouth twice a day and swallowed whole, so don't split or crush them. Taking them with food may help you tolerate them. Your doctor will raise your dose slowly,...
- Headache, diarrhea, nausea, jaw pain and muscle aches are common, especially while your dose is going up. Tell your doctor or pharmacist if they become hard to handle, since the do...
- Call right away if you have new or worsening shortness of breath, which could be fluid in the lungs. Also report symptoms that might suggest an overactive thyroid, or signs of an a...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Selexipag — tap one for details:
Selexipag may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 2, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 70710-1653-07 You're viewing this Main listing | 1 KIT in 1 CARTON * 1 BOTTLE in 1 CARTON / 140 TABLET, FILM COATED in 1 BOTTLE * 1 BOTTLE in 1 CARTON / 60 TABLET, FILM COATED in 1 BOTTLE | 2025-02-14 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| UPTRAVI Titration Pack 66215-0628-20 | Actelion | 140 tablets | — | AB | FDA listed | — |
| Selexipag TITRATION PACKthis 70710-1653-07 | Zydus | 140 tablets | — | — | FDA listed | — |
| Selexipag TITRATION PACK 70771-1801-07 | Zydus | 140 tablets | — | — | FDA listed | — |
| Selexipag 46014-6280-01 | Excella | 1 kit | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and 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 )
1.1Pulmonary 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 and 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 )
2.1Recommended 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.
2.4Interruptions 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 selexipag tablets at a lower dose and then retitrate.
2.5Dosage Adjustment in Patients with Hepatic Impairment No dose adjustment of selexipag is necessary for patients with mild hepatic impairment (Child-Pugh class A). For patients with moderate hepatic impairment (Child-Pugh class B), the starting dose of selexipag tablets is 200 mcg once daily . Increase in increments of 200 mcg once daily at weekly intervals, as tolerated [see Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3 )] .
Avoid use of selexipag in patients with severe hepatic impairment (Child-Pugh class C).
2.6Dosage Adjustment with Co-administration of Moderate CYP2C8 Inhibitors When co-administered with moderate CYP2C8 inhibitors (e.g., clopidogrel, deferasirox and teriflunomide), reduce the dosing of selexipag to once daily [see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.3 )] .
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Selexipag tablets are available in the following strengths: 200 mcg [Beige colored, round, film coated tablet, debossed with "S2" on one side and plain on other side] 400 mcg [Pink colored, round, film coated tablet, debossed with "S4" on one side and plain on other side.] 600 mcg [Grey colored, round, film coated tablet, debossed with "S6" on one side and plain on other side.] 800 mcg [Green colored, round, film coated tablet, debossed with "S8" on one side and plain on other side.] 1,000 mcg [Yellow colored, round, film coated tablet, debossed with "S10" on one side and plain on other side.] 1,200 mcg [Dark grey colored, round, film coated tablet, debossed with "S12" on one side and plain on other side.] 1,400 mcg [Dark yellow colored, round, film coated tablet, debossed with "S14" on one side and plain on other side.] 1,600 mcg [Brown colored, round, film coated tablet, debossed with "S16" on one side and plain on other side.] Tablets: 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,000 mcg, 1,200 mcg, 1,400 mcg, 1,600 mcg.
⛔ 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 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Pulmonary edema in patients with pulmonary veno-occlusive disease. If confirmed, discontinue treatment. ( 5.1 )
5.1Pulmonary Edema with Pulmonary Veno-Occlusive Disease Should signs of pulmonary edema occur, consider the possibility of associated pulmonary veno-occlusive disease. If confirmed, discontinue selexipag.
🤒 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.
6.1Clinical 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% Vomiting 18% 9% Pain in extremity 17% 8% Flushing 12% 5% Arthralgia 11% 8% Anemia 8% 5% Decreased appetite 6% 3% Rash 11% 8% These adverse reactions are more frequent during the dose titration phase. Hyperthyroidism was observed in 1% (n=8) of patients on selexipag tablets and in none of the patients on placebo.
Laboratory Test Abnormalities Hemoglobin In a Phase 3 placebo-controlled study in patients with PAH, mean absolute changes in hemoglobin at regular visits compared to baseline ranged from −0.34 to −0.02 g/dL in the selexipag group compared to −0.05 to 0.25 g/dL in the placebo group. A decrease in hemoglobin concentration to below 10 g/dL was reported in 8.6% of patients treated with selexipag tablets and 5 % of placebo-treated patients. Thyroid Function Tests In a Phase 3 placebo-controlled study in patients with PAH, a reduction (up to −0.3 MU/L from a baseline median of
2.5MU/L) in median thyroid-stimulating hormone (TSH) was observed at most visits in the selexipag group. In the placebo group, little change in median values was apparent. There were no mean changes in triiodothyronine or thyroxine in either group.
6.2Postmarketing Experience The following adverse reactions have been identified during post approval use of selexipag. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Vascular disorders: Symptomatic hypotension
🔄 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 ).
7.1CYP2C8 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 )] .
7.2CYP2C8 Inducers Concomitant administration with an inducer of CYP2C8 and UGT 1A3 and 2B7 enzymes (rifampin) halved exposure to the active metabolite. Increase dose up to twice of selexipag when co-administered with rifampin. Reduce selexipag when rifampin is stopped [see Clinical Pharmacology ( 12.3 )] .
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Nursing mothers: Discontinue selexipag or breastfeeding. ( 8.2 ) Severe hepatic impairment: Avoid use. ( 8.6 )
8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with selexipag in pregnant women. Animal reproduction studies performed with selexipag showed no clinically relevant effects on embryofetal development and survival. A slight reduction in maternal as well as in fetal body weight was observed when pregnant rats were administered selexipag during organogenesis at a dose producing an exposure to the active metabolite approximately 47 times that in humans at the maximum recommended human dose.
No adverse developmental outcomes were observed with oral administration of selexipag to pregnant rabbits during organogenesis at exposures to the active metabolite up to 50 times the human exposure at the maximum recommended human dose. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data Animal Data Pregnant rats were treated with selexipag using oral doses of 2 mg/kg/day, 6 mg/kg/day, and 20 mg/kg/day (up to 47 times the exposure to the active metabolite at the maximum recommended human oral dose of 1,600 mcg twice daily on an area under the curve [AUC] basis) during the period of organogenesis (gestation days 7 to 17). Selexipag did not cause adverse developmental effects to the fetus in this study. A slight reduction in fetal body weight was observed in parallel with a slight reduction in maternal body weight at the high dose.
Pregnant rabbits were treated with selexipag using oral doses of 3 mg/kg, 10 mg/kg, and 30 mg/kg (up to 50 times the exposure to the active metabolite at the maximum recommended human oral dose of 1,600 mcg twice daily on an AUC basis) during the period of organogenesis (gestation days 6 to 18). Selexipag did not cause adverse developmental effects to the fetus in this study. In a pre-and post-natal development study, pregnant rats were treated with selexipag from gestation day 7 through lactation day 20 at oral doses of 2, 6, and 20 mg/kg/day (up to 35 times the exposure to the active metabolite at the maximum recommended human dose of 1,600 mcg twice daily on an AUC basis).
Treatment with selexipag did not cause adverse developmental effects in this study at any dose.
8.2Lactation It is not known if selexipag is present in human milk. Selexipag or its metabolites were present in the milk of rats. Because many drugs are present in the human milk and because of the potential for serious adverse reactions in nursing infants, discontinue nursing or discontinue selexipag.
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
8.5Geriatric Use Of the 1,368 subjects in clinical studies of selexipag tablets, 248 subjects were 65 years of age and older, while 19 were 75 and older. No overall differences were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity cannot be ruled out.
8.6Patients with Hepatic Impairment No adjustment to the dosing regimen is needed in patients with mild hepatic impairment (Child-Pugh class A). A once-daily regimen is recommended in patients with moderate hepatic impairment (Child-Pugh class B) due to the increased exposure to selexipag and its active metabolite. There is no experience with selexipag in patients with severe hepatic impairment (Child-Pugh class C).
Avoid use of selexipag in patients with severe hepatic impairment [see Dosage and Administration ( 2.5 ) and Clinical Pharmacology ( 12.3 )] .
8.7Patients with Renal Impairment No adjustment to the dosing regimen is needed in patients with estima… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with selexipag in pregnant women. Animal reproduction studies performed with selexipag showed no clinically relevant effects on embryofetal development and survival. A slight reduction in maternal as well as in fetal body weight was observed when pregnant rats were administered selexipag during organogenesis at a dose producing an exposure to the active metabolite approximately 47 times that in humans at the maximum recommended human dose.
No adverse developmental outcomes were observed with oral administration of selexipag to pregnant rabbits during organogenesis at exposures to the active metabolite up to 50 times the human exposure at the maximum recommended human dose. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data Animal Data Pregnant rats were treated with selexipag using oral doses of 2 mg/kg/day, 6 mg/kg/day, and 20 mg/kg/day (up to 47 times the exposure to the active metabolite at the maximum recommended human oral dose of 1,600 mcg twice daily on an area under the curve [AUC] basis) during the period of organogenesis (gestation days 7 to 17). Selexipag did not cause adverse developmental effects to the fetus in this study. A slight reduction in fetal body weight was observed in parallel with a slight reduction in maternal body weight at the high dose.
Pregnant rabbits were treated with selexipag using oral doses of 3 mg/kg, 10 mg/kg, and 30 mg/kg (up to 50 times the exposure to the active metabolite at the maximum recommended human oral dose of 1,600 mcg twice daily on an AUC basis) during the period of organogenesis (gestation days 6 to 18). Selexipag did not cause adverse developmental effects to the fetus in this study. In a pre-and post-natal development study, pregnant rats were treated with selexipag from gestation day 7 through lactation day 20 at oral doses of 2, 6, and 20 mg/kg/day (up to 35 times the exposure to the active metabolite at the maximum recommended human dose of 1,600 mcg twice daily on an AUC basis).
Treatment with selexipag did not cause adverse developmental effects in this study at any dose.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 1,368 subjects in clinical studies of selexipag tablets, 248 subjects were 65 years of age and older, while 19 were 75 and older. No overall differences were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity cannot be ruled out.
🆘 Overdosage ▾
10 OVERDOSAGE Isolated cases of overdose with selexipag tablets up to 3,200 mcg were reported. Mild, transient nausea was the only reported consequence. In the event of overdose, supportive measures must be taken as required. Dialysis is unlikely to be effective because selexipag and its active metabolite are highly protein-bound.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Selexipag is a prostacyclin receptor (IP receptor) agonist that is structurally distinct from prostacyclin. Selexipag is hydrolyzed by carboxylesterase 1 to yield its active metabolite, which is approximately 37-fold as potent as selexipag. Selexipag and the active metabolite are selective for the IP receptor versus other prostanoid receptors (EP 1 to 4 , DP, FP, and TP).
12.2Pharmacodynamics Cardiac Electrophysiology: At the maximum tolerated dose of 1,600 mcg selexipag tablets twice daily, selexipag does not prolong the QT interval to any clinically relevant extent. Platelet Aggregation: Both selexipag and its active metabolite caused concentration-dependent inhibition of platelet aggregation in vitro with an IC 50 of 5.5 μM and 0.21 μM, respectively. However, at clinically relevant concentrations, there was no effect on platelet aggregation test parameters as seen following multiple-dose administrations of selexipag tablets in healthy subjects from 400 mcg up to 1,800 mcg twice daily.
Pulmonary Hemodynamics: A Phase 2 clinical study assessed hemodynamic variables after 17 weeks of oral treatment in patients with PAH WHO Functional Class II–III and concomitantly receiving another PAH therapy and/or phosphodiesterase type 5 (PDE-5) inhibitors. Patients titrating selexipag tablets to an individually tolerated dose (200 mcg twice daily increments up to 800 mcg twice daily) (N=33) achieved a statistically-significant mean reduction in pulmonary vascular resistance of 30.3% (95% confidence interval [CI] −44.7%, −12.2%) and an increase in cardiac index (median treatment effect) of
0.41L/min/m 2 (95% CI 0.10, 0.71) compared to placebo (N=10). Drug Interaction: In a study in healthy subjects, selexipag tablets (400 mcg twice a day) did not influence the pharmacodynamic effect of warfarin on the international normalized ratio.
12.3Pharmacokinetics The pharmacokinetics of selexipag and its active metabolite have been studied primarily in healthy subjects. The pharmacokinetics of selexipag and the active metabolite, after both single-and multiple-dose oral administration, were dose-proportional up to a single dose of 800 mcg and multiple doses of up to 1,800 mcg twice daily. In healthy subjects, inter-subject variability in exposure (area under the curve over a dosing interval, AUC) at steady-state following oral administration was 43% and 39% for selexipag and the active metabolite, respectively.
Intra-subject variability in exposure was 24% and 19% for selexipag and the active metabolite, respectively. Exposures to selexipag and the active metabolite at steady-state in PAH patients and healthy subjects were similar. The pharmacokinetics of selexipag and the active metabolite in PAH patients were not influenced by the severity of the disease and did not change with time.
The corresponding selexipag tablets and selexipag for injection doses provide similar exposure to the active metabolite in PAH patients at steady-state, whereas the exposure to selexipag is approximately twice as high after intravenous administration compared to oral administration. Both in healthy subjects and PAH patients, after oral administration, exposure at steady-state to the active metabolite is approximately 3-to 4-fold that of selexipag. Absorption The absolute bioavailability of orally administered selexipag is approximately 49%.
Upon oral administration, maximum observed plasma concentrations of selexipag and its active metabolite are reached within about 1 to 3 hours and 3 to 4 hours, respectively. In the presence of food, the absorption of selexipag was prolonged resulting in a delayed time to peak concentration (T max ) and ~30% lower peak plasma concentration (C max ). The exposure to selexipag and the active metabolite (AUC) did not significantly change in the presence of food.
Distribution The volume of distribution of selexipag at steady-state is
11.7L. Selexipag and its active metabolite are hig… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Selexipag is a prostacyclin receptor (IP receptor) agonist that is structurally distinct from prostacyclin. Selexipag is hydrolyzed by carboxylesterase 1 to yield its active metabolite, which is approximately 37-fold as potent as selexipag. Selexipag and the active metabolite are selective for the IP receptor versus other prostanoid receptors (EP 1 to 4 , DP, FP, and TP).
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Selexipag tablets, 200 mcg are beige colored, round, film coated tablet, debossed with "S2" on one side and plain on other side and are supplied as follows: NDC 70710-1551-6 in bottles of 60 tablets with child-resistant closure NDC 70710-1551-8 in bottles of 140 tablets with child-resistant closure Selexipag tablets, 400 mcg are pink colored, round, film coated tablet, debossed with "S4" on one side and plain on other side and are supplied as follows: NDC 70710-1552-6 in bottles of 60 tablets with child-resistant closure Selexipag tablets, 600 mcg are grey colored, round, film coated tablet, debossed with "S6" on one side and plain on other side and are supplied as follows: NDC 70710-1553-6 in bottles of 60 tablets with child-resistant closure Selexipag tablets, 800 mcg are green colored, round, film coated tablet, debossed with "S8" on one side and plain on other side and are supplied as follows: NDC 70710-1554-6 in bottles of 60 tablets with child-resistant closure Selexipag tablets, 1,000 mcg are yellow colored, round, film coated tablet, debossed with "S10" on one side and plain on other side and are supplied as follows: NDC 70710-1555-6 in bottles of 60 tablets with child-resistant closure Selexipag tablets, 1,200 mcg are dark grey colored, round, film coated tablet, debossed with "S12" on one side and plain on other side and are supplied as follows: NDC 70710-1556-6 in bottles of 60 tablets with child-resistant closure Selexipag tablets, 1,400 mcg are dark yellow colored, round, film coated tablet, debossed with "S14" on one side and plain on other side and are supplied as follows: NDC 70710-1557-6 in bottles of 60 tablets with child-resistant closure Selexipag tablets, 1,600 mcg are brown colored, round, film coated tablet, debossed with "S16" on one side and plain on other side and are supplied as follows: NDC 70710-1558-6 in bottles of 60 tablets with child-resistant closure Selexipag tablets are also supplied in a Titration Pack [NDC 70710-1653-7] that includes a 140-count bottle of 200-mcg tablets and a 60-count bottle of 800-mcg tablets.
Store at 20ºC to 25ºC (68ºF to 77ºF) [see USP Controlled Room Temperature]. Keep this and all drugs out of the reach of children.
📋 Description ▾
11 DESCRIPTION Selexipag tablets contains selexipag, a prostacyclin receptor agonist. The chemical name of selexipag is 2-{4-[(5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy}- N (methylsulfonyl) acetamide. It has a molecular formula of C 26 H 32 N 4 O 4 S and a molecular weight of 496.62.
Selexipag has the following structural formula: Selexipag is an off white to pale yellow crystalline powder that is practically insoluble in water. In the solid state selexipag is very stable, is not hygroscopic, and is not light sensitive. Depending on the dose strength, each round film-coated tablet for oral administration contains 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,000 mcg, 1,200 mcg, 1,400 mcg, or 1,600 mcg of selexipag.
The tablets include the following inactive ingredients: corn starch, colloidal silicon dioxide, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, microcrystalline cellulose and magnesium stearate. The tablets are film coated with a coating material containing hypromellose, propylene glycol, carnauba wax, titanium dioxide, along with mixtures of ferrosoferric oxide, iron oxide red or iron oxide yellow. Image
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Inform Patients: To take a missed dose as soon as possible, unless the next dose is within the next 6 hours. Not to split, crush, or chew tablets. Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Rev.: 09/22
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics The pharmacokinetics of selexipag and its active metabolite have been studied primarily in healthy subjects. The pharmacokinetics of selexipag and the active metabolite, after both single-and multiple-dose oral administration, were dose-proportional up to a single dose of 800 mcg and multiple doses of up to 1,800 mcg twice daily. In healthy subjects, inter-subject variability in exposure (area under the curve over a dosing interval, AUC) at steady-state following oral administration was 43% and 39% for selexipag and the active metabolite, respectively.
Intra-subject variability in exposure was 24% and 19% for selexipag and the active metabolite, respectively. Exposures to selexipag and the active metabolite at steady-state in PAH patients and healthy subjects were similar. The pharmacokinetics of selexipag and the active metabolite in PAH patients were not influenced by the severity of the disease and did not change with time.
The corresponding selexipag tablets and selexipag for injection doses provide similar exposure to the active metabolite in PAH patients at steady-state, whereas the exposure to selexipag is approximately twice as high after intravenous administration compared to oral administration. Both in healthy subjects and PAH patients, after oral administration, exposure at steady-state to the active metabolite is approximately 3-to 4-fold that of selexipag. Absorption The absolute bioavailability of orally administered selexipag is approximately 49%.
Upon oral administration, maximum observed plasma concentrations of selexipag and its active metabolite are reached within about 1 to 3 hours and 3 to 4 hours, respectively. In the presence of food, the absorption of selexipag was prolonged resulting in a delayed time to peak concentration (T max ) and ~30% lower peak plasma concentration (C max ). The exposure to selexipag and the active metabolite (AUC) did not significantly change in the presence of food.
Distribution The volume of distribution of selexipag at steady-state is
11.7L. Selexipag and its active metabolite are highly bound to plasma proteins (approximately 99% in total and to the same extent to albumin and alpha1-acid glycoprotein). Metabolism Selexipag is hydrolyzed to its active metabolite, (free carboxylic acid) in the liver and intestine by carboxylesterases.
Oxidative metabolism, catalyzed mainly by CYP2C8 and to a smaller extent by CYP3A4, leads to the formation of hydroxylated and dealkylated products. UGT1A3 and UGT2B7 are involved in the glucuronidation of the active metabolite. Except for the active metabolite, none of the circulating metabolites in human plasma exceeds 3% of the total drug-related material.
Elimination Elimination of selexipag is predominately via metabolism with a mean terminal half-life of 0.8 to 2.5 hours. The terminal half-life of the active metabolite is 6.2 to 13.5 hours. Selexipag does not accumulate following twice daily repeat administration.
There is minimal accumulation of the active metabolite upon twice daily repeat administration suggesting that the effective half-life is in the range of 3 to 4 hours. The total body clearance of selexipag is
17.9L/hour. Excretion In a study in healthy subjects with radiolabeled selexipag, approximately 93% of radioactive drug material was eliminated in feces and only 12% in urine. Neither selexipag nor its active metabolite were found in urine.
Specific Populations No clinically relevant effects of sex, race, age or body weight on the pharmacokinetics of selexipag and its active metabolite have been observed in healthy subjects or PAH patients. Age The pharmacokinetic variables (C max and AUC) were similar in adult and elderly subjects up to 75 years of age. There was no effect of age on the pharmacokinetics of selexipag and the active metabolite in PAH patients.
Hepatic Impairment In subjects with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment, exposure to selexipag was 2-a… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Cardiac Electrophysiology: At the maximum tolerated dose of 1,600 mcg selexipag tablets twice daily, selexipag does not prolong the QT interval to any clinically relevant extent. Platelet Aggregation: Both selexipag and its active metabolite caused concentration-dependent inhibition of platelet aggregation in vitro with an IC 50 of 5.5 μM and 0.21 μM, respectively. However, at clinically relevant concentrations, there was no effect on platelet aggregation test parameters as seen following multiple-dose administrations of selexipag tablets in healthy subjects from 400 mcg up to 1,800 mcg twice daily.
Pulmonary Hemodynamics: A Phase 2 clinical study assessed hemodynamic variables after 17 weeks of oral treatment in patients with PAH WHO Functional Class II–III and concomitantly receiving another PAH therapy and/or phosphodiesterase type 5 (PDE-5) inhibitors. Patients titrating selexipag tablets to an individually tolerated dose (200 mcg twice daily increments up to 800 mcg twice daily) (N=33) achieved a statistically-significant mean reduction in pulmonary vascular resistance of 30.3% (95% confidence interval [CI] −44.7%, −12.2%) and an increase in cardiac index (median treatment effect) of
0.41L/min/m 2 (95% CI 0.10, 0.71) compared to placebo (N=10). Drug Interaction: In a study in healthy subjects, selexipag tablets (400 mcg twice a day) did not influence the pharmacodynamic effect of warfarin on the international normalized ratio.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Efficacy of Selexipag Tablets in Patients with Pulmonary Arterial Hypertension The effect of selexipag tablets on progression of PAH was demonstrated in a multi-center, double-blind, placebo-controlled, parallel group, event-driven study (GRIPHON) in 1,156 patients with symptomatic (WHO Functional Class I [0.8%], II [46%], III [53%], and IV [1%]) PAH. Patients were randomized to either placebo (N = 582), or selexipag tablets (N = 574). The dose was increased in weekly intervals by increments of 200 mcg twice a day to the highest tolerated dose up to 1,600 mcg twice a day.
The primary study endpoint was the time to first occurrence up to end-of-treatment of: a) death, b) hospitalization for PAH, c) PAH worsening resulting in need for lung transplantation, or balloon atrial septostomy, d) initiation of parenteral prostanoid therapy or chronic oxygen therapy, or e) other disease progression based on a 15% decrease from baseline in 6MWD plus worsening of Functional Class or need for additional PAH-specific therapy. The mean age was 48 years, the majority of patients were white (65%) and female (80%).
Nearly all patients were in WHO Functional Class II and III at baseline. Idiopathic or heritable PAH was the most common etiology in the study population (58%) followed by PAH associated with connective tissue disease (29%), PAH associated with congenital heart disease with repaired shunts (10%), drugs and toxins (2%), and HIV (1%). At baseline, the majority of enrolled patients (80%) were being treated with a stable dose of another PAH therapy (15%), PDE-5 inhibitor (32%), or both (33%).
Patients on selexipag tablets achieved doses within the following groups: 200 to 400 mcg (23%), 600 to 1,000 mcg (31%) and 1,200 to 1,600 mcg (43%). Treatment with selexipag tablets resulted in a 40% reduction (99% CI: 22 to 54%; two-sided log-rank p-value < 0.0001) of the occurrence of primary endpoint events compared to placebo (Table 2; Figure 3). The beneficial effect of selexipag was primarily attributable to a reduction in hospitalization for PAH and a reduction in other disease progression events (Table 2).
The observed benefit of selexipag was similar regardless of the dose achieved when patients were titrated to their highest tolerated dose [see Dosage and Administration ( 2.1 )] . Figure 3 Kaplan-Meier Estimates of the First Morbidity-Mortality Event in GRIPHON Table 2 Primary Endpoints and Related Components in GRIPHON Selexipag N=574 Placebo N=582 Hazard Ratio (99% CI) p-value n % n % Primary endpoint events up to the end of treatment All primary endpoint events As first event: 155 27.0 242 41.6 0.60 [0.46,0.78] <0.0001 • Hospitalization for PAH • Other disease progression (Decrease in 6MWD plus worsening functional class or need for other therapy) • Death 78 38 13.6 6.6 109 100 18.7 17.2 28 4.9 18 3.1 • Parenteral prostanoid or chronic oxygen therapy • PAH worsening resulting in need for lung transplantation or balloon atrial septostomy 10 1 1.7 0.2 13 2 2.2
0.3It is not known if the excess number of deaths in the selexipag group is drug-related because there were so few deaths and the imbalance was not observed until 18 months into GRIPHON. Figures 4A, B, and C show time to first event analyses for primary endpoint components of hospitalization for PAH (A), other disease progression (B), and death (C) all censored 7 days after any primary end point event (because many patients on placebo transitioned to open-label selexipag at this point). Figure 4A Hospitalization for PAH as the First Endpoint in GRIPHON Figure 4B Disease Progression as the First Endpoint in GRIPHON Figure 4C Death as the First Endpoint in GRIPHON The treatment effect of selexipag on time to first primary event was consistent irrespective of background PAH therapy (i.e. in combination with another PAH therapy, PDE-5i, both, or without background therapy) (Figure 5).
Figure 5 Subgroup Analyses of the Primary Endpoint in GRIPHON Note: Race group… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis: In the 2-year carcinogenicity studies, chronic oral administration of selexipag revealed no evidence of carcinogenic potential in rats at 100 mg/kg/day and mice at 500 mg/kg/day which resulted in the exposures to the active metabolite more than 25 times the human exposure at the maximum recommended human oral dose of 1,600 mcg twice daily on an AUC basis. Mutagenesis : Selexipag and the active metabolite are not genotoxic on the basis of the overall evidence of conducted genotoxicity studies.
Fertility: In rats administered with selexipag orally, the no effect dose for effects on fertility was 60 mg/kg/day which resulted in the exposure to the active metabolite approximately 175 times the human exposure at the maximum recommended human oral dose of 1,600 mcg twice daily on an AUC basis.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis: In the 2-year carcinogenicity studies, chronic oral administration of selexipag revealed no evidence of carcinogenic potential in rats at 100 mg/kg/day and mice at 500 mg/kg/day which resulted in the exposures to the active metabolite more than 25 times the human exposure at the maximum recommended human oral dose of 1,600 mcg twice daily on an AUC basis. Mutagenesis : Selexipag and the active metabolite are not genotoxic on the basis of the overall evidence of conducted genotoxicity studies.
Fertility: In rats administered with selexipag orally, the no effect dose for effects on fertility was 60 mg/kg/day which resulted in the exposure to the active metabolite approximately 175 times the human exposure at the maximum recommended human oral dose of 1,600 mcg twice daily on an AUC basis.
📄 Patient Package Insert ▾
PATIENT INFORMATION Selexipag (se lex' i pag) tablets What is selexipag tablets? Selexipag tablets are a prescription medicine used to treat pulmonary arterial hypertension (PAH) which is high blood pressure in the arteries of your lungs. Selexipag tablets can help slow down the progression of your disease and lower your risk of being hospitalized for PAH.
It is not known if selexipag tablets are safe and effective in children. Do not take selexipag tablets if you take gemfibrozil because this medicine may affect how selexipag tablets work and cause side effects. are allergic to selexipag or any of the other ingredients of this medicine (listed under Inactive ingredients). Before you take selexipag tablets, tell your healthcare provider about all of your medical conditions, including if you: have liver problems. have narrowing of the pulmonary veins, a condition called pulmonary veno-occlusive disease. are pregnant or plan to become pregnant.
It is not known if selexipag tablets will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if selexipag passes into your breast milk. You and your healthcare provider should decide if you will take selexipag tablets or breastfeed.
You should not do both. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Selexipag tablets and other medicines may affect each other causing side effects.
Do not start any new medicine until you check with your healthcare provider. How should I take selexipag tablets? Take selexipag tablets exactly as your healthcare provider tells you to take it.
Do not stop taking selexipag tablets unless your healthcare provider tells you to stop. Your healthcare provider will slowly increase your dose to find the dose of selexipag tablets that is right for you. If you have side effects, your healthcare provider may tell you to change your dose of selexipag tablets.
Selexipag tablets can be taken with or without food. Taking selexipag tablets with food may help you tolerate selexipag tablets better. Selexipag tablets are usually taken 2 times each day.
Swallow selexipag tablets whole. Do not split, crush or chew selexipag tablets. If you miss a dose of selexipag tablets, take it as soon as you remember.
If your next scheduled dose is due within 6 hours, skip the missed dose. Take the next dose at your regular time. If you miss 3 or more days of selexipag tablets, call your healthcare provider to see if your dose needs to be changed.
If you take too much selexipag tablets, call your healthcare provider or go to the nearest hospital emergency room right away. What are the possible side effects of selexipag tablets? The most common side effects of selexipag tablets include: headache jaw pain muscle pain pain in arms or legs pain in joints decreased appetite diarrhea nausea vomiting flushing low red blood cell count rash These are not all of the possible side effects of selexipag tablets.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store selexipag tablets?
Store selexipag tablets at room temperature between 68°F and 77°F (20°C and 25°C). Keep selexipag tablets and all medicines out of the reach of children. General information about the safe and effective use of selexipag tablets Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.
Do not use selexipag tablets for a condition for which it was not prescribed. Do not give selexipag tablets to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your healthcare provider or pharmacist for information about selexipag tablets that is written for health professionals. What are the ingredients in selexipag tablets? Active ingredient: selexipag Inactive ingredients: corn starch, colloidal silicon dioxide, hydroxypropyl cellulose, low s… [Excerpted — this section continues on DailyMed.]
📄 Recent Major Changes ▾
RECENT MAJOR CHANGES Contraindications ( 4 ) 10/2021
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70710-1551-6 Selexipag Tablets 200 mcg 60 Tablets Rx only Zydus Pharma NDC 70710-1552-6 Selexipag Tablets 400 mcg 60 Tablets Rx only Zydus Pharma NDC 70710-1553-6 Selexipag Tablets 600 mcg 60 Tablets Rx only Zydus Pharma NDC 70710-1554-6 Selexipag Tablets 800 mcg 60 Tablets Rx only Zydus Pharma NDC 70710-1555-6 Selexipag Tablets 1,000 mcg 60 Tablets Rx only Zydus Pharma NDC 70710-1556-6 Selexipag Tablets 1,200 mcg 60 Tablets Rx only Zydus Pharma NDC 70710-1557-6 Selexipag Tablets 1,400 mcg 60 Tablets Rx only Zydus Pharma NDC 70710-1558-6 Selexipag Tablets 1,600 mcg 60 Tablets Rx only Zydus Pharma NDC 70710-1653-7 TITRATION PACK Selexipag Tablets 200 mcg 140 Tablets Rx only Selexipag Tablets 800 mcg 60 Tablets Rx only Zydus Pharma image image image image image image image image image
Medicare Part D spend CMS · PART D · 2026 (Q1)
About this NDC listing & data coverage
Kit / multi-component package
This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |