UPTRAVI® (selexipag) film-coated, round tablets are supplied in the following configurations:
|Strength (mcg)||Color||Debossing||NDC-XXXBottle of 60||NDC-XXXBottle of 140|
|600||Light violet||6||66215-606-06||Not Available|
|1200||Dark violet||12||66215-612-06||Not Available|
|1400||Dark yellow||14||66215-614-06||Not Available|
UPTRAVI® (selexipag) tablets are also supplied in a Titration Pack [NDC 66215-628-20] that includes a 140-count bottle of 200-mcg tablets and a 60-count bottle of 800-mcg tablets.
Store at 20°C to 25°C (68°F to 77°F). Excursions are permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
Keep out of reach of children.
UPTRAVI® (selexipag) for injection, for intravenous use, is supplied in a 10 mL Type I glass vial closed by a stopper and sealed with an aluminum flip-off button, containing 1800 mcg of selexipag [NDC 66215-718-01].
UPTRAVI (selexipag) for injection is available in cartons containing 1 single-dose vial.
Storage conditions for UPTRAVI for injection: Store the original carton containing glass vial in a refrigerator at 2°C to 8°C (36ºF to 46ºF) until use in order to protect from light.
Advise the patient to read the FDA-approved patient labeling (Patient Information).
- 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.
Actelion Pharmaceuticals US, Inc.
a Janssen Pharmaceutical CompanySouth San Francisco, CA 94080, USA
Made in the UK
© 2015 – 2021 Actelion Pharmaceuticals US, Inc.
|This Patient Information has been approved by the U.S. Food and Drug Administration.||Revised: 10/2021|
|UPTRAVI® (up-TRA-vee)(selexipag)tablets||UPTRAVI® (up-TRA-vee)(selexipag)for injection|
|What is UPTRAVI? |
|Do not take UPTRAVI if you: |
|Before you take UPTRAVI, tell your healthcare provider about all of your medical conditions, including if you: |
| How should I take UPTRAVI?UPTRAVI tablets |
|What are the possible side effects of UPTRAVI?The most common side effects of UPTRAVI include:|
| || |
|These are not all of the possible side effects of UPTRAVI.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 UPTRAVI tablets? Store UPTRAVI tablets at room temperature between 68°F and 77°F (20°C and 25°C).Keep UPTRAVI and all medicines out of the reach of children.|
|General information about the safe and effective use of UPTRAVI Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use UPTRAVI for a condition for which it was not prescribed. Do not give UPTRAVI 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 UPTRAVI that is written for health professionals.|
|What are the ingredients in UPTRAVI? UPTRAVI tablets Active ingredient: selexipagInactive ingredients: corn starch, D-mannitol, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, and magnesium stearate. The tablets are film coated with a coating material containing carnauba wax, hypromellose, propylene glycol, titanium dioxide, along with mixtures of iron oxide black, iron oxide red, or iron oxide yellow.UPTRAVI for injectionActive ingredient: selexipagInactive ingredients: glycine, phosphoric acid, polysorbate 20, and sodium hydroxide.Manufactured for:Actelion Pharmaceuticals US, Inc.a Janssen Pharmaceutical CompanySouth San Francisco, CA 94080, USAMade in the UKJNJ20211022© 2015 – 2021 Actelion Pharmaceuticals US, Inc.For more information, contact Janssen at 1-800-526-7736 (1-800-JANSSEN) or go to www.UPTRAVI.com.|
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