UPTRAVI (Page 5 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

UPTRAVI® (selexipag) film-coated, round tablets are supplied in the following configurations:

Strength (mcg) Color Debossing NDC-XXXBottle of 60 NDC-XXXBottle of 140
200 Light yellow 2 66215-602-06 66215-602-14
400 Red 4 66215-604-06 Not Available
600 Light violet 6 66215-606-06 Not Available
800 Green 8 66215-608-06 Not Available
1000 Orange 10 66215-610-06 Not Available
1200 Dark violet 12 66215-612-06 Not Available
1400 Dark yellow 14 66215-614-06 Not Available
1600 Brown 16 66215-616-06 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.

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 for:

Actelion Pharmaceuticals US, Inc.
a Janssen Pharmaceutical CompanySouth San Francisco, CA 94080, USA

Made in the UK

JNJ20211022

© 2015 – 2021 Actelion Pharmaceuticals US, Inc.

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 10/2021
PATIENT INFORMATION
UPTRAVI® (up-TRA-vee)(selexipag)tablets UPTRAVI® (up-TRA-vee)(selexipag)for injection
What is UPTRAVI?
  • UPTRAVI is a prescription medicine used to treat pulmonary arterial hypertension (PAH) which is high blood pressure in the arteries of your lungs.
  • UPTRAVI can help slow down the progression of your disease and lower your risk of being hospitalized for PAH.
It is not known if UPTRAVI is safe and effective in children.
Do not take UPTRAVI if you:
  • take gemfibrozil because this medicine may affect how UPTRAVI works and cause side effects.
  • are allergic to selexipag or any of the other ingredients of this medicine (listed under Inactive ingredients).
Before you take UPTRAVI, 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 UPTRAVI will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if UPTRAVI passes into your breast milk. You and your healthcare provider should decide if you will take UPTRAVI 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. UPTRAVI 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 UPTRAVI?UPTRAVI tablets
  • Take UPTRAVI exactly as your healthcare provider tells you to take it. Do not stop taking UPTRAVI unless your healthcare provider tells you to stop.
  • Your healthcare provider will slowly increase your dose to find the dose of UPTRAVI that is right for you.
  • If you have side effects, your healthcare provider may tell you to change your dose of UPTRAVI.
  • UPTRAVI can be taken with or without food. Taking UPTRAVI with food may help you tolerate UPTRAVI better.
  • UPTRAVI is usually taken 2 times each day.
  • Swallow UPTRAVI tablets whole. Do not split, crush or chew UPTRAVI tablets.
  • If you miss a dose of UPTRAVI, 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 UPTRAVI, call your healthcare provider to see if your dose needs to be changed.
  • If you take too much UPTRAVI, call your healthcare provider or go to the nearest hospital emergency room right away.
UPTRAVI given by intravenous (IV) injection
  • Your healthcare provider will give you UPTRAVI into your vein through an intravenous (IV) line.
  • Your healthcare provider will decide how much UPTRAVI for injection you will receive each day, based on your current dose of UPTRAVI tablets.
What are the possible side effects of UPTRAVI?The most common side effects of UPTRAVI 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
  • pain, redness or swelling at the injection site for UPTRAVI for injection
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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