Consumer medicine information

1. Why am I using UPTRAVI?

UPTRAVI contains the active ingredient selexipag. UPTRAVI is used to treat pulmonary arterial hypertension (PAH) in adults.
For more information, see Section 1. Why am I using UPTRAVI? in the full CMI.

2. What should I know before I use UPTRAVI?

Do not use if you have ever had an allergic reaction to selexipag or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use UPTRAVI? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with UPTRAVI and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use UPTRAVI?

• At the start of treatment, you will take the lowest dose. This is one 200 micrograms tablet in the morning and another 200 micrograms tablet in the evening. As instructed by your doctor, you will gradually increase your dose. This is called titration. It lets your body adjust to the new medicine. The goal of titration is to reach the highest dose you can tolerate. This can be up to a maximum dose of 1600 micrograms twice a day.

• Swallow the tablets whole, do not split, crush or chew the UPTRAVI tablets.

5. What should I know while using UPTRAVI?

6. Are there any side effects?

The most common side effects are headache, diarrhoea, feeling sick, being sick, jaw pain, muscle pain, pain in hands, arms, legs or feet, flushing, and joint pain. Serious side effects are allergic reaction or anaphylaxis and kidney failure.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Uptravi selexipag.

2 Qualitative and Quantitative Composition

Selexipag is a 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.
Each round film-coated tablet contains 200 microgram or multiples thereof (respectively 400, 600, 800, 1000, 1200, 1400, or 1600 microgram) selexipag. The film-coated tablets are not light sensitive.
See Section 6.1 List of Excipients.

3 Pharmaceutical Form

Uptravi 200 microgram, light yellow, debossed with '2', round, film-coated tablet.
Uptravi 400 microgram, red, debossed with '4', round, film-coated tablet.
Uptravi 600 microgram, light violet, debossed with '6', round, film-coated tablet.
Uptravi 800 microgram, green, debossed with '8', round, film-coated tablet.
Uptravi 1000 microgram, orange, debossed with '10', round, film-coated tablet.
Uptravi 1200 microgram, dark violet, debossed with '12', round, film-coated tablet.
Uptravi 1400 microgram, dark yellow, debossed with '14', round, film-coated tablet.
Uptravi 1600 microgram, brown, debossed with '16', round, film-coated tablet.
See Section 6.5 Nature and Contents of Container.

4 Clinical Particulars

4.9 Overdose

Isolated cases of overdose up to 3200 microgram 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.
Contact the Poisons Information Centre on 13 11 26 for advice on management of overdose.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Selexipag and its active metabolite are not genotoxic under in vivo conditions. The weight of evidence from a battery of genotoxicity studies indicates no cause for clinical concern.
Carcinogenicity. In 2 year carcinogenicity studies, selexipag produced possible increases in the incidences of thyroid adenomas in mice and Leydig cell adenomas in rats. The induction of such tumours is thought to reflect unique aspects of rodent biology that are not relevant to humans.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Active: selexipag.
Uptravi (selexipag) is a selective non-prostanoid prostacyclin IP receptor agonist. The chemical name of selexipag is 2-{4-[(5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy}-N-(methylsulfonyl) acetamide.
The molecular formula: C₂₆H₃₂N₄O₄S.
The molecular weight: 496.62 mg/mol.
Pharmacotherapeutic group: platelet aggregation inhibitors excl. heparin.
ATC code: B01AC27.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSSELEXI.gif CAS number. 475086-01-2.
See Section 2 Qualitative and Quantitative Composition.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/UPTRAVST.gif