Loading…
UPTRAVI is a brand name for Selexipag, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: UPTRAVI® (selexipag) is indicated for: the long-term treatment of idiopathic pulmonary arterial hypertension (iPAH), heritable pulmonary arterial hypertension (HPAH), PAH associated with connective tissue disorders and PAH associated with congenital heart disease, in adult patients with WHO fun ctional class (FC)…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment, Dosage adjustment with co-administration of moderate CYP2C8 inhibitors 06/2020 7 WARNINGS AND PRECAUTIONS 11/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.
RECENT MAJOR LABEL CHANGES ..................................................................................... 2 TABLE OF CONTENTS ..........................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION............................................................... 4 1 INDICATIONS.............................................................................................................. 1 Pediatrics ...........................................................................................................
2 Geriatrics............................................................................................................ 4 2 CONTRAINDICATIONS ...............................................................................................
4 4 DOSAGE AND ADMINISTRATION .............................................................................. 2 Recommended Dose and Dosage Adjustment .................................................... 4 Administration.....................................................................................................
5 Missed Dose....................................................................................................... 6 5 OVERDOSAGE ...........................................................................................................
6
). If a patient reaches a dose that cannot be tolerated, the dose should be reduced to the previous dose level. Individualised maintenance dose The highest tolerated dose reached during dose titration should be maintained. If the therapy over time is less tolerated at a given dose, symptomatic treatment or a dose reduction to the next lower dose should be considered.
, Child-Pugh class A). , Child-Pugh class B) (see 7 WARNINGS AND PRECAUTIONS). Do not use the drug in patients with severe hepatic impairment. Renal impairment No adjustment to the dosing regimen is needed in patients with mild or moderate renal impairment.
No change in starting dose is required in patients with severe renal impairment; dose titration should be done with caution in these patients (see 7 WARNINGS AND PRECAUTIONS). 3 Pharmacokinetics, Special Populations and Conditions).
There is limited clinical experience in patients over the age of 75 years, therefore UPTRAVI® should be used with caution in this population (see 7 WARNINGS AND PRECAUTIONS). Pediatric population (< 18 years) The safety and efficacy of UPTRAVI® in children aged 0 to less than 18 years have not been established.
No data are available. , clopidogrel, deferasirox and teriflunomide), reduce the dosing of UPTRAVI® to once daily. If the therapy is not tolerated at a given dose, symptomatic treatment and/or a dose reduction to the next lower dose should be considered.
4 Drug-Drug Interactions, In vivo studies). 4 Administration The film-coated tablets are to be taken orally in the morning and in the evening. UPTRAVI® may be taken with or without food. Tolerability may be improved when taken with food.
The tablets should not be split, crushed or chewed, and are to be swallowed with water. 5 Missed Dose If a dose of medication is missed, it should be taken as soon as possible. The missed dose should not be taken if it is almost time for the next scheduled dose (within approximately 6 hours).
11/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ..................................................................................... 2 TABLE OF CONTENTS ..........................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION............................................................... 4 1 INDICATIONS.............................................................................................................. 1 Pediatrics ...........................................................................................................
2 Geriatrics............................................................................................................ 4 2 CONTRAINDICATIONS ...............................................................................................
4 4 DOSAGE AND ADMINISTRATION .............................................................................. 2 Recommended Dose and Dosage Adjustment .................................................... 4 Administration.....................................................................................................
5 Missed Dose....................................................................................................... 6 5 OVERDOSAGE ...........................................................................................................
6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ........................ 6 7 WARNINGS AND PRECAUTIONS .............................................................................. 1 Special Populations ............................................................................................
1 Pregnant Women ............................................................................................ 2 Breast-feeding................................................................................................. 3 Pediatrics ........................................................................................................
Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient or component of the container. For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the product monograph.
, gemfibrozil) (see 9 DRUG INTERACTIONS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
If treatment is missed for 3 days or more, UPTRAVI® should be restarted at a lower dose and then titrated. 5 OVERDOSAGE Isolated cases of overdose up to 3200 micrograms 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. For management of a suspected drug overdose, contact your regional poison control centre.
0 Page 7 of 37 Tablet 1200 mcg carnauba wax, corn starch, D-mannitol, hydroxypropyl cellulose, hypromellose, iron oxide black (E172), iron oxide red (E172), low substituted hydroxypropyl cellulose, magnesium stearate, propylene glycol, titanium dioxide (E171) Tablet 1400 mcg carnauba wax, corn starch, D-mannitol, hydroxypropyl cellulose, hypromellose, iron oxide yellow (E172), low substituted hydroxypropyl cellulose, magnesium stearate, propylene glycol, titanium dioxide (E171) Tablet 1600 mcg carnauba wax, corn starch, D-mannitol, hydroxypropyl cellulose, hypromellose, iron oxide black (E172), iron oxide red (E172), iron oxide yellow (E172), low substituted hydroxypropyl cellulose, magnesium stearate, propylene glycol, titanium dioxide (E171) UPTRAVI® is available in the following 8 strengths of selexipag: 200 mcg Round, light-yellow, film-coated tablets with “2” debossed on one side.
400 mcg Round, red, film-coated tablets with “4” debossed on one side. 600 mcg Round, light-violet, film-coated tablets with “6” debossed on one side. 800 mcg Round, green, film-coated tablets with “8” debossed on one side. 1000 mcg Round, orange, film-coated tablets with “10” debossed on one side.
1200 mcg Round, dark-violet, film-coated tablets with “12” debossed on one side. 1400 mcg Round, dark-yellow, film-coated tablets with “14” debossed on one side. 1600 mcg Round, brown, film-coated tablets with “16” debossed on one side.
Availability UPTRAVI® […]
4 Geriatrics ........................................................................................................ 9 8 ADVERSE REACTIONS ..............................................................................................
1 Adverse Reaction Overview................................................................................ 2 Clinical Trial Adverse Reactions .......................................................................... 3 Less Common Clinical Trial Adverse Reactions.................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data .............................................................................................. 5 Post-Market Adverse Reactions ........................................................................
0 Page 3 of 37 9 DRUG INTERACTIONS ............................................................................................. 2 Drug Interactions Overview...............................................................................
4 Drug-Drug Interactions...................................................................................... 5 Drug-Food Interactions ..................................................................................... 6 Drug-Herb Interactions......................................................................................
7 Drug-Laboratory Test Interactions ..................................................................... 15 10 CLINICAL PHARMACOLOGY ................................................................................... 1 Mechanism of Action .....................................................................................
2 Pharmacodynamics ....................................................................................... 3 Pharmacokinetics.......................................................................................... 16 11 STORAGE, STABILITY AND DISPOSAL ..................................................................
19 12 SPECIAL HANDLING INSTRUCTIONS ..................................................................... 19 PART II: SCIENTIFIC INFORMATION .................................................................................. 20 13 PHARMACEUTICAL INFORMATION ........................................................................
20 14 CLINICAL TRIALS .................................................................................................... 1 Trial Design and Study Demographics ........................................................... 2 Study Results................................................................................................
21 15 MICROBIOLOGY....................................................................................................... 29 16 NON-CLINICAL TOXICOLOGY .................................................................................
29 PATIENT MEDICATION INFORMATION .............................................................................. 0 Page 4 of 37 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS UPTRAVI® (selexipag) is indicated for: the long-term treatment of idiopathic pulmonary arterial hypertension (iPAH), heritable pulmonary arterial hypertension (HPAH), PAH associated with connective tissue disorders and PAH associated with congenital heart disease, in adult patients with WHO fun ctional class (FC) II–III to delay disease progression.
Disease progression included: hospitalization for PAH, initiation of intravenous or […]