Patient Medication Information: uses, side effects, how to take - Uptravi
What is UPTRAVI® used for?
- UPTRAVI® is used for the long-term treatment of pulmonary arterial hypertension (PAH) in adults. It can be used on its own or with other medicines for PAH. PAH is high blood pressure in the blood vessels that carry blood from the heart to the lungs (the pulmonary arteries).
How does UPTRAVI® work?
UPTRAVI® widens the arteries that carry blood from the heart to the lung and reduces their hardening. This makes it easier for the heart to pump blood through the pulmonary arteries.
What are the ingredients in UPTRAVI®?
Medicinal ingredient: Selexipag
Non-medicinal ingredients: carnauba wax, corn starch, D-mannitol, hydroxypropyl cellulose, hypromellose, low substituted hydroxypropyl cellulose, magnesium stearate, propylene glycol, titanium dioxide (E171) In addition, the following strengths include:
- 600 mcg, 800 mcg, 1200 mcg and 1600mcg: iron oxide black (E172)
- 400 mcg, 600 mcg, 1000 mcg, 1200 mcg and 1600mcg: iron oxide red (E172)
- 200 mcg, 800 mcg, 1000 mcg, 1400 mcg and 1600 mcg: iron oxide yellow (E172)
UPTRAVI® comes in the following dosage forms:
Tablets:
- 200 mcg (round, light-yellow, film-coated tablets with “2” marked on one side)
- 400 mcg (round, red, film-coated tablets with “4” marked on one side)
- 600 mcg (round, light-violet, film-coated tablets with “6” marked on one side)
- 800 mcg (round, green, film-coated tablets with “8” marked on one side)
- 1000 mcg (round, orange, film-coated tablets with “10” marked on one side)
- 1200 mcg (round, dark-violet, film-coated tablets with “12” marked on one side)
- 1400 mcg (round, dark-yellow, film-coated tablets with “14” marked on one side)
- 1600 mcg (round, brown, film-coated tablets with “16” marked on one side)
Do not use UPTRAVI® if:
- you are allergic to selexipag or any of the other ingredients of this medicine.
- you are being treated with strong inhibitors of CYP2C8 (e.g., gemfibrozil).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take UPTRAVI®. Talk about any health conditions or problems you may have, including if you:
- have low blood pressure
- have liver problems
- have kidney problems or are on dialysis
- have narrowing of the pulmonary veins, a condition called pulmonary veno-occlusive disease or PVOD
- have overactive thyroid gland
are pregnant or plan to become pregnant
- are breastfeeding or plan to breastfeed
- have any other medical conditions
Other warnings you should know about:
Driving and using machines
UPTRAVI® can cause side effects such as headaches and low blood pressure. Before driving or using machines, make sure you know how you feel while taking UPTRAVI®.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with UPTRAVI®:
- Valproic acid (used to treat epilepsy)
- Rifampicin, rifapentine (antibiotic used to treat infections)
- Fluconazole (antifungal used to treat infection by fungi)
- Clopidogrel (medicine used to inhibit blood clots)
- Deferasirox (medicine used to remove excess iron from the body)
- Teriflunomide (medicine used to treat relapsing-remitting multiple sclerosis)
How to take UPTRAVI®:
- UPTRAVI® should only be prescribed by a doctor experienced in the treatment of pulmonary arterial hypertension.
- Always take UPTRAVI® exactly as your doctor has told you.
- Check with your doctor if you are not sure or have any questions.
- Take UPTRAVI® in the morning and in the evening, either with or without meals.
You might tolerate the medicine better when you take it with meals.
- Swallow the tablets whole with a glass of water.
- Do not split, crush or chew the tablets.
Finding the right dose for you
- At the start of treatment, you will take the lowest dose. This is one 200 microgram tablet in the morning and another 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 most appropriate dose to treat you; this will be the highest dose you can tolerate.
- During titration, you may experience side effects such as headache, jaw pain, aching joints, muscle pain or a general feeling of being in pain, diarrhoea, feeling sick to your stomach or throwing up, stomach ache or reddening of the face.
- Tell your doctor if you experience side effects, as your doctor may recommend that you change your UPTRAVI® dose.
- Tell your doctor if you are taking other medications as your doctor may recommend that you take UPTRAVI® only once daily.
- If any of these side effects are difficult for you to tolerate, talk to your doctor about how to manage or treat them. There are treatments available that can help relieve the side effects. Do not stop taking UPTRAVI® unless your doctor tells you to.
Usual dose:
The highest dose that you can tolerate during titration will become your maintenance dose. Your maintenance dose is the dose you should continue to take on a regular basis, in the morning and in the evening.
Not everyone will end up on the same maintenance dose. Your maintenance dose will be between 200 micrograms and 1600 micrograms in the morning and in the evening. What is important is that you reach the dose that is most appropriate to treat you.
After taking the same dose for a long time, you may experience side effects that you cannot tolerate or that have an effect on your normal daily activities. If this happens, contact your doctor. Your doctor may adjust your maintenance dose as needed.
Overdose:
| If you think you, or a person you are caring for, have taken too much UPTRAVI®, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
Missed dose:
If you forget to take UPTRAVI®, take a dose as soon as you remember. Continue to take your next dose at the usual time.
If it is nearly time for your next dose (within 6 hours before you would normally take it), skip the missed dose. Continue to take your next dose at the usual time.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking UPTRAVI®
- Keep taking UPTRAVI® unless your doctor tells you to stop.
- Contact your doctor right away if you miss doses for more than 3 days in a row.
- Your doctor may decide to restart your treatment at a lower dose to avoid side effects.
- Your dose may be gradually increased to your previous maintenance dose.
What are possible side effects from using UPTRAVI®?
These are not all the possible side effects you may have when taking UPTRAVI®. If you experience any side effects not listed here, tell your healthcare professional.
Like all medicines, UPTRAVI® can cause side effects. You may experience side effects during the titration period and after taking the same dose for a long time.
If you experience any of these side effects below that you cannot tolerate or do not respond to treatment, talk to your doctor. The dose you are taking may be too high for you and may need to be reduced.
Side effects include:
- headache
- jaw pain
- aching joints
- muscle pain or a general feeling of being in pain
- diarrhoea
- feeling sick to your stomach or throwing up
- stomach ache
- indigestion
- reddening of the face
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| VERY COMMON | |||
| Rash | ✓ | ||
| COMMON | |||
| Anaemia (low red blood cell levels): fatigue, loss of energy, looking pale, shortness of breath, weakness | ✓ | ||
| Hyperthyroidism (high thyroid hormone): anxiety or nervousness, weight loss, frequent and loose bowel movements, breathlessness, feeling hot and possibly feelings of having rapid, fluttering or pounding heart | ✓ | ||
| Decreased appetite | ✓ | ||
| Hypotension (low blood pressure): dizziness, fainting, light-headedness, blurred vision, nausea, vomiting, fatigue (may occur when you go from lying or sitting to standing up) | ✓ | ||
| UNKNOWN | |||
| Allergic reactions: difficulty swallowing or breathing, wheezing, drop in blood pressure, feeling sick to your stomach and throwing up, hives or rash, swelling of the face, lips, mouth, tongue or throat | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Keep out of the sight and reach of children.
Do not use UPTRAVI® after the expiration date, which is stated on the carton and on the blister after “EXP.” The expiration date refers to the last day of that month.
Store at room temperature (15 to 30°C). Store UPTRAVI® in its original package.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer require. These measures will help to protect the environment.
If you want more information about UPTRAVI®:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html), the manufacturer’s website (www.janssen.com/canada) or by calling 1-800-567-3331 and 1-800-387-8781.
Last Revised: April 21, 2022
© 2022 Janssen Inc.
All trademarks used under licence.