Bosentan Viatris (Bosentan)
Complete patient guide for uses, dosage, side effects, and safety information
Prescription RequiredQuick Facts
What Is Bosentan Viatris Used For?
Bosentan Viatris contains the active ingredient bosentan and belongs to a class of medicines called endothelin receptor antagonists.
Primary Uses
Bosentan Viatris is used to treat pulmonary arterial hypertension, which is high blood pressure in the blood vessels between the heart and the lungs.
How It Works
This medicine works by reducing abnormally high blood pressure by widening the blood vessels in your lungs.
How to Take Bosentan Viatris
Take Bosentan Viatris exactly as your doctor has instructed. It can be taken with or without food, in the morning and evening.
Dosage Instructions
Adults: The usual dose is one tablet twice daily. For the first 4 weeks, you will take a 62.5 mg tablet twice daily. After four weeks, your doctor may increase the dose to a 125 mg tablet twice daily depending on how you respond. Patients with low body weight (less than 40 kg but over 12 years old): Your doctor may advise you to take a 62.5 mg tablet twice daily. Children aged 3 years and over: The dose will be determined by your doctor depending on the child’s weight.
What If You Miss a Dose?
If you miss your dose and there is still a long time before your next dose, take it as soon as you remember and then continue as normal. If it is almost time for your next dose, skip the missed dose and take your next dose when you are meant to. Do not take a double dose to make up for the missed dose.
Important: Never take a double dose to make up for a missed dose. Do not stop taking this medicine suddenly unless your doctor tells you to, as stopping treatment may lead to worsening of your symptoms.
Available Tablet Strengths
Side Effects
Like all medications, this medicine can cause side effects. Most are mild and temporary, but some require medical attention.
Common Side Effects
These side effects occur relatively frequently and usually don’t require emergency care:
- headache
- respiratory tract infection
- dizziness or fainting
- anaemia
- abnormal liver function test
- inflamed throat and irritated nasal passages
- flushing (hot flashes)
- swelling of ankle, leg and joint or fluid retention
- joint pain
- low blood pressure
- fast heart beat
- tiredness
- itching, rash and skin inflammation
- blocked or runny nose
- heartburn or acid reflux
- diarrhoea
- redness of the skin
- blurred vision
- nosebleed
- body ache and pain
Seek immediate medical attention if you experience:
- shortness of breath or difficulty breathing
- anaphylaxis and/or swelling, especially around eyes, lips, tongue or throat
- nausea
- vomiting
- fever
- unusual tiredness
- stomach pain
- yellowing of skin or whites of eyes (jaundice)
- dark-coloured urine
- chest pain
Important Warnings
There are serious warnings associated with Bosentan Viatris that you must be aware of before starting treatment.
Who Should Not Take Bosentan Viatris
Do not take if you: are allergic to bosentan or any ingredients; are pregnant, think you may be pregnant, or intend to become pregnant; are breastfeeding; are being treated with ciclosporin A or glibenclamide; have moderate to severe liver disorder.
Medical Conditions to Discuss
Tell your doctor if you have: anaemia (low red blood cells); pulmonary arterial hypertension or lung disease; hypotension (low blood pressure); liver or kidney problems; heart disease; HIV infection; or if you take any other medicines.
Pregnancy and Breastfeeding
BOSENTAN VIATRIS causes birth defects and must not be used in pregnancy. You must have negative pregnancy tests before starting and monthly during treatment. If sexually active, you must use both hormonal and barrier contraception methods as this medicine reduces effectiveness of hormonal contraceptives. Stop taking at least 3 months before trying to become pregnant. Do not breastfeed while taking this medicine. Men should not father a child during treatment and for 3 months after stopping, as the medicine may harm sperm.
Birth Defects Warning: BOSENTAN VIATRIS causes birth defects and must not be used in pregnancy. Rare cases of liver cirrhosis and liver failure have been reported in patients taking BOSENTAN VIATRIS.
Drug Interactions
Some medicines may interfere with Bosentan Viatris and affect how it works. Tell your doctor about all medicines you are taking.
- hormonal contraceptives (oral, injectable, transdermal and implantable)
- simvastatin (medicines for lowering blood fats)
- diabetes medicines such as glibenclamide and tolbutamide
- antifungal medicines such as ketoconazole, itraconazole, fluconazole and voriconazole
- antibiotics such as rifampicin
- organ transplant medicines such as cyclosporine A, tacrolimus and sirolimus
- medicines for rheumatoid arthritis or psoriasis
- HIV medicines like lopinavir + ritonavir and nevirapine
- warfarin (blood thinner)
- digoxin (for heart rhythm)
- sildenafil or tadalafil (for erectile dysfunction and/or pulmonary arterial hypertension)
- seizure medicines like phenytoin, carbamazepine or phenobarbital
- nimodipine
- St John’s Wort (herbal medicine for depression)
Alcohol & Driving
Be careful with activities that require alertness until you know how Bosentan Viatris affects you.
Alcohol
Tell your doctor if you drink alcohol. There is no specific information available on how alcohol affects Bosentan Viatris.
Driving and Operating Machinery
Be careful before you drive or use any machines or tools until you know how Bosentan Viatris affects you. This medicine may cause dizziness, tiredness or blurred vision in some people.
Storage
Store below 25°C and protect from moisture. Keep in a cool, dry place away from moisture, heat or sunlight. Do not store in the bathroom, near a sink, in the car, or on window sills. Keep out of reach of children.
Overdose Information
If you think you have taken too much Bosentan Viatris, seek urgent medical attention immediately. Phone the Poisons Information Centre (Australia telephone 13 11 26) for advice, contact your doctor, or go to the Emergency Department at your nearest hospital, even if there are no signs of discomfort or poisoning.
Frequently Asked Questions
The source does not specify how long it takes to work, but your doctor will monitor your progress and may adjust your dose after the first 4 weeks depending on how you respond to the medicine.
Yes, Bosentan Viatris can be taken with or without food, in the morning and evening.
Do not stop taking this medicine suddenly unless your doctor tells you to. Stopping your treatment may lead to a worsening of your symptoms. Your doctor may tell you to reduce the dose over a few days before stopping completely.
You need liver function blood tests before starting treatment and every month after that. You also need blood tests for anaemia after 1 and 3 months, then every 3 months. If you are a woman of childbearing age, you need monthly pregnancy tests.
Bosentan Viatris may reduce the effectiveness of hormonal contraceptives such as the pill, patches, implants or injections. You must always use additional methods of contraception such as condoms and IUDs and not rely just on hormonal contraception.
The source does not provide specific information about elderly patients. You should discuss with your doctor if you have any concerns about age-related considerations.
Remind any doctor, dentist or pharmacist you visit that you are using Bosentan Viatris, as it may interact with other medicines and treatments.
Important Disclaimer
This information is intended for general educational purposes only and should not be considered medical advice. Always consult your healthcare provider or pharmacist before starting, stopping, or changing any medication.
If you think you may have a medical emergency, call your doctor or emergency services immediately.