62.5 mg film-coated tablets
bosentan
What STAYVEER is and what it is used for
STAYVEER tablets contain bosentan, which blocks a naturally occurring hormone called endothelin-1 (ET-1) that causes blood vessels to narrow. STAYVEER, therefore, causes the blood vessels to dilate and belongs to a group of medicines called “endothelin receptor antagonists”.
STAYVEER is used to treat:
- Pulmonary arterial hypertension (PAH): PAH is a disease that leads to severe narrowing of the blood vessels in the lungs. As a result, high blood pressure occurs in the blood vessels in the lungs (pulmonary arteries) that transport the blood from the heart to the lungs. This pressure reduces the amount of oxygen that can enter the blood in the lungs, making physical activity more difficult. STAYVEER dilates the pulmonary arteries and makes it easier for the heart to pump blood through them. This lowers blood pressure and relieves symptoms.
STAYVEER is used to treat patients with PAH class III to improve work capacity (the ability to perform physical activity) and symptoms. The class shows the severity of the disease, where class III means that physical activity is markedly limited. Some improvements have also been shown in patients with PAH class II. Class II means that physical activity is slightly limited. PAHs that STAYVEER is used for can be:
- primary (without identified cause or hereditary);
- caused by scleroderma (also called systemic sclerosis, a disease with abnormal growth of the connective tissue that supports the skin and other organs);
- caused by congenital heart defects where shunts (abnormal connections) cause abnormal blood flow through the heart and lungs.
- Digital ulcers: (sores on fingers and toes) in adult patients with a condition called scleroderma. STAYVEER reduces the number of new ulcers on fingers and toes that appear.
What you need to know before you take STAYVEER
Do not take STAYVEER
- if you are allergic to bosentan or any of the other ingredients of this medicine (listed in section 6)
- if you have liver problems (ask your doctor)
- if you are pregnant or may become pregnant because you are not using reliable contraceptive methods. Read the information under “Contraceptives” and “Other medicines and STAYVEER”
- if you are taking ciclosporin A (a medicine used after a transplant or to treat psoriasis )
If any of these apply to you, talk to your doctor.
Warnings and precautions
Checks that your doctor will do before the treatment
- blood tests to check liver function
- blood test to check for anemia (low hemoglobin )
- pregnancy test, if you are a woman of childbearing age
Some patients using STAYVEER have had abnormal liver function tests and anemia (low hemoglobin ).
Checks your doctor will do during treatment
Your doctor will arrange regular blood tests to check for changes in liver function and hemoglobin levels during treatment with STAYVEER.
For all these samples, see also the patient card (in the pack of STAYVEER tablets). These regular blood tests must be taken throughout the time you are taking STAYVEER. We suggest that you write down the date of the last test and also the next test (ask your doctor about the date) on the patient card, as help to remember when the next test is to be taken.
Blood tests for liver function
These will be taken once a month throughout your treatment with STAYVEER. After an increase in dose one, an additional sample will be taken after 2 weeks.
Blood test for anemia ( lack of blood )
This will be done once a month for the first 4 months of treatment and then once every 3 months, as patients taking STAYVEER can develop anemia.
If the results are abnormal, your doctor may decide to reduce the dose or stop treatment with STAYVEER and do further tests to investigate the cause.
Children and young people
STAYVEER is not recommended for children with systemic sclerosis and ongoing digital ulcer disease. See also section 3, How to take STAYVEER.
Other medicines and STAYVEER
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. You must tell your doctor if you are taking:
- ciclosporin A (a medicine used after transplants and to treat psoriasis ), which should not be used with STAYVEER.
- sirolimus or tacrolimus, which are medicines used after transplants, as are not recommended for use with STAYVEER.
- glibenclamide (to treat diabetes ), rifampicin (to treat tuberculosis ), fluconazole (to treat fungal infections), ketoconazole (to treat Cushing’s syndrome), or nevirapine (to treat HIV ), as these medicines are not recommended for use with STAYVEER.
- other medicines for the treatment of HIV – infection may need to be checked especially if they are used together with STAYVEER.
- hormonal contraceptives, which are not effective as a sole method of contraception while taking STAYVEER. Inside your STAYVEER package is a patient card that you should read carefully. Your doctor and/or gynecologist will determine which contraceptives are suitable for you.
- other drugs for the treatment of pulmonary hypertension: sildenafil and tadalafil
- warfarin (a blood thinner)
- simvastatin (used to treat hypercholesterolemia).
Driving ability and use of machinery
STAYVEER has no or negligible influence on the ability to drive or use machines. STAYVEER can cause hypotension (low blood pressure ) which can make you feel dizzy, and affect your vision and your ability to drive and use machines. If you feel dizzy or if your vision is impaired while taking STAYVEER, you should therefore not drive a car or operate tools or machines.
Pregnancy, breastfeeding, and fertility
Women of childbearing age
DO NOT take STAYVEER if you are pregnant or plan to become pregnant.
Pregnancy test
STAYVEER can harm unborn babies born before or during treatment. If you are female and could become pregnant, your doctor will ask you to take a pregnancy test before you start taking STAYVEER, and regularly while you are taking STAYVEER.
Contraceptive
If it is possible that you could become pregnant, use a safe method of birth control while taking STAYVEER. Your doctor or gynecologist can advise you on reliable methods of contraception while using STAYVEER. Because STAYVEER can make hormonal contraceptives (eg, oral, injectable, implantable, or contraceptive patch ) ineffective, this alone is not a safe method. Therefore, if you use hormonal contraceptives, you must also use a barrier method (eg female condoms, pessaries, birth control pad or your partner must also use a condom). Inside your STAYVEER package is a patient card. You should complete this card and take it with you to your doctor at your next visit so that your doctor or gynecologist can assess whether you need additional or alternative reliable methods of contraception. Pregnancy testing is recommended every month while taking STAYVEER if you are of childbearing potential.
Tell your doctor immediately if you become pregnant during treatment with STAYVEER or if you plan to become pregnant shortly.
Breast-feeding
Tell your doctor immediately if you are breastfeeding. You are advised to stop breastfeeding if you are prescribed STAYVEER. It is not known whether this medication is passed on to breast milk.
Fertility
If you are a man and using STAYVEER, the medicine may reduce the number of sperm. It cannot be ruled out that this may affect your ability to have children. Talk to your doctor if you have any questions or concerns about this.
STAYVEER contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost ‘sodium-free’.
How to take STAYVEER
Treatment with STAYVEER should only be initiated and monitored by a physician experienced in the treatment of PAH or systemic sclerosis. Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
STAYVEER with food and drink
STAYVEER can be taken with or without food.
Recommended dose
Adults
Treatment is usually started with 62.5 mg twice daily (morning and evening) for the first 4 weeks. After that, your doctor will usually prescribe one 125 mg tablet twice a day, depending on how you respond to STAYVEER.
Children and young people
Does one recommended for children applies only to PAH? In children aged 1 year and older, treatment is usually started with 2 mg/kg body weight twice daily (morning and evening). The doctor will tell you how to dose.
If you have the impression that the effect of STAYVEER is too strong or too weak, talk to your doctor as your dose may need to be changed.
How to take STAYVEER
The tablets must be taken twice daily (morning and evening), must be swallowed with water, and can be taken with or without food.
If you have taken too much STAYVEER
If you take more tablets than you were instructed to take, contact your doctor immediately.
If you forget to take STAYVEER
If you forget to take STAYVEER, take a dose as soon as you remember. Then continue to take your tablets at the usual times. Do not take a double dose to make up for missed tablets.
If you stop taking STAYVEER
If you suddenly stop your STAYVEER treatment, symptoms may worsen. Do not stop using STAYVEER unless your doctor tells you to. The doctor may instruct you to reduce the dose for a few days before stopping completely.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most serious side effects of STAYVEER are
- Abnormal liver function, which may affect more than 1 in 10 people
- Anemia (low blood count), may affect up to 1 in 10 people. Anemia can sometimes require a blood transfusion.
Your liver and blood counts will be monitored during your treatment with STAYVEER (see section 2). You must take these tests as prescribed by your doctor.
Symptoms that indicate your liver is not working normally include:
- nausea (feeling the need to vomit)
- vomiting
- fever
- stomach ache
- jaundice (yellowing of the skin or whites of the eyes)
- dark colored urine
- skin itching
- lethargy or tiredness (unusual tiredness or exhaustion)
- flu-like symptoms (muscle and joint pain with fever)
Tell your doctor immediately if you experience any of these side effects.
Other side effects ar
Very common (may affect more than 1 in 10 people):
- Headache
- Edema (swelling of the legs and ankles or other symptoms of fluid retention)
Common (may affect up to 1 in 10 people):
- Facial or skin flushing
- Hypersensitivity reaction (with skin inflammation, itching, and rash)
- Gastroesophageal reflux disease (acid reflux)
- Diarrhea
- Short-term loss of consciousness (fainting)
- Palpitations (rapid or irregular heartbeats)
- Low blood pressure
- Nasal congestion
Uncommon (may affect up to 1 in 100 people):
- Thrombocytopenia (lack of platelets )
- Neutropenia/leukopenia (low white blood cell count )
- Elevated liver enzyme levels with hepatitis ( inflammation of the liver) including possible worsening of underlying hepatitis and/or jaundice (yellowing of the skin or whites of the eyes).
Rare (may affect up to 1 in 1,000 people):
- Anaphylactic reactions (general allergic reaction ), angioedema (swelling, usually around the eyes, lips, tongue, or throat)
- Cirrhosis (scarring) of the liver, liver failure (serious disturbance of liver function)
Blurred vision has also been reported at an unknown frequency (frequency cannot be estimated from the available data).
Side effects in children and adolescents
Children treated with STAYVEER have the same reported side effects as adults.
How to store STAYVEER
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton and blister after “EXP”.
The white HDPE bottles should be used within 30 days of opening.
For PVC/PE/PVDC aluminum blisters:
Store at a maximum of 30 °C.
For white HDPE bottles:
This medical product does not require any special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- STAYVEER 62.5 mg film-coated tablets: The active substance is bosentan, as a monohydrate. Each tablet contains 62.5 mg bosentan (as monohydrate)
- Other ingredients in the tablet are corn starch, pregelatinized starch, sodium starch glycolate (Type A), povidone, glycerol behenate, and magnesium stearate. The film coating contains hypromellose, glycerol triacetate, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), and ethyl cellulose.
Appearance and package sizes of the medicine
STAYVEER 62.5 mg film-coated tablets are orange-white, round film-coated tablets debossed with “62.5” on one side.
PVC/PE/PVDC/aluminum blister card with 14 film-coated tablets. The cartons contain 56 or 112 film-coated tablets (STAYVEER 62.5 mg film-coated tablets).
White high-density polyethylene bottles with desiccant (silica gel) containing 56 film-coated tablets. The boxes contain 56 film-coated tablets (STAYVEER 62.5 mg film-coated tablets).
Do not swallow the desiccant.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Janssen‑Cilag International NV
Turnhoutseweg 30
B‑2340 Beerse
Belgium
Manufacturer
Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse
Belgium