What Adempas is used for and how to use it
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Adempas - Consumer Medicine Information

Manufacture: Bayer
Country: Canada
Condition: Pulmonary Hypertension
Class: Vasodilators
Form: Tablets
Ingredients: riociguat, cellulose microcrystalline, crospovidone, hypromellose 5cP, lactose monohydrate, magnesium stearate, sodium laurilsulfate. The film-coating is composed of ferric oxide red, ferric oxide yellow, hydroxypropylcellulose, hypromellose 3cP, propylene glycol, titanium dioxide

ADEMPAS

Riociguat Tablets

About this Medication

What the medication is used for

ADEMPAS is indicated to treat adult patients with:

  • CTEPH (Chronic Thromboembolic Pulmonary Hypertension) (WHO Group 4).

CTEPH is a disease where high blood pressure occurs in lung vessels (pulmonary arteries) which is caused by fixed blood clots hindering the blood flow. High pulmonary blood pressure in the lung vessels means that the heart needs to work harder to pump blood through the lungs. This causes people to feel tired, dizzy and short of breath.

ADEMPAS is intended for use in patients with CTEPH who cannot be operated (inoperable CTEPH) or in patients with persistent or recurrent high pulmonary blood pressure after surgical treatment.

  • PAH (Pulmonary Arterial Hypertension) (WHO Group 1)

PAH is a disease where high blood pressure occurs in lung vessels (pulmonary arteries). In patients with PAH, these arteries get narrower, so the heart has to work harder to pump blood through them. This causes people to feel tired, dizzy and short of breath.

What it does

CTEPH (WHO Group 4)

ADEMPAS contains riociguat, which is a soluble guanylate cyclase (sGC)-stimulator. It works by dilating the pulmonary arteries (the blood vessels that connect the heart to the lungs), lowering the high blood pressure and making it easier for the heart. This leads to an increase in exercise capacity (will increase a patient's ability to walk further) and an improvement of Functional Class (a World Health Organization measure of symptom severity and impact on daily activities).

PAH (WHO Group 1):

ADEMPAS contains riociguat, which is a soluble guanylate cyclase (sGC)-stimulator. It works by dilating the pulmonary arteries (the blood vessels that connect the heart to the lungs), lowering the high blood pressure and making it easier for the heart. This leads to an increase in exercise capacity (will increase a patient's ability to walk further), an improvement of Functional Class (a World Health Organization measure of symptom severity and impact on daily activities) and delayed clinical worsening in patients with PAH.

When it should not be used

  • if you are hypersensitive (allergic) to ADEMPAS or any other ingredients in the tablet.
  • if you are pregnant or planning to become pregnant.
  • If you are breast-feeding or plan to breast-feed.
  • if you are taking sildenafil (VIAGRA, REVATIO), tadalafil (CIALIS, ADCIRCA), vardenafil (LEVITRA, STAXYN), nitrates (medicines used to treat high blood pressure or heart disease) or nitric oxide donors (such as amyl nitrite) in any form.

What the medicinal ingredient is

Riociguat.

What the nonmedicinal ingredients are

Cellulose microcrystalline, crospovidone, hypromellose 5cP, lactose monohydrate, magnesium stearate, sodium laurilsulfate. The film-coating is composed of ferric oxide red, ferric oxide yellow, hydroxypropylcellulose, hypromellose 3cP, propylene glycol, titanium dioxide.

What dosage forms it comes in

Film-coated tablets: 0.5 mg (white), 1 mg (pale yellow), 1.5 mg (yellow-orange), 2 mg (pale orange), 2.5 mg (red-orange).

Warnings and Precautions

BEFORE you use ADEMPAS talk to your doctor or pharmacist if you have or have had any of the following conditions:

  • if you take PDE-5-inhibitors (such as sildenafil or tadalafil) used to treat high blood pressure in the pulmonary arteries (pulmonary arterial hypertension) or male erectile dysfunction (such as the above or vardenafil).
  • if you feel short of breath during treatment with ADEMPAS, this can be caused by a build-up of fluid in the lungs (pulmonary veno-occlusive disease). Talk to your doctor.
  • if you have recently experienced serious bleeding from the lung, or if you have undergone interventional treatment to stop coughing up blood (bronchial arterial embolization). In these cases the risk of bleeding from the lungs may increase further. Inform your doctor if you take medicines used to prevent blood clots (anticoagulants). You will be regularly monitored by your doctor.
  • if you have problems with your heart, circulation or are on antihypertensive therapy.
  • if you take medicines used to treat fungal infections (e.g. ketoconazole, itraconazole), or medicines for the treatment of HIV infection (e.g. ritonavir).
  • if you take medicines against cancer called tyrosine kinase inhibitors (e.g. erlotinib, gefitinib) or cyclosporine a medicine used to prevent rejection of transplanted organs. In this case your doctor will have to check your blood pressure regularly.
  • if you have low blood pressure.
  • if your liver is not working properly, if your kidneys are not working properly or if you are on dialysis.
  • ADEMPAS is not recommended for patients under 18 years of age, because there is no information on its use in children and adolescents.
  • Do not take ADEMPAS during pregnancy. If there is a chance you could become pregnant, use reliable forms of contraception while you are taking ADEMPAS. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking ADEMPAS.
  • If you are breast-feeding, ask your doctor or pharmacist for advice before taking ADEMPAS because it might harm your baby. A decision must be made whether to discontinue breast feeding or to stop therapy with ADEMPAS.

Interactions with this Medication

Drug-drug interaction

Drugs that may interact with ADEMPAS include:

  • nitric oxide donors (such as amyl nitrite)
  • nitrates (medicines used to treat high blood pressure or heart disease)
  • PDE-5-inhibitors, [such as sildenafil (VIAGRA, REVATIO) or tadalafil (CIALIS, ADCIRCA)] medicines used to treat high blood pressure in the pulmonary arteries (pulmonary arterial hypertension) or male erectile dysfunction [such as the above or vardenafil (LEVITRA, STAXYN)]
  • medicines used to treat fungal infections (e.g. ketoconazole, itraconazole)
  • medicine for the treatment of HIV infection (e.g. ritonavir)
  • cyclosporine (medicine used to prevent rejection of transplanted organs)
  • erlotinib (TARCEVA) or gefitinib (IRESSA) (medicines against cancer)
  • phenytoin and carbamazepine (antiepileptic medicines), phenobarbitone (antiepileptic medicine, sedative)
  • quinidine (antiarrhythmic, antimalarial agent)
  • carvedilol (for the treatment of heart failure and hypertension)

Drug-herb interaction

  • St. John's Wort (herbal treatment for depression)

Drug-food interaction

  • ADEMPAS contains lactose. If you have been told by any doctor that you have an intolerance to some sugars, inform your doctor before taking this medicinal product.

Drug-lifestyle interaction

If you smoke, it is recommended that you stop, as smoking may reduce the efficacy of ADEMPAS. Contact your doctor if you stop or start smoking during treatment as a dose adjustment might be required.

See also ABOUT THIS MEDICATION: When it should not be used, and SIDE EFFECTS AND WHAT TO DO ABOUT THEM.

Proper Use of this Medication

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Treatment should only be initiated and monitored by a doctor experienced in the treatment of CTEPH or PAH.

Usual adult dose

During the first weeks of treatment your doctor will need to measure your blood pressure at least every two weeks. This is required to decide on the correct dose of your medication (ADEMPAS is available in different strengths (0.5 mg to 2.5 mg)).

Initial treatment dose

  • Starting at one 1 mg tablet, three times daily for 2 weeks. Your physician may have prescribed 0.5 mg 3 times daily for 2 weeks, depending on your health status.
  • Tablets should be taken three times a day, approximately 6 to 8 hours apart, with or without food.
  • Your doctor will increase the strength of your tablet every 2 weeks to a maximum of 2.5 mg three times a day (maximum daily dose of 7.5 mg) unless you experience any side effects or very low blood pressure. If you may experience any side effects mentioned (see below section 'SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM'), contact your doctor.

Maintenance dose

Your doctor will continue to prescribe you ADEMPAS at the highest dose you are comfortable on unless you experience any side effect or very low blood pressure, symptoms like dizziness and fainting.

Overdose

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed dose

Do not take a double dose to make up for a forgotten dose. If a dose is missed, treatment should be continued with the next dose as planned.

Stopped treatment

Don't stop taking ADEMPAS without talking to your doctor first, because this medicine prevents the development of a serious condition.

In case treatment has to be interrupted for 3 days or more, please contact your doctor before restart of treatment.

Other medicines

Medicines used to treat stomach disease or heartburn, such as aluminum hydroxide/magnesium carbonate should be taken at least 1 hour after ADEMPAS.

Side Effects and what to do about them

Like all medicines, this medicine can cause side effects, although not everybody gets them. The most serious side effects are coughing up blood (hemoptysis) and bleeding from the lungs (pulmonary hemorrhage); cases with fatal outcome were observed.

Serious side effects, how often they happen and what to do about them

Symptom / EffectTalk with your
doctor or
pharmacist
Stop taking
drug and seek
immediate
emergency
medical
attention
Only if
severe
In all
cases
Very commonHeadache, dizziness
Indigestion
Swelling of limbs
(edema peripheral)
Nausea
Diarrhea
Vomiting
CommonPain in stomach and
bowels
(gastrointestinal or
abdominal pain),
bloating,
constipation or
heartburn
(gastroesophageal
reflux disease)
Reduction in red
blood cells which
can make your skin
pale and cause
weakness, tiredness,
dizziness, headache,
breathlessness,
unusually fast
heartbeat, or chest
pain
Unusually fast or
irregular heartbeats
(palpitations)
Low blood pressure
(lightheaded-ness,
dizziness)
Coughing up blood
(mild to moderate)
Nosebleed lasting
more than 5 minutes
Congestion in the
nose (nasal
congestion)
Difficulty in
swallowing
UncommonBleeding from the
lung/coughing up
blood (severe)
UnknownAllergic reactions
(symptoms like
sudden wheeziness
and chest pain or
tightness; or
swelling of eyelids,
face, lips, tongue or
throat.)

This is not a complete list of side effects. For any unexpected effects while taking ADEMPAS, contact your doctor or pharmacist.

How to Store it

Keep out of reach and sight of children. Store at room temperature between 15°C and 30°C. Do not use after the expiry date stated on the label.

Reporting Suspected Side Effects

Canada Vigilance Program

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.

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.

More Information

For more information, please contact your health professional or pharmacist first, or Bayer Medical
Information at 1-800-265-7382 or
canada.medinfo@bayer.com.