Adempas

The recommended starting dose of Adempas (Riociguat) is 1 mg taken 3 times daily for 2 weeks. It may be taken with or without food, but should be spaced approximately 6 to 8 hours apart. Your doctor will gradually increase the dose as long as your blood pressure does not become too low or other side effects are not tolerated. The total daily dose should not be more than 7.5 mg (2.5 mg taken 3 times daily).

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that Adempas (Riociguat) be taken exactly as prescribed by your doctor. Do not stop taking Adempas (Riociguat) suddenly, unless you are experiencing serious side effects. If you feel it is necessary to stop taking Adempas (Riociguat), discuss this with your doctor.

If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice. If you have missed taking the medication for three days or more, contact your doctor before restarting Adempas (Riociguat).

Store Adempas (Riociguat) at room temperature, protect it from light and moisture, and keep it out of the reach of children. Do not use Adempas (Riociguat) after the expiry date stated on the label.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

0.5 mg
Each film-coated, round, white tablet marked with the Bayer cross on one side and "0.5" and an "R" on the other side contains Adempas (Riociguat) 0.5 mg. Nonmedicinal ingredients: cellulose microcrystalline, crospovidone, hydroxypropylcellulose, hypromellose 3cP, hypromellose 5cP, lactose monohydrate, magnesium stearate, propylene glycol, sodium laurilsulphate, and titanium dioxide.

1 mg
Each film-coated, round, pale yellow tablet marked with the Bayer cross on one side and "1" and an "R" on the other side contains Adempas (Riociguat) 1 mg. Nonmedicinal ingredients: cellulose microcrystalline, crospovidone, ferric oxide yellow, hydroxypropylcellulose, hypromellose 3cP, hypromellose 5cP, lactose monohydrate, magnesium stearate, propylene glycol, sodium laurilsulphate, and titanium dioxide.

1.5 mg
Each film-coated, round, yellow-orange tablet marked with the Bayer cross on one side and "1.5" and an "R" on the other side contains Adempas (Riociguat) 1.5 mg. Nonmedicinal ingredients: cellulose microcrystalline, crospovidone, ferric oxide yellow, hydroxypropylcellulose, hypromellose 3cP, hypromellose 5cP, lactose monohydrate, magnesium stearate, propylene glycol, sodium laurilsulphate, and titanium dioxide.

2 mg
Each film-coated, round, pale orange tablet marked with the Bayer cross on one side and "2" and an "R" on the other side contains Adempas (Riociguat) 2 mg. Nonmedicinal ingredients: cellulose microcrystalline, crospovidone, ferric oxide red, ferric oxide yellow, hydroxypropylcellulose, hypromellose 3cP, hypromellose 5cP, lactose monohydrate, magnesium stearate, propylene glycol, sodium laurilsulphate, and titanium dioxide.

2.5 mg
Each film-coated, round, red-orange tablet marked with the Bayer cross on one side and "2.5" and an "R" on the other side contains Adempas (Riociguat) 2.5 mg. Nonmedicinal ingredients: cellulose microcrystalline, crospovidone, ferric oxide red, ferric oxide yellow, hydroxypropylcellulose, hypromellose 3cP, hypromellose 5cP, lactose monohydrate, magnesium stearate, propylene glycol, sodium laurilsulphate, and titanium dioxide.

Do not take Adempas (Riociguat) if you:

• are allergic to Adempas (Riociguat) or any ingredients of the medication
• are pregnant or planning to become pregnant
• are breast-feeding or planning to breast-feed
• are taking any of the following medications:
  • phosphodiesterase 5 inhibitors (e.g., Sildenafil, Tadalafil, Vardenafil)
  • nitrate medications (e.g., Nitroglycerin tablet, spray, or ointment)
  • nitric oxide donors (e.g., amyl nitrate)
• have a history of increased blood pressure in the lungs, associated with scarring of the lungs, caused by non-infectious pneumonia

There may be an interaction between Adempas (Riociguat) and any of the following:

• Aliskiren
• alpha-agonists (e.g., Clonidine, methyldopa)
• alpha-blockers (e.g., Alfuzosin, Doxazosin, Tamsulosin)
• Amiodarone
• Anagrelide
• angiotensin converting enzyme inhibitors (ACEIs; Captopril, Enalapril, Ramipril)
• angiotensin receptor blockers (ARBs; e.g., Candesartan, Irbesartan, Losartan)
• antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide)
• antipsychotics (e.g., Clozapine, Olanzapine, Quetiapine, Risperidone)
• Apalutamide
• Apomorphine
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• beta blockers (e.g., Atenolol, Propranolol, Sotalol)
• Bosentan
• brimonidine
• Bromocriptine
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• Carbamazepine
• Cobicistat
• conivaptan
• Cyclosporine
• Deferasirox
• Dipyridamole
• diuretics (water pills; e.g., Furosemide, Hydrochlorothiazide, triamterene)
• Dronedarone
• Duloxetine
• efavirenz
• Elagolix
• Eliglustat
• Enzalutamide
• etravirine
• Flibanserin
• grapefruit juice
• Guanfacine
• Hepatitis C antivirals (e.g., daclatasvir, dasabuvir, ombitasvir, paritaprevir)
• Hydralazine
• Imipramine
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• iron sucrose
• levodopa
• lumacaftor and Ivacaftor
• macrolide antibiotics (azithromycin, clarithromycin, erythromycin)
• Minoxidil
• Modafinil
• Morphine
• Nabilone
• nitrates (e.g., isosorbide dinitrate, nitroglycerin)
• nitrates (e.g., nitroglycerin, isosorbide dinitrate, isosorbide mononitrate)
• Obinutuzumab
• Oxcarbazepine
• Pentoxifylline
• Phenobarbital
• Phenytoin
• phosphodiesterase 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)
• Pramipexole
• primidone
• proton pump inhibitors (e.g., Lansoprazole, Omeprazole)
• quinidine
• quinine
• Rasagiline
• rifabutin
• rifampin
• Roflumilast
• Rotigotine
• sacubitril
• St. John's wort
• Sarilumab
• Selegiline
• theophyllines (e.g., Aminophylline, Oxtriphylline, Theophylline)
• Tizanidine
• Tocilizumab
• tolcapone
• tyrosine kinase inhibitors (e.g., Dabrafenib, Erlotinib, imatinib, Lapatinib)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Adempas (Riociguat). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking (including herbal treatments), whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Adempas (Riociguat).

HEALTH CANADA ADVISORY

August 15, 2016

Health Canada has issued new restrictions concerning the use of Adempas (Adempas (Riociguat)). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Bleeding: High blood pressure in the lungs tends to cause increased bleeding. Adempas (Riociguat) may further increase the risk of bleeding, particularly for people with a history of bleeding in the lungs. If you experience an increase in nosebleeds or you begin to cough up blood, contact your doctor immediately as this can become a medical emergency.

Dizziness: Adempas (Riociguat) may cause drowsiness or dizziness, affecting your ability to drive or operate machinery. Avoid these and other hazardous tasks until you have determined how Adempas (Riociguat) affects you.

Kidney function: The safety and effectiveness of using Adempas (Riociguat) have not been determined for people with severely reduced kidney function or those on dialysis. If you have kidney problems, discuss with your doctor how Adempas (Riociguat) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Adempas (Riociguat), and whether any special monitoring is needed.

Liver function: The safety and effectiveness of using Adempas (Riociguat) have not been determined for people with severe liver disease or reduced liver function. If you have liver problems, discuss with your doctor how Adempas (Riociguat) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Adempas (Riociguat), and whether any special monitoring is needed.

Low blood pressure: Adempas (Riociguat) may cause a lowering of blood pressure. If you have low blood pressure (e.g., systolic blood pressure < 95 mmHg), or have existing heart disease (e.g., Coronary Artery Disease, hypovolemia, severe left ventricular outflow obstruction, autonomic dysfunction) or are taking medications that lower blood pressure, discuss with your doctor how Adempas (Riociguat) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Adempas (Riociguat), and whether any special monitoring is needed.

Smoking: Cigarette smoking dramatically reduces how much Adempas (Riociguat) is available in your body and may result in Adempas (Riociguat) not working properly. It is advised that people taking Adempas (Riociguat) stop smoking. Discuss this with your doctor or pharmacist.

Pregnancy: Adempas (Riociguat) should not be used during pregnancy. If you become pregnant while taking Adempas (Riociguat), contact your doctor immediately. Women should use effective birth control during treatment with Adempas (Riociguat).

Breast-feeding: It is not known if Adempas (Riociguat) passes into breast milk. If you are a breast-feeding mother and are taking Adempas (Riociguat), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Adempas (Riociguat) have not been established for children.