Riociguat, Oral

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KEY POINTS

• This medicine is taken by mouth to treat high blood pressure in the lungs. Take it exactly as directed.
• This medicine can cause severe birth defects and must not be used by women who are pregnant.
• This medicine increases your risk of bleeding. Be careful while shaving, cutting fingernails or toenails, or when using sharp objects.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: sGC stimulator

Generic and brand names: riociguat, oral; Adempas

What is this medicine used for?

This medicine is taken by mouth to treat 2 kinds of pulmonary hypertension (high blood pressure in the lungs):

• Chronic thromboembolic pulmonary hypertension that can’t be treated with surgery
• Pulmonary arterial hypertension

For females only: You must be enrolled in a special program before you can receive this medicine. This medicine will be sent to you from a special pharmacy. It is not available through local pharmacies. Talk with your healthcare provider about this.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Bleeding problems such as hemophilia
• Heart disease or blood circulation problems
• High blood pressure or low blood pressure
• Kidney or liver problems
• Pulmonary veno-occlusive disease (PVOD), which is narrowing of blood vessels in your lungs
• Other lung problems, including coughing up blood

Also, tell your healthcare provider if you smoke, or if you quit smoking during treatment with this medicine. Smoking affects the way this medicine works and your dose of this medicine may need to be changed.

Do not take this medicine if you are taking:

• Any nitrate product such as amyl nitrite inhalant, nitroglycerin, isosorbide dinitrate, or isosorbide mononitrate
• Avanafil (Stendra), sildenafil (Revatio, Viagra), tadalafil (Adcirca, Cialis), or vardenafil (Levitra, Staxyn)
• Dipyridamole (Aggrenox, Persantine)
• Theophylline (Elixophyllin, Theo-24, Theochron)

This medicine can interact with many other medicines and cause harmful side effects. It is very important that you tell your healthcare provider about all the prescription medicines, nonprescription medicines, or supplements you take.

Females of childbearing age: This medicine has been reported to cause birth defects. Read the information that comes in the medicine package. You must meet certain conditions and sign a consent form. Hormone-based forms of birth control alone may not be reliable when taking this medicine. Use a nonhormonal form of birth control such as a condom, diaphragm or sponge while taking this medicine. You must have a negative pregnancy test before you start taking this medicine. You need to have monthly pregnancy tests and use 2 forms of birth control while taking this medicine and for a month after stopping it. Talk to your healthcare provider about what forms of birth control are right for you. Stop taking this medicine at the first sign that you may be pregnant and contact your healthcare provider right away. Do not breast-feed while taking this medicine.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take your dosage of this medicine exactly as your healthcare provider prescribes. Do not take more or take it more often than prescribed.

Check with your healthcare provider before using this medicine in children under age 18.

You may take this medicine with or without food.

What if I miss a dose?

If you miss a dose, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss 3 or more days of treatment, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: trouble breathing, dizziness.

What should I watch out for?

Your healthcare provider will need to see you regularly to check your blood pressure. Tell your provider if you have any symptoms of low blood pressure, such as dizziness, lightheadedness, or fainting. Your provider may change your dosage during treatment, especially when you first start taking this medicine. You may also need to have blood tests to see how this medicine affects you. Keep all appointments.

This medicine may cause you to bleed more easily or to bleed longer. Avoid sports and activities that may cause injuries. Talk with your healthcare provider about which sports or activities you should avoid.

This medicine may make you dizzy. Do not drive or operate machinery unless you are fully alert. You may feel dizzy or faint when you get up quickly after sitting or lying down. Getting up slowly may help. Also, drinking alcohol may make it worse. Do not drink alcohol unless your healthcare provider approves.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Severe dizziness; fainting; chest pain or irregular heartbeat; unexplained swelling of your hands, legs, feet, and ankles; trouble breathing or swallowing; coughing up blood; unusual bruising or bleeding; unusual tiredness or weakness.

Other: Headache, nausea, vomiting, mild dizziness, mild stomach pain, heartburn, constipation, diarrhea.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• ACE inhibitors such as benazepril (Lotensin), captopril, enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), quinapril (Accupril), and ramipril (Altace)
• Aliskiren (Tekturna) and aliskiren/hydrochlorothiazide (Tekturna HCT)
• Alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), tamsulosin (Flomax), and terazosin
• Anagrelide (Agrylin)
• Angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• Antacids that contain aluminum, calcium, or magnesium, such as Gaviscon, Maalox, Mylanta, Phillips' Chewable Tablets, Rolaids, or TUMS (Take antacids at least 1 hour before or 1 hour after you take this medicine.)
• Antibiotics such as azithromycin (Zithromax, Zmax), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antifungal medicines such as itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Antiviral medicines such as daclatasvir (Daklinza), ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira), ombitasvir/paritaprevir/ritonavir (Technivie), and simeprevir (Olysio)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), betaxolol, bisoprolol (Zebeta), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), pindolol, sotalol (Betapace, Sorine), and timolol
• Blood pressure medicines such as hydralazine, methyldopa, minoxidil, and reserpine
• Bosentan (Tracleer)
• Calcium channel blockers such as amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), diltiazem (Cardizem, Cartia, Tiazac), nicardipine (Cardene), and verapamil (Calan, Covera, Verelan)
• Cancer medicines such as abiraterone (Zytiga), crizotinib (Xalkori), dabrafenib (Tafinlar), enzalutamide (Xtandi), idelalisib (Zydelig), mitotane (Lysodren), nilotinib (Tasigna), and obinutuzumab (Gazyva)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor) and lomitapide (Juxtapid)
• Cilostazol (Pletal)
• Clonidine (Catapres, Kapvay)
• Conivaptan (Vaprisol)
• Dipyridamole (Persantine)
• Diuretics (water pills) such as bumetanide, chlorthalidone, furosemide (Lasix), hydrochlorothiazide (Microzide), and metolazone (Zaroxolyn)
• Eliglustat (Cerdelga)
• Eplerenone (Inspra)
• Erectile dysfunction medicines such as avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra, Staxyn)
• Flibanserin (Addyi)
• Heart medicines such as amiodarone (Cordarone, Pacerone), dronedarone (Multaq), quinidine, and ranolazine (Ranexa)
• HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), darunavir (Prezista), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune) and tacrolimus (Astagraf, Prograf, Protopic)
• Lumacaftor/ivacaftor (Orkambi)
• Medicines to treat breathing or lung problems such as aminophylline and theophylline
• Mefloquine
• Mirabegron (Myrbetriq)
• Nefazodone
• Nitrate medicines such as isosorbide (Dilatrate, Isordil, Monoket) and nitroglycerin (Minitran, Nitro-Dur, Nitrostat)
• Other medicines to treat pulmonary hypertension such as sildenafil (Revatio) and tadalafil (Adcirca)
• Pentoxifylline
• Propranolol (Hemangeol, Inderal, InnoPran)
• Quinine
• St. John's wort
• Vasodilators such as hydralazine, isoxsuprine, minoxidil, and nesiritide (Natrecor)

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

Do not drink alcohol while taking this medicine unless your healthcare provider approves.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.