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MOVING FORWARD WITH ADCIRCA (tadalafil) ONCE-DAILY

PAH treatment that can help improve exercise ability

ADCIRCA® (tadalafil) is a prescription medication used to treat pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II–III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%).

Frequently Asked Questions about ADCIRCA

For answers to common questions about ADCIRCA, click the links below:

What is the most important information I should know about ADCIRCA?
What is ADCIRCA?
Who should not take ADCIRCA?
What should I tell my healthcare provider before I take ADCIRCA?
Does ADCIRCA react with other medicines?
How should I take ADCIRCA?
Can I drink alcohol while taking ADCIRCA?
What are the most common side effects of ADCIRCA?
How should I store ADCIRCA?
What are the ingredients in ADCIRCA?
What are the possible benefits of taking ADCIRCA?
What types of PAH patients were included in the studies for ADCIRCA?
Can ADCIRCA be taken with other PAH medications?
How do I get ADCIRCA?
What if I cannot afford my co-pay for ADCIRCA?
What is the ASSIST program?

What is the most important information I should know about ADCIRCA?

Never take ADCIRCA with any nitrate medicine or guanylate cyclase stimulator:

  • Your blood pressure could drop quickly to an unsafe level
  • You could get dizzy, faint, or even have a heart attack or stroke

Nitrates include:

  • Medicines that treat chest pain (angina)
  • Nitroglycerin in any form, including tablets, patches, sprays, and ointments
  • Other nitrate medicines (isosorbide mononitrate or dinitrate)
  • Recreational drugs that are inhaled, called “poppers” (amyl nitrate, butyl nitrate, or butyl nitrite)

Guanylate cyclase stimulators include:

  • Riociguat (Adempas®) a medicine that treats pulmonary arterial hypertension and chronicthromboembolic pulmonary hypertension

Ask your healthcare provider or pharmacist if you are not sure whether you take a nitrate medicine or guanylate cyclase stimulator medicine.

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What is ADCIRCA?

ADCIRCA (pronounced AD-SUR-KUH) is a prescription medicine called a phosphodiesterase 5 inhibitor (PDE-5i) used to treat pulmonary arterial hypertension (PAH, high blood pressure in your lungs) to improve exercise ability.

  • ADCIRCA is the only PDE-5i for PAH taken once-daily
  • ADCIRCA may improve exercise ability
    • After 16 weeks of treatment, patients taking ADCIRCA increased their 6-minute walk distance (6MWD) by an average of 33 meters, or 108 feet compared to patients taking placebo (sugar pill)
      • 6MWD is a measure of how far you can walk in 6 minutes and is a measure of exercise ability
  • It is not known if ADCIRCA is safe or effective in children
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Who should not take ADCIRCA?

Your healthcare provider will determine if ADCIRCA is right for you. Do not take ADCIRCA if you:

  • Take any medicines called nitrates
  • Take any medicine called Guanylate cyclase stimulators
  • Use recreational drugs called “poppers” like amyl nitrate, butyl nitrate, or butyl nitrite
  • Are allergic to tadalafil or any other ingredient in ADCIRCA. Click here to see the ingredients of ADCIRCA
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What should I tell my healthcare provider before I take ADCIRCA?

Before taking ADCIRCA, tell your healthcare provider about all of your medical conditions, including if you:

  • Are allergic to ADCIRCA or Cialis® or any of its ingredients. Click here to see the ingredients of ADCIRCA
  • Have pulmonary veno-occlusive disease (PVOD)
  • Have heart problems such as angina (chest pain), heart failure, irregular heartbeats, or have had a heart attack
  • Have low blood pressure or high blood pressure that is not controlled
  • Have had a stroke
  • Have liver problems
  • Have kidney problems or get dialysis
  • Have stomach ulcers
  • Have retinitis pigmentosa, a rare genetic eye disease
  • Have ever had any sudden vision loss, including any damage to your optic nerve or NAION (nonarteritic anterior ischemic optic neuropathy)
  • Have ever had hearing problems such as ringing in the ears, dizziness, or loss of hearing
  • Have a deformed penis or Peyronie’s disease (curvature of the penis)
  • Have had an erection that lasted for more than 4 hours
  • Have blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia
  • Are pregnant or are planning to become pregnant. It is not known if ADCIRCA will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant
  • Are breast-feeding or plan to breast-feed. It is not known if ADCIRCA passes into your breast milk. You and your healthcare provider should decide if you will take ADCIRCA or breast-feed. You should not do both
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Does ADCIRCA react with other medicines?

You should tell your healthcare provider about all the medicines (prescription and nonprescription), vitamins, and herbal supplements you take. ADCIRCA and other medicines may affect each other.

Be sure to tell your healthcare provider if you take*:

  • Nitrates or guanylate cyclase stimulators (Click here for important safety considerations )
  • Antihypertensives, used to treat high blood pressure. Your blood pressure could suddenly drop. You could get dizzy or faint
  • Alpha-blockers, used to treat prostate disease and high blood pressure. Your blood pressure could suddenly drop. You could get dizzy or faint
  • Protease inhibitors, used to treat HIV infection, such as ritonavir (Norvir®, Kaletra®)
  • Ketoconazole (Extina®, Xolegel®, Ketozole®, Nizoral® A-D, Nizoral®), itraconazole (Sporanox®)
  • Erythromycin (several brand names exist. Please consult your healthcare provider to determine if you are taking this medicine)
  • Rifampin (Rifadin®, Rifamate®, Rifater®, Rimactane®)
  • Bosentan (Tracleer®)
  • Phenobarbital, phenytoin (Dilantin®), carbamazepine (Tegretol®)
  • Cialis or other medicines or treatments for erectile dysfunction (impotence)
  • ADCIRCA is also marketed as Cialis for the treatment of male erectile dysfunction (ED, impotence) and for the signs and symptoms of benign prostatic hyperplasia (BPH, enlarged prostate). Do not take both ADCIRCA and Cialis. Do not take ADCIRCA and other medicines or treatments for erectile dysfunction

Ask your healthcare provider or pharmacist for a list of all of the medicines you take, if you are not sure. Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist before starting treatment with a new medicine.

*The brands listed are trademarks of their respective owners and are not trademarks of Eli Lilly and Company. The makers of these brands are not affiliated with and do not endorse Eli Lilly and Company or its products.

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How should I take ADCIRCA?

ADCIRCA is a prescription medication used to treat pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with
NYHA Functional Class II–III symptoms and etiologies of idiopathic PAH (PAH of an unknown cause) or heritable PAH (a family history of PAH) (61%) or PAH associated with connective tissue diseases (23%).

Take ADCIRCA exactly as your healthcare provider tells you.

  • The dose for most patients is 40 mg, consisting of two 20-mg tablets taken once-daily
  • Take two 20-mg tablets of ADCIRCA at the same time of day every day
  • ADCIRCA can be taken with or without food
  • Do not bite, chew, or cut ADCIRCA tablets
  • Do not change your dose or stop taking ADCIRCA without speaking to your healthcare provider
  • If you take too much ADCIRCA, call your healthcare provider or go to an emergency department right away

*The brands listed are trademarks of their respective owners and are not trademarks of Eli Lilly and Company. The makers of these brands are not affiliated with and do not endorse Eli Lilly and Company or its products.

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Can I drink alcohol while taking ADCIRCA?

You should always consult with your healthcare provider regarding your treatment and alcohol use. Do not drink too much alcohol (for example, more than 4 alcoholic drinks) in a short period of time while you take ADCIRCA. Drinking too much alcohol can lower your blood pressure. You could get dizzy or faint.

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What are the most common side effects of ADCIRCA?

The most common side effects of ADCIRCA are headache, muscle pain, getting red or hot in the face (flushing), nausea, pain in the arms, legs or back, upset stomach, and stuffy or congested nose.

These are not all the possible side effects of ADCIRCA. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to the U.S. Food and Drug Administration (FDA) at 1-800-FDA-1088.

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How should I store ADCIRCA?

Store ADCIRCA at room temperature between 59°F and 86°F (15°C and 30°C).

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What are the ingredients in ADCIRCA?

ADCIRCA contains tadalafil, the same main ingredient in Cialis®:

  • Active ingredient: tadalafil
  • Inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin
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What are the possible benefits of taking ADCIRCA?

ADCIRCA may improve exercise ability. In the large clinical study for ADCIRCA, after 16 weeks of treatment, patients taking ADCIRCA increased their 6-minute walk distance (6MWD), or the distance they were able to walk in 6 minutes, by an average of 33 meters, or 108 feet.

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What types of PAH patients were included in the studies for ADCIRCA?

Studies establishing effectiveness included predominately patients with NYHA Functional Class II–III symptoms and etiologies of idiopathic PAH (PAH of an unknown cause) or heritable PAH (a family history of PAH) (61%) or PAH associated with connective tissue diseases (23%).

However, this is something that you should discuss with your healthcare provider to fully evaluate your treatment options and potential risk of interactions with any medications you are taking.

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Can ADCIRCA be taken with other PAH medications?

ADCIRCA has been studied in patients already taking a background of bosentan (a different medication used to treat PAH). However, this is something that you should discuss with your healthcare provider to fully evaluate your treatment options and potential risk of interactions with any medications you are taking.

Do not take ADCIRCA if you are taking a guanylate cyclase stimulator such as Riociguat (Adempas®) a medicine that treats pulmonary arterial hypertension and chronicthromboembolic pulmonary hypertension. Be sure to tell your healthcare provider if you take any guanylate cyclase stimulator. (Click here for important safety considerations)

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How do I get ADCIRCA?

ADCIRCA is an open channel product available by prescription only. Once you have a prescription from your physician, ADCIRCA is available nationwide through retail and specialty pharmacies, including the specialty pharmacies listed below (listed alphabetically)*:

  • Accredo®
  • CVS Health®

*The pharmacy list is not an exhaustive list and is current as of April 2014. This list is not an endorsement of any pharmacy or the quality of support it may provide. For specific information regarding the availability of ADCIRCA, please contact the pharmacy directly.

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What if I cannot afford my co-pay for ADCIRCA?

If you are on a commercial or private insurance plan, you may be eligible for a $20 co-pay per fill of ADCIRCA perscription through the ADCIRCA Co-pay Assistance Program.

Click here for more information about the ADCIRCA Co-pay Assistance Program and additional assistance through ASSIST, your Access Solutions and Support Team

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What is the ASSIST program?

There are a number of assistance programs available to help you obtain your medication, if you qualify. To find the program that best meets your needs, we have created ASSIST, your Access Solutions and Support Team.

When you call 1-877-UNITHER (1-877-864-8437), an ASSIST Advisor will work to figure out if a program is right for you.

Click here to learn more about ASSIST.

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Important Safety Considerations for ADCIRCA® (tadalafil)

  • You should discuss all of your medical conditions and all medications with your healthcare provider before starting ADCIRCA
  • Do not take ADCIRCA if you take any medications that contain nitrates (often used for chest pain) or any guanylate cyclase stimulators (for example riociguat Adempas®), as the combination could cause a sudden, unsafe drop in blood pressure
  • Do not take ADCIRCA if you are allergic to tadalafil or any other ingredient in ADCIRCA
  • If you experience chest pain after taking ADCIRCA, contact your healthcare provider
  • ADCIRCA is a type of medication called a phosphodiesterase 5 inhibitor (PDE-5i). PDE-5is can cause blood vessels to widen, which may result in a decrease in blood pressure. If you have heart-disease or any problems with low blood pressure, tell your healthcare provider before taking ADCIRCA, as these conditions may be affected by the action of ADCIRCA
  • If you have ever had blockage in the veins of your lungs, known as pulmonary veno-occlusive disease (PVOD), ADCIRCA is not recommended for you
  • Taking ADCIRCA with alcohol, or blood pressure medications, such as alpha-blockers, may lower blood pressure and cause hypotension (light-headedness or fainting)
  • Do not take ADCIRCA if you are taking rifampin (an antibiotic for certain bacterial infections), or antifungal medications, such as ketoconazole and itraconazole. If you require treatment with both ADCIRCA and ritonavir (Norvir®) at the same time, your dose of ADCIRCA will need to be adjusted. Inform your healthcare provider if you have kidney or liver problems before taking ADCIRCA
  • ADCIRCA contains the same ingredient (tadalafil) as Cialis®, which is used to treat erectile dysfunction (ED, impotence) and the signs and symptoms of benign prostatic hyperplasia (BPH, enlarged prostate). If you are taking ADCIRCA, do not take Cialis or other PDE-5is
  • In rare cases, patients reported side effects such as decreased eyesight or loss of vision in one or both eyes (NAION), or sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness. If you experience any of these side effects after taking ADCIRCA, seek medical attention right away
  • In rare cases, men taking PDE-5is (including tadalafil) for erectile dysfunction reported side effects such as an erection lasting more than four hours. If you experience a prolonged erection, seek medical attention right away
  • The most common side effects of ADCIRCA are headache, muscle pain, getting red or hot in the face (flushing), nausea, pain in the arms, legs or back, upset stomach, stuffy or congested nose

ADC.ISI.CON.KCGLB-4-108.v1

For more information about ADCIRCA, please see the Full Prescribing Information and
Patient Information or call 1-800-545-5979.

Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.

patient brochure learn about pah patient assistance

Important Safety Considerations for ADCIRCA® (tadalafil)

  • You should discuss all of your medical conditions and all medications with your healthcare provider before starting ADCIRCA
  • Do not take ADCIRCA if you take any medications that contain nitrates (often used for chest pain) or any guanylate cyclase stimulators (for example riociguat Adempas®), as the combination could cause a sudden, unsafe drop in blood pressure
  • Do not take ADCIRCA if you are allergic to tadalafil or any other ingredient in ADCIRCA
  • If you experience chest pain after taking ADCIRCA, contact your healthcare provider
  • ADCIRCA is a type of medication called a phosphodiesterase 5 inhibitor (PDE-5i). PDE-5is can cause blood vessels to widen, which may result in a decrease in blood pressure. If you have heart-disease or any problems with low blood pressure, tell your healthcare provider before taking ADCIRCA, as these conditions may be affected by the action of ADCIRCA
  • If you have ever had blockage in the veins of your lungs, known as pulmonary veno-occlusive disease (PVOD), ADCIRCA is not recommended for you
  • Taking ADCIRCA with alcohol, or blood pressure medications, such as alpha-blockers, may lower blood pressure and cause hypotension (light-headedness or fainting)
  • Do not take ADCIRCA if you are taking rifampin (an antibiotic for certain bacterial infections), or antifungal medications, such as ketoconazole and itraconazole. If you require treatment with both ADCIRCA and ritonavir (Norvir®) at the same time, your dose of ADCIRCA will need to be adjusted. Inform your healthcare provider if you have kidney or liver problems before taking ADCIRCA
  • ADCIRCA contains the same ingredient (tadalafil) as Cialis®, which is used to treat erectile dysfunction (ED, impotence) and the signs and symptoms of benign prostatic hyperplasia (BPH, enlarged prostate). If you are taking ADCIRCA, do not take Cialis or other PDE-5is
  • In rare cases, patients reported side effects such as decreased eyesight or loss of vision in one or both eyes (NAION), or sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness. If you experience any of these side effects after taking ADCIRCA, seek medical attention right away
  • In rare cases, men taking PDE-5is (including tadalafil) for erectile dysfunction reported side effects such as an erection lasting more than four hours. If you experience a prolonged erection, seek medical attention right away
  • The most common side effects of ADCIRCA are headache, muscle pain, getting red or hot in the face (flushing), nausea, pain in the arms, legs or back, upset stomach, stuffy or congested nose

ADC.ISI.CON.KCGLB-4-108.v1


For more information about ADCIRCA, please see the Full Prescribing Information and
Patient Information or call 1-800-545-5979.

-Thomas A Gieseke - 3 illustrations for Adcirca: pillbox with empty "Sunday" compartment, isolated dog and isolated pedometer. Indefinite buyout of rights for use in print and electronic media (iPad presentation) for use by Adcirca only -Copyright Clearance Center - Wolters Kluwer Health, Circulation, Nazzareno Galie, Bruce H. Brundage, Hossein A. Ghofrani, Ronald J. Oudiz, Gerald Simmonneau, Zeenat Safdar, Shelley Shapiro..., Tadalafil Therapy for Pulmonary Arterial Hypertension, License No: 3177700012726 -Nicholais Photography - Unlimited use of photos in print, digital, web for pro and consumer in the US -Bella Agency - Victoria Gardner, unlimited use in print, digital and web