PHCentral: Informing, supporting and advocating for Pulmonary Hypertension (PH) patients since 1999 » Medical Issues » Frequently Asked Questions by Patients about Adcirca®

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 nitrite)

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

What is Adcirca?

Adcirca (pronounced Ad-sur-kuh) is a medicine that widens blood vessels in the lungs of people with PAH. Adcirca is taken only once daily and requires no periodic laboratory testing.

Adcirca is the first once-daily phosphodiesterase type 5 (PDE-5) inhibitor for the treatment of PAH, and is indicated to improve exercise ability in World Health Organization pulmonary arterial hypertension (WHO Group 1) patients.

Adcirca treats PAH by widening blood vessels in the lungs. As a result, blood vessels can better carry oxygen-rich blood to the rest of the body.

Who should not take Adcirca?

Your healthcare provider will determine if Adcirca is right for you. You should not take Adcirca if you:

Take any medicines called nitrates.
Are allergic to tadalafil or any other ingredient in Adcirca
Click here to see what ingredients are in Adcirca
Click here to learn the most important information you should know about Adcirca

What should I tell my healthcare provider before taking Adcirca?

You should tell your healthcare provider about all of your medical conditions, including if you:

Are allergic to tadalafil, the active ingredient in Adcirca, or any other ingredients
Are currently taking any type of nitrate, such as nitroglycerin
Have pulmonary veno-occlusive disease (PVOD)
Have heart problems such as angina (chest pain), heart failure, irregular heartbeats or have had a heart attack
Are currently taking any other medications for PAH
Are currently taking an alpha blocker
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 or optic nerve problems
Have ever had any sudden vision loss
Have ever had hearing problems
Have a deformed penis shape or Peyronie's disease
Have had an erection that lasted more than 4 hours
Have blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia
Are pregnant or planning to become pregnant
Are breastfeeding or planning to breastfeed

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
Antihypertensives
Alpha blockers
Protease inhibitors
Ketoconazole
Erythromycin
Rifampin
Bosentan
Phenobarbital
Phenytoin
Carbamazepine
Cialis (tadalafil) and other PDE-5 inhibitors
Other medications to treat PAH

How should I take Adcirca?

The recommended dose for most patients consists of two 20-mg tablets that you swallow at the same time every day, one after the other. Do not bite, chew or cut Adcirca tablets. Adcirca can be taken with or without food. Patients should avoid drinking more than four alcoholic drinks in a short period of time while taking Adcirca. Drinking too much alcohol can lower your blood pressure causing you to feel dizzy or faint.

Can I drink alcohol while taking Adcirca?

Do not have 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.

What are the possible side effects of Adcirca?

The most common side effects of Adcirca include:

Headache (42%)
Muscle pain (14%)
Getting red or hot in the face (flushing) (13%)
Nausea (11%)
Pain in the arms, legs, or back (11%)
Upset stomach (10%)
Stuffy or congested nose (9%)

Seek immediate medical help if any of the following rare side effects happen to you:

Decreased eyesight or loss of vision in one or both eyes
Sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness
An erection that lasts more than 4 hours.

You should tell your healthcare provider if you experience any of these or other side effects with Adcirca.

How should I store Adcirca?

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

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

What are the benefits of using Adcirca to treat PAH?

In a large, Phase III clinical trial, by 16 weeks, patients taking Adcirca once daily achieved a mean (average) 33-meter improvement in 6 minute walk distance compared to those on placebo. In addition, some patients taking Adcirca experienced less clinical worsening compared to the placebo group.

What stage(s) of PAH does Adcirca treat?

Adcirca can be used in all functional classes of PAH. However, this is something that you should discuss with your doctor to fully evaluate your treatment options and potential risk of interactions with any medications you are taking.

Can Adcirca be taken with other PAH medications?

Adcirca has been studied in patients already taking a background of bosentan. However, this is something that you should discuss with your doctor to fully evaluate your treatment options and potential risk of interactions with any medications you are taking.

How do I get Adcirca?

Adcirca is available by prescription only. Once you have a prescription from your physician, Adcirca is available at retail and specialty pharmacies nationwide.

Are there any patient support programs for Adcirca?

United Therapeutics Corporation has recently launched a new support program called Living PAH for patients taking Adcirca. Living PAH provides access to peers who can offer emotional support as well as healthcare professionals who can answer non-medical questions and provide reimbursement assistance. For more information or to join, visit www.livingpah.com.

Where can I get reimbursement help?

If you need help with reimbursement for your Adcirca prescription, please call the Adcirca Patient Reimbursement Hotline at 1-877-948-9136. The hotline is staffed by medical insurance experts Monday through Friday, from 9 AM to 6 PM EST. They can answer coding and billing questions, verify insurance benefits, identify and assist with the submission of prior authorization documentation, determine program eligibility, and provide guidance regarding claims, denials, and appeals.

If you do not have insurance, the Adcirca Patient Reimbursement Hotline staff can investigate alternative sources of pharmaceutical insurance coverage or co-pay assistance for which you may be eligible. If you lack insurance coverage or alternative sources of pharmaceutical coverage, the hotline staff can refer you to the United Therapeutics Patient Assistance Program.

Indication

Adcirca is a prescription medication used to treat pulmonary arterial hypertension (WHO Group 1) to improve exercise ability.

Important Safety Information for Adcirca

You should discuss all of your medical conditions and all medications with your doctor before starting Adcirca.

Do not take Adcirca if you take any medications that contain nitrates (often used for chest pain), 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 doctor.

Adcirca is a type of medication called a PDE-5 inhibitor. Adcirca contains the same ingredient (tadalafil) as Cialis, which is used to treat erectile dysfunction (impotence). If you are taking Adcirca, do not take Cialis or other PDE-5 inhibitors.

PDE-5 inhibitors 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 doctor 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.

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. Taking Adcirca with alcohol, or blood pressure medications, such as alpha-blockers, may lower blood pressure and cause hypotension (fainting). Inform your doctor if you have kidney or liver problems before taking Adcirca.

In rare cases, men taking PDE-5 inhibitors (including tadalafil) for erectile dysfunction reported side effects such as a sudden decrease or loss of vision or hearing, or an erection lasting more than four hours. If you experience any of these side effects, 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.

Click here for Full Prescribing Information and Patient Information or call 1-800-545-5979.

LINKS:

Full Prescribing Information - http://www.adcirca.com/pdf/AdcircaPrescribingInformation.pdf

Patient Information - http://www.adcirca.com/pdf/AdcircaPatientInformation.pdf