Understanding Your Medication Safety with the United Cares Program

Navigating the complexities of Pulmonary Arterial Hypertension (PAH) treatment requires not only understanding your medication but also having access to comprehensive support. The United Cares Program is designed to empower patients like you with essential safety information and resources to manage your PAH journey effectively. This guide provides crucial safety details for several PAH medications, ensuring you are well-informed and can engage in informed discussions with your healthcare provider.

This resource covers key safety considerations for Orenitram, Remodulin, ADCIRCA, TYVASO, and TYVASO DPI. It is vital to remember that this information is for educational purposes and should not replace professional medical advice. Always consult your healthcare provider for personalized guidance and treatment plans.

Orenitram: Important Safety Information

Orenitram is a prescription medicine used to treat pulmonary arterial hypertension (PAH), helping to slow disease progression and improve exercise ability. Understanding its safety profile is crucial for effective treatment.

Who Should Not Take Orenitram?

It’s critical to avoid Orenitram if you have severe liver problems. This condition can affect how your body processes the medication, potentially leading to complications.

Before Starting Orenitram: What to Tell Your Healthcare Provider

To ensure Orenitram is safe for you, inform your healthcare provider about the following:

Liver Problems: If you have any liver conditions, discuss them with your doctor as it may affect Orenitram’s suitability for you.
Diverticulosis: This intestinal condition should be disclosed to your healthcare provider.
Pregnancy and Breastfeeding: Inform your doctor if you are pregnant, breastfeeding, or planning to become pregnant or breastfeed. The effects of Orenitram on unborn babies or breast milk are not fully known.
All Medications: Provide a complete list of all medicines you are taking, including prescription, over-the-counter drugs, vitamins, and herbal supplements. Orenitram can interact with other medications, potentially causing side effects. Specifically, mention if you are taking other treprostinil-containing medicines like Remodulin® or Tyvaso®.

How to Take Orenitram Safely

Follow your healthcare provider’s instructions carefully when taking Orenitram:

Dosage Changes: Never change your dose or stop taking Orenitram abruptly without consulting your doctor.
Dosage Schedule: Orenitram is typically taken 2 or 3 times daily, as prescribed by your healthcare provider. Dosage adjustments may be necessary based on side effects.
Taking with Food: Always take Orenitram with food to ensure proper absorption and reduce potential side effects.
Swallowing Tablets Whole: Swallow Orenitram tablets whole; do not split, chew, crush, or break them. Damaged tablets can release too much medicine at once, increasing side effect risks.
Missed Dose: If you miss a dose, take it as soon as you remember with food. If you miss two or more doses, contact your healthcare provider for guidance.
Overdose: In case of an overdose, seek immediate medical attention by calling your healthcare provider or going to the nearest emergency room.
Tablet Shell in Stool: It’s normal to see the tablet shell in your stool as it is not digested. However, if you have diverticulosis, be aware that the shell might get trapped in intestinal pouches.

Potential Side Effects of Orenitram

Orenitram can have side effects, some of which can be serious:

Worsening PAH Symptoms: Suddenly stopping Orenitram can worsen your PAH symptoms. Always consult your healthcare provider before making any changes to your dosage.
Common Side Effects: Common side effects include headache, diarrhea, nausea, vomiting, flushing, and pain in the arms, legs, and jaw. These are not exhaustive. Report any bothersome or persistent side effects to your healthcare provider.

For medical advice about side effects, consult your healthcare provider. You can also report side effects to the FDA at www.fda.gov/MedWatch or call 1-800-FDA-1088.

For complete information about Orenitram, please refer to the Full Prescribing Information and Patient Information available at www.orenitram.com or by calling Customer Service at 1-877-UNITHER (1-877-864-8437).

Remodulin: Key Safety Information

Remodulin is another prescription medication for adults with PAH, designed to reduce exercise-related symptoms. It is also approved to slow symptom worsening in PAH patients switching from epoprostenol.

Important Considerations Before Using Remodulin

Discuss the following with your healthcare provider before starting Remodulin:

Existing Medical Conditions and Medications: Inform your doctor about all medical conditions and medications you are taking, as these may interact with Remodulin, increasing side effect risks or reducing effectiveness.
Liver or Kidney Problems: If you have liver or kidney issues, your Remodulin dosage might need adjustment.
Low Blood Pressure or Bleeding Problems: Disclose any history of low blood pressure or bleeding disorders.
Medications Affecting Liver Enzymes: Mention if you are taking gemfibrozil (for high cholesterol), rifampin (for infection), or other drugs affecting liver enzymes, as dosage adjustments may be necessary.
Pregnancy and Breastfeeding: Inform your doctor if you are pregnant, breastfeeding, or planning to become pregnant. Remodulin’s effects on pregnancy and breastfeeding are not fully understood.

Serious Side Effects of Remodulin

Be aware of these potential serious side effects of Remodulin:

Bloodstream Infections and Sepsis (with IV infusion): Continuous intravenous (IV) Remodulin infusions using an external pump and central vein catheter carry a risk of bloodstream infections and sepsis, which can be fatal. Subcutaneous (SC) infusion is the preferred delivery method to minimize this risk.
Worsening PAH Symptoms: Do not stop or drastically reduce your Remodulin dose without consulting your doctor, as it can worsen PAH symptoms.
Low Blood Pressure (Symptomatic Hypotension): Remodulin can lower blood pressure, increasing the risk of hypotension, especially if you already have low blood pressure or take blood pressure-lowering medications.
Bleeding Problems: Remodulin may increase bleeding risk, particularly in individuals taking blood thinners (anticoagulants).

Possible Side Effects of Remodulin

Remodulin can cause various side effects:

Infusion Site Reactions (SC Infusion): Pain, redness, swelling, and rash at the infusion site are common with subcutaneous Remodulin infusion, sometimes requiring strong pain medication or discontinuation of treatment.
IV Infusion Site Complications: IV Remodulin infusion can lead to bloodstream infections, arm swelling, tingling, bruising, and pain.
Common Side Effects: Headache, diarrhea, nausea, rash, jaw pain, widened blood vessels (vasodilatation), and swelling from fluid retention (edema) are common side effects with both SC and IV Remodulin. This list is not exhaustive.

Report any side effects to your healthcare provider. You can also report side effects to the FDA at www.fda.gov/MedWatch or call 1-800-FDA-1088.

Alt text: A patient receiving Remodulin subcutaneous infusion via pump.

For more detailed information about Remodulin, consult your healthcare provider and refer to the Full Prescribing Information at www.remodulin.com or call Customer Service at 1-877-UNITHER (1-877-864-8437).

ADCIRCA (tadalafil): Important Safety Information

ADCIRCA is used to treat pulmonary arterial hypertension and belongs to a class of medications called phosphodiesterase 5 inhibitors (PDE-5i).

Key Safety Considerations for ADCIRCA

Before starting ADCIRCA, consider the following safety points:

Medical Conditions and Medications: Discuss all medical conditions and medications with your healthcare provider before taking ADCIRCA.
Nitrates and Guanylate Cyclase Stimulators: Do not take ADCIRCA if you are taking nitrates (for chest pain) or guanylate cyclase stimulators, as this combination can cause a dangerous drop in blood pressure.
Allergies: Avoid ADCIRCA if you are allergic to tadalafil or any of its ingredients.
Heart Disease and Low Blood Pressure: Inform your healthcare provider if you have heart disease or low blood pressure, as ADCIRCA can widen blood vessels and further lower blood pressure.
Pregnancy and Breastfeeding: Discuss with your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding.
Pulmonary Veno-Occlusive Disease (PVOD): ADCIRCA is not recommended if you have PVOD.
Alcohol and Blood Pressure Medications: Combining ADCIRCA with alcohol or blood pressure medications like alpha-blockers can increase the risk of hypotension (light-headedness or fainting).
Rifampin and Antifungal Medications: Avoid taking ADCIRCA with rifampin (antibiotic) or antifungal medications like ketoconazole and itraconazole. Dosage adjustments may be needed if you take ADCIRCA with ritonavir (Norvir®).
Kidney or Liver Problems: Inform your healthcare provider about any kidney or liver problems before starting ADCIRCA.
Cialis and Other PDE-5is: ADCIRCA contains the same ingredient (tadalafil) as Cialis®, used for erectile dysfunction (ED) and benign prostatic hyperplasia (BPH). Do not take ADCIRCA with Cialis or other PDE-5 inhibitors.
Vision and Hearing Changes: In rare cases, ADCIRCA can cause decreased eyesight or vision loss (NAION) or sudden hearing decrease or loss, sometimes with tinnitus and dizziness. Seek immediate medical attention if you experience these side effects.
Prolonged Erection (Priapism): Rarely, PDE-5 inhibitors, including tadalafil, can cause erections lasting more than four hours (priapism). Seek immediate medical attention if this occurs.

Common Side Effects of ADCIRCA

The most common side effects of ADCIRCA include headache, muscle pain, flushing, nausea, pain in arms, legs, or back, upset stomach, and stuffy nose.

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

Report side effects to your healthcare provider or to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.

Alt text: ADCIRCA (tadalafil) tablets for pulmonary arterial hypertension.

TYVASO and TYVASO DPI: Safety Information

TYVASO (treprostinil) Inhalation Solution and TYVASO DPI (treprostinil) Inhalation Powder are prescription medicines for adults with PAH and pulmonary hypertension associated with interstitial lung disease (PH-ILD).

Important Safety Information for TYVASO and TYVASO DPI

Before using TYVASO or TYVASO DPI, inform your healthcare provider if you have:

Low Blood Pressure: TYVASO products can lower blood pressure and may not be suitable if you already have low blood pressure.
Bleeding Problems: Disclose any history of bleeding disorders.
Asthma or COPD: Inform your doctor if you have asthma or chronic obstructive pulmonary disease (COPD).
Pregnancy and Breastfeeding: Discuss pregnancy and breastfeeding plans with your healthcare provider. It is unknown if TYVASO products harm unborn babies or pass into breast milk.

Also, tell your healthcare provider about all medicines you are taking, especially:

High Blood Pressure or Heart Disease Medications
Anticoagulants (blood thinners)
Diuretics (water pills)
Gemfibrozil (Lopid®) or Rifampin (Rimactane®, Rifadin®, Rifamate®, Rifater®)

Possible Side Effects of TYVASO and TYVASO DPI

TYVASO and TYVASO DPI can cause serious side effects:

Low Blood Pressure (Symptomatic Hypotension): TYVASO products can further lower blood pressure if you already have low blood pressure.
Bleeding Problems: Increased bleeding risk, especially if taking blood thinners.
Bronchospasm: Like other inhaled prostaglandins, TYVASO products can cause airway tightening (bronchospasm), leading to breathing difficulties.

Common Side Effects of TYVASO and TYVASO DPI

Common side effects include cough, headache, throat irritation and pain, nausea, flushing, fainting or loss of consciousness, dizziness, diarrhea, and shortness of breath. This is not a complete list.

Contact your doctor for medical advice about side effects or breathing problems. Report side effects to the FDA at www.fda.gov/MedWatch or call 1-800-FDA-1088.

Alt text: TYVASO DPI (treprostinil) Inhalation Powder and inhaler device.

For comprehensive information about TYVASO or TYVASO DPI, refer to the Full Prescribing Information for TYVASO or TYVASO DPI, Instructions for Use manuals for TD-100 and TD-300 TYVASO® Inhalation System and TYVASO DPI™ Inhalation Powder, and visit www.TYVASO.com or call 1-877-UNITHER (1-877-864-8437).

Disclaimer: This information is intended for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider for diagnosis and treatment. The United Cares Program is committed to providing resources to help you understand your PAH medications better and manage your health journey effectively.