Safety and Side Effects
What to tell your healthcare provider before taking Tyvaso
Before taking Tyvaso, tell your doctor about all of your medical conditions, including any of the following:
- Lung disease, such as asthma or chronic obstructive pulmonary disease (COPD)
- Lung infection
- Liver or kidney problems
- Low blood pressure
- Are pregnant or plan to become pregnant. It is not known if Tyvaso will harm your unborn baby. Women who can become pregnant should use effective birth control while taking Tyvaso
- Are breast-feeding or plan to breast-feed. It is not known if Tyvaso passes into your breast milk. Talk to your doctor about the best way to feed your baby while taking Tyvaso
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Tyvaso and other medicines may affect each other.
Especially tell your doctor if you take any of the following:
- Water pills (diuretics)
- Medicines that decrease blood clotting
- Other PAH medicines
- Medicines used to treat high blood pressure or heart disease
- Gemfibrozil (Lopid®), which is used to lower high blood cholesterol
- Rifampin (Rimactane®, Rifadin®, Rifamate®, Rifater®), an antibiotic used to treat infections
Know the medicines you take. Keep a list of them and show it to your doctor and specialty pharmacist when you get a new medicine.
It is not known if Tyvaso is safe or effective in people under 18 years of age.
Possible side effects of Tyvaso
The most common side effects of Tyvaso include the following:
- Throat irritation and pain
- Reddening of your face and neck (flushing)
- Fainting or loss of consciousness
Tyvaso can cause serious side effects, including the following:
- Tyvaso may increase the risk of bleeding, particularly in people who take blood thinners (anticoagulants)
- If you have low blood pressure, Tyvaso may lower your blood pressure further
Ask your doctor if you are not sure if these apply to you.
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Tyvaso. For more information, talk to your doctor or specialty pharmacist.
You may also contact United Therapeutics Corporation at 1-877-864-8437 or via e-mail at firstname.lastname@example.org to report adverse events or side effects, or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Next: Get Answers to Frequently Asked Questions About Tyvaso
IMPORTANT SAFETY INFORMATION FOR TYVASO
- Tyvaso is breathed in (inhalable) through your mouth into your lungs. Tyvaso should only be used with the Tyvaso Inhalation System.
Before you take Tyvaso, tell your healthcare provider about all of your medical conditions, including if you:
- Have a lung disease (such as asthma or chronic obstructive pulmonary disease (COPD)).
- Have a lung infection.
- Have liver or kidney problems, as your ability to tolerate Tyvaso may be affected.
- Have low blood pressure, as Tyvaso may cause symptomatic hypotension (low blood pressure).
- Are pregnant or plan to become pregnant. It is not known if Tyvaso will harm your unborn baby. Women who can become pregnant should use effective birth control while taking Tyvaso.
- Are breast-feeding or plan to breast-feed. It is not known if Tyvaso passes into your breast milk.
It is important to tell your healthcare provider about all the medicines you may be taking, including prescription and non-prescription medicines, vitamins, and herbal supplements, as they may affect your use of Tyvaso by increasing the risk of side effects or decreasing effectiveness. Especially tell your healthcare provider if you take any of these medicines:
Medicines that decrease blood clotting such as warfarin or heparin, as Tyvaso reduces the ability of your
blood to clot (coagulate), and increases your risk for bleeding if you are taking blood thinners
Diuretics (water pills), antihypertensives (medications used to treat high blood pressure or heart
disease), or other vasodilators (medications that lower blood pressure), as Tyvaso may increase your
risk for hypotension (low blood pressure).
Gemfibrozil such as Lopid (for high cholesterol) or rifampin such as Rimactane, Rifadin, Rifamate or
Rifater (for infection), as your Tyvaso dosage may need adjustment.
The most common side effects of Tyvaso are coughing, headache, throat irritation and pain, nausea, reddening of the face and neck (flushing), and fainting or loss of consciousness. These are not all the possible side effects of Tyvaso. Tell your healthcare provider about any side effects that bother you or do not go away. Your healthcare provider may be able to help you manage the side effects.
Tyvaso is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH) (WHO Group 1), which is high blood pressure in the arteries of your lungs. Tyvaso can improve exercise ability in people who also take bosentan (an endothelin receptor antagonist, (ERA)) or sildenafil (a phosphodiesterase-5 (PDE-5) inhibitor). Your ability to do exercise decreases 4 hours after taking Tyvaso.
The effects of Tyvaso are unknown in patients under 18 years of age.
Please see the Full Prescribing Information, Patient Package Insert, and the Tyvaso Inhalation System Instructions for Use manual.
For additional information about Tyvaso, visit www.tyvaso.com or call 1-877-UNITHER (1-877-864- 8437).
Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.
This information is provided for an informational purpose and is not intended as treatment advice. Patients should consult a healthcare professional for treatment advice.