Veletri

Veletri is a prescription medication used to treat pulmonary arterial hypertension in order to improve exercise capacity. Veletri belongs to a group of drugs called vasodilators, which help to relax the blood vessels within and around the lungs. This helps increase your ability to breathe, especially during exercise. It also acts as a blood thinner, which decreases the chance of a blood clot.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects include flushing, headache, nausea, and vomiting. Veletri can also cause dizziness. Do not drive or operate heavy machinery until you know how Veletri affects you.

Veletri is a prescription medication used to treat pulmonary arterial hypertension in order to improve exercise capacity.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Actelion Pharmaceuticals US, Inc.

Common side effects of Veletri include the following:

• flushing
• headache
• nausea
• vomiting
• hypotension (low blood pressure)
• anxiety, nervousness, agitation
• chest pain
• dizziness
• a slow heart beat
• stomach pain

This is not a complete list of Veletri side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• antihypertensives (medications to lower your blood pressure)
• diuretics such as
  • acetazolamide (Diamox)
  • amiloride (Midamor)
  • bumetanide (Bumex)
  • chlorothiazide (Diuril)
  • chlorthalidone (Thalitone)
  • ethacrynic acid (Edecrin)
  • furosemide (Lasix)
  • hydrochlorothiazide (Microzide, HCTZ)
  • metolazone (Zaroxolyn)
  • torsemide (Demadex)
  • triamterene (Dyrenium, Dyazide, Maxzide)
• vasodilators such as doxazosin (Cardura), prazosin (Minipress), terazosin (Hytrin), clonidine (Catapres), hydralazine (Bidil, Hydra-Zide), and minoxidil
• antiplatelets (a type of blood thinner) such as clopidogrel (Plavix), aspirin, prasugrel (Effient), ticagrelor (Brilinta), ticlopidine (Ticlid), abciximab (ReoPro), eptifibatide (Integrilin), tirofiban (Aggrastat), and cilostazol (Pletal)
• anticoagulants (blood thinners) such as warfarin (Coumadin, Jantoven), heparin, enoxaparin (Lovenox), fondaparinux (Arixtra), rivaroxaban (Xarelto), and apixaban (Eliquis)
• digoxin (Lanoxin)

This is not a complete list of Veletri drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Veletri including the following:

• Withdrawal effects. Veletri can cause serious withdrawal side effects. To avoid withdrawal side effects, do not suddenly stop taking Veletri. Your doctor will slowly decrease your dose before stopping this medicine altogether. Sudden and dramatic changes in dose may lead to unstable blood pressure, a return of pulmonary hypertension symptoms, or fatal low blood pressure.
• Sepsis. Veletri may cause a serious complication resulting from an infection in your bloodstream. Tell your doctor immediately if you develop signs of symptoms of a severe infection, such as fever, chills, low blood pressure, difficulty breathing, or fast heart rate. To reduce the risk of infection in the bloodstream, it is important to know how to properly care for the catheter and infusion pump.

Veletri can cause dizziness. Do not drive or operate heavy machinery until you know how Veletri affects you.

Do not take Veletri if you:

• are allergic to Veletri or to any of its ingredients
• have heart failure due to severe left heart disease
• have pulmonary edema (fluid in your lungs)

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Veletri, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Veletri, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Veletri or to any of its ingredients
• have congestive heart failure (a condition in which the heart doesn't pump blood as well as it should) due to severe left heart disease
• have pulmonary edema
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Veletri falls into category B. There are no well-done studies that have been done in humans with Veletri. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication. It is recommended that Veletri only be given to a pregnant woman if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Veletri crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Veletri.

Take Veletri exactly as prescribed.

Veletri comes in injectable form to be given directly into a vein (IV) through a central venous catheter (a thin tube that goes into a large vein near your heart). This medication is given as a continuous infusion, where you are constantly receiving the medication for 24 hours. 

When you take Veletri for the first time, you must be in a hospital or clinic setting where you will be monitored for serious reactions to the infusion. Your blood pressure and heart rate should also be monitored with any dose changes. If you are taking this medication, your healthcare professional may prescribe another kind of medicine used to prevent blood clots. Use of these types of medicines may increase the risk of bleeding.

After that, you may receive this medication through a portable infusion pump that you will receive from a specialty pharmacy along with your medication.

How does the IV line get placed?

A doctor (surgeon) places a very thin tube (the catheter) into your heart during a surgical procedure using local anesthesia. The doctor then connects the catheter line to a small, battery-powered pump that delivers the medication. Veletri, in liquid form, is stored in a small, removable cassette attached to the pump.

Your pump will be on at all times and you will carry or wear the pump at all times. It is important to know how to properly care for the tubing and infusion pump to prevent infection. You will also need to have access to a backup infusion pump and infusion sets to make sure you do not have interruptions in your delivery of Veletri.

Your healthcare provider will give you specific instructions for preparing and administering Veletri. It is important that you follow these instructions. Veletri should only be used with Sterile Water for Injection, USP, or Sodium Chloride 0.9% Injection, USP. Do not mix Veletri with other IV medicines or other solutions. 

Take this medication exactly as prescribed by your doctor. Follow the directions given to you carefully.

The initial dose your doctor recommends will be based on your weight and how you tolerate this medication. Your doctor will also determine the amount of Veletri you need on a continuous basis. This dose may change during the course of your therapy based on how you respond to this medication and if your symptoms persist. If side effects become intolerable, your doctor may lower your dose. Your portable infusion pump will control the rate of medication you receive. 

All dose changes must be closely monitored by your healthcare provider. Do not lower your dose of Veletri or stop taking it without talking to your doctor.

If you suspect you have received too much Veletri, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Veletri is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Veletri is only carried by specialty pharmacies and is not available through retail pharmacies.
• Each vial of Veletri is for single use only; discard any unused medication.
• Follow your healthcare provider's directions on how to prepare and store Veletri.
• Use Veletri at room temperature.
• Do not expose Veletri solution to direct sunlight.
• Keep this and all medications out of the reach of children.