Uptravi (Intravenous)

Selexipag injection is used to treat pulmonary arterial hypertension (PAH), which is high blood pressure in the main artery that carries blood from the right side of the heart (the ventricle) to the lungs. When the smaller blood vessels in the lungs resist blood flow more, the right ventricle has to work harder to pump enough blood through the lungs. It works by relaxing these blood vessels and increasing blood supply to the lungs, which reduces the heart's workload. This medicine helps slow down the progression of your disease and lowers your risk of being hospitalized for PAH.

This medicine is to be given only by or under the direct supervision of a doctor.

It is very important for your doctor to monitor your progress while you are taking this medicine to ensure it is working correctly. Blood tests may be needed to check for unwanted effects.

You should not receive this medicine with gemfibrozil (Lopid®). Using these two medicines together may raise your risk of more serious side effects.

Contact your doctor immediately if you experience blue lips and fingernails, chest pain, coughing that sometimes brings up pink frothy sputum, difficulty breathing that is fast or noisy, increased sweating, pale skin, or swelling in your legs and ankles. These could be signs of pulmonary edema (fluid in the lungs).

Do not take any other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines, as well as herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor will weigh the risks against the benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to determine how age affects the effects of selexipag injection in children. Safety and effectiveness have not been established.

Geriatric

Studies have not shown any specific problems in elderly patients that would limit the usefulness of selexipag injection. However, older adults may be more sensitive to the effects of this medicine than younger adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together, even if an interaction might occur. In these situations, your doctor may want to adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below when you are receiving this medicine. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Abiraterone Acetate
• Abrocitinib
• Gemfibrozil

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac
• Acemetacin
• Amtolmetin Guacil
• Apixaban
• Argatroban
• Bivalirudin
• Bromfenac
• Bufexamac
• Caplacizumab-yhdp
• Celecoxib
• Choline Salicylate
• Citalopram
• Clonixin
• Clopidogrel
• Dabigatran Etexilate
• Danaparoid
• Deferasirox
• Desirudin
• Desvenlafaxine
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• Duloxetine
• Edoxaban
• Escitalopram
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Heparin
• Ibuprofen
• Indomethacin
• Ketoprofen
• Ketorolac
• Lepirudin
• Levomilnacipran
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Milnacipran
• Morniflumate
• Nabumetone
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Omaveloxolone
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Paroxetine
• Phenindione
• Phenobarbital
• Phenprocoumon
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Primidone
• Proglumetacin
• Propyphenazone
• Proquazone
• Protein C
• Rifampin
• Rivaroxaban
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sertraline
• Sodium Salicylate
• Sulindac
• Tenoxicam
• Teriflunomide
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Valdecoxib
• Vilazodone
• Vortioxetine
• Warfarin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used at or around mealtimes, as interactions may happen. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Liver disease, moderate—Use with caution. The effects may be increased because the medicine may be removed from the body more slowly.

• Liver disease, severe—Use is not recommended for patients with this condition.

• Pulmonary venoocclusive disease (narrowing of the veins in the lungs)—Use with caution. This condition may get worse.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Incidence not known

• Blue lips and fingernails
• blurred vision
• chest pain
• confusion
• coughing that sometimes produces a pink frothy sputum
• difficult, fast, noisy breathing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• increased sweating
• pale skin
• swelling in the legs and ankles
• unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Dry, red, hot, or irritated skin
• pain, redness, or swelling at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Uptravi

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Peripheral Vasodilator

A nurse or other trained health professional will give you this medicine in a hospital. It is given through a needle placed into one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for 80 minutes. Your dose is based on your current dose of selexipag tablets. It is usually given 2 times a day.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.