Pronunciation:

se-LEX-i-pag

Brand Names:

• Uptravi

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Peripheral Vasodilator

Uses of This Medicine:

Selexipag injection is used to treat pulmonary arterial hypertension (PAH), which is the high blood pressure that occurs 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 become more resistant to blood flow, the right ventricle must work harder to pump enough blood through the lungs. It works by relaxing these blood vessels and increasing the supply of blood to the lungs, which reduces the workload of the heart. This medicine helps slow down the worsening 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.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of selexipag injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of selexipag injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of 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 required 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
• Asciminib
• Bivalirudin
• Bromfenac
• Bufexamac
• Caplacizumab-yhdp
• Carbamazepine
• Celecoxib
• Choline Salicylate
• Citalopram
• Clonixin
• Clopidogrel
• Dabigatran Etexilate
• Danaparoid
• Deferasirox
• Desirudin
• Desvenlafaxine
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• Duloxetine
• Edoxaban
• Eltrombopag
• 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
• Venlafaxine
• Vilazodone
• Vortioxetine
• Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Liver disease, moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

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

• Pulmonary venoocclusive disease (narrowing of the veins in the lungs)—Use with caution. May make this condition worse.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress while you are receiving this medicine to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

You should not receive this medicine together with gemfibrozil (Lopid®). Using these medicines together may increase your chance for more serious side effects.

Check with your doctor right away if you have blue lips and fingernails, chest pain, coughing that sometimes produces a pink frothy sputum, difficult, fast, or noisy breathing, increased sweating, pale skin, or swelling in the legs and ankles. These may be symptoms of pulmonary edema (fluid in the lungs).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

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