Selexipag (Intravenous)

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

This medicine should only be given 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 properly. Blood tests may be needed to check for side effects.

You should not receive this medicine with gemfibrozil (Lopid®). Taking these medicines together may increase the risk of serious side effects.

Contact your doctor immediately if you experience blue lips and fingernails, chest pain, coughing that may produce a pink frothy sputum, difficulty, fast, or noisy breathing, increased sweating, pale skin, or swelling in the legs and ankles. These may 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 and herbal or vitamin supplements.

In deciding to use a medicine, the risks of taking it must be weighed against the benefits. This is a decision you and your doctor will make together. 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 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.

Pediatric

There have not been appropriate studies on the effects of selexipag injection in children. Safety and effectiveness have not been established.

Geriatric

Studies done so far have not shown any specific problems in older adults that would limit the usefulness of selexipag injection. However, older patients 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 during breastfeeding. Weigh the potential benefits against the potential 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 while receiving this medicine. The following interactions have been highlighted for their potential significance and may not include all possible interactions.

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

Certain medicines should not be used at or around the time of eating food or specific types of food due to potential interactions. Using alcohol or tobacco with some medicines may also cause interactions. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how this medicine works. Make sure to inform your doctor if you have any other medical issues, especially:

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

• 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 may worsen the condition.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, 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 happen 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.