Selexipag (Oral)

Selexipag is used to treat symptoms of pulmonary arterial hypertension, 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 small blood vessels in the lungs become more resistant to blood flow, the right ventricle must work harder to pump enough blood through the lungs. Selexipag works by relaxing these blood vessels and increasing the supply of blood to the lungs, which reduces the workload of the heart.

This medicine is available only with your doctor's prescription.

It is very important that your doctor checks your progress at regular visits to ensure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not use 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, sometimes with wheezing, pale skin, increased sweating, 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.

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, tell your healthcare professional 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

There have not been appropriate studies on how selexipag affects children. Safety and effectiveness have not been established for this age group.

Geriatric

So far, studies have not shown any specific problems in older adults that would limit the use of selexipag. 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 medicine during breastfeeding. Weigh the potential benefits against the potential risks before using this medicine while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others can be used together with caution. Your doctor may need to adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the following medicines. The following interactions have been chosen 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 choose not to prescribe this medication or alter some of your other medicines.

• Abiraterone Acetate
• Abrocitinib
• Gemfibrozil

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. 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 around the time of eating food or certain types of food due to potential interactions. 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. Make sure to inform your doctor if you have any other medical problems, especially:

• Liver disease, moderate—Use with caution. The effects may be stronger because the medicine is 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 worsen.

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 immediately if any of the following side effects occur:

Incidence not known

• Blue lips and fingernails
• Chest pain
• Coughing that sometimes produces a pink frothy sputum
• Difficult, fast, noisy breathing
• Increased sweating
• Pale skin
• Swelling in the legs and ankles

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:

More common

• Decreased appetite
• Diarrhea
• Feeling of warmth
• Headache
• Joint pain
• Muscle aching or cramping
• Muscle pains or stiffness
• Nausea
• Pain in the jaw, arms, or legs
• Rash
• Redness of the face, neck, arms, and occasionally, upper chest
• Swollen joints
• Vomiting

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:

• Tablet

Therapeutic Class: Peripheral Vasodilator

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking this medicine without checking with your doctor first.

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

Swallow the tablet whole. Do not crush, break, or chew it. Taking this medicine with food may improve tolerability.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):For pulmonary arterial hypertension: Adults—At first, 200 micrograms (mcg) two times a day. Your doctor may increase your dose as needed and tolerated. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If your next regular dose is in less than 6 hours, skip the missed dose and go back to your regular dosing schedule. If you miss a dose for 3 or more days, call your doctor right away.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.