Opsumit

Opsumit is a prescription medication used to treat pulmonary arterial hypertension (PAH). PAH causes high blood pressure in the vessels that carry blood to the lungs. 

Opsumit belongs to a group of drugs called endothelin receptor antagonists. These work by stopping the action of endothelin, a natural substance that causes blood vessels to narrow and prevents normal blood flow in people who have PAH.

This medication comes in tablet form and is taken by mouth once daily, with or without food. Do not chew, divide, or break Opsumit tablets. Swallow Opsumit tablets whole.

Common side effects of Opsumit include low red blood cell counts (anemia), pharyngitis (swelling in the throat), and bronchitis. 

Opsumit is a prescription medication used to treat pulmonary arterial hypertension (PAH). PAH causes high blood pressure in the vessels that carry blood to the lungs. 

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

Serious side effects have been reported with Opsumit. See the “Opsumit Precautions” section.

Common side effects of Opsumit include the following:

• anemia (low blood cell counts)
• pharyngitis (swelling in the throat)
• bronchitis
• headache
• influenza (flu)
• urinary tract infection

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

Tell your doctor if you have any side effects that bother you or that do 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:

• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), delavirdine (Rescriptor), and nefazodone
• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), and St John's wort

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

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

• Fetal toxicity if administered during pregnancy.
• Liver toxicity and failure. Tell your healthcare provider right away if you have some or all of the following symptoms of liver toxicity, such as nausea, vomiting, pain in the upper right part of the stomach, dark urine, loss of appetite and yellowing of the skin or eyes. 
• Fluid retention. Your healthcare provider will monitor for significant fluid retention. 
• Decreased hemoglobin. Your healthcare provider will monitor hemoglobin before starting treatment with Opsumit and periodically during treatment. 
• Pulmonary edema (increased fluid in the lungs). Tell your healthcare provider right away if you have some or all of the following symptoms of pulmonary edema, such as difficulty breathing, cough, chest pain and tiredness. 
• Decreased sperm count. This may affect your ability to father a child. Talk to your healthcare provider if remaining able to father a child is important to you. 

Do not take Opsumit if you:

• are allergic to Opsumit or to any of its ingredients
• are pregnant or plan to become pregnant

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 Opsumit, there are no specific foods that you must exclude from your diet when receiving this medication.

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

• are allergic to Opsumit or to any of its ingredients
• have liver problems
• have heart problems
• 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.

Opsumit falls into category X. It has been shown that women taking Opsumit during pregnancy may have babies born with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. These medicines should never be used by pregnant women.

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

It is not known if Opsumit 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 you should stop using Opsumit or stop nursing. 

Take Opsumit exactly as prescribed.

Opsumit comes in tablet form and is taken by mouth once daily, with or without food. Do not chew, divide, or break Opsumit tablets. Swallow Opsumit tablets whole.

If you are a female with the ability to get pregnant, a negative pregancy test should be confirmed before starting treatment with Opsumit. After treatment is started, monthly pregnancy tests should occur. 

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Opsumit at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended dose of Opsumit for the treatment of pulmonary arterial hypertension (PAH) is 10 mg by mouth once daily, with or without food. 

If you take too much Opsumit, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Opsumit tablets at room temperature between 68°F and 77°F (20°C and 25°C).
• Keep Opsumit and all medicines out of the reach of children. 

WARNING: EMBRYO-FETAL TOXICITY

• Do not administer Opsumit to a pregnant female because it may cause fetal harm. 
• Females of reproductive potential: exclude pregnancy before start of treatment, monthly during treatment, and 1 month after stopping treatment.Prevent pregnancy during treatment and for one month after treatment by using acceptable methods of contraception.
• For all female patients, Opsumit is available only through a restricted program called the Opsumit Risk Evaluation andMitigation Strategy (REMS).