WARNING

While Opsumit (macitentan) can be beneficial for the treatment of pulmonary arterial hypertension (PAH), it is important to be aware of the potential risks associated with its use. Here is a brief overview:

• Liver Damage: Opsumit has the potential to cause liver problems, including elevated liver enzymes and liver toxicity. Regular monitoring of liver function is necessary during treatment.
• Anemia: Opsumit may lead to a decrease in red blood cell count, resulting in anemia. Periodic monitoring of hemoglobin levels is important, especially in patients with pre-existing anemia.
• Fluid Retention: Some individuals may experience fluid retention, resulting in swelling in the legs, ankles, or other parts of the body. It is important to promptly report any signs of fluid retention to the healthcare provider.
• Birth Defects: Opsumit is known to have a high risk of causing harm to a developing fetus. It is contraindicated in pregnancy, and effective contraception should be used by women of childbearing potential during treatment and for a period of time after discontinuation.
• Drug Interactions: Opsumit can interact with other medications, potentially affecting their efficacy or increasing the risk of adverse effects. Inform your healthcare provider about all the medications you are taking to ensure safe use of Opsumit.
• Other Side Effects: Common side effects of Opsumit include headache, nasal congestion, flushing, joint pain, and low blood pressure. Less frequent but more severe side effects may include lung problems and blood clot formation.

It’s crucial to consult with a healthcare professional who can assess your individual situation, discuss the potential risks and benefits of Opsumit, and closely monitor your health throughout the treatment course.

Why is this medication prescribed?

Opsumit (macitentan) is a prescription medication used for the treatment of pulmonary arterial hypertension (PAH) in adults. PAH is a chronic and progressive disorder characterized by high blood pressure in the arteries that supply the lungs. This increased pressure in the pulmonary arteries can lead to various symptoms such as shortness of breath, fatigue, chest pain, and fainting.

Opsumit belongs to a class of medications called endothelin receptor antagonists. It works by blocking the action of endothelin, a substance that narrows the blood vessels and contributes to the increased blood pressure in the pulmonary arteries. By blocking the effects of endothelin, Opsumit helps to relax and widen the blood vessels in the lungs, reducing the resistance to blood flow and lowering the blood pressure.

Opsumit is typically prescribed to slow down the progression of PAH, improve exercise capacity, and reduce the risk of hospitalization related to the disease. It is usually used as a long-term treatment and may be prescribed in combination with other medications approved for PAH management.

How should this medicine be used?

Opsumit (macitentan) should be used as directed by your healthcare provider. It is important to carefully follow the prescribed dosage and administration instructions. Here are some general guidelines for the use of Opsumit:

• Dosage: The typical starting dose of Opsumit is 10 mg once daily. Your healthcare provider will determine the appropriate dosage for you based on your individual needs and response to the medication.
• Administration: Opsumit should be taken orally with or without food, at approximately the same time each day. Swallow the tablet whole with a glass of water, and do not crush, chew, or break it.
• Compliance: It is important to take Opsumit exactly as prescribed, even if you are feeling well. Do not skip doses or stop the medication without consulting your healthcare provider.
• Regular Monitoring: Your healthcare provider will monitor your condition regularly, including assessing your liver function and checking your hemoglobin levels. Follow-up visits and laboratory tests will be scheduled to ensure the medication is working effectively and to detect any potential side effects.
• Contraception: Opsumit has a high risk of causing harm to a developing fetus. Effective contraception should be used by women of childbearing potential during treatment with Opsumit and for a period of time after stopping the medication. Discuss appropriate contraceptive methods with your healthcare provider.
• Other Medications: Inform your healthcare provider about all the medications you are taking, including prescription drugs, over-the-counter medications, and herbal supplements. Some medications may interact with Opsumit, so it is important to ensure their compatibility.

Always consult your healthcare provider for specific dosing instructions and any concerns or questions you may have regarding the use of Opsumit. They will provide you with personalized guidance based on your medical condition and individual needs.

Other uses for this medicine

Opsumit (macitentan) is primarily prescribed for the treatment of pulmonary arterial hypertension (PAH) and is not approved for other medical conditions. Its use should be limited to the approved indication under the supervision of a healthcare professional.

What special precautions should I follow?

Regarding special precautions with Opsumit, here are some important considerations:

• Pregnancy and Contraception: Opsumit has a high risk of causing harm to a developing fetus. It is contraindicated during pregnancy, and effective contraception should be used by women of childbearing potential during treatment and for a period of time after discontinuation. If pregnancy occurs during Opsumit treatment, the medication should be immediately stopped, and appropriate counseling and evaluation should be sought.
• Liver Function: Opsumit can cause liver damage. Regular monitoring of liver function, including liver enzyme levels, is essential before starting treatment and periodically throughout the course. If signs of liver injury (such as yellowing of the skin or eyes, abdominal pain, or dark urine) occur, immediate medical attention should be sought.
• Anemia: Opsumit may lead to a decrease in red blood cell count, resulting in anemia. Regular monitoring of hemoglobin levels is important, especially in patients with pre-existing anemia.
• Fluid Retention: Opsumit may cause fluid retention, leading to swelling in the legs, ankles, or other parts of the body. Report any signs of fluid retention promptly to your healthcare provider.
• Drug Interactions: Opsumit can interact with other medications, potentially affecting their efficacy or increasing the risk of adverse effects. Inform your healthcare provider about all the medications you are taking, including prescription drugs, over-the-counter medications, and herbal supplements.
• Other Medical Conditions: Inform your healthcare provider about any other medical conditions you have, such as liver problems, heart failure, or lung disease, as they may require special consideration when using Opsumit.

It is crucial to have regular follow-up appointments with your healthcare provider, adhere to the recommended monitoring schedule, and communicate any changes or concerns regarding your health while taking Opsumit. Your healthcare provider will provide you with specific guidance and precautions based on your individual circumstances.

What special dietary instructions should I follow?

There are no specific dietary instructions associated with taking Opsumit (macitentan). However, it is generally recommended to follow a healthy and balanced diet as advised by your healthcare provider. Eating a nutritious diet can support overall well-being and contribute to better management of your condition.

What should I do if I forget a dose?

If you forget to take a dose of Opsumit, take it as soon as you remember, unless it is close to the time for your next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Opsumit (macitentan) may cause side effects in some individuals. While not everyone experiences these side effects, it’s important to be aware of them. Common side effects of Opsumit include:

• Headache
• Nasal congestion or stuffiness
• Flushing (redness or warmth in the face or neck)
• Joint pain
• Diarrhea
• Nausea
• Abdominal pain
• Anemia (low red blood cell count)
• Lower respiratory tract infection
• Edema (swelling in the legs, ankles, or other body parts)
• Fatigue
• Dizziness

Less frequently, Opsumit can cause more serious side effects that require immediate medical attention. These may include:

• Liver problems: Signs of liver injury, such as yellowing of the skin or eyes (jaundice), dark urine, upper abdominal pain, or persistent nausea, should be reported to a healthcare professional.
• Fluid retention: If you experience rapid weight gain, swelling in the legs or ankles, or difficulty breathing, seek medical attention promptly.
• Pulmonary edema: Symptoms may include sudden shortness of breath, cough, chest pain, or rapid breathing. This requires immediate medical attention.
• Blood clots: Symptoms of blood clot formation can include sudden pain, swelling, or redness in the arms or legs, chest pain, or difficulty breathing. Seek immediate medical help if you experience these symptoms.
• Decreased sperm count: Opsumit can lower sperm count in men. This effect is reversible upon discontinuation of the medication.

It’s important to note that this is not an exhaustive list of side effects, and other side effects may occur. If you experience any concerning or persistent side effects while taking Opsumit, it is crucial to contact your healthcare provider for further evaluation and guidance.

Always consult with your healthcare provider for a comprehensive understanding of potential side effects, their frequency, and appropriate measures to manage them.

What should I know about storage and disposal of this medication?

• Storage: Keep Opsumit in its original container at room temperature, away from excessive heat, moisture, and direct sunlight. Do not freeze the medication. It’s important to store it out of reach of children and pets.
• Disposal: When it comes to disposing of unused or expired Opsumit, follow local guidelines and regulations. Do not flush the medication down the toilet or throw it in the trash. Consult with your healthcare provider, pharmacist, or local waste management authorities for proper disposal methods.

In case of emergency/overdose

In case of emergency or suspected overdose, it is crucial to seek immediate medical assistance. Contact your local emergency services or go to the nearest emergency room. Be sure to inform the healthcare professionals about the medication taken and the dosage.

What other information should I know?

• Regular Monitoring: Opsumit requires regular monitoring of your health condition, including liver function tests and hemoglobin levels. Follow the recommended schedule for check-ups and laboratory tests as advised by your healthcare provider.
• Compliance: It’s essential to take Opsumit as prescribed and adhere to the recommended dosage schedule. Do not adjust the dosage or stop taking the medication without consulting your healthcare provider.
• Drug Interactions: Inform your healthcare provider about all the medications you are taking, including prescription drugs, over-the-counter medications, and herbal supplements. Some medications may interact with Opsumit, potentially affecting its efficacy or increasing the risk of adverse effects.
• Medical Procedures: If you are scheduled for any surgical or dental procedures, inform the healthcare professionals involved that you are taking Opsumit. They can provide guidance on whether any adjustments are needed.
• Follow-Up Care: Stay in regular contact with your healthcare provider to monitor your response to Opsumit and address any concerns or questions that arise during the treatment period.

It’s important to consult your healthcare provider or pharmacist for specific instructions regarding storage, disposal, emergencies, and any other relevant information specific to your situation and the use of Opsumit.