WARNING

Macitentan is a medication used to treat pulmonary arterial hypertension (PAH), a condition characterized by high blood pressure in the arteries of the lungs. While it can be effective in managing PAH, like any medication, macitentan comes with potential risks and side effects. Here’s a brief overview:

• Liver Function: Macitentan may affect liver function. Regular monitoring of liver function is typically recommended during treatment. It’s important for individuals taking macitentan to promptly report any signs of liver problems, such as yellowing of the skin or eyes (jaundice), dark urine, or persistent nausea.
• Edema (Fluid Retention): Edema, or fluid retention, can occur as a side effect. This may lead to swelling in the ankles, legs, or other parts of the body. Patients should report any sudden weight gain or swelling to their healthcare provider.
• Anemia: Macitentan may cause a decrease in red blood cell count, leading to anemia. Regular blood tests are often performed to monitor for this side effect.
• Birth Defects: Macitentan has the potential to cause harm to a developing fetus. Therefore, it’s crucial for women of childbearing age to use reliable contraception during treatment.
• Interaction with Other Medications: Macitentan may interact with other medications, including hormonal contraceptives. Patients should inform their healthcare provider about all the medications they are taking to avoid potential interactions.
• Respiratory Issues: Some patients may experience shortness of breath or other respiratory issues. If these symptoms worsen, it’s important to seek medical attention.
• Hematologic Effects: Changes in blood cell counts, including decreases in white blood cell count, may occur. Regular blood tests help monitor these effects.
• Fluid in the Lungs (Pulmonary Edema): In some cases, macitentan may contribute to pulmonary edema. Symptoms include difficulty breathing and chest pain.

It’s crucial for individuals prescribed macitentan to have open and regular communication with their healthcare provider. They should report any unusual symptoms promptly, and healthcare professionals will monitor for potential complications through regular check-ups and tests. This information is a general overview, and specific risks can vary from person to person. Always consult with a healthcare professional for personalized advice based on your medical history and current health status.

Why is this medication prescribed?

Macitentan is a medication primarily prescribed to treat pulmonary arterial hypertension (PAH). PAH is a condition characterized by high blood pressure in the arteries that supply blood to the lungs. Macitentan belongs to a class of drugs known as endothelin receptor antagonists, and it works by blocking the effects of endothelin, a substance that narrows blood vessels and contributes to increased blood pressure.

How should this medicine be used?

Macitentan is a medication used to treat pulmonary arterial hypertension (PAH). It belongs to a class of drugs called endothelin receptor antagonists. PAH is a condition in which the blood vessels in the lungs become narrow, leading to increased blood pressure in the pulmonary arteries.

Here are general guidelines for using macitentan:

• Prescription and Dosage: Macitentan is available only with a prescription from a healthcare provider. The dosage may vary based on the severity of the condition and individual patient factors. Always follow the dosage instructions provided by your doctor.
• Administration: Macitentan is typically taken once daily with or without food. It’s essential to take the medication at the same time each day to maintain a consistent level in your body.
• Do Not Stop Abruptly: Do not stop taking macitentan without consulting your doctor, as abruptly stopping the medication can worsen your condition.
• Missed Dose: If you miss a dose, take it as soon as you remember. However, if it’s close to the time of your next dose, skip the missed dose and resume your regular dosing schedule.
• Side Effects: Be aware of potential side effects and report any unusual symptoms to your doctor. Common side effects may include headache, anemia, and swelling of the ankles and legs.
• Monitoring: Your doctor may monitor your liver function regularly, as macitentan can affect the liver. Regular check-ups and tests may be required to assess the effectiveness of the medication and to detect any potential side effects.
• Pregnancy and Contraception: Macitentan can harm an unborn baby, so it’s important to use effective contraception while taking the medication. Inform your doctor if you are pregnant or planning to become pregnant.
• Interactions: Inform your healthcare provider about all the medications, vitamins, and herbal supplements you are taking, as macitentan may interact with certain drugs.
• Special Considerations: People with certain medical conditions, such as liver problems, may need special monitoring while taking macitentan.

Always follow your doctor’s instructions and read the patient information provided with the medication. If you have any questions or concerns about using macitentan, consult your healthcare provider for personalized advice.

Other uses for this medicine

Macitentan is primarily used for the treatment of pulmonary arterial hypertension (PAH). PAH is a specific condition involving high blood pressure in the arteries of the lungs. However, it’s important to note that medication uses may evolve over time, and new indications or uses may have emerged since then. Always consult a healthcare professional or refer to updated medical sources for the latest information on drug uses.

What special precautions should I follow?

Regarding special precautions for Macitentan, it’s essential to follow your healthcare provider’s guidance and instructions. Here are some general precautions associated with Macitentan use:

• Pregnancy and Contraception: Macitentan can cause birth defects, and it’s contraindicated during pregnancy. Women of childbearing age should use reliable contraception before starting Macitentan, during treatment, and for a specific duration after discontinuation.
• Liver Function Monitoring: Regular monitoring of liver function is recommended. Macitentan may cause liver problems, and signs of liver issues, such as jaundice (yellowing of the skin or eyes), should be reported to a healthcare professional.
• Drug Interactions: Macitentan may interact with other medications, including hormonal contraceptives. Inform your healthcare provider about all the medications, supplements, and herbal products you are taking to avoid potential interactions.
• Adverse Effects: Be aware of potential side effects and report any unusual symptoms to your healthcare provider promptly.
• Dosage and Administration: Take Macitentan as prescribed by your healthcare provider. Follow the recommended dosage and administration instructions, and take the medication consistently at the same time each day.
• Missed Dose: If you miss a dose, take it as soon as you remember. If it’s almost time for the next dose, skip the missed dose and resume the regular dosing schedule.
• Regular Check-ups: Regularly attend follow-up appointments with your healthcare provider to monitor your response to treatment and assess for any potential issues.
• Medical History: Inform your healthcare provider about your complete medical history, including any pre-existing conditions, allergies, or other medications you are taking.

Remember, individual responses to medications can vary, and the information provided here is a general guideline. Always consult your healthcare provider for personalized advice and information tailored to your specific health condition and needs. If you have any specific questions or concerns about Macitentan, discuss them with your healthcare professional.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with Macitentan. However, it’s generally advisable to maintain a healthy and balanced diet. If you have any concerns about your diet or specific dietary restrictions, discuss them with your healthcare provider or a registered dietitian.

What should I do if I forget a dose?

If you forget to take a dose of Macitentan:

• Missed Dose: If you forget to take a dose, take it as soon as you remember. If it’s almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule.
• Double Dose: Do not take a double dose to make up for a missed one. Taking more than the prescribed amount can increase the risk of side effects.
• Consult Your Doctor: If you consistently forget doses or have concerns about missed doses, speak with your healthcare provider. They can provide guidance on how to manage missed doses and may adjust your treatment plan if needed.

What side effects can this medication cause?

Macitentan, like any medication, can cause side effects. It’s important to be aware of potential side effects and promptly inform your healthcare provider if you experience any unusual symptoms. Not everyone will experience these side effects, and some individuals may tolerate the medication well. Here are some common and serious side effects associated with Macitentan:

Common Side Effects:

• Headache: Headaches are a relatively common side effect of Macitentan.
• Flushing: Some individuals may experience redness or warmth in the face or neck.
• Ankle Swelling: Edema or swelling of the ankles is a potential side effect.
• Nasopharyngitis: Inflammation of the nasal passages may occur, leading to symptoms like a runny or stuffy nose.

Serious Side Effects:

• Liver Problems: Macitentan can affect liver function. Symptoms of liver problems may include yellowing of the skin or eyes (jaundice), dark urine, abdominal pain, or unexplained fatigue. Regular monitoring of liver function is typically recommended.
• Anemia: Macitentan may cause a decrease in red blood cell count, leading to anemia. Symptoms of anemia may include fatigue, weakness, and pale skin.
• Fluid Retention: In some cases, fluid retention can occur, leading to swelling in various parts of the body.
• Decreased Sperm Count: Macitentan may lead to a decrease in sperm count in males. This effect can be reversible upon discontinuation of the medication.
• Embryo-Fetal Toxicity: Macitentan is contraindicated during pregnancy due to the risk of harm to the developing fetus. Women of childbearing potential should use reliable contraception during treatment and for a specific period after stopping the medication.

It’s crucial to promptly report any unusual or severe symptoms to your healthcare provider. Additionally, individuals taking Macitentan should attend regular follow-up appointments to monitor their response to treatment and address any concerns.

This is not an exhaustive list of side effects, and there may be other side effects associated with Macitentan. The information provided here is a general overview, and specific considerations may vary based on individual health conditions. Always consult with your healthcare provider for personalized information and guidance related to your specific situation.

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

Storage:

• Room Temperature: Store Macitentan at room temperature, away from excessive heat and moisture.
• Keep Away from Light: Protect the medication from light by storing it in its original container.
• Childproof Container: Ensure that the medication is stored in a childproof container, out of the reach of children and pets.
• Avoid Pill Splitting: Do not split or crush Macitentan tablets unless advised to do so by your healthcare provider.

Disposal:

• Follow Local Regulations: Dispose of unused or expired medications in accordance with local regulations or guidelines. Do not flush them down the toilet unless instructed to do so.
• Take-Back Programs: Check if there are any medication take-back programs in your area. Many communities have designated locations for safe medication disposal.
• Consult Healthcare Provider: If you are unsure about how to dispose of Macitentan or any other medication, consult your healthcare provider or pharmacist for guidance.

In case of emergency/overdose

In case of an emergency or suspected overdose, seek medical attention immediately. Symptoms of an overdose may include severe dizziness, fainting, or difficulty breathing.

What other information should I know?

• Regular Monitoring: Attend regular follow-up appointments with your healthcare provider for monitoring of your condition and response to Macitentan.
• Inform Healthcare Providers: Inform all healthcare providers involved in your care about your use of Macitentan, including dentists and emergency medical personnel.
• Medication Review: Periodically review all medications, including over-the-counter drugs and supplements, with your healthcare provider to check for potential interactions.
• Stay Informed: Stay informed about the latest information regarding Macitentan, including any updates on its use, side effects, or precautions.
• Allergies: Inform your healthcare provider of any allergies you may have, including allergies to Macitentan or any of its ingredients.
• Travel Precautions: If you plan to travel, ensure that you have an adequate supply of Macitentan and that you understand how to take it while in different time zones.

Always follow your healthcare provider’s instructions regarding the use of Macitentan, and if you have any questions or concerns, discuss them with your healthcare professional. The information provided here is a general guide, and specific recommendations may vary based on individual health circumstances.