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Macitentan is associated with several important safety considerations and warnings that necessitate careful attention for those prescribed this medication. Below is a comprehensive overview of the critical safety information:

• Pregnancy Risk: Macitentan is contraindicated during pregnancy due to potential harm to an unborn baby. Although human studies are unavailable, animal studies indicate severe risks to fetal health. Therefore, macitentan is accessible only via the Opsumit REMS program to minimize these risks. Female patients who can conceive must undergo a pregnancy test prior to beginning treatment, monthly during treatment, and one month following the cessation of therapy. Effective contraception is essential throughout the treatment period and for at least one month after the last dose. If you are pregnant or planning to become pregnant, discuss the associated risks and benefits with your healthcare provider immediately.

• Liver Health: Macitentan may lead to liver damage, which can progress to liver failure. It is crucial to monitor liver function through blood tests before and during treatment. Seek immediate medical attention if you experience symptoms such as abdominal swelling or pain, jaundice, changes in stool color, nausea, vomiting, or dark urine. In some cases, discontinuation of macitentan might be necessary to prevent further liver damage.

• Fluid Retention: Use of macitentan can cause fluid accumulation, leading to swelling and shortness of breath, which can exacerbate existing heart failure. This condition may develop within weeks of beginning treatment. Inform your healthcare provider if you have a history of heart issues before starting macitentan. Contact your provider if you notice symptoms like shortness of breath, swelling in the extremities, irregular heartbeat, exercise intolerance, or persistent fatigue.

• Anemia Risk: Macitentan can lower hemoglobin levels, potentially causing anemia. Regular blood tests are required to ensure hemoglobin levels remain stable. Patients with a history of anemia should consult their healthcare provider to assess safety. Notify your provider if you experience symptoms such as weakness, shortness of breath, dizziness, rapid heartbeat, or pale complexion.

Please ensure to discuss any concerns or health conditions with your healthcare provider before using macitentan to ensure safe and effective use of the medication.

When taking this medication, you might experience mild side effects like a runny nose, sore throat, cough, headache, chills, or body aches. These symptoms are generally not a cause for concern, but if they persist or worsen, it's important to consult your healthcare provider. Some individuals may also notice cold-like symptoms, headaches, anemia, bronchitis, or urinary tract infections. These are typically mild, but should they continue or become bothersome, seeking advice from a healthcare professional is recommended.

There are more serious side effects that, although rare, require immediate attention. These include symptoms of liver problems such as persistent nausea or vomiting, loss of appetite, dark urine, stomach pain, or yellowing of the skin and eyes. Additionally, fluid buildup in the body can manifest as shortness of breath, swelling in the legs or feet, irregular heartbeat, chest pain, or unusual fatigue and weight gain. If you experience any of these, urgent medical care is necessary.

Furthermore, a very serious allergic reaction, while rare, can occur. If you notice symptoms such as a rash, itching or swelling of the face, tongue, or throat, severe dizziness, or trouble breathing, get medical help right away. Always be aware of how your body responds to new medication and report any symptoms that concern you to your healthcare provider.

Macitentan may interact with certain medications, potentially altering its effectiveness. Some drugs can interfere with how macitentan is processed in your body, affecting its function. These include sparsentan, amiodarone, azole antifungals like fluconazole and ketoconazole, cobicistat, macrolide antibiotics such as clarithromycin, and rifamycins like rifampin. Additionally, ritonavir is known to impact macitentan's performance.

Other medications that could interact with macitentan include apalutamide, boceprevir, carbamazepine, conivaptan, enzalutamide, fosphenytoin, idelalisib, indinavir, itraconazole, lopinavir, lumacaftor, mitotane, nefazodone, nelfinavir, phenytoin, posaconazole, saquinavir, St John's Wort, telaprevir, telithromycin, and voriconazole. If any of these are prescribed alongside macitentan, your doctor might adjust the dosage or frequency to minimize interaction risks.

To ensure safe use, always inform your healthcare provider about all medications and supplements you are taking, including over-the-counter drugs, vitamins, and herbal products.