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This medication carries important safety and warning information that must be carefully considered by patients and healthcare professionals. Below are critical points to keep in mind:

• Pregnancy Warning: This medication is contraindicated during pregnancy due to the risk of severe harm to an unborn child. Patients who can become pregnant must enroll in the Tryvio REMS program, which ensures the medication is used safely. Reliable birth control must be used before starting, during, and for one month after treatment. A pregnancy test is required before beginning the treatment. If you become pregnant or suspect pregnancy, inform your healthcare provider immediately.

• Liver Health: This medication can cause elevated liver enzyme levels, indicating potential liver injury. Regular medical appointments and blood tests are essential to monitor liver function. Seek immediate medical attention if you experience symptoms such as nausea, vomiting, upper abdominal pain, dark urine, loss of appetite, fatigue, fever, or jaundice.

• Fluid Retention: The use of this medication may lead to fluid retention, causing swelling or shortness of breath. This can exacerbate heart failure, especially in patients with pre-existing heart conditions. Inform your healthcare provider if you have a history of heart problems before starting this medication.

• Anemia Risk: The medication may lower hemoglobin levels, potentially causing anemia. If you have a history of anemia, discuss with your healthcare provider whether this treatment is appropriate for you.

• Effects on Male Fertility: This medication may reduce sperm count in males, possibly affecting future fertility. If you plan to have children, discuss alternative treatment options with your healthcare provider, as it is unclear whether the effect is reversible after discontinuation.

• Contraindications: This medication should not be used if you are currently pregnant. Always consult your healthcare provider if you have any concerns or if any contraindications apply to your situation.

Always follow your healthcare provider's advice and report any unusual symptoms or concerns immediately.

When taking Tryvio (aprocitentan) to manage high blood pressure, it's important to be aware of potential interactions with other medications and substances. Combining Tryvio with certain drugs can lead to increased side effects or reduced effectiveness. Here are some notable interactions:

• Sildenafil (commonly used for erectile dysfunction): Using sildenafil alongside Tryvio may enhance the blood pressure-lowering effects, potentially causing symptoms like dizziness, lightheadedness, fainting, flushing, headache, or a rapid heart rate. These effects are more likely at the start of treatment, after a dose increase, or if treatment is resumed after a break. It's advisable to avoid driving or operating heavy machinery until you know how this combination affects you.

• Tizanidine (a muscle relaxant): Combining tizanidine with Tryvio can lead to additive blood pressure-lowering effects, resulting in headaches, dizziness, lightheadedness, fainting, and changes in heart rate. These symptoms are most common at the beginning of treatment, after increasing the dose, or when restarting treatment. Use caution when standing up from a sitting or lying position, and avoid activities requiring alertness until you understand how this combination affects you.

• Iloperidone (used for certain mental health conditions): Taking iloperidone with Tryvio may also enhance blood pressure-lowering effects, leading to similar symptoms as mentioned above. It's important to monitor for these effects, especially when starting or adjusting doses.

• Cyclobenzaprine (a muscle relaxant): When used with Tryvio, cyclobenzaprine can contribute to lowered blood pressure, causing dizziness, lightheadedness, and fainting. Be cautious when moving from sitting or lying positions, and avoid driving until you know how this combination affects you.

• Triamcinolone (a corticosteroid): Prolonged use of triamcinolone may reduce the effectiveness of Tryvio in lowering blood pressure due to sodium and water retention. Inform your doctor if you experience sudden weight gain or swelling in your hands, ankles, or feet.

Additionally, it's recommended to avoid consuming large amounts of grapefruit or grapefruit juice while on Tryvio, as grapefruit can increase the levels of certain medications in your body and delay their effectiveness.

Always inform your healthcare provider about all medications, supplements, and herbal products you are taking to ensure safe and effective use of Tryvio. Do not stop or adjust any medications without consulting your doctor.