Each tablet contains 10 milligrams (mg) of macitentan and 40 mg of tadalafil.Children—Use and dose must be determined by your doctor. For pulmonary arterial hypertension (patient never had PAH treatment or is transitioning from ERA monotherapy):Adults—One tablet once a day for 1 week. Your doctor may adjust your dose as needed and tolerated.Children—Use and dose must be determined by your doctor. Adults—One tablet once a day for 1 week. Your doctor may adjust your dose as needed and tolerated. Children—Use and dose must be determined by your doctor. For pulmonary arterial hypertension (patient already had PAH treatment):Adults—One tablet once a day. For pulmonary arterial hypertension (patient never had PAH treatment or is transitioning from ERA monotherapy): If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use. It is very important that your doctor check your progress closely while you are receiving this medicine to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. For oral dosage form (tablets):For pulmonary arterial hypertension (patient never had PAH treatment or is transitioning from ERA monotherapy):Adults—One tablet once a day for 1 week. Your doctor may adjust your dose as needed and tolerated.Children—Use and dose must be determined by your doctor.For pulmonary arterial hypertension (patient already had PAH treatment):Adults—One tablet once a day. Using this medicine while you are pregnant can cause very serious birth defects. Use a highly effective birth control or 2 forms of effective birth control to keep from getting pregnant before starting, during treatment (even if the medicine is temporarily stopped), and for at least 1 month after your last dose. If you think you have become pregnant while using this medicine, tell your doctor right away. If you can get pregnant, you must have a negative pregnancy test before you can take this medicine.
May increase risk of unwanted side effects (eg, prolonged erection of the penis). Heart or blood vessel disease (eg, coronary artery disease) or Hyperlipidemia (high lipids or fats in the blood) or Low cup to disc ratio (eye condition also called "crowded disc") or May increase risk for non–arteritic anterior ischemic optic neuropathy (NAION). Eye or vision problems (eg, retinitis pigmentosa), known or Lung disease (eg, pulmonary veno-occlusive disease or PVOD)—Use is not recommended in patients with theses conditions. Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If you miss a period while you are using this medicine, tell your doctor right away. Do not take other medicines that contains tadalafil (Cialis®) or other PDE5 inhibitors, including sildenafil (Revatio® or Viagra®) or vardenafil (Levitra®). If you take too much tadalafil or take it together with these medicines, the chance for side effects will be higher. Do not use this medicine if you are also using riociguat or a nitrate medicine, often used to treat angina (chest pain). Some street drugs called "poppers" (eg, amyl nitrate, butyl nitrate, or nitrite) also contain nitrates. If you need to use a nitrate medicine, take it at least 48 hours after your last dose of tadalafil. Do not have 4 or more alcohol-containing drinks in a short period of time while you are taking tadalafil. Alcohol can increase your chances of getting a headache or dizziness, increase your heart rate, or lower your blood pressure. This medicine may decrease sperm count in some males and may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children. This medicine may cause serious liver problems. Check with your doctor right away if you have dark urine, fatigue, loss of appetite, nausea or vomiting, severe stomach pain, or yellow eyes or skin. Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. If this problem continues or gets worse, check with your doctor right away.
Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body. The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. Check with your doctor right away if you have pale skin, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness. If you experience sudden loss of vision in one or both eyes, contact your doctor immediately. Check with your doctor right away if you have a sudden decrease in hearing or loss of hearing, which may be accompanied by dizziness and ringing in the ears. This medicine may cause fluid retention (too much water in the body) and peripheral edema (swelling). Check with your doctor right away if you have bloating or swelling of the face, arms, hands, lower legs, or feet, decrease in amount of urine, noisy, rattling, or trouble breathing, rapid weight gain, swelling of the face, hands, feet, or lower legs, tingling of the hands or feet, or weight gain.
Your dose may need to be changed several times in order to find what works best for you. It is very important that you understand the requirements of the Macitentan-Containing Products REMS program and Medication Guide. Ask your doctor if you have any questions. Ask your pharmacist for the medication guide if you do not have one. You may take this medicine with or without food. If you experience a prolonged erection for more than 4 hours or a painful erection, contact your doctor immediately. This condition may require prompt medical treatment to prevent serious and permanent damage to your penis. Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur: Bloating or swelling of the face, arms, hands, lower legs, or feet dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position swelling of the fingers, hands, feet, or lower legs continuing ringing or buzzing or other unexplained noise in the ears fast, irregular, pounding, or racing heartbeat or pulse redness of the face, neck, arms and occasionally, upper chest blistering, peeling, or loosening of the skin inability to move the arms, legs, or facial muscles large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs pain or discomfort in the arms, jaw, back, or neck painful or prolonged erection of the penis red skin lesions, often with a purple center sores, ulcers, or white spots in the mouth or on the lips Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco. Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially: Congenital or anatomic conditions of the penis (eg, angulation, cavernosal fibrosis, or Peyronie’s disease) or Sickle-cell anemia (blood disorder)—Use with caution. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. Indicated for treatment of erectile dysfunction (ED) Cialis (or generic equivalent) or Chewtadzy only PRN use: 10 mg PO initially before sexual activity, with or without food; may be increased to 20 mg or reduced to 5 mg on basis of efficacy and tolerability; in most patients, maximum dosing frequency is once daily Once-daily use (Cialis): 2.5 mg/day PO in single daily dose, without regard to timing of sexual activity, with or without food; may be increased to 5 mg/day on basis of efficacy and tolerability Indicated for treatment of signs and symptoms of benign prostatic hyperplasia (BPH); daily use also indicated for treatment of patients with both BPH and erectile dysfunction Cialis (or generic equivalent) or Chewtadzy only BPH with ED: 5 mg PO once daily, taken at approximately same time each day without regard to timing of sexual activity Coadministration with finasteride for BPH: Tadalafil 5 mg plus finasteride 5 mg PO once daily for ≤26 weeks; incremental benefit of tadalafil decreases from 4 weeks until 26 weeks, and the benefit beyond 26 weeks is unknown Indicated for pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability; studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%) Adcirca, Alyq, Tadliq, or generic equivalent only 40 mg PO once daily; dividing dose for more frequent dosing is not recommended Patients also taking ritonavir: 20 mg PO once daily initially for ≥1 week; may be increased to 40 mg/day on basis of tolerability Cialis, Chewtadzy (PRN use)Mild (CrCl >50 mL/min): No dosage adjustment neededModerate (CrCl 30-50 mL/min): Not to exceed 5 mg PO once daily initially; maximum dosage, 10 mg PO q48hrSevere (CrCl <30 mL/min and on hemodialysis): Not to exceed 5 mg PO q72hr Mild (CrCl >50 mL/min): No dosage adjustment needed Moderate (CrCl 30-50 mL/min): Not to exceed 5 mg PO once daily initially; maximum dosage, 10 mg PO q48hr Severe (CrCl <30 mL/min and on hemodialysis): Not to exceed 5 mg PO q72hr Cialis (once daily use)ED (CrCl >50 mL/min): No dosage adjustment neededBPH or BPH/ED (CrCl 30-50 mL/min): 2.5 mg/day starting dose recommended; may increase to 5 mg according to individual responseED or BPH (CrCl <30 mL/min or hemodialysis): Not recommended ED (CrCl >50 mL/min): No dosage adjustment needed BPH or BPH/ED (CrCl 30-50 mL/min): 2.5 mg/day starting dose recommended; may increase to 5 mg according to individual response ED or BPH (CrCl <30 mL/min or hemodialysis): Not recommended Chewtadzy (once daily use)BPH, ED/BPHCrCl >50 mL/min: No dosage adjustment neededCrCl ≤50 mL/min or hemodialysis: Not recommended CrCl >50 mL/min: No dosage adjustment needed CrCl ≤50 mL/min or hemodialysis: Not recommended Adcirca, Alyq, TadliqMild-to-moderate (CrCl 31-80 mL/min): 20 mg PO once daily initially; may be increased to 40 mg once daily on basis of tolerabilitySevere (CrCl <30 mL/min and on hemodialysis): Avoid use Mild-to-moderate (CrCl 31-80 mL/min): 20 mg PO once daily initially; may be increased to 40 mg once daily on basis of tolerability Severe (CrCl <30 mL/min and on hemodialysis): Avoid use Cialis, Chewtadzy (PRN use)Mild-to-moderate (Child-Pugh class A or B): Not to exceed 10 mg PO once dailySevere (Child-Pugh class C): Not recommended Mild-to-moderate (Child-Pugh class A or B): Not to exceed 10 mg PO once daily Severe (Child-Pugh class C): Not recommended Cialis, Chewtadzy (once daily use)Mild-to-moderate (Child-Pugh class A or B): Data limited; caution advisedSevere (Child-Pugh cl