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OPSYNVI (macitentan/tadalafil)
- pulmonary arterial hypertension
10 mg-20 mg tablet
- Dosage information is not available
10 mg-40 mg tablet
- Dosage information is not available
- Adempas
- Bidil
- boceprevir
- Dilatrate-sr
- Imdur
- Incivek
- Isochron
- Isoditrate
- isosorbide dinitrate
- isosorbide mononitrate
- isosorbide-hydralazine
- Minitran
- Nithiodote
- Nitro-bid
- Nitro-dur
- Nitro-time
- nitroglycerin
- nitroglycerin in 5 % dextrose
- Nitrolingual
- Nitromist
- Nitropress
- nitroprusside
- Nitrostat
- riociguat
- sodium nitrite
- sodium nitrite-sod thiosulfate
- telaprevir
- Victrelis
Contraindicated
- amoxicil-clarithromy-lansopraz
- Aptivus
- Biaxin
- Biaxin Xl
- Biaxin Xl Pak
- clarithromycin
- conivaptan in 5 % dextrose
- Crixivan
- elvitegr-cobicist-emtric-tenof
- indinavir
- Invirase
- itraconazole
- Kaletra
- Ketek
- ketoconazole
- lopinavir-ritonavir
- nefazodone
- nelfinavir
- Norvir
- Norvir Soft Gelatin
- Noxafil
- Omeclamox-pak
- omeprazole-clarith-amoxicillin
- Onmel
- posaconazole
- Prevpac
- ritonavir
- saquinavir mesylate
- Sporanox
- Sporanox Pulsepak
- Stribild
- telithromycin
- tipranavir
- Vaprisol
- Vfend
- Vfend Iv
- Viracept
- voriconazole
Severe
Moderate
- alfuzosin
- Cardura
- Cardura Xl
- Dibenzyline
- doxazosin
- dutasteride-tamsulosin
- Flomax
- isoniazid-rifamp-pyrazinamide
- Jalyn
- Minipress
- phenoxybenzamine
- phentolamine
- prazosin
- Rifadin
- Rifamate
- rifampin
- rifampin-isoniazid
- Rifater
- tamsulosin
- terazosin
- Uroxatral
- Child-pugh class C hepatic impairment
- Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
- Chronic kidney disease stage 5 (failure) GFr<15 ml/min
- Lactation
- Pregnancy
Contraindicated
- Abnormal hepatic function tests
- Alcohol intoxication
- Anemia
- Anterior ischemic optic neuropathy
- Aortic valve stenosis
- Child-pugh class A hepatic impairment
- Child-pugh class B hepatic impairment
- Chronic heart failure
- Chronic kidney disease stage 2 (mild) GFR 60-89 ml/min
- Chronic kidney disease stage 3A (moderate) GFR 45-59
- Chronic kidney disease stage 3B (moderate) GFR 30-44
- Fibrosis of corpus cavernosum
- Hyperbilirubinemia
- Hypertrophic cardiomyopathy
- Hypotension
- Life-threatening cardiac arrhythmias
- Penile angulation
- Peptic ulcer
- Peyronie's disease
- Pigmentary retinopathy
- Pulmonary veno-occlusive disease
- Restrictive cardiomyopathy
- Unstable angina pectoris
Severe
Moderate
- Cerebrovascular accident
- Hearing loss
- Increased risk of bleeding
- Increased risk of bleeding due to coagulation disorder
- Kidney disease with likely reduction in GFR
- Leukemia
- Multiple myeloma
- Seizure disorder
- Severe uncontrolled hypertension
- Sickle cell disease
OPSYNVI (macitentan/tadalafil)
- pulmonary arterial hypertension
- Anemia
- Bronchitis
- Headache disorder
- Influenza
- Pharyngitis
- Urinary tract infection
More Frequent
Severe
Less Severe
- Abnormal hepatic function tests
- Acute abdominal pain
- Anemia
- Back pain
- Cough
- Diarrhea
- Dyspepsia
- Flushing
- Gastroesophageal reflux disease
- Myalgia
- Nasal congestion
- Nausea
- Pain in extremities
- Palpitations
- Pharyngitis
- Upper respiratory infection
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Abnormal hepatic function tests
- Acute myocardial infarction
- Angina
- Angioedema
- Anterior ischemic optic neuropathy
- Blurred vision
- Cerebrovascular accident
- Chest pain
- Conjunctivitis
- Drug-induced hepatitis
- Dysphagia
- Dyspnea
- Esophagitis
- Exfoliative dermatitis
- Facial edema
- Hearing loss
- Hepatic failure
- Hyperbilirubinemia
- Hypertension
- Hypotension
- Kidney disease with reduction in GFR
- Orthostatic hypotension
- Palpitations
- Priapism
- Rectal bleeding
- Retinal vascular occlusion
- Seizure disorder
- Stevens-johnson syndrome
- Syncope
- Tachycardia
- Vision impairment
- Visual field defect
Less Severe
- Acquired chromatopsia
- Arthralgia
- Body fluid retention
- Conjunctival hyperemia
- Dizziness
- Drowsy
- Edema
- Epistaxis
- Eye tearing
- Eyelid edema
- Fatigue
- Flushing
- Frequent erections
- Gastritis
- General weakness
- Hyperhidrosis
- Hypoesthesia
- Insomnia
- Loose stools
- Migraine
- Nasal congestion
- Neck pain
- Ocular pain
- Oligospermia
- Pain
- Paresthesia
- Peripheral edema
- Pruritus of skin
- Skin rash
- Tinnitus
- Transient global amnesia
- Urticaria
- Vertigo
- Visual changes
- Vomiting
- Xerostomia
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Macitentan
No safety and efficacy established.
No efficacy demonstrated in trials of Duchenne muscular dystrophy. Not indicated in pediatrics.
- 1 Day – 13 Years
- No safety and efficacy established.
- 1 Day – 18 Years
- No safety and efficacy established.
Tadalafil
No safety and efficacy established.
No efficacy demonstrated in trials of Duchenne muscular dystrophy. Not indicated in pediatrics.
- 1 Day – 13 Years
- No efficacy demonstrated in trials of Duchenne muscular dystrophy. Not indicated in pediatrics.
- 1 Day – 18 Years
- No efficacy demonstrated in trials of Duchenne muscular dystrophy. Not indicated in pediatrics.
Macitentan
- Severity Level:
1
- Additional Notes:
Tadalafil
- Severity Level:
2
- Additional Notes: Insufficient human data available
Contraindicated
Macitentan
Insufficient data available, potential for serious adverse effects
| General | Excretion Potential | Effect on Infant | Notes |
| Drug should not be given to breast feeding mothers | Unknown | Not known; no or inclusive data | Insufficient data available, potential for serious adverse effects |
Precaution Exists
Tadalafil
Insufficient human data available
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Unknown | Not known; no or inclusive data | Insufficient human data available |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
Tadalafil
Hepatic-Use caution with hepatic impairment. Renal-Adjust dose for moderate to severe renal impairment.
| Organ / System | HEP | REN | CARD | ENDO | NEURO / PSYCH | PULM |
| Increased Risk / Adverse Effects | Y | Y | Y | Y | N | N |
BEERS: N HEDIS: N STOPP: N
No Known Risk
None
- This medication must not be used during pregnancy. Macitentan may harm an unborn baby. It is important to prevent pregnancy while taking this medication and for 1 month after treatment.<br /><br />Female patients must use reliable birth control during treatment and for 1 month after the last dose. Ask your doctor which forms of birth control to use while taking this medication. Female patients must take a pregnancy test before starting treatment, monthly during treatment, and 1 month after the last dose.<br /><br />If you become pregnant or think you may be pregnant, tell your doctor right away. For female patients to receive this medication in the United States, they must understand, agree to, and carefully follow the requirements of the Macitentan-Containing Products REMS Program. If you are a female patient that lives in Canada or any other country, consult your doctor and pharmacist for your country's regulations.
| Pulmonary arterial hypertension | |
| I27.0 | Primary pulmonary hypertension |
| I27.21 | Secondary pulmonary arterial hypertension |
| 0-9 | A-Z |
|---|---|
| I27.0 | Primary pulmonary hypertension |
| I27.21 | Secondary pulmonary arterial hypertension |
Formulary Reference Tool