Opsynvi Dosage/Direction for Use

Recommended Dosage: OPSYNVI is taken orally once daily with or without food. Swallow the tablets whole, with water. Do not cut, crush, or chew tablets. If the patient misses a dose of OPSYNVI, tell the patient to take it as soon as possible and then take the next dose at the regularly scheduled time. Tell the patient not to take two doses at the same time if a dose has been missed.
For patients who are treatment-naïve to any PAH specific therapy or transitioning from ERA monotherapy: The recommended starting dose of OPSYNVI is one 10 mg/20 mg tablet taken orally once daily with or without food for one week. If tolerated, up titrate OPSYNVI to one 10 mg/40 mg tablet taken orally once daily with or without food as the maintenance dose.
For patients transitioning from PDE5 inhibitor monotherapy or PDE5 inhibitor and ERA therapy in combination: The recommended dose of OPSYNVI is one 10 mg/40 mg tablet taken orally once daily.
Pregnancy Testing in Females of Reproductive Potential: Exclude pregnancy before initiating treatment with OPSYNVI in females of reproductive potential [see Warnings, Contraindications, Precautions and Use in Pregnancy & Lactation].
Use in specific population: Pediatric Use: The safety and efficacy of OPSYNVI in children has not been established.
Geriatric Use: Of the total number of subjects in the clinical study of OPSYNVI for PAH, 20% were 65 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.
Renal Impairment: The use of OPSYNVI is not recommended in patients undergoing dialysis. Avoid use of OPSYNVI in patients with severe renal impairment (creatinine clearance 15-29 mL/min) because of increased tadalafil exposure (AUC), lack of clinical experience and the lack of ability to influence clearance by dialysis. For patients with mild (creatinine clearance 51-80 mL/min) to moderate (creatinine clearance 30-50 mL/min) renal impairment, the recommended dose should be consistent with the adult dosing [see Recommended Dosage as previously mentioned and Pharmacology: Pharmacokinetics under Actions].
Hepatic Impairment: OPSYNVI was not studied in severe hepatic impairment patients defined as a Model for End-Stage Liver Disease score ≥19. OPSYNVI must not be initiated in patients with severe hepatic impairment, or clinically significant elevated hepatic aminotransferases (greater than 3 times the Upper Limit of Normal at baseline (>3x ULN). For patients with mild to moderate hepatic impairment (Child Pugh Class A or B) the recommended dose should be consistent with the adult dosing see Recommended Dosage as previously mentioned [see Hepatotoxicity under Precautions and Pharmacology: Pharmacokinetics under Actions].