Recommended Dosage and Administration Information

• Swallow ROSZET tablets whole at any time of day, with or without food. Do not crush, dissolve, or chew tablets.
• The dosage range is 5 mg/10 mg to 40 mg/10 mg once daily.
• The recommended dose of ROSZET depends on a patient’s indication for usage, LDL-C, and individual risk for cardiovascular events.
• The starting dosage for patients switching to ROSZET from co-administration of a statin and ezetimibe is based on an equivalent dose of rosuvastatin and 10 mg of ezetimibe.
• Assess LDL-C when clinically appropriate, as early as 2 weeks after initiating ROSZET, and adjust the dosage if necessary.

Recommended Dosage in Asian Patients

Initiate ROSZET at 5 mg/10 mg daily due to increased rosuvastatin plasma concentrations. Consider the risk/benefit when treating Asian patients not adequately controlled at doses up to 20 mg/10 mg once daily [see Warnings and Precautions (5.1), Use in Specific Populations (8.8), and Clinical Pharmacology (12.3)].

Recommended Dosage in Patients with Renal Impairment

In patients with severe renal impairment (CLcr less than 30 mL/min/1.73 m2) not on hemodialysis, the recommended starting dosage is 5 mg/10 mg once daily and should not exceed 10 mg/10 mg once daily [see Warnings and Precautions (5.1) and Use in Specific Populations (8.6)].

There are no dosage adjustment recommendations for patients with mild and moderate renal impairment.

Dosage and Administration Modifications Due to Drug Interactions

• In patients taking a bile acid sequestrant, administer ROSZET at least 2 hours before or 4 hours after the bile acid sequestrant [see Drug Interactions (7.2)].
• When taking ROSZET with an aluminum and magnesium hydroxide combination antacid, administer ROSZET at least 2 hours before the antacid [see Drug Interactions (7.2)].
• Concomitant use of ROSZET with the following drugs requires dosage modifications of ROSZET [see Warnings and Precautions (5.1) and Drug Interactions (7.1)].

Darolutamide
Do not exceed ROSZET 5 mg/10 mg once daily.

Regorafenib
Do not exceed ROSZET 10 mg/10 mg once daily.

Antiviral Medications
Concomitant use of sofosbuvir/velpatasvir/voxilaprevir and ledipasvir/sofosbuvir with ROSZET is not recommended.

In patients taking simeprevir, dasabuvir/ombitasvir/paritaprevir/ritonavir, elbasvir/grazoprevir, sofosbuvir/velpatasvir, glecaprevir/pibrentasvir, atazanavir/ritonavir, and lopinavir/ritonavir initiate ROSZET at 5 mg/10 mg once daily. Do not exceed ROSZET 10 mg/10 mg once daily.

No dose adjustment is needed for concomitant use with fosamprenavir/ritonavir or tipranavir/ritonavir.