Important Dosage and Administration Information

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Measure the ATORVALIQ dose using a calibrated oral syringe or other oral dosing device scored using metric units of measurements (i.e., mL).

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Take ATORVALIQ orally once daily at any time of day, only on an empty stomach (1 hour before or 2 hours after a meal).

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Advise patients to take a missed dose as soon as possible. If the dose was missed by more than 12 hours, patients should not take the missed dose and resume with the next scheduled dose.

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Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating ATORVALIQ, and adjust the dosage if necessary.

Recommended Dosage in Adult Patients

The recommended starting dose of ATORVALIQ is 10 mg to 20 mg once daily. The dosage range is 10 mg to 80 mg once daily. Patients who require reduction in LDL-C greater than 45% may be started at 40 mg once daily.

Recommended Dosage in Pediatric Patients 10 Years of Age and Older with HeFH

The recommended starting dosage of ATORVALIQ is 10 mg once daily. The dosage range is 10 mg to 20 mg once daily.

Recommended Dosage in Pediatric Patients 10 Years of Age and Older with HoFH

The recommended starting dosage of ATORVALIQ is 10 mg to 20 mg once daily. The dosage range is 10 mg to 80 mg once daily.

Dosage Modifications Due to Drug Interactions

Concomitant use of ATORVALIQ with the following drugs requires dosage modification of ATORVALIQ [see Warnings and Precautions (5.1) and Drug Interactions (7.1)].

Anti-Viral Medications

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In patients taking saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir or letermovir, do not exceed ATORVALIQ 20 mg once daily.

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In patients taking nelfinavir, do not exceed ATORVALIQ 40 mg once daily.

Select Azole Antifungals or Macrolide Antibiotics

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In patients taking clarithromycin or itraconazole, do not exceed ATORVALIQ 20 mg once daily.

For additional recommendations regarding concomitant use of ATORVALIQ with other anti-viral medications, azole antifungals or macrolide antibiotics, [see Drug Interactions (7.1)].