ATOZET TABLET 10MG/10MG

1. INDICATIONS AND USAGE

Hypercholesterolaemia

ATOZET is indicated as adjunctive therapy to diet for use in adults with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate

• patients not appropriately controlled with a statin alone

• patients already treated with a statin and ezetimibe

ATOZET contains ezetimibe and atorvastatin. Atorvastatin has been shown to reduce the frequency of cardiovascular events [see 10. CLINICAL STUDIES – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information ]. A beneficial effect of ATOZET or ezetimibe on cardiovascular morbidity and mortality has not yet been demonstrated.

Homozygous Familial Hypercholesterolemia (HoFH)

ATOZET is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).

3. CONTRAINDICATIONS

• ATOZET is contraindicated in patients with hypersensitivity to ezetimibe, atorvastatin, or any of its inactive ingredients.

• Active liver disease or unexplained persistent elevations of serum transaminases exceeding three times the upper limit of normal (ULN).

• Pregnancy and nursing [see 6. USE IN SPECIFIC POPULATIONS, 6.1. Pregnancy and 6.2. Nursing Mothers – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information ].

• Atorvastatin is contraindicated in patients who are concomitantly treated with glecaprevir/pibrentasvir.

2. DOSAGE AND ADMINISTRATION

2.1 General

The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with ATOZET. The dosage should be individualized according to the baseline LDL-C level, the recommended goal of therapy, and the patient’s response. ATOZET can be administered as a single dose at any time of the day, with or without food.

2.2 Adults

Primary Hypercholesterolemia

The dosage range of ATOZET is 10/10 to 10/80 mg once daily. The recommended starting dose of ATOZET is 10/10 or 10/20 mg once daily. Patients who require a larger reduction in LDL-C (more than 55%) may be started at 10/40 mg once daily. After initiation and/or upon titration of ATOZET, lipid levels should be analyzed within 2 or more weeks and dosage adjusted accordingly.

Dosage in Patients with Homozygous Familial Hypercholesterolemia

The dosage of ATOZET in patients with homozygous familial hypercholesterolemia is 10/40 or 10/80 mg daily. ATOZET should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.

2.3 Pediatric Patients

Treatment with ATOZET is not recommended.

2.4 Geriatric Patients

No dosage adjustment is required for elderly patients.

2.5 Renal Impairment

No dosage adjustment is required for renally impaired patients.

2.6 Hepatic Impairment

No dosage adjustment is required in patients with mild hepatic impairment (Child-Pugh score 5 to 6). Treatment with ATOZET is not recommended in patients with moderate (Child-Pugh score 7 to 9) or severe (Child-Pugh score >9) liver dysfunction [see 3. CONTRAINDICATIONS, 4. WARNINGS AND PRECAUTIONS, 4.5 Hepatic Impairment – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information ].

2.7 Coadministration with Bile Acid Sequestrants

Dosing of ATOZET should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant.

2.8 Cyclosporine, Clarithromycin, Itraconazole, or Certain HIV/HCV Antiviral Agents

In patients taking cyclosporine or the HIV protease inhibitors tipranavir plus ritonavir or the hepatitis C protease inhibitor telaprevir, therapy with ATOZET should be avoided. In patients with HIV taking lopinavir plus ritonavir, caution should be used when prescribing ATOZET and the lowest dose necessary employed. In patients taking clarithromycin, itraconazole, or the hepatitis C antiviral agents boceprevir, elbasvir, grazoprevir or in patients with HIV taking a combination of saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, or fosamprenavir plus ritonavir, therapy with ATOZET should be limited to 10/20 mg, and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of atorvastatin is employed. In patients taking the HIV protease inhibitor nelfinavir, therapy with ATOZET should be limited to 10/40 mg, and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of ATOZET is employed [see 4. WARNINGS AND PRECAUTIONS, 4.1 Myopathy/Rhabdomyolysis – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information ].

2.9 Other Concomitant Lipid-Lowering Therapy

The combination of ATOZET and fibrates is not recommended [see 4. WARNINGS AND PRECAUTIONS, 4.6 Fibrates, and 5. DRUG INTERACTIONS AND OTHER FORMS OF INTERACTIONS, 5.3 Other Interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information ].