ATSWIFT-EZ FILM COATED TABLETS 80MG/10MG [SIN17496P]

Product Info

ATSWIFT-EZ FILM COATED TABLETS 80MG/10MG

[SIN17496P]

Indication

1. INDICATIONS AND USAGE

Hypercholesterolaemia

ATSWIFT-EZ 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

ATSWIFT-EZ 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 ATSWIFT-EZ or ezetimibe on cardiovascular morbidity and mortality has not yet been demonstrated.

Homozygous Familial Hypercholesterolemia (HoFH)
ATSWIFT-EZ 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).

Dosing

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 ATSWIFT-EZ. The dosage should be individualized according to the baseline LDL-C level, the recommended goal of therapy, and the patient’s response. ATSWIFT-EZ 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 ATSWIFT-EZ is 10/10 to 10/80 mg once daily. The recommended starting dose of ATSWIFT-EZ 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 ATSWIFT-EZ, lipid levels should be analyzed within 2 or more weeks and dosage adjusted accordingly.

Dosage in Patients with Homozygous Familial Hypercholesterolemia
The dosage of ATSWIFT-EZ in patients with homozygous familial hypercholesterolemia is 10/40 or 10/80 mg daily. ATSWIFT-EZ 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 ATSWIFT-EZ 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 ATSWIFT-EZ 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 ATSWIFT-EZ 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 ATSWIFT-EZ should be avoided. In patients with HIV taking lopinavir plus ritonavir, caution should be used when prescribing ATSWIFT-EZ 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 ATSWIFT-EZ 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 ATSWIFT-EZ should be limited to 10/40 mg, and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of ATSWIFT-EZ 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 ATSWIFT-EZ 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].

Contraindications

3. CONTRAINDICATIONS

ATSWIFT-EZ 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.