Drug Safety-related Labeling Changes (SrLC)

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LIPTRUZET (NDA-200153)

(ATORVASTATIN CALCIUM; EZETIMIBE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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09/25/2020 (SUPPL-12)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Immune-Mediated Necrotizing Myopathy

(New subsection added)

There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement with immunosuppressive agents. Additional neuromuscular and serologic testing may be necessary. Treatment with immunosuppressive agents may be required. Consider risk of IMNM carefully prior to initiation of a different statin. If therapy is initiated with a different statin, monitor for signs and symptoms of IMNM.

09/28/2017 (SUPPL-5)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Myopathy/Rhabdomyolysis

(Additions and/or revisions are underlined)

The risk of myopathy during treatment with statins is increased with concurrent administration of cyclosporine, fibric acid derivatives, erythromycin, clarithromycin, the hepatitis C antiviral agents telaprevir, a combination of elbasvir plus grazoprevir, combinations of HIV protease inhibitors, including saquinavir plus ritonavir, lopinavir plus ritonavir, tipranavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, and fosamprenavir plus ritonavir, niacin, or azole antifungals. Physicians considering combined therapy with LIPTRUZET and fibric acid derivatives, erythromycin, clarithromycin, a combination of elbasvir plus grazoprevir, a combination of saquinavir plus ritonavir, lopinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, or fosamprenavir plus ritonavir, azole antifungals, or lipid-modifying doses of niacin should carefully weigh the potential benefits and risks and should carefully monitor patients for any signs or symptoms of muscle pain, tenderness, or weakness, particularly during the initial months of therapy and during any periods of upward dosage titration of either drug.

Table 1: Drug Interactions Associated with Increased Risk of Myopathy/Rhabdomyolysis with Atorvastatin (Table has been revised; please refer to label)

6 Adverse Reactions

6.2 Postmarketing Experience

(Additions and/or revisions are underlined)

Nervous system disorders: headache; dizziness; paresthesia; peripheral neuropathy

Musculoskeletal and connective tissue disorders: myositis;

General disorders and administration site conditions: fatigue

7 Drug Interactions

7.9 Elbasvir and Grazoprevir

(Newly added subsection)

Concomitant administration of elbasvir and grazoprevir may lead to increased plasma concentrations of atorvastatin and an increased risk of myopathy; therefore, a dose adjustment of atorvastatin may be necessary. Coadministration of elbasvir and grazoprevir with atorvastatin increases plasma concentrations of atorvastatin by 1.9-fold due in part to BCRP and/or CYP3A, OATP1B1 inhibition; therefore, the dose of LIPTRUZET should not exceed 10/20 mg daily in patients receiving concomitant medication with products containing elbasvir and grazoprevir.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

Patient Information

(Additions and/or revisions are underlined)

Additional side effects that have been reported in people taking LIPTRUZET, ezetimibe or atorvastatin in clinical studies or general use include: joint pain; diarrhea; tendon problems; memory loss; confusion; depression; tiredness; upset stomach.

08/04/2017 (SUPPL-6)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Postmarketing Experience

Addition of the following:

Respiratory: interstitial lung disease

Questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Division of Drug Information
druginfo@fda.hhs.gov.

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