DIRA 1.0: Atlas of Drug-induced Rhabdomyolysis

ROSUVASTATIN CALCIUM

DIR Classification Postmarketing Surveillance Drug Property Information Reference

DIR Classification

Classification:Most-DIR concern

Severity Score:4

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

WARNINGS AND PRECAUTIONS
Skeletal Muscle Effects
Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with HMG-CoA reductase inhibitors, including rosuvastatin. These risks can occur at any dose level, but are increased at the highest dose (40 mg).
Rosuvastatin should be prescribed with caution in patients with predisposing factors for myopathy (e.g., age ≥ 65 years, inadequately treated hypothyroidism, renal impairment).
The risk of myopathy during treatment with rosuvastatin may be increased with concurrent administration of some other lipid-lowering therapies (fibrates or niacin), gemfibrozil, cyclosporine, atazanavir/ritonavir, lopinavir/ritonavir, or simeprevir [see DOSAGE AND ADMINISTRATION (2) and DRUG INTERACTIONS (7)]. Cases of myopathy, including rhabdomyolysis, have been reported with HMG-CoA reductase inhibitors, including rosuvastatin, coadministered with colchicine, and caution should be exercised when prescribing rosuvastatin with colchicine [see DRUG INTERACTIONS (7.7)].
Rosuvastatin therapy should be discontinued if markedly elevated creatine kinase levels occur or myopathy is diagnosed or suspected. Rosuvastatin therapy should also be temporarily withheld in any patient with an acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (e.g., sepsis, hypotension, dehydration, major surgery, trauma, severe metabolic, endocrine, and electrolyte disorders, or uncontrolled seizures).
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; muscle biopsy showing necrotizing myopathy without significant inflammation; improvement with immunosuppressive agents.
All patients should be advised to promptly report to their physician unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever or if muscle signs and symptoms persist after discontinuing rosuvastatin.
ADVERSE REACTIONS
The following serious adverse reactions are discussed in greater detail in other sections of the label:
• Rhabdomyolysis with myoglobinuria and acute renal failure and myopathy (including myositis) [see WARNINGS AND PRECAUTIONS (5.1)].
• Liver enzyme abnormalities [see WARNINGS AND PRECAUTIONS (5.2)].
DRUG INTERACTIONS
Gemfibrozil
Gemfibrozil significantly increased rosuvastatin exposure. Due to an observed increased risk of myopathy/rhabdomyolysis, combination therapy with rosuvastatin and gemfibrozil should be avoided. If used together, the dose of rosuvastatin should not exceed 10 mg once daily [see CLINICAL PHARMACOLOGY (12.3)].
Colchicine
Cases of myopathy, including rhabdomyolysis, have been reported with HMG‑CoA reductase inhibitors, including rosuvastatin, coadministered with colchicine, and caution should be exercised when prescribing rosuvastatin with colchicine [see WARNINGS AND PRECAUTIONS (5.1)].

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

Rhabdomyolysis

1595

41317

Other ADRs

34183

14083096

Odds Ratio = 15.905

Drug Property Information

ATC Code(s):

C10BX10 - rosuvastatin calcium

C10BX - "HMG CoA reductase inhibitors, other combinations"
C10B - "LIPID MODIFYING AGENTS, COMBINATIONS"
C10 - LIPID MODIFYING AGENTS
C - CARDIOVASCULAR SYSTEM

C10BX05 - rosuvastatin calcium

C10BX - "HMG CoA reductase inhibitors, other combinations"
C10B - "LIPID MODIFYING AGENTS, COMBINATIONS"
C10 - LIPID MODIFYING AGENTS
C - CARDIOVASCULAR SYSTEM

C10AA07 - rosuvastatin calcium

C10AA - HMG CoA reductase inhibitors
C10A - "LIPID MODIFYING AGENTS, PLAIN"
C10 - LIPID MODIFYING AGENTS
C - CARDIOVASCULAR SYSTEM

C10BA06 - rosuvastatin calcium

C10BA - HMG CoA reductase inhibitors in combination with other lipid modifying agents
C10B - "LIPID MODIFYING AGENTS, COMBINATIONS"
C10 - LIPID MODIFYING AGENTS
C - CARDIOVASCULAR SYSTEM

C10BX07 - rosuvastatin calcium

C10BX - "HMG CoA reductase inhibitors, other combinations"
C10B - "LIPID MODIFYING AGENTS, COMBINATIONS"
C10 - LIPID MODIFYING AGENTS
C - CARDIOVASCULAR SYSTEM

C10BX09 - rosuvastatin calcium

C10BX - "HMG CoA reductase inhibitors, other combinations"
C10B - "LIPID MODIFYING AGENTS, COMBINATIONS"
C10 - LIPID MODIFYING AGENTS
C - CARDIOVASCULAR SYSTEM

Active Ingredient:rosuvastatin calcium

Active Ingredient UNII:83MVU38M7Q

Drugbank ID:DB01098

PubChem Compound:446157

CAS Number:287714-41-4

Dosage Form(s):tablet, film coated

Route(s) Of Administrator:oral

Daily Dose:

10.0 mg/day C10AA07

Chemical Structure:

SMILE Code:
CC(C)C1=NC(=NC(=C1/C=C/[C@H](C[C@H](CC(=O)O)O)O)C2=CC=C(C=C2)F)N(C)S(=O)(=O)C

Reference

COHORT STUDY:

N/A

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67: Pressure group urges rosuvastatin recall.

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68: Rosuvastatin-warfarin drug interaction.

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