After a comprehensive review of all available data, the FDA is requesting all statin manufacturers to remove the contraindication in the prescribing information against using statins in pregnant patients. Although statin therapy should be discontinued in most pregnant patients, health care providers should consider the ongoing therapeutic needs of the individual patient, especially patients at very high risk of cardiovascular events during pregnancy, such as patients with homozygous familial hypercholesterolemia or those with established cardiovascular disease. Additionally, breastfeeding is still not recommended in patients taking a statin; health care providers should determine whether it is better to temporarily stop statin therapy while breastfeeding or to continue statin therapy and not have the patient breastfeed. If ongoing statin treatment is necessary, infant formula and other alternatives are available. The FDA expects that removing the contraindication will enable health care providers and patients to make individual decisions about benefit and risk, especially for those at very high risk of heart attack or stroke.
Further information is available at https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-removal-strongest-warning-against-using-cholesterol-lowering-statins-during-pregnancy.
Dosage guidance:
Dosing: Rosuvastatin 20 to 40 mg/day is considered a high-intensity statin (generally reduces low-density lipoprotein cholesterol [LDL-C] by ≥50%). Rosuvastatin 5 to 10 mg/day is considered a moderate-intensity statin (generally reduces LDL-C by ~30% to 49%). Assess response ~1 to 3 months after initiation of therapy or dose adjustment and every 3 to 12 months thereafter (ACC/AHA [Grundy 2019]). In patients of East Asian descent, rosuvastatin exposure can be ~2-fold higher compared to White patients; consider initial dosage reduction and risk versus benefit in East Asian patients not adequately controlled with rosuvastatin 20 mg once daily before increasing dose further (Newman 2019; manufacturer's labeling).
Clinical considerations: Consider combination therapy in patients who do not meet cholesterol treatment goals with dietary modification plus maximally tolerated statin therapy. Refer to individual agents for more information (ACC/AHA [Grundy 2019]).
Homozygous familial hypercholesterolemia: Oral: Initial: Dosing range: Ezetimibe 10 mg and rosuvastatin 5 to 40 mg once daily; titrate dose to achieve treatment goals.
Primary hyperlipidemia: Oral: Initial: Dosing range: Ezetimibe 10 mg and rosuvastatin 5 to 40 mg once daily; titrate dose to achieve treatment goals.
Patients switching from coadministration of rosuvastatin (or a different statin) and ezetimibe: Oral: Ezetimibe 10 mg and an equivalent dose of rosuvastatin.
Patients of Asian descent: Oral: Initial: Ezetimibe 10 mg and rosuvastatin 5 mg once daily; consider risk versus benefit in patients not adequately controlled with doses up to ezetimibe 10 mg and rosuvastatin 20 mg once daily.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
CrCl ≥30 mL/minute/1.73 m2: No dosage adjustment necessary.
CrCl <30 mL/minute/1.73 m2: Initial: Ezetimibe 10 mg and rosuvastatin 5 mg once daily; maximum: Ezetimibe 10 mg and rosuvastatin 10 mg once daily.
Hemodialysis: There are no specific dosage adjustments provided in the manufacturer's labeling. Refer to individual agents.
There are no specific dosage adjustments provided in the manufacturer's labeling; however, systemic exposure of rosuvastatin may be increased in patients with liver disease (increased AUC and Cmax); use is contraindicated in active liver disease or decompensated cirrhosis.
Refer to adult dosing.
See individual agents.
Hypersensitivity (eg, anaphylaxis, angioedema, erythema multiforme) to rosuvastatin, ezetimibe, or any component of the formulation; acute liver failure or decompensated cirrhosis.
Concerns related to adverse effects:
• Diabetes mellitus: Small increases in HbA1c (mean: ~0.1%) and fasting blood glucose have been reported with rosuvastatin; however, the benefits of statin therapy far outweigh the risk of dysglycemia.
• Elevated hepatic transaminases: A higher incidence of elevated transaminases (≥3 × ULN) has been observed with concomitant use of ezetimibe and statins compared to statin monotherapy; transaminase changes were generally not associated with symptoms or cholestasis and returned to baseline with or without discontinuation of therapy. Consider discontinuation of ezetimibe and/or the statin for persistently elevated transaminases (ALT or AST ≥3 × ULN).
• Hematuria/proteinuria: Hematuria (microscopic) and proteinuria have been observed; more commonly reported in adults receiving rosuvastatin 40 mg daily. Typically, transient and not associated with a decrease in renal function. Consider dosage reduction if unexplained hematuria and proteinuria persists.
• Hepatotoxicity: Postmarketing reports of fatal and nonfatal hepatic failure due to rosuvastatin are rare. If serious hepatotoxicity with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment, interrupt therapy. If an alternate etiology is not identified, do not restart rosuvastatin.
• Myopathy/rhabdomyolysis: Rhabdomyolysis with acute renal failure secondary to myoglobinuria and/or myopathy has been reported; patients should be monitored closely. This risk is dose related and is increased with concomitant use of interacting medications. Consult drug interactions database for more detailed information. If concurrent use is warranted, consider lower starting and maintenance doses of rosuvastatin. Use caution in patients with inadequately treated hypothyroidism, patients taking other drugs associated with myopathy (eg, colchicine), patients ≥65 years of age, and women; these patients are predisposed to myopathy. Immune-mediated necrotizing myopathy (IMNM) associated with HMG-CoA reductase inhibitors use has also been reported. Patients should be instructed to report unexplained muscle pain, tenderness, weakness, or brown urine, particularly if accompanied by malaise or fever. Discontinue therapy if markedly elevated CPK levels occur or myopathy is diagnosed/suspected; consider treatment with immunosuppressants and additional neuromuscular and serologic testing. Prior to initiating a different HMG-CoA reductase inhibitor, consider risk of IMNM; monitor closely.
Disease-related concerns:
• Hepatic impairment and/or ethanol use: Use with caution in patients who consume large amounts of ethanol or have a history of liver disease. Use is contraindicated with active liver disease or decompensated cirrhosis.
• Myasthenia gravis: May rarely worsen or precipitate myasthenia gravis (MG); monitor for worsening MG if treatment is initiated (AAN [Narayanaswami 2021]).
• Renal impairment: Dosage adjustment is required in patients with a CrCl <30 mL/minute/1.73 m2 and not receiving hemodialysis.
Special populations:
• Asian population: There is an increased risk of rosuvastatin-associated myopathy in certain subgroups; dosage adjustment is recommended for patients of Asian descent.
• Older adult: Use with caution in patients with advanced age; these patients are more predisposed to myopathy.
• Surgical patients: Based on current research and clinical guidelines, HMG-CoA reductase inhibitors should be continued in the perioperative period for noncardiac and cardiac surgery (ACC/AHA [Fleisher 2014]; ACC/AHA [Hillis 2011]). Perioperative discontinuation of statin therapy is associated with an increased risk of cardiac morbidity and mortality.
Other warnings/precautions:
• Appropriate use: Secondary causes of hyperlipidemia should be ruled out prior to therapy. Rosuvastatin has not been studied when the primary lipid abnormality is chylomicron elevation (Fredrickson types I and V).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Roszet: Ezetimibe 10 mg and rosuvastatin calcium 5 mg, Ezetimibe 10 mg and rosuvastatin calcium 10 mg, Ezetimibe 10 mg and rosuvastatin calcium 20 mg, Ezetimibe 10 mg and rosuvastatin calcium 40 mg
Generic: Ezetimibe 10 mg and rosuvastatin calcium 10 mg, Ezetimibe 10 mg and rosuvastatin calcium 20 mg, Ezetimibe 10 mg and rosuvastatin calcium 40 mg, Ezetimibe 10 mg and rosuvastatin calcium 5 mg
Yes
Tablets (Ezetimibe-Rosuvastatin Oral)
10-5 mg (per each): $3.00
10-10 mg (per each): $3.00
10-20 mg (per each): $3.00
10-40 mg (per each): $3.00
Tablets (Roszet Oral)
10-5 mg (per each): $10.00
10-10 mg (per each): $10.00
10-20 mg (per each): $10.00
10-40 mg (per each): $10.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Oral: Administer at approximately the same time each day. May be administered without regard to meals. Swallow whole; do not chew, crush, or dissolve tablets.
Homozygous familial hypercholesterolemia: Alone or as an adjunct to other LDL cholesterol (LDL-C)–lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH).
Primary hyperlipidemia: As an adjunct to diet to reduce LDL-C in adults with primary nonfamilial hyperlipidemia.
Refer to individual components.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Abiraterone Acetate: May enhance the myopathic (rhabdomyolysis) effect of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor therapy
Acipimox: May enhance the myopathic (rhabdomyolysis) effect of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor therapy
Antacids: May decrease the serum concentration of Rosuvastatin. Risk C: Monitor therapy
Apalutamide: May decrease the serum concentration of Rosuvastatin. Risk C: Monitor therapy
Asciminib: May increase the serum concentration of Rosuvastatin. Risk X: Avoid combination
Asunaprevir: May increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor therapy
Atazanavir: May increase the serum concentration of Rosuvastatin. Rosuvastatin may increase the serum concentration of Atazanavir. Management: Initiate rosuvastatin at 5 mg daily and do not exceed rosuvastatin 10 mg daily if coadministered with atazanavir/ritonavir. If combined, monitor for signs and symptoms of myopathy and rhabdomyolysis and for increased atazanavir toxicities. Risk D: Consider therapy modification
BCRP/ABCG2 Inhibitors: May increase the serum concentration of Rosuvastatin. Risk C: Monitor therapy
Bile Acid Sequestrants: May decrease the absorption of Ezetimibe. Management: Administer ezetimibe at least 2 hours before or 4 hours after any bile acid sequestrant. Risk D: Consider therapy modification
Capmatinib: May increase the serum concentration of Rosuvastatin. Management: Limit the dose of rosuvastatin to 10 mg daily when combined with capmatinib. Monitor closely for increased rosuvastatin effects/toxicities (eg, myalgias, rhabdomyolysis) when these agents are combined. Risk D: Consider therapy modification
CarBAMazepine: May decrease the serum concentration of Rosuvastatin. Risk C: Monitor therapy
Cobicistat: May increase the serum concentration of Rosuvastatin. Management: If coadministeed with cobicistat/atazanavir or cobicistat/darunavir, initiate rosuvastatin at the lowest dose. Do not exceed rosuvastatin 10 mg/day with concurrent use of atazanavir/cobicistat or 20 mg/day with concurrent use of darunavir/cobicistat. Risk D: Consider therapy modification
Colchicine: May enhance the myopathic (rhabdomyolysis) effect of HMG-CoA Reductase Inhibitors (Statins). Colchicine may increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). HMG-CoA Reductase Inhibitors (Statins) may increase the serum concentration of Colchicine. Risk C: Monitor therapy
CycloSPORINE (Systemic): May increase the serum concentration of Rosuvastatin. Management: Limit rosuvastatin to 5 mg daily in patients who are also receiving cyclosporine, and monitor patients for increased rosuvastatin toxicities. Canadian labeling contraindicates concomitant use of rosuvastatin with cyclosporine. Risk D: Consider therapy modification
Daclatasvir: May increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor therapy
DAPTOmycin: HMG-CoA Reductase Inhibitors (Statins) may enhance the adverse/toxic effect of DAPTOmycin. Specifically, the risk of skeletal muscle toxicity may be increased. Management: Consider temporarily stopping statin (HMG-CoA reductase inhibitor) therapy prior to daptomycin. If daptomycin is used with a statin, creatine phosphokinase (CPK) monitoring could be considered. Risk D: Consider therapy modification
Darolutamide: May increase the serum concentration of Rosuvastatin. Management: Limit the dose of rosuvastatin to 5 mg daily when combined with darolutamide. Monitor closely for increased rosuvastatin effects/toxicities (eg, myalgias, rhabdomyolysis) when these agents are combined. Risk D: Consider therapy modification
Dasabuvir: May increase the serum concentration of Rosuvastatin. Management: Limit the rosuvastatin dose to a maximum of 10 mg per day when used with the ombitasvir/paritaprevir/ritonavir/dasabuvir combination product. Labeling outside of the US recommends limiting the rosuvastatin dose to 5 mg per day. Risk D: Consider therapy modification
Dronedarone: May increase the serum concentration of Rosuvastatin. Risk C: Monitor therapy
Elacestrant: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy
Elagolix: May decrease the serum concentration of Rosuvastatin. Risk C: Monitor therapy
Elagolix, Estradiol, and Norethindrone: May decrease the serum concentration of Rosuvastatin. Risk C: Monitor therapy
Elbasvir and Grazoprevir: May increase the serum concentration of Rosuvastatin. Management: Initiate rosuvastatin at 5 mg daily and limit the rosuvastatin dose to a maximum of 10 mg per day during coadministration with elbasvir/grazoprevir. Monitor closely for evidence of rosuvastatin toxicities (eg, myopathy, rhabdomyolysis). Risk D: Consider therapy modification
Eltrombopag: May increase the serum concentration of Rosuvastatin. Management: Consideration a preventive 50% reduction in rosuvastatin adult dose when starting this combination. Risk D: Consider therapy modification
Enasidenib: May increase the serum concentration of Rosuvastatin. Management: Limit the dose of rosuvastatin to 10 mg once daily when combined with enasidenib. Risk D: Consider therapy modification
Encorafenib: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy
Eslicarbazepine: May decrease the serum concentration of Rosuvastatin. Risk C: Monitor therapy
Febuxostat: May increase the serum concentration of Rosuvastatin. Management: Limit the dose of rosuvastatin to 20 mg daily when combined with febuxostat. Monitor closely for increased rosuvastatin effects/toxicities (eg, myalgias, rhabdomyolysis) when these agents are combined. Risk D: Consider therapy modification
Fenofibrate and Derivatives: May enhance the adverse/toxic effect of Ezetimibe. Specifically, the risk of myopathy and cholelithiasis may be increased. Fenofibrate and Derivatives may increase the serum concentration of Ezetimibe. Risk C: Monitor therapy
Fibric Acid Derivatives: May enhance the adverse/toxic effect of Ezetimibe. Specifically, the risk of myopathy and cholelithiasis may be increased. Fibric Acid Derivatives may increase the serum concentration of Ezetimibe. Risk X: Avoid combination
Fostamatinib: May increase the serum concentration of Rosuvastatin. Management: Limit the dose of rosuvastatin to 20 mg daily when combined with fostamatinib. Monitor closely for increased rosuvastatin effects/toxicities (eg, myalgias, rhabdomyolysis) when these agents are combined. Risk D: Consider therapy modification
Fostemsavir: May increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). Management: Use the lowest possible starting statin dose and monitor patients closely for statin-related adverse effects (eg, muscle aches and pains) during coadministration with fostemsavir. Risk D: Consider therapy modification
Fusidic Acid (Systemic): May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors (Statins). Specifically, the risk for muscle toxicities, including rhabdomyolysis may be significantly increased. Management: Avoid concurrent use whenever possible. Use is listed as contraindicated in product characteristic summaries in several countries, although UK labeling suggests that use could be considered under exceptional circumstances and with close supervision. Risk X: Avoid combination
Futibatinib: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy
Gilteritinib: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy
Glecaprevir and Pibrentasvir: May increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). Management: Use the lowest statin dose possible if combined with glecaprevir/pibrentasvir and monitor for increased statin effects/toxicities. Avoid concomitant use with atorva-, simva-, or lovastatin. Limit rosuvastatin to 10 mg daily and reduce pravastatin dose 50% Risk D: Consider therapy modification
Itraconazole: May increase the serum concentration of Rosuvastatin. Risk C: Monitor therapy
Lanthanum: May decrease the serum concentration of HMG-CoA Reductase Inhibitors (Statins). Management: Administer HMG-CoA reductase inhibitors (eg, statins) at least two hours before or after lanthanum. Risk D: Consider therapy modification
Ledipasvir: May increase the serum concentration of Rosuvastatin. Risk X: Avoid combination
Leflunomide: May increase the serum concentration of Rosuvastatin. Management: Limit the maximum adult rosuvastatin dose to 10 mg/day in patients receiving leflunomide, and monitor for evidence of rosuvastatin toxicity (eg, muscle toxicity, elevated transaminase concentrations). Risk D: Consider therapy modification
Leniolisib: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk X: Avoid combination
Leniolisib: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk X: Avoid combination
Letermovir: May increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor therapy
Lopinavir: May increase the serum concentration of Rosuvastatin. Management: Initiate rosuvastatin at 5 mg daily and limit the rosuvastatin dose to a maximum of 10 mg per day when used with lopinavir/ritonavir. Monitor patients closely for evidence of rosuvastatin toxicities (eg, myopathy, rhabdomyolysis). Risk D: Consider therapy modification
Maribavir: May increase the serum concentration of Rosuvastatin. Risk C: Monitor therapy
Momelotinib: May increase the serum concentration of Rosuvastatin. Management: In patients who are receiving momelotinib, initiate rosuvastatin at a dose of 5 mg once daily and limit the rosuvastatin dose to a maximum of 10 mg once daily. Risk D: Consider therapy modification
Niacin: May enhance the myopathic (rhabdomyolysis) effect of Rosuvastatin. Risk C: Monitor therapy
Nirmatrelvir and Ritonavir: May increase the serum concentration of Rosuvastatin. Management: Consider temporarily discontinuing rosuvastatin during treatment with nirmatrelvir/ritonavir. It is not necessary to hold rosuvastatin either prior to or after completion of nirmatrelvir/ritonavir treatment. Risk D: Consider therapy modification
Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir: May increase the serum concentration of Rosuvastatin. Management: Initiate rosuvastatin at 5 mg daily and limit the rosuvastatin dose to a maximum of 10 mg per day when used with the ombitasvir/paritaprevir/ritonavir/dasabuvir combination product. Monitor for rosuvastatin toxicities (eg, myopathy, rhabdomyolysis). Risk D: Consider therapy modification
Pacritinib: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk X: Avoid combination
Pretomanid: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy
Protease Inhibitors: May increase the serum concentration of Rosuvastatin. Risk C: Monitor therapy
Raltegravir: May enhance the myopathic (rhabdomyolysis) effect of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor therapy
Red Yeast Rice: May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors (Statins). Risk X: Avoid combination
Regorafenib: May increase the serum concentration of Rosuvastatin. Management: Limit the dose of rosuvastatin to 10 mg daily when combined with regorafenib. Monitor closely for increased rosuvastatin effects/toxicities (eg, myalgias, rhabdomyolysis) when these agents are combined. Risk D: Consider therapy modification
Repaglinide: HMG-CoA Reductase Inhibitors (Statins) may increase the serum concentration of Repaglinide. Risk C: Monitor therapy
RifAMPin: May decrease the serum concentration of Rosuvastatin. Risk C: Monitor therapy
Rupatadine: May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors (Statins). Specifically, the risk for increased CPK and/or other muscle toxicities may be increased. Risk C: Monitor therapy
Simeprevir: May increase the serum concentration of Rosuvastatin. Management: Limit initial rosuvastatin dose to 5 mg/day when being started in a patient who is also being treated with simeprevir. The maximum rosuvastatin dose should not exceed 10 mg/day with concurrent use of simeprevir. Risk D: Consider therapy modification
Sparsentan: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk X: Avoid combination
Tafamidis: May enhance the myopathic (rhabdomyolysis) effect of Rosuvastatin. Tafamidis may increase the serum concentration of Rosuvastatin. Management: Avoid this combination if possible. If combined, initiate rosuvastatin at a dose of 5 mg once daily and do not exceed a dose of rosuvastatin 20 mg daily. Monitor for signs of myopathy and rhabdomyolysis. Risk D: Consider therapy modification
Taurursodiol: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk X: Avoid combination
Tedizolid: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy
Teriflunomide: May increase the serum concentration of Rosuvastatin. Management: Limit the maximum adult rosuvastatin dose to 10 mg/day in patients receiving teriflunomide, and monitor for evidence of rosuvastatin toxicity (eg, muscle toxicity, elevated transaminase concentrations). Risk D: Consider therapy modification
Ticagrelor: May enhance the myopathic (rhabdomyolysis) effect of Rosuvastatin. Ticagrelor may increase the serum concentration of Rosuvastatin. Risk C: Monitor therapy
Trabectedin: HMG-CoA Reductase Inhibitors (Statins) may enhance the myopathic (rhabdomyolysis) effect of Trabectedin. Risk C: Monitor therapy
Trofinetide: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Management: Avoid concurrent use with OATP1B1/1B3 substrates for which small changes in exposure may be associated with serious toxicities. Monitor for evidence of an altered response to any OATP1B1/1B3 substrate if used together with trofinetide. Risk D: Consider therapy modification
Velpatasvir: May increase the serum concentration of Rosuvastatin. Management: Initiate rosuvastatin at 5 mg daily and limit the rosuvastatin dose to a maximum of 10 mg per day during coadministration with sofosbuvir/velpatasvir. Monitor closely for evidence of rosuvastatin toxicities (eg, myopathy, rhabdomyolysis). Risk D: Consider therapy modification
Vitamin K Antagonists (eg, warfarin): HMG-CoA Reductase Inhibitors (Statins) may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy
Voclosporin: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy
Voxilaprevir: May increase the serum concentration of Rosuvastatin. Risk X: Avoid combination
Use during pregnancy is not recommended. Discontinue ezetimibe/rosuvastatin if pregnancy occurs during treatment.
Refer to individual monographs for additional information.
Rosuvastatin is present in breast milk; excretion of ezetimibe is not known.
Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer. Refer to individual monographs for additional information.
Red yeast rice contains variable amounts of several compounds that are structurally similar to HMG-CoA reductase inhibitors, primarily monacolin K (or mevinolin), which is structurally identical to lovastatin; concurrent use of red yeast rice with HMG-CoA reductase inhibitors may increase the incidence of adverse and toxic effects (Lapi 2008; Smith 2003).
Manufacturer's labeling:
Consider neuromuscular and serologic testing if immune-mediated necrotizing myopathy is suspected.
American College of Cardiology/American Heart Association blood cholesterol guideline recommendations (ACC/AHA [Grundy 2019]; ACC/AHA [Stone 2014 ]):
Lipid panel (total cholesterol, HDL, LDL, triglycerides): Baseline lipid panel; fasting lipid profile within 4 to 12 weeks after initiation or dose adjustment and every 3 to 12 months (as clinically indicated) thereafter. If 2 consecutive LDL levels are <40 mg/dL, consider decreasing the dose.
Hepatic transaminase levels: Baseline measurement of hepatic transaminase levels (AST and ALT); measure AST, ALT, total bilirubin, and alkaline phosphatase if symptoms suggest hepatotoxicity (eg, unusual fatigue or weakness, loss of appetite, abdominal pain, dark-colored urine, yellowing of skin or sclera) during therapy.
CPK: CPK should not be routinely measured. Baseline CPK measurement is reasonable for some individuals (eg, family history of statin intolerance or muscle disease, clinical presentation, concomitant drug therapy that may increase risk of myopathy). May measure CPK in any patient with symptoms suggestive of myopathy (pain, tenderness, stiffness, cramping, weakness, or generalized fatigue).
Evaluate for new-onset diabetes mellitus during therapy; if diabetes develops, continue statin therapy and encourage adherence to a heart-healthy diet, physical activity, a healthy body weight, and tobacco cessation.
If patient develops a confusional state or memory impairment, may evaluate patient for nonstatin causes (eg, exposure to other drugs), systemic and neuropsychiatric causes, and the possibility of adverse effects associated with statin therapy.
Ezetimibe: Inhibits absorption of cholesterol at the brush border of the small intestine, leading to a decreased delivery of cholesterol to the liver. Ezetimibe inhibits the enzyme Niemann-Pick C1-Like1 (NPC1L1), a sterol transporter.
Rosuvastatin: Inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, the rate-limiting enzyme in cholesterol synthesis (reduces the production of mevalonic acid from HMG-CoA); this then results in a compensatory increase in the expression of LDL receptors on hepatocyte membranes and a stimulation of LDL catabolism. In addition to the ability of HMG-CoA reductase inhibitors to decrease levels of high-sensitivity C-reactive protein (hsCRP), they also possess pleiotropic properties, including improved endothelial function, reduced inflammation at the site of the coronary plaque, inhibition of platelet aggregation, and anticoagulant effects (de Denus 2002; Ray 2005).
See individual agents.
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