Prescription Drug Information: Rosuvastatin Calcium (Page 3 of 8)

6.2 Postmarketing Experience

The following adverse reactions have been identified during postapproval use of rosuvastatin:

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood Disorders: thrombocytopenia

Hepatobiliary Disorders: hepatitis, jaundice, fatal and non-fatal hepatic failure

Musculoskeletal Disorders: arthralgia, rare reports of immune-mediated necrotizing myopathy associated with statin use

Nervous System Disorders: peripheral neuropathy, rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, and confusion) associated with the use of all statins. The reports are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks). There have been rare reports of new-onset or exacerbation of myasthenia gravis, including ocular myasthenia, and reports of recurrence when the same or a different statin was administered.

Psychiatric Disorders: depression, sleep disorders (including insomnia and nightmares)

Reproductive System and Breast Disorders: gynecomastia

Respiratory Disorders: interstitial lung disease

Skin and Subcutaneous Tissue Disorders: drug reaction with eosinophilia and systemic symptoms (DRESS), lichenoid drug eruption

7 DRUG INTERACTIONS

7.1 Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Rosuvastatin

Rosuvastatin is a substrate of CYP2C9 and transporters (such as OATP1B1, BCRP). Rosuvastatin plasma levels can be significantly increased with concomitant administration of inhibitors of CYP2C9 and transporters. Table 5 includes a list of drugs that increase the risk of myopathy and rhabdomyolysis when used concomitantly with rosuvastatin and instructions for preventing or managing them [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)].

Table 5: Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with rosuvastatin

Cyclosporine

Clinical Impact:

Cyclosporine increased rosuvastatin exposure 7-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use of cyclosporine or gemfibrozil with rosuvastatin.

Intervention:

If used concomitantly, do not exceed a dose of rosuvastatin 5 mg once daily.

Teriflunomide

Clinical Impact:

Teriflunomide increased rosuvastatin exposure more than 2.5-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use.

Intervention:

In patients taking teriflunomide, do not exceed a dose of rosuvastatin 10 mg once daily.

Enasidenib

Clinical Impact:

Enasidenib increased rosuvastatin exposure more than 2.4-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use.

Intervention:

In patients taking enasidenib, do not exceed a dose of rosuvastatin 10 mg once daily.

Capmatinib

Clinical Impact:

Capmatinib increased rosuvastatin exposure more than 2.1-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use.

Intervention:

In patients taking capmatinib, do not exceed a dose of rosuvastatin 10 mg once daily.

Fostamatinib

Clinical Impact:

Fostamatinib increased rosuvastatin exposure more than 2.0-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use.

Intervention:

In patients taking fostamatinib, do not exceed a dose of rosuvastatin 20 mg once daily.

Febuxostat

Clinical Impact:

Febuxostat increased rosuvastatin exposure more than 1.9-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use.

Intervention:

In patients taking febuxostat, do not exceed a dose of rosuvastatin 20 mg once daily.

Gemfibrozil

Clinical Impact:

Gemfibrozil significantly increased rosuvastatin exposure and gemfibrozil may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of gemfibrozil with rosuvastatin.

Intervention:

Avoid concomitant use of gemfibrozil with rosuvastatin. If used concomitantly, initiate rosuvastatin at 5 mg once daily and do not exceed a dose of rosuvastatin 10 mg once daily.

Tafamidis

Clinical Impact:

Tafamidis significantly increased rosuvastatin exposure and tafamidis may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of tafamidis with rosuvastatin.

Intervention:

Avoid concomitant use of tafamidis with rosuvastatin. If used concomitantly, initiate rosuvastatin at 5 mg once daily and do not exceed a dose of rosuvastatin 20 mg once daily. Monitor for signs of myopathy and rhabdomyolysis if used concomitantly with rosuvastatin.

Anti-Viral Medications

Clinical Impact:

Rosuvastatin plasma levels were significantly increased with concomitant administration of many anti-viral drugs, which increases the risk of myopathy and rhabdomyolysis.

Intervention:

Sofosbuvir/velpatasvir/voxilaprevir
Ledipasvir/sofosbuvir

Avoid concomitant use with rosuvastatin.

Simeprevir
Dasabuvir/ombitasvir/paritaprevir/ritonavir
Elbasvir/grazoprevir
Sofosbuvir/velpatasvir
Glecaprevir/pibrentasvir
Atazanavir/ritonavir
Lopinavir/ritonavir

Initiate with rosuvastatin 5 mg once daily, and do not exceed a dose of rosuvastatin 10 mg once daily.

Darolutamide

Clinical Impact:

Darolutamide increased rosuvastatin exposure more than 5-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use.

Intervention:

In patients taking darolutamide, do not exceed a dose of rosuvastatin 5 mg once daily.

Regorafenib

Clinical Impact:

Regorafenib increased rosuvastatin exposure and may increase the risk of myopathy.

Intervention:

In patients taking regorafenib, do not exceed a dose of rosuvastatin 10 mg once daily.

Fenofibrates (e.g., fenofibrate and fenofibric acid)

Clinical Impact:

Fibrates may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of fibrates with rosuvastatin.

Intervention:

Consider if the benefit of using fibrates concomitantly with rosuvastatin outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dose titration of either drug.

Niacin

Clinical Impact:

Cases of myopathy and rhabdomyolysis have occurred with concomitant use of lipid-modifying doses (≥1 g/day) of niacin with rosuvastatin.

Intervention:

Consider if the benefit of using lipid-modifying doses (≥1 g/day) of niacin concomitantly with rosuvastatin outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dose titration of either drug.

Colchicine

Clinical Impact:

Cases of myopathy and rhabdomyolysis have been reported with concomitant use of colchicine with rosuvastatin.

Intervention:

Consider if the benefit of using colchicine concomitantly with rosuvastatin outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dose titration of either drug.

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