Rosuvastatininteractions

See full prescribing information for details regarding concomitant use of CRESTOR with other drugs that increase the risk of myopathy and rhabdomyolysis. Aluminum and Magnesium Hydroxide Combination Antacids: Administer CRESTOR at least 2 hours before the antacid.

Warfarin: Obtain INR prior to starting CRESTOR. Monitor INR frequently until stable upon initiation, dosage titration or discontinuation.

7.1 Drug Interactions that

Increase the Risk of Myopathy and Rhabdomyolysis with CRESTOR 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 CRESTOR and instructions for preventing or managing them. Table 5: Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with CRESTOR Sofosbuvir/velpatasvir/voxilaprevir or Ledipasvir/sofosbuvir Prevention or Management: Avoid concomitant use with CRESTOR. Mechanism and Clinical Effect(s): Rosuvastatin plasma levels were significantly increased with concomitant administration of many anti-viral drugs, which increases the risk of myopathy and rhabdomyolysis. Gemfibrozil Prevention or Management: Avoid concomitant use of gemfibrozil with CRESTOR. If use is unavoidable, initiate CRESTOR at 5 mg once daily and do not exceed a dosage of CRESTOR 10 mg once daily. Mechanism and Clinical Effect(s): Gemfibrozil significantly increased rosuvastatin exposure and gemfibrozil may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Tafamidis Prevention or Management: Avoid concomitant use of tafamidis with CRESTOR. If use is unavoidable, initiate CRESTOR at 5 mg once daily and do not exceed a dosage of CRESTOR 20 mg once daily. Monitor for signs of myopathy and rhabdomyolysis if used concomitantly with CRESTOR. Mechanism and Clinical Effect(s): Tafamidis significantly increased rosuvastatin exposure and tafamidis may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Belumosudil Prevention or Management: In patients taking belumosudil, do not exceed a dosage of CRESTOR 5 mg once daily. Mechanism and Clinical Effect(s): Belumosudil increased rosuvastatin exposure more than 4.6-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Cyclosporine Prevention or Management: In patients taking cyclosporine, do not exceed a dosage of CRESTOR 5 mg once daily. Mechanism and Clinical Effect(s): Cyclosporine increased rosuvastatin exposure 7-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Darolutamide Prevention or Management: In patients taking darolutamide, do not exceed a dosage of CRESTOR 5 mg once daily. Mechanism and Clinical Effect(s): Darolutamide increased rosuvastatin exposure more than 5-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Additional Anti-Viral Medications Prevention or Management:

Simeprevir

Dasabuvir/ombitasvir/paritaprevir/ritonavir

Elbasvir/grazoprevir

Sofosbuvir/velpatasvir

Glecaprevir/pibrentasvir

Atazanavir/ritonavir

Lopinavir/ritonavir Initiate with CRESTOR 5 mg once daily, and do not exceed a dosage of CRESTOR 10 mg once daily. Mechanism and Clinical Effect(s): Rosuvastatin plasma levels were significantly increased with concomitant administration of many anti-viral drugs, which increases the risk of myopathy and rhabdomyolysis. Capmatinib Prevention or Management: In patients taking capmatinib, do not exceed a dosage of CRESTOR 10 mg once daily. Mechanism and Clinical Effect(s): Capmatinib increased rosuvastatin exposure more than 2.1-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Enasidenib Prevention or Management: In patients taking enasidenib, do not exceed a dosage of CRESTOR 10 mg once daily. Mechanism and Clinical Effect(s): Enasidenib increased rosuvastatin exposure more than 3.4-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Momelotinib Prevention or Management: In patients taking momelotinib, do not exceed a dosage of CRESTOR 10 mg once daily. Mechanism and Clinical Effect(s): Momelotinib increased rosuvastatin exposure by 2.7-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Regorafenib Prevention or Management: In patients taking regorafenib, do not exceed a dosage of CRESTOR 10 mg once daily. Mechanism and Clinical Effect(s): Regorafenib increased rosuvastatin exposure and may increase the risk of myopathy and rhabdomyolysis. Teriflunomide Prevention or Management: In patients taking teriflunomide, do not exceed a dosage of CRESTOR 10 mg once daily. Mechanism and Clinical Effect(s): Teriflunomide increased rosuvastatin exposure more than 2.5-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Ticagrelor Prevention or Management: In patients taking ticagrelor, do not exceed a dosage of CRESTOR 20 mg once daily. In patients at increased risk for rhabdomyolysis, consider dosages less than 20 mg per day. Mechanism and Clinical Effect(s): Ticagrelor increased rosuvastatin exposure by 2.3-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Febuxostat Prevention or Management: In patients taking febuxostat, do not exceed a dosage of CRESTOR 20 mg once daily. Mechanism and Clinical Effect(s): Febuxostat increased rosuvastatin exposure more than 1.9-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Fostamatinib Prevention or Management: In patients taking fostamatinib, do not exceed a dosage of CRESTOR 20 mg once daily. Mechanism and Clinical Effect(s): Fostamatinib increased rosuvastatin exposure more than 2.0-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Fenofibrates (e.g., fenofibrate and fenofibric acid) Prevention or Management: Consider if the benefit of using fibrates concomitantly with CRESTOR 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 dosage titration of either drug. Mechanism and Clinical Effect(s): Fibrates may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Colchicine Prevention or Management: Consider if the benefit of using colchicine concomitantly with CRESTOR 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 dosage titration of either drug. Mechanism and Clinical Effect(s): Cases of myopathy and rhabdomyolysis have been reported with concomitant use of colchicine with CRESTOR. Niacin Prevention or Management: Consider if the benefit of using lipid-modifying dosages (≥1 g/day) of niacin concomitantly with CRESTOR 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 dosage titration of either drug. Mechanism and Clinical Effect(s): Cases of myopathy and rhabdomyolysis have occurred with concomitant use of lipid-modifying dosages (≥1 g/day) of niacin with CRESTOR.

7.2 Drug Interactions that

Decrease the Efficacy of CRESTOR Table 6 presents drug interactions that may decrease the efficacy of CRESTOR and instructions for preventing or managing them.

Table 6: Drug Interactions that Decrease the Efficacy of CRESTOR Antacids Prevention or Management: In patients taking an antacid, administer CRESTOR at least 2 hours before the antacid. Mechanism and Clinical Effect(s): Concomitant aluminum and magnesium hydroxide combination antacid administration decreased the mean exposure of rosuvastatin 50%.

7.3 CRESTOR

Effects on Other Drugs Table 7 presents CRESTOR’s effect on other drugs and instructions for preventing or managing them.

Table 7: CRESTOR Effects on Other Drugs Warfarin Prevention or Management: In patients taking warfarin, obtain an INR before starting CRESTOR and frequently enough after initiation, dosage titration or discontinuation to ensure that no significant alteration in INR occurs. Once the INR is stable, monitor INR at regularly recommended intervals. Mechanism and Clinical Effect(s): Rosuvastatin significantly increased the INR in patients receiving warfarin.