ence not known
flatulence / Early / Incidence not known
fatigue / Early / Incidence not known
back pain / Delayed / Incidence not known
nausea / Early / Incidence not known
weakness / Early / Incidence not known
vomiting / Early / Incidence not known
malaise / Early / Incidence not known
chills / Rapid / Incidence not known
fever / Early / Incidence not known
photosensitivity / Delayed / Incidence not known
urticaria / Rapid / Incidence not known
purpura / Delayed / Incidence not known
alopecia / Delayed / Incidence not known
flushing / Rapid / Incidence not known
dizziness / Early / Incidence not known
insomnia / Early / Incidence not known
paresthesias / Delayed / Incidence not known
DRUG INTERACTIONS
Afatinib: If the concomitant use of simvastatin and afatinib is necessary, consider reducing the afatinib dose by 10 mg per day if the original dose is not tolerated; resume the previous dose of afatinib as tolerated after discontinuation of simvastatin. Afatinib is a P-glycoprotein (P-gp) substrate and inhibitor in vitro, and simvastatin is a P-gp inhibitor; coadministration may increase plasma concentrations of afatinib. Administration of another P-gp inhibitor, ritonavir (200 mg twice daily for 3 days), 1 hour before afatinib (single dose) increased the afatinib AUC and Cmax by 48% and 39%, respectively; there was no change in the afatinib AUC when ritonavir was administered at the same time as afatinib or 6 hours later. In healthy subjects, the relative bioavailability for AUC and Cmax of afatinib was 119% and 104%, respectively, when coadministered with ritonavir, and 111% and 105% when ritonavir was administered 6 hours after afatinib. The manufacturer of afatinib recommends permanent discontinuation of therapy for severe or intolerant adverse drug reactions at a dose of 20 mg per day, but does not address a minimum dose otherwise.
Albiglutide: Coadministration of albiglutide with simvastatin results in an increased Cmax of simvastatin and its active metabolite simvastatin acid by approximately 18% and 98%, respectively. In the same trial, AUC of simvastatin decreased by 40% and AUC of simvastatin acid increased by 36%. The mechanism of the interaction is not known, nor is the clinical significance of this potential interaction. If simvastatin and albiglutide are co-prescribed, it may be prudent to initially monitor the patient for altered simvastatin effect.
Aliskiren; Amlodipine: Simvastatin and amlodipine should be coadministered with caution due to an increased risk of myopathy, including rhabdomyolysis. If amlodipine and simvastatin must be administered together, do not exceed 20 mg/day simvastatin in adults. For adult patients chronically receiving simvastatin 80 mg/day who need to be started on amlodipine, the manufacturer of simvastatin recommends switching to an alternative statin with less potential for interactions.
Aliskiren; Amlodipine; Hydrochlorothiazide, HCTZ: Simvastatin and amlodipine should be coadministered with caution due to an increased risk of myopathy, including rhabdomyolysis. If amlodipine and simvastatin must be administered together, do not exceed 20 mg/day simvastatin in adults. For adult patients chronically receiving simvastatin 80 mg/day who need to be started on amlodipine, the manufacturer of simvastatin recommends switching to an alternative statin with less potential for interactions.
Amiodarone: Simvastatin and amiodarone, a CYP3A4 inhibitor, should be coadministered with cau |
