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Drug Interactions between FloLipid and vadadustat

This report displays the potential drug interactions for the following 2 drugs:

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Interactions between your drugs

Major

simvastatin vadadustat

Applies to: FloLipid (simvastatin) and vadadustat

Consumer information for this interaction is not currently available.

ADJUST DOSE: Coadministration with vadadustat, an inhibitor of breast cancer resistance protein (BCRP), may increase the plasma concentrations and pharmacologic effects of drugs that are substrates of BCRP such as atorvastatin, rosuvastatin, and simvastatin. The proposed mechanism involves decreased clearance due to inhibition of BCRP by vadadustat. According to product labeling, when vadadustat was coadministered with the BCRP substrates simvastatin and rosuvastatin, systemic exposure (AUC) of the substrates increased 2-fold, and 2 to 3-fold, respectively. High levels of HMG-CoA reductase inhibitory activity in plasma is associated with an increased risk of musculoskeletal toxicity, such as myopathy and rarely, rhabdomyolysis.

MANAGEMENT: When concomitant use of vadadustat is required, product labeling recommends limiting the starting dose of simvastatin to 5 mg and the daily dose to 20 mg, and the daily dose of rosuvastatin to 5 mg. The prescribing information for other BCRP substrates should be consulted for any dosage adjustments that may be required during coadministration and/or following the discontinuation of a BCRP inhibitor. Patients should be advised to monitor for signs and symptoms of adverse effects and promptly report any unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever.

Drug and food interactions

Major

simvastatin food

Applies to: FloLipid (simvastatin)

Grapefruit juice can significantly increase the blood levels of simvastatin. This can increase the risk of side effects such as liver damage and a rare but serious condition called rhabdomyolysis that involves the breakdown of skeletal muscle tissue. In some cases, rhabdomyolysis can cause kidney damage and even death. You should avoid the consumption of grapefruit or grapefruit juice during treatment with simvastatin. Drinking green tea or taking green tea extracts may also increase the blood levels of simvastatin in some patients. Talk to your doctor or pharmacist if you have any questions or concerns. It may be advisable to avoid excessive consumption of green tea and green tea products while on simvastatin. Let your doctor know immediately if you have unexplained muscle pain, tenderness, or weakness during treatment, especially if these symptoms are accompanied by fever or dark colored urine. You should also seek immediate medical attention if you develop fever, chills, joint pain or swelling, unusual bleeding or bruising, skin rash, itching, loss of appetite, fatigue, nausea, vomiting, dark colored urine, and/or yellowing of the skin or eyes, as these may be signs and symptoms of liver damage. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Moderate

vadadustat food

Applies to: vadadustat

Consumer information for this interaction is not currently available.

MONITOR: Smoking and alcohol consumption during therapy with vadadustat may increase the risk of gastrointestinal erosions. Serious erosions, including gastrointestinal bleeding and the need for red blood cell transfusions, have been reported during vadadustat clinical trials. Patients with a history of gastrointestinal erosion, peptic ulcer disease, and current tobacco smokers and alcohol drinkers may be at higher risk of gastrointestinal injury.

MANAGEMENT: Caution is advised if vadadustat is prescribed to current tobacco smokers or alcohol drinkers. Patients should be advised to contact their physician if they develop potential signs and symptoms of gastrointestinal injury such as abdominal pain, hematemesis, trouble swallowing, chest or throat pain, and/or black, tarry stools.

Moderate

simvastatin food

Applies to: FloLipid (simvastatin)

Simvastatin may cause liver problems and using it with substantial quantities of ethanol (alcohol) may increase that risk. You should limit the use of alcohol while being treated with these medications. Call your doctor immediately if you have fever, chills, joint pain or swelling, unusual bleeding or bruising, skin rash, itching, loss of appetite, fatigue, nausea, vomiting, abdominal pain, dark urine, pale stools, and/or yellowing of the skin or eyes, as these may be signs and symptoms of liver damage. Talk to your doctor or pharmacist if you have any questions or concerns. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Therapeutic duplication warnings

No warnings were found for your selected drugs.

Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.


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Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown No interaction information available.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.