Interactions between Kimyrsa and Panobinostat

Panobinostat has a moderate potential interaction with Anemia.

Panobinostat causes myelosuppression. Cases of severe thrombocytopenia, neutropenia and anemia have been reported with the use of panobinostat. It is recommended to obtain a baseline CBC and monitor the CBC frequently as clinically indicated. Dose modifications are recommended for myelosuppression.

Panobinostat has a major potential interaction with Arrhythmia.

Severe and fatal cardiac ischemic events, as well as severe arrhythmias, and electrocardiogram (ECG) changes have occurred in patients receiving panobinostat. Panobinostat may prolong cardiac ventricular repolarization (QT interval). Do not initiate treatment with panobinostat in patients with a QTcF >450 msec or clinically significant baseline ST-segment or T-wave abnormalities. If during treatment, the QTcF increases to >=480 msec, interrupt treatment. Arrhythmias may be exacerbated by electrolyte abnormalities. It is recommended to obtain ECG at baseline and periodically during treatment as clinically indicated. Monitor patient hydration status and electrolyte blood levels, including potassium, magnesium and phosphate, at baseline and frequently as clinically indicated during therapy and correct to prevent dehydration and electrolyte disturbances. If QT prolongation does not resolve, permanently discontinue treatment with panobinostat.

Panobinostat has a moderate potential interaction with Bone Marrow Depression/Low Blood Counts.

Panobinostat causes myelosuppression. Cases of severe thrombocytopenia, neutropenia and anemia have been reported with the use of panobinostat. It is recommended to obtain a baseline CBC and monitor the CBC frequently as clinically indicated. Dose modifications are recommended for myelosuppression.

The oritavancin in Kimyrsa has a moderate potential interaction with Coagulation Defects and Disorders.

Oritavancin has been shown to artificially prolong prothrombin time (PT) and international normalized ratio (INR) for up to 12 hours, making the monitoring of the anticoagulation effect of warfarin unreliable up to 12 hours after an oritavancin dose. Oritavancin has no effect on the coagulation system in vivo. Care should be taken when administering this agent to patients at risk for bleeding and they should be monitored for bleeding if concomitantly receiving warfarin. It is recommended to consider a non-phospholipid dependent coagulation test such as a Factor Xa (chromogenic) assay or an alternative anticoagulant not requiring aPTT monitoring for those patients requiring aPTT monitoring within 5 days of oritavancin dosing.

Panobinostat has a major potential interaction with Electrolyte Abnormalities.

Severe and fatal cardiac ischemic events, as well as severe arrhythmias, and electrocardiogram (ECG) changes have occurred in patients receiving panobinostat. Panobinostat may prolong cardiac ventricular repolarization (QT interval). Do not initiate treatment with panobinostat in patients with a QTcF >450 msec or clinically significant baseline ST-segment or T-wave abnormalities. If during treatment, the QTcF increases to >=480 msec, interrupt treatment. Arrhythmias may be exacerbated by electrolyte abnormalities. It is recommended to obtain ECG at baseline and periodically during treatment as clinically indicated. Monitor patient hydration status and electrolyte blood levels, including potassium, magnesium and phosphate, at baseline and frequently as clinically indicated during therapy and correct to prevent dehydration and electrolyte disturbances. If QT prolongation does not resolve, permanently discontinue treatment with panobinostat.

Panobinostat has a moderate potential interaction with Infection.

Localized and systemic infections, including pneumonia, bacterial infections, invasive fungal infections, and viral infections have been reported in patients taking panobinostat. It is recommended to monitor patients for signs and symptoms of infections during treatment; if a diagnosis of infection is made, institute appropriate anti-infective treatment promptly and consider interruption or discontinuation of therapy. Care should be exercised when prescribing this agent to patients at risk.

Panobinostat has a major potential interaction with Ischemic Heart Disease.

Severe and fatal cardiac ischemic events, as well as severe arrhythmias, and electrocardiogram (ECG) changes have occurred in patients receiving panobinostat. Panobinostat may prolong cardiac ventricular repolarization (QT interval). Do not initiate treatment with panobinostat in patients with a QTcF >450 msec or clinically significant baseline ST-segment or T-wave abnormalities. If during treatment, the QTcF increases to >=480 msec, interrupt treatment. Arrhythmias may be exacerbated by electrolyte abnormalities. It is recommended to obtain ECG at baseline and periodically during treatment as clinically indicated. Monitor patient hydration status and electrolyte blood levels, including potassium, magnesium and phosphate, at baseline and frequently as clinically indicated during therapy and correct to prevent dehydration and electrolyte disturbances. If QT prolongation does not resolve, permanently discontinue treatment with panobinostat.

The oritavancin in Kimyrsa has a moderate potential interaction with Liver Disease.

No dosage adjustment of oritavancin is needed in patients with mild or moderate hepatic impairment. Care should be taken when administering oritavancin to patients with severe hepatic impairment as the pharmacokinetics of this agent have not been studied.

Panobinostat has a moderate potential interaction with Liver Disease.

Hepatic impairment can increase panobinostat exposure. It is recommended to reduce the starting dose of panobinostat in patients with mild or moderate hepatic impairment. Avoid the use of panobinostat in patients with severe hepatic impairment. Liver function should be monitored prior to treatment and regularly during treatment. If abnormal liver function tests are observed dose adjustments might be considered and the patient should be followed until values return to normal or to pretreatment levels.

The oritavancin in Kimyrsa has a major potential interaction with Noninfectious Colitis.

Clostridioides difficile-associated diarrhea (CDAD), formerly pseudomembranous colitis, has been reported with almost all antibacterial drugs and may range from mild diarrhea to fatal colitis. The most common culprits include clindamycin and lincomycin. Antibacterial therapy alters the normal flora of the colon, leading to overgrowth of C difficile, whose toxins A and B contribute to CDAD development. Morbidity and mortality are increased with hypertoxin-producing strains of C difficile; these infections can be resistant to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea after antibacterial use. Since CDAD has been reported to occur more than 2 months after antibacterial use, careful medical history is necessary. Therapy with broad-spectrum antibacterials and other agents with significant antibacterial activity should be administered cautiously in patients with history of gastrointestinal disease, particularly colitis; pseudomembranous colitis (generally characterized by severe, persistent diarrhea and severe abdominal cramps, and sometimes associated with the passage of blood and mucus), if it occurs, may be more severe in these patients and may be associated with flares in underlying disease activity. Antibacterial drugs not directed against C difficile may need to be stopped if CDAD is suspected or confirmed. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C difficile, and surgical evaluation should be started as clinically indicated.

The oritavancin in Kimyrsa has a moderate potential interaction with Renal Dysfunction.

No dosage adjustment of oritavancin is needed in patients with mild or moderate renal impairment. Care should be taken when administering oritavancin to patients with severe renal impairment as the pharmacokinetics of this agent have not been evaluated. Oritavancin is not removed from blood by hemodialysis.

Panobinostat has a moderate potential interaction with Renal Dysfunction.

Mild renal impairment to severe renal impairment did not impact the plasma exposure of panobinostat. The use of panobinostat has not been studied in patients with end stage renal disease or patients on dialysis. Care should be exercised when using panobinostat in these patients as the dialyzability of panobinostat is unknown.