Interactions between Asciminib and Sorafenib
1 drug interaction and 7 additional warnings found for the following 2 drugs:
- asciminib
- sorafenib
Drug interactions
Moderate drug interactions
Moderate:
SORAfenib asciminib
Applies to: sorafenib and asciminib
Monitor
It is uncertain whether asciminib causes clinically significant prolongation of the QT interval of the electrocardiogram. In clinical studies, prolongation of the Fridericia-corrected QT interval (QTcF) was reported in 3 of 356 (0.8%) of patients, with one report of QTcF greater than 500 msec together with more than 60 msec QTcF increase from baseline. Asciminib is not reported to prolong the corrected QT (QTc) interval by greater than 20 msec at the maximum recommended clinical dosage (200 mg twice daily); however, a prolongation of up to 10 msec cannot be excluded. In general, the risk of an individual agent or a combination of agents causing ventricular arrhythmia in association with QT prolongation is largely unpredictable but may be increased by certain underlying risk factors such as congenital long QT syndrome, cardiac disease, and electrolyte disturbances (e.g., hypokalemia, hypomagnesemia, hypocalcemia). Moreover, the extent of drug-induced QT prolongation is dependent on the particular drug(s) involved and dosage(s) of the drug(s).
Management
Some authorities recommend caution and clinical monitoring when asciminib is used with drugs that are known to cause QT interval prolongation. An ECG should be obtained at baseline and during treatment as clinically indicated, particularly in patients with a history of cardiac arrhythmias, uncontrolled or significant cardiac disease (including bradycardia), or congenital or family history of long QT syndrome. Serum electrolytes, including potassium and magnesium should also be corrected prior to starting asciminib therapy and monitored during treatment as clinically indicated. Patients should be advised to seek prompt medical attention if they experience symptoms that indicate the occurrence of torsade de pointes such as dizziness, lightheadedness, fainting, palpitation, irregular heart rhythm, shortness of breath, or syncope.
References (2)
- (2021) "Product Information. Scemblix (asciminib)." Novartis Pharmaceuticals
- (2022) "Product Information. Scemblix (asciminib)." Novartis Pharmaceuticals UK Ltd, Scemblix 20 mg film-
Food/lifestyle interactions
Moderate food/lifestyle interactions
Moderate:
SORAfenib Food/Lifestyle
Applies to: sorafenib
Adjust dosing interval
Food may reduce the oral absorption and bioavailability of sorafenib. According to the product labeling, sorafenib bioavailability was reduced by 29% when administered with a high-fat meal compared to administration in the fasted state. When given with a moderate-fat meal, bioavailability was similar to that in the fasted state.
Management
To ensure maximal and consistent oral absorption, sorafenib should be taken at least one hour before or two hours after eating.
References (1)
- (2005) "Product Information. Nexavar (sorafenib)." Bayer Pharmaceutical Inc
Moderate:
asciminib Food/Lifestyle
Applies to: asciminib
Adjust dosing interval
Food may reduce the oral bioavailability of asciminib. When a single 40 mg dose of asciminib was administered with a low-fat meal (400 calories; 25% fat) in healthy volunteers, asciminib peak plasma concentration (Cmax) and systemic exposure (AUC) decreased by 35% and 30%, respectively, compared to asciminib administered in the fasted state. Administration with a high-fat meal (1000 calories; 50% fat) decreased the Cmax and AUC of asciminib by 68% and 62%, respectively.
Management
To ensure adequate asciminib exposures, food consumption should be avoided for at least 2 hours before and 1 hour after taking asciminib.
References (2)
- (2021) "Product Information. Scemblix (asciminib)." Novartis Pharmaceuticals
- (2022) "Product Information. Scemblix (asciminib)." Novartis Pharmaceuticals UK Ltd, Scemblix 20 mg film-
Disease interactions
5 potential interactions Applies to: 5 conditions, including High Blood Pressure, Pancreatitis, Interstitial Lung Disease, Cardiovascular Conditions and Disorders, and Pulmonary Impairment.
Cardiovascular Conditions and Disorders
Major:
asciminib
Asciminib has a major potential interaction with Cardiovascular Conditions and Disorders.
Cardiovascular toxicity has been reported with asciminib in patients with preexisting cardiovascular conditions or risk factors for cardiovascular disease. Reports of cardiovascular toxicity have included ischemia, arterial thrombotic and embolic conditions, and cardiac failure. Arrhythmia, including QTc prolongation, has been reported. Monitor patients with history of cardiovascular risk factors for cardiovascular signs and symptoms. Treat as clinically indicated. For cardiovascular toxicity, temporarily withhold, reduce dose, or permanently discontinue therapy, based on persistence of cardiovascular toxicity.
High Blood Pressure
Moderate:
asciminib
Asciminib has a moderate potential interaction with High Blood Pressure.
The use of asciminib may cause hypertension. Blood pressure should be well-controlled prior to initiating asciminib and treated as needed with standard anti-hypertensive therapy. For persistent hypertension despite anti-hypertensive medications, temporarily withhold, reduce dose, or permanently discontinue therapy, based on the persistence of hypertension.
Interstitial Lung Disease
Moderate:
sorafenib
SORAfenib has a moderate potential interaction with Interstitial Lung Disease.
The use of certain multikinase inhibitors has been associated with pulmonary toxicity. Serious cases of interstitial lung disease (ILD), including fatal cases and interstitial pneumonitis or pulmonary fibrosis have been reported. Caution is recommended when using these agents in patients with a history of interstitial pneumonitis or pulmonary fibrosis or those patients presenting with acute onset of new or progressive unexplained pulmonary symptoms such as dyspnea, cough, and fever pending diagnostic evaluation. If ILD is confirmed, these agents should be permanently discontinued and appropriate measures should be instituted. Treatment should be immediately withheld in patients diagnosed with ILD/pneumonitis and permanently discontinued if no other potential causes of ILD/pneumonitis have been identified.
Pancreatitis
Major:
asciminib
Asciminib has a major potential interaction with Pancreatitis.
Asciminib can cause increases in serum lipase. Patients with a previous history of pancreatitis might be at increased risk and should be monitored carefully for lipase elevations and any abdominal symptoms. Serum lipase should be monitored monthly and as clinically indicated. If lipase and amylase elevations are accompanied by abdominal symptoms, hold therapy, and rule out pancreatitis.
Pulmonary Impairment
Moderate:
sorafenib
SORAfenib has a moderate potential interaction with Pulmonary Impairment.
The use of certain multikinase inhibitors has been associated with pulmonary toxicity. Serious cases of interstitial lung disease (ILD), including fatal cases and interstitial pneumonitis or pulmonary fibrosis have been reported. Caution is recommended when using these agents in patients with a history of interstitial pneumonitis or pulmonary fibrosis or those patients presenting with acute onset of new or progressive unexplained pulmonary symptoms such as dyspnea, cough, and fever pending diagnostic evaluation. If ILD is confirmed, these agents should be permanently discontinued and appropriate measures should be instituted. Treatment should be immediately withheld in patients diagnosed with ILD/pneumonitis and permanently discontinued if no other potential causes of ILD/pneumonitis have been identified.
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More resources
asciminib
A total of 773 drugs are known to interact with asciminib.
- Asciminib is in the drug class BCR-ABL tyrosine kinase inhibitors.
- Asciminib is used to treat Chronic Myelogenous Leukemia.
sorafenib
A total of 451 drugs are known to interact with sorafenib.
- Sorafenib is in the following drug classes: multikinase inhibitors, VEGF/VEGFR inhibitors.
- Sorafenib is used to treat the following conditions:
Drug Interaction Classification
| Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit. | |
| Moderately clinically significant. Usually avoid combinations; use it only under special circumstances. | |
| 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. | |
| No interaction information available. |
Further information
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