| TRAE . | Management strategies . |
|---|---|
| Diarrhea | Diarrhea prevention • Dietary modifications (eg, eating small meals and avoiding greasy or spicy food, milk, caffeine, and alcohol) Diarrhea management • B-R-A-T diet (bananas, rice, apple sauce, toast/decaffeinated tea) • Maintaining of fluids (6-8 large glasses of water, clear liquids, or soup per day) • Treatment with anti-diarrheals, such as diphenoxylate-atropine • Treatment with loperamide orally at low doses for patients without underlying bradycardia, CHF, or congenital long QT syndrome due to risk of Torsades de Pointes ◦ Monitor potassium and magnesium levels and supplement if below the reference range ◦ Perform regular ECGs • Dose modifications (Table 5) |
| Nausea and vomiting | • Administering the tablet formulation of adagrasib with food • Eating smaller, more frequent meals • Maintaining liquids • Monitoring electrolytes and supplementing as required • Engagement of dietician • For chronic nausea/vomiting: anti-emetics appropriate for the patient; choice of anti-emetic should be determined by patient-specific factors, and tolerability of anti-emetic side effects ◦ Treatment with ondansetron up to 4 mg every 6 hours (maximum total daily dose of 16 mg) for patients without underlying bradycardia, CHF, or congenital long QT syndrome ◦ Monitor potassium and magnesium levels and supplement if below the reference range ◦ Perform regular ECGs • For acute nausea/vomiting: treatment with 5-HT3 receptor antagonists (including palonosetron) and a short course of dexamethasone, or NK1 receptor antagonists • For refractory nausea/vomiting: treatment with olanzapine • For patients who take medications for gastric acidity, consideration should be given around the concomitant use of proton pump inhibitors (PPIs) due to a potential decrease in exposure of adagrasib ◦ Antacids or H2 blockers may be used instead • Dose modifications (Table 5) |
| Fatigue | • Exercising (taking plenty of breaks) • Staying hydrated • Keeping a normal sleep routine • Assessing potential contributing factors • Treatment with medications such as methylphenidate and modafinil (may decrease appetite so patients should be monitored) • Dose modifications (Table 5) |
| ALT/AST/alkaline phosphatase increase | • Monitoring liver enzymes regularly during treatment (every month for 3 months if the patient does not experience abnormalities) • Evaluating contributing factors • For significant hepatotoxicity, treatment with glucocorticoids can be considered • Dose modifications (Table 5) |
| Electrocardiogram QTc prolongation | • Managing electrolyte deficiencies (eg, potassium, magnesium, etc.) • Baseline ECGs and additional monitoring as clinically indicated (including in patients with symptomatic QT prolongation) • Dose modifications (Table 5) • Further information source: Credible Meds (https://www.crediblemeds.org/everyone) |
| Blood creatinine increase | • Assessing volume status and applying a low threshold for fluid replacement • Monitoring blood creatinine levels regularly during treatment (every month for 3 months if the patient does not experience abnormalities) • Nonsteroidal anti-inflammatory drugs (such as ibuprofen for pain) should be avoided or used with caution when creatinine is elevated • Dose modifications (Table 5) |
| TRAE . | Management strategies . |
|---|---|
| Diarrhea | Diarrhea prevention • Dietary modifications (eg, eating small meals and avoiding greasy or spicy food, milk, caffeine, and alcohol) Diarrhea management • B-R-A-T diet (bananas, rice, apple sauce, toast/decaffeinated tea) • Maintaining of fluids (6-8 large glasses of water, clear liquids, or soup per day) • Treatment with anti-diarrheals, such as diphenoxylate-atropine • Treatment with loperamide orally at low doses for patients without underlying bradycardia, CHF, or congenital long QT syndrome due to risk of Torsades de Pointes ◦ Monitor potassium and magnesium levels and supplement if below the reference range ◦ Perform regular ECGs • Dose modifications (Table 5) |
| Nausea and vomiting | • Administering the tablet formulation of adagrasib with food • Eating smaller, more frequent meals • Maintaining liquids • Monitoring electrolytes and supplementing as required • Engagement of dietician • For chronic nausea/vomiting: anti-emetics appropriate for the patient; choice of anti-emetic should be determined by patient-specific factors, and tolerability of anti-emetic side effects ◦ Treatment with ondansetron up to 4 mg every 6 hours (maximum total daily dose of 16 mg) for patients without underlying bradycardia, CHF, or congenital long QT syndrome ◦ Monitor potassium and magnesium levels and supplement if below the reference range ◦ Perform regular ECGs • For acute nausea/vomiting: treatment with 5-HT3 receptor antagonists (including palonosetron) and a short course of dexamethasone, or NK1 receptor antagonists • For refractory nausea/vomiting: treatment with olanzapine • For patients who take medications for gastric acidity, consideration should be given around the concomitant use of proton pump inhibitors (PPIs) due to a potential decrease in exposure of adagrasib ◦ Antacids or H2 blockers may be used instead • Dose modifications (Table 5) |
| Fatigue | • Exercising (taking plenty of breaks) • Staying hydrated • Keeping a normal sleep routine • Assessing potential contributing factors • Treatment with medications such as methylphenidate and modafinil (may decrease appetite so patients should be monitored) • Dose modifications (Table 5) |
| ALT/AST/alkaline phosphatase increase | • Monitoring liver enzymes regularly during treatment (every month for 3 months if the patient does not experience abnormalities) • Evaluating contributing factors • For significant hepatotoxicity, treatment with glucocorticoids can be considered • Dose modifications (Table 5) |
| Electrocardiogram QTc prolongation | • Managing electrolyte deficiencies (eg, potassium, magnesium, etc.) • Baseline ECGs and additional monitoring as clinically indicated (including in patients with symptomatic QT prolongation) • Dose modifications (Table 5) • Further information source: Credible Meds (https://www.crediblemeds.org/everyone) |
| Blood creatinine increase | • Assessing volume status and applying a low threshold for fluid replacement • Monitoring blood creatinine levels regularly during treatment (every month for 3 months if the patient does not experience abnormalities) • Nonsteroidal anti-inflammatory drugs (such as ibuprofen for pain) should be avoided or used with caution when creatinine is elevated • Dose modifications (Table 5) |
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; ECG, electrocardiogram; QTc, QT corrected interval; TRAE, treatment-related adverse event.
| TRAE . | Management strategies . |
|---|---|
| Diarrhea | Diarrhea prevention • Dietary modifications (eg, eating small meals and avoiding greasy or spicy food, milk, caffeine, and alcohol) Diarrhea management • B-R-A-T diet (bananas, rice, apple sauce, toast/decaffeinated tea) • Maintaining of fluids (6-8 large glasses of water, clear liquids, or soup per day) • Treatment with anti-diarrheals, such as diphenoxylate-atropine • Treatment with loperamide orally at low doses for patients without underlying bradycardia, CHF, or congenital long QT syndrome due to risk of Torsades de Pointes ◦ Monitor potassium and magnesium levels and supplement if below the reference range ◦ Perform regular ECGs • Dose modifications (Table 5) |
| Nausea and vomiting | • Administering the tablet formulation of adagrasib with food • Eating smaller, more frequent meals • Maintaining liquids • Monitoring electrolytes and supplementing as required • Engagement of dietician • For chronic nausea/vomiting: anti-emetics appropriate for the patient; choice of anti-emetic should be determined by patient-specific factors, and tolerability of anti-emetic side effects ◦ Treatment with ondansetron up to 4 mg every 6 hours (maximum total daily dose of 16 mg) for patients without underlying bradycardia, CHF, or congenital long QT syndrome ◦ Monitor potassium and magnesium levels and supplement if below the reference range ◦ Perform regular ECGs • For acute nausea/vomiting: treatment with 5-HT3 receptor antagonists (including palonosetron) and a short course of dexamethasone, or NK1 receptor antagonists • For refractory nausea/vomiting: treatment with olanzapine • For patients who take medications for gastric acidity, consideration should be given around the concomitant use of proton pump inhibitors (PPIs) due to a potential decrease in exposure of adagrasib ◦ Antacids or H2 blockers may be used instead • Dose modifications (Table 5) |
| Fatigue | • Exercising (taking plenty of breaks) • Staying hydrated • Keeping a normal sleep routine • Assessing potential contributing factors • Treatment with medications such as methylphenidate and modafinil (may decrease appetite so patients should be monitored) • Dose modifications (Table 5) |
| ALT/AST/alkaline phosphatase increase | • Monitoring liver enzymes regularly during treatment (every month for 3 months if the patient does not experience abnormalities) • Evaluating contributing factors • For significant hepatotoxicity, treatment with glucocorticoids can be considered • Dose modifications (Table 5) |
| Electrocardiogram QTc prolongation | • Managing electrolyte deficiencies (eg, potassium, magnesium, etc.) • Baseline ECGs and additional monitoring as clinically indicated (including in patients with symptomatic QT prolongation) • Dose modifications (Table 5) • Further information source: Credible Meds (https://www.crediblemeds.org/everyone) |
| Blood creatinine increase | • Assessing volume status and applying a low threshold for fluid replacement • Monitoring blood creatinine levels regularly during treatment (every month for 3 months if the patient does not experience abnormalities) • Nonsteroidal anti-inflammatory drugs (such as ibuprofen for pain) should be avoided or used with caution when creatinine is elevated • Dose modifications (Table 5) |
| TRAE . | Management strategies . |
|---|---|
| Diarrhea | Diarrhea prevention • Dietary modifications (eg, eating small meals and avoiding greasy or spicy food, milk, caffeine, and alcohol) Diarrhea management • B-R-A-T diet (bananas, rice, apple sauce, toast/decaffeinated tea) • Maintaining of fluids (6-8 large glasses of water, clear liquids, or soup per day) • Treatment with anti-diarrheals, such as diphenoxylate-atropine • Treatment with loperamide orally at low doses for patients without underlying bradycardia, CHF, or congenital long QT syndrome due to risk of Torsades de Pointes ◦ Monitor potassium and magnesium levels and supplement if below the reference range ◦ Perform regular ECGs • Dose modifications (Table 5) |
| Nausea and vomiting | • Administering the tablet formulation of adagrasib with food • Eating smaller, more frequent meals • Maintaining liquids • Monitoring electrolytes and supplementing as required • Engagement of dietician • For chronic nausea/vomiting: anti-emetics appropriate for the patient; choice of anti-emetic should be determined by patient-specific factors, and tolerability of anti-emetic side effects ◦ Treatment with ondansetron up to 4 mg every 6 hours (maximum total daily dose of 16 mg) for patients without underlying bradycardia, CHF, or congenital long QT syndrome ◦ Monitor potassium and magnesium levels and supplement if below the reference range ◦ Perform regular ECGs • For acute nausea/vomiting: treatment with 5-HT3 receptor antagonists (including palonosetron) and a short course of dexamethasone, or NK1 receptor antagonists • For refractory nausea/vomiting: treatment with olanzapine • For patients who take medications for gastric acidity, consideration should be given around the concomitant use of proton pump inhibitors (PPIs) due to a potential decrease in exposure of adagrasib ◦ Antacids or H2 blockers may be used instead • Dose modifications (Table 5) |
| Fatigue | • Exercising (taking plenty of breaks) • Staying hydrated • Keeping a normal sleep routine • Assessing potential contributing factors • Treatment with medications such as methylphenidate and modafinil (may decrease appetite so patients should be monitored) • Dose modifications (Table 5) |
| ALT/AST/alkaline phosphatase increase | • Monitoring liver enzymes regularly during treatment (every month for 3 months if the patient does not experience abnormalities) • Evaluating contributing factors • For significant hepatotoxicity, treatment with glucocorticoids can be considered • Dose modifications (Table 5) |
| Electrocardiogram QTc prolongation | • Managing electrolyte deficiencies (eg, potassium, magnesium, etc.) • Baseline ECGs and additional monitoring as clinically indicated (including in patients with symptomatic QT prolongation) • Dose modifications (Table 5) • Further information source: Credible Meds (https://www.crediblemeds.org/everyone) |
| Blood creatinine increase | • Assessing volume status and applying a low threshold for fluid replacement • Monitoring blood creatinine levels regularly during treatment (every month for 3 months if the patient does not experience abnormalities) • Nonsteroidal anti-inflammatory drugs (such as ibuprofen for pain) should be avoided or used with caution when creatinine is elevated • Dose modifications (Table 5) |
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; ECG, electrocardiogram; QTc, QT corrected interval; TRAE, treatment-related adverse event.
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