If adverse reactions occur, a maximum of 2 dose reductions are permitted: first dose reduction, 480 mg orally once daily; second dose reduction, 240 mg orally once daily. If the patient cannot tolerate the lowest dose (240 mg orally once daily), discontinue treatment.
Dose Adjustment for Sotorasib Adverse Reactions
1. Interstitial Lung Disease (ILD)/Pneumonitis
Any grade: Suspend dosing if ILD/pneumonitis is suspected; permanently discontinue Sotorasib if ILD/pneumonitis is confirmed.
2. Nausea or Vomiting (despite appropriate supportive care)
Grade 3-4: Withhold Sotorasib until recovery to Grade 1 or less or baseline; resume at a reduced dose level.
3. Diarrhea (despite appropriate supportive care)
Grade 3-4: Withhold Sotorasib until recovery to Grade 1 or less or baseline; resume at a reduced dose level.
4. Other Grade 3-4 Adverse Reactions
Withhold Sotorasib until recovery to Grade 1 or less or baseline; resume at a reduced dose level.
Precautions
1. Safety and efficacy have not been established in patients under 18 years of age.
2. Coadministration with acid-reducing agents: Avoid concomitant use of Sotorasib with proton pump inhibitors and H₂ receptor antagonists; if an acid-reducing agent cannot be avoided, administer Sotorasib 4 hours before or 10 hours after administration of a local antacid.
Storage Requirements
Store Sotorasib at 20°C-25°C (68°F-77°F); excursions permitted between 15°C-30°C (59°F-86°F).
Monitoring Recommendations
1. Hepatic monitoring: Before treatment, every 3 weeks for the first 3 months of treatment, then monthly or as clinically indicated; increase monitoring frequency in patients with elevated transaminases and/or bilirubin.
2. Respiratory monitoring: Monitor for new or worsening pulmonary symptoms (suggestive of ILD/pneumonitis).
Patient Information
Read the FDA-approved patient labeling (Medication Guide) for Sotorasib.
Contact your healthcare provider immediately if you experience symptoms of hepatic dysfunction or new/worsening respiratory symptoms.
Do not breastfeed during Sotorasib treatment and for 1 week after the last dose.
Avoid concomitant use of Sotorasib with proton pump inhibitors and H₂ receptor antagonists; if an acid-reducing agent cannot be avoided, administer Sotorasib 4 hours before or 10 hours after administration of a local antacid.
If a dose of Sotorasib is missed by more than 6 hours, resume the next dose as scheduled on the following day.
