08/18/2025

Discontinuation of Amgen's 120 mg and 320 mg LUMAKRAS® (sotorasib) Tablets

For your awareness, Amgen has decided to discontinue the 120 mg and 320 mg tablet strength options of LUMAKRAS^®, effective December 31, 2025. However, due to high demand, supply of the 120 mg and 320 mg tablets cannot be guaranteed after September 2025. Please note that this is NOT a recall and does not relate to LUMAKRAS^® drug product, efficacy, or patient safety.

The LUMAKRAS^® 240 mg tablet remains available, and Amgen has sufficient product to meet the demand of patients who need to transition from the other tablet strengths. Beginning in January 2026, LUMAKRAS^® 240 mg will be the only tablet strength commercially available.

A new prescription and/or prior authorization will likely be required. We are recommending healthcare professionals begin proactively transitioning patients to help maintain continuity of therapy and avoid any gap in treatment.

PRODUCT UPDATE:

NO CHANGES:

* Provided with child-resistant closure

Given the similar appearance of tablets, it is important to reinforce the change in tablet strength with patients to help avoid any potential confusion and support taking a correct dose. As a reminder, 960mg once-daily remains the FDA-confirmed starting dose for LUMAKRAS^®. Treat until disease progression or unacceptable toxicity.¹

If you need more information, please do not hesitate to contact me or Amgen MedInfo at medicalinformation@amgen.com.

Additionally, you may direct your patients to Amgen SupportPlus for questions: (866) 264-2778 or AmgenSupportPlus.com.

INDICATION & IMPORTANT SAFETY INFORMATION

Indication
LUMAKRAS^® is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.

This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Important Safety Information

Hepatotoxicity
LUMAKRAS^® can cause hepatotoxicity and increased ALT or AST which may lead to drug-induced liver injury and hepatitis.

• In the pooled safety population of NSCLC patients who received single agent LUMAKRAS^® 960 mg hepatotoxicity occurred in 27% of patients, of which 16% were Grade ≥ 3. Among patients with hepatotoxicity who required dosage modifications, 64% required treatment with corticosteroids.
• In this pooled safety population of NSCLC patients who received single agent LUMAKRAS^® 960 mg, 17% of patients who received LUMAKRAS^® had increased alanine aminotransferase (ALT)/increased aspartate aminotransferase (AST); of which 9% were Grade ≥ 3. The median time to first onset of increased ALT/AST was 6.3 weeks (range: 0.4 to 42). Increased ALT/AST leading to dose interruption or reduction occurred in 9% of patients treated with LUMAKRAS^®. LUMAKRAS^® was permanently discontinued due to increased ALT/AST in 2.7% of patients. Drug-induced liver injury occurred in 1.6% (all grades) including 1.3% (Grade ≥ 3).
• In this pooled safety population of NSCLC patients who received single agent LUMAKRAS^® 960 mg, a total of 40% patients with recent (≤ 3 months) immunotherapy prior to starting LUMAKRAS^® had an event of hepatotoxicity. An event of hepatotoxicity was observed in 18% of patients who started LUMAKRAS^® more than 3 months after last dose of immunotherapy and in 17% of those who never received immunotherapy. Regardless of time from prior immunotherapy, 94% of hepatotoxicity events improved or resolved with dosage modification of LUMAKRAS^®, with or without corticosteroid treatment.
• Monitor liver function tests (ALT, AST, alkaline phosphatase and total bilirubin) prior to the start of LUMAKRAS^®, every 3 weeks for the first 3 months of treatment, then once a month or as clinically indicated, with more frequent testing in patients who develop transaminase and/or bilirubin elevations. Withhold, reduce the dose or permanently discontinue LUMAKRAS^® based on severity of the adverse reaction. Consider administering systemic corticosteroids for the management of hepatotoxicity.

Interstitial Lung Disease (ILD)/Pneumonitis

• LUMAKRAS^® can cause ILD/pneumonitis that can be fatal.
• In the pooled safety population of NSCLC patients who received single agent LUMAKRAS^® 960 mg ILD/pneumonitis occurred in 2.2% of patients, of which 1.1% were Grade ≥ 3, and 1 case was fatal. The median time to first onset for ILD/pneumonitis was 8.6 weeks (range: 2.1 to 36.7 weeks). LUMAKRAS^® was permanently discontinued due to ILD/pneumonitis in 1.3% of LUMAKRAS^®-treated patients. Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold LUMAKRAS^® in patients with suspected ILD/pneumonitis and permanently discontinue LUMAKRAS^® if no other potential causes of ILD/pneumonitis are identified.

Most Common Adverse Reactions

• The most common adverse reactions ≥ 20% were diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity, and cough.

Drug Interactions

• Advise patients to inform their healthcare provider of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, dietary and herbal products.
• Inform patients to avoid proton pump inhibitors and H2 receptor antagonists while taking LUMAKRAS^®.
• If coadministration with an acid-reducing agent cannot be avoided, inform patients to take LUMAKRAS^® 4 hours before or 10 hours after a locally acting antacid.

Please click here for full Prescribing Information.