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).

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SUPPORT FROM EVERY ANGLE


Amgen Assist 360™ is a single place for patients, caregivers, and healthcare professionals to go to find the support, tools, and resources most important to them.


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Connect with us live:

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Call 1-888-4ASSIST
(1-888-427-7478)

Monday through Friday — 9:00 am to 8:00 pm ET

Office Resources Resources for your office

BENEFITS VERIFICATION Submit, store, and retrieve benefit verifications for all patients currently on Amgen medications electronically with ease from our secure Amgen Assist 360™ Provider Portal.

REIMBURSEMENT COUNSELORS Call an Amgen Reimbursement Counselor directly for your benefit verification needs.

FIELD REIMBURSEMENT SPECIALISTS Schedule a remote or live appointment with a Field Reimbursement Specialist who can assist with:

  • General reimbursement questions, including product coding and billing information
  • Prior authorization and claims denials/appeals
  • Payer-specific inquiries and policy updates
  • Financial assistance, including Amgen FIRST STEP™ co-pay program support

Hands   Amgen Nurse Navigators are available to support your patients*


Patients are connected with a single point of contact who can help them find resources that are most important to them.* Amgen Nurse Navigators are there to support, not replace, your treatment plan and are trained to assist a patient with financial coverage and referrals to resources that may help their emotional wellness throughout their treatment journey.

Financial and co-pay assistance

For eligible commercially insured patients, the Amgen FIRST STEP™ co-pay program can help.

Medication answers

If your patients have questions about their Amgen medication, we can help them get the answers they need.

Referrals to day-to-day living resources

Patients can learn about independent nonprofit organizations that may provide community resources, one-on-one counseling services, and local support groups.

*Resources include referrals to independent nonprofit patient assistance programs. Eligibility for resources provided by independent nonprofit patient assistance programs is based on the nonprofit’s criteria. Amgen has no control over these programs and provides referrals as a courtesy only.

Amgen Nurse Navigators are only available to patients that are prescribed certain products. Nurse Navigators are there to support, not replace, your treatment plan and do not provide medical advice or case management services. Patients should always consult their healthcare provider regarding medical decisions or treatment concerns.

Terms, conditions, and program maximums apply. This program is not open to patients receiving prescription reimbursement under any federal-, state-, or government-funded healthcare program. Not valid where prohibited by law.

Amgen FIRST STEP™

For eligible§ commercially insured patients

Amgen FIRST STEP™ can help your eligible commercially insured patients cover their out-of-pocket prescription costs, including deductible, co-insurance, and co-payment.

  • $0 out-of-pocket for first dose or cycle
  • As little as $5 out-of-pocket for subsequent doses or cycles, up to the brand program benefit maximum
  • No income eligibility requirement

Visit Amgen FIRST STEP™ now

§Terms, conditions, and program maximums apply. This program is not open to patients receiving prescription reimbursement under any federal-, state-, or government-funded healthcare program. Not valid where prohibited by law.

Help your patients enroll today!

Download enrollment form

There are three easy ways to help patients submit their
enrollment form for Amgen Assist 360™


call

Call
1-888-4ASSIST

(1-888-427-7478)

Monday through Friday
9 am to 8 pm ET

call

Call
1-888-4ASSIST

(1-888-427-7478)

Monday through Friday
9 am to 8 pm ET

fax

Fax
1-888-407-9787

mail

Mail
PO Box 220354
Charlotte, NC 28222-9924

Connect with us

Call 1-888-4ASSIST
(1-888-427-7478)
amgenassist360.com

Monday through Friday — 9:00 am to 8:00 pm ET

Dispensing resources

Script fulfillment options

There are multiple ways for patients to receive LUMAKRAS™, depending on their insurance. These options include national specialty pharmacies, dispensing oncology clinics, and others.

mail

National specialty pharmacies

Oncology clinic

Oncology clinics

Distribution and dispensing resources

Download

Pharmacy Fact Sheet

Download

LUMAKRAS™ specialty
pharmacy and distributors list

Patient resources

Download

Click here to download a
brochure for your patients

IMPORTANT SAFETY INFORMATION

Hepatotoxicity

  • LUMAKRAS™ can cause hepatotoxicity, which may lead to drug-induced liver injury and hepatitis.
  • Among 357 patients who received LUMAKRAS™ in CodeBreaK 100, hepatotoxicity occurred in 1.7% (all grades) and 1.4% (Grade 3). A total of 18% of patients who received LUMAKRAS™ had increased alanine aminotransferase (ALT)/increased aspartate aminotransferase (AST); 6% were Grade 3 and 0.6% were Grade 4. In addition to dose interruption or reduction, 5% of patients received corticosteroids for the treatment of hepatotoxicity.
  • Monitor liver function tests (ALT, AST, 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, dose reduce or permanently discontinue LUMAKRAS™ based on severity of adverse reaction.

Interstitial Lung Disease (ILD)/Pneumonitis

  • LUMAKRAS™ can cause ILD/pneumonitis that can be fatal. Among 357 patients who received LUMAKRAS™ in CodeBreaK 100 ILD/pneumonitis occurred in 0.8% of patients, all cases were Grade 3 or 4 at onset, and 1 case was fatal. LUMAKRAS™ was discontinued due to ILD/pneumonitis in 0.6% of 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.

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).


Please see full Prescribing Information.

Important Safety Information

Hepatotoxicity

  • LUMAKRAS™ can cause hepatotoxicity, which may lead to drug-induced liver injury and hepatitis.
  • Among 357 patients who received LUMAKRAS™ in CodeBreaK 100, hepatotoxicity occurred in 1.7% (all grades) and 1.4% (Grade 3). A total of 18% of patients who received LUMAKRAS™ had increased alanine aminotransferase (ALT)/increased aspartate aminotransferase (AST); 6% were Grade 3 and 0.6% were Grade 4. In addition to dose interruption or reduction, 5% of patients received corticosteroids for the treatment of hepatotoxicity.
  • Monitor liver function tests (ALT, AST, 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, dose reduce or permanently discontinue LUMAKRAS™ based on severity of adverse reaction.