Non-small Cell Lung Cancer (NSCLC)

TYPE CODE DESCRIPTION

Diagnosis: ICD-10-CM

C33 Malignant neoplasm of trachea

C34.00–C34.02 Malignant neoplasm of bronchus and lung; main bronchus

C34.10–C34.12 Malignant neoplasm of bronchus and lung; upper lobe

C34.2 Malignant neoplasm of bronchus and lung; middle lobe

C34.30–C34.32 Malignant neoplasm of bronchus and lung; lower lobe

C34.80–C34.82 Malignant neoplasm of bronchus and lung; overlapping sites

C34.90–C34.92 Malignant neoplasm of bronchus and lung; unspecified part

Drug: NDC

Note: Payer requirements regarding use of a 10-digit or 11-digit NDC may vary. Both formats are listed here for your reference.

10-digit 11-digit

50242-130-01 50242-0130-01 150 mg (240 capsules)

ICD-10-CM=International Classification of Diseases, 10th Revision, Clinical Modification; NDC=National Drug Code.

INDICATION & IMPORTANT SAFETY INFORMATION IndicationALECENSA is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (mNSCLC) as detected by an FDA-approved test.

Important Safety InformationHepatotoxicity: Monitor liver function tests every 2 weeks during the first 3 months of treatment, then once a month and as clinically indicated, with more frequent testing in patients who develop transaminase and bilirubin elevations. Based on the severity of the adverse reaction, withhold then dose reduce, or permanently discontinue ALECENSA.

Interstitial Lung Disease (ILD)/Pneumonitis: ILD/pneumonitis occurred in 0.7% of patients. Immediately withhold ALECENSA in patients diagnosed with ILD/pneumonitis and permanently discontinue if no other potential causes of ILD/pneumonitis have been identified.

Renal Impairment: Renal impairment occurred in 8% of patients. Incidence of Grade ≥3 was 1.7%, of which 0.5% were fatal events. Based on the severity of the adverse reaction, withhold then dose reduce, or permanently discontinue ALECENSA.

Bradycardia: Monitor heart rate and blood pressure regularly. If symptomatic, withhold ALECENSA then dose reduce or permanently discontinue.

Severe Myalgia and Creatine Phosphokinase (CPK) Elevation: Advise patients to report any unexplained muscle pain, tenderness, or weakness. Assess CPK levels every 2 weeks for the first month of treatment and as clinically indicated in patients reporting symptoms. Based on the severity of the CPK elevation, withhold, then resume or dose reduce ALECENSA.

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SAMPLE CODING

Please see additional Important Safety Information in full Prescribing Information.

These codes are not all-inclusive; appropriate codes can vary by patient, setting of care and payer. Correct coding is the responsibility of the provider submitting the claim for the item or service. Please check with the payer to verify codes and special billing requirements. Genentech does not make any representation or guarantee concerning reimbursement or coverage for any service or item.

Many payers will not accept unspecified codes. If you use an unspecified code, please check with your payer.

Important Safety Information (cont) Embryo-Fetal Toxicity: ALECENSA can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with ALECENSA and for 1 week following the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with ALECENSA and for 3 months following the final dose.

Most Common Adverse Reactions: The most common adverse reactions (incidence ≥20%) were constipation (34%), fatigue (26%), myalgia (23%), edema (22%), and anemia (20%).

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please see additional Important Safety Information in full Prescribing Information.

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ALECENSA® and its logo are registered trademarks of Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.The Access Solutions logo are registered trademarks of Genentech, Inc.

© 2019 Genentech USA, Inc. So. San Francisco, CA All rights reserved. ACS/072419/0063 08/19

Please see additional Important Safety Information in full Prescribing Information.