Alecensa (Alectinib)

Brand Name

Alecensa

Generic Name

Alectinib

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FDA approval date: December 11, 2015

Classification: Kinase Inhibitor

Form: Capsule

What is Alecensa (Alectinib)?

ALECENSA is a kinase inhibitor indicated for: adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase -positive non-small cell lung cancer as detected by an FDA-approved test.

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Brand Information

ALECENSA (ALECTINIB HYDROCHLORIDE)

1DOSAGE FORMS AND STRENGTHS

150 mg hard capsules, white, with "ALE" printed in black ink on the cap and "150 mg" printed in black ink on the body.

2CONTRAINDICATIONS

None.

3ADVERSE REACTIONS

The following adverse reactions are discussed in greater detail in other sections of the label:

Hepatotoxicity
Interstitial Lung Disease (ILD)/Pneumonitis
Renal Impairment
Bradycardia
Severe Myalgia and Creatine Phosphokinase (CPK) Elevation
Hemolytic Anemia
Embryo-Fetal Toxicity

3.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The pooled safety population described in the WARNINGS AND PRECAUTIONS reflect exposure to ALECENSA as a single agent at 600 mg orally twice daily in 533 patients in Studies NP28761, NP28673, ALEX and ALINA

4OVERDOSAGE

No experience with overdose is available. There is no specific antidote for overdose with ALECENSA. Alectinib and its major active metabolite M4 are > 99% bound to plasma proteins; therefore, hemodialysis is likely to be ineffective in the treatment of overdose.

5DESCRIPTION

ALECENSA (alectinib) is a kinase inhibitor for oral administration. The molecular formula for alectinib is C

Alectinib HCl is a white to yellow white powder or powder with lumps with a pKa of 7.05 (base).

ALECENSA is supplied as hard capsules containing 150 mg of alectinib (equivalent to 161.33 mg alectinib HCl) and the following inactive ingredients: lactose monohydrate, hydroxypropylcellulose, sodium lauryl sulfate, magnesium stearate, and carboxymethylcellulose calcium. The capsule shell contains hypromellose, carrageenan, potassium chloride, titanium dioxide, corn starch, and carnauba wax. The printing ink contains red iron oxide (E172), yellow iron oxide (E172), FD&C Blue No. 2 aluminum lake (E132), carnauba wax, white shellac, and glyceryl monooleate.

6HOW SUPPLIED/STORAGE AND HANDLING

Hard capsules, white 150 mg capsules with "ALE" printed in black ink on the cap and "150 mg" printed in black ink on the body, available in:

7PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Inform patients of the following:

8PRINCIPAL DISPLAY PANEL - 150 mg Capsule Bottle Carton

NDC 50242-130-01

Alecensa

150 mg

Each capsule contains 150 mg of alectinib

Rx only

240 capsules

Genentech

11008914

PRINCIPAL DISPLAY PANEL - 150 mg Capsule Bottle Carton