Alectinib

What is Alectinib?

Alectinib ALECENSA is a kinase inhibitor used to treat ALK-positive lung cancer.

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What are the uses of this medicine?

This medicine is used to treat people with non-small cell lung cancer (NSCLC):

• that is caused by an abnormal anaplastic lymphoma kinase (ALK) gene, and
• that has spread to other parts of your body

How does this medicine work?

• Alectinib (al ek' ti nib) is a small molecule tyrosine kinase receptor inhibitor with potent activity against anaplastic lymphoma kinase (ALK) that is rearranged and mutated in slective cancers, including approximately 5% of non-small cell lung cancer (NSCLC).
• The mutated, rearranged ALK promotes unregulated cell growth and proliferation and is sometimes overexpressed in cancer cells.
• Alectinib has been found to inhibit mutated ALK in cell culture and in several clinical trials was found to induce objective responses in a proportion of patients with refractory, advanced NSCLC that are ALK-positive.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No clinically important drug interactions have been observed with ALECENSA.

Is this medicine FDA approved?

• It was approved for use in the United States in 2015.

How should this medicine be used?

• Select patients for the treatment of metastatic NSCLC with ALECENSA based on the presence of ALK positivity in tumor tissue or plasma specimens.

Recommended Dosage:

• The recommended dose of ALECENSA is 600 mg orally twice daily.
• The recommended dose of ALECENSA in patients with severe hepatic impairment (Child-Pugh C) is 450 mg orally twice daily.

Administration

• Take ALECENSA exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking ALECENSA unless your healthcare provider tells you to.
• Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with ALECENSA if you have side effects.
• Take ALECENSA 2 times a day.
• Take ALECENSA with food.
• Swallow ALECENSA capsules whole. Do not open or dissolve the capsule contents.
• If you miss a dose of ALECENSA, do not take the missed dose. Take your next dose at your regular time.
• If you vomit after taking a dose of ALECENSA, do not take an extra dose. Take your next dose at your regular time.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsules: 150 mg

This medicine is available in fallowing brand namesː

• ALECENSA

What side effects can this medication cause?

The most common side effects of this medicine include:

• tiredness
• constipation
• swelling in your hands, feet, ankles, face and eyelids
• muscle pain, tenderness, and weakness (myalgia).
• anemia

ALECENSA may cause serious side effects, including:

• Liver problems (hepatotoxicity)
• Lung problems
• Kidney problems
• Slow heartbeat (bradycardia)
• Muscle pain, tenderness, and weakness (myalgia)

What special precautions should I follow?

• Hepatotoxicity may occur. Monitor liver laboratory 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. In case of severe ALT, AST, or bilirubin elevations, withhold, then reduce dose, or permanently discontinue ALECENSA.
• ILD/pneumonitis occurred in three (0.7%) patients treated with ALECENSA. 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 occurred in 8% of patients treated with ALECENSA. Withhold ALECENSA for severe renal impairment, then resume ALECENSA at reduced dose upon recovery or permanently discontinue.
• Symptomatic bradycardia can occur with ALECENSA. Monitor heart rate and blood pressure regularly. If symptomatic, withhold ALECENSA then reduce dose, or permanently discontinue.
• Severe myalgia and creatine phosphokinase (CPK) elevation may occur. Assess CPK every 2 weeks during the first month of treatment and in patients reporting unexplained muscle pain, tenderness, or weakness. In case of severe CPK elevations, withhold, then resume or reduce dose.
• ALECENSA can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

What to do in case of emergency/overdose?

• No experience with overdose is available.

Management of overdosage:

• 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.

Can this medicine be used in pregnancy?

• ALECENSA can cause fetal harm when administered to a pregnant woman.
• There are no available data on ALECENSA use in pregnant women.

Can this medicine be used in children?

• The safety and effectiveness of ALECENSA in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: alectinib
• Inactive ingredients: lactose monohydrate, hydroxypropylcellulose, sodium lauryl sulfate, magnesium stearate and carboxymethylcellulose calcium. Capsule shell contains: hypromellose, carrageenan, potassium chloride, titanium dioxide, corn starch, and carnauba wax. 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.

Who manufactures and distributes this medicine?

• Distributed by: Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco

ALECENSA® is a registered trademark of Chugai Pharmaceutical Co., Ltd., Tokyo, Japan

What should I know about storage and disposal of this medication?

• Do not store ALECENSA at temperatures above 86°F (30°C).
• Store ALECENSA capsules in the original container.
• Keep ALECENSA capsules dry and away from light.
• Keep ALECENSA and all medicines out of the reach of children.

• Dailymed label info on Alectinib
• FDA Alectinib

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