Lumakras Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Sotorasib

Indications/Uses

KRAS G12C-mutated locally advanced or metastatic NSCLC in adults who have received at least 1 prior systemic therapy.

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Dosage/Direction for Use

960 mg (8 tab) once daily until disease progression or unacceptable toxicity. 1st dose reduction: 480 mg (4 tab) once daily. 2nd dose reduction: 240 mg (2 tab) once daily. Max: 2 dose reductions.

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Overdosage

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Administration

May be taken with or without food: Swallow whole, do not chew/crush/split. For patients w/ difficulty swallowing, disperse tab in 120 mL of non-carbonated room temp water w/o crushing & stir until dispersed into small pieces. Drink immediately or w/in 2 hr. Rinse glass w/ additional 120 mL of water & drink. Do not chew tab pieces. For NG or PEG tube administration, follow tube's manufacturer's instructions w/ appropriate water flushes.

Special Precautions

Hepatotoxicity leading to drug-induced liver injury & hepatitis. Monitor LFT (ALT, AST & total bilirubin) prior to start, every 3 wk for the 1st 3 mth of treatment, then once a mth. Withhold, reduce dose or permanently discontinue treatment based on severity of adverse reaction. Immediately withhold treatment in patients w/ suspected ILD/pneumonitis & permanently discontinue if no other potential causes of ILD/pneumonitis are identified. Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough, fever). Frequently monitor adverse reactions in patients w/ hepatic impairment. Pregnancy. Not to be used in lactation during treatment & for 1 wk after final dose. Ped patients.

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Use In Pregnancy & Lactation

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Adverse Reactions

Diarrhea, nausea, vomiting, constipation, abdominal pain; hepatotoxicity; cough, dyspnea; musculoskeletal pain, arthralgia; fatigue, edema; decreased appetite; pneumonia; rash. Increased AST, ALT, alkaline phosphatase, urine protein, decreased Ca, Na, albumin; increased aPTT, decreased lymphocytes & Hb.

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Drug Interactions

Decreased conc w/ gastric acid-reducing agents (eg, PPIs, H₂ receptor antagonists & locally acting antacids) & strong CYP3A4 inducers. Decreased plasma conc of CYP3A4 substrate. Increased plasma conc of P-gp (digoxin) & BCRP (rosuvastatin) substrate.

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Storage

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Description

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Action

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MIMS Class

Targeted Cancer Therapy

ATC Classification

L01XX73 - sotorasib ; Belongs to the class of other antineoplastic agents. Used in the treatment of cancer.

Thai FDA Category

Presentation/Packing

Form

Lumakras FC tab 120 mg

Packing/Price

7 × 8's

Lumakras

sotorasib

Manufacturer:

Amgen

Distributor:

Zuellig Pharma