Lumakras: Side Effects & Dosing

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Warnings Special Precautions Use In Pregnancy & Lactation Adverse Reactions Side Effects Drug Interactions Caution For Usage Storage Patient Counseling Information 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. In combination w/ panitumumab in adults w/ KRAS G12C‑mutated mCRC who have received prior fluoropyrimidine, oxaliplatin & irinotecan‑based chemotherapy.

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Dosage/Direction for Use

960 mg (8 tab) once daily (in combination w/ panitumumab for mCRC) 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

View Lumakras overdosage for action to be taken in the event of an overdose.

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 the process as previously mentioned & tube manufacturer's instructions w/ appropriate water flushes.

Warnings

For additional cautionary notes to warn of the potential risk of using the medicine... Click to view Lumakras detailed prescribing information

Special Precautions

Hepatotoxicity leading to drug-induced liver injury & hepatitis. Monitor LFT (ALT, AST, alkaline phosphatase & 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. Pregnant women; not to breastfeed during treatment & for 1 wk after final dose (refer to pregnancy & lactation treatment recommendation when used in combination w/ panitumumab). Ped patients.

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Use In Pregnancy & Lactation

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Adverse Reactions

Diarrhea, stomatitis, nausea, vomiting, constipation, abdominal pain; hepatotoxicity; cough, dyspnea; musculoskeletal pain, arthralgia; fatigue, edema; decreased appetite; pneumonia; rash, dry skin, pruritus, nail disorder, skin fissure, palmar-plantar erythrodysesthesia syndrome; hemorrhage; conjunctivitis. Increased AST, ALT, alkaline phosphatase, creatine kinase, urine protein; aPTT. Decreased Ca, Na, Mg, albumin, glucose; lymphocytes, WBC & Hb. Increased/decreased K.

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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 substrate (digoxin) & BCRP substrate (rosuvastatin).

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Lumakras detailed prescribing information

Storage

View Lumakras storage conditions for details to ensure optimal shelf-life.

Description

View Lumakras description for details of the chemical structure and excipients (inactive components).

Action

View Lumakras mechanism of action for pharmacodynamics and pharmacokinetics details.

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

Patient Counseling Information

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Presentation/Packing

Form

Lumakras FC tab 120 mg

Packing/Price

7 × 8's

Lumakras

sotorasib

Manufacturer:

Amgen

Distributor:

Zuellig Pharma