Lumakras

Lumakras

sotorasib

Manufacturer:

Amgen

Distributor:

Zuellig Pharma
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.
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.
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.
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.
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.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01XX73 - sotorasib ; Belongs to the class of other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Lumakras FC tab 120 mg
Packing/Price
7 × 8's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in