Sotoxen Tablet
Sotorasib
120 mg
Everest Pharmaceuticals Ltd.
| Pack size | 56's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 1,000.00 AED |
Indications
Sotoxen Tablet is used for:
Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer
Adult Dose
Oral
Non-Small Cell Lung Cancer (NSCLC)
Indicated for treatment of KRAS G12C-mutated locally advanced or metastatic NSCLC in adults who have received >1 prior systemic therapy
960 mg PO once daily until disease progression or unacceptable toxicity
Colorectal Cancer
Indicated in combination with panitumumab for treatment of KRAS G12C-mutated metastatic colorectal cancer (mCRC) in adults who received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy
960 mg PO once daily until disease progression or unacceptable toxicity
Refer to panitumumab prescribing information for recommended panitumumab dosage information
Child Dose
Renal Dose
Renal impairment
Mild-to-moderate (eGFR >30 mL/min/1.73 m2): No dosage adjustment necessary
Severe (eGFR <30 mL/min/1.73 m2): Not studied
Administration
Take with or without food at same time each day
Swallow tablets whole; do not chew, crush, or split tablets
When used in combination with panitumumab, administer first dose prior to first panitumumab infusion
Contra Indications
Precautions
Hepatotoxicity
Can cause hepatotoxicity (eg, increased ALT or AST) which may lead to drug-induced liver injury and hepatitis
Median time to first onset of increased ALT/AST: 6.3 weeks (range, 0.4-42)
Monitor liver function tests (LFTs) before initiation, every 3 weeks for first 3 months, then monthly or as clinically indicated
Increase frequently of LFT monitoring in patients who develop transaminase and/or bilirubin elevations
Hold, dose reduce, or permanently discontinue based on severity
Consider treatment with systemic corticosteroids
Interstitial lung disease (ILD)/pneumonitis
Severe and fatal ILD/pneumonitis reported
Median time to first onset: 8.6 weeks (range, 2.1-36.7)
Monitor for new or worsening pulmonary symptoms (eg, dyspnea, cough, fever)
Hold for suspected ILD/pneumonitis; permanently discontinue if ILD/pneumonitis confirmed or no other potential causes of symptoms identified
Pregnancy-Lactation
Pregnancy
No data are available on use in pregnant females
Animal data
In a rabbit embryofetal development study, oral administration of sotorasib during organogenesis resulted in lower fetal body weights and a reduction in the number of ossified metacarpals in fetuses at the 100-mg/kg dose level (~2.6x the human exposure based on AUC at the clinical dose of 960 mg), which was associated with maternal toxicity, including decreased body weight gain and food consumption during dosing phase
Lactation
There are no data on drug presence or its metabolites in human milk, effects on the breastfed children, or effects on milk production
Advise women not to breastfeed during treatment and for 1 week after final dose
Interactions
Acid-Reducing Agents: Avoid coadministration with proton pump inhibitors (PPIs) and H2 receptor antagonists. If an acid-reducing agent cannot be avoided, administer LUMAKRAS 4 hours before or 10 hours after a local antacid.
Strong CYP3A4 Inducers: Avoid coadministration with strong CYP3A4 inducers.
CYP3A4 Substrates: Avoid coadministration with CYP3A4 substrates for which minimal concentration changes may lead to therapeutic failures of the substrate. If coadministration cannot be avoided, adjust the substrate dosage in accordance to its Prescribing Information.
P-gp substrates: Avoid coadministration with P-gp substrates for which minimal concentration changes may lead to serious toxicities. If coadministration cannot be avoided, decrease the substrate dosage in accordance to its Prescribing Information.
Contraindicated (2)
mavacamten
pacritinib
Adverse Effects
Side effects of Sotorasib :
ADRs for single-agent therapy in patients with NSCLC
>10%
All grades
Decreased lymphocytes (48%)
Decreased hemoglobin (43%)
Diarrhea (42%)
Increased AST (39%)
Musculoskeletal pain (35%)
Decreased calcium (35%)
Increased alkaline phosphatase (33%)
Increased urine protein (29%)
Increased ALT (28%)
Decreased sodium (28%)
Hepatoxicity (27%)
Nausea (26%)
Fatigue (26%)
Decreased albumin (23%)
Increased aPTT (23%)
Cough (20%)
Vomiting (17%)
Constipation (16%)
Dyspnea (16%)
Abdominal pain (15%)
Edema (15%)
Decreased appetite (13%)
Arthralgia (12%)
Pneumonia (12%)
Rash (12%)
Grade 3 or 4
Hepatoxicity (16%)
Increased ALT (11%)
1-10%
All grades
Interstitial lung disease (ILD)/pneumonitis (2.2%)
Drug-induced liver injury (1.6%)
.
Grade 3 or 4
Increased AST (9%)
Musculoskeletal pain (8%)
Pneumonia (7%)
Diarrhea (5%)
Increased urine protein (3.9%)
Dyspnea (2.9%)
Increased alkaline phosphatase (2.5%)
Decreased lymphocytes (2%)
Fatigue (2%)
Increased aPTT (1.5%)
Cough (1.5%)
Vomiting (1.5%)
Drug-induced liver injury (1.3%)
ILD/pneumonitis (1.1%)
Decreased sodium (1%)
Decreased appetite (1%)
Arthralgia (1%)
Abdominal pain (1%)
Nausea (1%)
<1%
Grade 3 or 4
Decreased hemoglobin (0.5%)
Decreased albumin (0.5%)
Constipation (0.5%)
Mechanism of Action
KRAS G21C inhibitor
Forms irreversible, covalent bond with unique cysteine of KRAS G12C, locking the protein in an inactive state that prevents downstream signaling without affecting wild-type KRAS
Also, blocks KRAS signaling, inhibits cell growth, and promotes apoptosis only in KRAS G12C tumor cell lines
Epidermal growth factor receptor (EGFR) activation is a mechanism of resistance to KRAS G12C inhibition in KRAS G12C-mutant mCRC
Combination therapy with panitumumab, an EGFR antagonist, increased antitumor activity compared with sotorasib or panitumumab alone in a murine patient-derived colorectal tumor xenograft model
Note
Sotoxen 120 mg Tablet manufactured by Everest Pharmaceuticals Ltd.. Its generic name is Sotorasib. Sotoxen is availble in Bangladesh.
Farmaco BD drug index information on Sotoxen Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.