Sotoxen 120 mg Tablet

Generic Name: Sotorasib
Brand Name: Sotoxen
Strength: 120 mg
Form: Film-coated Oral Tablet
Pack Size: Commonly 56 tablets per bottle (varies)
Manufacturer: Everest Pharmaceuticals
Distributed by: NP Molecule

Indications:

Sotoxen (Sotorasib) is indicated for the treatment of:

• Non-small cell lung cancer (NSCLC) with KRAS G12C mutation, in adult patients who have received at least one prior systemic therapy.

Note: KRAS G12C mutation must be confirmed through an FDA-approved diagnostic test before starting treatment.

Pharmacology:

Sotorasib is a KRAS G12C inhibitor, a first-in-class targeted therapy.
It works by irreversibly binding to the mutated KRAS G12C protein, locking it in its inactive state. This prevents tumor growth and survival, offering a precision oncology option for patients with this mutation.

Dosage & Administration:

• Standard dose: 960 mg once daily, taken as 8 × 120 mg tablets.

• Administer orally with or without food at the same time each day.

• Tablets should be swallowed whole—not crushed or chewed.

Drug Interactions:

• Caution with strong CYP3A4 inducers (may reduce effectiveness).

• May interact with acid-reducing agents (antacids, PPIs).

Contraindications:

• Known hypersensitivity to Sotorasib or tablet ingredients.

Side Effects:

• Common: Diarrhea, nausea, liver enzyme elevation, fatigue, cough, decreased appetite.

• Serious: Hepatotoxicity, interstitial lung disease (ILD/pneumonitis), QT prolongation (rare).

Pregnancy & Lactation:

• Not recommended during pregnancy; may cause fetal harm.

• Breastfeeding should be avoided during treatment and for 1 week after the last dose.

Precautions & Warnings:

• Monitor liver function tests (LFTs) before and during treatment.

• Watch for signs of ILD/pneumonitis and discontinue if suspected.

• Dose modifications may be necessary based on adverse reactions.

Overdose Effects:

• May result in increased side effects (e.g., diarrhea, hepatotoxicity).

• Symptomatic treatment and monitoring recommended.

Therapeutic Class:

• Targeted Therapy

• KRAS G12C Inhibitor

Storage Conditions:

• Store below 30°C.

• Protect from light and moisture.

• Keep out of reach of children.