SOTOXEN (Sotorasib) 120 mg — Generic KRAS G12C Inhibitor for NSCLC

Generic Name: Sotorasib
Brand/Trade Name: SOTOXEN
Strength: 120 mg per tablet
Manufacturer: Everest Pharmaceuticals Limited, Bangladesh
Drug Class: KRAS G12C Inhibitor / Targeted Antineoplastic Agent
Route: Oral tablets
Prescription Required: Yes — For use only under oncologist supervision

⚠️ Important Notice: SOTOXEN (Sotorasib) is a prescription-only oncology medication. It must be prescribed by a licensed oncologist following confirmed KRAS G12C mutation testing. Do not use this medicine without proper diagnosis and medical supervision.

What Is SOTOXEN (Sotorasib)?

For decades, a specific cancer-driving mutation called KRAS G12C was considered untreatable. Scientists knew it existed. They knew it fueled the growth of thousands of lung cancers every year. But no drug could reliably lock onto it and shut it down — until Sotorasib changed everything.

As the U.S. National Cancer Institute (NCI) reported, the FDA’s approval of Sotorasib in May 2021 marked a historic milestone — the first KRAS-blocking drug ever approved, described by leading oncologists as “a big breakthrough in the whole field.” For a generation of scientists who had spent careers calling KRAS “undruggable,” it was a moment that redefined what precision oncology could achieve.

SOTOXEN brings that same active molecule — Sotorasib — to patients across South Asia and emerging markets through Everest Pharmaceuticals Limited, one of Bangladesh’s most established specialty oncology manufacturers. Everest Pharmaceuticals has built a reputation for producing clinically credible generic oncology medicines that make precision therapy accessible where it is needed most.

If you are navigating treatment options for lung cancer or other mutation-driven cancers, you can explore our full Oncology product range and our dedicated Leukemia treatment category for related targeted therapies on our platform.

What Is SOTOXEN Prescribed For?

SOTOXEN (Sotorasib) has one specific, precise indication — and it depends entirely on a genetic test result.

Non-Small Cell Lung Cancer (NSCLC) with KRAS G12C Mutation

SOTOXEN is indicated for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors carry a KRAS G12C mutation, and who have received at least one prior systemic therapy (such as platinum-based chemotherapy or immunotherapy).

According to the FDA’s official approval documentation, the accelerated approval was granted on May 28, 2021, based on objective response rate and duration of response data from the CodeBreaK 100 clinical trial.

NSCLC accounts for approximately 85% of all lung cancer cases globally. Within that population, KRAS mutations occur in roughly 25% of patients — and of those, the KRAS G12C variant represents about half. This makes KRAS G12C one of the single most common actionable mutations in all of oncology, affecting hundreds of thousands of patients worldwide each year.

Before prescribing SOTOXEN: An FDA-approved companion diagnostic test must confirm the presence of the KRAS G12C mutation in tumor tissue or liquid biopsy. A positive test result is a prerequisite — not a recommendation — for this treatment.

Is SOTOXEN Chemotherapy?

This is one of the most common questions patients ask — and the answer matters.

SOTOXEN is not chemotherapy. It is a targeted therapy — a molecularly precise medicine that acts on a specific cancer-driving mutation, not on all rapidly dividing cells in the body. This is a meaningful distinction. Chemotherapy cannot distinguish between cancer cells and healthy cells. Sotorasib can. It locks onto the KRAS G12C protein specifically, which is why its side effect profile looks quite different from traditional chemotherapy.

How Does SOTOXEN Work? (Mechanism of Action)

Understanding the mechanism behind Sotorasib requires a brief look at what KRAS normally does — and what goes wrong when it mutates.

KRAS is a molecular switch inside cells. In its normal state, it cycles between “on” (active) and “off” (inactive) depending on whether the cell needs to grow or divide. In healthy tissue, this switch works perfectly.

In cells with a KRAS G12C mutation, the switch is stuck permanently in the “on” position. The cell receives a constant, uninterrupted signal to grow and divide. The mutation locks KRAS into an active, GTP-bound state — and the result is uncontrolled cell proliferation. That’s the cancer.

What makes KRAS G12C unique — and why Sotorasib specifically works against it — is a structural vulnerability. The G12C mutation creates a pocket on the KRAS protein surface that is not present in the normal (wild-type) KRAS protein. Sotorasib is designed to slip into this pocket and form a permanent, covalent bond with the mutant protein.

Once bound:

1. The KRAS G12C protein is irreversibly locked in the “off” (inactive) state
2. The downstream oncogenic signaling cascade is shut down
3. Cancer cells dependent on this pathway stop receiving their growth signal
4. Tumor growth slows or stops

This covalent, irreversible mechanism is what made Sotorasib a first-in-class drug. It does not merely block the KRAS G12C protein temporarily — it deactivates it permanently. Normal (wild-type) KRAS is unaffected, which is why the drug’s toxicity profile is more selective than chemotherapy.

The pivotal Phase 2 trial published in the New England Journal of Medicine confirmed this mechanism translates into real clinical responses — with objective tumor response seen in over one-third of heavily pre-treated NSCLC patients.

Clinical Trial Evidence — What the Data Shows

SOTOXEN is backed by one of the most closely watched oncology trial programs in recent years. Here is what the clinical evidence actually shows:

CodeBreaK 100 — Phase 1/2 Trial (Basis for Accelerated Approval)

Per the FDA’s approval summary, the CodeBreaK 100 trial evaluated 124 patients with KRAS G12C–mutated NSCLC whose disease had progressed on at least one prior systemic therapy:

• Objective Response Rate (ORR): 36% — meaning over one in three patients had measurable tumor shrinkage
• Median Duration of Response: 10 months — responses were durable, not just transient
• Disease Control Rate: 80.6% — the vast majority of patients achieved at least stable disease

For a population of patients who had already been through immunotherapy and chemotherapy without sufficient benefit, these numbers represented a clinically meaningful advance.

CodeBreaK 100 — 2-Year Long-Term Follow-Up

Long-term data extended the picture further. Results reported by the NCI showed that approximately 51% of patients were still alive 1 year after starting sotorasib treatment, and 33% remained alive at 2 years — notable outcomes in a population with previously treated metastatic NSCLC.

CodeBreaK 200 — Phase 3 Trial vs. Docetaxel

The Phase 3 CodeBreaK 200 trial, presented at ESMO 2022, compared sotorasib directly against docetaxel — the standard second-line chemotherapy — in 345 patients with KRAS G12C–mutated NSCLC:

• Sotorasib reduced the risk of progression or death by 34% vs. docetaxel (HR 0.66, P=0.002)
• 12-month PFS rate: 24.8% with sotorasib vs. 10.1% with docetaxel — more than double
• Grade 3+ serious treatment-related adverse events: 33% with sotorasib vs. 40% with docetaxel — sotorasib was better tolerated than chemotherapy in this head-to-head comparison

Dosage — How to Take SOTOXEN

Standard Dose: 960 mg once daily (8 tablets of 120 mg taken together as a single daily dose)

How to take it correctly:

• Take once daily at the same time each day
• Can be taken with or without food
• Swallow tablets whole — do not crush, split, or chew them
• If you vomit after taking your dose, do not retake it — continue with the next scheduled dose
• If you miss a dose and it is more than 6 hours until your next scheduled dose, take the missed dose. If it is within 6 hours, skip it and continue as normal. Never double up.

How long to continue:
Treatment continues until disease progression or unacceptable side effects. Your oncologist will assess your response at regular imaging intervals and determine whether to continue, adjust, or stop treatment.

Dose Reductions:

Your oncologist may reduce the dose to 480 mg (4 tablets) or further based on the severity of any side effects — particularly liver enzyme elevations. Always follow your oncologist’s instructions on dose modifications.

Do not change your dose or stop treatment without consulting your oncologist first.

Key Benefits of SOTOXEN for Patients

First-in-class precision targeting: SOTOXEN targets the specific molecular defect that drives KRAS G12C–mutated cancers. No other mechanism reaches this target the same way.

Oral convenience: SOTOXEN is taken as tablets at home once daily. Patients do not need to come to a clinic for IV infusion — a significant quality-of-life advantage, particularly for those managing ongoing fatigue or who live far from major hospitals.

Durable responses: In clinical trials, patients who responded to Sotorasib maintained those responses for a median of 10 months — meaningful sustained disease control in a population with limited alternatives.

Better tolerated than chemotherapy: In the Phase 3 CodeBreaK 200 trial, significantly fewer patients experienced serious Grade 3 or higher adverse events with Sotorasib compared to docetaxel (33% vs. 40%).

A genuine option when other therapies have failed: For patients who have progressed through platinum chemotherapy and PD-1/PD-L1 immunotherapy, SOTOXEN provides a new, biologically rational treatment option where few exist.

Accessible generic alternative: Manufactured by Everest Pharmaceuticals Limited in Bangladesh — a company with a strong track record in oncology generics — SOTOXEN brings KRAS G12C inhibition within financial reach for patients across South Asia and developing markets where the branded version (Lumakras) may cost tens of thousands of dollars per month.

Side Effects — What Patients Should Know

SOTOXEN is better tolerated than most chemotherapy regimens, but it does carry its own side effect profile that patients and caregivers should understand before starting treatment.

Most Commonly Reported Side Effects (≥20% of patients):

• Diarrhea — the most frequently reported; usually manageable with supportive treatment
• Musculoskeletal pain — joint pain, back pain, or muscle aches
• Nausea
• Fatigue
• Hepatotoxicity — liver enzyme elevations (detected on blood tests, often without symptoms)
• Cough
• Abdominal pain
• Rash or skin reactions

Most of these are mild to moderate and can be managed with dose adjustments or supportive care. They tend to be most noticeable in the early weeks of treatment.

Serious Side Effects — Requires Prompt Medical Attention:

⚠️ Hepatotoxicity (Liver Toxicity)
This is the most clinically significant safety signal with Sotorasib. Liver enzyme elevations (AST, ALT, and alkaline phosphatase) occurred in a significant proportion of patients in trials. In some cases, these were severe. Liver function tests are a required part of monitoring throughout treatment — typically checked every 3 weeks for the first 3 months, then monthly thereafter.

Signs of liver injury to watch for: yellowing of the skin or eyes (jaundice), dark-coloured urine, unusual fatigue, upper right abdominal pain. If any of these occur, contact your oncologist immediately.

⚠️ Interstitial Lung Disease (ILD) / Pneumonitis
Inflammation in the lungs has been reported with Sotorasib, though less commonly. Symptoms include new or worsening shortness of breath, cough, or fever. Any respiratory change during treatment should be reported to your oncologist without delay.

⚠️ QTc Prolongation
Some degree of cardiac electrical effect has been noted. Patients with pre-existing heart rhythm conditions should be monitored accordingly.

Important Warnings and Precautions

Tell your oncologist before starting SOTOXEN if you:

• Have liver disease or a history of hepatitis
• Have a history of lung disease or breathing problems
• Have heart rhythm abnormalities
• Are currently taking any other prescription, over-the-counter, or herbal medications
• Have ever had a prior allergic reaction to any targeted cancer therapy

Pregnancy and Contraception:

Based on its mechanism of action, Sotorasib is expected to cause fetal harm. Women of childbearing potential must use effective contraception during treatment and for at least 6 months after the final dose. Male patients with female partners of childbearing potential should use effective contraception during treatment and for 3 months after the final dose.

If pregnancy occurs during treatment, notify your oncologist immediately.

Breastfeeding:

It is not known whether Sotorasib is excreted in human breast milk. Given the potential for serious adverse reactions, breastfeeding is not recommended during treatment or for at least 1 week after the final dose.

Pediatric Use:

The safety and effectiveness of Sotorasib in patients under 18 years of age have not been established.

Drug Interactions — What to Discuss With Your Oncologist

Sotorasib is metabolized by the liver enzyme CYP3A4 and is a substrate of P-glycoprotein (P-gp). This means certain other medications can meaningfully affect Sotorasib blood levels — either increasing the risk of toxicity or reducing its effectiveness.

Medications that may REDUCE Sotorasib effectiveness (CYP3A4 inducers):

• Rifampicin (antibiotic)
• Carbamazepine, phenytoin (anti-seizure medications)
• St. John’s Wort (herbal supplement)
• Avoid or use with extreme caution alongside Sotorasib

Medications that may INCREASE Sotorasib levels (CYP3A4 inhibitors):

• Ketoconazole, itraconazole (antifungals)
• Clarithromycin (antibiotic)
• Ritonavir (antiretroviral)
• May require dose adjustment — discuss with your oncologist

Sotorasib may AFFECT levels of these medications:

• Statins (e.g. rosuvastatin, atorvastatin) — Sotorasib may reduce their effectiveness
• Certain other CYP substrates

Always bring your complete medication list — including vitamins, herbal products, and over-the-counter medicines — to every oncology appointment. Drug interactions in precision oncology can significantly affect both safety and treatment response.

For an independent reference on Sotorasib drug interactions, MedlinePlus from the U.S. National Library of Medicine</a> provides a patient-facing drug reference maintained by medical experts.

Monitoring During SOTOXEN Treatment

Your oncologist will schedule regular tests during treatment to catch any side effects early. Typical monitoring includes:

• Liver function tests (LFTs) — AST, ALT, bilirubin — every 3 weeks for the first 12 weeks, then monthly
• Imaging scans (CT, PET) — at regular intervals to assess tumor response
• Blood counts — to monitor for hematological changes
• Kidney function tests — periodic monitoring

Do not miss scheduled blood tests. Liver toxicity from Sotorasib is manageable when caught early but can become serious if ignored.

How to Store SOTOXEN 120 mg Tablets

• Store at room temperature, below 30°C
• Keep in a cool, dry place away from direct sunlight and humidity
• Store in the original packaging until ready to use
• Keep out of reach of children and pets
• Do not use tablets past the expiry date printed on the pack
• Do not store in a bathroom or near a sink — moisture can degrade tablets

About Everest Pharmaceuticals Limited, Bangladesh

Everest Pharmaceuticals Limited is one of Bangladesh’s most recognized manufacturers of specialty and oncology medicines. Founded with a commitment to making clinically advanced therapies accessible in South Asia, Everest has built a portfolio that includes generic versions of some of the most important targeted therapies in modern oncology — including medicines for blood cancers, solid tumors, and rare diseases.

Their manufacturing operations comply with national drug administration standards, and their oncology product range serves patients across Bangladesh, Southeast Asia, and international markets where generic alternatives to expensive branded medicines are critically needed.

SOTOXEN is part of Everest’s growing targeted therapy portfolio, representing their commitment to precision oncology accessibility — the principle that effective cancer treatment should not be limited to patients in wealthy countries.

Related Medicines Available at 100Meds

Patients with NSCLC or other mutation-driven cancers often require a range of oncology medicines throughout their treatment journey. The following products on our platform may also be relevant:

• Ivosenib 250 mg (Ivosidenib) — A first-in-class IDH1 inhibitor for AML and bile duct cancer; another mutation-targeted therapy in our oncology range
• Generic Venetoclax 100 mg — A BCL-2 inhibitor used in blood cancers, manufactured by Everest Pharmaceuticals — the same manufacturer as SOTOXEN
• Dasanix 20 mg (Dasatinib) — A targeted kinase inhibitor used in leukemia and certain mutation-positive cancers
• Elopag 25 mg (Eltrombopag) — For managing thrombocytopenia, which may be relevant in patients receiving chemotherapy alongside targeted therapy
• Browse our complete Oncology range →

All treatment recommendations must come from your oncologist. These products are listed for informational reference only.

Frequently Asked Questions About SOTOXEN (Sotorasib)

Q: What is the generic name of SOTOXEN?
The generic (INN) name is Sotorasib. SOTOXEN is the brand name manufactured by Everest Pharmaceuticals Limited in Bangladesh. The original branded version, developed by Amgen, is sold as Lumakras.

Q: How do I know if SOTOXEN will work for my lung cancer?
SOTOXEN only works in tumors that carry the KRAS G12C mutation. Your oncologist must order an approved molecular test on tumor tissue or a liquid biopsy before prescribing this medicine. Without a confirmed positive test, Sotorasib is not indicated.

Q: Is Sotorasib the same as Lumakras?
Yes. Lumakras is Amgen’s branded version of Sotorasib. SOTOXEN contains the same active molecule — Sotorasib 120 mg per tablet — manufactured by Everest Pharmaceuticals as a generic formulation.

Q: How many tablets do I take per day?
The standard daily dose is 960 mg, which means 8 tablets of 120 mg taken together once daily. Your oncologist will confirm the exact schedule and may adjust based on your response and side effects.

Q: Is SOTOXEN (Sotorasib) chemotherapy?
No. Sotorasib is a targeted therapy — a precision oncology medicine that acts specifically on the KRAS G12C mutant protein. It does not work by broadly killing all dividing cells the way conventional chemotherapy does. Many patients tolerate it better than chemotherapy as a result.

Q: What is the price of SOTOXEN 120 mg at 100Meds?
Pricing depends on quantity required and regional availability. Please use the Inquire Now button or contact us via WhatsApp/Telegram for current, up-to-date pricing tailored to your order.

Q: Can I safely order SOTOXEN from 100Meds online?
100Meds operates as a verified pharmaceutical sourcing platform with documented, transparent supply chains. We do not dispense prescription oncology medicines without proper documentation. Contact our team and we will guide you through the process clearly and responsibly.

A Note to Patients, Families, and Oncology Teams

A diagnosis of metastatic NSCLC — particularly after prior treatment has failed — arrives with a weight that no medical vocabulary can fully describe. The question of “what comes next?” is one that families ask in hospital waiting rooms and at kitchen tables at midnight.

For patients whose cancer carries the KRAS G12C mutation, SOTOXEN represents a biologically specific answer to that question. Not a guarantee. Not a cure. But a clinically studied, precision-targeted treatment option developed for the exact molecular fault that is driving their disease — available as a simple daily tablet, manufactured to standard by one of Bangladesh’s trusted oncology pharmaceutical companies.

At 100Meds, we exist to bridge the gap between the medicine a patient needs and the medicine they can access. If your oncologist has identified KRAS G12C–mutated NSCLC as your diagnosis, we are here to help you obtain SOTOXEN safely, with full documentation and genuine support at every step.

Reach out to our team today.

This page is for informational purposes only and does not constitute medical advice. SOTOXEN (Sotorasib) is a prescription-only oncology medication. Treatment decisions must be made by a qualified oncologist following confirmed KRAS G12C mutation testing. Always consult your specialist before starting, stopping, or adjusting any cancer therapy.