Sotoxen 320 MG (Sotorasib INN)
Product Name : Sotoxen
Generic Name : Sotorasib
Formulation : Tablet
Available Pack Size : 90’s Pot
Available Strengths : 120mg & 320mg
Registrations :
Product Information
Sotoxen (Sotorasib) 320mg is a first-in-class oral KRAS G12C inhibitor used in the targeted treatment of KRAS G12C mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults who have received at least one prior systemic therapy, and of KRAS G12C mutation-positive metastatic colorectal cancer in combination with panitumumab. It works by covalently and irreversibly binding to the mutant cysteine residue of the KRAS G12C protein, locking it permanently in its inactive state and shutting down the growth signalling that drives tumour cell proliferation and survival. Manufactured by Everest Pharmaceuticals Ltd., Bangladesh and globally supplied by Mediaid Pharmacy with worldwide shipping.
Basic Product Information of Sotoxen (Sotorasib) 320mg
| Brand Name | Sotoxen 320 (Sotorasib) |
| Generic Name | Sotorasib INN |
| Drug Class | KRAS G12C Inhibitor (Covalent Irreversible Targeted Anticancer Therapy) |
| Available Strengths | 320mg (this listing) and 120mg |
| Formulation | Film-Coated Tablet |
| Pack Size | 90 Tablets per Pot (a complete 30-day supply at the standard 960mg daily dose) |
| Primary Indication | KRAS G12C Mutation-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer, and KRAS G12C Mutation-Positive Metastatic Colorectal Cancer |
| Companion Therapy | Used as a single agent in NSCLC. Used in combination with panitumumab (anti-EGFR antibody) in colorectal cancer. |
| Companion Diagnostic Required | Yes. KRAS G12C mutation must be confirmed in tumour tissue or plasma by a validated test before treatment begins. |
| Regulatory Approvals | Sotorasib received USFDA accelerated approval for KRAS G12C-mutated NSCLC in May 2021, and USFDA approval in combination with panitumumab for KRAS G12C-mutated metastatic colorectal cancer in January 2025. Also authorised in the European Union. |
| Originator Brand | Lumakras / Lumykras by Amgen |
| Manufacturer | Everest Pharmaceuticals Ltd., Bangladesh |
| Global Supplier | Mediaid Pharmacy, Worldwide Shipping Available |
| Registration Status | Manufacturer-listed oncology product. Contact Mediaid Pharmacy for current registration and export documentation for your country. |
| Storage Conditions | Store below 30 degrees Celsius in a dry place, protected from light and moisture. Keep tablets in the original pot with the closure tightly sealed. Keep out of the reach of children. |
How Sotoxen (Sotorasib) Works
Sotoxen contains Sotorasib, a potent and highly selective inhibitor of the KRAS G12C protein. KRAS is one of the most frequently mutated oncogenes in human cancer and functions as a molecular switch, cycling between an active GTP-bound state that transmits growth signals and an inactive GDP-bound resting state. The G12C mutation substitutes a cysteine residue at position 12, causing the switch to remain stuck in the active position and driving relentless cell proliferation and survival signalling.
KRAS was considered “undruggable” for nearly four decades because its surface offers no conventional binding pocket. Sotorasib overcomes this by covalently and irreversibly binding to the mutant cysteine that the G12C mutation itself creates, within a cryptic pocket that only becomes accessible when KRAS is in its inactive state. Its potency and selectivity are further enhanced by binding to both the P2 pocket and the His95 surface groove, locking the protein permanently in the inactive conformation.
The clinical significance of this design is mutation selectivity. Because the binding site depends on the mutated cysteine, Sotorasib inactivates KRAS G12C without affecting wild-type KRAS in healthy tissue. The result is blockade of downstream tumour signalling, inhibition of cell growth, and induction of apoptosis specifically within tumours carrying the mutation, sparing normal cells that depend on functional wild-type KRAS.
Indications for Sotoxen (Sotorasib)
Sotoxen (Sotorasib) is indicated for the following conditions, in each case only where a KRAS G12C mutation has been confirmed by a validated diagnostic test:
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Advanced Non-Small Cell Lung Cancer As a single agent for adult patients with KRAS G12C mutation-positive locally advanced or metastatic NSCLC who have received at least one prior systemic therapy. KRAS G12C is present in approximately 13 per cent of lung adenocarcinomas, making it one of the most common actionable drivers in the disease. |
Metastatic Colorectal Cancer In combination with panitumumab, for adult patients with KRAS G12C mutation-positive metastatic colorectal cancer who have received prior fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy. This is based on the Phase 3 CodeBreaK 300 trial. |
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Why Panitumumab Is Required in Colorectal Cancer In KRAS G12C-mutant colorectal cancer, activation of the epidermal growth factor receptor (EGFR) is a recognised mechanism of resistance to KRAS G12C inhibition. Adding the anti-EGFR antibody panitumumab closes this escape route and produces substantially greater antitumour activity than either agent alone. |
Mutation Testing Requirement KRAS G12C status must be confirmed in tumour tissue or a plasma sample before treatment. If the mutation is not detected in plasma, testing should be repeated on tumour tissue, because plasma testing can produce false negative results in patients with low circulating tumour DNA. |
Benefits of Sotoxen (Sotorasib) 320mg
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First-in-Class KRAS Inhibitor Sotorasib was the first KRAS-targeted therapy of any kind approved for human use, opening a treatment pathway for a driver mutation that had resisted drug development for almost forty years. Patients with KRAS G12C tumours now have a targeted oral option where none previously existed. |
Only Three Tablets Per Day The 320mg strength delivers the full 960mg daily dose in just three tablets, compared with eight tablets when using the 120mg strength. This substantially reduces daily pill burden for patients already managing multiple medications alongside cancer treatment. |
Exact 30-Day Pack At three tablets daily, one 90-tablet pot is precisely one month of treatment. This makes ordering, budgeting, and continuity of supply straightforward, with no part-packs or awkward carry-over quantities to track between shipments. |
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Selective for Mutant KRAS Only Because Sotorasib binds a cysteine created by the mutation itself, it spares wild-type KRAS in healthy tissue. This selectivity underlies a tolerability profile that differs markedly from conventional cytotoxic chemotherapy. |
Affordable Alternative to Lumakras Sotoxen contains the same active molecule as Lumakras by Amgen at a small fraction of the originator price, allowing patients and health systems in emerging markets to sustain continuous KRAS-targeted therapy rather than abandoning it on cost grounds. |
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Oral Home-Based Treatment Taken once daily by mouth with or without food. For lung cancer there is no infusion component at all, avoiding repeated hospital attendance and preserving quality of life during long-term therapy. |
GMP-Certified Oncology Manufacturing Produced by Everest Pharmaceuticals Ltd. in dedicated oncology facilities operating to current Good Manufacturing Practice standards, with batch-level analytical release testing for identity, assay, dissolution, and impurity profile. |
How to Take Sotoxen (Sotorasib)
Route: Oral. Swallow tablets whole with water.
Standard dose: 960mg once daily, which is three 320mg tablets taken together as a single daily dose, continued until disease progression or unacceptable toxicity. The same 960mg daily dose applies to both the lung cancer and colorectal cancer indications.
With panitumumab (colorectal cancer): The first dose of Sotoxen should be given before the first panitumumab infusion. If Sotoxen is withheld or discontinued, panitumumab must be withheld or discontinued as well. Sotoxen may be continued alone if panitumumab is permanently stopped.
With food: May be taken with or without food. Take the dose at approximately the same time each day.
If swallowing is difficult: Tablets may be dispersed in water without crushing. Stir until dispersed, drink immediately, then rinse the container with additional water and drink that too, so no dose is lost. Do not use any other liquid.
Missed dose: If a dose is missed by more than 6 hours, skip it and resume at the usual time the next day. Do not take two doses together to make up for a missed dose.
If vomiting occurs: Do not take an additional dose. Resume at the next scheduled dose.
Renal and hepatic impairment: No dose adjustment is recommended for mild to moderate renal or hepatic impairment. Data are limited in severe impairment.
Paediatric use: The safety and effectiveness of Sotoxen in paediatric patients have not been established.
Pack Supply Calculation for Ordering
Sotoxen 320mg, 90 tablets per pot: 3 tablets per day at the standard 960mg dose. One pot = exactly 30 days. A three-month supply is 3 pots; a six-month supply is 6 pots.
For comparison, Sotoxen 120mg: 8 tablets per day are needed for the same 960mg dose, so the 320mg strength is the more practical option for patients on the full dose.
We recommend ordering your next pot before the current one is finished, allowing for international shipping transit time, so that treatment is never interrupted. Mediaid Pharmacy can arrange scheduled multi-month supply.
Monitoring and Dosage Adjustments
Liver function monitoring is the single most important safety requirement with Sotoxen. Hepatotoxicity, seen as raised ALT, AST, and bilirubin, is the most clinically significant adverse effect and can occur without symptoms. Liver enzymes should be measured before starting treatment, every three weeks for the first three months, and monthly thereafter, or more frequently if abnormalities appear. Where transaminases rise above the defined thresholds, treatment is withheld until recovery and then resumed at the next lower dose level, or discontinued if the elevation is severe or accompanied by rising bilirubin.
Patients must also be monitored for interstitial lung disease and pneumonitis. Any new or worsening cough, breathlessness, fever, or chest discomfort should be reported immediately and treatment withheld pending investigation, as this reaction requires permanent discontinuation if confirmed. This can be difficult to distinguish from disease progression or infection in lung cancer patients, so a low threshold for imaging is appropriate. Additional monitoring covers gastrointestinal tolerance, particularly diarrhoea, and where panitumumab is co-administered, dermatological toxicity and serum magnesium. Steady-state drug levels are reached within approximately 22 days of starting treatment.
Drug Interactions and Important Information
Acid reducing agents are the most important interaction, as described in the warning above. Proton pump inhibitors and H2 receptor antagonists should be avoided outright, and local antacids separated from the Sotoxen dose by 4 hours before or 10 hours after.
Sotorasib is metabolised in part by CYP3A4. Strong CYP3A4 inducers such as rifampicin, carbamazepine, phenytoin, and St John’s Wort should be avoided because they lower Sotorasib exposure and may reduce efficacy. Sotorasib is also itself a CYP3A4 inducer, so it can lower the blood levels and effectiveness of sensitive CYP3A4 substrate medicines, including some hormonal contraceptives, certain statins, and various cardiovascular and psychiatric drugs.
Sotorasib inhibits P-glycoprotein (P-gp). Co-administration with P-gp substrates such as digoxin increases their plasma concentrations and the risk of toxicity. Where such a combination cannot be avoided, the dose of the P-gp substrate should be reduced in line with its own prescribing information and levels monitored. Always give your oncologist a complete list of all prescription medicines, over-the-counter products, vitamins, supplements, and herbal remedies before starting Sotoxen.
Side Effects and Precautions
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Common Side Effects Diarrhoea Musculoskeletal pain, including back and joint pain Nausea and vomiting Fatigue Raised liver enzymes (ALT and AST) Cough and shortness of breath Decreased appetite and abdominal pain Lymphopenia, anaemia and low sodium |
Serious Warnings and Precautions Hepatotoxicity, including severe transaminase elevation and drug-induced liver injury. Requires scheduled liver function monitoring throughout treatment. Interstitial lung disease and pneumonitis. Report any new or worsening cough, breathlessness, or fever immediately. Reduced efficacy if taken with proton pump inhibitors or H2 receptor antagonists. Severe or persistent diarrhoea requiring dose interruption and supportive management. Increased toxicity of P-glycoprotein substrate medicines such as digoxin. Skin toxicity, dry skin, and low magnesium when used in combination with panitumumab for colorectal cancer. Not recommended during pregnancy. Effective contraception should be discussed with your oncologist, noting that hormonal contraceptive efficacy may be reduced. Breastfeeding should be avoided during treatment. |
Who Should Use Sotoxen (Sotorasib)?
Sotoxen is intended for adult patients with a molecularly confirmed KRAS G12C mutation in locally advanced or metastatic non-small cell lung cancer who have already received at least one prior line of systemic therapy, and for adults with KRAS G12C mutation-positive metastatic colorectal cancer previously treated with fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy, where it is given alongside panitumumab. It is prescribed exclusively by medical oncologists working within a service capable of molecular tumour profiling and regular biochemical monitoring.
Sotoxen is not appropriate for patients whose tumours do not carry a KRAS G12C mutation, including those with other KRAS mutations such as G12D or G12V, for whom this medicine offers no benefit. Particular caution is required in patients with pre-existing liver disease, a history of interstitial lung disease or pneumonitis, or an ongoing requirement for acid-suppressing therapy that cannot be safely stopped. Patients who are pregnant or breastfeeding should not take Sotoxen.
Manufacturer: Everest Pharmaceuticals Ltd.
Everest Pharmaceuticals Ltd. is an established Bangladeshi pharmaceutical manufacturer with a substantial and rapidly expanding oncology and specialty medicine portfolio. The company operates dedicated manufacturing facilities built to current Good Manufacturing Practice standards, with segregated oncology production lines and in-house analytical quality control performed on every batch for identity, assay, dissolution, and impurity profile.
Everest’s targeted therapy range spans lung, colorectal, breast, prostate, renal, and skin cancers, and includes tyrosine kinase inhibitors, ALK inhibitors, CDK4/6 inhibitors, BRAF and MEK inhibitors, and now KRAS G12C inhibition. Sotoxen was among the first generic Sotorasib products produced anywhere in the world, and its availability in both 320mg and 120mg strengths allows the full clinical dosing ladder, from the standard 960mg dose through both recommended dose reductions, to be delivered from a single manufacturer.
Global Supplier: Mediaid Pharmacy with Worldwide Shipping
Mediaid Pharmacy is a trusted global supplier of specialty oncology and targeted therapy medications sourced from Bangladesh’s leading manufacturers. We make Sotoxen (Sotorasib) 320mg accessible to patients, oncologists, and institutional buyers worldwide through reliable worldwide shipping, with full order tracking and documentation support. Whether you are located in South Asia, the Middle East, Africa, Europe, Latin America, or beyond, our team can advise on pricing, stock availability, combined 320mg and 120mg ordering for dose flexibility, scheduled multi-month supply, and the documentation your country requires for personal import. Contact us directly via WhatsApp, phone, or WeChat for a quotation.
Why Choose Sotoxen (Sotorasib) from Mediaid Pharmacy?
KRAS G12C inhibition was one of the defining breakthroughs in modern precision oncology, giving patients with a previously untreatable driver mutation a targeted oral therapy for the first time. Originator pricing, however, has placed it far beyond reach for most patients outside high-income health systems. Sotoxen delivers the same active molecule as Lumakras by Amgen, at the same 960mg daily dose, for a small fraction of the cost. Manufactured by Everest Pharmaceuticals Ltd. to current GMP standards, supplied in a convenient three-tablet-per-day 320mg format with a clean 30-day pot, and shipped worldwide by Mediaid Pharmacy, it allows patients to remain on continuous KRAS-targeted therapy rather than rationing or stopping treatment. For patients with confirmed KRAS G12C mutation-positive lung or colorectal cancer seeking a proven, affordable, and reliably supplied Sotorasib option, Sotoxen from Mediaid Pharmacy is the trusted choice.
Frequently Asked Questions About Sotoxen (Sotorasib)
What is Sotoxen (Sotorasib) 320mg used for?
Sotoxen (Sotorasib) is a first-in-class KRAS G12C inhibitor used to treat KRAS G12C mutation-positive locally advanced or metastatic non-small cell lung cancer in adults who have received at least one prior systemic therapy. It is also used in combination with panitumumab for KRAS G12C mutation-positive metastatic colorectal cancer after prior chemotherapy. A KRAS G12C mutation test is required before treatment can begin.
How many Sotoxen 320mg tablets are taken per day?
Three tablets. The standard dose is 960mg once daily, which is three 320mg tablets taken together as a single daily dose, with or without food. This is the same dose for both the lung cancer and colorectal cancer indications. Using the 320mg strength means three tablets a day rather than the eight tablets required with the 120mg strength.
How long does one 90-tablet pot of Sotoxen 320mg last?
Exactly 30 days at three tablets daily. This makes ordering straightforward: one pot per month, three pots for a quarter, six pots for six months. We recommend placing your next order before the current pot runs out so that international shipping time does not interrupt treatment.
Can I take omeprazole or other stomach medicines with Sotoxen?
No. Proton pump inhibitors such as omeprazole, esomeprazole and pantoprazole, and H2 blockers such as famotidine, significantly reduce Sotorasib absorption and can make the treatment less effective. They should be avoided. If acid relief is needed, a local antacid may be used instead, taken at least 10 hours after or 4 hours before your Sotoxen dose. Discuss any indigestion or reflux medicine with your oncologist, including products bought without a prescription.
What happens if my oncologist needs to reduce my dose?
Dose reductions go from 960mg to 480mg once daily, and if needed from 480mg to 240mg once daily. These reduced doses cannot be made from 320mg tablets and the tablets must not be split, so you would need to switch to the Sotoxen 120mg strength. Mediaid Pharmacy supplies both strengths, and we can advise on holding a reserve of 120mg alongside your 320mg supply so a dose change can be made without a treatment gap.
Is Sotoxen the same as Lumakras (Sotorasib by Amgen)?
Sotoxen contains the same active pharmaceutical ingredient, Sotorasib, in the same 320mg film-coated tablet strength and the same 90-tablet pack presentation as Lumakras by Amgen. It is manufactured by Everest Pharmaceuticals Ltd. in Bangladesh and offered at a substantially lower cost, giving patients access to the same targeted mechanism of action without originator pricing.
What are the main side effects and safety concerns with Sotoxen?
The most common side effects are diarrhoea, musculoskeletal pain, nausea, fatigue, cough, and raised liver enzymes. The two most important safety concerns are liver toxicity, which requires regular blood tests because it often causes no symptoms until advanced, and inflammation of the lungs known as interstitial lung disease or pneumonitis. Any new or worsening cough, breathlessness, or fever should be reported to your oncologist straight away.
Can I order Sotoxen (Sotorasib) 320mg online with worldwide shipping?
Yes. Mediaid Pharmacy supplies Sotoxen (Sotorasib) 320mg and 120mg globally with worldwide shipping. A valid oncologist’s prescription is required. Contact us via WhatsApp, phone, or WeChat at +8801773428128 or email info@mediaidpharmacy.com to enquire about pricing, stock availability, multi-month supply planning, and delivery to your country.
Order Sotoxen (Sotorasib) 320mg with Worldwide Shipping
Phone / WhatsApp / WeChat: +8801773428128 | Email: info@mediaidpharmacy.com
