Sotoxen 120 mg (Sotorasib)

Overview of Sotoxen 120 mg

Sotoxen 120 mg is an oral targeted therapy used to treat non-small cell lung cancer (NSCLC) with a specific genetic mutation called KRAS G12C. It is a cutting-edge lung cancer therapy, which works by directly targeting that mutation, when it is difficult to treat with other therapy.

It is precise with a more personalized, mutation-specific treatment option that may offer improved outcomes with fewer systemic side effects compared to conventional chemotherapy.

The Active ingredient Sotorasib

Each Sotoxen 120 mg tablet contains active pharmaceutical ingredient(API) Sotorasib. It is a selective KRAS G12C inhibitor, among the most common oncogenic drivers in human cancer, yet until recently, were considered “undruggable.”

It effectively binds the KRAS G12C protein mutants by locking it in an inactive state so that it can not signal the cancer cells to multiply and grow again.

It has shown promising clinical efficacy in those patients who have not been cured by previous  traditional chemotherapy with the disease progression.

Manufactured by Everest Pharmaceuticals

Sotoxen 120 mg is developed and marketed by the Everest Pharmaceuticals Ltd, which is a globally renowned pharmaceuticals for making high-quality, and effective oncology medication. 

Everest Pharmaceuticals strictly follow the international manufacturing standards, ensuring product safety, authenticity and efficacy with a high competitive price.

How It Works

Mechanism of Action

Sotoxen 120 mg targets a genetic mutation referred to as KRAS G12C; this mutation is present in some patients who have non-small cell lung cancer. The mutation leads to uncontrolled growth of cancer cells; hence it is a disease driver in those individuals.

The drug works by itself. It attaches directly to the bad KRAS G12C protein and turns it off. In this way, it stops the messages that tell cancer cells to grow and multiply. This gives the body a better chance to slow or even shrink the tumor without hurting healthy cells.

What renders this approach unique is its selectivity— It is designed to target only the faulty protein and leave normal, non-mutated cells at peace. This can imply fewer side effects and a more focused treatment compared to traditional chemotherapy.

Precision Oncology in Action

It is a part of precision oncology, which is a growing field in cancer treatment, where treatment matches to the specific genetic makeup of a person’s cancer. In that case, a strategy works where the sole purpose of the treatment is to find the root cause of the disease on a molecular level instead of using a one-size -fits-all approach.

It offers a treatment option for the Patients with KRAS G12C-positive NSCLC that did not exist a few years ago, when people tried multiple targeted therapy but did not get any progress in the treatment. 

By turning off a key driver of cancer growth, it helps bring new hope to patients who previously had limited options.

Indications & Usage

Approved Uses

Sotoxen 120 mg was approved by the FDA to treat a specific NSCL mutation KRAS G12C in adult patients, who have received at least one prior therapy including chemotherapy or immunotherapy without any progression. 

It was approved after a successful clinical trial, where it showed significant changes in tumor response rate and disease control in this mutation, offering a new hope. 

Who Should Take This Drug?

Only adult patients who have been diagnosed with NSCLC with specific KRAS G12C gene mutation can take this medication under an oncologist. 

Your oncologist may suggest this medication if

• You have advanced NSCLC.
• Your tumor has tested positive for KRAS G12C via a validated test.

You’ve already been treated with at least one prior therapy and that did not work .

Patient Eligibility Criteria

At first you have to be eligible for this treatment, because Sotoxen 120 mg is used only for a specific lung cancer condition, yet it is not approved for other lung cancer medications. To know if it is appropriate for you, your doctor will do the following test first.

• Genetic Testing: Your tumor must be tested and confirmed to have the KRAS G12C mutation.
  
• Treatment History: It is typically used after one or more prior lines of treatment have failed.
  
• Overall Health: Your doctor will assess liver function, other medical conditions, and any medications you’re currently taking.

Dosage and Administration

Recommended Dose

The recommended dose is one Sotoxen 120 mg tablet daily once orally, with or without food, at the same time each day. 

Swallow the tablet whole—do not crush, chew, or split it.

Consistency is important, in cancer treatment, take your dose regularly and stick with your healthcare provider for monitoring and advice. 

Dosage Adjustments for Side Effects

If you experience certain side effects while taking Sotoxen—such as elevated liver enzymes, diarrhea, fatigue, or shortness of breath—your doctor may:

• Temporarily stop the treatment
• Lower your daily dose
• Permanently discontinue the medicine in severe cases
  

Adjustments are made to help manage your symptoms while continuing cancer treatment effectively. Do not forget to inform new or worsening side effects to your healthcare provider right away.

Missed Dose or Overdose Guidelines

Missed Dose:
If you miss a dose and it is less than 6 hours, take it as soon as possible. Do not take the dose if it is too late, skip the dose and continue with the regular one. 

Overdose:
If you take an overdose, inform your healthcare provider immediately. Overdose may intensify the side effects and hamper the regular treatment process. Understand the prescription before starting the dose.

If any of these serious effects occur, treatment may be paused or permanently discontinued, depending on severity.

Side Effects and Safety Information

Common Side Effects

Like other cancer treatments, Sotoxen 120 mg has some side effects that tend to be gone over time after starting treatment. But they also can be severe, if not monitored well by the healthcare provider. Inform your doctor if  side effects are not tolerable.

Some of the most commonly reported side effects include:

• Diarrhea
• Fatigue or weakness
• Nausea
• Joint or muscle pain
• Cough
• Decreased appetite
• Elevated liver enzymes (seen in routine blood tests)

These are the common side effects and every patient may not face these. These are manageable if you stay hydrated, eat healthy food, take proper rest and keep informing your healthcare provider.

Serious Adverse Reactions

Although these are the less common side effects recorded clinically but can be seen in patients depending on their medical conditions. If any of them are seen, patients need medical attention or dose adjustment.

These may include:

• Liver problems: It may increase liver enzymes (ALT, AST) and liver inflammation. Regular blood tests will be required to monitor this.
  
• Interstitial lung disease (ILD)/Pneumonitis: Signs of ILD/Pneumonitis are shortness of breath, cough, or fever. It should be reported immediately after being seen in the patients.
  
• Allergic reactions: Rash, itching, swelling, or difficulty in breathing could be signs of a rare allergic response.
  
• Gastrointestinal issues: Persistent or severe diarrhea and abdominal pain may indicate complications in patients during treatment.
  

If any of these serious effects occur, treatment may be paused or permanently discontinued, depending on severity.

Warnings and Precautions

Your medical history will be reviewed before Sotoxen 120 mg is started to see if there are any factors that place you at an increased risk of adverse effects. Consider the following precautions:

• Liver Function: Since Sotorasib may cause an increase in transaminases and also cause inflammation of the liver, regular liver tests are essential.
• Lung Health: Be alert for interstitial lung disease or pneumonitis, particularly if you develop unexplained cough or shortness of breath.
• Pregnancy and breastfeeding: It should not be used in pregnancy as it is likely to cause harm to the developing fetus. Do not breastfeed during treatment and for a period afterward.
• Contraception: Take adequate precautions to avoid pregnancy while on Sotoxen tablet and continue for at least one week after the last dose as the drug may have effects on reproductive health.

Monitoring and Precautions

Your healthcare provider will perform regular monitoring to ensure that treatment is working safely and effectively in your body. Regular monitoring wil include the following tests:

• Liver function tests (before and during treatment)
• Lung assessments if respiratory symptoms arise
• Kidney function and general blood work
• Review of any other medications you’re taking to avoid interactions

What should I know before taking Sotorasib

Precautions can save you from adverse side effects. You should take some precautions before you take sotorasib to treat non-small cell lung cancer.

• Doctor may do blood test for every 3 weeks for first 3 month and once in a month after 3 months to monitor liver functions. Other test might be done if necessary to monitor your progression and keep you safe from severe side effects.
• Inform your doctor if you feel any side effects that you can not tolerate any more.
• The medicine may cause interstitial lung diseases or pneumonitis. These are life threatening condition and need immediate medical action.
• Stop taking alcohol and smoking, these damage your lung and strengthen cancer cells to spread other parts of the body.
• Make balanced diet and healthy daily routine to keep yourself mentally and physically strong. You also can meditate it keeps your mind fresh and strong and increase your fighting capability any odd situation.
• Tell your doctor right away if you have liver disease, kidney disease, heart problem or if you had stroke before.
• Tell your doctor if you are taking any antibiotic, vitamin, or other medicine that interact with this drug.

Drug Interactions and Contraindications

Interacting Medications

Certain medications and supplements can affect the working process of Sotoxen 120 mg or increase the risk of side effects. Always share a full list of the medicines you’re taking including over-the-counter drugs, herbal supplements, and vitamins with your doctor before starting treatment.

Key drug interaction concerns include:

• CYP3A4 inducers (rifampin, phenytoin): These inducers may reduce Sotoxen’s effectiveness by speeding up its breakdown in the liver.

• Acid-reducing agents (proton pump inhibitors like omeprazole): These can lower the absorption of the medication and should be used cautiously or avoided.

• P-glycoprotein substrates (digoxin): Sotoxen may increase the levels of these drugs in the blood if both are taken together.

Other cancer treatments or investigational drugs: These may cause overlapping side effects or unpredictable interactions.

Pregnancy and Lactation

In animal study it was found that Sotoxen 120 mg may harm fetus in the worm during pregnancy. It is recommended to  avoid this drug in pregnant patients or using proper contraception during taking this medication.

In case of lactation it will be good not to feed breast milk to children or mothers can discontinue course if  their child are taking breast milk.

For any other clinical instruction patients must consult with their doctors.

Why to Choose Sotoxen 120 mg?

Sotoxen 120 mg (Sotorasib) provides new targeted therapy for patients having KRAS G12C-mutated non-small cell lung cancer (NSCLC). It works differently from conventional chemotherapy as a putative selective inhibitor of the KRAS G12C protein, which means it helps slow tumor growth blocking this protein specifically with less side effects. Information already available promises good response rates and disease control in patients who had previously exhausted all other treatment options. It has emerged as a frontrunner among KRAS inhibitors due to early approval, a well-established safety profile, and clinically consistent efficacy – its strong option in precision oncology.

Global Availability and How to Order

Sotoxen 120 mg is available around the world through authorized distributors like Onus Pharma. It will be provided upon a prescription, normally accompanying identification of the KRAS G12C mutation. This medicine is currently registered in countries of Asia and the Middle East, plus selected markets globally with options for shipping anywhere in the world where local laws allow. Buyers must ensure compliance with their country’s import and prescription laws. For exact price information, stock availability, and shipment timelines, you should contact Onus Pharma directly.

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Information ref: ( Mayo clinic)