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Sotorasib
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Introduction to Lumakras

Brief Overview of Lumakras (Sotorasib)

Lumakras, known by its generic name Sotorasib, is a groundbreaking medication in the treatment of non-small cell lung cancer (NSCLC). It is specifically designed for patients whose cancer has the KRAS G12C mutation, a common mutation in NSCLC. Lumakras has emerged as a significant advancement in targeted cancer therapy, offering new hope for patients with this specific genetic profile.

Role in Treating Non-Small Cell Lung Cancer (NSCLC)

Lumakras plays a pivotal role in treating NSCLC by targeting the KRAS G12C mutation. This mutation has been challenging to treat in the past, but Lumakras effectively inhibits the mutated protein, thereby slowing down the progression of the cancer. It is used in patients who have advanced or metastatic NSCLC and have received at least one prior systemic therapy.

What is Lumakras?

Detailed Description of Lumakras

Lumakras is a first-in-class inhibitor specifically designed to target the KRAS G12C mutation in NSCLC. It is an oral medication, marking a significant shift in the treatment paradigm for this type of lung cancer. Lumakras works by selectively binding to the mutated KRAS protein, blocking its ability to signal cancer cell growth and division.

The Class of Drugs it Belongs To (KRAS G12C Inhibitors)

Lumakras belongs to a new class of drugs known as KRAS G12C inhibitors. These drugs are designed to target and inhibit the activity of the KRAS G12C mutation, a genetic alteration found in a subset of cancer patients. This targeted approach allows for more precise and effective treatment strategies compared to traditional chemotherapy.

How it Works in the Body

In the body, Lumakras selectively binds to the KRAS G12C mutation, which is present in cancer cells but not in normal cells. By inhibiting this mutation, Lumakras effectively blocks the signaling pathways that promote cancer cell growth and survival. This targeted action results in the slowing or stopping of tumor growth and can lead to tumor shrinkage in some patients.

Key Information about Lumakras

Indications and Usage

Lumakras is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test. It is used in patients who have previously received systemic therapy, making it a second-line or later treatment option.

Notable Benefits and Limitations

The primary benefit of Lumakras is its targeted approach, which can lead to better outcomes and fewer side effects compared to traditional chemotherapy. However, its use is limited to patients with the specific KRAS G12C mutation. The effectiveness of Lumakras in broader NSCLC populations or other cancers with this mutation is still under investigation.

Age Restrictions, if Any

Currently, Lumakras is approved for use in adult patients. There is no established safety and efficacy profile for its use in pediatric patients.

How to Use Lumakras

Administration and Dosage

Lumakras (Sotorasib) should be taken orally, with or without food, as directed by a healthcare provider, usually once daily. The tablets must be swallowed whole and should not be chewed, crushed, or split. If swallowing difficulties arise, the tablet can be placed in water to break into small pieces but should not be completely dissolved. The dosage is based on the patient’s medical condition and response to treatment, and it’s crucial not to alter the dose without consulting a healthcare provider.

Regular Use and Missed Doses

Consistent use of Lumakras is important for its effectiveness. Patients are advised to take it at the same time each day to maintain a steady level of medication in the body. If a dose is missed and it’s more than 6 hours until the next dose, skip the missed dose and continue with the regular schedule. Doubling up on doses is not recommended.

Storage Information

Proper Storage Conditions

Lumakras should be stored at room temperature, away from light and moisture. It should not be stored in the bathroom and should be kept out of reach of children and pets.

Handling and Disposal

Unused or expired Lumakras should not be flushed down the toilet or poured into a drain. Patients should consult their pharmacist for proper disposal methods to ensure safety and environmental protection.

Potential Risks and Benefits

Benefits of Lumakras

The primary benefit of Lumakras is its targeted action against NSCLC with the KRAS G12C mutation, offering a new treatment option for patients who have previously received systemic therapy. This targeted approach can lead to better outcomes and fewer side effects compared to traditional chemotherapy.

Risks and Precautions

While Lumakras is beneficial for many patients, it comes with potential risks. It may cause liver problems, lung or breathing problems, and severe allergic reactions. Patients should be aware of the signs and symptoms of these conditions and seek medical attention if they occur. Regular monitoring by a healthcare provider is essential to manage these risks.

Contraindications

Lumakras is not recommended for use in patients with certain medical conditions, such as severe liver problems. It should also be used with caution in patients with lung or breathing problems other than lung cancer. The safety and effectiveness of Lumakras in pediatric patients have not been established.

Lumakras is a significant advancement in the treatment of NSCLC with the KRAS G12C mutation. Patients should follow their healthcare provider’s instructions closely and report any unusual symptoms or side effects immediately. Regular monitoring and open communication with a healthcare provider are key to managing the risks associated with Lumakras.

Side Effects of Lumakras

Common Side Effects

Lumakras, like many medications, can cause a range of side effects, though most are generally mild and manageable. Common side effects include gastrointestinal issues like diarrhea or constipation, muscle or joint pain, which can affect mobility and comfort, and nausea or vomiting, which can impact appetite and nutrition. Patients may also experience fatigue, a common side effect that can significantly affect daily activities and quality of life. Cough and abdominal pain are also reported, which can be bothersome and may require medical intervention if persistent. Some patients may experience skin rash and swelling in various body parts, including the arms, legs, eyes, or testicles, which can be uncomfortable and may indicate an underlying issue. Decreased appetite is another side effect that can lead to weight loss and nutritional deficiencies if not addressed. While these side effects are usually not severe, they can be bothersome and may require medical attention if they persist or worsen.

Serious Side Effects

Although less common, Lumakras can cause serious side effects that require immediate medical attention. Liver problems, including abnormal liver function tests and hepatitis, can be a significant concern and may manifest as jaundice, dark urine, light-colored stools, and abdominal pain. Hematological issues such as low levels of white or red blood cells can lead to increased susceptibility to infections and anemia, respectively. Severe diarrhea and muscle or bone pain can be debilitating and affect a patient’s ability to carry out daily activities. Cardiovascular issues, including heart problems like heart failure or heart attacks, are particularly serious and require urgent care. Stomach ulcers, presenting as severe abdominal pain and possibly bleeding, are another serious side effect. Lung problems, potentially leading to breathing difficulties, and serious infections like pneumonia are also concerns. Additionally, electrolyte imbalances, such as low levels of calcium or sodium in the blood, can lead to various symptoms and complications. Patients experiencing any of these serious side effects should seek immediate medical attention.

Allergic Reactions

Allergic reactions to Lumakras, though rare, can occur and range from mild to severe. Mild allergic reactions may present as skin rash, itchiness, and flushing, which can be uncomfortable but are generally not life-threatening. However, severe allergic reactions are a medical emergency and can include symptoms such as swelling under the skin, particularly in areas like the eyelids, lips, hands, or feet, and swelling of the tongue, mouth, or throat, which can lead to difficulty breathing. These severe reactions require immediate medical attention as they can be life-threatening. Patients should be aware of these potential allergic reactions and seek medical help if they experience any concerning symptoms.

Drug Interactions with Lumakras

Interactions with Other Medications

Lumakras, like many medications, has the potential to interact with various other drugs, which can significantly impact its effectiveness and safety. One of the key concerns is its interaction with medications that affect liver enzyme activity. These drugs can alter the way Lumakras is metabolized and removed from the body, potentially leading to either increased toxicity or reduced efficacy of Lumakras. For instance, drugs that induce liver enzymes may decrease the levels of Lumakras, reducing its effectiveness, while those that inhibit liver enzymes may increase Lumakras levels, raising the risk of side effects. Additionally, Lumakras can interact with other types of medications, including those used for treating other conditions. This includes over-the-counter drugs, prescription medications, and even herbal supplements. Therefore, it’s crucial for patients to provide their healthcare providers with a comprehensive list of all medications and supplements they are taking. This allows the healthcare provider to assess potential drug interactions and make informed decisions about the patient’s treatment regimen.

Managing Drug Interactions

Effectively managing drug interactions is a critical aspect of patient care, especially for those on Lumakras. Healthcare providers may need to adjust the dosages of Lumakras or other medications the patient is taking to mitigate the risk of interactions. In some cases, alternative medications may be prescribed to avoid interactions. Regular monitoring, including blood tests and clinical assessments, can help in identifying any adverse effects or changes in the efficacy of the treatment due to drug interactions. Patients play a vital role in this process by adhering to their prescribed treatment plan and communicating openly with their healthcare provider. They should always consult their healthcare provider before starting or stopping any medication, including over-the-counter drugs and supplements. This is particularly important for patients on Lumakras, as even seemingly harmless medications or supplements can have significant interactions with their cancer treatment. By working closely with their healthcare providers and following their advice, patients can help ensure that their treatment is both safe and effective.

Warnings and Precautions for Lumakras

Precautions for Specific Populations

Lumakras requires careful consideration when prescribed to certain patient populations. Patients with pre-existing lung or liver problems should use Lumakras with caution due to the potential for exacerbation of these conditions. The medication can cause or worsen liver issues, making regular liver function tests crucial. Similarly, for patients with lung problems, Lumakras may increase the risk of lung-related side effects. Additionally, individuals who have previously experienced allergic reactions to Lumakras need to be cautious. In such cases, alternative treatments should be considered, and if Lumakras is used, it should be under close medical supervision with immediate access to emergency care in case of a severe allergic reaction.

Pregnancy and Breastfeeding

The use of Lumakras during pregnancy and breastfeeding is not recommended due to the unknown effects on the unborn baby and breastfed infants. There is a potential risk of fetal harm when administered to pregnant women, and it is unknown whether Lumakras is excreted in human milk. Women of childbearing potential should be advised to use effective contraception during treatment with Lumakras and for a specified period after the last dose to prevent potential harm to the fetus. Similarly, breastfeeding should be discontinued during treatment with Lumakras and for a period after the final dose to avoid potential risks to the nursing infant.

Monitoring and Regular Check-ups

Regular monitoring is essential for patients taking Lumakras. This includes routine liver function tests to detect any signs of hepatotoxicity early. Blood cell counts are also important to monitor, as Lumakras can affect white and red blood cell levels, potentially leading to complications such as increased infection risk or anemia. Patients should be vigilant for any signs of side effects, especially those related to liver and lung function, and report them to their healthcare provider immediately. Regular check-ups allow for timely adjustments in therapy, whether it’s dose modification or discontinuation of Lumakras, to ensure patient safety and treatment efficacy.

While Lumakras offers a significant therapeutic benefit for patients with NSCLC harboring the KRAS G12C mutation, its use comes with potential risks that require careful management. Patients and healthcare providers must work closely together, maintaining open communication and regular monitoring to manage these risks effectively. This collaborative approach ensures that patients receive the maximum benefit from Lumakras while minimizing potential adverse effects.

Clinical Studies and Research

Overview of Clinical Trials

Lumakras (sotorasib) has been evaluated in several clinical trials, particularly focusing on its efficacy in treating KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). The most notable of these trials is the CodeBreaK 100, a single-arm, open-label, global, multicenter clinical trial. This trial played a crucial role in the accelerated approval of Lumakras by the FDA.

Key Findings from CodeBreaK 100

In the CodeBreaK 100 trial, Lumakras was administered to 126 patients with locally advanced or metastatic KRAS G12C-mutated NSCLC who had progressed on prior therapy. The major efficacy outcomes were based on the objective response rate (ORR) and duration of response (DOR). The results showed an ORR of 36% and a median DOR of 10.0 months. These findings underscored the potential of Lumakras as an effective treatment option for this specific patient population.

Long-Term Efficacy and Safety Data

The trial also provided median 2-year follow-up data, which is crucial for understanding the long-term efficacy and safety of Lumakras. Over 5,200 patients in the US have been prescribed Lumakras, and more than 3,400 healthcare professionals have recommended it, indicating its growing acceptance in the medical community.

Patient Information and Instructions

Understanding Lumakras

Patients prescribed Lumakras should be informed about its specific use for KRAS G12C-mutated NSCLC and the importance of an FDA-approved test to confirm this mutation. It’s crucial for patients to understand that Lumakras is not a chemotherapy drug but a targeted therapy specifically designed for a certain genetic profile of lung cancer.

Instructions for Use

Patients should take Lumakras exactly as prescribed by their healthcare provider. The medication should be taken orally, once daily, with or without food. The tablets should be swallowed whole and not chewed, crushed, or split. If difficulty swallowing occurs, there are specific instructions for dissolving the tablet in water.

Potential Side Effects and Management

Patients should be aware of both the common and serious side effects of Lumakras. They should be instructed on how to recognize signs of serious side effects, such as liver problems or lung issues, and to seek medical attention promptly if these occur.

Importance of Regular Monitoring

Regular monitoring, including liver function tests and blood cell counts, is essential for patients taking Lumakras. Patients should be encouraged to keep all medical and lab appointments for continuous evaluation of the drug’s efficacy and safety.

Patient Support and Resources

Patients can access various support resources, including Amgen Assist 360, which provides assistance with treatment-related questions and financial support options. It’s important for patients to have access to comprehensive support to manage their treatment effectively.

Frequently Asked Questions

Lumakras, known by its generic name Sotorasib, is a groundbreaking medication approved for treating adults with non-small cell lung cancer (NSCLC) that has spread or cannot be surgically removed. Specifically, it targets tumors with the KRAS G12C gene mutation. This medication represents a significant advancement in targeted cancer therapy, offering a new hope for patients with this specific genetic profile of lung cancer.

Lumakras functions by selectively targeting and inhibiting the KRAS G12C mutation found in some cancer cells. This mutation is a known driver in many cancer cases, and by inhibiting it, Lumakras can effectively slow down or stop the growth of cancer cells. This targeted approach allows for more precise and effective treatment strategies compared to traditional chemotherapy, which can affect both cancerous and healthy cells.

Lumakras is prescribed to adults with NSCLC that has metastasized or cannot be surgically removed, and whose tumors have the KRAS G12C mutation. Patients should have received at least one prior systemic therapy before starting Lumakras. It’s important for patients to undergo an FDA-approved test to confirm the presence of the KRAS G12C mutation in their tumors before beginning treatment with Lumakras.

Lumakras is not a form of chemotherapy. It is classified as a targeted therapy that specifically inhibits the KRAS G12C mutation in cancer cells. Unlike chemotherapy, which can indiscriminately affect both cancerous and healthy cells, Lumakras’s targeted action focuses on the cancer cells with the specific mutation, potentially leading to fewer side effects and a more effective treatment for patients with this mutation.

Common side effects of Lumakras include diarrhea, muscle or bone pain, nausea, fatigue, liver problems, and cough. Serious side effects can include liver problems, lung or breathing problems, and severe allergic reactions. Patients should be aware of these potential side effects and report any unusual or severe symptoms to their healthcare provider immediately. Regular monitoring and communication with a healthcare provider are key to managing these risks.

Lumakras is an oral medication taken once daily, with or without food. The tablets should be swallowed whole and not chewed, crushed, or split. If a patient has difficulty swallowing the tablet whole, there are specific instructions for dissolving the tablet in water. Consistent adherence to the prescribed regimen is crucial for the effectiveness of the treatment.

Lumakras is not a cure for lung cancer. However, it can significantly slow the progression of the disease in patients with the KRAS G12C mutation, improving quality of life and potentially extending survival. Lumakras represents a significant advancement in the treatment of this specific type of lung cancer, offering a new therapeutic option for patients who have limited treatment choices.

The safety of Lumakras in pregnant or breastfeeding women is not well established. Due to potential risks to the unborn baby or breastfed infant, it is advised to avoid using Lumakras during pregnancy and breastfeeding. Women of childbearing potential should use effective contraception during treatment with Lumakras and for some time after the last dose as advised by their healthcare provider.

In clinical trials, Lumakras has shown promising results in treating NSCLC with the KRAS G12C mutation. The objective response rate in these trials was significant, indicating that a considerable proportion of patients experienced tumor shrinkage or disease stabilization. The effectiveness of Lumakras highlights its potential as a valuable treatment option for patients with this specific genetic mutation in their lung cancer.

The safety and effectiveness of Lumakras in pediatric patients have not been established. Currently, Lumakras is approved only for use in adults. Clinical trials and studies focusing on pediatric populations would be required to determine the safety and efficacy of Lumakras in children.

Before starting Lumakras, it is crucial to inform your healthcare provider about all your medical conditions, especially if you have liver or lung problems. Additionally, discussing all the medicines, vitamins, and supplements you are taking is important to avoid potential drug interactions. Your healthcare provider needs this information to ensure that Lumakras is safe for you and to adjust the treatment plan if necessary.

Antacids, particularly proton pump inhibitors and H2 blockers, can affect the absorption of Lumakras, potentially making it less effective. It’s recommended to avoid these medications while on Lumakras, or to take them at specific times before or after taking Lumakras. Consult with your healthcare provider for guidance on managing heartburn or acid reflux while on Lumakras.

If you miss a dose of Lumakras and it’s been less than 6 hours since your scheduled dose, take it as soon as you remember. If it’s been more than 6 hours, skip the missed dose and take your next dose at the regular time. Do not double the dose to catch up. Consistent medication adherence is important for the effectiveness of Lumakras.

The duration of Lumakras treatment varies depending on individual response and tolerance to the medication. It’s generally taken until the disease progresses or unacceptable toxicity occurs. Regular assessments by your healthcare provider will determine the appropriate duration of treatment with Lumakras for your specific condition.

Lumakras can interact with several medications, which can affect how it works or increase the risk of side effects. These interactions include medications that affect liver enzyme activity, which can alter the removal of Lumakras from the body. Patients should inform their healthcare provider about all medications they are taking to manage potential interactions effectively.

Regular monitoring, including liver function tests and monitoring for lung or breathing problems, is required while on Lumakras. This monitoring helps in early detection and management of any potential adverse effects, ensuring the safe and effective use of Lumakras.

Lumakras can cause liver problems, including increased liver enzymes and hepatitis. Regular liver function tests are recommended to monitor for any signs of liver toxicity. Patients should be aware of the symptoms of liver problems, such as jaundice, dark urine, light-colored stools, and abdominal pain, and report them to their healthcare provider immediately.

If you experience severe side effects from Lumakras, it’s crucial to contact your healthcare provider immediately. Severe side effects may include signs of liver problems (such as jaundice, dark urine, or abdominal pain), severe respiratory issues, or allergic reactions. Your healthcare provider may advise you to stop taking Lumakras temporarily or permanently, depending on the severity of the side effects. They might also adjust your dosage or prescribe additional treatments to manage these side effects. In some cases, hospitalization may be required for close monitoring and treatment. It’s important for patients to understand that prompt action and open communication with their healthcare provider are key to safely managing severe side effects of Lumakras.

The use of Lumakras in combination with other cancer treatments should be carefully evaluated by a healthcare provider. While Lumakras is a targeted therapy specifically designed for NSCLC with the KRAS G12C mutation, its interaction with other cancer treatments, such as chemotherapy, radiation therapy, or other targeted therapies, needs careful consideration. Combining treatments can potentially increase the effectiveness against cancer but also raises the risk of compounded side effects. Clinical trials may be exploring these combinations, and your healthcare provider can provide the most current information and guidance based on your specific medical condition and treatment history.

Lumakras should be stored at room temperature, away from direct light and moisture. It’s important to keep the medication in its original container and out of reach of children and pets. Do not store Lumakras in the bathroom, as the humidity can affect the medication. If you have unused or expired Lumakras, do not dispose of it in household trash or wastewater. Consult your pharmacist or local waste disposal company for proper disposal methods, as this helps protect the environment and ensures that the medication is not accidentally used by others.