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Kanjinti
Trastuzumab
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Introduction to Kanjinti

Brief Overview of Kanjinti (Trastuzumab-anns)

Kanjinti, with its generic name trastuzumab-anns, is a biosimilar to Herceptin® (trastuzumab) and is used in the treatment of HER2-overexpressing breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma. As a biosimilar, it has similar effectiveness, safety, and quality to the original biologic drug but is typically available at a lower cost.

Role in Treating Cancer

Kanjinti plays a crucial role in the treatment of specific types of cancer. For HER2-overexpressing breast cancer, it is used in various treatment settings, including adjuvant (post-surgery) therapy and metastatic cases. In metastatic gastric cancer, it is used in combination with chemotherapy as a first-line treatment. The medication targets the HER2 protein, which is overexpressed in these cancers, helping to inhibit the growth and spread of cancer cells.

What is Kanjinti?

Detailed Description of Kanjinti

Kanjinti is a monoclonal antibody that specifically targets the HER2 receptor, a protein found on the surface of some cancer cells. By binding to these receptors, Kanjinti inhibits the proliferation of cancer cells that overexpress HER2. This targeted approach makes it an effective treatment for cancers that exhibit this specific protein in excess.

The Class of Drugs it Belongs To

As a monoclonal antibody and a biosimilar to Herceptin, Kanjinti belongs to a class of cancer therapies known as HER2 inhibitors. These drugs are designed to target and block the HER2 protein, thereby slowing the growth and spread of cancer cells that overexpress this protein.

How it Works in the Body

Kanjinti works by binding to the HER2 receptors on the surface of cancer cells. This binding inhibits the activation of signaling pathways that promote cell growth and division, effectively slowing or stopping the growth of tumors that overexpress the HER2 protein. This targeted action is crucial in treating cancers where HER2 plays a key role in tumor growth.

Key Information about Kanjinti

Indications and Usage

Kanjinti is indicated for the treatment of HER2-overexpressing breast cancer in both the adjuvant and metastatic settings. It is also indicated for the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. The drug is used in combination with chemotherapy regimens and is selected based on the presence of HER2 overexpression in the cancer cells.

Notable Benefits and Limitations

The primary benefit of Kanjinti is its targeted approach to treating HER2-positive cancers, which can lead to improved outcomes in these patients. However, its use is limited to cancers that overexpress the HER2 protein. Like other cancer treatments, Kanjinti can cause side effects, and its effectiveness can vary from patient to patient.

Age Restrictions, if Any

Kanjinti is used primarily in adult populations. The safety and effectiveness of Kanjinti in pediatric patients have not been established.

How to Use Kanjinti

Administration and Dosage

Kanjinti is administered as an intravenous (IV) infusion, typically in a hospital or clinic setting by a healthcare professional. The infusion is given over 90 minutes for the first dose, and if well-tolerated, subsequent infusions may be shortened to 30 minutes. The dosage and frequency depend on the specific cancer being treated and the patient’s response to therapy. For breast cancer, it’s given either weekly or every three weeks, while for gastric cancer, it’s administered every three weeks in combination with chemotherapy.

Instructions for Missed Doses

If a patient misses a scheduled dose of Kanjinti, they should contact their healthcare provider to reschedule as soon as possible. The timing of the next dose will be determined by the healthcare provider based on the specific circumstances.

Storage Information

Proper Storage Conditions

Kanjinti should be stored in a refrigerator at a temperature between 2°C and 8°C (36°F and 46°F). It must not be frozen and should be kept in its original container to protect it from light. The medication should be handled and prepared by a healthcare professional.

Handling and Disposal

Kanjinti is a potent medication that requires careful handling. Any unused or expired medication should be disposed of properly, following guidelines for the disposal of hazardous drugs. Patients should not handle or dispose of the medication themselves.

Potential Risks and Benefits

Benefits of Kanjinti

Kanjinti offers significant benefits in treating HER2-positive breast and gastric cancers. It can improve survival rates, reduce tumor size, and is effective in both early-stage and metastatic cancers. As a targeted therapy, it specifically attacks cancer cells that overexpress the HER2 protein, which can lead to better outcomes with potentially fewer side effects compared to traditional chemotherapy.

Risks and Precautions

While Kanjinti is effective, it comes with potential risks. Common side effects include infusion reactions, heart problems, lung issues, and diarrhea. Patients with a history of heart disease or lung problems should use Kanjinti with caution. Regular monitoring of heart and lung function is recommended during treatment.

Contraindications

Kanjinti is contraindicated in patients with known hypersensitivity to trastuzumab, the active ingredient, or to any of its excipients. It should also be used with caution in patients with a history of severe allergic reactions to other medications or substances.

Kanjinti is a critical medication for the treatment of HER2-positive breast and gastric cancers. Patients should be aware of the proper administration, storage, potential benefits, and risks associated with its use. Regular monitoring and communication with healthcare providers are essential for managing these risks effectively.

Side Effects of Kanjinti

Common Side Effects

Kanjinti (trastuzumab-anns) is associated with a range of common side effects, which, while generally manageable, can significantly impact the quality of life of patients. These side effects include respiratory symptoms such as coughing and nasal congestion, which can be bothersome and persistent. Gastrointestinal issues are also common, with patients frequently experiencing diarrhea, nausea, vomiting, and loss of appetite. These symptoms can lead to nutritional deficiencies and weight loss if not properly managed. Additionally, patients often report experiencing dizziness, fever, chills, headaches, and muscle aches, which can affect daily activities and overall well-being. Skin reactions like rashes and increased sweating are also common, along with a general feeling of fatigue and weakness. It’s crucial for patients to monitor these symptoms and communicate any persistent or troublesome side effects to their healthcare provider for appropriate management.

Serious Side Effects

Serious side effects of Kanjinti, though less frequent, are significant and demand immediate medical attention. Cardiomyopathy, manifesting as heart failure and decreased left ventricular ejection fraction, is a notable risk, particularly when used with anthracycline-containing chemotherapy regimens. Patients may experience serious infusion reactions and pulmonary toxicity, which can be life-threatening. These reactions typically occur during or within 24 hours of administration and include symptoms like dyspnea and clinically significant hypotension. In pregnant women, exposure to Kanjinti can lead to oligohydramnios, which may result in complications such as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Patients should be acutely aware of these risks and seek immediate medical care if they experience symptoms indicative of these serious side effects.

Allergic Reactions

Allergic reactions to Kanjinti, while rare, can range from mild to severe. Mild allergic reactions typically involve skin manifestations such as rashes, itching, or flushing, usually localized and manageable. However, in rare cases, patients may experience severe allergic reactions, which are medical emergencies. These severe reactions can include pronounced symptoms such as anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. Such reactions require immediate medical intervention. Patients should be aware of these potential allergic responses and are advised to seek urgent medical attention if they experience symptoms indicative of a severe allergic reaction.

Drug Interactions

Interactions with Other Medications

Kanjinti can interact with certain medications, potentially leading to increased risks of side effects. Notably, it should be used with caution when administered with anthracycline-containing chemotherapy regimens due to an increased risk of cardiomyopathy. Patients should inform their healthcare provider of all medications, supplements, and over-the-counter drugs they are taking.

Managing Drug Interactions

To manage these interactions, healthcare providers may adjust dosages, change medications, or closely monitor the patient. It’s important for patients to follow their doctor’s instructions and not to start or stop any medication without consulting their healthcare provider.

Warnings and Precautions

Precautions for Specific Populations

Patients with certain pre-existing conditions should exercise caution when using Kanjinti. Those with a history of heart disease or lung problems should be closely monitored due to the risk of cardiomyopathy and pulmonary toxicity. Patients with infections should also be cautious, as Kanjinti can decrease the body’s ability to fight infection.

Pregnancy and Breastfeeding

The safety of Kanjinti during pregnancy and breastfeeding is not well established. Exposure to Kanjinti during pregnancy can result in serious fetal harm. Women of childbearing potential should use effective contraception during treatment and for a period after the last dose. The risks and benefits should be carefully weighed for breastfeeding women.

Other Considerations

Patients should discuss their complete health history with their healthcare provider before starting Kanjinti. This includes any heart or lung problems, infections, or previous allergic reactions to medications. Alternative treatments may be considered for patients for whom Kanjinti is not suitable.

While Kanjinti is an effective treatment for certain cancers, patients should be aware of its potential side effects, drug interactions, and the precautions necessary for its safe use. Regular monitoring and open communication with a healthcare provider are key to managing these risks effectively.

Clinical Studies and Research on Kanjinti

Overview of Clinical Trials

Kanjinti® (trastuzumab-anns) has been rigorously tested in clinical trials to ensure its efficacy and safety in treating HER2-overexpressing breast cancer and gastric cancer. These trials have focused on demonstrating that Kanjinti is as effective and safe as the reference product, Herceptin® (trastuzumab).

Key Findings from Clinical Trials

The clinical trials have shown that Kanjinti is bioequivalent to Herceptin, with similar efficacy in terms of tumor response and survival rates. In the LILAC study, which compared Kanjinti with EU-sourced Herceptin in women with HER2-positive early breast cancer, the results supported the biosimilarity of Kanjinti in terms of safety and effectiveness. Additionally, pharmacokinetic studies have confirmed the bioequivalence between Kanjinti and both EU- and US-sourced Herceptin.

Long-Term Efficacy and Safety Data

Long-term data from these trials indicate that Kanjinti maintains a similar safety profile to Herceptin, with no new or unexpected safety concerns. The trials also support the continued efficacy of Kanjinti in treating HER2-overexpressing cancers over extended periods.

Patient Information and Instructions

Understanding Kanjinti Treatment

Patients prescribed Kanjinti should understand that it is a biosimilar to Herceptin, used for treating HER2-overexpressing breast and gastric cancers. It works by targeting the HER2 protein on cancer cells, inhibiting their growth. Patients should be aware of the need for regular monitoring and follow-up during treatment.

Instructions for Treatment and Follow-up

Kanjinti is administered through intravenous infusion, typically in a clinical setting. Patients should follow their treatment schedule closely and attend all appointments for infusions. They should also be aware of the potential side effects and report any adverse reactions to their healthcare provider.

Managing Side Effects and Concerns

Patients should be informed about the common and serious side effects of Kanjinti and advised to contact their healthcare provider if they experience any severe or unusual symptoms. Regular follow-up appointments are necessary to monitor the patient’s response to the treatment and to check for any side effects.

Clinical studies have shown Kanjinti to be an effective and safe treatment for HER2-overexpressing breast and gastric cancers. Patients receiving Kanjinti should be well-informed about their treatment, adhere to their infusion schedule, and maintain regular communication with their healthcare provider to ensure the best possible outcomes.

Frequently Asked Questions

Kanjinti is used to treat HER2-overexpressing new or metastatic breast cancer. It can be used alone or with other cancer medicines like carboplatin, cyclophosphamide, docetaxel, doxorubicin, paclitaxel. Additionally, Kanjinti is used in combination with cisplatin and capecitabine or 5-fluorouracil to treat HER2-overexpressing metastatic stomach and gastroesophageal cancer. It works by preventing the growth of tumors that produce extra amounts of the HER2 protein.

Kanjinti is administered through intravenous infusion by a healthcare professional. The first infusion is given over 90 minutes, and if well-tolerated, subsequent infusions may be shortened to 30 minutes. The infusion must be given slowly, and the patient is monitored during and after the administration for any adverse reactions.

Common side effects of Kanjinti include dizziness, fever, chills, headache, muscle aches, nausea, vomiting, skin rash, sore throat, stuffy or runny nose, unusual tiredness, weakness, cough, diarrhea, ear congestion or pain, increased cough, joint pain, loss of appetite, nasal congestion, pain or tenderness around the eyes and cheekbones, shivering, sneezing, sweating, swelling of the feet or lower legs, tightness in the chest, trouble with sleeping, and vomiting.

Serious side effects of Kanjinti include cardiomyopathy, which can lead to heart failure and decreased left ventricular ejection fraction, especially when used with anthracycline-containing chemotherapy regimens. Infusion reactions and pulmonary toxicity, which can be life-threatening, may occur during or within 24 hours of administration. Symptoms include dyspnea or clinically significant hypotension. In pregnant women, exposure to Kanjinti can result in oligohydramnios and complications like pulmonary hypoplasia, skeletal abnormalities, and neonatal death.

Allergic reactions to Kanjinti are rare but can occur. Mild allergic reactions can manifest as skin rash, itchiness, and flushing. More severe allergic reactions, though uncommon, can include anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. These severe reactions require immediate medical attention.

Kanjinti is not safe during pregnancy as exposure can result in oligohydramnios and oligohydramnios sequence, leading to complications like pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Women of childbearing potential should use effective contraception during therapy and for 7 months after the last dose of Kanjinti.

Appropriate studies have not been performed on the relationship of age to the effects of Kanjinti in the pediatric population. Therefore, safety and efficacy have not been established for children.

Kanjinti is a monoclonal antibody that interferes with the growth of cancer cells by targeting the HER2 protein. It binds to the HER2 protein on cancer cells, preventing them from growing and spreading. This targeted approach helps destroy cancer cells while minimizing effects on normal cells.

If you miss a dose of Kanjinti, contact your doctor or treatment clinic for instructions. It’s important to maintain a consistent treatment schedule, and your healthcare provider will guide you on the best course of action for missed doses.

Patients using Kanjinti should be monitored for heart problems, lung disease, and infections. It’s important to report any symptoms like chest pain, increased coughing, trouble breathing, or signs of infection to your healthcare provider. Regular heart function tests may be required during treatment.

Kanjinti can be used with other cancer medications, but it’s important to be aware of potential interactions, especially with anthracycline-containing chemotherapy regimens. Your healthcare provider will determine the best combination of treatments based on your specific condition.

Risks of Kanjinti treatment include cardiomyopathy, infusion reactions, pulmonary toxicity, and potential harm to a fetus during pregnancy. Patients should be aware of these risks and discuss them with their healthcare provider.

The duration of Kanjinti treatment varies depending on the type and stage of cancer being treated. Your healthcare provider will determine the length of treatment based on your response to therapy and the progression of your disease.

Before starting Kanjinti, discuss your complete medical history, including any heart or lung problems, infections, or allergies. It’s also important to inform your healthcare provider about any other medications you are taking.

Kanjinti can cause lung problems, including interstitial pneumonitis and pulmonary fibrosis. Symptoms like difficulty breathing, cough, and chest tightness should be reported to your healthcare provider immediately.

Kanjinti should be stored in a refrigerator at a temperature between 2°C and 8°C (36°F and 46°F). It must not be frozen and should be kept in its original container to protect it from light.

Kanjinti can affect heart function, leading to conditions like cardiomyopathy and heart failure. Patients with pre-existing heart conditions should use Kanjinti with caution, and regular monitoring of heart function is recommended during treatment.

Biosimilar drugs are medications that are similar in terms of safety, efficacy, and quality to an existing approved biologic drug. Kanjinti is a biosimilar to Herceptin (trastuzumab), offering a similar therapeutic effect at potentially lower costs.

Kanjinti can be used in elderly patients, but they may be more likely to have age-related heart problems, which may require caution. It’s important for elderly patients to be closely monitored during treatment with Kanjinti.

After completing Kanjinti treatment, patients will continue to be monitored for any recurrence of cancer and potential long-term side effects. Follow-up care typically includes regular medical check-ups, imaging tests, and heart function assessments.