Imjudo: An FDA-Approved Immunotherapy Drug Combined With Durvalumab For Unresectable Hepatocellular Carcinoma

Introduction

Imjudo (tremelimumab) is a type of immunotherapy drug called a checkpoint inhibitor. It uses the immune system to recognize and attack cancer cells. Imjudo is manufactured by AstraZeneca and was approved by the FDA in 2022 for the treatment of unresectable liver cancer in combination with Imfinzi (durvalumab).

FDA Approval

Imjudo was approved by the FDA On November 10, 2022, for the treatment of unresectable liver cancer in combination with Imfinzi (durvalumab). The approval was based on the results of the HIMALAYA Phase III trial, which showed that a single priming dose of Imjudo added to Imfinzi reduced the risk of death by 22% compared to Imfinzi alone.

Manufacturer Details

Imjudo is manufactured by AstraZeneca, a global biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines.

Indication Of Imjudo

IMJUDO is a medication that works by blocking a protein called CTLA-4, which is associated with immune cells called cytotoxic T-lymphocytes. It is used in combination with another drug called durvalumab to treat adults with a type of liver cancer called unresectable hepatocellular carcinoma (uHCC). This combination of medications is aimed at helping the body’s immune system fight against the cancer that cannot be removed through surgery.

What Is Unresectable Hepatocellular Carcinoma (uHCC) 

Unresectable Hepatocellular Carcinoma (uHCC) is a type of liver cancer where surgical removal, or resection, of the tumor is not a viable or recommended option. This can be attributed to factors such as the tumor’s size, location, or extent, as well as the overall health condition of the patient. Resection is a commonly employed treatment for localized hepatocellular carcinoma (HCC), where the tumor can be surgically excised.

In instances of uHCC, the cancer has typically progressed to a point where complete surgical removal is not feasible due to advanced stages or widespread distribution. 

Treatment strategies for unresectable hepatocellular carcinoma often involve non-surgical approaches, including chemotherapy, targeted therapies, immunotherapy, radiofrequency ablation, transarterial chemoembolization (TACE), and other locoregional therapies. 

Symptoms: Unresectable Hepatocellular Carcinoma may include fatigue, abdominal pain or discomfort, unintentional weight loss, jaundice (yellowing of the skin and eyes), swelling in the abdomen, and general malaise.

Mechanism Of Imjudo

Imjudo is a checkpoint inhibitor that blocks the activity of CTLA-4, a protein that inhibits the immune system’s ability to attack cancer cells. By blocking CTLA-4, Imjudo allows the immune system to recognize and attack cancer cells.

Dosage And Administration

The recommended dosage of Imjudo for treating unresectable liver cancer in combination with Imfinzi (durvalumab) is tailored based on weight and conditions. Imjudo injection is administered as an intravenous infusion after dilution, and it is essential to use separate infusion bags and filters for each drug product, avoiding co-administration of other drugs through the same infusion line.

Warnings and Precautions

Potential for serious allergic reactions: Imjudo is contraindicated in patients with a history of severe hypersensitivity reaction to tremelimumab or any of its excipients. Patients should be advised to report any history of allergic reactions to Imjudo or any other medication during treatment.

Immune-mediated adverse reactions: Imjudo can cause immune-mediated adverse reactions, which may require additional monitoring and management.

Infusion-related reactions: Imjudo and Imfinzi can cause severe or life-threatening infusion-related reactions. Monitor for signs and symptoms of infusion-related reactions and interrupt, slow, or stop the infusion as needed.

Hypothyroidism: Imjudo can cause hypothyroidism, and patients should be monitored for signs and symptoms of this condition.

Pregnancy And Breastfeeding 

• Based on their mechanism of action and data from animal studies, both Imfinzi and Imjudo can cause fetal harm when administered to a pregnant woman. 
• There is no information about whether Imjudo, a component of IMJUDO, is present in human breast milk and its impact on a nursing infant or milk production.
• Due to the potential for severe adverse reactions in breastfed infants, it is recommended that women refrain from breastfeeding while undergoing treatment with IMJUDO and for a period of three months after the final dose.

Contraception

• Advise pregnant women of the potential risk to a fetus. In females of reproductive potential, verify pregnancy status before initiating the medicine.
• It is advised to use effective contraception during treatment with Imfinzi and Imjudo and for 3 months after the last dose of Imfinzi and Imjudo.

Pediatric And Geriatric Use 

• Imjudo has not been proven to be safe and effective for use in pediatric and geriatric patients.

Kidney And Liver

• The safety and effectiveness of Imjudo in patients with renal or hepatic impairment have not been established.

Side Effects of Imjudo

• Common side effects of Imjudo include anemia, diarrhea, fluid imbalance, itching, liver enzyme changes, low platelet counts, low white blood cell counts, nausea, nerve damage, pancreas enzyme changes, psoriasis, skin rash, thyroid disorders, and vomiting. 
• Serious adverse reactions occurred in 25% of patients who received Imjudo, with serious adverse reactions in ≥5% including differentiation syndrome and transaminitis. 
• Clinically relevant adverse reactions in <10% of patients who received Imjudo include biliary tract disorder, biliary colic, cholangitis, and cholestasis, as well as electrocardiogram QT prolongation. 
• Imjudo can also cause hepatotoxicity, presenting as increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased blood alkaline phosphatase, and/or elevated bilirubin.

Drugs Interaction

No formal drug interaction studies have been conducted with Imjudo. Imjudo may interact with certain medications, supplements, or substances, potentially affecting its effectiveness or causing adverse reactions. It is crucial to inform your healthcare provider about all the medications, supplements, or herbal products you are taking before starting Imjudo. Your healthcare provider can assess potential drug interactions and make any necessary adjustments to your treatment plan.

Storage Condition of Imjudo

Imjudo should be stored in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect it from light until the time of use. Do not freeze or shake.

Other Information

It is essential to store Imjudo at the recommended temperature and in a safe place, out of reach of children. Additionally, it is important to keep track of your Imjudo prescription and refills to ensure continuous and uninterrupted treatment.

How To Buy Imjudo Online?

For individuals seeking access to Imjudo, navigating the importation process may be essential due to intricate regulations. Sansfro Health, a specialized pharmaceutical procurement company, is poised to offer assistance throughout this importation journey while ensuring pricing transparency. 

To inquire about the Imjudo price in India and gain insights into the importation process, please connect with our dedicated Patient Support Team at (+91) 9315705373 or reach out via email at help@sansfro.com. Rest assured, Sansfro Health is dedicated to simplifying the medication importation process and providing accurate pricing details. 

Conclusion

Imjudo is a checkpoint inhibitor that is used in combination with Imfinzi for the treatment of unresectable liver cancer. Imjudo has undergone rigorous testing and has received approval from the FDA for the treatment of specific medical conditions. The FDA approval process ensures that the medication meets the necessary safety and efficacy standards set by the regulatory authority. 

It is important to follow the guidance and prescription of a healthcare professional when using Imjudo. Remember to communicate any concerns or side effects with your healthcare provider, and always seek their advice before making any changes to your treatment plan. For more details on this medicine, contact your doctor immediately. 

Reference 

1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761289lbl.pdf
2. https://www.astrazeneca-us.com/media/press-releases/2022/imjudo-tremelimumab-in-combination-with-imfinzi-durvalumab-approved-in-the-us-for-patients-with-unresectable-liver-cancer.html 
3. https://www.drugs.com/imjudo.html