Imjudo

About Imjudo 

• Imjudo has received approval from the US FDA administration on October 21, 2022. 
• Imjudo is an antineoplastics, which belongs to the class called anti-CTLA4 antibodies. 
• Durvalumab, in combination with Imjudo, is indicated for the treatment of unresectable hepatocellular carcinoma (uHCC) (A form of liver cancer that is not surgically removable) or non-small cell lung cancer (NSCLC) that has metastasized, in adult patients.
• Individuals with prolonged liver diseases, liver scarring due to hepatitis B or hepatitis C infection, excessive alcohol consumption, and those with fat buildup in the liver face an increased risk of hepatocellular carcinoma.
• Imjudo, in conjunction with durvalumab and platinum-based chemotherapy, can be employed to treat adults with metastatic non-small cell lung cancer (NSCLC) lacking sensitizing mutations in the epidermal growth factor receptor (EGFR) or genomic tumor aberrations in the anaplastic lymphoma kinase (ALK).
• It is not known if this medicine is safe and effective in children.

Strength

Injection: 25 mg/1.25 mL (20 mg/mL); 300 mg/15 mL (20 mg/mL) solution in a single-dose vial. 

Recommended Dosage

The administration of intravenous (IV) injections requires skilled healthcare professionals who employ aseptic techniques, such as handwashing, glove usage, and site cleaning. It is imperative to continuously monitor for any adverse reactions during the process. Your physician will determine the appropriate dosage based on your body weight. 

• For those weighing 30 kg and above: Administer a single dose of Imjudo 300 mg along with durvalumab 1,500 mg on Cycle 1/Day 1. Subsequent cycles involve durvalumab alone every 4 weeks.
• For those weighing less than 30 kg: Administer a single dose of Imjudo 4 mg/kg along with durvalumab 20 mg/kg on Cycle 1/Day 1. Subsequent cycles involve durvalumab alone every 4 weeks.

Important

No dose reduction is recommended. Suspend treatment for severe (Grade 3) reactions and permanently discontinue for life-threatening (Grade 4) reactions or an inability to reduce corticosteroid dosage to 10 mg or less within 12 weeks.

Consult your healthcare professional for personalized advice regarding alcohol consumption and driving while taking medications like Imjudo. Adhere to your healthcare provider’s guidance, as alcohol can interact with medications, potentially affecting their effectiveness or causing adverse effects. Inform your healthcare provider about your alcohol use and other medications, as they can offer specific guidance based on your health condition and potential interactions with Imjudo. Exercise caution with activities requiring alertness, such as driving, until you understand how the medication affects you.

Warnings & Precautions

• Do not receive Imjudo if you are allergic to tremelimumab or any of its ingredients. Consult your doctor if uncertain.
• Before receiving Imjudo, it is important to discuss your medical history with your doctor, particularly if you have an autoimmune disease, have undergone organ transplantation, experience lung or breathing issues, or have liver problems. 
• Imjudo may lead to immune-mediated adverse reactions affecting various organ systems, with potential severity. 
• These reactions include pneumonitis, colitis, hepatitis, endocrinopathies, dermatologic issues, nephritis with renal dysfunction, and pancreatitis. 
• Regular monitoring is essential, involving assessments of liver enzymes, creatinine, adrenocorticotropic hormone levels, and thyroid function before each dose. 
• The treatment approach, whether adjustment or discontinuation, depends on the severity and type of the observed immune-mediated reaction. 
• Additionally, for infusion-related reactions, appropriate actions such as interruption, slowing the infusion rate, or permanent discontinuation of treatment should be considered based on the severity of the reaction.
• Inform your doctor about any current, recent, or potential intake of other medications, including herbal supplements and non-prescription drugs.

Common Imjudo Side Effects:

• Rash
• Diarrhea
• Fatigue
• Pruritus (itchiness)
• Musculoskeletal pain
• Abdominal pain 
• Increased AST (aspartate aminotransferase)
• Increased ALT (alanine aminotransferase)
• Decreased hemoglobin
• Decreased sodium
• Increased bilirubin
• Increased alkaline phosphatase
• Decreased lymphocytes

Use in Specific Population

• Imjudo is not intended for use in individuals under 18 years of age, as it has not been studied in this population. 
• Administration of Imjudo to pregnant women can pose a risk of fetal harm, and its use during pregnancy is not recommended due to a lack of available data. Inform your doctor if you are pregnant, planning to become pregnant, or suspect pregnancy. 
• Women capable of becoming pregnant must use effective contraception during Imjudo treatment and for at least 3 months after the final dose. 
• If you are breastfeeding, consult your doctor, as it is unclear whether Imjudo passes into human breast milk. 
• You may be advised to refrain from breastfeeding during treatment and for at least 3 months after the last dose.

Storage and Handling

• Store Imjudo at room temperature of 2°C to 8°C (36°F to 46°F).
• Do not freeze or shake the injection.
• Protect Imjudo from light and moisture.
• Keep Imjudo out of the reach of children and pets.

**Dosage: 

Cycle 1

•  ≥30 kg: Tremelimumab 300 mg IV + Durvalumab 1500 mg intravenous. 
• <30 kg: Tremelimumab 4 mg/kg IV + Durvalumab 20 mg/kg intravenous.

Cycle 2

• ≥30 kg: Durvalumab 1500 mg intravenous every 4 weeks/
• <30 kg: Durvalumab 20 mg/kg intravenous every 4 weeks.