IMJUDO 300 mg/15mL
tremelimumab · INJECTION, SOLUTION · AstraZeneca Pharmaceuticals LP
IMJUDO is a injection, solution containing tremelimumab at 300 mg/15mL, taken intravenous. Manufactured by AstraZeneca Pharmaceuticals LP.
Key Facts
- Brand Name
- IMJUDO
- Generic Name
- tremelimumab
- NDC Code (Product)
0310-4535- Manufacturer
- AstraZeneca Pharmaceuticals LP
- Strength
- 300 mg/15mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA761289
- Drug Class
- CTLA-4-directed Blocking Antibody [EPC]
- Marketing Start
- 10/21/2022
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE IMJUDO is a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody indicated: • in combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). ( 1.1 ) • in combination with durvalumab and platinum-based chemotherapy for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. ( 1.2 ) 1.1 Hepatocellular Carcinoma IMJUDO, in combination with durvalumab, is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). 1.2 Non-Small Cell Lung Cancer (NSCLC) IMJUDO, in combination with durvalumab and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Administer IMJUDO as an intravenous infusion over 60 minutes after dilution. ( 2.3 ) • uHCC: Weight 30 kg and more: IMJUDO 300 mg as a single dose in combination with durvalumab 1,500 mg at Cycle 1/Day 1, followed by durvalumab as a single agent every 4 weeks ( 2.1 ) Weight less than 30 kg: IMJUDO 4 mg/kg as a single dose in combination with durvalumab 20 mg/kg at Cycle 1/Day 1, followed by durvalumab as a single agent every 4 weeks ( 2.1 ) • Metastatic NSCLC: Weight 30 kg and more: 75 mg every 3 weeks in combination with durvalumab 1,500 mg and platinum-based chemotherapy for 4 cycles, and then administer durvalumab 1,500 mg every 4 weeks as a single agent with histology-based pemetrexed therapy every 4 weeks, and a fifth dose of IMJUDO 75 mg in combination with durvalumab dose 6 at week 16 ( 2.1 ) Weight less than 30 kg: 1 mg/kg every 3 weeks in combination with durvalumab 20 mg/kg and platinum-based chemotherapy for 4 cycles, and then administer durvalumab 20 mg/kg every 4 weeks as a single agent with histology-based pemetrexed therapy every 4 weeks, and a fifth dose of IMJUDO 1 mg/kg in combination with durvalumab dose 6 at week 16 ( 2.1 ) • See fu…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling. • Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.1) ] . • Infusion-Related Reactions [see Warnings and Precautions (5.2) ]. Most common adverse reactions (≥ 20%) of patients with uHCC are rash, diarrhea, fatigue, pruritus, musculoskeletal pain, and abdominal pain. Most common laboratory abnormalities (≥ 40%) of patients with uHCC are AST increased, ALT increased, hemoglobin decreased, sodium decreased, bilirubin increased, alkaline phosphatase increased, and lymphocytes decreased. ( 6.1 ) Most common adverse reactions (≥ 20%) of patients with metastatic NSCLC were nausea, fatigue, musculoskeletal pain, decreased appetite, rash, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observe…
Frequently Asked Questions
What is IMJUDO used for?
IMJUDO contains tremelimumab. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is IMJUDO a controlled substance?
IMJUDO is not classified as a controlled substance by the DEA.
What is the generic name for IMJUDO?
The generic name for IMJUDO is tremelimumab. There are no other listed brand versions of tremelimumab.
What is the NDC code for IMJUDO 300 mg/15mL?
The NDC (National Drug Code) for IMJUDO 300 mg/15mL is 0310-4535, listed by AstraZeneca Pharmaceuticals LP.
Other IMJUDO Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)