Imjudo Injection Dosage
Generic name: TREMELIMUMAB 25mg in 1.25mL
Dosage form: injection, solution
Drug class: Anti-CTLA-4 monoclonal antibodies
Medically reviewed by Drugs.com. Last updated on Jul 24, 2024.
Recommended Dosage
The recommended dosages of IMJUDO are presented in Tables 1, 2 and 3.
Administer IMJUDO as an intravenous infusion after dilution as recommended.
IMJUDO in Combination with Durvalumab
Indication |
Recommended IMJUDO Dosage |
Duration of Therapy |
uHCC |
Patients with a body weight of 30 kg and more:
Patients with a body weight of less than 30 kg: |
After Cycle 1 of combination therapy, administer durvalumab as a single agent every 4 weeks until disease progression or unacceptable toxicity |
IMJUDO in Combination with Durvalumab and Platinum-Based Chemotherapy
The recommended dosage schedule and regimens for IMJUDO for the treatment of metastatic non-small cell lung cancer (NSCLC) are provided in Tables 2 and 3.
Weigh patients prior to each infusion.
Calculate the appropriate dose using Table 3 below based on the patient’s weight and tumor histology.
Week*,† | |||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
0 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | 19 | 20 | 21 | 22 | 23 | 24 | |
|
|||||||||||||||||||||||||
Cycle: |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
|||||||||||||||||
X |
X |
X |
X |
X |
|||||||||||||||||||||
X |
X |
X |
X |
X |
X |
X |
X |
||||||||||||||||||
Chemotherapy |
X |
X |
X |
X |
X¶ |
X¶ |
X¶ |
X¶ |
|
||||
Tumor Histology |
Patient Weight |
IMJUDO Dosage |
Durvalumab* Dosage |
Platinum-based Chemotherapy Regimen* |
Non-Squamous |
≥ 30 kg |
75 mg |
1,500 mg |
OR
|
< 30 kg |
1 mg/kg |
20 mg/kg |
||
Squamous |
≥ 30 kg |
75 mg |
1,500 mg |
OR
|
< 30 kg |
1 mg/kg |
20 mg/kg |
Dosage Modifications for Adverse Reactions
No dose reduction for treatment is recommended. In general, withhold treatment regimen for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue treatment regimen for life-threatening (Grade 4) immune-mediated adverse reactions, recurrent severe (Grade 3) immune-mediated reactions that require systemic immunosuppressive treatment, or an inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks of initiating corticosteroids.
Recommended treatment modifications are presented in Table 4.
Adverse Reaction | Severity* | Dosage Modification |
---|---|---|
|
||
Immune-Mediated Adverse Reactions |
||
Pneumonitis |
Grade 2 |
Withhold† |
Grade 3 or 4 |
Permanently discontinue |
|
Colitis |
Grade 2 |
Withhold† |
Grade 3 or 4 |
Permanently discontinue |
|
Intestinal perforation |
Any grade |
Permanently discontinue |
Hepatitis with no tumor involvement of the liver |
ALT or AST increases to more than 3 and up to 8 times the ULN or total bilirubin increases to more than 1.5 and up to 3 times ULN |
Withhold† |
ALT or AST increases to more than 8 times ULN or total bilirubin increases to more than 3 times the ULN |
Permanently discontinue |
|
Hepatitis with tumor involvement of the liver‡ |
AST or ALT is more than 1 and up to 3 times ULN at baseline and increases to more than 5 and up to 10 times ULN or AST or ALT is more than 3 and up to 5 times ULN at baseline and increases to more than 8 and up to 10 times ULN |
Withhold† |
AST or ALT increases to more than 10 times ULN or Total bilirubin increases to more than 3 times ULN |
Permanently discontinue |
|
Endocrinopathies |
Grade 3 or 4 |
Withhold until clinically stable or permanently discontinue depending on severity |
Nephritis with Renal Dysfunction |
Grade 2 or 3 increased blood creatinine |
Withhold† |
Grade 4 increased blood creatinine |
Permanently discontinue |
|
Exfoliative Dermatologic Conditions |
Suspected SJS, TEN, or DRESS |
Withhold† |
Confirmed SJS, TEN, or DRESS |
Permanently discontinue |
|
Myocarditis |
Grade 2, 3, or 4 |
Permanently discontinue |
Neurological Toxicities |
Grade 2 |
Withhold† |
Grade 3 or 4 |
Permanently discontinue |
|
Other Adverse Reactions |
||
Infusion-related reactions |
Grade 1 or 2 |
Interrupt or slow the rate of infusion |
Grade 3 or 4 |
Permanently discontinue |
|
ALT = alanine aminotransferase, AST = aspartate aminotransferase, DRESS = Drug Rash with Eosinophilia and Systemic Symptoms, SJS = Stevens Johnson Syndrome, TEN = toxic epidermal necrolysis, ULN = upper limit normal |
Preparation and Administration
Preparation
- •
- Visually inspect drug product for particulate matter and discoloration. Discard if the solution is cloudy, discolored, or visible particles are observed.
- •
- Do not shake the vial.
- •
- Withdraw the required volume from the vial(s) of IMJUDO and discard the vial with any unused portion.
- •
- Transfer into an intravenous bag containing 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP and dilute to a concentration between 0.1 mg/mL and 10 mg/mL. Mix diluted solution by gentle inversion. Do not shake the solution.
Storage of Diluted IMJUDO Infusion Solution
- •
- IMJUDO does not contain a preservative. Administer infusion solution immediately once prepared. If infusion solution is not administered immediately and needs to be stored, the total time from preparation to the start of administration should not exceed:
- •
- 24 hours in a refrigerator at 2°C to 8°C (36°F to 46°F)
- •
- 24 hours at room temperature up to 30°C (86°F)
- •
- Do not freeze.
- •
- Do not shake.
Administration
- •
- Administer IMJUDO infusion solution intravenously over 60 minutes through an intravenous line containing a sterile, low-protein binding 0.2 or 0.22 micron filter.
- •
- Use separate infusion bags and filters for each drug product.
IMJUDO In Combination with Other Products
- •
- Administer all drug products as separate intravenous infusions.
- •
- Do not co-administer other drugs through the same infusion line.
- •
- For platinum-based chemotherapy, refer to Prescribing Information for administration information.
- •
- For pemetrexed treatment, refer to Prescribing Information for administration information.
Combination Regimens: Order of Infusions
IMJUDO in Combination with Durvalumab
- •
- Infuse IMJUDO, followed by durvalumab on the same day of dosing.
IMJUDO in Combination with Durvalumab and Platinum-based Chemotherapy
- •
- Infuse IMJUDO first, followed by durvalumab and then platinum-based chemotherapy on the day of dosing.
IMJUDO in Combination with Durvalumab and Pemetrexed Therapy
- •
- Infuse IMJUDO first, followed by durvalumab and then pemetrexed treatment on the day of dosing.
Combination Regimens: Infusion Instructions
IMJUDO in Combination with Durvalumab
- •
- Observe patient for 60 minutes following completion of IMJUDO infusion. Then administer durvalumab as a separate intravenous infusion over 60 minutes
IMJUDO in Combination with Durvalumab and Platinum-based Chemotherapy/ Pemetrexed Therapy
Cycle 1:
Infuse IMJUDO over one hour. One to two hours after completion of IMJUDO infusion, infuse durvalumab over one hour. One to two hours after completion of durvalumab infusion, administer platinum-based chemotherapy.
Subsequent Cycles:
If there are no infusion reactions during cycle 1, subsequent cycles of durvalumab can be given immediately after IMJUDO. The time between the end of the durvalumab infusion and the start of chemotherapy can be reduced to 30 minutes.
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