Anti-CTLA-4 monoclonal antibodies
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Imjudo Injection Dosage

Drug Detail:Imjudo (Tremelimumab-actl)

Generic Name: TREMELIMUMAB 25mg in 1.25mL

Dosage Form: injection, solution

Drug Class: Anti-CTLA-4 monoclonal antibodies

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

Recommended Dosing for Unresectable Hepatocellular Carcinoma

The recommended dosage of IMJUDO is presented in Tables 1, 2 and 3.

Administer IMJUDO as an intravenous infusion after dilution as recommended [see Dosage and Administration (2.3)].

IMJUDO in Combination with Durvalumab

Table 1. Recommended dosage of IMJUDO
*
Administer IMJUDO prior to durvalumab on the same day.
†
Refer to the Prescribing Information for durvalumab dosing information.

Indication

Recommended IMJUDO dosage

Duration of Therapy

uHCC

Patients with a body weight of 30 kg and more:

•
A single dose of IMJUDO* 300 mg followed by durvalumab† 1,500 mg at Day 1 of Cycle 1
•
Continue durvalumab 1,500 mg as a single agent every 4 weeks

Patients with a body weight of less than 30 kg:

•
A single dose of IMJUDO* 4 mg/kg followed by durvalumab† 20 mg/kg at Day 1 of Cycle 1;
•
Continue durvalumab 20 mg/kg as a single agent every 4 weeks

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.

Table 2: Recommended Dosage Schedule
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
*
continue durvalumab until disease progression or intolerable toxicity.
†
dosing interval change from every 3 weeks to every 4 weeks starting at cycle 5.
‡
intravenous infusion over 60 minutes [see Dosage and Administration (2.3)].
§
if patients receive fewer than 4 cycles of platinum-based chemotherapy, the remaining cycles of IMJUDO (up to a total of 5) should be given after the platinum-based chemotherapy phase, in combination with durvalumab, every 4 weeks.
optional pemetrexed therapy from week 12 until disease progression or intolerable toxicity for patients with non-squamous disease who received treatment with pemetrexed and carboplatin/cisplatin.

Cycle:

1

2

3

4

5

6

7

8

IMJUDO‡§

X

X

X

X

X

Durvalumab*‡

X

X

X

X

X

X

X

X

Chemotherapy

X

X

X

X

X

X

X

X
Table 3: Recommended Regimen and Dosage
*
Refer to the Prescribing Information for dosing information.

Tumor Histology

Patient Weight

IMJUDO

Dosage

Durvalumab*

Dosage

Platinum-based

Chemotherapy Regime*

Non-Squamous

≥ 30 kg

75 mg

1,500 mg
•
carboplatin & nabpaclitaxl

OR

•
carboplatin or cisplatin & pemetrexed

< 30 kg

1 mg/kg

20 mg/kg

Squamous

≥ 30 kg

75 mg

1,500 mg
•
carboplatin & nabpaclitaxl

OR

•
carboplatin or cisplatin & gemcitabine

< 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 2.

Table 4. Recommended Dosage Modifications for Adverse Reactions
Adverse Reaction Severity* Dosage Modification
*
Based on National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03.
†
Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or an inability to reduce corticosteroid dose to 10 mg of prednisone or less per day (or equivalent) within 12 weeks of initiating corticosteroids.
‡
If AST and ALT are less than or equal to ULN at baseline in patients with liver involvement, withhold or permanently discontinue durvalumab based on recommendations for hepatitis with no liver involvement.

Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.1)]

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 [see Warnings and Precautions (5.2)]

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 transfer into an intravenous bag containing 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. Mix diluted solution by gentle inversion. Do not shake the solution. The maximum final concentration of the diluted solution should not exceed 10 mg/mL. The total volume of diluent for use with each dose and patient weight is presented in Table 5.
•
Discard partially used or empty vials of IMJUDO.
Table 5. IMJUDO Infusion Conditions
Dose Patient Weight Maximum diluent volume

300 mg

≥ 30 kg

150 mL

4 mg/kg

< 30 kg

80 mL

75 mg

≥ 30 kg

150 mL

1 mg/kg

< 30 kg

80 mL

Storage of 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 [see Warnings and Precautions (5.2)]. 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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