Ipilimumab

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may interact with ipilimumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

IV Compatibility

0.9% NaCl (normal saline)

Dextrose 5% (D5W)

IV Preparation

Do not shake vial

Allow the vials to stand at room temperature for ~5 minutes prior to preparation of infusion

Withdraw the required volume and transfer into an intravenous bag

Dilute with 0.9% NaCl (normal saline) or 5% dextrose (D5W) to prepare a diluted solution with a final concentration ranging from 1-2 mg/mL

Mix diluted solution by gentle inversion

IV Administration

Do not mix with, or administer as an infusion with, other medicinal products

Flush the IV line with 0.9% NaCl or D5W after each dose.

Administer diluted solution over 90 minutes through an IV line containing a sterile, nonpyrogenic, low-protein-binding in-line filter

Storage

Unopened vials

• Store refrigerated at 2-8°C (36-46°F)
• Do not freeze
• Protect vials from light

Diluted solution

• Store the diluted solution for no more than 24 hours under refrigeration (2-8°C, 36-46°F) or at room temperature (20-25°C, 68-77°F)
• Discard partially used vials or empty vials

Ipilimumab may be found in some form under the following brand names:

• Yervoy

Ipilimumab is usually administered by a healthcare provider in a medical setting making it unlikely for an overdose to occur. However, if an overdose is suspected, seek emergency medical attention.

Since ipilimumab is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

No formal drug interaction studies to date.1

Ipilimumab is a recombinant human IgG1 immunoglobulin monoclonal antibody which binds to the cytotoxic T-lymphocyte associated antigen 4 (CTLA-4). CTLA-4 is a down-regulator of T-cell activation pathways. Blocking CTLA-4 allows for enhanced T-cell activation and proliferation. In melanoma, ipilimumab may indirectly mediate T-cell immune responses against tumors.

Half-Life Elimination

Terminal: 15.4 days

Body weight: Clearance is increased with increasing body weight.

Melanoma, unresectable or metastatic: IV: 3 mg/kg every 3 weeks for a maximum of 4 doses (Hodi 2010); doses may be delayed due to toxicity, but all doses must be administered within 16 weeks of the initial dose.

Melanoma, adjuvant treatment: IV: 10 mg/kg every 3 weeks for 4 doses, followed by 10 mg/kg every 12 weeks for up to 3 years unless disease progression or unacceptable toxicity occur (Eggermont 2016); if toxicity occurs, doses are omitted (not delayed).

Melanoma, unresectable or metastatic, first-line combination therapy (off-label use): IV: 3 mg/kg every 3 weeks for 4 doses (in combination with nivolumab; with nivolumab continued until disease progression or unacceptable toxicity) (Larkin 2015).

Small cell lung cancer, progressive (off-label use): IV: 3 mg/kg every 3 weeks (in combination with nivolumab) for 4 doses, followed by nivolumab monotherapy (Antonia 2016).

Initial dose: 3 mg/kg IV over 90 minutes every 3 weeks for a total of 4 doses

Comment:
-In the event of toxicity, doses may be delayed, but all treatment must be administered within 16 weeks of the first dose.

Use: For the treatment of unresectable or metastatic melanoma

No adjustment recommended.

Administration advice:
-It should not be mixed or administered with any other drug. The diluted solution should be administered over 90 minutes through an IV line containing a sterile, nonpyogenic, low-protein binding in-line filter. Following each administration, the IV line should be flushed with 0.9% sodium chloride or 5% dextrose.

Storage requirements:
-This drug should be stored in a refrigerator at 36 to 46 degrees Fahrenheit (2 to 8 degrees Celsius) and protected from light.
-Vials should not be shaken or frozen.