Dosing & Uses
Dosage Forms & Strengths
injectable solution, single-dose
- 5mg/mL (10mL, 40mL)
Melanoma
Unresectable or metastatic melanoma
- Indicated for treatment of unresectable or metastatic melanoma in adults and children aged ≥12 yr
- 3 mg/kg IV q3Weeks for a maximum of 4 doses
-
Combination with nivolumab
- Indicated in combination with nivolumab for unresectable or metastatic melanoma in adults
- Ipilimumab 3 mg/kg IV q3Weeks PLUS
- Nivolumab 1 mg/kg IV on the same day for maximum of 4 doses or until unacceptable toxicity, whichever occurs earlier
- After completing 4 doses of combination therapy: Administer nivolumab 240 mg IV q2Weeks or 480 mg IV q4Weeks as a single agent until disease progression or unacceptable toxicity
Cutaneous Melanoma
- Indicated for adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes >1 mm who have undergone complete resection, including total lymphadenectomy
- 10 mg/kg IV q3Weeks for 4 doses followed by 10 mg/kg q12Weeks for up to 3 yr
Renal Cell Carcinoma
Indicated in combination with nivolumab for patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma
Ipilimumab 1 mg/kg IV q3Weeks following nivolumab on the same day for 4 doses
After completing 4 doses of combination therapy, continue nivolumab as a single-agent until intolerable toxicity or disease progression
Also see nivolumab drug monograph for dose and continuation as monotherapy
Microsatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer
Indicated in combination with nivolumab for microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan
Ipilimumab 3 mg/kg IV immediately following nivolumab 1 mg/kg IV on the same day, q3Weeks for 4 doses
After completing 4 doses of combination therapy, continue nivolumab as a single-agent until intolerable toxicity or disease progression
Also see nivolumab drug monograph for dose and continuation as monotherapy
Hepatocellular Carcinoma
Indicated in combination with nivolumab for hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib
Ipilimumab 3 mg/kg IV immediately following nivolumab 1 mg/kg IV on the same day, q3Weeks for 4 doses
After completing 4 doses of combination therapy, continue nivolumab as a single-agent until intolerable toxicity or disease progression
Also see nivolumab drug monograph for dose and continuation as monotherapy
Non-Small Cell Lung Cancer
Combination with nivolumab
- Indicated in combination with nivolumab for first-line treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumors express PD-L1 (≥1%) with no EGFR or ALK genomic tumor aberrations
- Nivolumab 360 mg IV q3Weeks, PLUS
- Ipilimumab 1 mg/kg IV q6Weeks
- Continue until disease progression, unacceptable toxicity, or for up to 2 years in patients without disease progression
Combination with nivolumab and platinum-based chemotherapy
- Indicated in combination with nivolumab and 2 cycles of platinum-doublet chemotherapy, for first-line treatment of metastatic or recurrent NSCLC in adults with no EGFR or ALK genomic tumor aberrations
- Nivolumab 360 mg IV q3Weeks, PLUS
- Ipilimumab 1 mg/kg IV q6Weeks, PLUS
- Histology-based platinum doublet chemotherapy q3Weeks for 2 cycles
- Continue until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression
Malignant Pleural Mesothelioma
Indicated in combination with nivolumab for patients with unresectable malignant pleural mesothelioma, as first-line treatment
Ipilimumab 1 mg/kg IV q6Weeks, PLUS
Nivolumab 360 mg IV q3Weeks
Continue in combination with nivolumab until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression
Esophageal Cancer
Indicated for first-line treatment of unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) in combination with nivolumab
1 mg/kg IV q6Weeks plus nivolumab 3 mg/kg IV q2Weeks or 360 mg IV q3Weeks
Continue until disease progression, unacceptable toxicity, or up to 2 yr
Dosage Modifications
Note: No dose reduction is recommended for adverse reactions
Renal impairment
- All severities: No dosage adjustment required
Hepatic impairment
- Mild (TB >1 to 1.5x ULN or AST >ULN): No dose adjustment required
- Moderate-to-severe (TB >1.5x ULN and any AST): Not studied; caution advised
Pneumonitis
- Grade 2: Withhold therapy; resume when complete or partial resolution occurs (Grade <1) after corticosteroid taper
- Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone ≤10 mg/day (or equivalent) within 12 weeks of initiating steroids
- Grade 3 or 4: Permanently discontinue
Colitis
- Grade 2: Withhold therapy; resume when complete or partial resolution occurs (Grade <1) after corticosteroid taper
- Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone ≤10 mg/day (or equivalent) within 12 weeks of initiating steroids
- Grade 3 or 4: Permanently discontinue
Hepatitis with no tumor involvement of the liver
- AST or ALT increases to >3 and ≤8x ULN or total bilirubin increases to >1.5 and <3x ULN: Withhold therapy; resume when complete or partial resolution occurs (Grade <1) after corticosteroid taper
- Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone ≤10 mg/day (or equivalent) within 12 weeks of initiating steroids
- AST or ALT increases to >8x ULN or total bilirubin increases to >3x ULN: Permanently discontinue
Hepatitis with tumor involvement of the liver
-
Withhold therapy
- Baseline AST or ALT >1 and ≤3x ULN and increases to >5 and ≤10x ULN
- Baseline AST or ALT >3 and ≤5x ULN and increases to >8 and ≤10x ULN
- Resume when complete or partial resolution occurs (Grade <1) after corticosteroid taper
- Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone ≤10 mg/day (or equivalent) within 12 weeks of initiating steroids
-
Permanently discontinue
- AST or ALT increases to >10x ULN or total bilirubin increases to >3x ULN
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 therapy; resume when complete or partial resolution occurs (Grade <1) after corticosteroid taper
- Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone ≤10 mg/day (or equivalent) within 12 weeks of initiating steroids
- Grade 4 increased blood creatinine: Permanently discontinue
Exfoliative dermatologic conditions
- Suspected Steven Johnson Syndrome (SJS), toxic epidermal necrosis (TEN), or Drug Rash with Eosinophilia and Systemic Symptoms (DRESS): Withhold therapy
- Confirmed SJS, TEN, or DRESS: Permanently discontinue
- Myocarditis H4
- Grade 2, 3, or 4: Permanently discontinue
Neurologic toxicities
- Grade 2: Withhold therapy; resume when complete or partial resolution occurs (Grade <1) after corticosteroid taper
- Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone ≤10 mg/day (or equivalent) within 12 weeks of initiating steroids
- Grade 3 or 4: Permanently discontinue
Infusion-related reactions
- Grade 1 or 2: Interrupt or slow infusion rate
- Grade 3 or 4: Permanently discontinue
Dosing Considerations
Patient selection
- Patients selection should be based on PD-L1 expression
- Information on FDA-approved tests is available at: http://www.fda.gov/CompanionDiagnostics
Orphan Designations
Small cell lung cancer
Orphan sponsor
- Bristol-Myers Squibb Company; 5 Research Parkway; Wallingford, Connecticut 06492
Dosage Forms & Strengths
injectable solution, single-dose
- 5mg/mL (10mL, 40mL)
Unresectable or metastatic melanoma
Indicated as a single agent or in combination with nivolumab in adults and children aged ≥12 yr
<12 years: Safety and efficacy not established
Single agent
- ≥12 years: 3 mg/kg IV q3Weeks for a maximum of 4 doses
Combination with nivolumab
- Indicated in combination with nivolumab for unresectable or metastatic melanoma in adults
- Ipilimumab 3 mg/kg IV q3Weeks PLUS
- Nivolumab 1 mg/kg IV on the same day for maximum of 4 doses or until unacceptable toxicity, whichever occurs earlier
-
After completing 4 doses of combination therapy, administer nivolumab as a single agent
- ≥12 years and <40 kg: 3 mg/kg IV q2Weeks or 6 mg/kg IV q4Weeks until disease progression or unacceptable toxicity
- ≥12 years and ≥40 kg: 240 mg IV q2Weeks or 480 mg IV q4Weeks until disease progression or unacceptable toxicity
Microsatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer
Indicated in combination with nivolumab for patients aged ≥12 years with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan
<12 years: Safety and efficacy not established
≥12 years: 1 mg/kg IV q3Weeks following nivolumab on the same day; repeat for up to 4 doses or until intolerable toxicity or disease progression
Also see nivolumab drug monograph for dose and continuation as monotherapy
Dosage Modifications
Renal impairment
- All severities: No dosage adjustment required
Hepatic impairment
- Mild (TB >1 to 1.5 x ULN or AST >ULN): No dose adjustment required
- Moderate-to-severe (TB >1.5 x ULN and any AST): Not studied; caution advised
Interrupt or slow rate of infusion
- Grade 1 or 2 infusion-related reactions
Withhold
-
Resume in patients with complete or partial resolution (Grade 0 or 1) after corticosteroid taper
- Grade 2 colitis or diarrhea
- Grade 2 pneumonitis
- Grade 2 or 3 increased blood creatinine nephritis with renal dysfunction
- Grade 2 neurological toxicities
- Grade 2 myocarditis
-
Resume when acute symptoms have resolved
- Grade 2 to 4 hypophysitis
-
Resume when AST/ALT returns to baseline
- Hepatitis (AST or ALT >3x to <5x ULN or total bilirubin >1.5x to <3x ULN)
Withhold until specialist assessment
- Grade 2 exfoliative or bullous dermatologic conditions
Withhold if not clinically stable
- Grade 2 to 4 endocrinopathies
Permanently discontinue
- Grade 3 or 4 colitis or diarrhea
- Hepatitis (AST or ALT >5x ULN or total bilirubin >3x ULN)
- Grade 3 or 4 exfoliative or bullous dermatologic conditions
- Grade 3 or 4 pneumonitis
- Grade 4 increased blood creatinine
- Grade 3 or 4 myocarditis
- Grade 2 to 4 ophthalmologic that does not improve to Grade 1 within 2 weeks while receiving topical therapy or that requires systemic treatment
- Grade 3 or 4 neurological toxicities if signs of encephalitis or respiratory insufficiency due to neurological toxicity regardless of grade
- Grade 3 or 4 infusion-related reactions
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (8)
- axicabtagene ciloleucel
ipilimumab, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- brexucabtagene autoleucel
ipilimumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ciltacabtagene autoleucel
ipilimumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- idecabtagene vicleucel
ipilimumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- lisocabtagene maraleucel
ipilimumab, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- palifermin
palifermin increases toxicity of ipilimumab by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hr before, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.
- selinexor
selinexor, ipilimumab. unspecified interaction mechanism. Avoid or Use Alternate Drug. Patients treated with selinexor may experience neurological toxicities. Avoid taking selinexor with other medications that may cause dizziness or confusion.
- tisagenlecleucel
ipilimumab, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
Monitor Closely (9)
- cholera vaccine
ipilimumab decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.
- dengue vaccine
ipilimumab decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.
- efgartigimod alfa
efgartigimod alfa will decrease the level or effect of ipilimumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.
- efgartigimod/hyaluronidase SC
efgartigimod/hyaluronidase SC will decrease the level or effect of ipilimumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.
- ponesimod
ponesimod and ipilimumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- rozanolixizumab
rozanolixizumab will decrease the level or effect of ipilimumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing rozanolixizumab and using alternative therapies.
- siponimod
siponimod and ipilimumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- ublituximab
ublituximab and ipilimumab both increase immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered
- vemurafenib
ipilimumab, vemurafenib. Either increases toxicity of the other by Other (see comment). Modify Therapy/Monitor Closely. Comment: Grade 3 increases in transaminases and bilirubin observed in a majority of patients when coadministered.
Minor (0)
Adverse Effects
>10%
Dermatitis immune-mediated manifestations (up to 70%)
Fatigue (41%)
Diarrhea (32%)
Pruritus (31%)
Rash (29%)
1-10%
Colitis (8%)
Immune-mediated enterocolitis (7%)
Immune-mediated hepatitis (2%)
Endocrinopathies (1.8%) including adrenal insufficiency, hypogonadism, and hypothyroidism
<1%
Neurologic immune-mediated manifestations (eg, Guillain-Barre, peripheral motor neuropathy)
Ocular immune-mediated manifestations (eg, uveitis, iritis)
Nephrotic immune-mediated manifestations (nephritis)
Pulmonary immune-mediated manifestations (pneumonitis)
Other immune-mediated adverse reactions (<1%) include nephritis, pneumonitis, meningitis, pericarditis, uveitis, iritis, and hemolytic anemia
Meningitis
Pericarditis
Myocarditis
Angiopathy
Temporal arteritis
Vasculitis
Polymyalgia rheumatica
Conjunctivitis
Blepharitis
Episcleritis
Scleritis
Leukocytoclastic vasculitis
Erythema multiforme
Psoriasis
Pancreatitis
Arthritis
Autoimmune thyroiditis
Postmarketing Reports
Skin and subcutaneous tissue disorders: Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)
Blood and lymphatic system disorders: Hemophagocytic lymphohistiocytosis (HLH)
Immune System: Graft-versus-host disease, solid organ transplant rejection
Warnings
Contraindications
None
Cautions
Severe infusion-related reactions can occur; discontinue in patients with severe or life-threatening infusion reactions
Fatal or serious graft-versus-host disease (GVHD) can occur in patients who receive a CTLA-4 receptor blocking antibody either before or after allogeneic hematopoietic stem cell transplantation (HSCT); closely monitor for evidence of GVHD and intervene promptly; consider benefit versus risks of treatment with a CTLA-4 receptor blocking antibody after allogeneic HSCT
May cause fetal harm when administered to pregnant females
When used in combination with nivolumab, refer to nivolumab prescribing information for additional risk information that applies to the combination use treatment
Immune-mediated adverse reactions
- Owing to the mechanism of action that blocks T-cell inhibitory signal via CTLA-4 pathway, thereby removing inhibition of the immune response to potential immune-mediated adverse reactions
- In general, if interruption or discontinuation is necessary, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less; upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month; consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy
- Therapy can cause immune-mediated rash or dermatitis, including bullous and exfoliative dermatitis, Stevens-Johnson Syndrome, toxic epidermal necrolysis (TEN), and DRESS (drug rash with eosinophilia and systemic symptoms); topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-bullous/exfoliative rashes; withhold or permanently discontinue therapy depending on severity
- Immune-mediated adverse reactions (eg, hepatitis, dermatologic adverse reactions, endocrinopathies, pneumonitis, immune-mediated nephritis with renal dysfunction), which may be severe or fatal, can occur in any organ system or tissue
- Therapy can cause immune-mediated colitis, which may be fatal; cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis; in cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies
- Immune-mediated hypophysitis; hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts; hypophysitis can cause hypopituitarism. Initiate hormone replacement as clinically indicated; withhold or permanently discontinue therapy depending on severity
- May occur at any time after initiating therapy
- Immune-mediated adverse reactions usually manifest during treatment, but can also manifest after discontinuation
- Early detection and management are essential to ensure safe use
- Monitor for signs and symptoms of underlying immune-mediated adverse reactions
- Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose
- Adrenal insufficiency reported requiring hormone replacement therapy; insufficiency resolved in some patients therapy withheld, some patients received additional treatment after symptom improvement and some had recurrence
- Institute medical management promptly, including specialty consultation as appropriate
- Ipilimumab administered as single agent or in combination with nivolumab, caused <1% clinically significant immune-mediated adverse reactions, some withfatal outcome, including
-
Nervous System
- Autoimmune neuropathy (2%), meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis, Guillain-Barré syndrome, nerve paresis, motor dysfunction
-
Cardiovascular
- Angiopathy, myocarditis, pericarditis, temporal arteritis, vasculitis
-
Ocular
- Blepharitis, episcleritis, iritis, orbital myositis, scleritis, uveitis. Some cases can be associated with retinal detachment; if uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, which has been observed in patients receiving this drug and may require treatment with systemic corticosteroids to reduce risk of permanent vision loss
-
Gastrointestinal
- Duodenitis, gastritis, pancreatitis
-
Musculoskeletal and Connective Tissue
- Arthritis, myositis, polymyalgia rheumatica,polymyositis, rhabdomyolysis
-
Other (hematologic/immune)
- Aplastic anemia, conjunctivitis, cytopenias, eosinophilia, erythema multiforme, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), hypersensitivity vasculitis, meningitis, neurosensory hypoacusis, psoriasis, sarcoidosis, systemic inflammatory response syndrome, and solid organ transplant rejection
-
Pregnancy & Lactation
Pregnancy
Based on findings from animal studies and its mechanism of action, may cause fetal harm when administered to pregnant females
There is insufficient human data for drug exposure in pregnant females
Advise pregnant females of the potential risk to a fetus
Human IgG1 is known to cross the placental barrier and ipilimumab is an IgG1; therefore, ipilimumab has the potential to be transmitted from the mother to the developing fetus
Verify pregnancy status in females of reproductive potential prior to initiation
Report pregnancies to Bristol-Myers Squibb at 1-844-593-7869
Contraception
- Females of reproductive potential: Use effective contraception during treatment and for 3 months following last dose
Animal data
Administration of ipilimumab to cynomolgus monkeys from onset of organogenesis through delivery resulted in higher incidences of abortion, stillbirth, premature delivery (with corresponding lower birth weight), and higher incidences of infant mortality in a dose-related manner
- Effects of ipilimumab are likely to be greater during second and third trimesters of pregnancy
Lactation
Unknown whether distributed in human breast milk
Advise women to discontinue breastfeeding during treatment and for 3 months after last dose
In monkeys, ipilimumab was present in milk
There are no data to assess the effects on milk production
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Recombinant, human cytotoxic T-lymphocyte antigen 4 (CTLA-4) - blocking antibody
CTLA-4 is a negative regulator of T-cell activation; ipilimumab binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86
Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation
Proposed mechanism of action is indirect, possibly through inhibition of CTLA-4 signaling, which can in turn reduce T-regulatory cell function and may contribute to a general increase in T cell responsiveness, including the anti-tumor immune response
IgG1 kappa immunoglobulin with an approximate molecular weight of 148 kd; produced in mammalian (Chinese hamster ovary) cell culture
Absorption
Minimum plasma concentration: 19.4 mcg/mL (steady-state)
Distribution
Vd: 7.21 L (steady-state)
Elimination
Half-life (terminal): 15.4 days
Clearance: 16.8 mL/hr
When administered in combination with nivolumab, ipilimumab clearance was unchanged in presence of antiipilimumab antibodies and the CL of nivolumab increased by 20% in the presence of antinivolumab antibodies
Administration
IV Incompatibilities
Do not coadminister with other drugs through same IV line
IV Compatibilities
0.9% NaCl
Dextrose 5% (D5W)
IV Preparation
Do not shake vial
Allow vials to stand at room temperature for ~5 minutes
Withdraw required volume and transfer into an IV bag
Dilute with 0.9% NaCl or D5W to prepare a diluted solution with a final concentration ranging from 1-2 mg/mL
Mix diluted solution by gentle inversion
Discard partially used or empty vials
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
Infusion rate
- Unresectable or metastatic melanoma, renal cell carcinoma, MSI-H dMMR, hepatocellular carcinoma, NSCLC, malignant pleural mesothelioma: Infuse over 30 minutes
- Cutaneous melanoma: Infuse over 90 minutes
- Combined with ipilimumab: Infuse nivolumab first over 30 min followed by ipilimumab over 30 min on the same day; use separate infusion bags and filters for each infusion
- Infuse through an IV line containing a sterile, nonpyrogenic, low-protein-binding in-line filter
Administration with nivolumab
- When administered in combination with nivolumab, infuse nivolumab first followed by ipilimumab on the same day
- Use separate infusion bags and filters for each infusion
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 refrigerated (2-8°C; 36-46°F) or at room temperature (20-25°C; 68-77°F) for up to 24 hr
- Discard partially used vials or empty vials
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Yervoy intravenous - | 50 mg/10 mL (5 mg/mL) vial |  | |
| Yervoy intravenous - | 200 mg/40 mL (5 mg/mL) vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
ipilimumab intravenous
IPILIMUMAB - INJECTION
(IP-i-LIM-ue-mab)
COMMON BRAND NAME(S): Yervoy
USES: Ipilimumab is used to treat various cancers. Ipilimumab belongs to a class of drugs known as monoclonal antibodies. It works by slowing or stopping the growth of cancer cells. However, it can have serious side effects in other parts of your body (see also Side Effects section).
HOW TO USE: Read the Medication Guide and Patient Wallet Card provided by your pharmacist before you start using ipilimumab and before each treatment with this medication. If you have any questions, ask your doctor or pharmacist. Carry the Patient Wallet Card with you at all times. Show the card to all of your health care providers to let them know that you are being treated with ipilimumab.This medication is given by injection into a vein as directed by your doctor, usually by slow injection over 30 or 90 minutes. The injection is given by a health care professional. The dosage and treatment schedule are based on your medical condition, weight, and response to treatment.To decrease the risk of side effects, your doctor may prescribe other medications to take along with this medication. Carefully follow your doctor's directions for all your medications.Infusion reactions may occur while you are receiving this drug. Tell your doctor right away if you have symptoms such as shortness of breath, feeling faint, dizziness, or fever.Use this medication regularly to get the most benefit from it. It may help to mark your calendar with a reminder.
SIDE EFFECTS: See also How To Use section.Tiredness, nausea, or vomiting may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.This medication can cause serious (sometimes fatal) side effects in many parts of the body. These effects can occur during treatment with ipilimumab, but can also occur months after the last dose of this medication. Get medical help right away if you have any very serious side effects, including: headache that doesn't go away, signs of intestinal problems (such as diarrhea, mucus or blood in your stool, stomach pain), signs of liver disease (such as yellowing of skin/eyes, dark urine), unusual bleeding/bruising, unusual weakness, mouth sores, numbness/tingling in hands/feet, signs of thyroid problems (such as feeling cold all the time, heat intolerance, weight gain/loss, fast/pounding/irregular heartbeat), mental /mood changes, change in sex drive, signs of kidney problems (such as change in the amount of urine), increased thirst/urination, dizziness, fainting, eye pain/redness, vision changes (such as blurred vision, double vision, decreased vision, blindness), signs of lung problems (such as chest pain, shortness of breath, new/worsening cough), seizure, muscle pain, hearing loss, night sweats.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using ipilimumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: organ transplant, stem cell transplant with donor cells, immune system disorders (such as Guillain-Barre syndrome, lupus, sarcoidosis, Crohn's disease, ulcerative colitis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using ipilimumab. Ipilimumab may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of birth control while using this medication and for 3 months after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.This medication passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug and for 3 months after stopping treatment. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.A product that may interact with this drug include: vemurafenib.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Lab and/or medical tests (such as liver/thyroid/kidney function, ACTH blood levels) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.
STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.
Information last revised August 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
