ipilimumab (Rx)

Brand and Other Names:Yervoy
  • Print

Dosing & Uses

AdultPediatric

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

Ipilimumab1 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 3 mg/kg IV q2Weeks, 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/kg 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

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 H4

  • Grade 1 or 2: Interrupt or slow infusion rate
  • Grade 3 or 4: Permanently discontinue

Dosing Considerations

Patient selection

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)

Malignant Melanoma

Indicated for treatment of unresectable or metastatic melanoma in adults and adolescents aged ≥12 yr

<12 years: Safety and efficacy not established

≥12 years: 3 mg/kg IV q3Week for a maximum of 4 doses  

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
Next:

Interactions

Interaction Checker

and ipilimumab

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (2)

              • 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.

              Monitor Closely (5)

              • 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.

              • 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.

              • 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.

              • 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)

                Previous
                Next:

                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

                Previous
                Next:

                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
                • Institute medical management promptly, including specialty consultation as appropriate
                Previous
                Next:

                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.

                Previous
                Next:

                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

                Previous
                Next:

                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

                • Melanoma: Infuse over 90 minutes
                • Renal cell carcinoma, MSI-H dMMR, hepatocellular carcinoma, NSCLC, malignant pleural mesothelioma: Infuse over 30 minutes
                • 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
                Previous
                Next:

                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                Yervoy intravenous
                -
                200 mg/40 mL (5 mg/mL) vial
                Yervoy intravenous
                -
                50 mg/10 mL (5 mg/mL) vial

                Copyright © 2010 First DataBank, Inc.

                Previous
                Next:

                Patient Handout

                Patient Education
                ipilimumab intravenous

                IPILIMUMAB - INJECTION

                (IP-i-LIM-ue-mab)

                COMMON BRAND NAME(S): Yervoy

                USES: Ipilimumab is used to treat various cancers (such as skin, kidney, liver, lung, colorectal). 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 each time you get a refill. 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: Tiredness, nausea, or vomiting may occur. If any of these effects persist or worsen, 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: 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, persistent headache, 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. Ask about reliable forms of birth control while using this medication and for 3 months after stopping treatment. 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 2021. Copyright(c) 2021 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.

                Previous
                Next:

                Formulary

                FormularyPatient Discounts

                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.

                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
                Additional Offers
                Email to Patient

                From:

                To:

                The recipient will receive more details and instructions to access this offer.

                By clicking send, you acknowledge that you have permission to email the recipient with this information.

                Email Forms to Patient

                From:

                To:

                The recipient will receive more details and instructions to access this offer.

                By clicking send, you acknowledge that you have permission to email the recipient with this information.

                Previous
                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.