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Drug overview for YERVOY (ipilimumab):
Generic name: IPILIMUMAB (IP-i-LIM-ue-mab)
Drug class: Antineoplastic-Cytotoxic T-Lymp. antigen (CTLA-4),R-MC Antib
Therapeutic class: Antineoplastics
Ipilimumab, a recombinant, fully human monoclonal antibody that binds to cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), is an antineoplastic agent.
No enhanced Uses information available for this drug.
Generic name: IPILIMUMAB (IP-i-LIM-ue-mab)
Drug class: Antineoplastic-Cytotoxic T-Lymp. antigen (CTLA-4),R-MC Antib
Therapeutic class: Antineoplastics
Ipilimumab, a recombinant, fully human monoclonal antibody that binds to cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), is an antineoplastic agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
YERVOY 50 MG/10 ML VIAL
YERVOY 200 MG/40 ML VIAL
The following indications for YERVOY (ipilimumab) have been approved by the FDA:
Indications:
Adjuvant treatment of melanoma
EGFR negative, ALK negative, non-small cell lung cancer
Esophageal squamous cell carcinoma
Liver cell carcinoma
Malignant mesothelioma of pleura
Metastatic malignant melanoma
Microsatellite instability-high colorectal cancer
PD-L1 positive, EGFR-negative, ALK-negative metastatic non-small cell lung cancer
Renal cell carcinoma
Professional Synonyms:
Carcinoma of kidney
DMMR colorectal cancer
EGFR-negative, ALK mut (-) non-small cell lung cancer
EGFR-negative, ALK-negative, NSCLC
Grawitz tumor
Hepatocarcinoma
Hepatocellular carcinoma
Hypernephroid carcinoma
Hypernephroma
Kidney adenocarcinoma
Mismatch repair deficient colorectal cancer
MSI-H colorectal cancer
Nephroid carcinoma
PD-L1 expressing, EGFR mutation negative, ALK mutation negative metastatic NSCLC
PD-L1 positive metastatic non-small cell lung cancer with no EGFR or ALK mutations
PD-L1 positive, EGFR-negative, ALK-negative NSCLC
Renal adenocarcinoma
Renal carcinoma
Renal cell adenocarcinoma
SCC of esophagus
Indications:
Adjuvant treatment of melanoma
EGFR negative, ALK negative, non-small cell lung cancer
Esophageal squamous cell carcinoma
Liver cell carcinoma
Malignant mesothelioma of pleura
Metastatic malignant melanoma
Microsatellite instability-high colorectal cancer
PD-L1 positive, EGFR-negative, ALK-negative metastatic non-small cell lung cancer
Renal cell carcinoma
Professional Synonyms:
Carcinoma of kidney
DMMR colorectal cancer
EGFR-negative, ALK mut (-) non-small cell lung cancer
EGFR-negative, ALK-negative, NSCLC
Grawitz tumor
Hepatocarcinoma
Hepatocellular carcinoma
Hypernephroid carcinoma
Hypernephroma
Kidney adenocarcinoma
Mismatch repair deficient colorectal cancer
MSI-H colorectal cancer
Nephroid carcinoma
PD-L1 expressing, EGFR mutation negative, ALK mutation negative metastatic NSCLC
PD-L1 positive metastatic non-small cell lung cancer with no EGFR or ALK mutations
PD-L1 positive, EGFR-negative, ALK-negative NSCLC
Renal adenocarcinoma
Renal carcinoma
Renal cell adenocarcinoma
SCC of esophagus
The following dosing information is available for YERVOY (ipilimumab):
The recommended adult dosage of ipilimumab for the treatment of unresectable or metastatic melanoma is 3 mg/kg given by IV infusion once every 3 weeks for a total of 4 doses.
Ipilimumab therapy should be permanently discontinued in patients experiencing any severe or life-threatening immune-mediated adverse reactions. (See Warnings under Cautions: Warnings/Precautions.)
Ipilimumab therapy should be temporarily withheld in patients experiencing any moderate immune-mediated adverse reactions or symptomatic endocrinopathy. (See Warnings under Cautions: Warnings/Precautions.) If the adverse reaction completely or partially resolves to grade 0 or 1 and the patient is receiving 7.5 mg or less of prednisone per day (or equivalent), ipilimumab may be resumed at a dosage of 3 mg/kg every 3 weeks until all 4 planned doses have been administered or 16 weeks have elapsed since the first dose, whichever occurs first.
Ipilimumab therapy should be permanently discontinued in patients experiencing persistent moderate immune-mediated adverse reactions and in those unable to reduce corticosteroid dosage to 7.5 mg or less of prednisone per day (or equivalent).
Ipilimumab therapy should be permanently discontinued in patients unable to complete the full treatment course within 16 weeks after receiving the first dose.
Ipilimumab therapy should be permanently discontinued in patients experiencing any severe or life-threatening immune-mediated adverse reactions. (See Warnings under Cautions: Warnings/Precautions.)
Ipilimumab therapy should be temporarily withheld in patients experiencing any moderate immune-mediated adverse reactions or symptomatic endocrinopathy. (See Warnings under Cautions: Warnings/Precautions.) If the adverse reaction completely or partially resolves to grade 0 or 1 and the patient is receiving 7.5 mg or less of prednisone per day (or equivalent), ipilimumab may be resumed at a dosage of 3 mg/kg every 3 weeks until all 4 planned doses have been administered or 16 weeks have elapsed since the first dose, whichever occurs first.
Ipilimumab therapy should be permanently discontinued in patients experiencing persistent moderate immune-mediated adverse reactions and in those unable to reduce corticosteroid dosage to 7.5 mg or less of prednisone per day (or equivalent).
Ipilimumab therapy should be permanently discontinued in patients unable to complete the full treatment course within 16 weeks after receiving the first dose.
Ipilimumab is administered by IV infusion. Ipilimumab is available as a 5-mg/mL, preservative-free, injection concentrate in single-use vials containing 50 or 200 mg of the drug. Ipilimumab injection concentrate should be protected from light, stored at 2-8degreesC, and should not be frozen.
Ipilimumab injection concentrate must be diluted prior to administration. Prior to dilution, the appropriate number of vials containing ipilimumab injection concentrate should stand at room temperature for approximately 5 minutes. For IV infusion, the appropriate dose should be withdrawn from the vial(s) and injected into an IV bag.
The injection concentrate should then be diluted with 0.9% sodium chloride or 5% dextrose injection to achieve a final ipilimumab concentration of 1-2 mg/mL. This diluted solution should be mixed by gentle inversion.
Vials containing ipilimumab injection concentrate and diluted solutions of the drug should not be shaken. The diluted solution may be refrigerated or stored at controlled room temperature for no more than 24 hours. Any partially used vials, including unused diluted solution, should be discarded.
Ipilimumab injection concentrate should not be admixed or infused with other drugs. Final diluted ipilimumab solutions should be infused IV over 90 minutes using an in-line, sterile, nonpyrogenic, low-protein-binding filter. The IV line should be flushed with 0.9% sodium chloride or 5% dextrose injection after each dose.
Ipilimumab injection concentrate must be diluted prior to administration. Prior to dilution, the appropriate number of vials containing ipilimumab injection concentrate should stand at room temperature for approximately 5 minutes. For IV infusion, the appropriate dose should be withdrawn from the vial(s) and injected into an IV bag.
The injection concentrate should then be diluted with 0.9% sodium chloride or 5% dextrose injection to achieve a final ipilimumab concentration of 1-2 mg/mL. This diluted solution should be mixed by gentle inversion.
Vials containing ipilimumab injection concentrate and diluted solutions of the drug should not be shaken. The diluted solution may be refrigerated or stored at controlled room temperature for no more than 24 hours. Any partially used vials, including unused diluted solution, should be discarded.
Ipilimumab injection concentrate should not be admixed or infused with other drugs. Final diluted ipilimumab solutions should be infused IV over 90 minutes using an in-line, sterile, nonpyrogenic, low-protein-binding filter. The IV line should be flushed with 0.9% sodium chloride or 5% dextrose injection after each dose.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| YERVOY 50 MG/10 ML VIAL | Maintenance | Adults infuse 3 mg/kg over 30 minute(s) by intravenous route every 3 weeks for 4 doses |
| YERVOY 200 MG/40 ML VIAL | Maintenance | Adults infuse 3 mg/kg over 30 minute(s) by intravenous route every 3 weeks for 4 doses |
No generic dosing information available.
The following drug interaction information is available for YERVOY (ipilimumab):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for YERVOY (ipilimumab):
Drug contraindication overview.
The manufacturer states that there are no known contraindications to the use of ipilimumab.
The manufacturer states that there are no known contraindications to the use of ipilimumab.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Lactation |
There are 3 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Guillain-barre syndrome |
| Myasthenia gravis |
| Pregnancy |
There are 3 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Hyperthyroidism |
| Hypothyroidism |
| Kidney disease with reduction in glomerular filtration rate (GFr) |
The following adverse reaction information is available for YERVOY (ipilimumab):
Adverse reaction overview.
Adverse effects reported in 5% or more of patients receiving ipilimumab include fatigue, diarrhea, pruritus, rash, and colitis.
Adverse effects reported in 5% or more of patients receiving ipilimumab include fatigue, diarrhea, pruritus, rash, and colitis.
There are 68 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Colitis Lymphopenia |
Abnormal hepatic function tests Anemia Enterocolitis Hepatitis Hypercortisolism Hyperthyroidism Hypothyroidism Ileus Pituitary insufficiency |
| Rare/Very Rare |
|---|
|
Acute respiratory distress syndrome Adrenocortical insufficiency Aplastic anemia Autoimmune hemolytic anemia Autoimmune hepatitis Cytomegalovirus colitis DRESS syndrome Duodenitis Encephalitis Erythema multiforme Esophagitis Gastrointestinal perforation Gastrointestinal ulcer Giant cell arteritis Graft-versus-host disease Guillain-barre syndrome Hashimoto thyroiditis Hearing loss Hemophagocytic lymphohistiocytosis Hepatic failure Histiocytic necrotizing lymphadenitis Hypersensitivity angiitis Hypersensitivity drug reaction Hypersensitivity pneumonitis Hypophysitis Interstitial nephritis Interstitial pneumonitis Intestinal perforation Iritis Meningitis Multiple organ failure Muscle weakness Myasthenia gravis Myelitis Myocarditis Myositis Nephritis Orbital myositis Organ transplant rejection Pancreatitis Pericarditis Peripheral motor neuropathy Polymyalgia rheumatica Polymyositis Posterior reversible encephalopathy syndrome Renal failure Retinal detachment Rhabdomyolysis Sarcoidosis Scleritis Sepsis Stevens-johnson syndrome Toxic epidermal necrolysis Uveitis Vasculitis Vision impairment Vogt-koyanagi-harada disease |
There are 24 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Anorexia Diarrhea Fatigue Fever Headache disorder Nausea Pruritus of skin Skin rash Weight loss |
Hypogonadotropic hypogonadism Insomnia Skin inflammation Urticaria Vomiting |
| Rare/Very Rare |
|---|
|
Arthritis Blepharitis Blurred vision Conjunctivitis Eosinophilia Hypoesthesia Paresthesia Peripheral sensory neuropathy Psoriasis Reduced visual acuity |
The following precautions are available for YERVOY (ipilimumab):
Safety and efficacy of ipilimumab have not been established in pediatric patients younger than 18 years of age.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Category C. (See Users Guide.)
It is not known whether ipilimumab is distributed into milk. A decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.
No substantial difference in safety and efficacy relative to younger adults have been observed.
The following prioritized warning is available for YERVOY (ipilimumab):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for YERVOY (ipilimumab)'s list of indications:
| Adjuvant treatment of melanoma | |
| C43 | Malignant melanoma of skin |
| C43.0 | Malignant melanoma of lip |
| C43.1 | Malignant melanoma of eyelid, including canthus |
| C43.10 | Malignant melanoma of unspecified eyelid, including canthus |
| C43.11 | Malignant melanoma of right eyelid, including canthus |
| C43.111 | Malignant melanoma of right upper eyelid, including canthus |
| C43.112 | Malignant melanoma of right lower eyelid, including canthus |
| C43.12 | Malignant melanoma of left eyelid, including canthus |
| C43.121 | Malignant melanoma of left upper eyelid, including canthus |
| C43.122 | Malignant melanoma of left lower eyelid, including canthus |
| C43.2 | Malignant melanoma of ear and external auricular canal |
| C43.20 | Malignant melanoma of unspecified ear and external auricular canal |
| C43.21 | Malignant melanoma of right ear and external auricular canal |
| C43.22 | Malignant melanoma of left ear and external auricular canal |
| C43.3 | Malignant melanoma of other and unspecified parts of face |
| C43.30 | Malignant melanoma of unspecified part of face |
| C43.31 | Malignant melanoma of nose |
| C43.39 | Malignant melanoma of other parts of face |
| C43.4 | Malignant melanoma of scalp and neck |
| C43.5 | Malignant melanoma of trunk |
| C43.51 | Malignant melanoma of anal skin |
| C43.52 | Malignant melanoma of skin of breast |
| C43.59 | Malignant melanoma of other part of trunk |
| C43.6 | Malignant melanoma of upper limb, including shoulder |
| C43.60 | Malignant melanoma of unspecified upper limb, including shoulder |
| C43.61 | Malignant melanoma of right upper limb, including shoulder |
| C43.62 | Malignant melanoma of left upper limb, including shoulder |
| C43.7 | Malignant melanoma of lower limb, including hip |
| C43.70 | Malignant melanoma of unspecified lower limb, including hip |
| C43.71 | Malignant melanoma of right lower limb, including hip |
| C43.72 | Malignant melanoma of left lower limb, including hip |
| C43.8 | Malignant melanoma of overlapping sites of skin |
| C43.9 | Malignant melanoma of skin, unspecified |
| EGFR negative, ALK negative, non-small cell lung cancer | |
| C34 | Malignant neoplasm of bronchus and lung |
| C34.0 | Malignant neoplasm of main bronchus |
| C34.00 | Malignant neoplasm of unspecified main bronchus |
| C34.01 | Malignant neoplasm of right main bronchus |
| C34.02 | Malignant neoplasm of left main bronchus |
| C34.1 | Malignant neoplasm of upper lobe, bronchus or lung |
| C34.10 | Malignant neoplasm of upper lobe, unspecified bronchus or lung |
| C34.11 | Malignant neoplasm of upper lobe, right bronchus or lung |
| C34.12 | Malignant neoplasm of upper lobe, left bronchus or lung |
| C34.2 | Malignant neoplasm of middle lobe, bronchus or lung |
| C34.3 | Malignant neoplasm of lower lobe, bronchus or lung |
| C34.30 | Malignant neoplasm of lower lobe, unspecified bronchus or lung |
| C34.31 | Malignant neoplasm of lower lobe, right bronchus or lung |
| C34.32 | Malignant neoplasm of lower lobe, left bronchus or lung |
| C34.8 | Malignant neoplasm of overlapping sites of bronchus and lung |
| C34.80 | Malignant neoplasm of overlapping sites of unspecified bronchus and lung |
| C34.81 | Malignant neoplasm of overlapping sites of right bronchus and lung |
| C34.82 | Malignant neoplasm of overlapping sites of left bronchus and lung |
| C34.9 | Malignant neoplasm of unspecified part of bronchus or lung |
| C34.90 | Malignant neoplasm of unspecified part of unspecified bronchus or lung |
| C34.91 | Malignant neoplasm of unspecified part of right bronchus or lung |
| C34.92 | Malignant neoplasm of unspecified part of left bronchus or lung |
| Esophageal squamous cell carcinoma | |
| C15 | Malignant neoplasm of esophagus |
| C15.3 | Malignant neoplasm of upper third of esophagus |
| C15.4 | Malignant neoplasm of middle third of esophagus |
| C15.5 | Malignant neoplasm of lower third of esophagus |
| C15.8 | Malignant neoplasm of overlapping sites of esophagus |
| C15.9 | Malignant neoplasm of esophagus, unspecified |
| Liver cell carcinoma | |
| C22.0 | Liver cell carcinoma |
| Malignant mesothelioma of pleura | |
| C45.0 | Mesothelioma of pleura |
| Metastatic malignant melanoma | |
| C43 | Malignant melanoma of skin |
| C43.0 | Malignant melanoma of lip |
| C43.1 | Malignant melanoma of eyelid, including canthus |
| C43.10 | Malignant melanoma of unspecified eyelid, including canthus |
| C43.11 | Malignant melanoma of right eyelid, including canthus |
| C43.111 | Malignant melanoma of right upper eyelid, including canthus |
| C43.112 | Malignant melanoma of right lower eyelid, including canthus |
| C43.12 | Malignant melanoma of left eyelid, including canthus |
| C43.121 | Malignant melanoma of left upper eyelid, including canthus |
| C43.122 | Malignant melanoma of left lower eyelid, including canthus |
| C43.2 | Malignant melanoma of ear and external auricular canal |
| C43.20 | Malignant melanoma of unspecified ear and external auricular canal |
| C43.21 | Malignant melanoma of right ear and external auricular canal |
| C43.22 | Malignant melanoma of left ear and external auricular canal |
| C43.3 | Malignant melanoma of other and unspecified parts of face |
| C43.30 | Malignant melanoma of unspecified part of face |
| C43.31 | Malignant melanoma of nose |
| C43.39 | Malignant melanoma of other parts of face |
| C43.4 | Malignant melanoma of scalp and neck |
| C43.5 | Malignant melanoma of trunk |
| C43.51 | Malignant melanoma of anal skin |
| C43.52 | Malignant melanoma of skin of breast |
| C43.59 | Malignant melanoma of other part of trunk |
| C43.6 | Malignant melanoma of upper limb, including shoulder |
| C43.60 | Malignant melanoma of unspecified upper limb, including shoulder |
| C43.61 | Malignant melanoma of right upper limb, including shoulder |
| C43.62 | Malignant melanoma of left upper limb, including shoulder |
| C43.7 | Malignant melanoma of lower limb, including hip |
| C43.70 | Malignant melanoma of unspecified lower limb, including hip |
| C43.71 | Malignant melanoma of right lower limb, including hip |
| C43.72 | Malignant melanoma of left lower limb, including hip |
| C43.8 | Malignant melanoma of overlapping sites of skin |
| C43.9 | Malignant melanoma of skin, unspecified |
| Microsatellite instability-high colorectal cancer | |
| C18 | Malignant neoplasm of colon |
| C18.0 | Malignant neoplasm of cecum |
| C18.1 | Malignant neoplasm of appendix |
| C18.2 | Malignant neoplasm of ascending colon |
| C18.3 | Malignant neoplasm of hepatic flexure |
| C18.4 | Malignant neoplasm of transverse colon |
| C18.5 | Malignant neoplasm of splenic flexure |
| C18.6 | Malignant neoplasm of descending colon |
| C18.7 | Malignant neoplasm of sigmoid colon |
| C18.8 | Malignant neoplasm of overlapping sites of colon |
| C18.9 | Malignant neoplasm of colon, unspecified |
| C19 | Malignant neoplasm of rectosigmoid junction |
| C20 | Malignant neoplasm of rectum |
| C21.8 | Malignant neoplasm of overlapping sites of rectum, anus and anal canal |
| Pd-l1 positive, EGFr-negative, ALk-negative metast NSCLC | |
| C34 | Malignant neoplasm of bronchus and lung |
| C34.0 | Malignant neoplasm of main bronchus |
| C34.00 | Malignant neoplasm of unspecified main bronchus |
| C34.01 | Malignant neoplasm of right main bronchus |
| C34.02 | Malignant neoplasm of left main bronchus |
| C34.1 | Malignant neoplasm of upper lobe, bronchus or lung |
| C34.10 | Malignant neoplasm of upper lobe, unspecified bronchus or lung |
| C34.11 | Malignant neoplasm of upper lobe, right bronchus or lung |
| C34.12 | Malignant neoplasm of upper lobe, left bronchus or lung |
| C34.2 | Malignant neoplasm of middle lobe, bronchus or lung |
| C34.3 | Malignant neoplasm of lower lobe, bronchus or lung |
| C34.30 | Malignant neoplasm of lower lobe, unspecified bronchus or lung |
| C34.31 | Malignant neoplasm of lower lobe, right bronchus or lung |
| C34.32 | Malignant neoplasm of lower lobe, left bronchus or lung |
| C34.8 | Malignant neoplasm of overlapping sites of bronchus and lung |
| C34.80 | Malignant neoplasm of overlapping sites of unspecified bronchus and lung |
| C34.81 | Malignant neoplasm of overlapping sites of right bronchus and lung |
| C34.82 | Malignant neoplasm of overlapping sites of left bronchus and lung |
| C34.9 | Malignant neoplasm of unspecified part of bronchus or lung |
| C34.90 | Malignant neoplasm of unspecified part of unspecified bronchus or lung |
| C34.91 | Malignant neoplasm of unspecified part of right bronchus or lung |
| C34.92 | Malignant neoplasm of unspecified part of left bronchus or lung |
| Renal cell carcinoma | |
| C64 | Malignant neoplasm of kidney, except renal pelvis |
| C64.1 | Malignant neoplasm of right kidney, except renal pelvis |
| C64.2 | Malignant neoplasm of left kidney, except renal pelvis |
| C64.9 | Malignant neoplasm of unspecified kidney, except renal pelvis |
Formulary Reference Tool