Agent(s)

Boxed Warnings and Contraindication(s)

Abraxane (paclitaxel [protein bound])(1)

Abraxane has a boxed warning for severe myelosuppression:

• Do not administer Abraxane therapy to patients with baseline neutrophil counts of < 1,500 cells/mm^3
• Monitor for neutropenia, which may be severe and result in infection or sepsis
• Perform frequent complete blood cell counts on all patients receiving Abraxane

Abraxane is contraindicated in patients with:

• Neutrophil counts of < 1,500 cells/mm^3
• Severe hypersensitivity reactions to Abraxane

ADCETRIS (brentuximab vedotin)(2)

ADCETRIS has a boxed warning for progressive mutifocal leukoencephalopathy (PML):

• JC virus infection resulting in PML and death can occur in patients receiving ADCETRIS

ADCETRIS is contraindicated in patients with:

• Concomitant use with bleomycin due to pulmonary toxicity

ALIMTA (pemetrexed)(3)

ALIMTA is contraindicated for patients with:

• History of severe hypersensitivity reaction to pemetrexed

Alkeran (melphalan)(94)

Alkeran is contraindicated for:

• Melphalan should not be used in patients whose disease has demonstrated prior resistance to this agent
• Patients who have demonstrated hypersensitivity to melphalan should not be given the drug

Anktiva (nogapendekin alfa inbakicept-pmln)(49)

• None

ARRANON (nelarabine)(5)

ARRANON has a boxed warning for neurologic adverse reactions:

• Severe neurologic adverse reactions have been reported with the use of ARRANON. These adverse reactions have included altered mental states including severe somnolence, central nervous system effects including convulsions, and peripheral neuropathy ranging from numbness and paresthesias to motor weakness and paralysis. There have also been reports of adverse reactions associated with demyelination, and ascending peripheral neuropathies similar in appearance to Guillain-Barré syndrome
• Full recovery from these adverse reactions has not always occurred with cessation of therapy with ARRANON. Monitor frequently for signs and symptoms of neurologic toxicity. Discontinue ARRANON for neurologic adverse reactions of NCI Common Toxicity Criteria for Adverse Events (CTCAE) Grade 2 or greater

ARRANON has no contraindications of use

Arzerra (ofatumumab)(6)

Arzerra has a boxed warning for Hepatitis B virus reactivation and progressive multifocal leukoencephalopathy (PML)

• Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death
• Progressive Multifocal Leukoencephalopathy (PML) resulting in death

Arzerra has no contraindications of use

ASPARLAS (calaspargase pegol-mknl)(7)

ASPARLAS is contraindicated in patients with:

• History of serious hypersensitivity reactions to pegylated L-asparaginase
• History of serious thrombosis during L-asparaginase therapy
• History of serious pancreatitis related to previous L-asparaginase treatment
• History of serious hemorrhagic events during previous L-asparaginase therapy
• Severe hepatic impairment

Axtle (pemetrexed)(109)

Axtle is contraindicated for patients with:

• History of severe hypersensitivity reaction to pemetrexed

AZEDRA (iobenguane I 131)(93)

• None

Beleodaq (belinostat)(8)

• None

Belrapzo (Bendamustine)(9)

Belrapzo is contraindicated for:

• Patients with a history of hypersensitivity reaction to bendamustine, polyethylene glycol 400, propylene glycol, or monothioglycerol

BENDEKA (bendamustine)(10)

BENDEKA is contraindicated for:

• Patients with a history of hypersensitivity reaction to bendamustine, polyethylene glycol 400, propylene glycol, or monothioglycerol

BESPONSA (inotuzumab ozogamicin)(11)

BESPONSA has a boxed warning for hepatotoxicity, including hepatic ven-occlusive disease (VOD) (also known as sinusoidal obstruction syndrome) and increased risk of post-hepatic stem cell transplant (HSCT) non-relapse mortality

• Hepatotoxicity, including fatal and life-threatening VOD occurred in patients who received BESPONSA
• A higher post-HSCT non-relapse mortality rate occurred in patients receiving BESPONSA

BESPONSA has no contraindications of use

BiCNU (Carmustine)(82)

BiCNU has a boxed warning for myelosuppression and pulmonary toxicity:

• Suppression of marrow function, notably thrombocytopenia and leukopenia, is the most common and severe of the toxic effects of Carmustine for Injection. Monitor blood counts
• Pulmonary toxicity from Carmustine for Injection appears to be dose related. Patients receiving greater than 1400 mg/m cumulative dose are at significantly higher risk than those receiving less

Contraindication:

• Hypersensitivity

BLINCYTO (blinatumomab)(13)

BLINCYTO has a boxed warning for cytokine release syndrome and neurological toxicities including immune effector cell-associated toxicity syndrome:

• Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO. Interrupt or discontinue BLINCYTO and treat with corticosteroids as recommended
• Neurological toxicities, including immune effector cell-associated neurotoxicity syndrome (ICANS), which may be severe, life-threatening, or fatal, occurred in patients receiving BLINCYTO. Interrupt or discontinue BLINCYTO as recommended

BLINCYTO is contraindicated in patients with:

• Known hypersensitivity to blinatumomab or to any component of the product formulation

Bortezomib (bortezomib)(14,81)

Bortezomib is contraindicated for:

• Patients with hypersensitivity (not including local reactions) to bortezomib or boron including anaphylactic reactions
• Intrathecal administration

Bizengri (zenocutuzumab-zbco)(107)

• None

Camptosar (irinotecan)(12)

Camptosar has a boxed warning for diarrhea and myelosuppression:

• Early and late forms of diarrhea can occur. Early diarrhea may be accompanied by cholinergic symptoms which may be prevented or ameliorated by atropine. Late diarrhea can be life threatening and should be treated promptly with loperamide. Monitor patients with diarrhea and give fluid and electrolytes as needed. Institute antibiotic therapy if patients develop ileus, fever, or severe neutropenia. Interrupt CAMPTOSAR and reduce subsequent doses if severe diarrhea occurs
• Severe myelosuppression may occur

Camptosar is contraindicated for patients with:

• Hypersensitivity to Camptosar or any of its excipients

Columvi (glofitamab-gxbm)(97)

Columvi has a boxed warning for cytokine release syndrome:

• Cytokine Release Syndrome (CRS), including serious or fatal reactions, can occur in patients receiving COLUMVI. Premedicate before each dose, and initiate treatment with the COLUMVI step-up dosing schedule to reduce the risk of CRS. Withhold COLUMVI until CRS resolves or permanently discontinue based on severity

Columvi has no contraindications of use

Cosmegen (dactinomycin)(95)

• None

Cyclophosphamide (98)

Cyclophosphamide has contraindications for patients with:

• Hypersensitivity to cyclophosphamide
• Urinary outflow obstruction

Cyramza (ramucirumab) (15)

• None

DANYELZA (naxitamab-gqgk) (16)

DANYELZA has a boxed warning for serious infusion-related reactions and neurotoxicity:

• Serious Infusion-Related Reactions: DANYELZA can cause serious infusion reactions, including cardiac arrest, anaphylaxis, hypotension, bronchospasm, and stridor. Premedicate prior to each DANYELZA infusion as recommended. Reduce the rate, interrupt infusion, or permanently discontinue DANYELZA based on severity
• Neurotoxicity: DANYELZA can cause severe neurotoxicity, including severe neuropathic pain, transverse myelitis, and reversible posterior leukoencephalopathy syndrome (RPLS). Premedicate to treat neuropathic pain as recommended. Permanently discontinue DANYELZA based on the adverse reaction and severity

DANYELZA has a contraindication for patients with:

• History of severe hypersensitivity reaction to naxitamab-gqgk

DARZALEX (daratumumab) (17)

DARZALEX has a contraindication for:

• Patients with a history of severe hypersensitivity to daratumumab or any of the components of the formulation

Darzalex Faspro (daratumumab and hyaluronidase-fihj) (18)

DARZALEX Faspro has a contraindication for:

• Patients with a history of severe hypersensitivity to daratumumab, hyaluronidase or any of the components of the formulation

Datroway (datopotamab deruxtecan-dink) (108)

• None

DOXIL (doxorubicin hydrochloride liposome)(19)

DOXIL has a boxed warning for cardiomyopathy and infusion-related reactions:

• DOXIL liposomal infusion can cause myocardial damage, including acute left ventricular failure. The risk of cardiomyopathy was 11% when the cumulative anthracycline dose was between 450 mg/m to 550 mg/m . Assess left ventricular cardiac function prior to initiation of DOXIL liposomal infusion, during treatment, and after treatment
• Serious, life-threatening, and fatal infusion‑related reactions can occur. Acute infusion-related reactions occurred in 11% of patients with solid tumors. Withhold DOXIL liposomal infusion for infusion-related reactions and resume at a reduced rate. Discontinue DOXIL liposomal infusion for serious or life-threatening infusion-related reactions

DOXIL has contraindications for patients with:

• Hypersensitivity reactions to doxorubicin hydrochloride or the components of DOXIL liposomal infusion

ELAHERE (mirvetuximab soravtansine-gynx)(86)

ELAHERE has a boxed warning for ocular toxicity:

• ELAHERE can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis
• Conduct an ophthalmic exam including visual acuity and slit lamp exam prior to initiation of ELAHERE, every other cycle for the first 8 cycles, and as clinically indicated
• Withhold ELAHERE for ocular toxicities until improvement and resume at the same or reduced dose.
• Discontinue ELAHERE for Grade 4 ocular toxicities.

ELAHERE has no contraindications of use

ELREXFIO (elranatamab-bcmm)(99)

ELREXFUI has boxed warnings for cytokine release syndrome and neurologic toxicity including immune effector cell-associated neurotoxicity syndrome:

• Cytokine Release Syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving ELREXFIO. Initiate treatment with ELREXFIO step-up dosing schedule to reduce risk of CRS. Withhold ELREXFIO until CRS resolves or permanently discontinue based on severity
• Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), and serious and life-threatening reactions, can occur in patients receiving ELREXFIO. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS, during treatment. Withhold ELREXFIO until the neurologic toxicity resolves or permanently discontinue based on severity
• ELREXFIO is available only through a restricted program called the ELREXFIO Risk Evaluation and Mitigation Strategy (REMS)

ELREXFIO has no contraindications of use

ELZONRIS (tagraxofusp-erzs)(20)

ELZONRIS has a boxed warning for capillary leak syndrome:

• Capillary Leak Syndrome (CLS), which may be life-threatening or fatal if not properly managed, can occur in patients receiving ELZONRIS

ELZONRIS has no contraindications of use

Empliciti (elotuzumab)(21)

• None

Emrelis (telisotuzumab vedotin-tllv)(113)

• None

ENHERTU (fam-trastuzumab deruxtecan-nxki)(22)

ENHERTU has boxed warnings for interstitial lung disease and embryo-fetal toxicity:

• Interstitial lung disease (ILD) and pneumonitis, including fatal cases, have been reported with ENHERTU. Monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory symptoms. Permanently discontinue ENHERTU in all patients with Grade 2 or higher ILD/pneumonitis. Advise patients of the risk and to immediately report symptoms
• Exposure to ENHERTU during pregnancy can cause embryo-fetal harm. Advise patients of these risks and the need for effective contraception

ENHERTU has no contraindications of use

Epkinly (epcoritamab-bysp)(96)

Epkinly has boxed warnings for cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome

• Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving EPKINLY. Initiate treatment with the EPKINLY step-up dosage schedule to reduce the incidence and severity of CRS. Withhold EPKINLY until CRS resolves or permanently discontinue based on severity
• Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), including lifethreatening and fatal reactions, can occur with EPKINLY. Monitor patients for neurological signs or symptoms of ICANS during treatment. Withhold EPKINLY until ICANS resolves or permanently discontinue based on severity

Epkinly has no contraindications of use

ERBITUX (cetuximab)(23)

ERBITUX has boxed warnings for infusion reactions and cardiopulmonary arrest:

• ERBITUX can cause serious and fatal infusion reactions. (5.1, 6) Immediately interrupt and permanently discontinue ERBITUX for serious infusion reactions
• Cardiopulmonary arrest or sudden death occurred in patients with squamous cell carcinoma of the head and neck receiving ERBITUX with radiation therapy or with a cetuximab product with platinum-based therapy and fluorouracil. Monitor serum electrolytes, including serum magnesium, potassium, and calcium, during and after ERBITUX administration

ERBITUX has no contraindications of use

Evomela (melphalan)(24)

Evomela has boxed warnings for:

• Severe bone marrow suppression with resulting infection or bleeding may occur. Controlled trials comparing intravenous (IV) melphalan to oral melphalan have shown more myelosuppression with the IV formulation. Monitor hematologic laboratory parameters
• Hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received the IV formulation of melphalan. Discontinue treatment with Evomela for serious hypersensitivity reactions
• Melphalan produces chromosomal aberrations in vitro and in vivo. Evomela should be considered potentially leukemogenic in humans

Evomela has a contraindication for patients with:

• History of serious allergic reaction to melphalan

FASLODEX (fulvestrant)(25)

FASLODEX has a contraindication for patients with:

• Hypersensitivity

FOLOTYN (pralatrexate)(26)

• None

Frindovyx (cyclophosphamide)(110)

Frindovyx has contraindications for patients with:

• Hypersensitivity to cyclophosphamide
• Urinary outflow obstruction

Fyarro (sirolimus protein-bound)(72)

Fyarro has a contraindication for patients with:

• History of severe hypersensitivity to sirolimus, or other rapamycin derivatives, or albumin

Gazyva (obinutuzumab)(27)

Gazyva has boxed warnings for hepatitis B virus reactivation and progressive multifocal leukoencephalopathy:

• Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death
• Progressive Multifocal Leukoencephalopathy (PML) resulting in death

Gazyva has a contraindication for patients with:

• Patients with known hypersensitivity reactions (e.g., anaphylaxis) to obinutuzumab or any of the excipients, including serum sickness with prior obinutuzumab use

GLIADEL WAFER (carmustine implant)(92)

• None

Halaven (eribulin mesylate)(28)

• None

HEPZATO (melphalan hydrochloride)(101)

HEPZATO has boxed warnings for severe peri-procedural complications and myelosuppression:

• Severe peri-procedural complications including hemorrhage, hepatocellular injury, and thromboembolic events may occur with intra-hepatic administration of HEPZATO. Assess patients for these adverse reactions during and for 72 hours following administration of HEPZATO
• HEPZATO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy called the HEPZATO KIT REMS
• Myelosuppression with resulting severe infection, bleeding, or symptomatic anemia may occur with HEPZATO. Monitor hematologic laboratory parameters and delay additional cycles of HEPZATO therapy until blood counts have improved

HEPZATO has contraindications for:

• Active intracranial metastases or brain lesions with a propensity to bleed
• Liver failure, portal hypertension, or known varices at risk for bleeding
• Surgery or medical treatment of the liver in the previous 4 weeks
• Active cardiac conditions including, but not limited to, unstable coronary syndromes (unstable or severe angina or myocardial infarction), worsening or new-onset congestive heart failure, significant arrhythmias, or severe valvular disease
• History of allergies or known hypersensitivity to melphalan or a component or material utilized within the HEPZATO Kit including natural rubber latex, heparin, and severe hypersensitivity to iodinated contrast not controlled by antihistamines and steroids

Herceptin (trastuzumab)(29)

Herceptin has boxed warnings for cardiomyopathy, embryo-fetal toxicity, and pulmonary toxicity:

• Cardiomyopathy: HERCEPTIN HYLECTA can result in subclinical and clinical cardiac failure manifesting as CHF, and decreased LVEF, with greatest risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue HERCEPTIN for cardiomyopathy
• Pulmonary Toxicity: Discontinue HERCEPTIN for anaphylaxis, angioedema, interstitial pneumonitis or acute respiratory distress syndrome
• Embryo-Fetal Toxicity: Exposure to HERCEPTIN during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death. Advise patients of these risks and the need for effective contraception

Herceptin has no contraindications of use

Herceptin HYLECTA (trastuzumab and hyaluronidase)(30)

Herceptin has boxed warnings for cardiomyopathy, embryo-fetal toxicity, and pulmonary toxicity:

• Cardiomyopathy: HERCEPTIN HYLECTA can result in subclinical and clinical cardiac failure manifesting as CHF, and decreased LVEF, with greatest risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue HERCEPTIN HYLECTA for cardiomyopathy
• Pulmonary Toxicity: Discontinue HERCEPTIN HYLECTA for anaphylaxis, angioedema, interstitial pneumonitis or acute respiratory distress syndrome
• Embryo-Fetal Toxicity: Exposure to HERCEPTIN HYLECTA during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death. Advise patients of these risks and the need for effective contraception

Herceptin has no contraindications of use

Hercessi (trastuzumab-strf)(106)

Hercessi has boxed warnings for cardiomyopathy, infusion reactions, embryo-fetal toxicity, and pulmonary toxicity:

• Cardiomyopathy: Trastuzumab products can result in subclinical and clinical cardiac failure manifesting as CHF, and decreased LVEF, with greatest risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue Hercessi for cardiomyopathy
• Infusion Reactions, Pulmonary Toxicity: Discontinue Hercessi for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome
• Embryo-Fetal Toxicity: Exposure to trastuzumab products during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death. Advise patients of these risks and the need for effective contraception

Hercessi has no contraindications of use

Herzuma (trastuzumab-pkrb)(31)

Herzuma has boxed warnings for cardiomyopathy, infusion reactions, embryo-fetal toxicity, and pulmonary toxicity:

• Cardiomyopathy: Trastuzumab products can result in subclinical and clinical cardiac failure manifesting as CHF, and decreased LVEF, with greatest risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue HERZUMA for cardiomyopathy
• Infusion Reactions, Pulmonary Toxicity: Discontinue HERZUMA for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome
• Embryo-Fetal Toxicity: Exposure to trastuzumab products during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death. Advise patients of these risks and the need for effective contraception

Herzuma has no contraindications of use

IMDELLTRA (tarlatamab-dlle)(102)

IMDELLTRA has boxed warnings for cytokine release syndrome and neurologic toxicity including immune effector cell-associated neurotoxicity syndrome:

• Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving IMDELLTRA. Initiate treatment with the IMDELLTRA using step-up dosing schedule to reduce the incidence and severity of CRS. Withhold IMDELLTRA until CRS resolves or permanently discontinue based on severity
• Neurologic toxicity including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), including serious or life-threatening reactions, can occur in patients receiving IMDELLTRA. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment and treat promptly. Withhold IMDELLTRA until ICANS resolves or permanently discontinue based on severity

IMDELLTRA has no contraindications of use

IMLYGIC (talimogene laherparepvec)(32)

IMLYGIC has contraindications for:

• Immunocompromised patients
• Pregnant patients

ISTODAX (romidepsin)(34)

• None

Ivra (melphalan)(111)

Ivra has boxed warnings for severe bone marrow suppression, hypersensitivity, and leukemogenicity:

• Severe bone marrow suppression with resulting infection or bleeding may occur. Controlled trials comparing intravenous melphalan to oral melphalan have shown more myelosuppression with the intravenous formulation. Monitor hematologic laboratory parameters
• Hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received the intravenous formulation of melphalan. Discontinue treatment with IVRA for serious hypersensitivity reactions
• Melphalan produces chromosomal aberrations in vitro and in vivo. IVRA should be considered potentially leukemogenic in humans

Ivra has a contraindication for patients with:

• History of severe hypersensitivity to melphalan

Jelmyto (mitomycin)(35)

Jelmyto has contraindications for patients with:

• Perforation of the bladder or upper urinary tract

JEVTANA (cabazitaxel)(36)

Jevtana has boxed warnings for neutropenia and hypersensitivity:

• Neutropenic deaths have been reported. Obtain frequent blood counts to monitor for neutropenia. JEVTANA is contraindicated in patients with neutrophil counts of ≤1,500 cells/mm^3 . Primary prophylaxis with G-CSF is recommended in patients with high-risk clinical features. Consider primary prophylaxis with G-CSF in all patients receiving a dose of 25 mg/m^2
• Severe hypersensitivity can occur and may include generalized rash/erythema, hypotension and bronchospasm. Discontinue JEVTANA immediately if severe reactions occur and administer appropriate therapy
• Contraindicated if history of severe hypersensitivity reactions to cabazitaxel or to drugs formulated with polysorbate 80

Jevtana has contraindications for patients with:

• Neutrophil counts of less than or equal to 1,500/mm^3
• History of severe hypersensitivity to Jevtana or polysorbate 80
• Severe hepatic impairment (Total Bilirubin > 3 X ULN)

Kadcyla (ado-trastuzumab)(37)

Kadcyla has boxed warnings for hepatotoxicity, cardiac toxicity, and embryo-fetal toxicity:

• Hepatotoxicity, liver failure and death have occurred in KADCYLA-treated patients. Monitor hepatic function prior to initiation and prior to each dose. Institute dose modifications or permanently discontinue as appropriate
• KADCYLA may lead to reductions in left ventricular ejection fraction (LVEF). Assess LVEF prior to initiation. Monitor and withhold dosing or discontinue as appropriate
• Embryo-Fetal Toxicity: Exposure to KADCYLA during pregnancy can result in embryo-fetal harm. Advise patients of these risks and the need for effective contraception

Kadcyla has no contraindications of use

KANJINTI (trastuzumab-anns)(38)

KANJINTI has boxed warnings for cardiomyopathy, infusion reactions, embryo-fetal toxicity, and pulmonary toxicity:

• Cardiomyopathy: Trastuzumab products can result in subclinical and clinical cardiac failure manifesting as CHF, and decreased LVEF, with greatest risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue KANJINTI for cardiomyopathy
• Infusion Reactions, Pulmonary Toxicity: Discontinue KANJINTI for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome
• Embryo-Fetal Toxicity: Exposure to trastuzumab products during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death. Advise patients of these risks and the need for effective contraception

KANJINTI has no contraindications of use

KIMMTRAK (tebentafusp-tebn)(74)

KIMMTRAK has a boxed warning for cytokine release syndrome:

• Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK. Monitor for at least 16 hours following first three infusions and then as clinically indicated

KIMMTRAK has no contraindications of use

Kyprolis (carfilzomib)(39)

• None

Lunsumio (mosunetuzumab-axgb)(88)

Lunsumio has a boxed warning for cytokine release syndrome:

• Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving LUNSUMIO. Initiate treatment with the LUNSUMIO step-up dosing schedule to reduce the risk of CRS. Withhold LUNSUMIO until CRS resolves or permanently discontinue based on severity

Lunsumio has no contraindications of use

Lynozyfic (linvoseltamab-gcpt) (115)

Lynozyfic has boxed warnings for cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome

Lynozyfic has no contraindications of use

Margenza (margetuximab-cmkb)(42)

Margenza has boxed warnings for left ventricular dysfunction and embryo-fetal toxicity:

• Left Ventricular Dysfunction: MARGENZA may lead to reductions in left ventricular ejection fraction (LVEF). Evaluate cardiac function prior to and during treatment. Discontinue MARGENZA treatment for a confirmed clinically significant decrease in left ventricular function
• Embryo-Fetal Toxicity: Exposure to MARGENZA during pregnancy can cause embryofetal harm. Advise patients of the risk and need for effective contraception

Margenza has no contraindications of use

MONJUVI (tafasitamab-cxix)(43)

• None

MYLOTARG (gemtuzumab ozogamicin)(44)

MYLOTARG has a boxed warning for hepatotoxicity:

• Hepatotoxicity, including severe or fatal hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), has been reported in association with the use of MYLOTARG

MYLOTARG has contraindications for patients with:

• Hypersensitivity to MYLOTARG or any of its components

Ogivri (trastuzumab-dkst)(45)

Ogivri has boxed warnings for cardiomyopathy, infusion reactions, embryo-fetal toxicity, and pulmonary toxicity:

• Cardiomyopathy: Trastuzumab products can result in subclinical and clinical cardiac failure manifesting as CHF, and decreased LVEF, with greatest risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue Ogivri for cardiomyopathy
• Infusion Reactions, Pulmonary Toxicity: Discontinue Ogivri for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome
• Embryo-Fetal Toxicity: Exposure to trastuzumab products during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death. Advise patients of these risks and the need for effective contraception

Ogivri has no contraindications of use

Onivyde (irinotecan liposome)(46)

Onivyde has boxed warnings for severe neutropenia and severe diarrhea:

• Severe or life-threatening neutropenia , including fatal neutropenic sepsis and fatal neutropenic fever, has occurred in patients receiving ONIVYDE in combination with oxaliplatin, fluorouracil and leucovorin and in combination with fluorouracil and leucovorin. Withhold ONIVYDE for absolute neutrophil count below 1500/mm^3 or neutropenic fever. Monitor blood cell counts periodically during treatment
• Severe and life-threatening diarrhea has occurred in patients receiving ONIVYDE in combination with oxaliplatin, fluorouracil and leucovorin and in combination with fluorouracil and leucovorin. Do not administer ONIVYDE to patients with bowel obstruction. Withhold ONIVYDE for diarrhea of Grade 2-4 severity. Administer loperamide for late diarrhea of any severity. Administer atropine, if not contraindicated, for early diarrhea of any severity

Onivyde has contraindications for patients with:

• Severe hypersensitivity reaction to Onivyde or irinotecan HCL

Ontruzant (trastuzumab-dttb)(47)

Ontruzant has boxed warnings for cardiomyopathy, infusion reactions, embryo-fetal toxicity, and pulmonary toxicity:

• Cardiomyopathy: trastuzumab products can result in subclinical and clinical cardiac failure manifesting as CHF, and decreased LVEF, with greatest risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue Ontruzant for cardiomyopathy
• Infusion Reactions, Pulmonary Toxicity: Discontinue Ontruzant for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome
• Embryo-Fetal Toxicity: Exposure to trastuzumab products during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death. Advise patients of these risks and the need for effective contraception

Ontruzant has no contraindications of use

PADCEV EJFV (enfortumab vedotin-ejfv)(48)

PADCEV has boxed warnings for serious skin reactions:

• PADCEV can cause severe and fatal cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)
• Immediately withhold PADCEV and consider referral for specialized care for suspected SJS or TEN or severe skin reactions
• Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions

PADCEV has no contraindications of use

PEMFEXY (pemetrexed)(73)

PEMFEXY is contraindicated in patients with:

• History of hypersensitivity reaction to pemetrexed

PEMRYDI RTU (pemetrexed)(40)

PEMRYDI is contraindicated in:

• Patients with a history of severe hypersensitivity reaction to pemetrexed

PERJETA (pertuzumab)(50)

PERJETA has boxed warnings for left ventricular dysfunction and embryo-fetal toxicity:

• Left Ventricular Dysfunction: PERJETA can result in subclinical and clinical cardiac failure manifesting as decreased LVEF and CHF. Evaluate cardiac function prior to and during treatment. Discontinue PERJETA treatment for a confirmed clinically significant decrease in left ventricular function
• Embryo-fetal Toxicity: Exposure to PERJETA can result in embryo-fetal death and birth defects. Advise patients of these risks and the need for effective contraception

PERJETA is contraindicated in patients with:

• Known hypersensitivity to pertuzumab or to any of its excipients

PHESGO (pertuzumab, trastuzumab, and hyaluronidase-zzxf)(51)

PHESGO has boxed warnings for cardiomyopathy, embryo-fetal toxicity, and pulmonary toxicity:

• Cardiomyopathy: PHESGO administration can result in subclinical and clinical cardiac failure manifesting as CHF, and decreased LVEF, with greatest risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue PHESGO for cardiomyopathy
• Embryo-fetal Toxicity: Exposure to PHESGO can result in embryo-fetal death and birth defects. Advise patients of these risks and the need for effective contraception
• Pulmonary Toxicity: Discontinue PHESGO for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome

PHESGO is contraindicated in:

• Patients with known hypersensitivity to pertuzumab, or trastuzumab, or hyaluronidase, or to any of its excipients

PLUVICTO (lutetium Lu 177 vipovotide tetraxetan)(91)

• None

POLIVY (polatuzumab vedotin-piiq)(52)

• None

Portrazza (necitumumab)(53)

Portrazza has boxed warnings for cardiopulmonary arrest and hypomagnesemia:

• Cardiopulmonary arrest and/or sudden death occurred in 3% of patients treated with PORTRAZZA in combination with gemcitabine and cisplatin. Closely monitor serum electrolytes, including serum magnesium, potassium, and calcium, with aggressive replacement when warranted during and after PORTRAZZA administration
• Hypomagnesemia occurred in 83% of patients receiving PORTRAZZA in combination with gemcitabine and cisplatin, and was severe in 20%. Monitor patients for hypomagnesemia, hypocalcemia, and hypokalemia prior to each dose of PORTRAZZA during treatment and for at least 8 weeks following completion of PORTRAZZA. Withhold PORTRAZZA for Grade 3 or 4 electrolyte abnormalities. Replete electrolytes as medically appropriate

Portrazza has no contraindications of use

RYBREVANT (amivantamab-vmjw)(55)

• None

RYLAZE (asparaginase erwinia chrysanthemi [recombinant]-rywn)(71)

Rylaze is contraindicated in patients with:

• History of serious hypersensitivity reactions to Rylaze, including anaphylaxis
• Serious pancreatitis during previous L-asparaginase therapy
• Serious thrombosis during previous L-asparaginase therapy
• Serious hemorrhagic events during previous L-asparaginase therapy
• Severe hepatic impairment

SARCLISA (isatuximab-irfc)(56)

SARCLISA is contraindicated in:

• Patients with severe hypersensitivity to isatuximab-irfc or any of its excipients

SYNRIBO (omacetaxine mepesuccinate)(57)

• None

TALVEY (talquetamab-tgvs)(100)

TALVEY has boxed warnings for cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome:

• Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TALVEY. Initiate TALVEY treatment with step-up dosing to reduce the risk of CRS. Withhold TALVEY until CRS resolves or permanently discontinue based on severity
• Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), and serious and life-threatening or fatal reactions, can occur in patients receiving TALVEY. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold or permanently discontinue TALVEY based on severity
• TALVEY is available only through a restricted program called the TECVAYLI and TALVEY Risk Evaluation and Mitigation Strategy (REMS)

TALVEY has no contraindications of use

TECVAYLI (teclistamab-gcyv)(84)

TECVAYLI has boxed warnings for  cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome:

• Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TECVAYLI. Initiate treatment with TECVAYLI step-up dosing schedule to reduce risk of CRS. Withhold TECVAYLI until CRS resolves or permanently discontinue based on severity
• Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious and life-threatening reactions, can occur in patients receiving TECVAYLI. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold TECVAYLI until neurologic toxicity resolves or permanently discontinue based on severity
• TECVAYLI is available only through a restricted program called the TECVAYLI and TALVEY Risk Evaluation and Mitigation Strategy (REMS)

TECVAYLI has no contraindications of use

Tepylute (thiotepa) (112)

Tepylute has boxed warnings for severe myelosuppression and carcinogenicity:

• May cause severe marrow suppression or ablation with resulting infection or bleeding. Monitor hematologic laboratory parameters
• Potentially carcinogenic in humans

Tepylute has contraindications for patients with:

• Hypersensitivity to the active substance
• Concomitant use with live or attenuated vaccines

TIVDAK (tisotumab vedotin-tftv)(58)

TIVDAK has boxed warnings for ocular toxicity:

• TIVDAK can cause severe ocular toxicities resulting in changes in vision, including severe vision loss and corneal ulceration
• Conduct an ophthalmic exam, including an assessment of ocular symptoms, visual acuity, and slit lamp exam of the anterior segment of the eye prior to initiation of TIVDAK, prior to every cycle for the first nine cycles, and as clinically indicated
• Adhere to the required premedication and eye care before, during, and after infusion
• Withhold TIVDAK until improvement and resume, reduce the dose, or permanently discontinue, based on severity

TIVDAK has no contraindications of use

Trazimera (trastuzumab-qyyp)(59)

Trazimera has boxed warnings for cardiomyopathy, infusion reactions, embryo-fetal toxicity, and pulmonary toxicity:

• Cardiomyopathy: Trastuzumab products can result in subclinical and clinical cardiac failure manifesting as CHF, and decreased LVEF, with greatest risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue TRAZIMERA for cardiomyopathy
• Infusion Reactions, Pulmonary Toxicity: Discontinue TRAZIMERA for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome
• Embryo-Fetal Toxicity: Exposure to trastuzumab products during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death. Advise patients of these risks and the need for effective contraception

Trazimera has no contraindications of use

TREANDA (bendamustine)(60)

TREANDA has a contraindication for:

• Patients with a history of a hypersensitivity reaction to bendamustine. Reactions have included anaphylaxis and anaphylactoid reactions

TRODELVY (sacituzumab govitecan-hziy)(61)

TRODELVY has boxed warnings for neutropenia and diarrhea:

• Severe or life threatening neutropenia may occur. Withhold TRODELVY for absolute neutrophil count below 1500/mm or neutropenic fever. Monitor blood cell counts periodically during treatment. Consider G-CSF for secondary prophylaxis. Initiate antiinfective treatment in patients with febrile neutropenia without delay
• Severe diarrhea may occur. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤ Grade 1 and reduce subsequent doses

TRODELVY has contraindications for patients with:

• Severe hypersensitivity reaction to TRODELVY

Unituxin (dinutuximab)(62)

Unituxin has boxed warnings for serious infusion reactions and neurotoxicity:

• Infusion Reactions: Life-threatening infusion adverse reactions occur with Unituxin. Administer required prehydration and premedication. Immediately interrupt for severe infusion reactions and permanently discontinue for anaphylaxis
• Neurotoxicity: Unituxin causes severe neuropathic pain. Administer intravenous opioid prior to, during, and for 2 hours following completion of the Unituxin infusion. Severe peripheral sensory neuropathy ranged from 2% to 9% in patients with neuroblastoma. Severe peripheral motor neuropathy has also been reported. Discontinue for severe unresponsive pain, severe sensory neuropathy, and moderate to severe peripheral motor neuropathy

Unituxin has contraindications for patients with:

• History of anaphylaxis to dinutuximab

Vectibix (panitumumab)(63)

Vectibix has a boxed warning for dermatologic toxicity:

• Dermatologic toxicities were reported in 90% of patients and were severe in 15% of patients receiving monotherapy

Vectibix has no contraindications of use

VELCADE (bortezomib)(64)

VELCADE has contraindications for patients with:

• Hypersensitivity (not including local reactions) to bortezomib, boron, or mannitol, including anaphylactic reactions
• VELCADE is contraindicated for intrathecal administration

Vidaza (azacitidine)(90)

Vidaza is contraindicated in patients with:

• Advanced malignant hepatic tumors
• Hypersensitivity to Azacitidine or Mannitol

Vivimusta (bendamustine)(85)

Vivimusta is contraindicated in patients with:

• History of a hypersensitivity reaction to bendamustine, polyethylene glycol 400, dehydrated alcohol, or monothioglycerol. Reactions to bendamustine hydrochloride have included anaphylaxis and anaphylactoid reactions

Vyloy (zolbetuximab-clzb)(103)

• None

VYXEOS (daunorubicin and cytarabine)(65)

VYXEOS has boxed warning: Do not interchange with other daunorubicin and/or cytarabine containing products:

• VYXEOS has different dosage recommendations than daunorubicin hydrochloride injection, cytarabine injection, daunorubicin citrate liposome injection, and cytarabine liposome injection. Verify drug name and dose prior to preparation and administration to avoid dosing errors

VYXEOS is contraindicated in patients with:

• History of serious hypersensitivity to daunorubicin, cytarabine or any component of the formulation

Xofigo (radium Ra 223 dichloride)(89)

• None

Yondelis (trabectedin)(66)

Yondelis is contraindicated in patients with:

• Known hypersensitivity to trabectedin

ZALTRAP (ziv-aflibercept)(67)

• None

ZEPZELCA (lurbinectedin)(69)

• None

ZEVALIN (ibritumomab tiuxetan)(68)

ZEVALIN has boxed warnings for severe infusion reactions, prolonged and severe cytopenias, and severe cutaneous and mucocutaneous reactions

ZEVALIN has no contraindications of use

Ziihera (zanidatamab-hrii)(104)

Ziihera has a boxed warning for embryo-fetal toxicity:

• Exposure to ZIIHERA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception

Ziihera has no contraindications of use

Zusduri (mitomycin)(114)

Zusduri is contraindicated in patients with:

• Perforation of the bladder
• Prior hypersensitivity reaction to mitomycin or any component of the product

Zynlonta (loncastuximab tesirine-lpyl)(70)

• None