Tafasitamab is a humanized, CD19-directed cytolytic monoclonal antibody intended for the treatment of B-cell malignancies.^[rx] It is produced using recombinant DNA technology in Chinese hamster ovary cells and contains an IgG1/2 hybrid Fc-domain which has been modified with 2 amino acid substitutions to enhance its cytotoxicity relative to non-engineered anti-CD19 antibodies.^[rx],[rx]

The CD19 surface protein is highly expressed on the surface of B-cells, where it appears to play a role in enhancing B-cell receptor signaling.^[rx] Its relative ubiquity across different stages of B-cell development, including pre-B and mature B-lymphocytes,^{[rx], as well as its presence in several B-cell malignancies (e.g. chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), diffuse large B-cell lymphoma (DLBCL))[rx],} has made it a desirable target in the treatment these B-cell malignancies. Tafasatimab is designed to bind to and block the activity of the CD19 surface antigen, which ultimately results in the lysis of B-cells (both healthy and malignant).^[rx]

Having previously received Breakthrough Therapy, Fast Track, and Orphan designations from the FDA,^[rx] tafasatimab-cxix (Monjuvi®) received accelerated approval on July 31st, 2020, for the treatment of relapsed or refractory DLBCL in adult patients who cannot receive autologous stem cell transplants.^[rx] It must be used in combination with lenalidomide, as this combination results in greater efficacy as compared to either agent alone.^[rx]

Mechanism of action

The CD19 surface antigen is a protein expressed on the surface of pre-B and mature B-lymphocytes^[rx] that appears to play a role in enhancing B-cell receptor signaling and is considered integral to their survival.^[rx] These surface proteins are also highly expressed in several B-cell malignancies, such as chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and diffuse large B-cell lymphoma (DLBCL).^[rx]

Tafasitamab is a CD19-directed cytolytic monoclonal antibody that, upon binding and blocking the activity of CD19, causes lysis of B-cells. This process is mediated through both direct apoptosis and immune-mediated effector mechanisms, such as antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).^[rx]

Tafasitamab induces a reduction in circulating B-cell counts by binding to a surface antigen, CD19, which is important for their survival.^[rx] Patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) experienced a 97% reduction in peripheral blood B-cell counts following 8 days of treatment, with a 100% reduction reached within 16 weeks of treatment.^[rx]

Tafasitamab can cause infusion-related reactions, particularly during the initial cycles of therapy. Symptoms may include chills, flushing, dyspnea, and hypertension. Patients may be administered premedications (such as acetaminophen, antihistamines, or glucocorticoids) 0.5 – 2 hours prior to infusion to minimize infusion-related reactions.^[rx] Tafasitamab may also cause significant myelosuppression, and subsequent infection, due to its mechanism of action – patients should undergo monitoring throughout therapy for signs of myelosuppression and/or infection.^[rx]

Indications

• Tafasitamab is indicated, in combination with lenalidomide, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified who are ineligible for autologous stem cell transplant (ASCT).^[rx]
• Tafasitamab, in combination with lenalidomide, is indicated for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).^[rx]
• Tafasitamab is a medication used in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
• This drug in combination with lenalidomide, is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT)
• In the EU, injury is indicated in combination with lenalidomide followed by tafasitamab monotherapy for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma who are not eligible for autologous stem cell transplant.^[rx]
• Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
• Relapsed Diffuse large B-cell lymphoma NOS

Use in Cancer

Tafasitamab-cxix is approved to treat:

• Diffuse large B-cell lymphoma (certain types) that has relapsed (come back) or is refractory (does not respond to treatment). It is used with lenalidomide in adults who cannot receive an autologous stem cell transplant.

This use is approved under FDA’s Accelerated Approval Program. As a condition of approval, a confirmatory trial(s) must show that tafasitamab-cxix provides a clinical benefit in these patients. Tafasitamab-cxix is also being studied in the treatment of other types of cancer.

Contraindications

• a bad infection
• anemia
• decreased blood platelets
• low levels of a type of white blood cell called neutrophils
• pregnancy
• a patient who is producing milk and breastfeeding

Dosage

Strengths: 200 mg

Lymphoma

12 mg/kg IV (based on actual body weight; Administer in combination with lenalidomide 25 mg orally for a maximum of 12 cycles, then continue this drug as monotherapy until disease progression or unacceptable toxicity:

• CYCLE 1: 12 mg/kg IV on Days 1, 4, 8, 15, and 22
• CYCLE 2: 12 mg/kg IV on Days 1, 8, 15, and 22
• CYCLE 3: 12 mg/kg IV on Days 1 and 15
• NOTE: Each therapy cycle is 28 days.
• For the first infusion, use an infusion rate of 70 mL/h for the first 30 minutes, then increase the rate so that the infusion is administered within 1.5 to 2.5 hours; administer all subsequent infusions within 1.5 to 2 hours.
• Refer to the lenalidomide prescribing information for lenalidomide dosage recommendations.
• Administer premedications 30 minutes to 2 hours prior to starting infusion to minimize infusion-related reactions.
• Premedications may include acetaminophen, histamine H1 receptor antagonists, histamine H2 receptor antagonists, and/or glucocorticosteroids.
• For patients not experiencing infusion-related reactions during the first 3 infusions, premedication is optional for subsequent infusions.
• If a patient experiences an infusion-related reaction, administer premedications before each subsequent infusion.

Dose Adjustments

DOSE MODIFICATIONS FOR ADVERSE REACTIONS:
INFUSION-RELATED REACTIONS (IRRS):

• GRADE 2: Interrupt therapy and treat the IRR; when resolved to Grade 1, resume infusion at no more than 50% of the rate at which the reaction occurred; if the patient does not experience further reaction within 1 hour and vital signs are stable, the infusion rate may be increased every 30 minutes as tolerated to rate at which the reaction occurred.
• GRADE 3: Interrupt therapy and treat the IRR; when resolved to Grade 1, resume infusion at no more than 25% of the rate at which the reaction occurred; if the patient does not experience further reaction within 1 hour and vital signs are stable, the infusion rate may be increased every 30 minutes as tolerated to a maximum of 50% of the rate at which the reaction occurred; if after rechallenge the reaction returns, stop the infusion immediately.
• GRADE 4: Permanently discontinue therapy.

MYELOSUPPRESSION:

• Platelet counts 50,000/mcL or less: Withhold this drug and lenalidomide and monitor complete blood count (CBC) weekly until the platelet count is 50,000/mcL or higher; resume this drug at the same dose and lenalidomide at a reduced dose (refer to lenalidomide prescribing information for dose modifications).
• Neutrophil count of 1000/mcL or less for at least 7 days OR neutrophil count of 1000/mcL or less with an increase of body temperature to 100.4F (38C) OR neutrophil count less than 500/mcL: Withhold this drug and lenalidomide and monitor CBC weekly until the neutrophil count is 1000/mcL or higher; ; resume this drug at the same dose and lenalidomide at a reduced dose (refer to lenalidomide prescribing information for dose modifications).

Administration advice:

• Infuse the entire contents of the bag.
• Do not coadminister other drugs through the same infusion line.
• No incompatibilities have been observed between this drug with infusion containers made of polypropylene (PP), polyvinylchloride (PVC), polyethylene (PE), polyethylene terephthalate (PET), or glass and infusion sets made of polyurethane (PUR) or PVC.

Storage requirements:

• Store unopened product refrigerated at 36F to 46F (2C to 8C) in the original carton to protect it from light. Do not shake. Do not freeze.
• Use the reconstituted solution immediately.
• If needed, store the reconstituted solution in the vial for a maximum of 12 hours either refrigerated at 36F to 46F (2C to 8C) or room temperature at 68F to 77F (20C to 25C) before dilution. Protect from light during storage.

Reconstitution/preparation techniques:

• Reconstitute and dilute this drug prior to infusion.
• The manufacturer’s product information should be consulted.

Side Effects

The Most Common

• diarrhea
• constipation
• nausea
• vomiting
• loss of appetite
• back pain
• muscle spasms
• sore throat, fever, chills, cough, burning or painful urination, or other signs of infection
• fever or unusual bruising or bleeding
• pale skin, fatigue, or shortness of breath

Drug Interactions

DRUG	INTERACTION
Abciximab	The risk or severity of adverse effects can be increased when Abciximab is combined with Tafasitamab.
Adalimumab	The risk or severity of adverse effects can be increased when Adalimumab is combined with Tafasitamab.
Aducanumab	The risk or severity of adverse effects can be increased when Aducanumab is combined with Tafasitamab.
Alemtuzumab	The risk or severity of adverse effects can be increased when Alemtuzumab is combined with Tafasitamab.
Alirocumab	The risk or severity of adverse effects can be increased when Alirocumab is combined with Tafasitamab.
Ambroxol	The risk or severity of methemoglobinemia can be increased when Tafasitamab is combined with Ambroxol.
Amivantamab	The risk or severity of adverse effects can be increased when Tafasitamab is combined with Amivantamab.
Anifrolumab	The risk or severity of adverse effects can be increased when Anifrolumab is combined with Tafasitamab.
Ansuvimab	The risk or severity of adverse effects can be increased when Tafasitamab is combined with Ansuvimab.
Anthrax immune globulin human	The risk or severity of adverse effects can be increased when Anthrax immune globulin human is combined with Tafasitamab.
Antilymphocyte immunoglobulin	The risk or severity of adverse effects can be increased when Antilymphocyte immunoglobulin (horse) is combined with Tafasitamab.
Antithymocyte immunoglobulin	The risk or severity of adverse effects can be increased when Antithymocyte immunoglobulin (rabbit) is combined with Tafasitamab.
Articaine	The risk or severity of methemoglobinemia can be increased when Tafasitamab is combined with Articaine.
Asfotase alfa	The risk or severity of adverse effects can be increased when Asfotase alfa is combined with Tafasitamab.
Atezolizumab	The risk or severity of adverse effects can be increased when Atezolizumab is combined with Tafasitamab.
Atoltivimab	The risk or severity of adverse effects can be increased when Tafasitamab is combined with Atoltivimab.
Avelumab	The risk or severity of adverse effects can be increased when Avelumab is combined with Tafasitamab.
Bamlanivimab	The risk or severity of adverse effects can be increased when Tafasitamab is combined with Bamlanivimab.
Basiliximab	The risk or severity of adverse effects can be increased when Basiliximab is combined with Tafasitamab.
Belantamab mafodotin	The risk or severity of adverse effects can be increased when Tafasitamab is combined with Belantamab mafodotin.
Belimumab	The risk or severity of adverse effects can be increased when Belimumab is combined with Tafasitamab.
Benralizumab	The risk or severity of adverse effects can be increased when Benralizumab is combined with Tafasitamab.
Benzocaine	The risk or severity of methemoglobinemia can be increased when Tafasitamab is combined with Benzocaine.
Benzyl alcohol	The risk or severity of methemoglobinemia can be increased when Tafasitamab is combined with Benzyl alcohol.
Besilesomab	The risk or severity of adverse effects can be increased when Besilesomab is combined with Tafasitamab.
Bevacizumab	The risk or severity of adverse effects can be increased when Bevacizumab is combined with Tafasitamab.
Bezlotoxumab	The risk or severity of adverse effects can be increased when Bezlotoxumab is combined with Tafasitamab.
Bimekizumab	The risk or severity of adverse effects can be increased when Bimekizumab is combined with Tafasitamab.
Blinatumomab	The risk or severity of adverse effects can be increased when Blinatumomab is combined with Tafasitamab.
Brentuximab vedotin	The risk or severity of adverse effects can be increased when Brentuximab vedotin is combined with Tafasitamab.
Brodalumab	The risk or severity of adverse effects can be increased when Brodalumab is combined with Tafasitamab.
Brolucizumab	The risk or severity of adverse effects can be increased when Brolucizumab is combined with Tafasitamab.
Bupivacaine	The risk or severity of methemoglobinemia can be increased when Tafasitamab is combined with Bupivacaine.
Burosumab	The risk or severity of adverse effects can be increased when Burosumab is combined with Tafasitamab.
Butacaine	The risk or severity of methemoglobinemia can be increased when Tafasitamab is combined with Butacaine.
Butamben	The risk or severity of methemoglobinemia can be increased when Tafasitamab is combined with Butamben.
Canakinumab	The risk or severity of adverse effects can be increased when Canakinumab is combined with Tafasitamab.
Caplacizumab	The risk or severity of adverse effects can be increased when Caplacizumab is combined with Tafasitamab.
Capromab pendetide	The risk or severity of adverse effects can be increased when Capromab pendetide is combined with Tafasitamab.
Capsaicin	The risk or severity of methemoglobinemia can be increased when Tafasitamab is combined with Capsaicin.
Casirivimab	The risk or severity of adverse effects can be increased when Tafasitamab is combined with Casirivimab.
Catumaxomab	The risk or severity of adverse effects can be increased when Catumaxomab is combined with Tafasitamab.
Cemiplimab	The risk or severity of adverse effects can be increased when Cemiplimab is combined with Tafasitamab.
Certolizumab pegol	The risk or severity of adverse effects can be increased when Certolizumab pegol is combined with Tafasitamab.
Cetuximab	The risk or severity of adverse effects can be increased when Cetuximab is combined with Tafasitamab.
Chloroprocaine	The risk or severity of methemoglobinemia can be increased when Tafasitamab is combined with Chloroprocaine.
Cilgavimab	The risk or severity of adverse effects can be increased when Tafasitamab is combined with Cilgavimab.
Cinchocaine	The risk or severity of methemoglobinemia can be increased when Tafasitamab is combined with Cinchocaine.
Cocaine	The risk or severity of methemoglobinemia can be increased when Tafasitamab is combined with Cocaine.
Conjugated estrogens	Conjugated estrogens may increase the thrombogenic activities of Tafasitamab.
Daratumumab	The risk or severity of adverse effects can be increased when Daratumumab is combined with Tafasitamab.
Darbepoetin alfa	The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Tafasitamab.
Denosumab	The risk or severity of adverse effects can be increased when Denosumab is combined with Tafasitamab.
Dienestrol	Dienestrol may increase the thrombogenic activities of Tafasitamab.
Diethylstilbestrol	Diethylstilbestrol may increase the thrombogenic activities of Tafasitamab.
Digoxin Immune Fab	The risk or severity of adverse effects can be increased when Digoxin Immune Fab (Ovine) is combined with Tafasitamab.
Dinutuximab	The risk or severity of adverse effects can be increased when Dinutuximab is combined with Tafasitamab.
Diphenhydramine	The risk or severity of methemoglobinemia can be increased when Tafasitamab is combined with Diphenhydramine.
Dostarlimab	The risk or severity of adverse effects can be increased when Tafasitamab is combined with Dostarlimab.
Dulaglutide	The risk or severity of adverse effects can be increased when Dulaglutide is combined with Tafasitamab.
Dupilumab	The risk or severity of adverse effects can be increased when Dupilumab is combined with Tafasitamab.
Durvalumab	The risk or severity of adverse effects can be increased when Durvalumab is combined with Tafasitamab.
Dyclonine	The risk or severity of methemoglobinemia can be increased when Tafasitamab is combined with Dyclonine.
Ebola Zaire vaccine (live	The therapeutic efficacy of Ebola Zaire vaccine (live, attenuated) can be decreased when used in combination with Tafasitamab.
Eculizumab	The risk or severity of adverse effects can be increased when Eculizumab is combined with Tafasitamab.
Efalizumab	The risk or severity of adverse effects can be increased when Efalizumab is combined with Tafasitamab.
Eflapegrastim	The risk or severity of adverse effects can be increased when Eflapegrastim is combined with Tafasitamab.
Eftrenonacog alfa	The risk or severity of adverse effects can be increased when Eftrenonacog alfa is combined with Tafasitamab.
Elotuzumab	The risk or severity of adverse effects can be increased when Elotuzumab is combined with Tafasitamab.
Emapalumab	The risk or severity of adverse effects can be increased when Emapalumab is combined with Tafasitamab.
Emicizumab	The risk or severity of adverse effects can be increased when Emicizumab is combined with Tafasitamab.
Eptinezumab	The risk or severity of adverse effects can be increased when Eptinezumab is combined with Tafasitamab.
Erenumab	The risk or severity of adverse effects can be increased when Erenumab is combined with Tafasitamab.
Erythropoietin	The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Tafasitamab.
Esterified estrogens	Esterified estrogens may increase the thrombogenic activities of Tafasitamab.
Estetrol	Estetrol may increase the thrombogenic activities of Tafasitamab.
Estradiol	Estradiol may increase the thrombogenic activities of Tafasitamab.
Estradiol acetate	Estradiol acetate may increase the thrombogenic activities of Tafasitamab.
Estradiol benzoate	Estradiol benzoate may increase the thrombogenic activities of Tafasitamab.
Estradiol cypionate	Estradiol cypionate may increase the thrombogenic activities of Tafasitamab.
Estradiol valerate	Estradiol valerate may increase the thrombogenic activities of Tafasitamab.
Estriol	Estriol may increase the thrombogenic activities of Tafasitamab.
Estrone	Estrone may increase the thrombogenic activities of Tafasitamab.
Estrone sulfate	Estrone sulfate may increase the thrombogenic activities of Tafasitamab.
Ethinylestradiol	Ethinylestradiol may increase the thrombogenic activities of Tafasitamab.
Ethyl chloride	The risk or severity of methemoglobinemia can be increased when Tafasitamab is combined with Ethyl chloride.
Etidocaine	The risk or severity of methemoglobinemia can be increased when Tafasitamab is combined with Etidocaine.
Evolocumab	The risk or severity of adverse effects can be increased when Evolocumab is combined with Tafasitamab.
Fanolesomab	The risk or severity of adverse effects can be increased when Fanolesomab is combined with Tafasitamab.
Fremanezumab	The risk or severity of adverse effects can be increased when Fremanezumab is combined with Tafasitamab.
Galcanezumab	The risk or severity of adverse effects can be increased when Galcanezumab is combined with Tafasitamab.
Gemtuzumab ozogamicin	The risk or severity of adverse effects can be increased when Gemtuzumab ozogamicin is combined with Tafasitamab.
Glofitamab	The risk or severity of adverse effects can be increased when Tafasitamab is combined with Glofitamab.
Golimumab	The risk or severity of adverse effects can be increased when Golimumab is combined with Tafasitamab.
Guselkumab	The risk or severity of adverse effects can be increased when Guselkumab is combined with Tafasitamab.
Hepatitis B immune globulin	The risk or severity of adverse effects can be increased when Hepatitis B immune globulin is combined with Tafasitamab.
Human cytomegalovirus globulin	The risk or severity of adverse effects can be increased when Human cytomegalovirus immune globulin is combined with Tafasitamab.
Human immunoglobulin G	The risk or severity of adverse effects can be increased when Human immunoglobulin G is combined with Tafasitamab.
Human Rho(D) immune globulin	The risk or severity of adverse effects can be increased when Human Rho(D) immune globulin is combined with Tafasitamab.
Human varicella-zoster i	The risk or severity of adverse effects can be increased when Human varicella-zoster immune globulin is combined with Tafasitamab.

Ibalizumab	The risk or severity of adverse effects can be increased when Ibalizumab is combined with Tafasitamab.
Ibritumomab tiuxetan	The risk or severity of adverse effects can be increased when Ibritumomab tiuxetan is combined with Tafasitamab.
Idarucizumab	The risk or severity of adverse effects can be increased when Idarucizumab is combined with Tafasitamab.
Imdevimab	The risk or severity of adverse effects can be increased when Tafasitamab is combined with Imdevimab.
Imlifidase	The therapeutic efficacy of Tafasitamab can be decreased when used in combination with Imlifidase.
Inebilizumab	The risk or severity of adverse effects can be increased when Inebilizumab is combined with Tafasitamab.
Infliximab	The risk or severity of adverse effects can be increased when Infliximab is combined with Tafasitamab.
Inotuzumab ozogamicin	The risk or severity of adverse effects can be increased when Inotuzumab ozogamicin is combined with Tafasitamab.
Ipilimumab	The risk or severity of adverse effects can be increased when Ipilimumab is combined with Tafasitamab.
Isatuximab	The risk or severity of adverse effects can be increased when Isatuximab is combined with Tafasitamab.
Ixekizumab	The risk or severity of adverse effects can be increased when Ixekizumab is combined with Tafasitamab.
Lanadelumab	The risk or severity of adverse effects can be increased when Lanadelumab is combined with Tafasitamab.
Lecanemab	The risk or severity of adverse effects can be increased when Lecanemab is combined with Tafasitamab.
Levobupivacaine	The risk or severity of methemoglobinemia can be increased when Tafasitamab is combined with Levobupivacaine.
Lidocaine	The risk or severity of methemoglobinemia can be increased when Tafasitamab is combined with Lidocaine.
Loncastuximab tesirine	The risk or severity of adverse effects can be increased when Tafasitamab is combined with Loncastuximab tesirine.
Maftivimab	The risk or severity of adverse effects can be increased when Tafasitamab is combined with Maftivimab.
Margetuximab	The risk or severity of adverse effects can be increased when Margetuximab is combined with Tafasitamab.
Meloxicam	The risk or severity of methemoglobinemia can be increased when Tafasitamab is combined with Meloxicam.
Mepivacaine	The risk or severity of methemoglobinemia can be increased when Tafasitamab is combined with Mepivacaine.
Mepolizumab	The risk or severity of adverse effects can be increased when Mepolizumab is combined with Tafasitamab.
Mestranol	Mestranol may increase the thrombogenic activities of Tafasitamab.
Methoxy polyethylen	The risk or severity of Thrombosis can be increased when Methoxy polyethylene glycol-epoetin beta is combined with Tafasitamab.
Mirvetuximab soravtansine	The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Tafasitamab.
Mogamulizumab	The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Tafasitamab.
Mosunetuzumab	The risk or severity of adverse effects can be increased when Tafasitamab is combined with Mosunetuzumab.
Muromonab	The risk or severity of adverse effects can be increased when Muromonab is combined with Tafasitamab.
Natalizumab	The risk or severity of adverse effects can be increased when Natalizumab is combined with Tafasitamab.
Necitumumab	The risk or severity of adverse effects can be increased when Necitumumab is combined with Tafasitamab.
Nivolumab	The risk or severity of adverse effects can be increased when Nivolumab is combined with Tafasitamab.
Obiltoxaximab	The risk or severity of adverse effects can be increased when Obiltoxaximab is combined with Tafasitamab.
Obinutuzumab	The risk or severity of adverse effects can be increased when Obinutuzumab is combined with Tafasitamab.
Ocrelizumab	The risk or severity of adverse effects can be increased when Ocrelizumab is combined with Tafasitamab.
Odesivimab	The risk or severity of adverse effects can be increased when Tafasitamab is combined with Odesivimab.
Ofatumumab	The risk or severity of adverse effects can be increased when Ofatumumab is combined with Tafasitamab.
Olaratumab	The risk or severity of adverse effects can be increased when Olaratumab is combined with Tafasitamab.
Omalizumab	The risk or severity of adverse effects can be increased when Omalizumab is combined with Tafasitamab.
Oxetacaine	The risk or severity of methemoglobinemia can be increased when Tafasitamab is combined with Oxetacaine.
Oxybuprocaine	The risk or severity of methemoglobinemia can be increased when Tafasitamab is combined with Oxybuprocaine.
Palivizumab	The risk or severity of adverse effects can be increased when Palivizumab is combined with Tafasitamab.
Panitumumab	The risk or severity of adverse effects can be increased when Panitumumab is combined with Tafasitamab.
Peginesatide	The risk or severity of Thrombosis can be increased when Peginesatide is combined with Tafasitamab.
Pembrolizumab	The risk or severity of adverse effects can be increased when Pembrolizumab is combined with Tafasitamab.
Pertuzumab	The risk or severity of adverse effects can be increased when Pertuzumab is combined with Tafasitamab.
Phenol	The risk or severity of methemoglobinemia can be increased when Tafasitamab is combined with Phenol.
Polatuzumab vedotin	The risk or severity of adverse effects can be increased when Polatuzumab vedotin is combined with Tafasitamab.
Polyestradiol phosphate	Polyestradiol phosphate may increase the thrombogenic activities of Tafasitamab.
Pramocaine	The risk or severity of methemoglobinemia can be increased when Tafasitamab is combined with Pramocaine.
Prilocaine	The risk or severity of methemoglobinemia can be increased when Tafasitamab is combined with Prilocaine.
Procaine	The risk or severity of methemoglobinemia can be increased when Tafasitamab is combined with Procaine.
Proparacaine	The risk or severity of methemoglobinemia can be increased when Tafasitamab is combined with Proparacaine.
Propoxycaine	The risk or severity of methemoglobinemia can be increased when Tafasitamab is combined with Propoxycaine.
Quinestrol	Quinestrol may increase the thrombogenic activities of Tafasitamab.
Ramucirumab	The risk or severity of adverse effects can be increased when Ramucirumab is combined with Tafasitamab.
Ranibizumab	The risk or severity of adverse effects can be increased when Ranibizumab is combined with Tafasitamab.
Ravulizumab	The risk or severity of adverse effects can be increased when Ravulizumab is combined with Tafasitamab.
Raxibacumab	The risk or severity of adverse effects can be increased when Raxibacumab is combined with Tafasitamab.
Relatlimab	The risk or severity of adverse effects can be increased when Relatlimab is combined with Tafasitamab.
Reslizumab	The risk or severity of adverse effects can be increased when Reslizumab is combined with Tafasitamab.
Risankizumab	The risk or severity of adverse effects can be increased when Risankizumab is combined with Tafasitamab.
Rituximab	The risk or severity of adverse effects can be increased when Rituximab is combined with Tafasitamab.
Romosozumab	The risk or severity of adverse effects can be increased when Romosozumab is combined with Tafasitamab.
Ropivacaine	The risk or severity of methemoglobinemia can be increased when Tafasitamab is combined with Ropivacaine.
Sacituzumab govitecan	The risk or severity of adverse effects can be increased when Sacituzumab govitecan is combined with Tafasitamab.
Sarilumab	The risk or severity of adverse effects can be increased when Sarilumab is combined with Tafasitamab.
Secukinumab	The risk or severity of adverse effects can be increased when Secukinumab is combined with Tafasitamab.
Siltuximab	The risk or severity of adverse effects can be increased when Siltuximab is combined with Tafasitamab.
Sotrovimab	The risk or severity of adverse effects can be increased when Tafasitamab is combined with Sotrovimab.
Spesolimab	The risk or severity of adverse effects can be increased when Tafasitamab is combined with Spesolimab.
Sulesomab	The risk or severity of adverse effects can be increased when Sulesomab is combined with Tafasitamab.
Sutimlimab	The risk or severity of adverse effects can be increased when Sutimlimab is combined with Tafasitamab.
S Conj Estrogens, A	Synthetic Conjugated Estrogens, A may increase the thrombogenic activities of Tafasitamab.
S Estrogens, B	Synthetic Conjugated Estrogens, B may increase the thrombogenic activities of Tafasitamab.
Teplizumab	The risk or severity of adverse effects can be increased when Teplizumab is combined with Tafasitamab.
Tetanus immu globulin	The risk or severity of adverse effects can be increased when Tetanus immune globulin, human is combined with Tafasitamab.
Tetracaine	The risk or severity of methemoglobinemia can be increased when Tafasitamab is combined with Tetracaine.
Tezepelumab	The risk or severity of adverse effects can be increased when Tafasitamab is combined with Tezepelumab.
Tibolone	Tibolone may increase the thrombogenic activities of Tafasitamab.
Tildrakizumab	The risk or severity of adverse effects can be increased when Tildrakizumab is combined with Tafasitamab.
Tisotumab vedotin	The risk or severity of adverse effects can be increased when Tafasitamab is combined with Tisotumab vedotin.
Tixagevimab	The risk or severity of adverse effects can be increased when Tafasitamab is combined with Tixagevimab.
Tocilizumab	The risk or severity of adverse effects can be increased when Tocilizumab is combined with Tafasitamab.
Tositumomab	The risk or severity of adverse effects can be increased when Tositumomab is combined with Tafasitamab.
Tralokinumab	The risk or severity of adverse effects can be increased when Tralokinumab is combined with Tafasitamab.
Trastuzumab	The risk or severity of adverse effects can be increased when Trastuzumab is combined with Tafasitamab.
Trastuzumab deruxtecan	The risk or severity of adverse effects can be increased when Trastuzumab deruxtecan is combined with Tafasitamab.
Trastuzumab emtansine	The risk or severity of adverse effects can be increased when Trastuzumab emtansine is combined with Tafasitamab.
Tremelimumab	The risk or severity of adverse effects can be increased when Tremelimumab is combined with Tafasitamab.
Ublituximab	The risk or severity of adverse effects can be increased when Ublituximab is combined with Tafasitamab.
Ustekinumab	The risk or severity of adverse effects can be increased when Ustekinumab is combined with Tafasitamab.
Vedolizumab	The risk or severity of adverse effects can be increased when Vedolizumab is combined with Tafasitamab.

Pregnancy and Lactation

US FDA pregnancy category: Not assigned.

Pregnancy

Based on its mechanism of action, MONJUVI may cause fetal B-cell depletion when administered to a pregnant woman [see Clinical Pharmacology (12.1)]. There are no available data on MONJUVI use in pregnant women to evaluate for a drug-associated risk. Animal reproductive toxicity studies have not been conducted with tafasitamab-cxix. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. MONJUVI is administered in combination with lenalidomide for up to 12 cycles. Lenalidomide can cause embryo-fetal harm and is contraindicated for use in pregnancy. Refer to the lenalidomide prescribing information for additional information. Lenalidomide is only available through a REMS
program.

Lactation

There are no data on the presence of tafasitamab-cxix in human milk or the effects on the breastfed child or milk production. Maternal immunoglobulin G is known to be present in human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to MONJUVI are unknown. Because of the potential for serious adverse reactions in the breastfed child, advise women not
to breastfeed during treatment with MONJUVI and for at least 3 months after the last dose. Refer to lenalidomide prescribing information for additional information.

Why is this medication prescribed?

Tafasitamab-cxix injection is used in adults along with lenalidomide (Revlimid) to treat certain types of non-Hodgkin’s lymphoma (types of cancer that begin in a type of white blood cells that normally fights infection) that have returned or that did not respond to other treatments in those who cannot receive a stem cell transplant. Tafasitamab-cxix injection is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells.

How should this medicine be used?

Tafasitamab-cxix comes as a powder to be mixed with a liquid and given into a vein by a doctor or nurse in a healthcare setting. Tafasitamab-cxix is usually given on days 1, 4, 8, 15, and 22 of cycle 1, on days 1, 8, 15 and 22 on cycles 2 and 3, and on days 1 and 15 of cycles 4 to 12. Each treatment cycle is 28 days and tafasitamab-cxix is given for up to 12 cycles. The length of treatment depends on how well your body responds to the medication and any side effects you experience.

Tafasitamab-cxix may cause serious reactions while you receive the medication. You may be given other medications to treat or help prevent reactions to tafasitamab-cxix. A doctor or nurse will watch you closely while you are receiving the infusion to be sure you are not having a serious reaction to the medication. Tell your doctor or nurse immediately if you experience any of the following symptoms: chills, flushing, headache, or shortness of breath.

Your doctor may temporarily or permanently stop your treatment if you experience certain side effects. Be sure to tell your doctor how you are feeling during your treatment with tafasitamab-cxix.

Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before receiving tafasitamab-cxix,

• tell your doctor and pharmacist if you are allergic to tafasitamab-cxix, any other medications, or any of the ingredients in tafasitamab-cxix injection. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have an infection or if you have or have ever had an infection that keeps coming back.
• tell your doctor if you are pregnant or plan to become pregnant. You should use birth control to prevent pregnancy during your treatment with tafasitamab-cxix and for at least 3 months after your final dose. Talk to your doctor about types of birth control that will work for you. If you become pregnant while receiving tafasitamab-cxix injection, call your doctor.
• tell your doctor if you are breastfeeding. Do not breastfeed during your treatment with tafasitamab-cxix and for 3 months after your final dose.

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