Tafasitamab: Drug information

(For additional information see "Tafasitamab: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)

Brand Names: US

Monjuvi

Brand Names: Canada

Minjuvi

Pharmacologic Category

Antineoplastic Agent, Anti-CD19;
Antineoplastic Agent, Monoclonal Antibody

Dosing: Adult

Diffuse large B-cell lymphoma, relapsed or refractory

Diffuse large B-cell lymphoma, relapsed or refractory: IV:

**Tafasitamab Dosing Schedule (Salles 2020)**
Cycle^a	Dosing schedule
^aEach treatment cycle is 28 days. ^bDosing is based on actual body weight.
Cycle 1	12 mg/kg^b on days 1, 4, 8, 15, and 22 (in combination with lenalidomide)
Cycles 2 and 3	12 mg/kg^b on days 1, 8, 15, and 22 (in combination with lenalidomide)
Cycle 4 and beyond	12 mg/kg^b on days 1 and 15 every 28 days (in combination with lenalidomide)
Administer tafasitamab in combination with lenalidomide for a maximum of 12 cycles, followed by tafasitamab monotherapy until disease progression or unacceptable toxicity.

Administer in a facility with immediate access to emergency equipment and appropriate medical support to manage infusion reactions.

Premedication: Administer premedication (may include acetaminophen, an H₁receptor antagonist, an H₂ receptor antagonist, and/or glucocorticoids) 30 minutes to 2 hours prior to infusion to minimize infusion reaction. If no infusion reaction during the initial 3 infusions, premedication is optional for subsequent infusions. If an infusion reaction occurs, administer premedication(s) prior to each subsequent infusion.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

Note: Renal function may be estimated using the Cockcroft-Gault equation.

CrCl 30 to 89 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling; however, CrCl 30 to 89 mL/minute had no clinically meaningful difference on tafasitamab pharmacokinetics.

CrCl <30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

End stage renal disease: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Hepatic Impairment: Adult

Mild impairment (total bilirubin ≤ ULN and AST > ULN, or total bilirubin 1 to 1.5 times ULN and any AST): There are no dosage adjustments provided in the manufacturer's labeling; however, mild impairment had no clinically meaningful difference on tafasitamab pharmacokinetics.

Moderate or severe impairment (total bilirubin >1.5 times ULN and any AST): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Obesity: Adult

American Society of Clinical Oncology guidelines for appropriate systemic therapy dosing in adults with cancer with a BMI ≥30 kg/m² : The dosing in the FDA-approved prescribing information should be followed in all patients, regardless of obesity status. If a patient with a BMI ≥30 kg/m²experiences high-grade toxicity from systemic anticancer therapy, the same dosage modification recommendations should be followed for all patients, regardless of obesity status (Ref). Note: Dosing is based on actual body weight (per the prescribing information).

Dosing: Adjustment for Toxicity: Adult

Tafasitamab Dosage Modifications for Adverse Reactions
Adverse reaction	Severity	Dosage modification
Hematologic toxicity	Platelets ≤50,000/mm³	Withhold tafasitamab (and lenalidomide) and monitor CBC weekly until platelet count is ≥50,000/mm³, then resume tafasitamab at the same dose (and lenalidomide at a reduced dose; refer to Lenalidomide monograph).
Hematologic toxicity	Neutrophil count ≤1,000/mm³ for at least 7 days or neutrophil count ≤1,000/mm³ with body temperature increase to ≥100.4°F (≥38°C) or neutrophil count <500/mm³	Withhold tafasitamab (and lenalidomide) and monitor CBC weekly until neutrophil count is ≥1,000/mm³, then resume tafasitamab at the same dose (and lenalidomide at a reduced dose; refer to Lenalidomide monograph).
Infusion-related reaction	Grade 2 (moderate)	Interrupt infusion immediately and manage signs/symptoms. Once signs/symptoms resolve or reduce to grade 1, resume infusion at no more than 50% of the rate at which the reaction occurred. If no further reaction within 1 hour and vital signs are stable, may increase infusion rate every 30 minutes as tolerated to rate at which the reaction occurred.
	Grade 3 (severe)	Interrupt infusion immediately and manage signs/symptoms. Once signs/symptoms resolve or reduce to grade 1, resume infusion at no more than 25% of the rate at which the reaction occurred. If no further reaction within 1 hour and vital signs are stable, may increase infusion rate every 30 minutes as tolerated to a maximum of 50% of the rate at which the reaction occurred. Stop infusion immediately if reaction returns upon rechallenge.
	Grade 4 (life threatening)	Stop infusion immediately and permanently discontinue tafasitamab.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions (Significant): Considerations

Bone marrow suppression

Tafasitamab may cause severe hematologic toxicity, including neutropenia, thrombocytopenia, and anemia. Grade 3 or 4 neutropenia, including febrile neutropenia, is common. Treatment interruption and/or dosage modification for hematologic toxicity may be warranted depending on severity.

Infection

Tafasitamab commonly causes infection, including serious infection (grade 3 or higher). Opportunistic infection may also occur. In the clinical study, frequently observed infections included respiratory tract infection, urinary tract infection, bronchitis, nasopharyngitis, and pneumonia. The most frequently reported grade 3 infection was pneumonia.

Onset: Varied; infections may occur at any time during therapy and following the last dose.

Infusion reactions

Tafasitamab may cause an infusion related reaction. Signs and symptoms include chills, fever, flushing, dyspnea, skin rash, and hypertension. Based on severity, interrupting the infusion or discontinuation may be warranted.

Onset: Rapid; the majority of patients experienced infusion related reactions during cycle 1 or 2.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Cardiovascular: Peripheral edema (24%)

Dermatologic: Skin rash (15%)

Endocrine & metabolic: Decreased serum albumin (26%), decreased serum calcium (47%), decreased serum magnesium (22%), decreased serum phosphate (20%), hypokalemia (19%), increased gamma-glutamyl transferase (34%), increased serum glucose (49%), increased uric acid (20%)

Gastrointestinal: Abdominal pain (15%), constipation (17%), decreased appetite (22%), diarrhea (36%), nausea (15%), vomiting (15%)

Genitourinary: Urinary tract infection (17%)

Hematologic & oncologic: Anemia (36%; grade 3: 7%), febrile neutropenia (12%; grades 3/4: 12%), neutropenia (51%; grade 3: 25%; grade 4: 25%), prolonged partial thromboplastin time (46%; grade 3/4: 4%), thrombocytopenia (31%; grade 3: 12%; grade 4: 6%)

Hepatic: Increased serum aspartate aminotransferase (20%)

Infection: Infection (73%, including opportunistic infection; serious infection: 26%)

Nervous system: Fatigue (≤38%)

Neuromuscular & skeletal: Asthenia (≤38%), back pain (19%), muscle spasm (15%)

Renal: Increased serum creatinine (20%)

Respiratory: Bronchitis (16%), cough (26%), dyspnea (12%), respiratory tract infection (24%)

Miscellaneous: Fever (24%)

1% to 10%:

Dermatologic: Alopecia (3%), erythema of skin (5%), hyperhidrosis (3%), pruritus (10%)

Endocrine & metabolic: Weight loss (5%)

Gastrointestinal: Dysgeusia (6%)

Hematologic & oncologic: Basal cell carcinoma of skin (1%), lymphocytopenia (6%)

Infection: Sepsis (5%)

Nervous system: Headache (9%), paresthesia (7%)

Neuromuscular & skeletal: Arthralgia (9%), limb pain (9%), musculoskeletal pain (3%)

Respiratory: Exacerbation of chronic obstructive pulmonary disease (1%), nasal congestion (5%), nasopharyngitis (10%), pneumonia (10%)

Miscellaneous: Infusion related reaction (6%)

Contraindications

There are no contraindications listed in the manufacturer's US labeling.

Canadian labeling: Hypersensitivity to tafasitamab or any component of the formulation.

Warnings/Precautions

Special populations:

• Older adult: Patients ≥65 years of age experienced more serious adverse reactions compared to younger patients.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous [preservative free]:

Monjuvi: Tafasitamab-cxix 200 mg (1 ea)

Generic Equivalent Available: US

Pricing: US

Solution (reconstituted) (Monjuvi Intravenous)

200 mg (per each): $1,593.94

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous:

Minjuvi: 200 mg (1 ea)

Prescribing and Access Restrictions

Tafasitamab is available through specialty distributors. Information regarding distribution is available from the manufacturer at https://www.monjuvihcp.com/resources.

Administration: Adult

IV: Infuse initial infusion at a rate of 70 mL/hour for the first 30 minutes, then increase the rate so that the infusion is administered within 1.5 to 2.5 hours. Infuse subsequent infusions over 1.5 to 2 hours. Infuse entire contents of bag. Do not administer other medications through the same infusion line. No incompatibilities have been observed between tafasitamab and infusion sets made of polyurethane (PUR) or PVC.

Administer in a facility with immediate access to emergency equipment and appropriate medical support to manage infusion reactions. Premedications are recommended to minimize infusion reaction. Monitor for infusion reactions.

Use: Labeled Indications

Diffuse large B-cell lymphoma, relapsed or refractory: Treatment (in combination with lenalidomide) of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified in adults, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant.

Medication Safety Issues

Sound-alike/look-alike issues:

Tafasitamab may be confused with fostamatinib, trastuzumab.

High alert medication:

This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes which have a heightened risk of causing significant patient harm when used in error.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

5-Aminosalicylic Acid Derivatives: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination

Antithymocyte Globulin (Equine): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy

Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination

BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

BCG Products: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination

Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy

Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination

Chikungunya Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination

Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy

Chloramphenicol (Systemic): Myelosuppressive Agents may enhance the myelosuppressive effect of Chloramphenicol (Systemic). Risk X: Avoid combination

Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk X: Avoid combination

Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination

CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor therapy

Coccidioides immitis Skin Test: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing these oncologic agents several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification

COVID-19 Vaccine (Adenovirus Vector): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification

COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy

COVID-19 Vaccine (mRNA): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider therapy modification

COVID-19 Vaccine (Subunit): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy

COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy

Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider therapy modification

Dengue Tetravalent Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination

Denosumab: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider therapy modification

Deucravacitinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination

Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Risk X: Avoid combination

Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination

Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination

Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination

Inebilizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy

Influenza Virus Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification

Leflunomide: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider therapy modification

Mumps- Rubella- or Varicella-Containing Live Vaccines: May enhance the adverse/toxic effect of Immunosuppressants (Miscellaneous Oncologic Agents). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination

Nadofaragene Firadenovec: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination

Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination

Ocrelizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy

Ofatumumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy

Olaparib: Myelosuppressive Agents may enhance the myelosuppressive effect of Olaparib. Risk C: Monitor therapy

Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy

Pimecrolimus: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination

Pneumococcal Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination

Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the potential for allergic or hypersensitivity reactions to Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification

Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

Rabies Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification

Ritlecitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination

Ropeginterferon Alfa-2b: Myelosuppressive Agents may enhance the myelosuppressive effect of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider therapy modification

Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Ruxolitinib (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination

Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification

Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor therapy

Tacrolimus (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination

Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination

Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination

Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Tofacitinib. Risk X: Avoid combination

Typhoid Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination

Ublituximab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy

Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination

Vaccines (Inactivated/Non-Replicating): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 3 after therapy is complete. Risk D: Consider therapy modification

Vaccines (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination

Yellow Fever Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination

Reproductive Considerations

Females of reproductive potential should use effective contraception during therapy and for at least 3 months after the last tafasitamab dose.

Tafasitamab is initially used in combination with lenalidomide for relapsed or refractory diffuse large B-cell lymphoma. Refer to the Lenalidomide monograph for additional information related to pregnancy testing, male and female contraception, and fertility. In the clinical study, when tafasitamab was continued as monotherapy, urine pregnancy testing was conducted prior to each tafasitamab infusion (Salles 2020).

Pregnancy Considerations

Tafasitamab is a humanized monoclonal antibody (IgG_{1/2 hybrid}). Placental transfer of human IgG is dependent upon the IgG subclass, maternal serum concentrations, newborn birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009).

Based on the mechanism of action, tafasitamab may cause depletion of fetal CD-19 positive immune cells. The administration of live vaccines should be deferred for neonates and infants exposed to tafasitamab in utero until a hematology evaluation can be completed.

Tafasitamab is initially used in combination with lenalidomide, which is contraindicated in pregnancy. Refer to the Lenalidomide monograph for additional information.

Breastfeeding Considerations

It is not known if tafasitamab is present in breast milk.

Tafasitamab is a monoclonal antibody (IgG_{1/2 hybrid}); maternal IgG can be detected in breast milk. Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during tafasitamab treatment and for at least 3 months after the last tafasitamab dose.

Tafasitamab is used in combination with lenalidomide. Refer to the Lenalidomide monograph for additional information.

Monitoring Parameters

Monitor CBC prior to each treatment cycle and throughout treatment. Evaluate pregnancy status prior to treatment initiation (in females of reproductive potential). Monitor for signs/symptoms of infection, infusion reactions.

The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.

Mechanism of Action

Tafasitamab is a humanized CD19-directed, Fc-modified monoclonal antibody that binds to CD19 antigen, which is expressed on the surface of pre-B and mature B lymphocytes and on several B-cell malignancies, including diffuse large B-cell lymphoma. After binding to CD19, tafasitamab mediates B-cell lysis through apoptosis and immune effector mechanisms, including antibody-dependent cellular cytotoxicity and phagocytosis. Administering in combination with lenalidomide results in increased antibody-dependent cellular cytotoxicity activity compared to either agent alone.

Pharmacokinetics (Adult Data Unless Noted)

Onset: Peripheral B-cell counts were reduced by 97% after 8 days and by 100% at the nadir (reached within 16 weeks of treatment).

Distribution: V_d: 9.3 L.

Half-life elimination: 17 days.

Excretion: Clearance: 0.41 L/day.

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Body weight: Body weight (40 to 163 kg) has a significant effect on tafasitamab pharmacokinetics, with higher clearance and V_d expected with higher body weight.

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(AT) Austria: Minjuvi;
(CH) Switzerland: Minjuvi;
(CZ) Czech Republic: Minjuvi;
(FI) Finland: Minjuvi;
(FR) France: Minjuvi;
(IT) Italy: Minjuvi;
(NL) Netherlands: Minjuvi;
(NO) Norway: Minjuvi;
(PR) Puerto Rico: Monjuvi;
(QA) Qatar: Minjuvi;
(SE) Sweden: Minjuvi

Griggs JJ, Bohlke K, Balaban EP, et al. Appropriate systemic therapy dosing for obese adult patients with cancer: ASCO guideline update. J Clin Oncol. 2021;39(18):2037-2048. doi:10.1200/JCO.21.00471 [PubMed 33939491]
Hwang JP, Feld JJ, Hammond SP, et al. Hepatitis B virus screening and management for patients with cancer prior to therapy: ASCO provisional clinical opinion update. J Clin Oncol. 2020;38(31):3698-3715. doi:10.1200/JCO.20.01757 [PubMed 32716741]
Minjuvi (tafasitamab) [product monograph]. Oakville, Ontario, Canada: Innomar Strategies; August 2021.
Monjuvi (tafasitamab) [prescribing information]. Boston, MA: Morphosys US Inc; June 2021.
Palmeira P, Quinello C, Silveira-Lessa AL, et al. IgG placental transfer in healthy and pathological pregnancies. Clin Dev Immunol. 2012;2012:985646. doi:10.1155/2012/985646 [PubMed 22235228]
Pentsuk N, van der Laan JW. An interspecies comparison of placental antibody transfer: new insights into developmental toxicity testing of monoclonal antibodies. Birth Defects Res B Dev Reprod Toxicol. 2009;86(4):328-344. doi:10.1002/bdrb.20201 [PubMed 19626656]
Salles G, Duell J, González Barca E, et al. Tafasitamab plus lenalidomide in relapsed or refractory diffuse large B-cell lymphoma (L-MIND): a multicentre, prospective, single-arm, phase 2 study. Lancet Oncol. 2020;21(7):978-988. doi:10.1016/S1470-2045(20)30225-4 [PubMed 32511983]

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Tafasitamab: Drug information