CD19-Directed Monoclonal Antibody (Fc-Enhanced) Pregnancy: May cause fetal B-cell depletion when administered to a pregnant woman, based on its mechanism of action; there are no available data in pregnant women and no animal reproductive toxicity studies. IgG monoclonal antibodies cross the placenta and tafasitamab may deplete fetal CD19-positive immune cells — defer live vaccines in neonates and infants exposed in utero until a haematology evaluation is complete. Note that tafasitamab is given with lenalidomide, which can cause embryo-fetal harm and is contraindicated in pregnancy. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

Tafasitamab

Brand names: Minjuvi

Tafasitamab is an Fc-modified anti-CD19 monoclonal antibody used with lenalidomide for relapsed or refractory diffuse large B-cell lymphoma in patients not eligible for autologous stem-cell transplant.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 12 mg/kg based on actual body weight, as an intravenous infusion (same dose for both licensed indications).

Route: Intravenous infusion

Frequency: Relapsed or refractory diffuse large B-cell lymphoma (28-day cycles): Cycle 1 — Days 1, 4, 8, 15 and 22; Cycles 2 and 3 — Days 1, 8, 15 and 22; Cycle 4 and beyond — Days 1 and 15. Relapsed or refractory follicular lymphoma (28-day cycles): Cycles 1 to 3 — Days 1, 8, 15 and 22; Cycles 4 to 12 — Days 1 and 15.

SOURCE: US FDA prescribing information (MONJUVI, Incyte Corporation, label date 2025-06-23) via openFDA/DailyMed — NO UK SPC was present in the fetched bundle; clinician to cross-check against the UK SPC. COMBINATION PARTNERS as stated in the US label: in DLBCL, give with lenalidomide 25 mg for a maximum of 12 cycles, then continue tafasitamab as monotherapy until disease progression or unacceptable toxicity; in follicular lymphoma, give with lenalidomide 20 mg (Days 1-21 in Cycles 1 to 12) and rituximab 375 mg/m2 (Cycles 1 to 5). Refer to the lenalidomide and rituximab prescribing information for their own dosing, including lenalidomide dosing in renal insufficiency and lenalidomide thromboprophylaxis recommendations. PREMEDICATION: administer 30 minutes to 2 hours before starting the infusion to minimise infusion-related reactions — may include acetaminophen (paracetamol), 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 reaction occurs, premedicate before each subsequent infusion. ADMINISTRATION SETTING: give via a healthcare professional with immediate access to emergency equipment and appropriate medical support to manage infusion-related reactions. INFUSION-RELATED REACTION MODIFICATIONS: Grade 2 — interrupt immediately; on resolution to Grade 1 resume at no more than 50% of the rate at which the reaction occurred, then increase every 30 minutes as tolerated. Grade 3 — interrupt immediately; on resolution to Grade 1 resume at no more than 25% of the prior rate, increasing every 30 minutes as tolerated to a maximum of 50% of the prior rate; if a Grade 3 reaction recurs, stop and permanently discontinue. Grade 4 — stop immediately and permanently discontinue. MYELOSUPPRESSION MODIFICATIONS: for platelets 50,000/mcL or less, or neutrophils 1,000/mcL or less for at least 7 days, or neutrophils 1,000/mcL or less with temperature 38 degrees C or higher, or neutrophils less than 500/mcL — withhold tafasitamab and lenalidomide, monitor full blood count weekly until recovery, then resume tafasitamab at the SAME dose and lenalidomide at a reduced dose. Product strength: 200 mg lyophilised powder single-dose vial requiring reconstitution and dilution.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

None (US label §4 states: None)

Side effects

Infusion-related reactions — 6% of DLBCL patients and 16% of FL patients; signs and symptoms include fever, chills, rash, flushing, dyspnoea and hypertension, with 80% occurring during cycle 1 or 2
Myelosuppression — neutropenia, thrombocytopenia and anaemia (most common Grade 3 or 4 laboratory abnormalities in FL are decreased neutrophils and decreased lymphocytes)
Infections — bacterial, fungal and viral infections can occur during and following treatment; respiratory tract infection is among the most common reactions in both indications
Fatigue, pyrexia and peripheral oedema
Gastrointestinal: diarrhoea, constipation and decreased appetite
Cough, rash and musculoskeletal pain

Clinical monograph

How it works

It binds CD19 on B-cells and enhances antibody-dependent cellular cytotoxicity and phagocytosis, leading to depletion of malignant B-lymphocytes.

Prescribing in practice

Infusion-related reactions can occur, particularly with the first infusion, so premedication and close monitoring during administration are required.
Causes myelosuppression, especially neutropenia and thrombocytopenia, mandating regular blood counts when given with lenalidomide.
Prior anti-CD19 therapy may affect efficacy; confirm the treatment history and follow the combination schedule with lenalidomide as licensed.

Monitoring

Monitor full blood count regularly and observe closely for infusion-related reactions and infection.

Counselling the patient

Report any reaction during or shortly after the infusion, such as fever, chills, or breathlessness.
Report signs of infection, bruising, or bleeding promptly.
Attend scheduled blood tests and infusion appointments.

Evidence & guidelines

Tafasitamab plus lenalidomide for diffuse large B-cell lymphoma is supported by the L-MIND study and licensed for transplant-ineligible patients.

Reference: L-MIND trial (Salles et al. Lancet Oncol 2020); NICE TA739; MHRA SPC Minjuvi; RE-MIND2 study (Duell et al. Haematologica 2021); Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Pathways