MINJUVI (Tafasitamab)
Anti-CD19 monoclonal antibody for relapsed or refractory B-cell lymphomas
MINJUVI (tafasitamab) is a CD19-targeting monoclonal antibody used for treating adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). It works by binding to CD19 on the surface of malignant B-cells, leading to cancer cell destruction. MINJUVI is administered as an intravenous infusion in combination with lenalidomide, and additionally with rituximab for follicular lymphoma.
Quick Facts
Key Takeaways
- MINJUVI is a targeted monoclonal antibody that binds to CD19 on B-cells, used for relapsed or refractory DLBCL (with lenalidomide) and FL (with lenalidomide and rituximab).
- The standard dose is 12 mg/kg body weight given as an IV infusion, with the schedule varying by cycle and indication.
- Common side effects include decreased blood cell counts, infections, rash, infusion reactions, fatigue, and gastrointestinal symptoms.
- Must not be used during pregnancy; effective contraception is required during treatment and for at least 3 months after the last dose.
- Store unopened vials refrigerated (2–8 °C), protected from light. Must not be frozen or shaken.
What Is MINJUVI and What Is It Used For?
Quick Answer: MINJUVI (tafasitamab) is a monoclonal antibody that targets the CD19 protein on B-cells. It is used to treat adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) when previous treatments have been unsuccessful.
MINJUVI contains the active substance tafasitamab, a type of protein known as a monoclonal antibody. Monoclonal antibodies are engineered proteins designed to recognise and attach to specific targets on the surface of cells. Tafasitamab is specifically designed to target and destroy cancer cells by attaching to CD19, a protein found on the surface of white blood cells called B-cells or B-lymphocytes. When tafasitamab binds to CD19, it triggers the immune system to destroy these cells through multiple mechanisms, including antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).
The Fc region of tafasitamab has been engineered (Fc-modified) to enhance its ability to engage immune effector cells, particularly natural killer (NK) cells and macrophages. This modification gives tafasitamab greater potency in recruiting the body's own immune defences to eliminate malignant B-cells compared to unmodified antibodies targeting the same protein.
Indications
MINJUVI is indicated for the treatment of adults with the following B-cell blood cancers:
- Diffuse large B-cell lymphoma (DLBCL): Used when the cancer has returned after previous treatment (relapsed) or when at least one prior treatment has not been sufficiently effective (refractory). It is used in patients who are not eligible for autologous stem cell transplantation.
- Follicular lymphoma (FL): Used in adults with relapsed or refractory FL who have received at least one prior therapy.
DLBCL is the most common type of non-Hodgkin lymphoma, accounting for approximately 30–40% of all cases worldwide. It is an aggressive cancer that arises from B-lymphocytes and can grow rapidly. Follicular lymphoma is the second most common type of non-Hodgkin lymphoma and typically follows a more indolent (slow-growing) course, although it can transform into more aggressive disease over time.
Combination Therapy
MINJUVI is not used alone for initial treatment. The combination partners depend on the indication:
- For relapsed/refractory DLBCL: MINJUVI is used together with lenalidomide for up to 12 cycles. After the combination phase, treatment continues with MINJUVI alone (monotherapy) until disease progression or unacceptable toxicity.
- For relapsed/refractory FL: MINJUVI is used together with both lenalidomide and rituximab. Rituximab is administered for up to 5 cycles, and the entire regimen (MINJUVI plus lenalidomide) continues for a maximum of 12 cycles.
The approval of MINJUVI for DLBCL was based on the L-MIND study, a pivotal Phase II clinical trial that demonstrated an overall response rate of 57.5% and a complete response rate of 40.0% in patients with relapsed or refractory DLBCL. For follicular lymphoma, approval was supported by the InMIND study, a Phase III randomised trial comparing tafasitamab plus lenalidomide plus rituximab versus placebo plus lenalidomide plus rituximab.
What Should You Know Before Taking MINJUVI?
Quick Answer: Do not use MINJUVI if you are allergic to tafasitamab or any of its ingredients. Tell your doctor about all medical conditions, current medications, and whether you are pregnant, breastfeeding, or planning to become pregnant. Live vaccines should be avoided during treatment.
Contraindications
MINJUVI must not be used if you have a known hypersensitivity (allergy) to tafasitamab or to any of the excipients listed in the composition section. Allergic reactions to the active substance or excipients such as polysorbate 20 should be reported to your healthcare provider before treatment begins.
Warnings and Precautions
Before starting treatment with MINJUVI, inform your doctor if you currently have an infection or have a history of recurrent infections. Your healthcare team will monitor you carefully for the following potential complications throughout treatment:
Infusion-related reactions occur most frequently during the first infusion. Your doctor will monitor you during and after each MINJUVI infusion for signs of reaction. Inform your doctor immediately if you experience fever, chills, flushing, rash, or breathing difficulties within 24 hours after the infusion. Pre-medications are given before each infusion to reduce the risk, and may be discontinued at later infusions if no reactions occur.
Treatment with MINJUVI can seriously reduce certain types of blood cells, including neutrophils (white blood cells that fight infection), platelets (which help blood clot), and red blood cells (which carry oxygen). Inform your doctor immediately if you develop fever of 38 °C or higher, or signs of unusual bruising or bleeding. Blood counts will be monitored before each treatment cycle.
Serious infections, including potentially fatal infections, can occur during and after MINJUVI treatment. Report any signs of infection to your doctor, such as fever of 38 °C or higher, chills, cough, or pain during urination. Particular vigilance is needed if your white blood cell counts are low.
PML is a very rare and life-threatening brain infection. Tell your doctor immediately if you develop memory loss, speech difficulties, difficulty walking, vision problems, or numbness or weakness in the face, an arm, or a leg. These may be signs of PML and require urgent investigation.
During treatment, rapid breakdown of cancer cells can release substances (such as potassium and uric acid) into the blood at unusually high levels. Symptoms include nausea, vomiting, poor appetite, tiredness, dark urine, decreased urine output, flank or back pain, muscle cramps, numbness, or heart palpitations. Pre-treatment medications and blood tests are used to monitor for and prevent TLS.
Children and Adolescents
MINJUVI is not recommended for children and adolescents under 18 years of age because there is no clinical data on safety and efficacy in this population. The CD19 target is present on normal developing B-cells, and the effects of CD19-targeted therapy on the developing immune system in children have not been adequately characterised.
Other Medicines and MINJUVI
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or might take. This includes prescription medicines, over-the-counter products, and herbal supplements. While no formal drug interaction studies have been conducted with tafasitamab, the following is important:
- Live vaccines: Administration of live or live-attenuated vaccines is not recommended during treatment with tafasitamab due to the immunosuppressive effects of the drug. Inactivated vaccines may be given, but the immune response may be diminished.
- Lenalidomide: As MINJUVI is given in combination with lenalidomide, all warnings and precautions for lenalidomide also apply. Refer to the lenalidomide prescribing information for its specific drug interactions.
- Rituximab: For follicular lymphoma patients, rituximab is part of the combination regimen. All rituximab-specific precautions and interactions also apply.
Pregnancy and Breastfeeding
Contraception: Women of childbearing potential must use effective contraception during treatment with MINJUVI and for at least 3 months after the last dose. Pregnancy must be excluded before starting treatment.
Pregnancy: MINJUVI must not be used during pregnancy or by women of childbearing potential who are not using effective contraception. Tafasitamab may cause harm to the developing foetus due to its mechanism of action, which depletes B-cells. If you become pregnant during treatment, inform your doctor immediately. Additionally, lenalidomide is a known teratogen and must not be used during pregnancy; all requirements of the lenalidomide pregnancy prevention programme must be met.
Breastfeeding: Do not breastfeed during treatment with MINJUVI and for at least 3 months after the last dose. It is not known whether tafasitamab is excreted in human breast milk, but human IgG antibodies are known to pass into breast milk.
Driving and Using Machines
MINJUVI has no or negligible direct effect on the ability to drive or operate machinery. However, fatigue has been reported in patients receiving tafasitamab, and this should be taken into consideration when driving or using machines.
Important Information About Excipients
Sodium content: Each dose of MINJUVI (based on 5 vials for a patient weighing 83 kg) contains 37.0 mg sodium, equivalent to 1.85% of the WHO recommended maximum daily sodium intake for adults. Patients on controlled sodium diets should be aware of this.
Polysorbate 20: Each vial contains 1 mg polysorbate 20, which may cause allergic reactions in sensitive individuals. Inform your doctor if you have any known allergies to polysorbates.
How Does MINJUVI Interact with Other Drugs?
Quick Answer: No formal drug-drug interaction studies have been conducted with tafasitamab. The key interactions relate to its combination partners (lenalidomide and rituximab) and the contraindication of live vaccines during treatment due to immunosuppression.
As a monoclonal antibody, tafasitamab is not expected to be metabolised by cytochrome P450 enzymes or other drug-metabolising enzymes. Therefore, pharmacokinetic drug-drug interactions through enzyme inhibition or induction are not anticipated. However, clinically relevant interactions may occur through pharmacodynamic mechanisms, particularly relating to immune function.
Combination Partners
MINJUVI is specifically designed to be used in combination with other anti-cancer agents. Understanding the interaction profile of these combination partners is essential for safe treatment:
| Interacting Drug | Type | Clinical Significance | Recommendation |
|---|---|---|---|
| Lenalidomide | Combination partner | Synergistic anti-tumour effect; additive myelosuppression | Used together per protocol; monitor blood counts closely |
| Rituximab | Combination partner (FL only) | Additive B-cell depletion; increased infection risk | Used together for FL; monitor for prolonged immunosuppression |
| Live vaccines | Contraindicated | Risk of disseminated vaccine infection due to immunosuppression | Avoid during and after treatment until immune recovery |
| Inactivated vaccines | Caution advised | Reduced immune response; vaccination may be less effective | May be given but efficacy may be diminished |
| Other immunosuppressants | Additive effect | Increased risk of infections and cytopenias | Monitor closely; dose adjustments may be necessary |
Immunological Considerations
Because tafasitamab depletes both normal and malignant CD19-positive B-cells, patients may develop hypogammaglobulinaemia (low levels of immunoglobulins). This can persist for months after treatment completion and increases vulnerability to infections. Monitoring of immunoglobulin levels is recommended, and immunoglobulin replacement therapy may be considered for patients with recurrent infections and significantly low IgG levels.
Patients receiving MINJUVI in combination with lenalidomide should also be aware of lenalidomide-specific drug interactions, including potential interactions with warfarin (increased INR), digoxin (increased plasma levels), and erythropoiesis-stimulating agents (increased thrombotic risk). Refer to the lenalidomide prescribing information for comprehensive interaction data.
What Is the Correct Dosage of MINJUVI?
Quick Answer: The recommended dose of MINJUVI is 12 mg per kilogram of body weight, administered as an intravenous infusion. The infusion schedule varies by cycle: more frequent infusions in early cycles, tapering to every two weeks in later cycles. Treatment is supervised by a physician experienced in cancer therapy.
MINJUVI is always administered in a clinical setting under the supervision of a healthcare professional experienced in the treatment of cancer. Patients are monitored during and after each infusion for infusion-related reactions. The dose is calculated based on the patient's actual body weight at the start of treatment.
Dosage for Relapsed/Refractory DLBCL
DLBCL Treatment Schedule
Dose: 12 mg/kg body weight given as intravenous infusion
- Cycle 1 (28 days): Infusion on days 1, 4, 8, 15, and 22
- Cycles 2–3 (28 days each): Infusion on days 1, 8, 15, and 22
- Cycle 4 onwards (28 days each): Infusion on days 1 and 15
Lenalidomide: 25 mg orally on days 1–21 of each 28-day cycle, for up to 12 cycles. The physician will adjust the dose if needed.
After completion of up to 12 cycles of combination therapy, MINJUVI monotherapy continues on days 1 and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
Dosage for Relapsed/Refractory Follicular Lymphoma
FL Treatment Schedule
Tafasitamab dose: 12 mg/kg body weight given as intravenous infusion
- Cycles 1–3 (28 days each): Infusion on days 1, 8, 15, and 22
- Cycles 4–12 (28 days each): Infusion on days 1 and 15
Rituximab: 375 mg/m² body surface area, given as IV infusion on days 1, 8, 15, and 22 in cycle 1, then on day 1 of cycles 2–5.
Lenalidomide: 20 mg orally on days 1–21 of each 28-day cycle for up to 12 cycles. The physician may adjust the dose as needed.
Treatment with all three drugs is completed after a maximum of 12 cycles (rituximab after 5 cycles).
Infusion Rate
| Infusion | Initial Rate | Total Duration | Notes |
|---|---|---|---|
| First infusion (Cycle 1, Day 1) | 70 mL/hour for first 30 min | Approximately 2.5 hours | Increase rate after 30 min if tolerated |
| All subsequent infusions | Standard rate | 1.5–2 hours | If previous infusions were well tolerated |
Children
MINJUVI is not recommended for use in children and adolescents under 18 years of age. No paediatric clinical data are available.
Elderly
No dose adjustment is required based on age alone. However, elderly patients may be more susceptible to infections and cytopenias. Clinical trial data included patients up to 86 years of age, and the safety profile was generally consistent across age groups, though more vigilant monitoring is recommended in older patients.
Missed Dose
If a planned infusion of MINJUVI is missed, it should be administered as soon as possible. The treatment schedule should then be adjusted to maintain the prescribed interval between doses. Do not double the dose to make up for a missed infusion.
Overdose
Since MINJUVI is administered in a hospital or clinic under medical supervision, overdose is unlikely. There is no specific antidote for tafasitamab overdose. In case of overdose, the patient should be closely monitored for signs and symptoms of adverse reactions, and appropriate symptomatic and supportive treatment should be initiated as needed.
What Are the Side Effects of MINJUVI?
Quick Answer: The most common side effects of MINJUVI include decreased blood cell counts (neutropenia, thrombocytopenia, anaemia), infections, rash, itching, infusion-related reactions, fatigue, fever, and gastrointestinal disturbances. Serious side effects include severe infections, pneumonia, and sepsis.
Like all medicines, MINJUVI can cause side effects, although not everybody gets them. The frequency and severity of side effects may be influenced by the combination regimen used. Many side effects are manageable with appropriate supportive care and dose modifications.
Contact your doctor or nurse immediately if you notice any of the following serious side effects, as you may need urgent treatment: signs of serious infection (fever, chills, sore throat, cough, shortness of breath, nausea, vomiting, diarrhoea — especially if you have been told your white blood cell count is low), pneumonia (lung infection), or sepsis (bloodstream infection).
Very Common
May affect more than 1 in 10 people
- Decreased white blood cells (neutropenia) — may cause fever ≥38 °C or infection symptoms
- Decreased platelets (thrombocytopenia) — unusual bruising or bleeding
- Decreased red blood cells (anaemia) — pale skin, tiredness, shortness of breath
- Infections (bacterial, viral, or fungal) including respiratory infections, bronchitis, pneumonia, urinary tract infection
- Rash
- Itching (pruritus)
- Infusion-related reactions — fever, chills, flushing, breathing difficulties
- Low potassium in blood (hypokalaemia)
- Muscle cramps
- Back pain
- Swelling in arms and/or legs (oedema)
- Weakness, fatigue, general malaise
- Fever (pyrexia)
- Diarrhoea
- Constipation
- Abdominal pain
- Nausea
- Vomiting
- Cough
- Shortness of breath (dyspnoea)
- Decreased appetite
- Headache
Common
May affect up to 1 in 10 people
- Worsening breathlessness in people with chronic obstructive pulmonary disease (COPD)
- Abnormal skin sensations (paraesthesia) — tingling, prickling, numbness
- Skin redness (erythema)
- Chills (rigors)
- Altered taste (dysgeusia)
- Hair loss (alopecia)
- Abnormal sweating (hyperhidrosis)
- Pain in arms and legs
- Muscle and joint pain (myalgia, arthralgia)
- Weight loss
- Nasal congestion
- Inflammation of mucous membranes (mucositis)
- Low lymphocyte count (lymphopenia)
- Hypogammaglobulinaemia (low immunoglobulin levels)
- Low calcium, low magnesium (seen in blood tests)
- Elevated C-reactive protein, creatinine, liver enzymes (GGT, transaminases), bilirubin (seen in blood tests)
- Basal cell carcinoma (a type of skin cancer)
Uncommon
May affect up to 1 in 100 people
- Tumour lysis syndrome (TLS) — abnormal blood chemistry levels caused by rapid breakdown of cancer cells during treatment
Managing Side Effects
Many side effects of MINJUVI can be managed effectively with supportive care. Your healthcare team will monitor your blood counts regularly and may adjust doses, delay treatment cycles, or prescribe supportive medications such as growth factors (G-CSF) for neutropenia, antibiotics for infection prophylaxis, or transfusions for significant anaemia or thrombocytopenia.
Infusion-related reactions are managed by slowing or temporarily stopping the infusion and administering antihistamines, corticosteroids, or antipyretics. Pre-medication before each infusion significantly reduces the risk and severity of these reactions. If you experience any new or worsening symptoms during treatment, report them promptly to your healthcare team for appropriate management.
Reporting Side Effects
Reporting suspected adverse reactions after the medicine has been authorised is important for ongoing benefit-risk monitoring. Healthcare professionals and patients can report suspected side effects to their national regulatory authority (e.g., the FDA in the United States, the MHRA in the United Kingdom, or the EMA in Europe).
How Should You Store MINJUVI?
Quick Answer: Store unopened MINJUVI vials in a refrigerator (2–8 °C), protected from light in the original carton. Do not freeze or shake. Keep out of the sight and reach of children.
Proper storage of MINJUVI is essential to maintain the stability and efficacy of the medicine. As a biological product containing a monoclonal antibody, temperature control is critical. The following storage conditions apply:
- Unopened vials: Store in a refrigerator at 2–8 °C. Keep the vial in the outer carton to protect from light. Do not use after the expiry date stated on the vial label and carton.
- Reconstituted solution (before dilution): Stable for up to 30 days at 2–8 °C, or up to 24 hours at 25 °C. From a microbiological standpoint, use immediately unless reconstituted under controlled aseptic conditions.
- Diluted solution (ready for infusion): Stable for up to 14 days at 2–8 °C, followed by up to 24 hours at up to 25 °C. From a microbiological standpoint, use immediately unless diluted under controlled aseptic conditions.
- Do not freeze or shake at any stage.
Any unused medicine or waste material should be disposed of in accordance with local regulations for cytotoxic or hazardous pharmaceutical waste. MINJUVI is intended for single use only and does not contain any preservatives. Each vial should be used for one patient only, and any remaining solution should be discarded.
What Does MINJUVI Contain?
Quick Answer: Each vial of MINJUVI contains 200 mg tafasitamab as the active substance. After reconstitution with 5 mL sterile water, the solution contains 40 mg/mL tafasitamab. Excipients include sodium citrate dihydrate, citric acid monohydrate, trehalose dihydrate, and polysorbate 20.
Active Ingredient
The active substance is tafasitamab, a humanised Fc-modified monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Each vial contains 200 mg tafasitamab. After reconstitution with 5 mL of sterile water for injections, each mL of solution contains 40 mg tafasitamab.
Excipients (Inactive Ingredients)
- Sodium citrate dihydrate — buffering agent to maintain pH stability
- Citric acid monohydrate — buffering agent
- Trehalose dihydrate — stabiliser to protect the protein during freeze-drying
- Polysorbate 20 — surfactant to prevent protein aggregation (1 mg per vial; may cause allergic reactions)
Appearance and Packaging
MINJUVI is a white to slightly yellowish powder supplied in a clear glass vial with a rubber stopper, aluminium seal, and plastic flip-off cap. Each carton contains 1 single-use vial. The reconstituted solution should be colourless to slightly yellowish and free from visible particles. If the solution is cloudy, discoloured, or contains particles, the vial must be discarded.
Reconstitution and Dilution
MINJUVI must be reconstituted and diluted by a healthcare professional using aseptic technique before intravenous administration. The reconstituted solution (40 mg/mL) is further diluted in a 250 mL infusion bag of 0.9% sodium chloride to achieve a final concentration of 2–8 mg/mL tafasitamab. Do not use other diluents. Do not co-administer other medications through the same infusion line. Do not administer as an intravenous push or bolus injection.
Frequently Asked Questions About MINJUVI
MINJUVI (tafasitamab) is used to treat adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant, and adults with relapsed or refractory follicular lymphoma (FL). For DLBCL, it is used in combination with lenalidomide. For FL, it is used with lenalidomide and rituximab.
MINJUVI is given as an intravenous infusion (drip) in a hospital or clinical setting. The first infusion takes approximately 2.5 hours, and subsequent infusions take 1.5 to 2 hours. It is administered in 28-day cycles, with the frequency of infusions decreasing over time as treatment progresses. The dose is 12 mg per kilogram of body weight.
The most common side effects (affecting more than 1 in 10 patients) include decreased blood cell counts (neutropenia, thrombocytopenia, anaemia), infections, rash, itching, infusion-related reactions, low potassium, muscle cramps, back pain, fatigue, fever, diarrhoea, constipation, nausea, vomiting, cough, shortness of breath, decreased appetite, and headache. Your healthcare team will monitor you closely and manage these effects as needed.
No. MINJUVI must not be used during pregnancy. Women of childbearing potential must use effective contraception during treatment and for at least 3 months after the last dose. Pregnancy must be excluded before starting treatment. This is especially important because MINJUVI is used with lenalidomide, which is a known teratogen that can cause severe birth defects.
For DLBCL, combination therapy with lenalidomide lasts up to 12 cycles (approximately 12 months), after which MINJUVI monotherapy continues indefinitely until disease progression or unacceptable side effects. For follicular lymphoma, the complete regimen with lenalidomide and rituximab lasts a maximum of 12 cycles. Each cycle is 28 days long.
Unopened MINJUVI vials should be stored in a refrigerator at 2–8 °C, protected from light in the original carton. Once reconstituted, the solution is stable for up to 30 days at 2–8 °C or 24 hours at room temperature. The diluted infusion solution is stable for up to 14 days at 2–8 °C followed by up to 24 hours at room temperature. It must never be frozen or shaken.
References
- European Medicines Agency (EMA). MINJUVI (tafasitamab) — Summary of Product Characteristics. Last updated December 2025. Available at: ema.europa.eu.
- 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.
- Duell J, Maddocks KJ, González-Barca E, et al. Long-term outcomes from the Phase II L-MIND study of tafasitamab (MOR208) plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma. Haematologica. 2021;106(9):2417–2426.
- Zinzani PL, Maddocks KJ, Engert A, et al. InMIND: a randomised, double-blind, placebo-controlled, Phase III study of tafasitamab plus lenalidomide plus rituximab versus placebo plus lenalidomide plus rituximab in patients with relapsed/refractory follicular lymphoma. Blood. 2023;142(Supplement 1):Abstract 603.
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: B-Cell Lymphomas. Version 1.2026.
- Tilly H, Morschhauser F, Sehn LH, et al. Polatuzumab vedotin in previously untreated diffuse large B-cell lymphoma. N Engl J Med. 2022;386(4):351–363.
- World Health Organization (WHO). Model List of Essential Medicines. 23rd List, 2023.
- British National Formulary (BNF). Tafasitamab. Updated January 2026.
Medical Editorial Team
This article has been written and reviewed by iMedic's medical editorial team, which includes board-certified specialists in oncology and haematology. All content is based on current international clinical guidelines, peer-reviewed research, and approved product information.
Reviewed by specialist physicians in clinical oncology and haematology according to EMA, FDA, and NCCN guidelines.
Level 1A evidence based on randomised controlled trials and systematic reviews. GRADE framework applied.