Minjuvi: Uses, Side Effects and Dosage

What is Minjuvi used for?

• Diffuse large B-cell lymphoma (DLBCL) – a type of cancer found mainly in the lymph nodes made up of white blood cells that have become malignant. Minjuvi is used to treat adult patients who have had their cancer return after other treatments or when other treatments did not work.
• Follicular lymphoma (FL) – a type of cancer found mainly in the follicles (small sacs) of lymph nodes made up of white blood cells that have become malignant. Minjuvi is used together with other therapies to treat adult patients who have had their cancer return after other treatments or when other treatments did not work.

For the following indication, Minjuvi® has been approved with conditions (NOC/c). This means it has passed Health Canada’s review and can be bought and sold in Canada, but the manufacturer has agreed to complete more studies to make sure the drug works the way it should. For more information, talk to your healthcare professional.

• Minjuvi (tafasitamab for injection) 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, including DLBCL arising from low grade lymphoma, who are not eligible for autologous stem cell transplant (ASCT).

For the following indication Minjuvi has been approved without conditions. This means it has passed Health Canada’s review and can be bought and sold in Canada.

Serious Warnings and Precautions

• Infections: Fatal, life threatening, or serious infections have been reported in patients treated with Minjuvi
• Decreased production of blood cells: Serious and severe reduction in blood cells have been reported in patients treated with Minjuvi
• A serious and life-threatening brain condition called progressive multifocal leukoencephalopathy (PML) has been observed after treatment with Minjuvi
• Recurrence of hepatitis B viral infection can occur with Minjuvi treatment
• Minjuvi (tafasitamab for injection) is indicated in combination with rituximab and lenalidomide for the treatment of adult patients with Grade 1, 2, or 3a relapsed or refractory follicular lymphoma (FL).

What is a Notice of Compliance with Conditions (NOC/c)?

A Notice of Compliance with Conditions (NOC/c) is a type of approval to sell a drug in Canada.

Health Canada only gives an NOC/c to a drug that treats, prevents, or helps identify a serious or life-threatening illness. The drug must show promising proof that it works well, is of high quality, and is reasonably safe. Also, the drug must either respond to a serious medical need in Canada, or be much safer than existing treatments.

Drug makers must agree in writing to clearly state on the label that the drug was given an NOC/c, to complete more testing to make sure the drug works the way it should, to actively monitor the drug’s performance after it has been sold, and to report their findings to Health Canada.

How does Minjuvi work?

Minjuvi contains the active substance tafasitamab, an anti-cancer agent, which is a monoclonal antibody that has been designed to kill cancer cells. The monoclonal antibody acts by binding to a protein on the surface of cancerous B cells in order to kill the cells and to recruit normal immune cells, which also can target and kill the cancer cells.

For DLBCL, Minjuvi is given with another drug called lenalidomide.

For FL, Minjuvi is given in combination with two other drugs, rituximab and lenalidomide.

What are the ingredients in Minjuvi?

Medicinal ingredients: tafasitamab

Non-medicinal ingredients: citric acid monohydrate, polysorbate 20, sodium citrate dihydrate, and trehalose dihydrate.

Minjuvi comes in the following dosage forms:

For injection: 200 mg of tafasitamab as white to slightly yellowish lyophilized powder in single-dose vial for reconstitution and further dilution.

Do not use Minjuvi if:

You are allergic to tafasitamab or to any of the other ingredients in the medicine.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Minjuvi. Talk about any health conditions or problems you may have, including if you:

• have an active infection or have had one recently.
• have hepatitis B or have recovered from hepatitis B in the past.

• are pregnant or plan to become pregnant. Minjuvi may harm your unborn baby. You should not become pregnant during treatment with Minjuvi. Do not receive treatment with Minjuvi in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.

  • you should use an effective method of birth control (contraception) during treatment and for at least 3 months after your last dose of Minjuvi.
  • tell your healthcare professional right away if you become pregnant or think you may be pregnant during treatment with Minjuvi.
  • are breast-feeding or plan to breast-feed. It is not known if Minjuvi passes into your breast-milk. Do not breast-feed during treatment and for at least 3 months after your last dose of Minjuvi.

Other warnings you should know about:

• Infusion-related reactions

  • Your healthcare professional will monitor you for infusion reactions during your infusion of Minjuvi. Tell your health care professional right away if you get chills, flushing, headache, or shortness of breath during an infusion with Minjuvi.

• Low blood cell counts (platelets, red blood cells, and white blood cells)

  • Low blood cell counts are common with Minjuvi, but can also be serious or severe. Your healthcare professional will monitor your blood counts during treatment with Minjuvi. Tell your healthcare professional right away if you get a fever of 38°C or above, or any bruising or bleeding.

• Infections

  • Serious infections, including infections that can cause death, have happened in people during treatment with Minjuvi and after the last dose. Tell your healthcare professional right away if you get a fever of 38°C or above, or develop any signs or symptoms of infection.

• Hepatitis B reactivation

  • Patients who have previously had hepatitis B may be at greater risk of hepatitis B reactivation after receiving Minjuvi. Hepatitis B reactivation has been observed after treatment with Minjuvi. Your doctor will monitor you for hepatitis B and may make changes to your treatment if necessary.

• Progressive multifocal leukoencephalopathy

  • A serious and life-threatening brain condition called progressive multifocal leukoencephalopathy (PML) has been observed after treatment with Minjuvi. Tell your doctor immediately if you have memory loss, trouble thinking, difficulty with walking, clumsiness, experience falls or weakness on one side of the body, changes in mood or loss of vision. Your doctor will check if you need to see a neurologist.

• Tumour Lysis Syndrome (also called TLS) (the development of unusual levels of some chemicals such as potassium and uric acid, in the blood caused by fast breakdown of cancer cells during treatment)

  • Your healthcare professional will do blood tests to check for TLS.
  • Tell your doctor immediately if you have palpitations/irregular heartbeats; vomiting; fatigue/weakness; difficulty concentrating/trouble thinking; swelling, numbness or tingling in hands, face or feet; back pain; muscle cramps; fainting or trouble breathing.

• Immunizations

  • The safety of immunization with live vaccines following Minjuvi therapy has not been investigated, and vaccination with live vaccines is not recommended concurrently with Minjuvi therapy.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with Minjuvi:

No known interactions

How to take Minjuvi:

• Minjuvi will be given to you by your healthcare professional in a healthcare setting. Minjuvi is given as an intravenous infusion.

Usual dose:

• You will receive other medications prior to each dose of Minjuvi to reduce the chances of an infusion reaction. Your health care professional may decide you do not need these medicines after several infusions if you do not have any reactions to the infusion.
• Minjuvi will be given to you in cycles of 28 days.

• For patients with Diffuse large B-cell lymphoma

  • Minjuvi is given at a dose of 12 mg per kilogram body weight as an intravenous infusion by your healthcare professional. How often you have to come to the hospital to receive Minjuvi will depend on how many 28-day cycles you have received. It is important to come to the hospital to receive Minjuvi as instructed by your healthcare professional.
  • Minjuvi is given while you are taking another drug called lenalidomide. Your healthcare professional will tell you how much and when to take lenalidomide during the first 12 cycles.
  • If you complete the all twelve cycles, your healthcare professional will instruct you to stop taking lenalidomide and will continue to give you Minjuvi on its own in the hospital so long as your healthcare professional considers you are benefiting from this therapy.

• For patients with follicular lymphoma

  • Minjuvi is given at a dose of 12 mg per kilogram body weight as an intravenous infusion by your healthcare professional in a hospital setting.
  • Minjuvi is also given while you are taking two other drugs: rituximab and lenalidomide. You will be instructed by your healthcare professional when to come to the hospital to receive rituximab and Minjuvi. Your healthcare professional will also tell you how much and when to take lenalidomide.
  • You will be treated for a maximum of 12 cycles so long as your healthcare professional considers you are benefiting from this treatment.

Overdose:

If you think you, or a person you are caring for, have taken too much Minjuvi, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

What are possible side effects from using Minjuvi?

These are not all the possible side affects you may feel when taking Minjuvi. If you experience any side effects not listed here, contact your healthcare professional.

The most common side effects of Minjuvi when given with lenalidomide in people with DLBCL include:

• decreased blood count (certain white blood cells and red blood cells)
• feeling tired or weak
• decreased platelets
• diarrhea, constipation, nausea, vomiting
• cough
• trouble breathing
• fever
• swelling of lower legs or hands
• respiratory tract infection
• urinary tract infections
• decreased appetite

The most common side effects of Minjuvi when given with rituximab and lenalidomide in people with FL include:

• viral and bacterial infections
• diarrhea
• constipation
• rash
• feeling tired or weak

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Minjuvi is stored refrigerated at 2°C to 8°C in the original carton to protect from light. Do not shake. Do not freeze.

Keep out of reach and sight of children.

If you want more information about Minjuvi:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html), the manufacturer’s website (www.incytebiosciences.ca), or by calling 1-833-309-2759.

Wilmington, Delaware 19803 USA

All trademarks used under license.

Date of Authorization: 2026-04-17