MINJUVI 200 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

MINJUVI 200 mg powder for concentrate for solution for infusion

tafasitamab

This medicinal product is subject to additional monitoring, which will allow for the quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you how to report side effects.

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is MINJUVI and what is it used for
2. What you need to know before you use MINJUVI
3. How to use MINJUVI
4. Possible side effects
5. Storage of MINJUVI
6. Contents of the pack and other information

1. What is MINJUVI and what is it used for

What is MINJUVI

MINJUVI contains the active substance tafasitamab. It is a type of protein called a monoclonal antibody designed to destroy cancer cells. This protein works by binding to a specific target on the surface of a type of white blood cell called B cells or lymphocytes B. When tafasitamab binds to the surface of these cells, the cells die.

What is MINJUVI used for

MINJUVI is used to treat adults with a type of B cell lymphoma called diffuse large B cell lymphoma. It is used when the cancer has come back after previous treatment, or has not responded to treatment, if patients cannot receive a stem cell transplant.

What other medicines is MINJUVI used with

MINJUVI is used with another cancer medicine, lenalidomide, at the start of treatment, after which treatment with MINJUVI continues alone.

2. What you need to know before you use MINJUVI

Do not use MINJUVI

• if you are allergic to tafasitamab or any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions

Tell your doctor or pharmacist before you start using MINJUVI if you have an infection or a history of recurring infections.

During treatment with MINJUVI you may notice the following:

• Infusion-related reactions

Infusion-related reactions may occur more frequently during the first infusion. Your doctor will monitor you for infusion-related reactions during the infusion of MINJUVI. Tell your doctor immediately if you experience reactions such as fever, chills, flushing, rash, or difficulty breathing within 24 hours after the infusion.

Your doctor will give you treatment before each infusion to reduce the risk of infusion-related reactions. If you do not experience reactions, your doctor may decide that you do not need these medicines with subsequent infusions.

• Reduced number of blood cells

Treatment with MINJUVI may reduce the number of certain types of blood cells in your body, such as white blood cells called neutrophils, platelets, and red blood cells. Tell your doctor immediately if you have a fever of 38 °C or higher or show any signs of bruising or bleeding, as these may be signs of this reduction. Your doctor will check your blood cell counts during treatment and before the start of each treatment cycle.

• Infections

During and after treatment with MINJUVI, serious infections can occur, including potentially life-threatening infections. Tell your doctor if you notice signs of infection, such as fever of 38 °C or higher, chills, cough, or pain when urinating.

• Progressive multifocal leukoencephalopathy (PML)

PML is a rare and potentially life-threatening brain infection. Tell your doctor immediately if you have symptoms such as memory loss, difficulty speaking or walking, vision problems, or numbness or weakness in the face, arms, or legs.

If you have any of these symptoms before or during treatment with MINJUVI or notice any changes, tell your doctor immediately, as they may be signs of PML.

• Tumor lysis syndrome

Some people may have unusually high levels of certain substances (such as potassium and uric acid) in the blood due to the rapid breakdown of cancer cells during treatment. This is called tumor lysis syndrome. Tell your doctor if you have symptoms such as nausea, vomiting, loss of appetite, or fatigue, dark urine, decreased urine output, pain in the side or back, muscle cramps, numbness, or palpitations. Your doctor may give you treatment before each infusion to reduce the risk of tumor lysis syndrome and perform blood tests to detect it.

Tell your doctor immediately if you notice any of these problems.

Children and adolescents

MINJUVI is not recommended for children and adolescents under 18 years of age, as there is no information on the use of this age group.

Other medicines and MINJUVI

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Live vaccines are not recommended during treatment with tafasitamab.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

• Contraception

Women of childbearing age should use effective contraceptive methods during treatment with MINJUVI and for up to 3 months after the end of treatment.

• Pregnancy

Do not use MINJUVI during pregnancy if you are of childbearing age and do not use contraceptive methods. Pregnancy must be excluded before treatment. Tell your doctor immediately if you become pregnant or think you may be pregnant during treatment with MINJUVI.

MINJUVI is given with lenalidomide for a maximum of 12 cycles. Lenalidomide can cause harm to the fetus and must not be used during pregnancy or in women of childbearing age, unless all the conditions of the lenalidomide pregnancy prevention program are met. Your doctor will give you more information and advice.

• Breastfeeding

Do not breastfeed during treatment with MINJUVI until at least 3 months after the last dose. It is not known if tafasitamab passes into breast milk.

Driving and using machines

MINJUVI has no or negligible influence on the ability to drive and use machines. However, fatigue has been reported in patients taking tafasitamab, and this should be taken into account when driving and using machines.

MINJUVI contains sodium

This medicine contains 37.0 mg of sodium (the main component of cooking/table salt) in each dose of 5 vials (the dose for a patient with a weight of 83 kg). This is equivalent to 1.85% of the maximum recommended daily intake of sodium for an adult.

3. How to use MINJUVI

Your treatment will be supervised by a doctor who is experienced in the treatment of cancer. MINJUVI will be given to you into a vein by infusion (drip). During and after the infusion, you will be frequently monitored for infusion-related side effects.

MINJUVI will be given to you in 28-day cycles. The dose you receive will be based on your weight and will be calculated by your doctor.

The recommended dose is 12 mg of tafasitamab per kilogram of body weight. It is given as an infusion into a vein according to the following schedule:

• Cycle 1: infusion on day 1, 4, 8, 15, and 22 of the cycle
• Cycles 2 and 3: infusion on day 1, 8, 15, and 22 of each cycle
• Cycle 4 and subsequent cycles: infusion on day 1 and 15 of each cycle

In addition, your doctor will prescribe that you take lenalidomide capsules for a maximum of 12 cycles. The recommended initial dose of lenalidomide is 25 mg once daily from day 1 to 21 of each cycle.

Your doctor may adjust the initial dose and subsequent dosing as needed.

After a maximum of 12 cycles of combination therapy, treatment with lenalidomide will be stopped. Then, cycles of treatment with MINJUVI will continue until the disease worsens or you experience unacceptable side effects.

If you have received more MINJUVI than you should

Since the medicine is given in a hospital under the supervision of a doctor, this is unlikely. Tell your doctor if you think you may have received too much MINJUVI.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor or nurse immediatelyif you notice any of the following serious side effects (you may need urgent medical treatment). They can be new symptoms or a change in your current symptoms.

• serious infections, possible symptoms: fever, chills, sore throat, cough, shortness of breath, nausea, vomiting, diarrhea. These could be especially important if you have been told you have a low level of white blood cells called neutrophils.
• pneumonia (lung infection)
• sepsis (infection in the bloodstream)

Other side effects

Tell your doctor or nurse immediately if you notice any of the following side effects:

Very common(may affect more than 1 in 10 people)

• reduced number of blood cells

• white blood cells, especially a type called neutrophils; possible symptoms: fever of 38 °C or higher or any symptoms of infection
• platelets; possible symptoms: bruising or bleeding without injury or only minor injury
• red blood cells; possible symptoms: pale skin or lips, tiredness, shortness of breath

• bacterial, viral, or fungal infections, such as respiratory infections, bronchitis,

pneumonia, urinary tract infections

• rash
• low potassium levels in the blood in tests
• muscle cramps
• back pain
• swelling of the arms or legs due to fluid accumulation
• weakness, tiredness, feeling unwell
• fever
• diarrhea

• constipation
• abdominal pain
• nausea
• vomiting
• cough
• shortness of breath
• decreased appetite

Common(may affect up to 1 in 10 people)

• worsening of breathing difficulties caused by narrowing of the airways in the lungs called chronic obstructive pulmonary disease (COPD)
• headache
• abnormal skin sensations, such as tingling, itching, numbness
• itching
• redness of the skin
• infusion-related reactions

These reactions can occur during infusion of MINJUVI or within 24 hours after the infusion. Possible symptoms are fever, chills, flushing, or difficulty breathing.

• altered sense of taste
• hair loss
• abnormal sweating
• pain in the arms and legs
• pain in muscles and joints
• weight loss
• nasal congestion
• inflammation of the membranes covering organs such as the mouth
• lack of a type of white blood cell called lymphocytes in blood tests
• a problem with the immune system called hypogammaglobulinemia
• in blood tests, low levels of

• calcium

• magnesium

• in blood tests, high levels of

• reactive protein C, which could be a consequence of inflammation or infection
• serum creatinine, a product of muscle tissue breakdown
• liver enzymes: gamma glutamyltransferase, transaminases
• bilirubin, a yellow breakdown product of blood pigment

• a type of skin cancer called basal cell carcinoma

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of MINJUVI

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label of the vial and on the carton after EXP. The expiry date is the last day of the month shown.

Store in a refrigerator (2 °C to 8 °C).

Keep the vial in the outer packaging to protect it from light.

Disposal of unused medicine and all materials that have come into contact with it should be done in accordance with local regulations.

6. Container Contents and Additional Information

Composition of MINJUVI

• The active ingredient is tafasitamab. One vial contains 200 mg of tafasitamab. After reconstitution, each ml of solution contains 40 mg of tafasitamab.
• The other components are sodium citrate dihydrate, citric acid monohydrate, trehalose dihydrate, polysorbate 20 (see section 2 "MINJUVI contains sodium").

Appearance and Container Contents of the Product

MINJUVI is a powder for concentrate for solution for infusion. It is a lyophilized powder, white to slightly yellow, in a transparent glass vial with a rubber stopper, aluminum seal, and plastic press-fit closure.

Each box contains 1 vial.

Marketing Authorization Holder and Manufacturer

Incyte Biosciences Distribution B.V.

Paasheuvelweg 25

1105 BP Amsterdam

Netherlands

Date of Last Revision of this Leaflet: MM/YYYY.

This medicinal product has been authorized with a "conditional approval". This approval mechanism means that more information on this medicinal product is expected.

The European Medicines Agency will review the new information on this medicinal product at least once a year, and this leaflet will be updated as necessary.

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

On the European Medicines Agency website, this leaflet can be found in all languages of the European Union/European Economic Area.

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This information is intended only for healthcare professionals:

MINJUVI is supplied in single-use sterile vials without preservatives. MINJUVI must be reconstituted and diluted before intravenous infusion. Use adequate aseptic technique for reconstitution and dilution.

Reconstitution Instructions

• Determine the dose of tafasitamab based on the patient's weight by multiplying 12 mg by the patient's weight (kg). Then, calculate the number of tafasitamab vials needed (each vial contains 200 mg of tafasitamab).
• Using a sterile syringe, carefully add 5.0 ml of sterile water for injectable preparations to each MINJUVI vial. Direct the flow towards the vial walls and not directly onto the lyophilized powder.
• Gently swirl the reconstituted vial or vials to facilitate dissolution of the lyophilized powder. Do not shake or move vigorously. Do not withdraw the contents until all solid parts have completely dissolved. The lyophilized powder should dissolve within 5 minutes.
• The reconstituted solution should appear as a colorless to slightly yellow solution. Before proceeding, ensure that there are no particles or discoloration with a visual inspection. If the solution is turbid, colored, or contains visible particles, discard the vial.

Dilution Instructions

• A 250 ml infusion bag with 9 mg/ml (0.9%) sodium chloride injectable solution must be used.
• Calculate the total volume of reconstituted tafasitamab solution needed at 40 mg/ml.

Withdraw the same volume from the infusion bag and discard it.

• Withdraw the calculated total volume (ml) of reconstituted tafasitamab solution from the vial or vials and slowly add it to the 0.9% sodium chloride infusion bag. Discard any unused portion of tafasitamab remaining in the vial.
• The final concentration of the diluted solution should be between 2 mg/ml and 8 mg/ml of tafasitamab.
• Gently mix the intravenous bag by slowly inverting it. Do not shake.

Administration Method

• During the first infusion of cycle 1, the intravenous infusion rate should be 70 ml/h for the first 30 minutes. Then, the rate should be increased to complete the first infusion within a 2.5-hour period.
• All subsequent infusions should be administered over a period of 1.5 to 2 hours.
• Do not administer with other medicinal products through the same infusion line.
• Do not administer MINJUVI as an intravenous push or bolus.

Reconstituted Solution (Before Dilution)

Chemical and physical stability has been demonstrated for up to 30 days between 2°C and 8°C or for up to 24 hours at 25°C.

From a microbiological point of view, the reconstituted solution should be used immediately. If not used immediately, the in-use storage time and conditions are the responsibility of the user and would normally not exceed 24 hours between 2°C and 8°C, unless the reconstitution has been performed in controlled and validated aseptic conditions. Do not freeze or shake.

Diluted Solution (For Infusion)

Chemical and physical stability has been demonstrated for up to 14 days between 2°C and 8°C, followed by up to 24 hours at a maximum of 25°C.

From a microbiological point of view, the diluted solution should be used immediately. If not used immediately, the storage time before use and storage conditions are the responsibility of the user and should not exceed 24 hours between 2°C and 8°C, unless the dilution has been performed under controlled and validated aseptic conditions. Do not freeze or shake.

Disposal of unused medicinal products and all materials that have come into contact with them should be done in accordance with local regulations.