Minjuvi 200 mg polvo para concentrado para solucion para perfusion

Prospect: information for the user

MINJUVI 200 mg powder for concentrate for solution for infusion

tafasitamab

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

•Keep this prospect, as you may need to read it again.

•If you have any doubts, consult your doctor or pharmacist.

•If you experience adverse effects, consult your doctor or pharmacist,even if they are adverse effects that do not appear in this prospect. See section 4.

1.What is MINJUVI and what it is used for

2.What you need to know before starting to use MINJUVI

3.How to use MINJUVI

4.Possible adverse effects

5.Storage of MINJUVI

6.Contents of the package and additional information

What is MINJUVI

MINJUVI contains the active ingredient tafasitamab. It is a type of protein called monoclonal antibody and is designed to destroy cancer cells. This protein acts 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 lymphocyte cancer called large B cell lymphoma. It is used when the cancer has recurred after previous treatment, or has not responded to it, if patients cannot receive a stem cell transplant.

What other medications is MINJUVI administered with

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

No use MINJUVI

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use MINJUVI if you have an infection or a history of recurrent 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. Inform your doctor immediately if you experience reactions such as fever, chills, flushing, skin rash, or breathing difficulties 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 medications with subsequent infusions.

• Reduction in blood cell count

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

• Infections

During treatment with MINJUVI and after treatment, you may develop severe infections, including potentially life-threatening infections. Inform your doctor if you observe signs of infection, such as a fever of 38°C or higher, chills, cough, or pain when urinating.

• Progressive multifocal leukoencephalopathy (PML)

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

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

• Tumor lysis syndrome

Some people may develop 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 known as tumor lysis syndrome. Inform your doctor if you experience symptoms such as nausea, vomiting, loss of appetite, fatigue, dark urine, 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.

Contact 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 medications and MINJUVI

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

It is not recommended to use live vaccines during treatment with tafasitamab.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

• Contraception

It is recommended that women of childbearing age use effective contraceptive methods during treatment with MINJUVI and for up to 3 months after treatment.

• Pregnancy

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

MINJUVI is administered with lenalidomide for a maximum of 12 cycles. Lenalidomide can cause fetal damage and should not be used during pregnancy or in women of childbearing age, unless all conditions of the lenalidomide pregnancy prevention program are met. Your doctor will give you more information and recommendations.

• Breastfeeding

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

Driving and operating machinery

The influence of MINJUVI on the ability to drive and operate machinery is negligible or insignificant. However, fatigue has been reported in patients taking tafasitamab, and this should be taken into account when driving and operating machinery.

MINJUVI contains sodium

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

A doctor with experience in cancer treatment will supervise your treatment. MINJUVI will be administered through a vein via infusion (drip). During infusion and after this, you will be monitored frequently to detect adverse effects related to the infusion.

MINJUVI will be administered in cycles of 28 days. The dose you receive is 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 administered through a vein infusion 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: 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 initial recommended dose of lenalidomide is 25 mg once a day from days 1 to 21 of each cycle.

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

After a maximum of 12 cycles of combination therapy, treatment with lenalidomide is discontinued. Subsequent cycles of treatment with MINJUVI will continue until the disease worsens or you experience unacceptable adverse effects.

If you have received more MINJUVI than you should

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

•severe infections, possible symptoms: fever, chills, sore throat, cough, shortness of breath, nausea, vomiting, diarrhea. These may be especially important if you have been told that you have a low level of white blood cells called neutrophils.

•pneumonia (lung infection)

•sepsis (infection in the circulatory system)

Other side effects

Inform 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 more or any symptom of infection
• platelets; possible symptoms: unusual bruising or bleeding without injury or only minor injuries
• red blood cells; possible symptoms: pale skin or lips, fatigue, shortness of breath

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

pulmonary inflammation, urinary tract infections

• skin rash

• low potassium levels in the blood in blood tests

• muscle cramps

• back pain

• swelling of the arms or legs due to fluid accumulation

• weakness, fatigue, general feeling of discomfort

• fever

• diarrhea

• constipation

• abdominal pain

• nausea

• vomiting

• cough

• shortness of breath

• loss of appetite

Common(may affect up to 1 in 10 people)

• worsening of breathing difficulty caused by narrowing of the pulmonary airways called chronic obstructive pulmonary disease (COPD)
• headache

• abnormal sensation of the skin, such as tingling, itching, numbness

• itching

• skin redness

• reactions related to perfusion

These reactions may occur during MINJUVI perfusion or within 24 hours after perfusion. Possible symptoms are fever, chills, redness, or difficulty breathing.

• alteration of taste

• hair loss

• abnormal sweating

• pain in the arms and legs

• muscle and joint pain

• weight loss

• nasal congestion

• inflammation of the membranes covering organs such as the mouth

• low levels of white blood cells called lymphocytes in blood tests

• a problem with the immune system called hypogammaglobulinemia

• low levels of

• calcium

• magnesium

• high levels of

• proteins C reactive, which could be a consequence of inflammation or infection

• serum creatinine, a product of muscle tissue degradation

• liver enzymes: gamma glutamyltransferase, transaminases

• bilirubin, a yellow pigment degradation substance

• skin cancer called basal cell carcinoma

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the vial label and on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2 °C and 8 °C).

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

The disposal of unused medication and all materials that have been in contact with it will be carried out in accordance with local regulations.

MINJUVI Composition

• The active ingredient is tafasitamab. A 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, polisorbate 20 (see section 2 “MINJUVI contains sodium”).

Appearance of the product and contents of the pack

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

Each box contains 1 vial.

Marketing authorization holder and manufacturer responsible

Incyte Biosciences Distribution B.V.

Paasheuvelweg 25

1105 BP Amsterdam

Netherlands

Last update of the summary of product characteristics: MM/AAAA.

This medicinal product has been authorized under a conditional approval. This type of approval means that further information is expected to be obtained.

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

Other sources of information

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

This summary of product characteristics can be found on the website of the European Medicines Agency in all languages of the European Union/European Economic Area.

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This information is intended for healthcare professionals only:

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

Instructions for reconstitution

• Determine the dose of tafasitamab according to the patient's weight by multiplying 12 mg by the patient's weight (kg). Then, calculate the number of vials of tafasitamab needed (each vial contains 200 mg of tafasitamab).
• Using a sterile syringe, carefully add 5.0 ml of sterile water for injections to each vial of MINJUVI. Direct the flow towards the walls of each vial and not directly onto the lyophilized powder.
• Gently agitate the vial or vials reconstituted to facilitate the dissolution of the lyophilized powder. Do not shake or move forcefully. Do not withdraw the contents until all solid parts have completely dissolved. The lyophilized powder should dissolve within 5 minutes.
• The reconstituted solution should have an appearance of colorless to slightly yellowish 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.

Instructions for dilution

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

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

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

Administration route

• In the first infusion of cycle 1, the intravenous infusion rate must be 70 ml/h for the first 30 minutes. After that, the rate must be increased to complete the first infusion within 2.5 hours.
• All subsequent infusions must be administered within 1.5 to 2 hours.
• Do not administer with other medications through the same infusion route.
• Do not administer MINJUVI as a bolus or pulse intravenous injection.

Reconstituted solution (before dilution)

Chemical and physical stability has been demonstrated for use for a maximum of 30 days between 2 °C and 8 °C or for a maximum of 24 hours at 25 °C.

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

Diluted solution (for infusion)

Chemical and physical stability has been demonstrated for use for a maximum of 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 must be used immediately. If not used immediately, the storage time until use and the conditions prior to use will be the responsibility of the user and should not exceed 24 hours between 2 °C and 8 °C, unless dilution was performed under controlled and validated aseptic conditions. Do not freeze or agitate.

The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.