200 mg powder for concentrate for solution for infusion
tafasitamab
What MINJUVI is and what it is used for
What MINJUVI is
MINJUVI contains the active substance tafasitamab. This is a type of protein called a monoclonal antibody and is designed to kill cancer cells. This protein works by attaching to a specific target on the surface of white blood cells called B cells or B lymphocytes. When tafasitamab attaches to the surface of these cells, the cells die.
What MINJUVI is used for
MINJUVI is used to treat adults with B-cell-type cancer called diffuse large-cell B-cell lymphoma. It is used when cancer has returned after previous treatment when previous treatment has not had (sufficient) effect and for patients who cannot be treated with stem cell transplantation instead.
Other medicines that MINJUVI is given with
Minjuvi is used together with another cancer medicine, lenalidomide, at the beginning of treatment. Thereafter, the ‑treatment proceeds with only MINJUVI.
What you need to know before using 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 cautions
Talk to your doctor or pharmacist before using MINJUVI, if you have an infection or if you have had a recurrent infection before.
You may experience the following during treatment with Minjuvi:
- Infusion-related reactions
Infusion-related reactions may occur most frequently during the first infusion . Your doctor will tell you if you get any infusion-related reactions during your MINJUVI‑ infusion . Tell your doctor immediately if you get any reactions such as fever, chills, redness , rash or difficulty breathing within 24 hours after the infusion .
Your doctor will treat you before each infusion to reduce the risk of infusion-related reactions. If you do not get any reactions, your doctor may decide that you do not need these medicines for later infusions . - Reduced blood cell
counts Treatment with MINJUVI can seriously reduce the amount of certain types of blood cells in your body, such as blood cells called neutrophils , platelets or red blood cells . Tell your doctor immediately if you develop a fever of 38 ° C or higher, or signs of bruising or bleeding, as this may indicate a decrease.
Your doctor will check the number of blood cells throughout the treatment and before starting any new treatment cycle. - Infection Er
Serious infections , including infections that can be fatal, can occur during and after MINJUVI treatment. Tell your doctor if you notice signs of infection , such as fever of 38 ° C or higher, chills, cough or pain when urinating. - Tumor light syndrome
Some people may develop unusually high levels of certain substances (such as potassium and uric acid ) in their blood during treatment because the cancer cells break down so quickly. This is called tumor lysis syndrome. Tell your doctor if you experience symptoms such as nausea, vomiting, poor appetite or fatigue, dark urine, decreased urine output or pain in the side or back, muscle cramps, numbness or palpitations. Your doctor will treat you before each infusion to reduce the risk of tumor lysis syndrome and take blood samples to check if you have tumor lysis syndrome.
Tell your doctor immediately if you experience any serious side effects.
Children and young people
MINJUVI is not recommended for children and adolescents under 18 years of age, as there is no information on use in these groups.
Other medicines and MINJUVI
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The use of live vaccines during treatment with tafasitamab is not recommended.
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 taking this medicine.
- Contraceptives
Fertile women are advised to use effective contraception during treatment with MINJUVI and for up to at least 3 months after stopping treatment.
- Pregnancy
Do not use MINJUVI during pregnancy, even if you are a fertile woman who is not using contraception. Pregnancy must be ruled out before starting 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 up to 12 cycles. Lenalidomide can harm the unborn fetus and should not be used during pregnancy or by fertile women , unless all the conditions of lenalidomide’s pregnancy prevention program are met. Your doctor will give you more information and recommendations.
- Breast-feeding
Do not breast-feed during treatment with MINJUVI and for at least three months after the last dose . It is not known whether tafasitamab is excreted in human milk.
Driving and using machines
MINJUVI has no or negligible effect on the ability to drive and use machines. However, fatigue has been reported in patients taking tafasitamab and this should be considered when driving or using machines.
MINJUVI contains sodium
This medicine contains 37.0 mg sodium (the main ingredient in table salt/table salt) in each dose of 5 vials ( dose one to one patient of 83 kg). This corresponds to 1.85% of the maximum recommended daily sodium intake for adults.
How to use MINJUVI
A doctor with experience in cancer treatment will review your treatment. MINJUVI will be given into one of your veins via infusion (drip). During and after infusion one, you will be regularly checked for infusion-related side effects.
MINJUVI will be given to you in cycles of 28 days. The dose you receive is based on your weight and will be decided by your doctor.
The recommended dose is 12 mg tafasitamab per kilogram body weight. The drug is given as an infusion into a vein according to the following schedule:
- Cycle 1: infusion day 1, 4, 8, 15 and 22 of the cycle
- Cycle 2 and 3: infusion day 1, 8, 15 and 22 of each cycle
- Cycle 4 and onwards: infusion day 1 and day 15 of each cycle
Your doctor will also prescribe lenalidomide capsules for up to twelve cycles. The recommended starting dose of lenalidomide is 25 mg daily on days 1 to 21 of each cycle.
Your doctor will adjust the starting dose and subsequent dose as needed.
Treatment with lenalidomide is discontinued after a maximum of twelve cycles of combination therapy. Treatment cycles with MINJUVI alone then continue until the disease worsens or you get unacceptable side effects.
If you have received more MINJUVI than you should
Because the medicine is given in a hospital under the supervision of a doctor, an overdose 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 product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor or nurse immediately if you notice any of the following serious side effects – you may need urgent treatment. These can be new symptoms or a change in your current symptoms.
- severe infection , possible symptoms: fever, chills, sore throat, cough, shortness of breath, nausea, vomiting, diarrhea. These symptoms can be especially pronounced if you have been told that you have low levels of white blood cells called neutrophils .
- pneumonia ( pneumonia )
- sepsis (blood infection)
Other side effects are
Tell your doctor or nurse if you notice any of the following side effects:
Very common (may affect more than 1 in 10 people)
- decreased number of blood cells
- white blood cells , especially of the type known as neutrophils , possible symptoms: fever of 38 ° C or higher, or other symptoms of infection
- platelets; Possible symptoms: unusual bruising or bleeding, which occurred without injury or minor damage
- Red blood cells; Possible symptoms: pale skin or lips, fatigue, shortness of breath
- infection is caused by bacteria, viruses or fungi, such as respiratory infections, tracheal catarrh , pneumonia , urinary tract infection
- rash
- low potassium content in the blood (seen during blood tests)
- muscle cramps
- back pain
- swelling in arms and / or legs due to fluid retention
- weakness, fatigue, general malaise
- fever
- diarrhea
- constipation
- abdominal pain
- nausea
- vomiting
- cough
- respiratory distress
- decreased appetite
Common (may affect up to 1 in 10 people)
- increased respiratory distress in people with narrow airways, so-called chronic obstructive airways disease (COPD)
- headache
- abnormal sensation in the skin, such as ant crawls, tingling, numbness
- itching
- reddening of the skin
- infusion-related reactions
These may occur during infusion of Minjuvi or within 24 hours after infusion . Possible symptoms are fever, chills, redness and difficulty breathing. - changed taste
- hair loss
- abnormal sweating
- pain in the arms and legs
- muscle‑ and joint pain
- weight loss
- nasal congestion
- inflammation of the mucous membranes, eg in the oral mucosa
- deficiency of certain white blood cells called lymphocytes (seen in blood tests)
- problems with the immune system called hypogammaglobulinemia
- in blood tests, low levels of
- calcium
- magnesium
- in blood tests, increased levels of
- C ‑ reactive protein , which may be due to inflammation or infection
- creatinine , a breakdown product of muscle tissue
- liver enzyme: gamma glutamyltransferase, transaminase er
- bilirubin , a yellow breakdown agent from blood pigments
- a skin cancer called basal cell carcinoma
How to store 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 bottle label and the carton after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C).
Keep the vial in the outer carton. Sensitive to light.
Any unused product or waste material should be disposed of per local requirements.
Contents of the package and other information
Content declaration
- The active substance is tafasitamab. One vial contains 200 mg tafasitamab. After reconstitution , each ml of solution contains 40 mg tafasitamab.
- The other ingredients are sodium citrate dihydrate, citric acid monohydrate, trehalose dihydrate, polysorbate 20 (see section 2 “Minjuvi contains sodium”).
What the medicine looks like and contents of the pack
MINJUVI is a powder for concentrate for solution for infusion. It is a white to slightly yellowish powder in a clear glass vial with a rubber stopper, aluminum seal, and plastic cap.
Each carton contains 1 vial.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Incyte Biosciences Distribution BV
Paasheuvelweg 25
1105 BP Amsterdam
Netherlands
Manufacturer
MorphoSys AG
Semmelweis. 7
82152 Planegg
Germany
This medicine has been authorized according to the rules of “conditional marketing authorization”. This means that more information about the drug is expected.
The European Medicines Agency reviews new information on this medicine at least every year and updates this leaflet as needed.