MINJUVI contains the active substance tafasitamab. This is a type of
protein called a monoclonal antibody designed to kill cancer cells. This
protein acts by attaching to a specific target on the surface of a type
of white blood cell called B cells or B lymphocytes. When tafasitamab
sticks to the surface of these cells, the cells die.

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
Talk to your doctor or pharmacist or nurse before using MINJUVI if you
have an infection or a history of recurring infections.
You might notice the following during treatment with MINJUVI:
• Infusion-related reactions
Infusion-related reactions may occur most frequently during the first
infusion. Your doctor will monitor you for infusion-related reactions
during your infusion of MINJUVI. Inform your doctor immediately if
you have reactions such as fever, chills, flushing, rash or breathing
difficulties within 24 hours of infusion.
Your doctor will give you treatment before each infusion to reduce
the risk of infusion-related reactions. If you do not have reactions,
your doctor may decide that you do not need these medicines with
later infusions.
• Reduced number of blood cells
Treatment with MINJUVI can severely reduce the number of
some 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 fever of 38 °C or above, or any signs of
bruising or bleeding, as these may be signs of such a reduction.
Your doctor will check your blood cell counts throughout treatment
and before starting each treatment cycle.
• Infections
Serious infections, including infections that can cause death, can
occur during and following MINJUVI treatment. Tell your doctor if
you notice signs of an infection, such as fever of 38 °C or above,
chills, cough or pain on urination.
• Tumour lysis syndrome
Some people may develop unusually high levels of some
substances (such as potassium and uric acid) in the blood caused
by the fast breakdown of cancer cells during treatment. This is
called tumour lysis syndrome. Tell your doctor if you have symptoms
such as nausea, vomiting, lack of appetite or fatigue, dark urine,
decreased urine or side or back pain, muscle cramps, numbness, or
heart palpitations. Your doctor may give you treatment before each
infusion to reduce the risk of tumour lysis syndrome and perform
blood tests to check you for tumour lysis syndrome.
Tell your doctor immediately if you notice any of these problems.
Children and adolescents
MINJUVI is not recommended in children and adolescents under 18
years, as there is no information about the use in 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.
The use of live vaccines during treatment with tafasitamab is not
recommended.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine.
• Contraception
Use of effective contraception during treatment with MINJUVI and
for at least 3 months after end of treatment is recommended for
women of childbearing potential.
• Pregnancy
Do not use MINJUVI during pregnancy and if you are of childbearing
potential not using contraception. Pregnancy must be ruled out
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 up to 12 cycles.
Lenalidomide can harm the unborn baby and must not
be used during pregnancy and in women of childbearing
potential, unless all of the conditions of the lenalidomide pregnancy
prevention programme are met. Your doctor will provide you with
more information and recommendations.
• Breast-feeding
Do not breast-feed during treatment with MINJUVI until at least
3 months after the last dose. It is not known whether 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 or
using machines.
MINJUVI contains sodium
This medicine contains 37.0 mg sodium (main component of cooking/
table salt) in each dose of 5 vials (the dose of a patient weighing 83
kg). This is equivalent to 1.85% of the recommended maximum daily
dietary intake of sodium for an adult.

A doctor experienced in treating cancer will supervise your treatment.
MINJUVI will be given into one of your veins via infusion (drip). During
and after the infusion, you will be checked regularly for infusion-related
side effects.
MINJUVI will be given to you in cycles of 28 days. The dose you get is
based on your weight and will be worked out by your doctor.
The recommended dose is 12 mg tafasitamab per kilogram body
weight. This 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 after: infusion on day 1 and 15 of each cycle
In addition, your doctor will prescribe you to take 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.
The doctor adjusts the starting dose and subsequent dosing if needed.
After a maximum of twelve cycles of combination therapy, treatment
with lenalidomide is stopped.
Treatment cycles with MINJUVI alone are then continued until the
disease gets worse or you develop unacceptable side effects.
If you have been given more MINJUVI than you should
Because the medicine is given in hospital under a doctor’s supervision,
this is unlikely. Tell your doctor if you think you may have been given
too much MINJUVI.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist or nurse.

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 medical
treatment. These may be new symptoms or a change in your current
symptoms.

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

Other side effects
Tell your doctor or nurse 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 above, or any symptoms of an
infection
– platelets; possible symptoms: unusual bruising or bleeding
without or on only minor injury
– red blood cells; possible symptoms: pale skin or lips, tiredness,
shortness of breath

• bacterial, viral or fungal infections, such as respiratory tract
infections, bronchitis, lung inflammation, urinary tract infections
• rash
• low blood potassium level in tests
• muscle cramps
• back pain
• swelling of arms and/or legs due to build-up of fluid
• weakness, tiredness, feeling generally unwell
• fever
• diarrhoea
• 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 narrowed lung airways
called chronic obstructive pulmonary disease (COPD)
• headache
• abnormal sensation of the skin, such as tingling, prickling,
numbness
• itching
• redness of skin
• infusion-related reactions
These reactions may occur during infusion of MINJUVI or within 24
hours after infusion.
Possible symptoms are fever, chills, flushing or breathing difficulties.
• altered sense of taste
• hair loss
• abnormal sweating
• pain in arms and legs
• muscle and joint pain
• decreased weight
• nasal congestion
• inflammation of the membranes lining organs such as the mouth
• lack of certain white blood cells called lymphocytes in blood tests
• a problem with the immune system called hypogammaglobulinaemia
• in blood tests, low blood level of
– calcium
– magnesium
• in blood tests, increased blood level of
– C-reactive protein, which could be the result of inflammation or
infection
– creatinine, a breakdown product from muscle tissue
– liver enzymes: gamma-glutamyltransferase, transaminases
– bilirubin, a yellow breakdown substance of the blood pigment
• a skin cancer called basal cell carcinoma
Reporting of side effects
If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
 

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
vial label and carton after EXP. The expiry date refers to the last day of
that month.
Store in a refrigerator (2 °C – 8 °C).
Keep the vial in the outer carton in order to protect from light.
Any unused medicine or waste material should be disposed of in
accordance with local requirements.