MYLOTARG 5 мг Порошок для концентрата для раствора для инфузий

Содержание инструкции

1. MYLOTARG 5 mg powder for concentrate for solution for infusion
   1. What is MYLOTARG and what is it used for
   2. What you need to know before using MYLOTARG
   3. How to use MYLOTARG
   4. Possible side effects
   5. How to store MYLOTARG
   6. Package Contents and Other Information

MYLOTARG 5 mg powder for concentrate for solution for infusion

gemtuzumab ozogamicin

Read this leaflet carefully before you use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

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

1. What is MYLOTARG and what is it used for

MYLOTARG contains the active substance gemtuzumab ozogamicin, an antineoplastic medicinal product,
consisting of a monoclonal antibody linked to a substance intended to kill cancer cells.
This substance is delivered to cancer cells by the monoclonal antibody. A monoclonal
antibody is a protein that recognizes certain cancer cells.
MYLOTARG is used for the treatment of a certain type of blood cancer called acute myeloid leukemia (AML), in which the bone marrow produces abnormal white blood cells. MYLOTARG is
intended for the treatment of AML in patients 15 years of age and older who have not received other
treatments. MYLOTARG is not intended for use in patients with a type of cancer called acute promyelocytic leukemia (APL).

2. What you need to know before using MYLOTARG

Do not use MYLOTARG if:

• you are allergic to gemtuzumab ozogamicin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
When you receive this medicine for the first time and during the treatment cycle, tell your doctor
or nurse if:

• you have or have had liver problems: MYLOTARG can cause, during or after treatment, a potentially fatal condition called hepatic veno-occlusive disease, in which the blood vessels in the liver are damaged and blocked by blood clots, which can lead to fluid retention, rapid weight gain, increased liver size (which may be painful) and ascites (excessive fluid accumulation in the abdominal cavity).
• allergic reaction:you experience wheezing during breathing, have difficulty breathing, shortness of breath or cough with or without mucus, hives, itching, swelling or a feeling of fever and chills (signs of an infusion-related reaction) during or shortly after the MYLOTARG infusion.
• infection:you have or think you have an infection, develop chills or tremors, feel hot or have a fever. Some infections can be serious and potentially fatal.
• bleeding:you experience unusual bleeding, bleeding from the gums, bruise easily or have recurrent nosebleeds.
• anemia:you have headache, feel tired, are dizzy or are pale.
• infusion reaction:during or immediately after the MYLOTARG infusion you experience symptoms such as dizziness, decreased urination, confusion, vomiting, nausea, swelling, shortness of breath or irregular heartbeat (this may be a potentially fatal complication known as tumor lysis syndrome).

Children and adolescents
MYLOTARG should not be used in children and adolescents under 15 years of age because the data
available in this population are limited.

Other medicines and MYLOTARG
Tell your doctor or nurse if you are taking, have recently taken or might take
any other medicines. This includes medicines you can buy without a prescription and herbal medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or nurse for advice before you are given this medicine.
You must avoid becoming pregnant or conceiving due to the potential adverse effects on the
child. Women must use 2 effective methods of contraception during treatment and for at least
7 months after the last dose. Men must use 2 effective methods of contraception during the
treatment and for at least 4 months after the last dose. Contact your doctor immediately if you or your
partner become pregnant during treatment with this medicine.
Seek medical advice regarding fertility preservation before treatment.
If you need to undergo treatment with MYLOTARG, you must stop breastfeeding during
treatment and for at least 1 month after treatment. Consult your doctor.

Driving and operating machinery
If you experience unusual fatigue, dizziness or headache (these are very common side effects of MYLOTARG), you should not drive vehicles or operate machinery .
MYLOTARG contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is essentially sodium-free.

3. How to use MYLOTARG

• A doctor or nurse will administer MYLOTARG to you through an intravenous drip (intravenous infusion) gradually over 2 hours.
• The doctor will decide the correct dose.
• The doctor or nurse may adjust the dose, suspend it, or completely stop treatment with MYLOTARG if you experience any undesirable effects.
• The doctor may reduce the dose based on your response to treatment.
• The doctor will perform blood tests during treatment to check for undesirable effects and your response to treatment.
• Before receiving MYLOTARG, you will be given medications that help reduce symptoms such as fever and chills, known as infusion reactions, during or immediately after the MYLOTARG infusion.

If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some of these side effects can be serious and can occur during or after
treatment with MYLOTARG. Tell your doctor or nurse immediatelyif you get any of the
following serious side effects (see also section 2 “What you need to know before you take
MYLOTARG”):

• Liver problemsTell your doctor immediately if you get a rapid increase in weight, feel pain in the upper right side of your abdomen, or have fluid build-up that causes abdominal swelling. Your doctor may perform blood tests and detect abnormalities in specific liver blood parameters, which could be signs of a life-threatening condition called hepatic veno-occlusive disease.
• Bleeding (sign of a low number of blood cells called platelets)Tell your doctor immediately if you bruise easily or if you have regular nosebleeds, or if you have tarry stools, cough up blood, if your sputum contains traces of blood, if you feel dizzy, faint or confused.
• Infections (sign of a low number of white blood cells called neutrophils)Some infections can be serious and can be caused by viruses, bacteria or other causes that can be life-threatening.
• Complication known as tumor lysis syndromeTell your doctor immediately if you get dizziness, decreased urination, confusion, vomiting, nausea, swelling, shortness of breath or irregular heartbeat.
• Infusion reactionsMedicines like this one (monoclonal antibodies) can cause infusion reactions such as skin rash, shortness of breath, difficulty breathing, chest tightness, chills or fever, back pain.

Other side effects include:

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

• Infections (including serious infections)
• Reduced number of platelets (which help the blood to clot) in the blood
• Reduced number of white blood cells, which can cause general weakness and a tendency to develop infections
• Reduced number of red blood cells (anaemia), which can cause tiredness and shortness of breath
• High blood sugar levels
• Decreased appetite
• Headache
• Fast heartbeat
• Bleeding
• Low blood pressure
• High blood pressure
• Shortness of breath
• Vomiting
• Diarrhoea
• Abdominal pain
• Feeling unwell (nausea)
• Inflammation of the mouth
• Constipation
• Abnormal liver blood parameters (which may be indicators of liver damage)
• Skin rash
• Fever
• Edema (excess fluid in body tissue, causing swelling of hands and feet)
• Fatigue
• Chills
• Changes in blood levels of various enzymes (can be detected by blood tests)
• Prolonged time for blood to clot (which can lead to prolonged bleeding)
• Excess uric acid in the blood

Common (may affect up to 1 in 10 people):

• Signs of an infusion reaction, such as skin rash, shortness of breath, difficulty breathing, chest tightness, chills or fever, back pain during or after the infusion of MYLOTARG
• Signs of liver enlargement (hepatomegaly), such as a swollen belly
• Excessive fluid build-up in the abdomen/stomach
• Indigestion
• Inflammation of the esophagus (swallowing channel)
• Hepatic veno-occlusive disease (VOD) including signs of liver enlargement, pain in the upper right side of the abdomen, yellowing of the skin and whites of the eyes, fluid build-up in the abdomen, weight gain and abnormal liver-specific blood parameters.
• Yellowing of the skin or whites of the eyes caused by liver or blood problems (jaundice)
• Redness of the skin
• Itchy skin
• Organ failure

Uncommon (may affect up to 1 in 100 people):

• Liver failure
• Budd-Chiari syndrome, which includes pain in the upper right abdomen, abnormal enlargement of the liver, and/or fluid build-up in the abdomen associated with blood clots in the liver. Symptoms may also include feeling unwell (nausea) and/or vomiting.

Frequency not known (the frequency cannot be estimated from the available data):

• Interstitial pneumonia (inflammation of the lungs causing cough and difficulty breathing)
• Inflammation of the intestine in association with decreased white blood cell counts
• Inflammation of the urinary bladder resulting in bleeding from the bladder

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

5. How to store MYLOTARG

MYLOTARG will be stored by healthcare professionals at the hospital or clinic.
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 on the
pack after EXP. The expiry date refers to the last day of that month.

Closed vial:Store in a refrigerator (2°C - 8°C). Do not freeze. Keep the vial
in the original package to protect it from light.

Reconstituted and diluted solution: Protect reconstituted and
diluted MYLOTARG solutions from light. The solutions must be used immediately. Do not freeze the reconstituted
or diluted solution.
If it is not possible to use the solution immediately:

• After reconstitution, the original vial can be stored for a maximum of 16 hours in a refrigerator (2°C - 8°C) or for no more than 3 hours at room temperature (below 30°C).
• The diluted solution can be stored for a maximum of 18 hours in a refrigerator (2°C - 8°C) and for no more than 6 hours at room temperature (below 30°C). The allowed storage time at room temperature (below 30°C) includes the time required for preparing the diluted solution, equilibration, if necessary, and administration. The maximum time from preparation of the diluted solution to administration must not exceed 24 hours.

Do not use this medicine if you notice the presence of particles or a change in color before
administration.
Do not dispose of any medicine in wastewater or household waste. Ask your doctor how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What MYLOTARG contains

• The active ingredient is gemtuzumab ozogamicin.
• One vial contains 5 mg of gemtuzumab ozogamicin.
• After reconstitution, each mL of the concentrated solution contains 1 mg of gemtuzumab ozogamicin.
• The other ingredients are dextran 40, sucrose, sodium chloride, disodium phosphate monohydrate, anhydrous disodium hydrogen phosphate. See section 2, “MYLOTARG contains sodium”.

Description of the appearance of MYLOTARG and package contents
MYLOTARG is a powder for concentrate for solution for infusion. It is supplied as a tablet or
powder of white to off-white colour.
Each pack contains 1 amber glass vial with a rubber stopper and crimp closure with a
protective cap.

Marketing Authorisation Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer
Pfizer Service Company BV
Hoge Wei 10
1930, Zaventem
Belgium
For further information on this medicine, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Luxembourg/Luxemburg
Pfizer NV/SA
Tél/Tel: +32 (0)2 554 62 11

Lietuva
Pfizer Luxembourg SARL filialas Lietuvoje
Tel: + 370 52 51 4000

България
Пфайзер Люксембург САРЛ, Клон
България
Тел.: +359 2 970 4333

Magyarország
Pfizer Kft.
Tel: +36-1-488-37-00

Česká republika
Pfizer, spol. s r.o.
Tel: +420 283 004 111

Malta
Vivian Corporation Ltd.
Tel: + 35621 344610

Danmark
Pfizer ApS
Tlf: +45 44 20 11 00

Nederland
Pfizer bv
Tel: +31 (0) 800 63 34 636

Deutschland
PFIZER PHARMA
GmbH
Tel: +49 (0)30 550055 51000

Norge
Pfizer AS
Tlf: +47 67 52 61 00

Eesti
Pfizer Luxembourg SARL Eesti filiaal
Tel: +372 666 7500

Österreich
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15-0

Ελλάδα
Pfizer Ελλάς A.E.
Τηλ: +30 210 6785 800

Polska
Pfizer Polska Sp. z o.o.
Tel: +48 22 335 61 00

España
Pfizer, S.L.
Tel: +34 91 490 99 00

Portugal
Laboratórios Pfizer, Lda.
Tel: +351 21 423 5500

France
Pfizer
Tel: +33 (0)1 58 07 34 40

România
Pfizer Romania S.R.L.
Tel: +40 (0) 21 207 28 00

Hrvatska
Pfizer Croatia d.o.o.
Tel: + 385 1 3908 777

Slovenija
Pfizer Luxembourg SARL
Pfizer, podružnica za svetovanje s področja
farmacevtske dejavnosti, Ljubljana
Tel: + 386 (0)1 52 11 400

Ireland
Pfizer Healthcare Ireland
Tel: 1800 633 363 (toll free)
+44 (0)1304 616161

Slovenská republika
Pfizer Luxembourg SARL, organizačná zložka
Tel: + 421 2 3355 5500

Ísland
Icepharma hf.
Sími: +354 540 8000

Suomi/Finland
Pfizer Oy
Puh/Tel: +358 (0)9 43 00 40

Italia
Pfizer S.r.l.
Tel: +39 06 33 18 21

Sverige
Pfizer AB
Tel: +46 (0)8 550-520 00

Κύπρος
Pfizer Ελλάς A.E. (Cyprus Branch)
Τηλ: +357 22 817690

United Kingdom (Northern Ireland)
Pfizer Limited
Tel: +44 (0) 1304 616161

Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel: + 371 670 35 775

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines
Agency, http://www.ema.europa.eu. Also, links to other websites on rare diseases and related
therapeutic treatments are provided.
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The following information is intended exclusively for healthcare professionals:
Use appropriate aseptic technique for reconstitution and dilution procedures. MYLOTARG is
sensitive to light and must be protected from ultraviolet light during reconstitution, dilution
and administration.

Reconstitution

• Calculate the required dose (mg) of MYLOTARG.
• Before reconstitution, allow the vial to reach room temperature (below 30°C) for approximately 5 minutes. Reconstitute each 5 mg vial with 5 mL of water for injections, to obtain a single-use solution of 1 mg/mL of gemtuzumab ozogamicin.
• Gently rotate the vial to aid dissolution. Do not shake.
• Inspect the reconstituted solution for particulate matter and colour changes. The reconstituted solution may contain small particles from white to off-white, from opaque to translucent and from amorphous to fibre-like.
• MYLOTARG does not contain bacteriostatic preservatives.
• If the reconstituted solution cannot be used immediately, it can be stored in the original vial for up to 16 hours in a refrigerator (2°C - 8°C) or for up to 3 hours at room temperature (below 30°C). Protect from light and do not freeze.

Dilution

• Calculate the required volume of the reconstituted solution needed to obtain the appropriate dose based on the patient’s body surface area. Withdraw this amount from the vials using a syringe. Mylotarg vials contain 5 mg of medicinal product without

overfill. When reconstituted to a concentration of 1 mg/mL as directed, the withdrawable content
of the vial is 4.5 mg (4.5 mL). Protect from light. Discard any reconstituted solution remaining in the
vial.

• Doses must be mixed to a concentration between 0.075 mg/mL and 0.234 mg/mL according to the following instructions: o Doses less than 3.9 mg must be prepared for administration using a syringe. Add the reconstituted MYLOTARG solution to a syringe with 9 mg/mL (0.9%) sodium chloride solution for injections, to obtain a final concentration between 0.075 mg/mL and 0.234 mg/mL. Protect from light. o Doses greater than or equal to 3.9 mg must be diluted in a syringe or intravenous infusion bag in an appropriate volume of 9 mg/mL (0.9%) sodium chloride solution for injections to ensure a final concentration between 0.075 mg/mL and 0.234 mg/mL. Protect from light.
• Gently invert the infusion container to mix the diluted solution. Do not shake.
• After dilution with 9 mg/mL (0.9%) sodium chloride solution for injections, the MYLOTARG solution must be infused immediately. If it cannot be used immediately, the diluted solution can be stored for up to 18 hours in a refrigerator (2°C - 8°C) and for no more than 6 hours at room temperature (below 30°C). The allowed storage time at room temperature (below 30°C) includes the time required to prepare the diluted solution, equilibration, if necessary, and administration to the patient. The maximum time from preparation of the diluted solution to administration must not exceed 24 hours. Protect from light and do not freeze.
• The infusion container is recommended to be made of polyvinyl chloride (PVC) with DEHP, ethylene vinyl acetate (EVA) or polyolefin (polypropylene and/or polyethylene).

Administration

• The diluted solution must be filtered. A 0.2 micron polyethersulfone (PES) in-line filter with low protein binding capacity must be used for the infusion of MYLOTARG.
• Doses administered via a syringe must use small-bore (microbore) infusion lines with a 0.2 micron polyethersulfone (PES) in-line filter with low protein binding capacity.
• During infusion, the bag or syringes for intravenous administration must be protected from light using an appropriate protective cover (including ultraviolet light). The infusion line does not need to be protected from light.
• Infuse the diluted solution over 2 hours. The infusion must be completed before the end of the 6-hour maximum storage time of the diluted solution at room temperature (below 30°C).
• Infusion lines made of PVC (containing or not containing DEHP), polyurethane or polyethylene are recommended.

MYLOTARG must not be mixed or administered in infusion with other medicines.

Disposal

• The prescribed procedures for disposal of toxic waste for anti-cancer medicines must be followed.