Product Information for the User

MYLOTARG 5mg powder for concentrate for solution for infusion

gemtuzumab ozogamicin

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

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this product information. See section4.

1.What is MYLOTARG and how is it used

2.What you need to know before receiving MYLOTARG

3.How to administer MYLOTARG

4.Possible adverse effects

5.Storage of MYLOTARG

6.Contents of the package and additional information

MYLOTARG contains the active ingredient gemtuzumab ozogamicin, a cancer medication, which is composed of a monoclonal antibody linked to a substance intended to eliminate cancer cells. This substance is distributed to cancer cells via the monoclonal antibody. A monoclonal antibody is a protein that recognizes certain cancer cells.

MYLOTARG is used to treat a specific type of blood cancer called acute myeloid leukemia (AML) in which the bone marrow produces abnormal white blood cells. MYLOTARG is indicated for the treatment of AML in patients aged 15 years or older who have not had other treatments. MYLOTARG should not be used in patients with a type of cancer called acute promyelocytic leukemia (APL).

You should not receive MYLOTARG if:

• You are allergic to gemtuzumab ozogamicin or any of the other components of this medication (listed in section6).

Warnings and precautions

Inform your doctor or nurse if you have or have had any of the following:

• liver problems:MYLOTARG may cause a potentially life-threatening condition called hepatic veno-occlusive disease, in which the blood vessels in the liver are damaged and blocked by blood clots, leading to fluid retention, rapid weight gain, painful liver enlargement, and ascites (excessive fluid accumulation in the abdominal cavity).
• allergic reaction:You experience a sharp hissing sound during breathing (sibilance), difficulty breathing, shortness of breath, or cough with or without mucus, hives, itching, swelling, or a feeling of fever and chills (signs of a reaction associated with infusion) during or shortly after the infusion of MYLOTARG.
• infection:You have or think you have an infection, experience chills or tremors, feel hot, or have a fever. Some infections can be severe and potentially life-threatening.
• bleeding:You experience unusual bleeding, bleeding gums, easy bruising, or frequent nasal bleeding.
• anemia:You experience headaches, feel tired, experience dizziness, or look pale.
• infusion reaction:You experience symptoms such as dizziness, decreased urine output, confusion, vomiting, nausea, swelling, shortness of breath, or changes in heart rhythm (this may be a potentially life-threatening complication known as tumor lysis syndrome) during or shortly after the infusion of MYLOTARG.

Children and adolescents

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

Other medications and MYLOTARG

Inform your doctor or nurse if you are taking, have taken recently, or may need to take any other medication. This includes over-the-counter medications and herbal remedies.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or nurse before using this medication.

Avoid becoming pregnant or conceiving a child due to potential adverse effects on the child. Women should use 2effective contraceptive methods during treatment and for at least 7months after the last dose of treatment. Men should use 2effective contraceptive methods during treatment and for at least 4months after the last dose of treatment. Contact your doctor immediately if you or your partner become pregnant while taking this medication.

Request information on fertility preservation before treatment.

If you need to receive MYLOTARG, you will need to stop breastfeeding during treatment and for at least 1month after completing it. Consult your doctor.

Driving and operating machinery

If you feel unusually tired, dizzy, or experience headaches (these are very common side effects of MYLOTARG), do not drive or operate machinery.

MYLOTARG contains sodium

This medication contains less than 1mmol of sodium (23mg) per dose; it is essentially “sodium-free.”

• A doctor or nurse will administer MYLOTARG through an intravenous line in your vein (intravenous infusion), gradually over 2 hours.hours.
• Your doctor will decide on the correct dose.

• Your doctor or nurse may adjust the dose, interrupt, or completely discontinue treatment with MYLOTARG if you experience certain adverse effects.
• Your doctor may reduce the dose based on your response to treatment.
• Your doctor will perform blood tests during treatment to detect adverse effects and monitor your response to treatment.

• Before receiving MYLOTARG, you will be given other medications to help reduce certain symptoms such as, for example, fever and chills, known as infusion reactions, during or shortly after the infusion of MYLOTARG.

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

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

Some of these side effects can be serious and may occur during or after treatment with MYLOTARG. Inform your doctor or nurse immediately if you experience any of the following serious side effects (see also section 2: “What you need to know before your doctor administers MYLOTARG”):

• Liver problems
  Inform your doctor immediately if you rapidly gain weight, feel pain in the upper right side of your abdomen, or have fluid accumulation that causes abdominal swelling. Your doctor may perform blood tests and detect abnormalities in liver function tests, which could be signs of a potentially fatal condition called veno-occlusive liver disease.
  
• Bleeding (signs of a low number of blood cells known as platelets)

Inform your doctor immediately if you experience frequent bruising or nasal bleeding, or if you have black stools, coughing up blood, sputum with blood, dizziness, fainting, or confusion.

• Infections (signs of a low number of white blood cells known as neutrophils)

Some infections can be serious and may be caused by viruses, bacteria, or other potentially fatal causes.

• A complication known as tumor lysis syndrome
  Inform your doctor immediately if you experience dizziness, decreased urine output, confusion, vomiting, nausea, swelling, shortness of breath, or irregular heart rhythm.

• Reactions to infusion
  Medicines of this type (monoclonal antibodies) can cause infusion reactions such as, for example, rash, shortness of breath, difficulty breathing, chest tightness, chills, or fever, or back pain.

The side effects include:

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

• Infections (including severe infections)
• Decreased platelet count in the blood (cells that help blood clot)
• Decreased white blood cell count, which can cause general weakness and a tendency to contract infections
• Decreased red blood cell count (anemia), which can cause fatigue and shortness of breath
• High blood sugar levels
• Decreased appetite
• Headache
• Fast heart rate
• Bleeding
• Low blood pressure
• High blood pressure
• Shortness of breath
• Vomiting
• Diarrhea
• Abdominal pain
• General discomfort (nausea)
• Mouth inflammation
• Constipation
• Anomalies in liver function tests (which may be indicators of liver damage)
• Rash
• Fever
• Edema (excess fluid in the body tissue, causing swelling of the hands and feet)
• Fatigue
• Chills
• Changes in levels of different enzymes in the blood (may appear in blood tests)
• Prolonged coagulation time (which may cause prolonged bleeding)
• High uric acid levels in the blood

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

• Signs of infusion reactions such as, for example, 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 swollen abdomen
• Abnormal liver function
• Excessive fluid accumulation in the abdomen/stomach
• Indigestion
• Esophageal inflammation (swallowing tube)
• Veno-occlusive liver disease (VOD), which includes signs of liver enlargement, pain in the upper right side of the abdomen, yellowing of the skin and whites of the eyes, fluid accumulation in the abdomen, weight gain, abnormal liver function test results
• Yellowing of the skin or whites of the eyes caused by liver or blood problems (jaundice)
• Redness of the skin
• Itching of the skin
• Organ failure

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

• Liver failure
• Budd-Chiari syndrome, which includes pain in the upper right side of the abdomen, an abnormally large liver, and/or fluid accumulation in the abdomen associated with blood clots in the liver. Symptoms may also include general discomfort (nausea) and/or vomiting.

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

• Pneumonia interstitial (inflammation of the lungs that causes coughing and difficulty breathing)
• Inflammation of the intestine associated with low white blood cell counts
• Inflammation of the urinary bladder that causes bleeding from the bladder

Reporting of side effects

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

MYLOTARG will be stored by healthcare professionals in the hospital or clinic.

Keep this medication out of sight and reach of children.

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

Unopened vial:Store in the refrigerator (between 2°C and 8°C). Do not freeze. Store in the original packaging to protect it from light.

Reconstituted and diluted solution:Protect MYLOTARG reconstituted and diluted solutions from light. The solutions must be used immediately. Do not freeze the reconstituted or diluted solution.

If not used immediately:

• After reconstitution, the original vial can be stored for a maximum of 16hours in the refrigerator (between 2°C and 8°C) or for a maximum of 3hours at room temperature (below 30°C).

• The diluted solution can be stored for a maximum of 18hours in the refrigerator (between 2°C and 8°C) and for a maximum of 6hours at room temperature (below 30°C). The maximum time at room temperature (below 30°C) includes the time required for the preparation of the diluted solution, equilibrated if necessary, and administration. The maximum time from the preparation of the diluted solution to administration must not exceed 24hours.

Do not use this medication if you observe particles or discoloration before administration.

Medicines should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of MYLOTARG

• 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 components are dextran 40, sucrose, sodium chloride, dihydrogen phosphate monohydrate, and anhydrous disodium hydrogen phosphate.See section 2, “MYLOTARG contains sodium”.

Appearance of the product and contents of the pack

MYLOTARG is a powder for concentrate for solution for infusion. It is presented as a white to off-white paste or powder.

Each pack contains 1 vial of amber type I glass with a rubber stopper and a flip-off type closure.

Marketing authorisation holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

Responsible for manufacturing

Pfizer Service Company BV

Hoge Wei 10

1930, Zaventem

Belgium

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:

Last update of this leaflet:

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.There are also links to other websites on rare diseases and orphan medicines.

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This information is intended only for healthcare professionals:

Use an appropriate aseptic technique for the reconstitution and dilution procedures. MYLOTARG is sensitive to light and should 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 vial of 5 mg with 5 ml of injectable solution to obtain a single-use solution of 1 mg/ml of gemtuzumab ozogamicin.
• Gently move the vial to facilitate dissolution. Do not agitate.
• Inspect the reconstituted solution for particles or discoloration. The reconstituted solution may contain small white to off-white particles, which are opaque to translucent and have no defined shape or a shape similar to fibers.
• MYLOTARG does not contain bacteriostatic preservatives.
• If the reconstituted solution cannot be used immediately, it can be stored in the original vial for a maximum of 16 hours in the refrigerator (between 2°C and 8°C) or for a maximum of 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. Extract this amount from the vial using a syringe. The MYLOTARG vials contain 5 mg of medication without overfilling. When reconstituted to a concentration of 1 mg/ml according to the instructions, the extractable content of the vial is 4.5 mg (4.5 ml). Protect from light. Discard any unused reconstituted solution remaining in the vial.
• The doses should be mixed to a concentration of between 0.075 mg/ml and 0.234 mg/ml according to the following instructions:
• • Doses below 3.9 mg should be prepared for administration using a syringe. Add the MYLOTARG reconstituted solution to a syringe with a 9 mg/ml (0.9%) sodium chloride injectable solution to achieve a final concentration of between 0.075 mg/ml and 0.234 mg/ml. Protect from light.
  • Doses of 3.9 mg or higher should be diluted in a syringe or intravenous bag with an appropriate volume of 9 mg/ml (0.9%) sodium chloride injectable solution to ensure a final concentration of between 0.075 mg/ml and 0.234 mg/ml. Protect from light.
• Invert the infusion bag gently to mix the diluted solution. Do not agitate.
• After dilution with 9 mg/ml (0.9%) sodium chloride injectable solution, the MYLOTARG solution should be infused immediately. If not used immediately, the diluted solution can be stored for a maximum of 18 hours in the refrigerator (between 2°C and 8°C) and for a maximum of 6 hours at room temperature (below 30°C). The maximum time from preparation of the diluted solution to administration should not exceed 24 hours. Protect from light and do not freeze.
• It is recommended that the infusion bags be made of PVC (with or without DEHP), polyurethane, or polyethylene.

Administration

• The diluted solution must be filtered.The MYLOTARG infusion will use a 0.2 micra low-protein-binding polyethersulfone (PES) filter in line.
• Doses administered using a syringe should use small-caliber infusion lines (microbore) with a 0.2 micra low-protein-binding polyethersulfone (PES) filter in line.
• During infusion, the intravenous bags or syringes should be protected from light (including ultraviolet light) with a cover that blocks light entry. The infusion line does not need to be protected from light.
• Infuse the diluted solution over 2 hours. The infusion should be completed before the end of the allowed 6-hour storage time for the diluted solution at room temperature (below 30°C).
• It is recommended that the infusion lines be made of PVC (with or without DEHP), polyurethane, or polyethylene.

Do not mix or administer MYLOTARG in infusion with other medications.

Elimination

• Use established procedures for disposing of toxic waste for cancer medications.