MYLOTARG - Gemtuzumabozogamicin uses, dose and side effects

MYLOTARG contains the active substance gemtuzumabozogamicin, an anticancer medicine, which consists of a monoclonal antibody bound to a substance that is intended to kill cancer cells. This substance is delivered to the cancer cells by the monoclonal antibody. A monoclonal antibody is a protein that recognizes certain cancer cells.

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

What you need to know before you get MYLOTARG

You should not receive MYLOTARG if you:

is allergic to gemtuzumabozogamicin or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

When you first receive this medicine and during treatment, tell your doctor or nurse if you:

have or have ever had liver problems : MYLOTARG can cause, during or after treatment, a potentially life-threatening condition called venous occlusive liver disease, which causes the blood vessels in the liver to be damaged and clogged by blood clots and can cause fluid retention, rapid weight gain, increased liver size (such as may be painful) and ascites (excessive fluid accumulation in the abdomen).
allergic reaction: experience a loud wheezing sound when you breathe (hiss), difficulty breathing, shortness of breath or cough with or without mucus, hives , itching , swelling or if you get a fever or chills (signs of an infusion reaction) during or shortly after infusion one of MYLOTARG.
infection: have or think you have an infection , develop chills or chills or feel hot or have a fever. Some infections can be serious and life threatening.
bleeding: gets unusual bleeding, bleeding from the gums, gets bruised easily or gets nosebleeds regularly.
anemia ( anemia ): headache, tiredness, dizziness or pale face.
infusion reaction: during or shortly after infusion of MYLOTARG experience symptoms such as dizziness, decreased urination, confusion, vomiting, nausea, swelling, shortness of breath, disturbed heart rhythm (this may be a potentially life-threatening condition called tumor lysis syndrome).

Children and young people

MYLOTARG should not be used in children and adolescents under 15 years of age. There are limited data on treatment in this patient group.

Other medicines and MYLOTARG

Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines and herbal medicines.

Pregnancy, breastfeeding and fertility

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.

You need to avoid getting pregnant or becoming a dad. Women must use two effective contraceptives during treatment and for at least 7 months after the last dose. Men must use two effective contraceptives during treatment and for at least 4 months after the last dose. Contact your doctor immediately if you or your partner becomes pregnant while taking this medicine.

Discuss fertility preservation measures with your doctor before treatment.

If you are to be treated with MYLOTARG, you must stop breastfeeding during the treatment period and for at least one month after the treatment. Talk to your doctor.

Driving and using machines

If you feel unusually tired, dizzy, or have headaches (these are very common side effects of MYLOTARG), do not drive or use machines.

MYLOTARG contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose. It is basically “sodium-free”.

How to get MYLOTARG

A doctor or nurse will give you MYLOTARG by drip into a vein ( intravenous infusion ) slowly over 2 hours.
The doctor or nurse will determine the appropriate dose .

Your doctor may change your dose , suspend or stop treatment with MYLOTARG if you experience any side effects .
Your doctor may reduce your dose depending on how you respond to treatment.
Your doctor will take blood samples during treatment to check for any side effects and to see how you respond to treatment.
Before you receive MYLOTARG, you will be given medicines that help reduce symptoms such as fever and chills, so-called infusion reactions, which may occur during or shortly after the MYLOTARG infusion .
If you have any further questions on the use of this product, ask your doctor or nurse.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Liver problems
Tell your doctor immediately if you gain weight quickly, have pain in the upper right side of the abdomen or accumulate fluid that causes the abdomen to swell. Your doctor may do blood tests and detect abnormal liver blood tests, which may be a sign of a potentially life-threatening condition called venous occlusive liver disease.
Bleeding (signs of a low number of blood cells called platelets )Tell your doctor immediately if you get bruises easily or if you have regular nosebleeds, have black tar-like stools, cough up blood, bloody mucus or have changes in your mental state.
Infection er (signs of a low number of blood cells called neutrophils er)Some infections can be serious and can be due to viruses , bacteria or other causes that can be life-threatening.

Complication known as tumor lysis syndrome
Tell your doctor immediately if you experience symptoms such as dizziness, decreased urination, confusion, vomiting, nausea, swelling, shortness of breath or disturbed heart rhythm.
Infusion reactions
Drugs of this type (monoclonal antibodies ) can cause infusion reactions such as rash, shortness of breath, difficulty breathing, chest tightness, chills or fever, back pain.

Other side effects can be:

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

Infection is (including severe infection is)
Decreased platelet count (cells that help the blood to clot)
Decreased number of white blood cells , which can lead to general weakness and a tendency to get infection
Decreased red blood cell count ( anemia ), which can lead to fatigue and shortness of breath
High blood sugar
Reduced appetite
Headache
Fast heartbeat
Bleeding
Low blood pressure
High blood pressure
Shortness of breath
Vomiting
Diarrhea
Stomach pain
Nausea
Inflammation of the mouth
Constipation
Abnormal liver blood tests (which may be a sign of liver damage)
Rash
Fever

Edema (too much fluid in body tissues, which causes swollen hands and feet)
Fatigue

Overindulge
Changes in the levels of different enzymes in your blood (may show up in your blood tests)
Prolonged clotting time for the blood
High level of uric acid in the blood

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

Signs of an infusion reaction, such as rash, shortness of breath, difficulty breathing, chest tightness, chills or fever, back pain during or after MYLOTARG infusion
Signs of an enlarged liver ( hepatomegaly ), such as an enlarged stomach
Abnormal liver function
Accumulation of fluid in the abdomen / stomach
Digestive problems
Inflammation of the esophagus
Venocclusive disease (VOD) in the liver, which includes signs of enlarged liver, pain in the upper right part of the stomach, yellowish skin and whites of the eyes, accumulation of fluid in the abdomen, weight gain, abnormal liver blood tests
Yellowish skin or yellowish whites of the eyes caused by liver or blood problems (jaundice)
Reddening of the skin
Skin itching
Organ failure

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

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

Has been reported (occurs in an unknown number of users):

Interstitial pneumonia ( pneumonia that causes coughing and difficulty breathing)
Intestinal inflammation associated with low white blood cell count
Inflammation of the bladder that causes bleeding from the bladder

How to store MYLOTARG

MYLOTARG will be stored by staff 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 the carton after EXP. The expiration date is the last day of the specified month.

Unopened vial: Store in a refrigerator (2-8 ° C). Do not freeze. Keep the vial in the original carton. Sensitive to light.

Ready-made and diluted solution: Protect the prepared and diluted MYLOTARG solutions from light. The solutions should be used immediately. The reconstituted or diluted solution must not be frozen.

If not used immediately:

After reconstitution , the original bottle can be stored for up to 16 hours in a refrigerator (2 ° C-8 ° C) or up to 3 hours at room temperature (below 30 ° C).
The diluted solution can be stored for up to 18 hours in a refrigerator (2 ° C-8 ° C) and up to 6 hours at room temperature (below 30 ° C). The allowable time at room temperature (below 30 ° C) includes the time required for reconstitution of the diluted solution, equilibration as needed and administration . The maximum time from reconstitution of the diluted solution until administration should not exceed 24 hours.

Do not use this medicine if you notice any particles or discoloration before administration.

Medicines should not be disposed of via wastewater or household waste. Ask your doctor how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

The active substance is gemtuzumabozogamicin.
1 vial contains 5 mg gemtuzumabozogamicin.
After reconstitution , 1 ml of the concentrated solution contains 1 mg of gemtuzumabozogamicin.
The other ingredients are dextran 40, sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate and disodium hydrogen phosphate (anhydrous). See section 2, “MYLOTARG contains sodium”.

What the medicine looks like and contents of the pack

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

Each carton contains a yellow-brown glass vial with a rubber stopper and a shrink seal with a snap cap.

Marketing Authorisation Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Brussels

Belgium

Manufacturer

Pfizer Service Company BVBA

High Road 10

B-1930, Zaventem