Mylotarg

DRUG DESCRIPTION

Mylotarg® (gemtuzumab ozogamicin for Injection) is a chemotherapy agent composed of a recombinant humanized IgG4, kappa antibody conjugated with a cytotoxic antitumor antibiotic, calicheamicin, isolated from fermentation of a bacterium, Micromonospora echinospora subsp. calichensis. The antibody portion of Mylotarg (gemtuzumab ozogamicin for injection) binds specifically to the CD33 antigen, a sialic acid-dependent adhesion protein found on the surface of leukemic blasts and immature normal cells of myelomonocytic lineage, but not on normal hematopoietic stem cells.

Mylotarg® (gemtuzumab ozogamicin) Structural Formula Illustration

The anti-CD33 hP67.6 antibody is produced by mammalian cell suspension culture using a myeloma NS0 cell line and is purified under conditions which remove or inactivate viruses. Three separate and independent steps in the hP67.6 antibody purification process achieves retrovirus inactivation and removal. These include low pH treatment, DEAE-Sepharose chromatography, and viral filtration. Mylotarg (gemtuzumab ozogamicin for injection) contains amino acid sequences of which approximately 98.3% are of human origin. The constant region and framework regions contain human sequences while the complementarity-determining regions are derived from a murine antibody (p67.6) that binds CD33. This antibody is linked to N-acetyl-gamma calicheamicin via a bifunctional linker. Gemtuzumab ozogamicin has approximately 50% of the antibody loaded with 4-6 moles calicheamicin per mole of antibody. The remaining 50% of the antibody is not linked to the calicheamicin derivative. Gemtuzumab ozogamicin has a molecular weight of 151 to 153 kDa.

Mylotarg (gemtuzumab ozogamicin for injection) is a sterile, white, preservative-free lyophilized powder containing 5 mg of drug conjugate (protein equivalent) in an amber vial. The drug product is light sensitive and must be protected from direct and indirect sunlight and unshielded fluorescent light during the preparation and administration of the infusion. The inactive ingredients are: dextran 40; sucrose; sodium chloride; monobasic and dibasic sodium phosphate.

What are the possible side effects of gemtuzumab (Mylotarg)?

Some people receiving a gemtuzumab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, or have fever, chills, or trouble breathing within 24 hours after receiving the injection.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

    ...

Read All Potential Side Effects and See Pictures of Mylotarg »

What are the precautions when taking gemtuzumab ozogamicin for injection (Mylotarg)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, lung disease, other blood/bone marrow disorders (e.g., increased white blood cell count), bone marrow transplant, recent/current infections.

Before having surgery, tell your doctor or dentist that you are using this medication.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine...

Read All Potential Precautions of Mylotarg »


Mylotarg Consumer (continued)

SIDE EFFECTS: See also Warning section.

Fever, chills, dizziness, headache, nausea, vomiting, or pain/swelling at injection site may occur during or after the infusion. Tell your doctor or pharmacist promptly if any of these effects occur, persist, or worsen. You may be given additional medications to help control these symptoms. Mouth sores, a mild rash, constipation, or diarrhea may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Many people using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: increased thirst/urination, change in the amount of urine, muscle spasm/weakness, seizures, fast/irregular heartbeat, black/bloody stools.

Get medical help right away if any of these rare but very serious side effects occur: slurred speech, weakness on one side of the body, confusion, pain/redness/swelling of arms or legs.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, lung disease, other blood/bone marrow disorders (e.g., increased white blood cell count), bone marrow transplant, recent/current infections.

Before having surgery, tell your doctor or dentist that you are using this medication.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

Wash your hands well to prevent the spread of infections.

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This medication is not recommended for use during pregnancy. Consult your doctor for more details. If you become pregnant or think you may be pregnant, tell your doctor immediately.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Mylotarg Patient Information Including Side Effects

Brand Names: Mylotarg

Generic Name: gemtuzumab (Pronunciation: jem TOOZ oo mab)

  • What is gemtuzumab (Mylotarg)?
  • What are the possible side effects of gemtuzumab (Mylotarg)?
  • What is the most important information I should know about gemtuzumab (Mylotarg)?
  • What should I discuss with my healthcare provider before taking gemtuzumab (Mylotarg)?
  • How is gemtuzumab given (Mylotarg)?
  • What happens if I miss a dose (Mylotarg)?
  • What happens if I overdose (Mylotarg)?
  • What should I avoid while using gemtuzumab (Mylotarg)?
  • What other drugs will affect gemtuzumab (Mylotarg)?
  • Where can I get more information?

What is gemtuzumab (Mylotarg)?

Gemtuzumab is a cancer medication. Gemtuzumab interferes with the growth of cancer cells and slows their growth and spread in the body.

Gemtuzumab is used to treat acute myeloid leukemia, a type of blood cancer. Gemtuzumab is usually given to people who are at least 60 years old and have a relapse of their disease and who cannot receive other cancer medications.

Gemtuzumab may also be used for other purposes not listed in this medication guide.

What are the possible side effects of gemtuzumab (Mylotarg)?

Some people receiving a gemtuzumab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, or have fever, chills, or trouble breathing within 24 hours after receiving the injection.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • pain in your upper right stomach, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • swelling, rapid weight gain;
  • feeling like you might pass out;
  • pale skin, easy bruising or bleeding (such as nosebleeds), purple or red pinpoint spots under your skin;
  • fever, chills, body aches, unusual weakness, flu symptoms;
  • white patches or sores inside your mouth or on your lips;
  • chest pain or tightness, feeling short of breath;
  • lower back pain, blood in your urine;
  • increased thirst, fruity breath odor, increased urination;
  • urinating less than usual or not at all;
  • numbness or tingly feeling around your mouth;
  • muscle weakness, tightness, or contraction, overactive reflexes;
  • fast or slow heart rate, weak pulse; or
  • confusion, uneven heart rate, leg discomfort, muscle weakness or limp feeling.

Less serious side effects may include:

  • nausea, vomiting;
  • diarrhea or constipation;
  • headache;
  • dizziness, anxiety, depressed mood; or
  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about gemtuzumab (Mylotarg)?

You should not receive this medication if you are allergic to gemtuzumab

Do not receive gemtuzumab without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Before receiving gemtuzumab, tell your doctor if you have any type of infection, lung or breathing problems, liver or kidney disease, if you have ever received a stem cell transplant, or if you are being treated with other cancer medications.

Gemtuzumab can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. Do not miss any follow-up visits to your doctor.

Contact your doctor at once if you develop signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, or unusual weakness.

Do not receive a "live" vaccine while you are being treated with gemtuzumab, and avoid coming into contact with anyone who has recently received a live vaccine.

Related Drug Centers
  • Mylotarg


Related Drugs Index: