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Gemtuzumab ozogamicin

Generic name: gemtuzumab ozogamicin [jem-TOOZ-ue-mab-OH-zoe-ga-MYE-sin]
Brand name: Mylotarg
Dosage Form: intravenous injection powder (4.5 mg).
Drug class: CD33 monoclonal antibodies

What is Gemtuzumab ozogamicin ?

Gemtuzumab is a monoclonal antibody that's linked to chemotherapy drugs. A monoclonal antibody is made to destroy and target only specific cells in the human body. This could help protect healthy cells. The treatment of newly diagnosed acute leukemia is with gemtuzumab-ozogamicin in adults and children older than 1 month. Gemtuzumab  ozogamicin can also be used to treat CD33-positive acute myeloid leukemia in adults or children older than 2 years after other treatments have failed. This medication guide does not list all possible uses for gemtuzumab.

Side effects of  Gemtuzumab ozogamicin

In case of symptoms associated with allergic reactions such as difficulty breathing, hives or facial or throat swelling it is imperative that medical assistance be sought immediately.

During or soon after the injection, some side effects can occur. You should tell your caregiver if you experience any of the following symptoms: cold, itchiness, fever, lightheadedness, or shortness of breath. You may also experience these symptoms up to one hour after receiving gemtuzumab-ozogamicin.

Gemtuzumab ozogamicin may cause serious side effects. If you experience:

  • Dry mouth; bad breath;
  • Signs of liver issues: right-sided upper stomach pain, jaundice (yellowing of skin or eyes), rapid weight gain, arm or leg swellings or painful midsection swellings;
  • Low blood cell counts include fever, flu symptoms, swollen or sore gums, skin lesions, difficulty breathing, pale skin, and unusual fatigue.
  • Unusual bleeding: bleeding gums, abnormal vaginal bleed, blood in urine or stools; bloody vomit or bloody cough;
  • Signs of brain bleeding include sudden numbness, weakness or headaches (especially to one side), or problems with speech and vision.

Gemtuzumab can cause serious liver damage or bleeding. Both of these conditions are life-threatening. Should certain side effects arise during cancer therapy, your cancer treatments could either be stopped permanently or delayed significantly.

The side effects of gemtuzumab are:

  • Bleeding;
  • Fever, infection;
  • Mouth sores;
  • Nausea, vomiting, and constipation;
  • Headache;
  • Abnormal liver function tests

There may be other side effects.Need medical advice regarding side effects? Consult with your physician immediately. The FDA can be contacted at 1-800-FDA-1088 to report side effects.

Similar/related drugs

Ventoclax, Vincristine, Venclexta, Azacitidine, Cytarabine, and Mylotarg

Warnings

Gemtuzumab can cause liver damage or bleeding, which could be fatal. Contact your doctor immediately if you experience any of the following: upper stomach pain; yellowing skin or eyes; rapid weight gain; swelling in your midsection. You may also have problems with your speech, vision, or hearing.

Before you take this drug

If you have an allergy to gemtuzumab, it is best not to use this treatment.

Tell your doctor about any of the following:

  • Liver disease
  • Long-qt syndrome
  • A stem cell transplant is performed.
  • An electrolyte imbalance can occur when there is a low level of magnesium or potassium in the blood.

If either the mother or father uses gemtuzumab, it can cause birth defects or harm to the unborn child.

  • You may need to take a pregnancy test first if you're a woman. Use birth control while taking this medication and for 6 months following your last dose.
  • Use effective birth control if you're a man and your partner can get pregnant. Continue to use birth control for at least three months after your last dose.
  • If you become pregnant while using gemtuzumab, tell your doctor immediately.

Both men and women may be affected by this medicine. It is still important to use birth control to avoid pregnancy, as gemtuzumab can harm the child if it does happen. Do not breastfeed for 1 month after the last dose of this medication.

How to take Gemtuzumab ozogamicin?

Infusions of gemtuzumab are given into the vein. This injection will be given by a healthcare provider. You will only receive gemtuzumab-ozogamicin on specific days during each treatment cycle. The length of treatment will be determined by your doctor. Other medications will be prescribed to prevent side effects that could be serious or an infusion reaction. Take these medications as prescribed by your doctor. The infusion of gemtuzumab can take up to 2 hours. After receiving the medicine, you will be closely monitored for at least one hour to ensure that there is no infusion reaction. Gemtuzumab-ozogamicin can cause serious liver problems or even death, such as veno-occlusive diseases (blocked vessels in the liver, which can lead to damage to the liver). You will be required to undergo frequent medical testing. The results of your tests may delay the cancer treatment.

What happens if I miss the dose?

If you are unable to attend your appointment for gemtuzumab, please call your doctor.

What happens if I overdose?

Overdoses are unlikely because gemtuzumab is administered by a healthcare provider in a medical environment.

What should be avoided?

Avoid any activities that could increase your risk of injury or bleeding. Take extra precautions to avoid bleeding when shaving or brushing your teeth.

Interaction with other drug

Gemtuzumab can cause serious heart problems. This risk is higher if you are also taking other medications for asthma, heart disease, depression, mental illness, or HIV. Other drugs, such as vitamins and herbal remedies, may interact with gemtuzumab. Inform your doctor of all the medicines you are taking and those that you stop or start using.