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Mylotarg

gemtuzumab
Used for Leukemia
Used for Leukemia

Mylotarg (gemtuzumab ozogamicin) is an antibody-drug conjugate that’s used to treat a certain type of acute myeloid leukemia (AML) in adults and children. It specifically finds and kills leukemia cancer cells in the body. Mylotarg (gemtuzumab ozogamicin) is given as an injection into your vein (intravenously or IV) at an infusion center or provider’s office. This medication might cause side effects such as tiredness, low platelets, and liver problems.

Reviewed by:
reviewer
Allison Baxley, PharmD, BCOP
reviewer
Cydnee Ng, PharmD
Last reviewed on October 17, 2023
BasicsSide effectsPros & consPharmacist tipsFAQsWarningsDosageContraindicationsReferencesPricesMedicare
basics-icon

What is Mylotarg (gemtuzumab ozogamicin)?

What is Mylotarg (gemtuzumab ozogamicin) used for?

  • Newly-diagnosed acute myeloid leukemia (AML) that’s CD33-positive in adults and children 1 month or older

  • Previously-treated acute myeloid leukemia (AML) that’s CD33-positive in adults and children 2 years and older

How Mylotarg (gemtuzumab ozogamicin) works

Mylotarg (gemtuzumab ozogamicin) is a type of cancer medication known as an antibody-drug conjugate. It’s made up of two parts: a monoclonal antibody and a chemotherapy drug called calicheamicin.

The antibody takes Mylotarg (gemtuzumab ozogamicin) to acute myeloid leukemia cells in the body that have a specific protein called CD33. Once there, the chemotherapy damages the leukemia cell’s DNA, which kills the cancer cell.

Drug Facts

Common BrandsMylotarg
Drug ClassAntibody-drug conjugate
Controlled Substance ClassificationNot a controlled medication
Generic StatusNo lower-cost generic available
AvailabilityPrescription only
basics-icon

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

The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.

Common Side Effects

  • Fever (up to 79%)
  • Liver problems (up to 51%)
  • Tiredness (up to 46%)
  • Infection (up to 44%)
  • Heart problems (up to 28%)
  • Bleeding (up to 25%)
  • Nausea and vomiting (up to 21%)
  • Constipation (up to 21%)
  • Mouth sores (up to 21%)

Other Side Effects

Serious Side Effects

Contact your healthcare provider immediately if you experience any of the following.
  • Serious liver problems: swollen belly, sudden weight gain, yellow skin, yellow eyes, stomach pain
  • Bleeding: nosebleeds, blood in stool, unexplained bruising, blood in urine, sudden headache
  • Infusion-related reactions: fever, fast heart rate, chills, trouble breathing, low blood pressure

Source: DailyMed

The following side effects have also been reported

Side effects that you should report to your care team as soon as possible:

  • Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
  • Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
  • Bleeding in the brain—severe headache, stiff neck, confusion, dizziness, change in vision, numbness or weakness of the face, arm, or leg, trouble speaking, trouble walking, vomiting
  • Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
  • Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
  • Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded
  • Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

  • Constipation
  • Headache
  • Loss of appetite
  • Nausea
  • Pain, redness, or swelling with sores inside the mouth or throat
  • Vomiting
pros-and-cons

Pros and cons of Mylotarg (gemtuzumab ozogamicin)

thumbs-up

Pros

First-choice treatment for people with CD33-positive AML

Specifically targets leukemia cells (the antibody part of the medication takes the chemotherapy to the cancer cells)

Approved to treat both children and adults

thumbs-down

Cons

Given as an intravenous infusion, so requires a needle

Requires additional medications before each dose to prevent infusion-related reactions

Might cause serious liver problems including veno-occlusive disease (VOD)

pharmacist-tips

Pharmacist tips for Mylotarg (gemtuzumab ozogamicin)

pharmacist

  • It’s important to go to your appointments for your blood tests whenever your provider recommends doing so. Routine blood tests help monitor for certain Mylotarg (gemtuzumab ozogamicin) side effects, such as low blood cell counts and liver irritation. Sometimes, these side effects won’t cause symptoms and changes in your test results are the only sign of a side effect.

    • Mylotarg (gemtuzumab ozogamicin) might cause infusion reactions (e.g., fever, chills, fast heart rate). You’ll take several medications before each dose to prevent serious reactions to the infusion. These medications might include acetaminophen (Tylenol) and an antihistamine, like diphenhydramine (Benadryl).

      • Avoid getting sick by washing your hands often, avoiding crowds, and washing raw fruits and vegetables thoroughly before eating them. You might be more likely to get sick while you’re taking Mylotarg (gemtuzumab ozogamicin). The medication can sometimes make your white blood cell counts drop and raise your risk for infections.

        • Check your temperature at least once a day. Call your provider right away if you have a fever (a temperature of 100.4 degrees Fahrenheit or higher). It’s important for your provider to know if you get sick, and sometimes a fever can be the only sign that you’re sick.

          • It’s not recommended to breastfeed while you’re taking Mylotarg (gemtuzumab ozogamicin) and for 1 month after your last dose. We don’t know whether the medication passes into human milk. But because of the way Mylotarg works, it could harm a breastfeeding infant.

            faqs

            Frequently asked questions about Mylotarg (gemtuzumab ozogamicin)

            Is Mylotarg (gemtuzumab ozogamicin) a chemotherapy medication?
            Not exactly. Mylotarg (gemtuzumab ozogamicin) is a type of cancer medication called an antibody-drug conjugate — it’s a combination of a targeted therapy (“antibody”) and chemotherapy (“drug”). This medication doesn’t attack any cell that’s growing quickly in the body like traditional chemotherapy does. Instead, the antibody part of Mylotarg takes the medication to cells in the body that have a specific protein called CD33, which acute myeloid leukemia cells do. Then, the medication attaches to this protein on the leukemia cell like an anchor so that the chemotherapy can attack that particular cell. Attaching to specific cells helps lower the chance of having some side effects that are common with traditional chemotherapy, such as nausea and hair loss.
            Does Mylotarg (gemtuzumab ozogamicin) cause infusion-related reactions?
            Yes, people taking Mylotarg (gemtuzumab ozogamicin) might experience infusion-related reactions. Most reactions happen during the infusion or within 24 hours after the infusion ends. Symptoms typically include fever, chills, fast heart rate, trouble breathing, and low blood pressure. Your provider will give you a few medications to take before each Mylotarg infusion to prevent a reaction. These medications can include acetaminophen (Tylenol) and diphenhydramine (Benadryl). Your healthcare team will also watch for reactions during your infusion and for at least 1 hour after your infusion. If a reaction happens, whether you can continue to take Mylotarg depends on how severe your reaction is.
            Is Mylotarg (gemtuzumab ozogamicin) safe to take if I have liver problems?
            Speak with your provider about the risks and benefits of taking Mylotarg (gemtuzumab ozogamicin) if you have liver problems. People with liver problems who take Mylotarg are at higher risk for developing veno-occlusive disease (VOD). VOD causes blockages in the blood vessels in the liver, which can cause the liver to work less well and possibly lead to damage to other organs (e.g., lungs, kidneys). If your provider decides it’s okay to take Mylotarg, your provider will follow up with you often. During treatment, your provider will order blood tests to check for signs of liver injury (i.e., high bilirubin or liver enzyme levels). Be sure to tell your provider right away if you have sudden weight gain, bloating in the belly area, pain or tenderness on the upper right side of your belly, or yellowish skin or eyes. These can be symptoms of liver problems like VOD. You’ll have to stop taking Mylotarg if you develop VOD.
            Can Mylotarg (gemtuzumab ozogamicin) cause tumor lysis syndrome?
            It’s possible for tumor lysis syndrome to happen while you’re taking Mylotarg (gemtuzumab ozogamicin). This is because the medication works to kill leukemia cells. Tumor lysis syndrome is a complication that happens when cancer cells are destroyed and they release what was inside them into the bloodstream. This can be dangerous because it can lead to high levels of potassium and uric acid in the blood, which can cause problems with your heart and kidneys. Because tumor lysis syndrome is possible with Mylotarg, your provider will monitor you closely and give you extra fluids when you start the medication. Your provider also might recommend other medications like allopurinol (Zyloprim) to prevent complications.
            Does Mylotarg (gemtuzumab ozogamicin) cause nausea?
            Mylotarg (gemtuzumab ozogamicin) doesn’t typically cause nausea. But sometimes, Mylotarg is taken together with other chemotherapy medications that might cause nausea. If you do have nausea, your provider might recommend medications to help manage this side effect. Contact your provider if you have nausea that bothers you or isn’t managed well with any anti-nausea medications you have.
            Is Mylotarg (gemtuzumab ozogamicin) safe in pregnancy?
            No, Mylotarg (gemtuzumab ozogamicin) isn’t safe to take during pregnancy. It can cause harm to an unborn baby. If you’re female and are able to get pregnant, use effective birth control while you’re taking Mylotarg and for at least 6 months after your last dose. Males should also use birth control (e.g., condoms) if they’re taking this medication and are sexually active with someone who can get pregnant. They should continue to use birth control after treatment for at least 3 months after the last dose.
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            warings-icon

            What are the risks and warnings for Mylotarg (gemtuzumab ozogamicin)?

            Mylotarg (gemtuzumab ozogamicin) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.

            risk-warning

            Serious liver problems

            • Risk factors: History of liver problems | People who’ve had a stem cell transplant

              Some people taking Mylotarg (gemtuzumab ozogamicin) developed serious liver problems, including veno-occlusive disease (VOD). VOD is a condition that causes blockages in the blood vessels in the liver, which causes the liver to work less well. If not treated, it can lead to damage to other organs, like the lungs and kidneys.

              The three main symptoms of VOD are high bilirubin levels in the blood; sudden weight gain, especially in the belly (ascites); and tenderness in the upper right side of your belly. Your providers will monitor you for liver problems, but be sure to let them know right away if you have sudden weight gain or belly pain. Depending on the type of liver problem, you might have to stop taking Mylotarg.

              risk-warning

              Infusion-related reactions

              Mylotarg (gemtuzumab ozogamicin) can cause infusion-related reactions, including a severe allergic reaction called anaphylaxis. Most reactions happen during the infusion or within 24 hours after the infusion is finished. Typical symptoms include fever, fast heart rate, chills, trouble breathing, and low blood pressure.

              You’ll take several medications before your Mylotarg infusion to prevent a reaction. These additional medications include acetaminophen (Tylenol) and diphenhydramine (Benadryl). Your healthcare team will watch for reactions during your infusion and for at least 1 hour after your infusion ends. Sometimes, people who experience a reaction can continue to take Mylotarg after a treatment break or after taking more preventative medications. But other times, the cancer medication must be permanently stopped if the reaction is serious. Get medical attention right away if you have symptoms of an infusion reaction after you’ve left the clinic.

              risk-warning

              Bleeding

              • Risk factors: Taking Mylotarg (gemtuzumab ozogamicin) together with chemotherapy

                People taking Mylotarg (gemtuzumab ozogamicin) commonly develop low platelet counts in their body. Platelets are the cells in your blood that form blood clots and prevent bleeding. So when they’re low, your body can’t stop bleeding as well. Your provider will check your blood cell counts while you’re taking Mylotarg.

                Contact your provider right away if you have signs of low platelets such as bruising, nose bleeds, bleeding that takes longer to stop, or blood in stool or urine. Your provider might need to hold off on giving you a dose of Mylotarg until your blood tests show that your body is starting to make more platelets and that your platelet count is going back up. Or sometimes, you’ll need to stop taking the medication altogether.

                risk-warning

                Heart rhythm problems

                • Risk factors: History of abnormal heart rhythms | Taking other medications that can affect heart rhythm

                  Some people taking medications containing calicheamicin, the chemotherapy part of Mylotarg (gemtuzumab ozogamicin), have experienced heart rhythm changes. It’s not clear whether Mylotarg causes these changes in heart rhythm. To be safe, your provider might follow up with you more often if you have heart rhythm problems (e.g., long QT syndrome) or if you take another medication that can change heart rhythm, such as amiodarone (Pacerone). This is because you might be at risk for these heart rhythm changes.

                  risk-warning

                  Potentially poor response to treatment for people with AML in poor-risk group

                  When you’re diagnosed with AML, your provider will typically perform a test to predict how well the cancer will likely respond to treatment and determine your risk group: favorable (good), intermediate, and adverse (poor). Knowing your risk group helps your provider determine which treatment is best for you.

                  Studies suggest that Mylotarg (gemtuzumab ozogamicin) might work better for people in the good- and intermediate-risk groups, but not as well for people in the poor-risk group. Providers might prefer to use a different treatment plan than with Mylotarg for some people in the poor-risk group. Your provider will consider the risks and benefits of treating your cancer with Mylotarg based on your risk group. Talk to your provider about what treatment choices you have and the risks and benefits for each one.

                  risk-warning

                  Harm to unborn baby

                  Based on animal studies, Mylotarg (gemtuzumab ozogamicin) might harm an unborn baby or raise the risk for miscarriage (pregnancy loss) when it’s given during pregnancy. For this reason, if you’re a female who can get pregnant, you should use birth control while you’re taking Mylotarg until at least 6 months after the last dose. If you’re a male who’s sexually active with a partner who’s able to have children, use condoms during treatment and for at least 3 months after your last dose. Let your provider know right away if you or your partner becomes pregnant while you’re taking Mylotarg.

                  dosage

                  Mylotarg (gemtuzumab ozogamicin) dosage forms

                  Typical dosing for Mylotarg (gemtuzumab ozogamicin)

                  The dose and treatment schedule depends on your age, your AML status, and whether you’re taking Mylotarg (gemtuzumab ozogamicin) along with other chemotherapy.

                  In general, Mylotarg (gemtuzumab ozogamicin) is given as an infusion through the vein (IV) by a healthcare provider.

                  First-choice treatment for newly-diagnosed AML

                  • Adults

                    • The dose is based on your body size using body surface area (BSA), which takes into account your weight and height.

                    • When used together with other chemotherapy: A treatment course consists of 1 induction cycle and then 2 consolidation cycles.

                      • Induction cycle: The typical dose is 3 mg/m2 given IV on days 1, 4 and 7.

                      • Consolidation cycles: The typical dose is 3 mg/m2 given IV on day 1.

                    • When used by itself: A treatment course consists of 1 induction cycle and up to 8 consolidation cycles.

                      • Induction cycle: The typical dose is 6 mg/m2 given IV on day 1 and then 3 mg/m2 given IV on day 8.

                      • Consolidation cycles: The typical dose is 2 mg/m2 given IV on day 1 every 4 weeks.

                  • Children 1 month and older: Treatment days vary based on the treatment protocol that the healthcare team is following. The dose is based on body size, either using body surface area (mg/m2) or using body weight (mg/kg).

                  Previously-treated AML

                  • People 2 years and older: The typical dose is 3 mg/m2 given IV on days 1, 4, and 7 for one course of treatment.

                  contraindications-icon

                  Mylotarg (gemtuzumab ozogamicin) contraindications

                  Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Mylotarg (gemtuzumab ozogamicin) will not be safe for you to take.

                  • Allergic reaction to Mylotarg (gemtuzumab ozogamicin)

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                  References

                  Best studies we found

                  American Cancer Society. (n.d.). Targeted therapy.

                  American Cancer Society. (2020). What are infusion or immune reactions?

                  American Cancer Society. (2023). Chemotherapy for acute myeloid leukemia (AML).

                  View All References (21)

                  American Cancer Society. (2023). Typical treatment of acute myeloid leukemia (except APL).

                  American Cancer Society. (2024). Fevers.

                  American Liver Foundation. (2023). Ascites.

                  American Red Cross. (2021). The function of platelets: 5 things you might not know.

                  Centers for Disease Control and Prevention. (n.d.). What you need to know: Neutropenia and risk for infection.

                  Farzam, K., et al. (2023). QT prolonging drugs. StatPearls.

                  Fu, Z., et al. (2022). Antibody drug conjugate: The “biological missile” for targeted cancer therapy. Signal Transduction and Targeted Therapy.

                  Gupta, A., et al. (2018). Tumor lysis syndrome. Journal of the American Medical Association Oncology.

                  MedlinePlus. (2022). Bilirubin blood test.

                  MedlinePlus. (2022). Uric acid test.

                  Molica, M., et al. (2021). CD33 expression and gentuzumab ozogamicin in acute myeloid leukemia: Two sides of the same coin. Cancers.

                  National Cancer Institute. (2024). Acute myeloid leukemia treatment (PDQ®)–Patient version.

                  National Comprehensive Cancer Network. (2021). Anemia and neutropenia: Low red and white blood cell counts.

                  National Comprehensive Cancer Network. (2023). Acute myeloid leukemia.

                  National Heart, Lung, and Blood Institute. (2022). Long QT syndrome.

                  Patel, K., et al. (2017). Febrile neutropenia. Journal of the American Medical Association Oncology.

                  Richardson, P. G., et al. (2020). Veno-occlusive disease/sinusoidal obstruction syndrome in patients with prior gemtuzumab ozogamicin: Literature analysis of survival after defibrotide treatment. Blood Cancer Journal.

                  Senzolo, M., et al. (2007). Veno occlusive disease: Update on clinical management. World Journal of Gastroenterology.

                  Vollmar, B. S., et al. (2021). Calicheamicin antibody–drug conjugates with improved properties. Molecular Cancer Therapeutics.

                  Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. (2021). Mylotarg- gemtuzumab ozogamicin injection, powder, lyophilized, for solution [package insert]. DailyMed.

                  Xu, Q., et al. (2021). Clinical benefits and safety of gemtuzumab ozogamicin in treating acute myeloid leukemia in various subgroups: An updated systematic review, meta-analysis, and network meta-analysis. Frontiers in Immunology.

                  GoodRx Health has strict sourcing policies and relies on primary sources such as medical organizations, governmental agencies, academic institutions, and peer-reviewed scientific journals. Learn more about how we ensure our content is accurate, thorough, and unbiased by reading our editorial guidelines.
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