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Mylotarg Side Effects

Generic name: gemtuzumab

Medically reviewed by Drugs.com. Last updated on Jan 2, 2025.

Note: This document provides detailed information about Mylotarg Side Effects associated with gemtuzumab. Some dosage forms listed on this page may not apply specifically to the brand name Mylotarg.

Applies to gemtuzumab: intravenous powder for solution.

Important warnings This medicine can cause some serious health issues

Intravenous route (powder for solution)

Should only be used as single agent chemotherapy and not in combination chemotherapy regimens outside clinical trials.

Severe myelosuppression occurs when gemtuzumab is used at recommended doses.

Severe hypersensitivity reactions (including anaphylaxis), and other infusion-related reactions which may include severe pulmonary events have occurred with therapy.

Some of these hypersensitivity reactions have been fatal.

Patients with high peripheral blast counts may be at greater risk for pulmonary events and tumor lysis syndrome; physicians should consider leukoreduction with hydroxyurea or leukapheresis to reduce the peripheral white count to below 30,000/ microliters prior to administration of gemtuzumab.

Hepatotoxicity, including severe hepatic veno-occlusive disease (VOD), has been reported with therapy.

Physicians should monitor their patients carefully for symptoms of hepatotoxicity, particularly VOD.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests are needed to check for any unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

While you are being treated with gemtuzumab (the active ingredient contained in Mylotarg) and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Gemtuzumab may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Gemtuzumab can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor or nurse right away if you have blue lips, fingernails, or skin; difficult or fast breathing; dizziness, fainting, or lightheadedness; fever or chills; rash; trouble breathing or swallowing; or any swelling of your hands, face, or mouth after receiving this medicine.

Check with your doctor immediately if you have any symptoms of liver problems including skin and eyes turning yellow, dark brown-colored urine, right-sided abdominal or stomach pain, fever, or severe tiredness.

This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount; joint pain, stiffness, or swelling; lower back, side, or stomach pain; a rapid weight gain; swelling of the feet or lower legs; or unusual tiredness or weakness.

Serious side effects of Mylotarg

Along with its needed effects, gemtuzumab may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking gemtuzumab:

More common side effects

  • black, tarry stools
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blood in the stools or urine
  • bluish color of the fingernails, lips, skin, palms, or nailbeds
  • blurred vision
  • burning or stinging of the skin
  • chest pain
  • chills
  • confusion
  • convulsions (seizures)
  • cough or hoarseness
  • cracked lips
  • decrease or increase in urine
  • diarrhea
  • difficulty with swallowing
  • dizziness
  • dry mouth
  • excessive sweating
  • fainting
  • fast or slow heartbeat
  • fever
  • flushed, dry skin
  • fruit-like breath odor
  • headache, sudden and severe
  • heavy, nonmenstrual vaginal bleeding
  • inability to speak
  • increased thirst or hunger
  • irregular heartbeat
  • large, flat, blue, or purplish patches in the skin
  • lightheadedness
  • lower back, joint, or side pain
  • loss of appetite
  • mood changes
  • muscle pain or cramps
  • muscle trembling or twitching
  • nausea or vomiting
  • numbness or tingling in the hands, feet, or lips
  • pain, difficulty, or burning while urinating
  • painful cold sores or blisters on the lips, nose, eyes, or genitals
  • pale skin
  • palpitations
  • persistent bleeding or oozing from puncture sites, mouth, or nose
  • pinpoint red spots on the skin
  • pounding in the ears
  • rapid, shallow breathing
  • rapid weight gain
  • red or purplish patches or spots on the skin
  • severe or continuing dull nervousness
  • shortness of breath
  • slurred speech
  • small red or purple spots on the skin
  • sneezing
  • sore throat
  • sores, ulcers, or white spots on the lips, tongue, or inside the mouth
  • stomachache
  • sweating
  • swelling or inflammation of the mouth, face, fingers, feet, or lower legs
  • swollen glands
  • temporary blindness
  • tightness in the chest
  • tingling of the hands or feet
  • troubled breathing, exertional
  • unexplained nosebleeds
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • weakness in the arm or leg on one side of the body, sudden and severe
  • wheezing
  • yellow eyes or skin

Other side effects of Mylotarg

Some side effects of gemtuzumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common side effects

  • acid or sour stomach
  • belching
  • difficulty with moving
  • dry, red, hot, or irritated skin
  • full or bloated feeling or pressure in the stomach
  • heartburn
  • indigestion
  • lack or loss of strength
  • muscle pain or stiffness
  • pain, swelling, or redness in the joints
  • runny, stuffy nose
  • stomach discomfort upset
  • swelling of the abdominal or stomach area
  • trouble with sleeping

For healthcare professionals

Applies to gemtuzumab: intravenous powder for injection.

Hematologic adverse events

Other

Gastrointestinal

Respiratory

Hepatic

Genitourinary

Genitourinary side effects have included vaginal hemorrhage (12%) and hematuria (10%)[Ref]

Immunologic

Renal

Cardiovascular

Dermatologic

Nervous system

Metabolic

Hypersensitivity

See also:

References

1. "Product Information. Mylotarg (gemtuzumab ozogamicin)." Wyeth-Ayerst Laboratories

Further information

Mylotarg side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.