Gemtuzumab Side Effects

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

Applies to gemtuzumab: intravenous powder for solution.

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, 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:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

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 gemtuzumab

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:

Other side effects of gemtuzumab

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:

For healthcare professionals

Applies to gemtuzumab: intravenous powder for injection.

Hematologic adverse events

• Very common (10% or more): Bleeding (25%), thrombocytopenia (24%), febrile neutropenia (18%)
• Common (1% to 10%): Hemorrhage
• Frequency not reported: Myelosuppression, anemia^[Ref]

Other

• Very common (10% or more): Fever (79%), fatigue (46%)
• Common (1% to 10%): Pain
• Frequency not reported: Chills^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea (21%), vomiting (21%), constipation (21%), mucositis (21%)
• Common (1% to 10%): Diarrhea
• Postmarketing reports: Neutropenic colitis (sometimes fatal)^[Ref]

Respiratory

• Common (1% to 10%): Pneumonia, lung edema
• Frequency not reported: Hypoxia, respiratory failure, dyspnea
• Postmarketing reports: Fungal lung infections (including Pulmonary mycosis and Pneumocystis jirovecii pneumonia) (sometimes fatal), interstitial pneumonia (sometimes fatal)^[Ref]

Hepatic

• Very common (10% or more): Increased AST (40%), increased ALT (16%)
• Common (1% to 10%): Veno-occlusive liver disease (VOD) (sometimes fatal), hyperbilirubinemia^[Ref]

Genitourinary

• Postmarketing reports: Hemorrhagic cystitis (sometimes fatal)

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

Immunologic

• Very common (10% or more): Infection (44%), sepsis (32%)
• Postmarketing reports: Bacterial infections (including Stenotrophomonas infection), potential for immunogenicity^[Ref]

Renal

• Frequency not reported: Renal failure secondary to tumor lysis syndrome^[Ref]

Cardiovascular

• Common (1% to 10%): Tachycardia
• Frequency not reported: QT interval prolongation, hypotension^[Ref]

Dermatologic

• Very common (10% or more): Rash (16%)^[Ref]

Nervous system

• Very common (10% or more): Headache (19%)^[Ref]

Metabolic

• Very common (10% or more): Hypophosphatemia (64%), hypokalemia (57%), hyponatremia (44%), alkaline phosphatase increased (13%), aspartate aminotransferase increased (14%), alanine aminotransferase increased (10%)
• Common (1% to 10%): Blood bilirubin increased^[Ref]

Hypersensitivity

• Frequency not reported: Hypersensitivity (including anaphylaxis)^[Ref]

See also:

Further information

Gemtuzumab 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.

Medical Disclaimer