Mylotarg Side Effects

Generic name: gemtuzumab

Medically reviewed by Drugs.com. Last updated on Jul 21, 2024.

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.

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:

• 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 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:

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:

See also:

For healthcare professionals

Applies to gemtuzumab: intravenous powder for injection.

General adverse events

The most common adverse reactions were hemorrhage, infection, pyrexia/fever, nausea, vomiting, constipation, headache, increased AST, increased ALT, rash, mucositis, febrile neutropenia, decreased appetite, chills, thrombocytopenia, fatigue, stomatitis, diarrhea, abdominal pain, and neutropenia.^[Ref]

Cardiovascular

• Very common (10% or more): Hypotension (up to 20.2%), hypertension (up to 17.3%), tachycardia (up to 13%)
• Frequency not reported: Capillary leak syndrome

Hypertension included hypertension and increased blood pressure.

Tachycardia included tachycardia, sinus tachycardia, increased heart rate, and supraventricular tachycardia.

Dermatologic

• Very common (10% or more): Rash (up to 19.9%)
• Common (1% to 10%): Erythema, pruritus

Rash included rash, dermatitis, allergic dermatitis, bullous dermatitis, contact dermatitis, exfoliative dermatitis, drug eruption, allergic pruritus, erythematous rash, macular rash, maculopapular rash, papular rash, pruritic rash, and vesicular rash.

Erythema included catheter site erythema, erythema, and infusion site erythema.

Gastrointestinal

• Very common (10% or more): Nausea (up to 71.1%), vomiting (up to 60.6%), stomatitis (up to 36.1%), diarrhea (up to 33.9%), abdominal pain (up to 33.2%), constipation (up to 25.3%), nausea/vomiting (up to 21%)
• Common (1% to 10%): Dyspepsia, ascites, esophagitis
• Postmarketing reports: Neutropenic colitis

Stomatitis included mucosal inflammation, oropharyngeal pain, stomatitis, mouth ulceration, oral pain, oral mucosal blistering, aphthous stomatitis, tongue ulceration, glossodynia, oral mucosal erythema, glossitis, and oropharyngeal blistering.

Abdominal pain included abdominal pain, lower abdominal pain, upper abdominal pain, abdominal discomfort, and abdominal tenderness.

Hematologic

• Very common (10% or more): Decreased hemoglobin (up to 100%), decreased platelets (up to 100%), decreased WBC/leukocytes (up to 100%), decreased absolute lymphocytes (up to 98.5%), decreased neutrophils (up to 97.7%), hemorrhage (up to 90.1%), increased prothrombin time (up to 84.8%), prolonged activated partial thromboplastin time (up to 80%), thrombocytopenia (up to 48.4%), neutropenia (up to 30.3%), anemia (up to 27.1%), leukopenia (up to 26.7%), febrile neutropenia (up to 19.1%)
• Common (1% to 10%): Pancytopenia, lymphopenia
• Frequency not reported: Myelosuppression

Hemorrhage included other hemorrhage (up to 64.9%), epistaxis (up to 62.6%), subcutaneous hemorrhage (up to 60.3%), upper gastrointestinal hemorrhage (up to 33.6%), lower gastrointestinal hemorrhage (up to 17.6%), and central nervous system hemorrhage (up to 5.1%).

In the combination therapy study (n=131), all grades and grade 3/4 bleeding/hemorrhagic reactions were reported in 90.1% and 20.6% of patients, respectively. The most frequent grade 3 bleeding/hemorrhagic reactions were hematemesis (3.1%), hemoptysis (3.1%), and hematuria (2.3%); grade 4 bleeding/hemorrhagic reactions were reported in 4 patients (gastrointestinal hemorrhage, hemorrhage, and pulmonary alveolar hemorrhage [2 patients]), and fatal bleeding/hemorrhagic reactions were reported in 3 patients (cerebral hematoma, intracranial hematoma, and subdural hematoma). In the monotherapy study (n=50), all grade bleeding/hemorrhagic events were reported in 16 patients. Grade 3/4 hemorrhagic events occurred in 2 patients (grade 3 gastric hemorrhage and grade 4 traumatic intracranial hemorrhage [1 patient each]); no fatal bleeding/hemorrhagic events were reported.

Thrombocytopenia included decreased platelet count and thrombocytopenia.

Neutropenia included neutropenia, granulocytopenia, and decreased neutrophil count.

Anemia included anemia and decreased hemoglobin.

Leukopenia included leukopenia and decreased WBC count.

Pancytopenia included pancytopenia and bone marrow failure.

Lymphopenia included lymphopenia and decreased lymphocyte count.

Hepatic

• Very common (10% or more): Increased AST (up to 89.2%), increased ALT (up to 78.3%), increased blood bilirubin (up to 51.6%), increased transaminases (up to 24.5%), bleeding (up to 23%), hyperbilirubinemia (up to 13%)
• Common (1% to 10%): Veno-occlusive liver disease, hepatomegaly, abnormal hepatic function, jaundice, increased GGT
• Uncommon (0.1% to 1%): Hepatic failure, Budd-Chiari syndrome
• Frequency not reported: Hepatotoxicity, sinusoidal obstruction syndrome

Of the 126 patients with increased AST, 124 patients with increased ALT, and 119 patients with increased blood bilirubin at baseline (grade 2 or lower), 14%, 10%, and 8% progressed to grade 3 or higher, respectively.

Increased transaminases included increased transaminases, hepatocellular injury, increased ALT, increased AST, and increased hepatic enzyme.

Hyperbilirubinemia included increased blood bilirubin and hyperbilirubinemia.

Veno-occlusive liver disease included veno-occlusive disease and veno-occlusive liver disease.

Abnormal hepatic function included abnormal liver function test and abnormal hepatic function.

Hypersensitivity

• Frequency not reported: Anaphylaxis

Immunologic

• Very common (10% or more): Antidrug antibody (up to 12%)
• Common (1% to 10%): Neutralizing antibody

Metabolic

• Very common (10% or more): Hyperglycemia (up to 92%), worsened hypophosphatemia (up to 64%), worsened hypokalemia (up to 57%), worsened hyponatremia (up to 44%), hyperuricemia (up to 32.5%), decreased appetite (up to 27.1%)
• Common (1% to 10%): Tumor lysis syndrome
• Frequency not reported: Hypoalbuminemia
• Postmarketing reports: Tumor lysis syndrome

Hyperglycemia included hyperglycemia and increased blood glucose.

Nervous system

• Very common (10% or more): Headache (up to 38.3%)

Other

• Very common (10% or more): Pyrexia/fever (up to 82.7%), increased alkaline phosphatase (up to 79.7%), infection (up to 77.9%), chills (up to 67.9%), fatigue (up to 41.2%), sepsis (up to 32%), edema (up to 21.3%), mucositis (up to 21%), increased blood LDH (up to 16.6%)
• Common (1% to 10%): Infusion-related reaction, multiorgan failure, pain
• Frequency not reported: Death, septic shock, hemorrhagic shock
• Postmarketing reports: Fungal lung infections, bacterial infections

Pyrexia included pyrexia, increased body temperature, and hyperthermia.

Of the 120 patients with increased alkaline phosphatase at baseline (grade 2 or lower), 13% progressed to grade 3 or higher.

Infection included sepsis and bacteremia (up to 53.4%), other infections (up to 28.4%), viral infection (up to 24.2%), fungal infection (up to 15.3%), lower respiratory tract infection (up to 13%), bacterial infection (up to 9.2%), gastrointestinal infection (up to 8.4%), skin infection (up to 7.9%), and upper respiratory tract infection (up to 4.3%).

In the combination therapy study (n=131), all causality severe (grade 3 or higher) infections occurred in 77.9% of patients. Treatment-related death due to septic shock was reported in 1 patient; fatal severe infection was reported in 2 patients treated with this drug and 4 patients in the control arm. In the monotherapy study (n=50), grade 3/4 infections were reported in 20% of patients. The most frequent (at least 5%) reported grade 3/4 infections were sepsis and pneumonia in 3 patients each; 6 patients had grade 5 infection (sepsis [4 patients], atypical pneumonia [1 patient], and COVID-19 pneumonia [1 patient]).

Fatigue included fatigue, asthenia, lethargy, and malaise.

Edema included edema, face edema, peripheral edema, swelling face, generalized edema, and periorbital edema.

Infusion-related reaction included infusion-related reaction, urticaria, hypersensitivity, bronchospasm, drug hypersensitivity, and injection site urticaria.

Fungal lung infections reported during postmarketing experience included pulmonary mycosis and Pneumocystis jirovecii pneumonia.

Bacterial infections reported during postmarketing experience included Stenotrophomonas infection.

Renal

• Postmarketing reports: Hemorrhagic cystitis

Respiratory

• Very common (10% or more): Dyspnea (up to 27.4%)
• Common (1% to 10%): Pneumonia, lung edema
• Postmarketing reports: Interstitial pneumonia

Dyspnea included dyspnea and exertional dyspnea.

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.

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