Gemtuzumab

Gemtuzumab is a prescription medication used for the treatment of acute myeloid leukemia. 

• Gemtuzumab is available under the following different brand names: Mylotarg.

Common side effects of Gemtuzumab include:

• Bleeding,
• Fever,
• Infection,
• Mouth sores,
• Nausea,
• Vomiting,
• Constipation,
• Headache, and
• Abnormal liver function tests

Serious side effects of Gemtuzumab include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Feeling cold,
• Itching,
• Fever,
• Lightheadedness,
• Shortness of breath,
• Sores or white patches in or around the mouth,
• Trouble swallowing or talking,
• Dry mouth,
• Bad breath,
• Altered sense of taste,
• Right-sided upper stomach pain,
• Yellowing of the skin or eyes,
• Rapid weight gain,
• Swelling in the arms or legs,
• Painful swelling in the midsection,
• Flu symptoms,
• Swollen gums,
• Skin sores,
• Cough,
• Pale skin,
• Unusual tiredness,
• Bleeding gums,
• Abnormal vaginal bleeding,
• Blood in the urine or stools,
• Coughing up blood,
• Vomit that looks like coffee grounds,
• Sudden numbness or weakness (especially on one side of the body),
• Sudden severe headache, and
• Problem with your speech or vision

Rare side effects of Gemtuzumab include:

• None 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injection, lyophilized cake powder for reconstitution

• 4.5 mg/single-dose vial

Acute Myeloid Leukemia

Adult dosage

• Newly Diagnosed CD33-positive AML
• Combination regimen
  • Induction cycle: 3 mg/m2 Intravenous (up to one 4.5-mg vial) on Days 1, 4, and 7 in combination with daunorubicin and cytarabine
  • For patients requiring a second induction cycle, do not administer gemtuzumab during the second induction cycle.
  • Consolidation: 3 mg/m2 Intravenous on Day 1 (up to one 4.5-mg vial) in combination with daunorubicin and cytarabine
• Monotherapy
  • Treatment course consists of 1 cycle of induction and up to 8 cycles of continuation therapy.
  • Induction: 6 mg/m2 Intravenous on Day 1, and 3 mg/m2 on Day 8
  • Continuation therapy: 2 mg/m2 Intravenous on Day 1 every 4 weeks
• Relapsed or Refractory CD33-positive AML
  • 3 mg/m2 on Days 1, 4, and 7 for 1 cycle

Newly Diagnosed Acute Myeloid Leukemia

Pediatric dosage

• Below 1 month: Safety and efficacy not established.
• Above 1 month
  • Body surface area (BSA) below 0.6 m2: 0.1 mg/kg Intravenous
  • BSA above 0.6 m2: 3 mg/m2 Intravenous
  • First induction cycle: Give once in combination with standard chemotherapy.
  • Second induction cycle: No gemtuzumab was given.
  • First intensification cycle: No gemtuzumab was given.
  • Second intensification cycle: Give once in combination with standard chemotherapy; consider risks and potential benefits before giving gemtuzumab
  • Third intensification cycle: No gemtuzumab was given.

Relapse or refractory AML

Pediatric dosage

• 3 mg/m2 (up to one 4.5-mg vial) on Days 1, 4, and 7 for 1 cycle

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Gemtuzumab has severe interactions with no other drugs.
• Gemtuzumab has serious interactions with at least 33 other drugs.
• Gemtuzumab has moderate interactions with at least 118 other drugs.
• Gemtuzumab has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice or health questions or concerns.

Contraindications

• Hypersensitivity to the active substance in gemtuzumab or any of its components or to any of the excipients

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Gemtuzumab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Gemtuzumab?”

Cautions

• Hepatotoxicity, including severe or fatal VOD also known as SOS, has been reported; see Black Box Warnings
• For patients being treated with gemtuzumab in combination with daunorubicin and cytarabine for newly diagnosed de novo AML, when cytogenetics testing results become available consider whether the potential benefit of continuing treatment outweighs the risks for the individual patient
• Animal data report gemtuzumab may cause embryo-fetal harm when administered to pregnant women; see Pregnancy
• Infusion-related reactions
  • Life-threatening or fatal infusion-related reactions can occur during or within 24 hours following alemtuzumab infusion
  • Premedicate before gemtuzumab infusion
  • Monitor vital signs frequently during infusion.
  • Interrupt infusion immediately for patients who are suspected of infusion-related reactions, especially dyspnea, bronchospasm, or hypotension.
  • Monitor patients during and for the above1 hour after the infusion is completed or until signs/symptoms completely resolve.
  • Discontinue gemtuzumab use in patients who develop signs or symptoms of anaphylaxis (.g, severe respiratory symptoms or clinically significant hypotension)
• Hemorrhage
  • Risk of fatal or life-threatening hemorrhage owing to prolonged thrombocytopenia
  • Proportion of patients with persistent thrombocytopenia increased with progressive treatment phases and was higher in patients treated with combination therapy plus gemtuzumab than with chemotherapy alone.
  • Assess blood cell counts before each gemtuzumab dose; monitor frequently after treatment until the resolution of cytopenias
  • Monitor patients for signs/symptoms of bleeding during treatment; manage severe bleeding, hemorrhage, or persistent thrombocytopenia by treatment interruption or discontinuation and provide appropriate medical care.
• QT interval prolongation
  • QT interval prolongation has been observed in patients treated with other drugs containing calicheamicin.
  • Obtain ECG and electrolytes before initiating the drug and during treatment as needed in patients with a history of or predisposition for QTc prolongation, who are taking drugs known to prolong QT interval, or with electrolyte disturbances.

Pregnancy and Lactation

• Based on animal data, gemtuzumab can cause embryo-fetal harm when administered to a pregnant woman
• No available data on gemtuzumab use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage.
• In rat embryo-fetal development studies, gemtuzumab ozogamicin caused embryofoetal toxicity at maternal systemic exposures that were above 0.4 times the exposure in patients at the maximum recommended dose, based on AUC.
• For patients who are pregnant, or become pregnant during treatment, advise the patient of the potential risk to a fetus
• Verify the pregnancy status of females of reproductive potential before initiating treatment.
• Gemtuzumab may impair fertility in males or females of reproductive potential.
• Contraception
  • Advise females of reproductive potential to avoid becoming pregnant while receiving gemtuzumab.
  • Advise females of reproductive potential to use effective contraception during treatment and for at least 6 months after the last dose.
  • Advise males with female partners of reproductive potential to use effective contraception during treatment and for at least 3 months after the last dose.
• Lactation
  • No data on the presence of gemtuzumab ozogamicin or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production
  • Owing to the potential for adverse reactions in breastfed infants, women should not breastfeed during treatment and for at least 1 month after the final dose.