Mylotarg

Last updated on RxList: 3/9/2020
Mylotarg Side Effects Center

What Is Mylotarg?

Mylotarg (gemtuzumab ozogamicin for injection) is a cancer medication used to treat acute myeloid leukemia, a type of blood cancer. Mylotarg is usually given to people who are at least 60 years old and have a relapse of their disease and who cannot receive other cancer medications. The brand name Mylotarg is discontinued, but generic versions may be available.

What Are Side Effects of Mylotarg?

Common side effects of Mylotarg (gemtuzumab ozogamicin for injection) include:

Dosage for Mylotarg

The recommended dose of Mylotarg is 9 mg/m², infused over a 2-hour period.

What Drugs, Substances, or Supplements Interact with Mylotarg?

Mylotarg may interact with "live" vaccines, or other chemotherapy treatments. Tell your doctor all medications and supplements you use.

Mylotarg During Pregnancy and Breastfeeding

Mylotarg can cause harm to a fetus or cause birth defects. Before you receive Mylotarg, tell your doctor if you are pregnant. Use birth control, and tell your doctor if you become pregnant during treatment. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Additional Information

Our Mylotarg (gemtuzumab ozogamicin for injection) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Mylotarg Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during or shortly after the injection. Tell your caregiver right away if you feel cold, itchy, feverish, light-headed, or short of breath. These symptoms could also occur up to 1 hour after your gemtuzumab ozogamicin injection.

Call your doctor at once if you have:

  • sores or white patches in or around your mouth, trouble swallowing or talking, dry mouth, bad breath, altered sense of taste;
  • signs of liver problems--right-sided upper stomach pain, jaundice (yellowing of the skin or eyes), rapid weight gain, swelling in your arms or legs, painful swelling in your midsection;
  • low blood cell counts--fever, flu symptoms, swollen gums, skin sores, cough, trouble breathing, pale skin, unusual tiredness;
  • unusual bleeding--bleeding gums, abnormal vaginal bleeding, blood in your urine or stools, coughing up blood or vomit that looks like coffee grounds; or
  • signs of bleeding in the brain--sudden numbness or weakness (especially on one side of the body), sudden severe headache, problems with speech or vision.

Gemtuzumab ozogamicin can increase your risk of bleeding or liver damage, either of which may be life-threatening. Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • bleeding;
  • fever, infection;
  • mouth sores;
  • nausea, vomiting, constipation;
  • headache; or
  • abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Mylotarg (Gemtuzumab Ozogamicin for Injection)

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Mylotarg Professional Information

SIDE EFFECTS

The following serious adverse reactions associated with MYLOTARG are discussed in detail in other sections of the prescribing information:

  • Hepatotoxicity, including VOD [see WARNINGS AND PRECAUTIONS]
  • Infusion related reactions [see WARNINGS AND PRECAUTIONS]
  • Hemorrhage [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Combination Therapy In Newly-Diagnosed De Novo CD33-positive AML

The safety evaluation of MYLOTARG (3 mg/m² Day 1, 4 and 7 in combination with daunorubicin and cytarabine [DA]) in adults is based on data from ALFA-0701 for 131 patients treated with MYLOTARG plus DA and in 137 patients treated with DA alone [see Clinical Studies]. In this study, 123 patients received all 3 fractionated doses of MYLOTARG and 7 patients missed at least 1 dose, with a mean total dose administered during induction of 14.51 mg (range: 4.6-18.0). MYLOTARG was received by 91 (70%) patients in the MYLOTARG arm during Consolidation 1 and 64 (49%) patients in the MYLOTARG arm during Consolidation 2.

Safety data consisting of selected TEAEs considered most important for understanding the safety profile of MYLOTARG as well as all adverse events (AEs) that led to the permanent discontinuation of treatment were retrospectively collected. The selected TEAEs consisted of all grades hemorrhages, all grades VOD, and severe infections.

Discontinuation due to any adverse reaction occurred in 31% of patients in the MYLOTARG arm versus 7% in the DA arm. The most frequent (greater than or equal to 1%) adverse reactions for patients treated with MYLOTARG that led to permanent discontinuation were thrombocytopenia (15%), VOD (3%), and septic shock (2%).

Fatal adverse reactions occurred in 8 patients (6%) in the MYLOTARG arm versus 3 patients (2%) in the DA arm. In the MYLOTARG arm, 3 patients died of VOD, 4 patients died of hemorrhage-related events (CNS hemorrhage, hemorrhagic shock), and 1 patient died of suspected cardiac cause. In the DA arm, 3 patients died of sepsis.

Table 2: Selected Grade 3 and Higher Adverse Reactions in Patients with Newly-Diagnosed De Novo AML in ALFA-0701

MYLOTARG + Daunorubicin + Cytarabine (n, %)Daunorubicin + Cytarabine (n, %)
InductionN = 131N = 137
Infectiona61 (47%)53 (39%)
Hemorrhageb24 (18%)12 (9%)
Veno-occlusive liver diseasec3 (2%)0
Consolidation 1N = 91N = 103
Infectiona50 (55%)43 (42%)
Hemorrhageb5 (5%)0
Veno-occlusive liver diseasec00
Consolidation 2N = 64N = 107
Infectiona32 (50%)54 (50%)
Hemorrhageb4 (6%)0
Veno-occlusive liver diseasec00
Abbreviations: AML=acute myeloid leukemia; N=number of patients; PT=preferred term.
a Infection is a grouped term consisting of multiple preferred terms.
b Hemorrhage is a grouped term consisting of multiple preferred terms.
c Veno-occlusive liver disease includes the following reported PTs: Veno-occlusive liver disease, venoocclusive disease.

All patients in ALFA-0701 developed severe neutropenia, thrombocytopenia and anemia. The incidence of Grade 3-4 thrombocytopenia that was prolonged in the absence of active leukemia was higher in patients treated with MYLOTARG (Table 3).

Table 3: Prolonged Cytopeniasa in ALFA-0701

MYLOTARG + Daunorubicin + Cytarabine (n/N, %)Daunorubicin + Cytarabine (n/N, %)
Induction
Prolonged thrombocytopenia19/101 (19%)7/97 (7%)
Prolonged neutropenia3/106 (3%)0/101 (0%)
Consolidation 1
Prolonged thrombocytopenia21/87 (24%)6/91 (7%)
Prolonged neutropenia3/88 (3%)1/97 (1%)
Consolidation 2
Prolonged thrombocytopenia22/62 (35%)25/103 (24%)
Prolonged neutropenia1/62 (2%)2/105 (2%)
a Platelets less than 50 Gi/L or neutrophils less than 0.5 Gi/L lasting past cycle Day 42 in the absence of active leukemia.

Table 4 summarizes shifts in selected chemistry abnormalities by treatment arm for patients treated in ALFA0701.

Table 4: ALFA-0701 - Chemistry Laboratory Values: Shifts in Subjects with Baseline Grade 2 or Lower Values

Laboratory AbnormalityMYLOTARG + Daunorubicin + CytarabineDaunorubicin + Cytarabine
Subjects (n) with baseline Grade less than or equal to 2Progressed to Grade greater than or equal to 3 (n, %)Subjects (n) with baseline Grade less than or equal to 2Progressed to Grade greater than or equal to 3 (n, %)
Hypophosphatemia11775 (64%)12752 (41%)
Hypokalemia12773 (57%)13341 (31%)
Hyponatremia12957 (44%)13436 (27%)
Alkaline phosphatase increased12016 (13%)1287 (5%)
Aspartate aminotransferase increased12618 (14%)13211 (8%)
Alanine aminotransferase increased12413 (10%)13220 (15%)
Blood bilirubin increased1199 (8%)1265 (4%)

Monotherapy For Newly-Diagnosed CD33-positive AML

The safety evaluation of MYLOTARG (6 mg/m² then 3 mg/m², with 7 days between the doses) as monotherapy is based on a randomized, open-label, Phase 3 trial of MYLOTARG (N=118) versus best supportive care (BSC) (N=119) in patients with previously untreated AML who were considered ineligible for intensive chemotherapy in Study AML-19 [see Clinical Studies].

The overall incidence of any Grade adverse reactions reported in AML-19 was 87% in the MYLOTARG arm and 90% in the BSC arm. The incidence of Grade greater than or equal to 3 adverse reactions was 61% in the MYLOTARG arm and 68% in the BSC arm. Death due to any Adverse Event was reported in the MYLOTARG arm of 19 (17%) compared to the BSC arm of 23 (20%).

Table 5: Selected Adverse Reactions in AML-19

MYLOTARG
n=111
Best Supportive Care
n=114
Any GradeGrade ≥ 3Any GradeGrade ≥ 3
Liver57 (51%)8 (7%)52 (46%)7 (6%)
Fatigue51 (46%)13 (12%)69 (61%)24 (21%)
Infection49 (44%)39 (35%)48 (42%)39 (34%)
Cardiac31 (28%)7 (6%)37 (33%)16 (14%)
Bleeding28 (25%)14 (13%)34 (30%)14 (12%)
Febrile neutropenia20 (18%)20 (18%)27 (24%)27 (24%)
Metabolic18 (16%)4 (4%)17 (15%)7 (6%)
Renal7 (6%)4 (4%)9 (8%)5 (4%)

Monotherapy For Relapsed Or Refractory CD33-positive AML

The adverse reactions described in this section reflect exposure to MYLOTARG 3 mg/m² on Days 1, 4 and 7 as monotherapy in 57 patients with relapsed AML treated on MyloFrance-1 [see Clinical Studies]. All 57 (100%) patients received the 3 planned doses of MYLOTARG.

During the treatment period, Grade 3 treatment-emergent adverse events (TEAEs) that occurred in greater than 1% patients included sepsis (32%), fever (16%), rash (11%), pneumonia (7%), bleeding (7%), mucositis (4%), pain (4%), diarrhea (2%), headaches (2%), tachycardia (2%), and lung edema (2%). No Grade 4 toxicity was observed. All grade TEAEs that occurred in greater than 15% of patients included fever (79%), infection (42%), increased AST (40%), bleeding (23%), nausea and vomiting (21%), constipation (21%), mucositis (21%), headache (19%), increased ALT (16%), and rash (16%). No infectious deaths occurred. Grade 1 or 2 hyperbilirubinemia developed in 4 (7%) patients. No episodes of VOD occurred. Seven patients received HSCT after MYLOTARG treatment. Three patients received an allogeneic BMT and 4 patients were treated with autologous BMT. No patients developed VOD following HSCT.

Postmarketing Experience

The following adverse drug reactions have been identified during post-approval use of MYLOTARG. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal Disorders: Neutropenic colitis*

Infections and Infestations: fungal lung infections including Pulmonary mycosis and Pneumocystis jirovecii pneumonia*; and bacterial infections including Stenotrophomonas infection

Renal and Urinary Disorders: Hemorrhagic cystitis*

Respiratory, Thoracic and Mediastinal Disorders: Interstitial pneumonia*

* including fatal events

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. Immunogenicity of MYLOTARG was not studied in clinical trials using the recommended dose regimens.

Read the entire FDA prescribing information for Mylotarg (Gemtuzumab Ozogamicin for Injection)

© Mylotarg Patient Information is supplied by Cerner Multum, Inc. and Mylotarg Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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