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Mylotarg

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Mylotarg

Mylotarg Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Mylotarg (gemtuzumab ozogamicin for injection) is a cancer medication used to treat acute myeloid leukemia, a type of blood cancer. It 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 of this medication is discontinued, but generic versions may be available. Common side effects include nausea, vomiting, diarrhea, constipation, headache, dizziness, anxiety, depressed mood, or sleep problems (insomnia).

The recommended dose of Mylotarg is 9 mg/mē, infused over a 2-hour period. Mylotarg may interact with "live" vaccines, or other chemotherapy treatments. Tell your doctor all medications and supplements you use. 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.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Mylotarg in Detail - Patient Information: Side Effects

Some people receiving a gemtuzumab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, or have fever, chills, or trouble breathing within 24 hours after receiving the injection.

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

Call your doctor at once if you have a serious side effect such as:

  • pain in your upper right stomach, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • swelling, rapid weight gain;
  • feeling like you might pass out;
  • pale skin, easy bruising or bleeding (such as nosebleeds), purple or red pinpoint spots under your skin;
  • fever, chills, body aches, unusual weakness, flu symptoms;
  • white patches or sores inside your mouth or on your lips;
  • chest pain or tightness, feeling short of breath;
  • lower back pain, blood in your urine;
  • increased thirst, fruity breath odor, increased urination;
  • urinating less than usual or not at all;
  • numbness or tingly feeling around your mouth;
  • muscle weakness, tightness, or contraction, overactive reflexes;
  • fast or slow heart rate, weak pulse; or
  • confusion, uneven heart rate, leg discomfort, muscle weakness or limp feeling.

Less serious side effects may include:

  • nausea, vomiting;
  • diarrhea or constipation;
  • headache;
  • dizziness, anxiety, depressed mood; or
  • sleep problems (insomnia).

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Mylotarg Overview - Patient Information: Side Effects

SIDE EFFECTS: Consult your pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Mylotarg (Gemtuzumab Ozogamicin for Injection)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Mylotarg FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Mylotarg (gemtuzumab ozogamicin for injection) has been administered to 277 patients with relapsed AML at 9 mg/m² . Mylotarg (gemtuzumab ozogamicin for injection) was generally given as two intravenous infusions separated by 14 days.

Acute Infusion-Related Events (Table 3)

TABLE 3: NUMBER AND PERCENTAGE OF PATIENTS REPORTED TO HAVE ACUTE INFUSION-RELATED ADVERSE EVENTS (N = 277)

Adverse Event Any Severity (%) Grade 3 or 4 (%)
Fever 227 (82) 17 (6)
Nausea 188 (68) 8 (3)
Chills 183 (66) 21 (8)
Vomiting 162 (58) 3 (1)
Headache 102 (37) 2 (< 1)
Dyspnea 73 (26) 4 (1)
Hypotension 55 (20) 12 (4)
Hypertension 43 (16) 5 (2)
Hyperglycemia 29 (10) 3 (1)
Hypoxia 15 (5) 4 (1)

Fever and chills were commonly reported despite prophylactic treatment with acetaminophen and antihistamines (see WARNINGS section). Generally, these symptoms occurred at the end of the 2 hour infusion and resolved after 2 to 4 hours with supportive therapy including acetaminophen, diphenhydramine, and intravenous fluids. These events all occurred on the same day as gemtuzumab ozogamicin infusion. Fewer infusion-related events were observed after the second dose. Methylprednisolone given prior to Mylotarg (gemtuzumab ozogamicin for injection) infusion may ameliorate infusion-related symptoms.

Antibody Formation: Antibodies to gemtuzumab ozogamicin were not detected in any of the 277 patients, including the 20 patients who received more than 1 course of study drug, in the Phase 2 clinical studies. Two patients in a Phase 1 study developed antibody titers against the calicheamicin/calicheamicin-linker portion of gemtuzumab ozogamicin after three doses. One patient experienced transient fever, hypotension and dyspnea; the other patient had no clinical symptoms. No patient developed antibody responses to the hP67.6 antibody portion of Mylotarg (gemtuzumab ozogamicin for injection) .

Myelosuppression: Severe myelosuppression is the major toxicity associated with Mylotarg (gemtuzumab ozogamicin for injection) .

Neutropenia: During the treatment phase, 267/272 (98%) patients experienced Grade 3 or Grade 4 neutropenia. For all patients, the median times to ANC recovery at 500/μL for the CR and CRp patients were 40.0 and 43.0 days, respectively.

Anemia, Thrombocytopenia: During the treatment phase, 143/276 (52%) patients experienced Grade 3 or Grade 4 anemia and 272/276 (99%) patients experienced Grade 3 or Grade 4 thrombocytopenia. A summary of the platelet recovery for responding patients is provided in Table 4.

TABLE 4: MEDIAN TIME TO RECOVERY OF PLATELET COUNTS FOR ALL CR AND CRp PATIENTS (DAYS)

  CR CRp
Platelet levels < 60 years of age ≥ 60 years of age < 60 years of age ≥ 60 years of age
> 25,000/μL 35 38 39 75
50,000/μL 42 40 56 100
75,000/μL 48 42 122 NA
100,000/μL 56 50 NA NA
Abbreviation: NA = Not Available

Infection: During the treatment phase, 84/277 (30%) patients experienced Grade 3 or Grade 4 infections, including opportunistic infections. The most frequent Grade 3 or Grade 4 infection-related treatment-emergent adverse events (TEAEs) were sepsis (17%), pneumonia (8%), shock (4%), infection (3%), stomatitis (2%), and herpes simplex (2%).

Bleeding: During the treatment phase, 36/277 (13%) patients experienced Grade 3 or Grade 4 bleeding. The most common bleeding events for all patients were epistaxis (3%), cerebral hemorrhage (2%), intracranial hemorrhage (1%), melena (1%), petechiae (1%), hematuria (1%), and disseminated intravascular coagulation (1%).

A greater proportion of NR patients (15%) experienced NCI grade 3 or 4 bleeding events compared with OR patients (7%). Among CR patients, 1 grade 3 bleeding event, epistaxis, was experienced. Bleeding events occurred in 1/35 CR patients and 4/36 CRp patients.

Transfusions: During the treatment phase, more transfusions were required in the NR and CRp patients compared with the CRs (Table 5):

TABLE 5: NUMBER OF TRANSFUSIONS BY RESPONSE GROUP

Transfusions All Patients CR CRp NR
  N = 277 N = 35 N = 36 N = 206
Platelet transfusions
Mean (SD) NA 6.8 (7) 23.7 (67) 15.7 (20)
(95% CI)* NA (5.6, 8.0) (12.5, 34.9) (14.3, 17.1)
RBC transfusions
Mean (SD) NA 2.9 (3) 5.4 (4) 8.1 (22)
(95% CI) NA (2.4, 3.4) (4.7, 10.1) (8.0, 8.2)
* calculated - mean ± se where se = sd/sqr(n)

Mucositis: A total of 69/277 (25%) patients were reported to have a TEAE consistent with oral mucositis or stomatitis. During the treatment phase, 9/277 (3%) patients experienced Grade 3 or 4 stomatitis/mucositis after the first dose.

Hepatotoxicity: In clinical studies, 80/274 (29%) patients experienced Grade 3 or Grade 4 hyperbilirubinemia. 26/274 (9%) of patients experienced Grade 3 or Grade 4 abnormalities in levels of ALT, and 49/274 (18%) patients experienced Grade 3 or Grade 4 abnormalities in levels of AST. One patient died with liver failure in the setting of tumor lysis syndrome and multisystem organ failure 22 days after treatment. Another patient died after an episode of persistent jaundice and hepatosplenomegaly 156 days after treatment. Ascites, an event that can be associated with liver damage, was observed in 8 patients. Abnormalities of liver function were often transient and reversible.

VOD: A total of 299 courses of Mylotarg (gemtuzumab ozogamicin for injection) were administered in 277 relapsed patients and 16 episodes of VOD (in 15 patients) were identified (16/299, 5%). The incidence of VOD in patients treated with Mylotarg (gemtuzumab ozogamicin for injection) who had no prior or subsequent HSCT was 1.0%. The risk of developing VOD was 20% for patients with a history of HSCT prior to Mylotarg (gemtuzumab ozogamicin for injection) administration. In patients who received HSCT after Mylotarg (gemtuzumab ozogamicin for injection) administration, the risk of developing VOD was 15%. (See Table 6). In the 15 patients that developed VOD, 9 patients had fatal VOD or ongoing VOD at the time of death:

TABLE 6: INCIDENCE OF VOD REPORTED BY TREATMENT GROUPS

  Number
Courses of
Mylotarg (gemtuzumab ozogamicin for injection)
Number
Episodes
of VOD
Incidence
of VOD
(episodes per courses)
Number
Patients in
Classification
Number
Patients
with VOD
Incidence
of VOD
(in patients)
Mylotarg Total 299 16 5% 277 15 5%
Mylotarg Only 215 2 1% 200 2 1%
HSCT with Mylotarg (total)a 84 14 17% 77 13 17%
HSCT prior to Mylotargb,c 30 6 20% 27 6 22%
HSCT following Mylotargb,c 54 8 15% 52 8 15%
a: 3 patients are included in more than one HSCT category.
b: 2 patients with a pre-trial history of HSCT each received HSCT after Mylotarg (gemtuzumab ozogamicin for injection) .
c: 1 patient received Mylotarg (gemtuzumab ozogamicin for injection) followed by HSCT and then received a second course of Mylotarg (gemtuzumab ozogamicin for injection) . This patient developed VOD after HSCT and again after the second course of Mylotarg (gemtuzumab ozogamicin for injection) .

Skin:Pruritus was reported in 18/277 (6%) patients, while rash occurred in 51/277 (18%) patients. Cutaneous herpes simplex was reported in 59/277 (21%) patients. No patient experienced alopecia.

Early Mortality in Clinical Studies

The overall mortality rate within 28 days of last dose was 16% (44/277). The mortality rate was 14% (17/120) for patients who were < 60 years old, and 17% (27/157) for patients who were ≥ 60 years old.

Retreatment Events: Twenty (20) patients received additional courses of Mylotarg (gemtuzumab ozogamicin for injection) in the studies. One (1) patient received a total of 4 courses of treatment.

Dose Relationship for Adverse Events: Dose-relationship data were generated from a small dose-escalation study. The most common clinical adverse event observed in this study was an infusion-related symptom complex of fever and chills. In general, the severity of fever, but not chills, increased as the dose level increased. Only one dose level of Mylotarg (gemtuzumab ozogamicin for injection) was studied in the Phase 2 clinical trials in relapsed AML.

Treatment-Emergent Adverse Events (TEAE): TEAEs (Grades 1-4) that occurred in ≥ 10% of the patients regardless of causality are listed in Table 7.

TABLE 7: COMMONLY REPORTED ( ≥ 10%) TREATMENT-EMERGENT ADVERSE EVENTS BY AGE GROUP: NUMBER (%) OF PATIENTS

Body System
Adverse Event
Patient Age in Years
Age ≥ 60
(n = 157)
Age < 60
(n = 120)
Any Age
(n = 277)
Any adverse event 157 (100) 119 (99) 276 (100)
Body as a whole
Abdominal pain 41 (26) 47 (39) 88 (32)
Asthenia 56 (36) 44 (37) 100 (36)
Back pain 19 (12) 19 (16) 38 (14)
Chills 101 (64) 82 (68) 183 (66)
Fever 122 (78) 105 (88) 227 (82)
Headache 42 (27) 60 (50) 102 (37)
Infection 16 (10) 10 (8) 26 (9)
Neutropenic fever 30 (19) 18 (15) 48 (17)
Pain 28 (18) 21 (18) 49 (18)
Sepsis 40 (25) 33 (28) 73 (26)
Cardiovascular system
Hemorrhage 14 (9) 16 (13) 30 (11)
Hypertension 27 (17) 16 (13) 43 (16)
Hypotension 28 (18) 27 (23) 55 (20)
Tachycardia 17 (11) 11 (9) 28 (10)
Digestive system
Anorexia 43 (27) 26 (22) 69 (25)
Constipation 36 (23) 27 (23) 63 (23)
Diarrhea 47 (30) 43 (36) 90 (32)
Dyspepsia 13 (8) 15 (13) 28 (10)
Gum hemorrhage 8 (5) 17 (14) 25 (9)
Liver function tests abnormal 31 (20) 35 (29) 66 (24)
Nausea 99 (63) 89 (74) 188 (68)
Stomatitis 34 (22) 35 (29) 69 (25)
Vomiting 83 (53) 79 (66) 162 (58)
Hemic and lymphatic system
Anemia 34 (22) 26 (22) 60 (22)
Ecchymosis 17 (11) 11 (9) 28 (10)
Leukopenia 67 (43) 62 (52) 129 (47)
Petechiae 30 (19) 24 (20) 54 (19)
Thrombocytopenia 77 (49) 62 (52) 139 (50)
Metabolic and nutritional
Alkaline phosphatase increased 15 (10) 6 (5) 21 (8)
Bilirubinemia 18 (11) 15 (13) 33 (12)
Hyperglycemia 17 (11) 12 (10) 29 (10)
Hypocalcemia 15 (10) 14 (12) 29 (10)
Hypokalemia 38 (24) 35 (29) 73 (26)
Hypomagnesemia 4 (3) 12 (10) 16 (6)
Hypophosphatemia 9 (6) 12 (10) 21 (8)
Lactic dehydrogenase increased 28 (18) 17 (14) 45 (16)
Peripheral edema 30 (19) 10 (8) 40 (14)
Musculoskeletal system      
Myalgia 5 (3) 13 (11) 18 (6)
Nervous system      
Anxiety 15 (10) 8 (7) 23 (8)
Depression 15 (10) 9 (8) 24 (9)
Dizziness 15 (10) 18 (15) 33 (12)
Insomnia 17 (11) 16 (13) 33 (12)
Respiratory system
Cough increased 28 (18) 19 (16) 47 (17)
Dyspnea 41 (26) 32 (27) 73 (26)
Epistaxis 37 (24) 41 (34) 78 (28)
Pharyngitis 16 (10) 17 (14) 33 (12)
Pneumonia 20 (13) 15 (13) 35 (13)
Pulmonary physical finding 13 (8) 12 (10) 25 (9)
Rhinitis 11 (7) 12 (10) 23 (8)
Skin and appendages
Herpes simplex 29 (18) 30 (25) 59 (21)
Pruritus 6 (4) 12 (10) 18 (6)
Rash 29 (18) 22 (18) 51 (18)
Urogenital system
Metrorrhagia 1 (2) 6 (10) 7 (3)
Vaginal hemorrhage 3 (5) 9 (15) 12 (4)
Adverse event associated with miscellaneous factors
Local reaction to procedure 27 (17) 33 (28) 60 (22)

TEAEs of NCI grade 3 or 4 severity that occurred in part I of studies with an incidence of ≥ 10% in at least 1 age subgroup, are presented in Table 8.

TABLE 8: NUMBER (%) OF PATIENTS REPORTING NCI GRADE 3 OR 4 TREATMENT-EMERGENT ADVERSE EVENTS DURING PART I BY AGE GROUP: EVENTS WITH INCIDENCE ≥ 10%

Body System
Adverse Event
Patient Age in Years
Age ≥ 60
(n = 157)
Age < 60
(n = 120)
Any Age
(n = 277)
Any adverse event 138 (88) 112 (93) 250 (90)
Body as a whole
Chills 17 (11) 9 (8) 26 (9)
Fever 20 (13) 16 (13) 36 (13)
Sepsis 23 (15) 24 (20) 47 (17)
Digestive system
Liver function tests abnormal 11 (7) 12 (10) 23 (8)
Hemic and lymphatic system
Anemia 19 (12) 19 (16) 38 (14)
Leukopenia 67 (43) 60 (50) 127 (46)
Thrombocytopenia 75 (48) 61 (51) 136 (49)
Respiratory system
Dyspnea 15 (10) 8 (7) 23 (8)
Abbreviation: NCI = National Cancer Institute.

Clinically important laboratory abnormalities with a Grade 3 or 4 severity are listed in Table 9

TABLE 9: NUMBER (%a) OF PATIENTS WITH LABORATORY TEST RESULTS OF GRADE 3 OR 4 SEVERITYb

Efficacy and Safety Studies Grades 3 - 4
Test Age ≥ 60
(n = 157)
Age < 60
(n = 120)
All Patients
(n = 277)
Hematologic
  Hemoglobin 79/157 (50) 64/119 (54) 143/276 (52)
  WBC 149/157 (95) 117/119 (98) 266/276 (96)
  Total neutrophils,absolute 152/155 (98) 115/117 (98) 267/272 (98)
  Lymphocytes 144/155 (93) 111/117 (95) 255/272 (94)
  Platelet count 155/157 (99) 117/119 (98) 272/276 (99)
  Prothrombin time 2/35 (6) 4/34 (12) 6/69 (9)
  Partial thromboplastin time 1/66 (2) 1/61 (2) 2/127 (2)
Non-hematologic
  Glucose (hypo/hyper)  19/155 (12) 13/119 (11) 32/274 (12)
  Creatinine 1/157 ( < 1) 4/119 (3) 5/276 (2)
  Total bilirubin 45/156 (29) 35/118 (30) 80/274 (29)
  AST 25/156 (16) 24/118 (20) 49/274 (18)
  ALT 12/156 (8) 14/118 (12) 26/274 (9)
  Alkaline phosphatase 4/156 (3) 7/118 (6) 11/274 (4)
  Calcium (hypo/hyper) 14/157 (9) 21/119 (18) 35/276 (13)
a: Percentage is based on the number of patients receiving a particular laboratory test during the study as is indicated for each test.
b: Severity as defined by NCI common toxicity scale version 1.

There were considered to be no clinically important differences in TEAEs between patients < 60 years of age and those patients ≥ 60.

There were considered to be no clinically important differences in TEAEs between female and male patients.

Other Clinical Experience

In postmarketing experience and other clinical trials, additional cases of VOD have been reported, some in association with the use of other chemotherapeutic agents, underlying hepatic disease/abnormal liver function, or a history of prior or subsequent HSCT. Renal failure, renal failure secondary to TLS, renal impairment, hypersensitivity reactions (including bradycardia), anaphylaxis, pulmonary events, pulmonary hemorrhage, gastrointestinal hemorrhage, Budd Chiari Syndrome, portal vein thrombosis, and neutropenic sepsis have also been reported in association with the use of Mylotarg. (See WARNINGS section).

Observational Study: A prospective postmarketing registry study is being conducted to assess the safety of Mylotarg (gemtuzumab ozogamicin for injection) under conditions of routine clinical practice. The primary objectives is to estimate the incidence of hepatic veno-occlusive disease (VOD) among patients treated with Mylotarg (gemtuzumab ozogamicin for injection) . In an interim analysis of 225 patients, SAEs are presented according to an “events of special interest” (ESI) classification comprised of hepatic (including VOD), renal, infusion-related, pulmonary, and hypersensitivity events (Table 10).

There were 816 SAEs reported in 197/225 patients (87.6% of all patients). Of the SAEs, 159 were also ESIs reported in 64 (28.4%) patients. The percentage of patients experiencing a serious ESI was 9.8% (hepatic), 6.7% (renal), 8.0% (infusion-related), and 12.9% (pulmonary). Among the 816 SAEs, 225 (27.6%) were fatal events (multiple concurrent fatal events could be reported for a patient) reported in 134 (59.6%) patients. Using the ESI classification, there were 30 fatal ESIs reported in 19 (8.4%) patients.

In this registry, the incidence of VOD based on an independent review is 10.2% (23/225). Among patients with HSCT before or after Mylotarg (gemtuzumab ozogamicin for injection) infusion the incidence of VOD was 14.9% (10/67 patients). For patients without HSCT the VOD incidence was 8.2% (12/146 patients). HSCT status was not reported in 8.3% (19/225) of patients.

TABLE 10: SERIOUS ADVERSE EVENTS REPORTED IN THE MYLOTARG (gemtuzumab ozogamicin for injection) PROSPECTIVE OBSERVATIONAL STUDY (N=225)a

Reported events All events Fatal events
Number events Number patients Percent patients (n=225) Number events Number patients Percent patients (n=225)
TOTAL 816 197 87.6 225 134 59.6
Hepatic 51 22 9.8 6 4 1.8
Renal 21 15 6.7 5 5 2.2
Infusion-related 35 18 8.0 4 1 0.4
Pulmonary 52 29 12.9 15 13 5.8
Hypersensitivity 0 0 - 0 0 -
Other 657 188 83.6 195 130 57.8
aBased on interim data, the denominator represents all patients in the registry, including 11 patients for whom no adverse events were reported at the time of database lock for the interim analysis.

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

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