Data from FDA - Curated by EPG Health - Last updated 09 May 2018

Indication(s)

1 INDICATIONS AND USAGE MYLOTARG is a CD33-directed antibody-drug conjugate indicated for: treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults (1.1). treatment of relapsed or refractory CD33-positive AMLin adults and in pediatric patients 2 years and older (1.2). 1.1 Newly-Diagnosed CD33-positive Acute Myeloid Leukemia (AML) MYLOTARG is indicated for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia in adults. 1.2 Relapsed or Refractory CD33-positive AML MYLOTARG is indicated for the treatment of relapsed or refractory CD33-positive acute myeloid leukemia in adults and in pediatric patients 2 years and older.

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Advisory information

contraindications
4. CONTRAINDICATIONS MYLOTARG is contraindicated in patients with a history of hypersensitivity to the active substance in MYLOTARG or any of its components or to any of the excipients. Reactions have included anaphylaxis [see Warnings and Precautions (5.2) and Adverse Reactions (6)]. Hypersensitivity to MYLOTARG or any of its components (4).
Adverse reactions
6 ADVERSE REACTIONS 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 (5.1)] Infusion related reactions [see Warnings and Precautions (5.2)] Hemorrhage [see Warnings and Precautions (5.3)] The most common adverse reactions (greater than 15%) were hemorrhage, infection, fever, nausea, vomiting, constipation, headache, increased AST, increased ALT, rash, and mucositis (6). To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 (14.1)]. 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, %) Abbreviations: AML=acute myeloid leukemia; N=number of patients; PT=preferred term. Induction N = 131 N = 137 InfectionInfection is a grouped term consisting of multiple preferred terms. 61 (47%) 53 (39%) HemorrhageHemorrhage is a grouped term consisting of multiple preferred terms. 24 (18%) 12 (9%) Veno-occlusive liver diseaseVeno-occlusive liver disease includes the following reported PTs: Veno-occlusive liver disease, veno-occlusive disease. 3 (2%) 0 Consolidation 1 N = 91 N = 103 Infection 50 (55%) 43 (42%) Hemorrhage 5 (5%) 0 Veno-occlusive liver disease 0 0 Consolidation 2 N = 64 N = 107 Infection 32 (50%) 54 (50%) Hemorrhage 4 (6%) 0 Veno-occlusive liver disease 0 0 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 CytopeniasPlatelets less than 50 Gi/L or neutrophils less than 0.5 Gi/L lasting past cycle Day 42 in the absence of active leukemia. in ALFA-0701 MYLOTARG + Daunorubicin + Cytarabine (n/N, %) Daunorubicin + Cytarabine (n/N, %) Induction Prolonged thrombocytopenia 19/101 (19%) 7/97 (7%) Prolonged neutropenia 3/106 (3%) 0/101 (0%) Consolidation 1 Prolonged thrombocytopenia 21/87 (24%) 6/91 (7%) Prolonged neutropenia 3/88 (3%) 1/97 (1%) Consolidation 2 Prolonged thrombocytopenia 22/62 (35%) 25/103 (24%) Prolonged neutropenia 1/62 (2%) 2/105 (2%) Table 4 summarizes shifts in selected chemistry abnormalities by treatment arm for patients treated in ALFA-0701. Table 4. ALFA-0701 – Chemistry Laboratory Values: Shifts in Subjects with Baseline Grade 2 or Lower Values MYLOTARG + Daunorubicin + Cytarabine Daunorubicin + Cytarabine Laboratory Abnormality Subjects (n) with baseline Grade less than or equal to 2 Progressed to Grade greater than or equal to 3 (n, %) Subjects (n) with baseline Grade less than or equal to 2 Progressed to Grade greater than or equal to 3 (n, %) Hypophosphatemia 117 75 (64%) 127 52 (41%) Hypokalemia 127 73 (57%) 133 41 (31%) Hyponatremia 129 57 (44%) 134 36 (27%) Alkaline phosphatase increased 120 16 (13%) 128 7 (5%) Aspartate aminotransferase increased 126 18 (14%) 132 11 (8%) Alanine aminotransferase increased 124 13 (10%) 132 20 (15%) Blood bilirubin increased 119 9 (8%) 126 5 (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 (14.1)]. 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 Grade Grade ≥ 3 Any Grade Grade ≥ 3 Liver 57 (51%) 8 (7%) 52 (46%) 7 (6%) Fatigue 51 (46%) 13 (12%) 69 (61%) 24 (21%) Infection 49 (44%) 39 (35%) 48 (42%) 39 (34%) Cardiac 31 (28%) 7 (6%) 37 (33%) 16 (14%) Bleeding 28 (25%) 14 (13%) 34 (30%) 14 (12%) Febrile neutropenia 20 (18%) 20 (18%) 27 (24%) 27 (24%) Metabolic 18 (16%) 4 (4%) 17 (15%) 7 (6%) Renal 7 (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 (14.1)]. 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. 6.2 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 colitisincluding fatal events Infections and Infestations: fungal lung infections including Pulmonary mycosis and Pneumocystis jirovecii pneumonia; and bacterial infections including Stenotrophomonas infection Renal and Urinary Disorders: Hemorrhagic cystitis1 Respiratory, Thoracic and Mediastinal Disorders: Interstitial pneumonia1 6.3 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.

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION Newly-diagnosed, de novo AML (combination regimen): – Induction: 3 mg/m2 (up to one 4.5 mg vial) on Days 1, 4, and 7 in combination with daunorubicin and cytarabine (2.2). – Consolidation: 3 mg/m2 on Day 1 (up to one 4.5 mg vial) in combination with daunorubicin and cytarabine. (2.2). Newly-diagnosed AML (single-agent regimen): – Induction: 6 mg/m2 (not limited to one 4.5 mg vial) on Day 1 and 3 mg/m2 (not limited to one 4.5 mg vial) on Day 8 (2.2). – Continuation: For patients without evidence of disease progression following induction, up to 8 continuation courses of MYLOTARG 2 mg/m2 (not limited to one 4.5 mg vial) on Day 1 every 4 weeks (2.2). Relapsed or refractory AML(single-agent regimen): –3 mg/m2 (up to one 4.5 mg vial) on Days 1, 4, and 7 (2.2). Premedicate with a corticosteroid, antihistamine, and acetaminophen 1 hour prior to MYLOTARG (2.1). 2.1 Premedication and Special Considerations Premedicate adults with acetaminophen 650 mg orally and diphenhydramine 50 mg orally or intravenously 1 hour prior to MYLOTARG dosing and 1 mg/kg methylprednisolone or an equivalent dose of an alternative corticosteroid within 30 minutes prior to infusion of MYLOTARG. Premedicate children with acetaminophen 15 mg/kg (maximum of 650 mg), diphenhydramine 1 mg/kg (maximum of 50 mg), and 1 mg/kg methylprednisolone orally or intravenously; additional doses of acetaminophen and diphenhydramine may be administered every 4 hours after the initial pretreatment dose. Repeat with the same dose of methylprednisolone or an equivalent corticosteroid for any sign of an infusion reaction, such as fever, chills, hypotension, or dyspnea during the infusion or within 4 hours afterwards [see Warnings and Precautions (5.2)]. Use appropriate measures to prevent tumor lysis syndrome. For patients with hyperleukocytosis (leukocyte count greater than or equal to 30 Gi/L), cytoreduction is recommended prior to administration of MYLOTARG. 2.2 Recommended Dosage Newly-Diagnosed De Novo CD33-positive AML (combination regimen) A treatment course including MYLOTARG in combination therapy for adults with newly-diagnosed de novo CD33-positive AML consists of 1 induction cycle and 2 consolidation cycles [see Clinical Studies (14.1)]. For the induction cycle, the recommended dose of MYLOTARG is 3 mg/m2 (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 MYLOTARG during the second induction cycle. For the consolidation cycles, the recommended dose of MYLOTARG is 3 mg/m2 on Day 1 (up to one 4.5 mg vial) in combination with daunorubicin and cytarabine. Newly-Diagnosed CD33-positive AML (single-agent regimen) A treatment course of MYLOTARG as a single agent for adults with newly-diagnosed CD33-positive AML consists of 1 cycle of induction and up to 8 cycles of continuation therapy [see Clinical Studies (14.1)]. For the induction cycle, the recommended dose of MYLOTARG is 6 mg/m2 (not limited to one 4.5 mg vial) as a single agent on Day 1, and 3 mg/m2 (not limited to one 4.5 mg vial) on Day 8. For continuation, the recommended dose of MYLOTARG is 2 mg/m2 (not limited to one 4.5 mg vial) as a single agent on Day 1 every 4 weeks. Relapsed or Refractory CD33-positive AML (single-agent regimen) The recommended dose of MYLOTARG as a single agent for treatment of relapsed or refractory CD33-positive AML is 3 mg/m2 (up to one 4.5 mg vial) on Days 1, 4, and 7. Treatment in the relapsed or refractory setting consists of a single course of MYLOTARG [see Clinical Studies (14.1)]. 2.3 Dosage Modifications for Toxicities Monitor blood counts frequently through resolution of cytopenias. Monitor blood counts and chemistries at least three times per week through recovery from treatment-related toxicities. Management of some adverse reactions [see Warnings and Precautions (5) and Adverse Reactions (6)] may require dose interruptions or permanent discontinuation of MYLOTARG Table 1 shows the dose modification guidelines for hematologic and nonhematologic toxicities. Table 1. Dosage Modifications for Hematologic and Nonhematologic Toxicities Hematologic and Nonhematologic Toxicities Recommended Action Abbreviations: ALT=alanine aminotransferase; AST=aspartate aminotransferase; VOD=veno-occlusive disease; ULN=upper limit of normal. For patients receiving MYLOTARG in combination therapy Persistent thrombocytopenia If platelet count does not recover to greater than or equal to 100 Gi/L within 14 days following the planned start date of the consolidation cycle (14 days after hematologic recovery following previous cycle), discontinue MYLOTARG (do not administer MYLOTARG in the consolidation cycles). Persistent neutropenia If neutrophil count does not recover to greater than 0.5 Gi/L within 14 days following the planned start date of the consolidation cycle (14 days after hematologic recovery following previous cycle), discontinue MYLOTARG (do not administer MYLOTARG in the consolidation cycles). For all patients receiving MYLOTARG (Monotherapy or in Combination) VOD Discontinue MYLOTARG [see Warnings and Precautions (5.1)]. Total bilirubin greater than 2 × ULN, or AST and/or ALT greater than 2.5 × ULN Delay treatment with MYLOTARG until recovery of total bilirubin to less than or equal to 2 × ULN and AST and ALT to less than or equal to 2.5 × ULN prior to each dose. Omit scheduled dose if delayed more than 2 days between sequential infusions. Infusion-related reactions Interrupt the infusion and institute appropriate medical management. Administer acetaminophen, diphenhydramine and/or methylprednisolone, if needed (see Section 2.1) Provide supportive care measures as needed. For mild, moderate or severe infusion related reactions, once symptoms resolve, consider resuming the infusion at no more than half the rate at which the reaction occurred. Repeat the procedure above in the event of recurrence of symptoms. Permanently discontinue MYLOTARG upon occurrence of a severe infusion reaction or for any life-threatening infusion reaction [see Warnings and Precautions (5.2)]. Other severe or life-threatening non-hematologic toxicities Delay treatment with MYLOTARG until recovery to a severity of no more than mild. Omit scheduled dose if delayed more than 2 days between sequential infusions. 2.4 Instructions for Reconstitution, Dilution, and Administration Use appropriate aseptic technique for the reconstitution and dilution procedures. Protect the reconstituted and diluted MYLOTARG solution from light. Reconstitution MYLOTARG is a cytotoxic drug. Follow applicable special handling and disposal procedures.1 Calculate the dose (mg) and number of vials of MYLOTARG required. Prior to reconstitution, allow drug product vials to reach ambient temperature for approximately 5 minutes. Reconstitute each vial with 5 mL of Sterile Water for Injection, USP to obtain a concentration of 1 mg/mL of MYLOTARG that delivers 4.5 mL (4.5 mg). Gently swirl the vial to aid dissolution. DO NOT SHAKE. Inspect the reconstituted solution for particulates and discoloration. The reconstituted solution may contain small white to off-white, opaque to translucent, and amorphous to fiber-like particles. MYLOTARG contains no bacteriostatic preservatives. Use reconstituted solution immediately or after being refrigerated at 2–8°C (36–46°F) for up to 1 hour. PROTECT FROM LIGHT. DO NOT FREEZE. Dilution Calculate the required volume of the reconstituted solution needed to obtain the appropriate dose according to patient body surface area. Withdraw this amount from the vial(s) using a syringe. PROTECT FROM LIGHT. Discard any unused reconstituted solution left in the vial. Doses must be mixed to a concentration between 0.075 mg/mL to 0.234 mg/mL according to the following instructions: Doses less than 3.9 mg must be prepared for administration by syringe. Add the reconstituted MYLOTARG solution to a syringe with 0.9% Sodium Chloride Injection to a final concentration between 0.075 mg/mL to 0.234 mg/mL. PROTECT FROM LIGHT. Doses greater than or equal to 3.9 mg are to be diluted in a syringe or an IV bag in an appropriate volume of 0.9% Sodium Chloride Injection to ensure a final concentration between 0.075 mg/mL to 0.234 mg/mL. PROTECT FROM LIGHT. Gently invert the infusion container to mix the diluted solution. DO NOT SHAKE. Following dilution with 0.9% Sodium Chloride Injection, MYLOTARG solution should be infused immediately. If not used immediately, store at room temperature (15–25°C; 59–77°F) for up to 6 hours, which includes the 2-hour infusion time and 1-hour, if needed, to allow the refrigerated diluted solution to equilibrate to room temperature. The diluted solution can be refrigerated at 2–8°C (36–46°F) for up to 12 hours which includes up to 1-hour in the vial post-reconstitution. PROTECT FROM LIGHT and DO NOT FREEZE. Administration Use an in-line 0.2 micron polyethersulfone (PES) filter for infusion of MYLOTARG. Protect the intravenous bag from light using a light-blocking cover during infusion. The infusion line does not need to be protected from light. Infuse the diluted solution over 2 hours. Do not mix MYLOTARG with, or administer as an infusion with, other medicinal products.
Use in special populations
8 USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed (8.2). 8.1 Pregnancy Risk Summary Based on its mechanism of action and findings from animal studies [see Clinical Pharmacology (12.1) and Nonclinical Toxicology (13.1)], MYLOTARG can cause embryo-fetal harm when administered to a pregnant woman. There are no available data on MYLOTARG 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 embryo-fetal toxicity at maternal systemic exposures that were greater than or equal to 0.4 times the exposure in patients at the maximum recommended dose, based on AUC (see Data). If MYLOTARG is used during pregnancy, or if the patient becomes pregnant while taking MYLOTARG, advise the patient of the potential risk to a fetus. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. Data Animal Data In an embryo-fetal development study in rats, pregnant animals received daily intravenous doses up to 1.2 mg/m2/day gemtuzumab ozogamicin during the period of organogenesis. Embryo-fetal toxicities including fetal growth retardation as evidenced by decreased live fetal weights, incidence of fetal wavy ribs and delayed skeletal ossification were observed at greater than or equal to 0.15 mg/m2/day. Increased embryo-fetal lethality and fetal morphological anomalies (digital malformations, absence of the aortic arch, anomalies in the long bones in the forelimbs, misshapen scapula, absence of a vertebral centrum, and fused sternebrae) were observed at greater than or equal to 0.36 mg/m2/day. All doses with embryo-fetal effects were observed in the presence of maternal toxicity that included decreases in gestational body weight gain, food consumption, and gravid uterine weight. The lowest dose at which embryo-fetal effects were observed in rats (0.15 mg/m2/day) was 0.4 times the exposure in patients at the maximum recommended human dose, based on AUC. 8.2 Lactation Risk Summary There are 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. Because of the potential for adverse reactions in breastfed infants, women should not breastfeed during treatment with MYLOTARG and for at least 1 month after the final dose. 8.3 Females and Males of Reproductive Potential Pregnancy Testing Based on animal studies, MYLOTARG can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) and Nonclinical Toxicology (13.1)]. Verify the pregnancy status of females of reproductive potential prior to initiating MYLOTARG. Contraception Females Advise females of reproductive potential to avoid becoming pregnant while receiving MYLOTARG. Advise females of reproductive potential to use effective contraception during treatment with MYLOTARG and for at least 6 months after the last dose [see Nonclinical Toxicology (13.1)]. Males Advise males with female partners of reproductive potential to use effective contraception during treatment with MYLOTARG and for at least 3 months after the last dose [see Nonclinical Toxicology (13.1)]. Infertility Females Based on findings in animals, MYLOTARG may impair fertility in females of reproductive potential [see Nonclinical Toxicology (13.1)]. Males Based on findings in animals, MYLOTARG may impair fertility in males of reproductive potential [see Nonclinical Toxicology (13.1)]. 8.4 Pediatric Use The safety and efficacy of MYLOTARG in combination with daunorubicin and cytarabine have not been established in the pediatric patients with newly-diagnosed de novo AML. The safety and efficacy of MYLOTARG as a single agent in the pediatric patients with relapsed or refractory AML is supported by a single-arm trial in 29 patients in the following age groups: 1 patient 1 month to less than 2 years old, 13 patients 2 years to less than 12 years old, and 15 patients 12 years to 18 years old. A literature review included an additional 96 patients with ages ranging from 0.2 to 21 years. No differences in efficacy and safety were observed by age. 8.5 Geriatric Use Use of MYLOTARG in combination with daunorubicin and cytarabine in newly-diagnosed adult patients with de novo AML is supported by a randomized, controlled trial that included 50 patients greater than or equal to 65 years old. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Use of MYLOTARG monotherapy in newly-diagnosed adult patients with AML is supported by a randomized controlled trial with 118 patients treated with MYLOTARG. All patients were over the age of 60 years and 65% of patients were above 75 years. No overall differences in effectiveness were observed by age. Use of MYLOTARG as single-agent treatment of relapsed or refractory AML is supported by a single-arm trial that included 27 patients 65 years or older. No overall differences in effectiveness were observed between these patients and younger patients. Elderly patients experienced a higher rate of fever and severe or greater infections.

More information

Category Value
Authorisation number BLA761060
Agency product number 8GZG754X6M
Orphan designation No
Product NDC 0008-4510
Date Last Revised 13-04-2018
Type HUMAN PRESCRIPTION DRUG
Storage and handling 16.1 Storage and Handling Refrigerate (2–8°C; 36–46°F) MYLOTARG vials and store in the original carton to protect from light. DO NOT FREEZE. MYLOTARG is a cytotoxic drug. Follow applicable special handling and disposal procedures.1
Marketing authorisation holder Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.
Warnings WARNING: HEPATOTOXICITY Hepatotoxicity, including severe or fatal hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), has been reported in association with the use of MYLOTARG as a single agent, and as part of a combination chemotherapy regimen. Monitor frequently for signs and symptoms of VOD after treatment with MYLOTARG. (5.1 and 6.1) WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. Hepatotoxicity, including severe or fatal hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), has been reported in association with the use of MYLOTARG. (5.1, 6.1)