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Mylotarg is a brand name for Gemtuzumab Ozogamicin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: MYLOTARG is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients aged 15 years and above with previously untreated, de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL) (see sections 4.4 and 5.1).
Verbatim from this product's EMA label. Tap a section to expand.
MYLOTARG should be administered under the supervision of a physician experienced in the use of anticancer medicinal products and in an environment where full resuscitation facilities are immediately available. MYLOTARG should be used only in patients eligible to receive intensive induction chemotherapy.
4). 4). 3 Posology Induction The recommended dose of MYLOTARG is 3 mg/m2/dose (up to a maximum of one 5 mg vial) infused over a 2-hour period on Days 1, 4, and 7 in combination with DNR 60 mg/m2/day infused over 30 minutes on Day 1 to Day 3, and AraC 200 mg/m2/day by continuous infusion on Day 1 to Day 7.
If a second induction is required, MYLOTARG should not be administered during second induction therapy. Only DNR and AraC should be administered during the second induction cycle, at the following recommended dosing: DNR 35 mg/m2/day on Days 1 and 2, and AraC 1 g/m2 every 12 hours, on Day 1 to Day 3.
0 × 109 cells/L with a platelet count of 100 × 109/L or more in the peripheral blood in the absence of transfusion, up to 2 consolidation courses of intravenous DNR (60 mg/m2 for 1 day [first course] or 2 days [second course]) in combination with intravenous AraC (1 g/m2 per 12 hours, infused over 2 hours on Day 1 to Day 4) with intravenous MYLOTARG (3 mg/m2/dose infused over 2 hours up to a maximum dose of one 5 mg vial on Day 1) are recommended.
Table 1. Dosing regimens for MYLOTARG in combination with chemotherapy Treatment course MYLOTARG daunorubicin cytarabine Inductiona 3 mg/m2/dose (up to a maximum of one 5 mg vial) on Days 1, 4, and 7 60 mg/m2/day on Day 1 to Day 3 200 mg/m2/day on Day 1 to Day 7 Second induction (if required) MYLOTARG should not be administered during second induction.
35 mg/m2/day on Day 1 to Day 2 1 g/m2/every 12 hours on Day 1 to Day 3 Consolidation Course 1a,b 3 mg/m2/dose (up to a maximum of one 5 mg vial) on Day 1 60 mg/m2/day on Day 1 1 g/m2/every 12 hours on Day 1 to Day 4 Consolidation Course 2a,b 3 mg/m2/dose (up to a maximum of one 5 mg vial) on Day 1 60 mg/m2/day on Day 1 to Day 2 1 g/m2/every 12 hours on Day 1 to Day 4 a.
See Table 3 and Table 4 for dose modification information. b. For patients experiencing a complete remission (CR) following induction. Dose and schedule modifications Schedule modification for hyperleukocytosis In patients with hyperleukocytic (leukocyte count ≥ 30 000/mm3) AML, cytoreduction is recommended either with leukapheresis, oral hydroxyurea or AraC with or without hydroxyurea to reduce the peripheral white blood cell (WBC) count 48 hours prior to administration of MYLOTARG.
Summary of the safety profile The overall safety profile of MYLOTARG is based on data from patients with acute myeloid leukaemia from the combination therapy study ALFA-0701, monotherapy studies, and from post-marketing experience.
In the combination therapy study, safety data consisting of selected treatment emergent adverse events (TEAEs) considered most important for understanding the safety profile of MYLOTARG consisted of all grades haemorrhages, all grades VOD, and severe infections.
All of these TEAEs were determined to be adverse drug reactions. Because of this limited data collection, laboratory data from the combination therapy study are included in Table
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 8). 8). Due to the risk of VOD/SOS, signs and symptoms of VOD/SOS should be closely monitored; these may include elevations in ALT, AST, total bilirubin, and alkaline phosphatase, which should be monitored prior to each dose of MYLOTARG, hepatomegaly (which may be painful), rapid weight gain, and ascites.
Monitoring only total bilirubin may not identify all patients at risk of VOD/SOS. For patients who develop abnormal liver tests, more frequent monitoring of liver tests and clinical signs and symptoms of hepatotoxicity is recommended.
For patients who proceed to HSCT, close monitoring of liver tests is recommended during the post-HSCT period, as appropriate. No definitive relationship was found between VOD and time of HSCT relative to higher MYLOTARG monotherapy doses, however, the ALFA-0701 study recommended an interval of 2 months between the last dose of MYLOTARG and HSCT.
2). In patients who experience VOD/SOS, MYLOTARG should be discontinued and patients treated according to standard medical practice. 8). There have been reports of fatal infusion reactions in the post-marketing setting. Signs and symptoms of infusion related reactions may include fever and chills, and less frequently hypotension, tachycardia, and respiratory symptoms that may occur during the first 24 hours after administration.
Infusion of MYLOTARG should be performed under close clinical monitoring, including pulse, blood pressure, and temperature. 2). Infusion should be interrupted immediately for patients who develop evidence of severe reactions, especially dyspnoea, bronchospasm, or clinically significant hypotension.
Patients should be monitored until signs and symptoms completely resolve. 2). 8). Complications associated with neutropenia and thrombocytopenia may include infections and bleeding/haemorrhagic reactions respectively. Infections and bleeding/haemorrhagic reactions were reported, some of which were life-threatening or fatal.
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4 If AraC is used for leukoreduction with or without hydroxyurea in patients with previously untreated, de novo hyperleukocytic AML receiving MYLOTARG in combination therapy, apply the following modified schedule (Table 2): Table 2.
Schedule modification for the treatment of hyperleukocytosis with cytarabine Treatment course MYLOTARG daunorubicin cytarabine hydroxyurea Inductiona 3 mg/m2/dose (up to a maximum of one 5 mg vial) on Days 3, 6, and 9 60 mg/m2/day on Day 3 to Day 5 200 mg/m2/day on Day 1 to Day 7 Day 1 (as per standard medical practice) See Table 1 for dose recommendations for consolidation course.
a. See Table 3 and Table 4 for additional dose modification information. 4). 8). Tables 3 and 4 show the dose modification guidelines for haematological and non-haematological toxicities, respectively. Table 3. Dose modifications for haematological toxicities Haematological toxicities Dose modifications Persistent thrombocytopenia (Platelets < 100 000/mm3 at the planned start date of the consolidation course) • Postpone start of consolidation course.
• If platelet count recovers to ≥ 100 000/mm3 within 14 days following the planned start date of the consolidation course: initiate consolidation therapy (see as described in Table 1). • If platelet count recovers to < 100 000/mm3 and ≥ 50 000/mm3 within 14 days following the planned start date of the consolidation course: MYLOTARG should not be re-introduced and consolidation therapy should consist of DNR and AraC only.
• If platelet count recovery remains < 50 000/mm3 for greater than 14 days consolidation therapy should be re-evaluated and a BMA should be performed to re-assess the patients’ status. Persistent neutropenia • If neutrophil count does not recover to greater than 500/mm3 within 14 days following the planned start date of the consolidation cycle (14 days after haematologic recovery following previous cycle), discontinue MYLOTARG (do not administer MYLOTARG in the consolidation cycles).
Abbreviations:
AML=acute myeloid leukaemia; AraC=cytarabine; BMA=bone marrow aspirate, DNR=daunorubicin. 5 Table 4. 4). 5 × ULN prior to each dose. Consider omitting scheduled dose if delayed more than 2 days between sequential infusions. […]
7 Complete blood counts should be monitored prior to each dose of MYLOTARG. During treatment, patients should be monitored for signs and symptoms of infection, bleeding/haemorrhage, or other effects of myelosuppression. Routine clinical and laboratory surveillance testing during and after treatment is indicated.
2). 8). Fatal reports of TLS complicated by acute renal failure have been reported in the post-marketing setting. 2). Patients should be monitored for signs and symptoms of TLS and treated according to standard medical practice. , rasburicase) must be taken.
1). 1). 6). Excipients This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’. 2 and […]