Gemtuzumab ozogamicin parenteral
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Parenteral formulations of gemtuzumab ozogamicin.
Leukaemia - acute myeloid
Combination therapy with daunorubicin and cytarabine in patients aged 15 years or above with previously untreated, de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL).
Due to the complexity and specialist nature of dosage regimens for the treatment of malignant disease, specific dosing information for neoplastic disease is not included.
Doses may vary significantly if this agent is used as monotherapy or different combinations.
When using this agent, specialist literature, national guidelines, cancer network protocols and Trust chemotherapy protocols should be consulted.
Additional Dosage Information
Dose modifications for haematological toxicities
Persistent thrombocytopenia (platelet count below 100,000 per mm cubed at the planned start of the consolidation course): Postpone the planned start of the consolidation course.
If platelet count recovers to greater than or equal to 100,000 per mm cubed within 14 days: Initiate consolidation therapy.
If platelet count recovers to between 50,000 per mm cubed and 100,000 per mm cubed within 14 days: Discontinue gemtuzumab ozogamicin and initiate daunorubicin and cytarabine consolidation therapy only.
If platelet count remains below 50,000 per mm cubed for more than 14 days: Re-evaluate consolidation therapy and perform bone marrow aspirate to re-assess the status of the patient.
Persistent neutropenia (Neutrophil count below 500 per mm cubed at the planned start of the consolidation course): Postpone the planned start of consolidation course.
If neutrophil count recovers to greater than or equal to 500,000 per mm cubed within 14 days: Initiate consolidation therapy.
If neutrophil count remains below 500 per mm cubed for more than 14 days: Discontinue gemtuzumab ozogamicin.
Dose modifications for non-haematological toxicities
Venoocclusive disease (VOD)/sinusoidal obstruction syndrome (SOS):Discontinue gemtuzumab ozogamicin.
Total bilirubin greater than 2 times ULN (upper limit of normal), with AST/ALT greater than 2.5 times ULN:Interrupt gemtuzumab ozogamicin until total bilirubin recovers to less than or equal to 2 times ULN, with AST/ALT less than or equal to 2.5 times ULN, prior to each dose. Consider omitting scheduled dose if delayed more than 2 days between sequential infusions.
Infusion related reactions:Interrupt infusion of gemtuzumab ozogamicin and appropriately manage symptoms based on severity. Monitor patient until symptoms completely resolve, and then resume infusion. Consider permanent discontinuation for severe or life-threatening infusion reactions.
Severe or life-threatening non-haematological toxicities: Interrupt gemtuzumab ozogamicin until symptoms recover to a mild classification at least. Consider omitting scheduled dose if delayed more than 2 days between sequential infusions.
For intravenous infusion over a 2 hour period only.
Children under 15 years
Elevated serum transaminases - greater than 2.5 times upper limit of normal
Serum bilirubin above 2 times upper limit of normal
Precautions and Warnings
History of progenitor cell transplantation
Moderate hepatic impairment
Advise ability to drive/operate machinery may be affected by side effects
Consider premedication with antihistamine and/or corticosteroid
Give pre-treatment counselling and consideration of oocyte cryopreservation
Give pre-treatment counselling and consideration of sperm cryopreservation
Maintain adequate hydration of patient prior / during treatment
Premedicate with a hypouricaemic agent
Premedication with antipyretic recommended
Treatment to be initiated and supervised by a specialist
Consult local policy on the safe use of anti-cancer drugs
Interrupt treatment if infusion reaction occurs & monitor until resolution
Record name and batch number of administered product
Staff: Not to be handled by pregnant staff
Consider leucoreduction if leucocytes above 30 x 10 to the power 9/L
Monitor liver function tests at baseline and before each dose
Monitor complete blood counts before each dose
Monitor for signs and symptoms of veno occlusive disease
Monitor patient for infusion-associated reactions (IARs)
Monitor patients for signs of tumour lysis syndrome
Monitor pulse, blood pressure and temperature regularly
Consider discontinuing treatment if hepatotoxicity occurs
Consider suspending/reducing dose if AST/ALT greater than 2.5 x ULN
If veno-occlusive disorder occurs, discontinue and do not restart therapy
Consider discontinuing if severe infusion reactions occur
Discontinue permanently if life threatening infusion reactions occur
Interrupt therapy if platelet count less than 100 x 10 to the power of 9/L
Interrupt therapy if severe non-haematological reaction occurs
Suspend treatment if total bilirubin greater than 2 x ULN
Female: Contraception required during and for 7 months after treatment
Male & female: Two methods of contraception required (including barrier)
Male: Contraception required during and for 4 months after treatment
Breastfeeding: Do not breastfeed during & for 1 month after treatment
Adult patients who have previously received gemtuzumab ozogamicin as monotherapy, either before or after a haematopoietic stem cell transplant, are at an increased risk of developing veno-occlusive disease.
Cytogenetic testing results, when available, should be considered when evaluating the potential benefit of continuing treatment versus the risk to the patient.
Patients with severe infection, haemorrhage, or other effects of myelosuppression, including severe neutropenia or persistent thrombocytopenia, may require a dose delay or discontinuation of gemtuzumab ozogamicin.
Appropriate measures to prevent the development of tumour lysis-related hyperuricaemia, such as hydration, administration of antihyperuricemics or other agents for treatment of hyperuricaemia must be taken.
Pregnancy and Lactation
Gemtuzumab ozogamicin is contraindicated in pregnancy.
Use of gemtuzumab ozogamicin during pregnancy is contraindicated by the manufacturer. Animal studies have shown teratogenic effects. Human data is limited and as such a potential risk cannot be ruled out.
Gemtuzumab ozogamicin is contraindicated in breastfeeding.
Use of gemtuzumab ozogamicin during breastfeeding and for at least 1 month after is contraindicated by the manufacturer. The presence of gemtuzumab ozogamicin in human breast milk and the effect on exposed infants are unknown.
Abnormal liver function
Alanine aminotransferase increased
Aspartate aminotransferase increased
Gamma glutamyl transferase (GGT) increased
Hepatic veno-occlusive disease
Increase in alkaline phosphatase
Increase in lactate dehydrogenase
Increase in serum transaminases
Infusion related reaction
Prothrombin time increased
Reduced neutrophil count
Serum bilirubin increased
Tumour lysis syndrome
White blood cell count decreased
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: October 2019
Summary of Product Characteristics: Mylotarg 5mg powder for concentrate for solution for infusion. Pfizer limited. Revised December 2018.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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