Description

Simple

A medication used to treat acute myeloid leukemia, a type of blood cancer.

Clinical

A monoclonal anti-CD33 antibody used to treat CD33-positive acute myeloid leukemia.

Overview

Gemtuzumab ozogamicin is a recombinant humanized IgG4 kappa antibody which is conjugated with calicheamicin derivative, a cytotoxic antitumor antibiotic isolated from fermentation of Micromonospora echinospora ssp. calichensis. Gemtuzumab ozogamicin has approximately 50% of the antibody loaded with 4-6 moles calicheamicin per mole of antibody [FDA Label]. The antibody is specifically directed against the CD33 antigen present on leukemic myeloblasts in most patients with acute myeloid leukemia (AML). By binding to the CD33 antigen on tumors, the cytotoxic agent blocks the growth of cancerous cells and causes cell death.

Marketing approval of gemtuzumab ozogamicin was granted on May 17, 2000 by FDA as a treatment for patients with CD33-positive AML in first relapse who are 60 years of age or older and who are not considered candidates for cytotoxic chemotherapy [1]. However, it was voluntarily withdrawn from the market in 2010 due to safety concerns, increased patient deaths and insufficient evidence of clinical benefit during confirmatory trials [5]. On... Read more

Pharmacology

Indication

Indicated for the treatment of patients with CD33 positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for other cytotoxic chemotherapy. Indicated for the treatment of patients aged 2 years and older with CD33-positive AML who have e... Read more

Pharmacodynamic

Used for the treatment of acute myeloid leukemia (AML), mylotarg binds to the CD33 antigen, which is expressed on the surface of leukemic cells in more than 80% of patients with AML. The CD33 antigen is not expressed on pluripotent hematopoietic stem cells or nonhematopoietic cells. This gives mylot... Read more

Mechanism of action

Mylotarg is directed against the CD33 antigen expressed by hematopoietic cells. Binding of the anti-CD33 antibody portion of Mylotarg with the CD33 antigen results in the formation of a complex that is internalized. Upon internalization, the calicheamicin derivative is released inside the lysosomes... Read more

Absorption

In pediatric patients receiving a dose level of 9mg/m^2, the peak plasma concentration (Cmax) was approximately 3.47±1.04 mg/L with the AUC of 136 ±107 mg * h/L [ Read more

Protein binding

Information currently not available.

Volume of distribution

The volume of distribution at steady state (Vss) was approximately 6.5 ± 5.5 L in pediatric patients receiving a dose level of 9mg/m^2 [ Read more

Clearance

The mean clearance rate was approximately 0.12±0.15 L/h/m^2 in pediatric patients receiving a dose level of 9mg/m^2 [ Read more

Half life

In pediatric patients receiving a dose level of 9mg/m^2, the half life was approximately 64±44 h after the first dose [ Read more

Route of elimination

Information currently not available.

Toxicity

The most frequently reported toxicities are myelosuppression and hepatic veno-occlusive disorder.

Adverse Effects

Contraindications

Information currently not available.

Food Interactions

    Information currently not available.

Interactions

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  • Paracetamol(acetaminophen)
  • Paxil(paroxetine)
  • Pamelor(nortriptyline)
  • Panadol(acetaminophen)
  • Patanol(olopatadine ophthalmic)
  • Pataday(olopatadine ophthalmic)
  • Parnate(tranylcypromine)
  • Pazeo(olopatadine ophthalmic)
(R)-warfarin
The risk or severity of bleeding can be increased when (R)-warfarin is combined with Gemtuzumab ozogamicin.
(S)-Warfarin
The risk or severity of bleeding can be increased when (S)-Warfarin is combined with Gemtuzumab ozogamicin.
2-Methoxyethanol
The risk or severity of adverse effects can be increased when Gemtuzumab ozogamicin is combined with 2-Methoxyethanol.
4-hydroxycoumarin
The risk or severity of bleeding can be increased when 4-hydroxycoumarin is combined with Gemtuzumab ozogamicin.
9-(N-methyl-L-isoleucine)-cyclosporin A
The risk or severity of adverse effects can be increased when Gemtuzumab ozogamicin is combined with 9-(N-methyl-L-isoleucine)-cyclosporin A.
Abatacept
The risk or severity of adverse effects can be increased when Gemtuzumab ozogamicin is combined with Abatacept.
Abciximab
The risk or severity of adverse effects can be increased when Abciximab is combined with Gemtuzumab ozogamicin.
Abetimus
The risk or severity of adverse effects can be increased when Gemtuzumab ozogamicin is combined with Abetimus.
Abituzumab
The risk or severity of adverse effects can be increased when Gemtuzumab ozogamicin is combined with Abituzumab.
Abrilumab
The risk or severity of adverse effects can be increased when Gemtuzumab ozogamicin is combined with Abrilumab.
Acenocoumarol
The risk or severity of bleeding can be increased when Acenocoumarol is combined with Gemtuzumab ozogamicin.
Acetylsalicylic acid
The risk or severity of bleeding can be increased when Acetylsalicylic acid is combined with Gemtuzumab ozogamicin.
Acteoside
The risk or severity of adverse effects can be increased when Gemtuzumab ozogamicin is combined with Acteoside.
Adalimumab
The risk or severity of adverse effects can be increased when Adalimumab is combined with Gemtuzumab ozogamicin.
Adecatumumab
The risk or severity of adverse effects can be increased when Gemtuzumab ozogamicin is combined with Adecatumumab.
Adenovirus type 7 vaccine live
The risk or severity of infection can be increased when Adenovirus type 7 vaccine live is combined with Gemtuzumab ozogamicin.
Aducanumab
The risk or severity of adverse effects can be increased when Gemtuzumab ozogamicin is combined with Aducanumab.
Afelimomab
The risk or severity of adverse effects can be increased when Gemtuzumab ozogamicin is combined with Afelimomab.
Aldesleukin
The risk or severity of adverse effects can be increased when Aldesleukin is combined with Gemtuzumab ozogamicin.
Aldosterone
The risk or severity of adverse effects can be increased when Gemtuzumab ozogamicin is combined with Aldosterone.
5 References
  1. 1 . Bross PF, Beitz J, Chen G, Chen XH, Duffy E, Kieffer L, Roy S, Sridhara R, Rahman A, Williams G, Pazdur R: Approval summary: gemtuzumab ozogamicin in relapsed acute myeloid leukemia. Clin Cancer Res. 2001 Jun;7(6):1490-6.PubMed: 11410481
  2. 2 . Giles FJ, Kantarjian HM, Kornblau SM, Thomas DA, Garcia-Manero G, Waddelow TA, David CL, Phan AT, Colburn DE, Rashid A, Estey EH: Mylotarg (gemtuzumab ozogamicin) therapy is associated with hepatic venoocclusive disease in patients who have not received stem cell transplantation. Cancer. 2001 Jul 15;92(2):406-13.PubMed: 11466696
  3. 3 . Wadleigh M, Richardson PG, Zahrieh D, Lee SJ, Cutler C, Ho V, Alyea EP, Antin JH, Stone RM, Soiffer RJ, DeAngelo DJ: Prior gemtuzumab ozogamicin exposure significantly increases the risk of veno-occlusive disease in patients who undergo myeloablative allogeneic stem cell transplantation. Blood. 2003 Sep 1;102(5):1578-82. Epub 2003 May 8.PubMed: 12738663
  4. 4 . Buckwalter M, Dowell JA, Korth-Bradley J, Gorovits B, Mayer PR: Pharmacokinetics of gemtuzumab ozogamicin as a single-agent treatment of pediatric patients with refractory or relapsed acute myeloid leukemia. J Clin Pharmacol. 2004 Aug;44(8):873-80.PubMed: 15286091
  5. 5 . FDA Press Announcements: FDA approves Mylotarg for treatment of acute myeloid leukemia Link