Mylotarg (Gemtuzumab Ozogamicin)

Brand Name

Mylotarg

Generic Name

Gemtuzumab Ozogamicin

View Brand Information

FDA approval date: September 07, 2017

Classification: CD33-directed Immunoconjugate

Form: Injection

What is Mylotarg (Gemtuzumab Ozogamicin)?

MYLOTARG is a CD33-directed antibody and cytotoxic drug conjugate indicated for: treatment of newly-diagnosed CD33-positive acute myeloid leukemia in adults and pediatric patients 1 month and older.

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Brand Information

Mylotarg (gemtuzumab ozogamicin)

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. (

1DOSAGE FORMS AND STRENGTHS

For injection: 4.5 mg as a white to off-white lyophilized cake or powder in a single-dose vial for reconstitution and further dilution.

2CONTRAINDICATIONS

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

3ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

Hepatotoxicity, including VOD
Infusion-related reactions
Hemorrhage

3.1Clinical 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.

3.2Postmarketing 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 cystitis

Respiratory, Thoracic and Mediastinal Disorders: Interstitial pneumonia

3.3Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. Immunogenicity of MYLOTARG was not studied in clinical trials using the recommended dose regimens.

4DESCRIPTION

Gemtuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of the CD33-directed monoclonal antibody (hP67.6; recombinant humanized immunoglobulin [Ig] G4, kappa antibody produced by mammalian cell culture in NS0 cells) that is covalently linked to the cytotoxic agent N-acetyl gamma calicheamicin. Gemtuzumab ozogamicin consists of conjugated and unconjugated gemtuzumab. The conjugated molecules differ in the number of activated calicheamicin derivative moieties attached to gemtuzumab. The number of conjugated calicheamicin derivatives per gemtuzumab molecule ranges from predominantly zero to 6, with an average of 2 to 3 moles of calicheamicin derivative per mole of gemtuzumab.

MYLOTARG (gemtuzumab ozogamicin) for injection is supplied as a sterile, white to off-white, preservative-free lyophilized cake or powder for intravenous administration. Each single-dose vial delivers 4.5 mg gemtuzumab ozogamicin. Inactive ingredients are dextran 40 (41.0 mg), sodium chloride (26.1 mg), sodium phosphate dibasic anhydrous (2.7 mg), sodium phosphate monobasic monohydrate (0.45 mg), and sucrose (69.8 mg). After reconstitution with 5 mL of Sterile Water for Injection USP, the concentration is 1 mg/mL of gemtuzumab ozogamicin with a deliverable volume of 4.5 mL (4.5 mg).

5REFERENCES

1. OSHA Hazardous Drugs. OSHA.

6HOW SUPPLIED/STORAGE AND HANDLING

MYLOTARG (gemtuzumab ozogamicin) for injection is a white to off-white lyophilized cake or powder supplied in a carton (NDC 0008-4510-01) containing one 4.5 mg single-dose vial

7PRINCIPAL DISPLAY PANEL - 4.5 mg Vial Label

Pfizer

NDC 0008-4510-01

MYLOTARG™

4.5 mg/vial

For Intravenous Infusion Only

Single-dose vial.

No Preservatives

Principal Display Panel - 4.5 mg Vial Label

8PRINCIPAL DISPLAY PANEL - 4.5 mg Vial Carton

Pfizer

NDC 0008-4510-01

MYLOTARG™

4.5 mg/vial

For Intravenous Infusion Only

Reconstitution and dilution

No Preservatives

One Single-Dose Vial.

Rx only

Principal Display Panel - 4.5 mg Vial Carton