Mylotarg (Gemtuzumab Ozogamicin)
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A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
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Prescription Required
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Product Details
Description
Mylotarg (gemtuzumab ozogamicin) is a medication given via an intravenous (IV) infusion to treat acute myeloid leukemia (AML) that has been newly diagnosed in adults and pediatric patients who are at least 1 month old. It is also used to treat relapsed or refractory AML in adults and pediatric patients who are at least 2 years of age.
Fact Table
Formula
C6450H9918N1712O2010S42
License
US FDA, EMA
Bioavailability
Not applicable (IV administration)
Legal status
Prescription only (Rx)
Chemical Name
Gemtuzumab Ozogamicin
Elimination half-life
72 hours
Dosage (Strength)
4.5 mg/vial
Pregnancy
Contraindicated
Brands
Mylotarg
Protein binding
Not reported
PubChem CID
16034294
MedlinePlus
a607046
ChEBI
CHEBI:135108
ATC code
L01XC06
DrugBank
DB00056
KEGG
D09301
Routes of administration
Intravenous (IV)
Directions
Your doctor will determine an appropriate treatment regimen for you. Mylotarg will be administered via an IV infusion by a healthcare professional. Talk to your doctor about any questions or concerns you may have.
Ingredients
The active ingredient in Mylotarg is gemtuzumab ozogamicin.
Inactive ingredients include 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).
Contraindications
Patients who are allergic to Mylotarg or to any of its ingredients should not receive it.
Cautions
- Mylotarg contains the following FDA Boxed Warning:
- Mylotarg is associated with liver toxicity, including severe or fatal liver veno-occlusive disease, also called sinusoidal obstruction syndrome.
- Before you start treatment with Mylotarg, talk to your doctor about:
- All the prescription and over-the-counter medications you take
- Your allergies
- Your current health problems and past medical history
- Your pregnancy or breastfeeding status
- Infusion-related reactions, including anaphylaxis, can occur during Mylotarg infusion; therefore, patients may receive a corticosteroid, acetaminophen, and diphenhydramine prior to the infusion. Patients should be monitored during and for at least 1 hour after receiving Mylotarg.
- Severe bleeding that may cause death can occur. Platelet counts should be checked frequently.
- Harm to an unborn baby can occur. Effective contraception is recommended for females of childbearing age during treatment with Mylotarg and for at least 6 months after the final dose. Males with female partners who are of childbearing age are recommended to use effective contraception during treatment with Mylotarg and for at least 3 months after the final dose.
- Breastfeeding is not recommended.
Side Effects
Bleeding, infection, fever, nausea, vomiting, constipation, headache, increased liver enzymes, rash, inflamed mouth or gut, low neutrophil counts with a fever, and decreased appetite are common Mylotarg side effects; however, other side effects may also occur. Immediately inform your doctor of any side effects that bother you or won’t go away.
Ask your doctor about Mylotarg.
Reference
Mylotarg. Philadelphia, PA: Wyeth Pharmaceuticals LLC; 2021.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 14559
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