Mylotarg (Gemtuzumab Ozogamicin)

Prescription medicineOnly Available By Prescription

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Example: If you find a product on Canada Drugs Direct for $50.00 and find the same product for $40.00 at another mail order pharmacy, we will provide you with a $12.50 discount, bringing your total to $37.50.

To get the discount please make sure to mention the price match to the customer service team when they call to collect payment for your order. Or call toll free at 1-888-904-8467 to place the order through the phone.

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What is a Generic Drug?

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.

Description

Mylotarg (gemtuzumab ozogamicin) injection is used for treating adults and pediatric patients who are 1 month old and older with newly diagnosed acute myeloid leukemia (AML). It is also used for treating adults and pediatric patients who are 2 years of age and older with relapsed or refractory AML.

Fact Table
Formula C6518H9916N1734O2065S40
License FDA approved
Bioavailability Not applicable (intravenous administration)
Legal status Prescription only
Chemical Name Gemtuzumab Ozogamicin
Elimination half-life Approximately 62 hours
Dosage (Strength) 4.5 mg/vial
Pregnancy Not recommended; consult a healthcare provider
Brands Mylotarg
Protein binding Not significantly bound
PubChem CID 24972295
MedlinePlus a607044
ChEBI 134722
ATC code L01XC05
DrugBank DB00056
KEGG D04252
Routes of administration Intravenous

Directions

Your treatment plan will be prescribed by your healthcare provider. A healthcare professional will administer Mylotarg intravenous (IV) infusion. Any questions or concerns may be referred to your healthcare provider.

Ingredients

Gemtuzumab ozogamicin is the active ingredient in Mylotarg.

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) are the inactive ingredients.

Contraindications

Mylotarg should not be administered to patients with an allergy to any of its ingredients.

Cautions

  • Mylotarg is associated with the following FDA Boxed Warning:
    • Liver toxicity may occur, including severe or fatal liver veno-occlusive disease, also called sinusoidal obstruction syndrome.
  • Before you begin receiving Mylotarg, inform your healthcare provider:
    • Of all the prescription and nonprescription medications you take, including vitamins, herbals, and supplements
    • Of your allergies
    • Of your current health problems
    • Of your past medical history
    • If you are pregnant or breastfeeding
  • The following may occur with Mylotarg treatment:
    • Anaphylaxis or other infusion-related reactions. Your healthcare provider may prescribe a corticosteroid, acetaminophen, and diphenhydramine for you to receive before the infusion. You should be monitored during the infusion and for at least 1 hour after administration.
    • Severe and potentially fatal bleeding. Frequent monitoring of platelet counts should be performed.
    • Fetal harm; therefore, females of childbearing potential are advised to use effective contraceptive methods during Mylotarg treatment and for at least 6 months after receiving the final dose. Males with female partners who are of childbearing potential should be advised to use effective contraceptive methods during Mylotarg treatment and for at least 3 months after the final dose.
  • Breastfeeding is not advised.

Side Effects

Mylotarg side effects include but are not limited to bleeding, infection, fever, nausea, vomiting, constipation, headache, increased liver enzymes, rash, inflamed mouth or gut, low neutrophil counts with a fever, and decreased appetite. Let your healthcare provider know right away if you experience bothersome or persistent side effects.

Talk to your healthcare provider 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.

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