Question 1

What is Mylotarg?

Accepted Answer

Mylotarg is a type of medication known as an antibody-drug conjugate. It works by combining a monoclonal antibody with a powerful chemotherapy agent to target and destroy specific cancer cells while minimizing damage to healthy cells.

The antibody portion of the medication recognizes and attaches to a specific protein found on the surface of target cells. Once attached, the drug is absorbed into the cell, where it releases a toxin that interferes with the cell's DNA and leads to cell death.

Question 2

What is Mylotarg used for?

Accepted Answer

Mylotarg is used to treat acute myeloid leukemia .

Question 3

How does Mylotarg work?

Accepted Answer

Mechanism of Action

Mylotarg works by targeting a specific protein called CD33 . This protein is found on the surface of most myeloblasts (immature white blood cells) in patients with acute myeloid leukemia (AML).

The medication is an antibody-drug conjugate, which means it is composed of two main parts linked together:

A monoclonal antibody: This part acts like a homing device to find and attach to the CD33 protein on the surface of the cancer cells.

A cytotoxic agent: This is a powerful anti-cancer drug called calicheamicin.

How it destroys cancer cells

The process of how Mylotarg works inside the body involves several steps:

Binding and Entry: The antibody portion of the drug attaches to the CD33 protein on the leukemia cell. Once attached, the cell pulls the drug complex inside itself.

Release: Inside the cell, the link between the antibody and the chemotherapy drug is broken, releasing the calicheamicin.

DNA Damage: The chemotherapy drug travels to the cell's nucleus and causes double-strand breaks in the DNA.

Cell Death: This severe DNA damage prevents the cancer cell from growing or multiplying and eventually causes it to die.

Because Mylotarg specifically targets cells with the CD33 protein, it is designed to focus its effects on leukemia cells while potentially sparing some types of healthy cells that do not carry this marker.

Question 4

What are the active ingredients in Mylotarg?

Accepted Answer

The active ingredient in Mylotarg is gemtuzumab ozogamicin .

Question 5

What are the side effects of Mylotarg?

Accepted Answer

Common side effects of Mylotarg may include:

fever

nausea

fatigue

and others

Always consult with a healthcare professional about potential side effects.

Question 6

What drug class is Mylotarg?

Accepted Answer

Mylotarg belongs to the antibody-drug conjugate drug class.

Question 7

What is the dosage of Mylotarg and how do I take it?

Accepted Answer

How it is administered

Mylotarg is given as an infusion into a vein by a healthcare provider in a hospital or clinic setting. The infusion process typically lasts about two hours.

Treatment schedule

This medication is usually given in cycles. The specific timing and frequency of these cycles depend on whether Mylotarg is being used alone or in combination with other chemotherapy treatments. Your healthcare team will monitor your blood counts and overall health to determine the exact schedule for your doses.

Premedication

Before receiving an infusion of Mylotarg, you may be given other medications to help prevent or reduce the severity of infusion-related reactions. These premedications often include fever reducers, antihistamines, or corticosteroids.

Missed doses

Since this medication is administered by a medical professional, it is important to attend all scheduled appointments. If you miss a dose, contact your healthcare provider as soon as possible to reschedule your treatment.

Question 8

Is Mylotarg safe during pregnancy and breastfeeding?

Accepted Answer

Pregnancy

Mylotarg may cause fetal harm when administered to a pregnant woman. Because of these risks, healthcare providers usually confirm a negative pregnancy status before starting the medication.

Patients who are able to become pregnant should use effective contraception during treatment and for at least 6 months after the final dose. Males with female partners of reproductive potential should use effective birth control during treatment and for at least 3 months after the last dose.

If a patient becomes pregnant or thinks they might be pregnant while receiving this medication, they should contact their healthcare provider immediately to discuss the potential risks to the fetus.

Breastfeeding

It is currently unknown if Mylotarg passes into breast milk. Because the drug could cause serious adverse reactions in a nursing infant, it is recommended that patients do not breastfeed during treatment and for at least 1 month after the final dose.

Question 9

What forms and strengths does Mylotarg come in?

Accepted Answer

Mylotarg is supplied in the following form:

Lyophilized powder for injection: This is a sterile, preservative-free powder provided in a single-dose vial.

A healthcare professional prepares the medication by reconstituting the powder and diluting it before it is administered into a vein through an intravenous infusion.

Question 10

What is the FDA approval status of Mylotarg?

Accepted Answer

FDA Approval and Indications

Mylotarg (gemtuzumab ozogamicin) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of CD33-positive acute myeloid leukemia (AML). Its approved indications include:

Newly diagnosed CD33-positive AML: For use in adults and pediatric patients 1 month and older.

Relapsed or refractory CD33-positive AML: For use in adults and pediatric patients 2 years and older.

The medication was originally approved in 2000 under the accelerated approval pathway but was voluntarily withdrawn from the market in 2010. It was re-approved by the FDA in 2017 with a lower recommended dose, a different schedule, and a new patient population.

Boxed Warning

Mylotarg carries a boxed warning for hepatotoxicity. Severe, life-threatening, or fatal hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), has been reported in patients receiving this drug. VOD is a condition where the small blood vessels in the liver become blocked.

The risk of developing VOD is higher in patients who have undergone a hematopoietic stem cell transplant (HSCT), those who receive Mylotarg after a transplant, or those who proceed to a transplant after treatment. Healthcare providers must monitor patients for signs of liver injury, such as jaundice, rapid weight gain, and liver enlargement.

Biomarker Testing

The FDA requires confirmation of CD33 expression on leukemia cells before starting treatment with Mylotarg. This is typically determined using a validated test to ensure the patient is a candidate for this targeted therapy.

Question 11

What should I know about Mylotarg and fda approval?

Accepted Answer

Approval History

Mylotarg was originally granted accelerated approval by the FDA in 2000. It was later voluntarily withdrawn from the market in 2010 after a clinical trial failed to confirm clinical benefit and raised safety concerns regarding toxicity. Following the submission of new data and a revised dosing regimen, the FDA re-approved Mylotarg in September 2017.

Current Indications

The FDA has approved Mylotarg for the following specific uses:

Newly diagnosed AML: For the treatment of newly diagnosed CD33-positive acute myeloid leukemia in adults and pediatric patients 1 month and older.

Relapsed or refractory AML: For the treatment of CD33-positive acute myeloid leukemia that has returned or did not respond to previous treatments in adults and pediatric patients 2 years and older.

In June 2020, the FDA expanded the indication for newly diagnosed CD33-positive AML to include pediatric patients 1 month and older, based on clinical evidence showing the drug's safety and efficacy in this younger population.

Mylotarg

📋Overview

What It's Used For

How It Works

Side Effects

Warnings & Precautions

Dosage & How to Take

Pregnancy & Breastfeeding

Forms & Strengths

FDA / Regulatory Status

Fda Approval Information

FAQ

📚References

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