US FDA approved drug Mylotarg that contains active pharmaceutical ingredient gemtuzumab ozogamicin which is monoclonal antibody for the treatment of acute myeloid leukemia in CD33-positive AML patients. In past, this drug was voluntarily withdrawn from market in 2010 because the drug was failed to verify clinical benefits after subsequent confirmatory trials. The drug will be again in market after 7 years of absence following its approval by US FDA on September 1, 2017.
Acute myeloid leukemia (AML) is a kind of cancer that targets white blood cells. In this disease mutation occurs in specific genes due to which bone marrow produce abnormal and immature white blood cells that are physiologically non-functional. Onset of symptoms include mild to moderate fever, busing, asthenia (loss of energy), muscular pain. In later stages, internal hemorrhage may leads to bleeding inside the body. Proper diagnosis of can only done via blood tests or bone marrow biopsy.
Research is still underway to find out exact underlying cause that trigger mutations and mediates the pathophysiology this disease. Many scientists believe that certain factors like genetic predisposition, exposure to radiations and chemicals, smoking play important in the pathophysiology of disease. Some viral infections of bone marrow may also trigger such kind of disease if they persist for longer duration of time.
Mylotarg/Gentuzumab ozogamicin is a combination of humanized monoclonal antibody (Gentuzumab) specifically designed to bind with CD-33 and second drug is cytotoxic anti-tumor antibiotic calicheamicin. After administration it readily binds with CD-33 and then ozogamicin exerts its anti-tumor antibiotic effects.
Mylotarg Side effects
According to health authorities this drug may exhibit following side effects after its administration
- Increase susceptibility to infections
- Elevated level of liver enzymes
- Swelling in extremities
- Mouth Ulcers
- Blockage of the veins
US FDA approved Mylotarg for the treatment of for the treatment of acute myeloid leukemia in CD33-positive AML patients. The drug has also been approved for the treatment of CD33-positive AML in both pediatric and adult patients who have experienced a relapse or who have not responded to initial treatment.
Mylotarg is formulated as single dose vial that contains 4.5mg lyophilized cake powder for reconstitution. Standard dosage frequency of Mylotarg is 3 mg/m2 (up to one 4.5 mg vial) on Days 1, 4, and 7 in combination with daunorubicin.
This drug is administered by your healthcare practitioner (HCP), which usually means:
- It may comes under special items category.
- You cannot fill this prescription in a regular pharmacy. Your doctor, hospital, or clinic will provide this medication because of possible complications or other issues.
- This drug is likely to be covered under your medical benefit if you have insurance.