Pronunciation:

jem-TOOZ-oo-mab oh-zoe-ga-MYE-sin

Brand Names:

• Mylotarg

Dosage Forms:

• Powder for Solution

Warnings:

Should only be used as single agent chemotherapy and not in combination chemotherapy regimens outside clinical trials. Severe myelosuppression occurs when gemtuzumab is used at recommended doses. Severe hypersensitivity reactions (including anaphylaxis), and other infusion-related reactions which may include severe pulmonary events have occurred with therapy. Some of these hypersensitivity reactions have been fatal. Patients with high peripheral blast counts may be at greater risk for pulmonary events and tumor lysis syndrome; physicians should consider leukoreduction with hydroxyurea or leukapheresis to reduce the peripheral white count to below 30,000/ microliters prior to administration of gemtuzumab. Hepatotoxicity, including severe hepatic veno-occlusive disease (VOD), has been reported with therapy. Physicians should monitor their patients carefully for symptoms of hepatotoxicity, particularly VOD .

Classifications:

Therapeutic

Antineoplastic Agent

Pharmacologic

Monoclonal Antibody

Uses of This Medicine:

Gemtuzumab injection is a monoclonal antibody that is used to treat a type of cancer called acute myeloid leukemia (AML) in patients 60 years of age or older. It is used when other cancer treatments have not worked very well for these patients. Gemtuzumab interferes with the growth of leukemia cells, which are then destroyed by the body.

This medicine was to be administered only by or under the immediate supervision of your doctor.

Products containing gemtuzumab were withdrawn from the U.S. market by Pfizer Inc. on October 15, 2010.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children

Appropriate studies have not been performed on the relationship of age to the effects of gemtuzumab injection in the pediatric population. Safety and efficacy have not been established.

Older adults

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of gemtuzumab injection in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast-feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Breathing problems or
• Hypotension (low blood pressure) or
• Kidney disease or
• Liver disease or
• Lung disease or
• Neutropenia (low white blood cell count) or
• Thrombocytopenia (low platelet count) Use with caution. May make these conditions worse.

• Chickenpox, or recent exposure, or
• Herpes zoster (shingles) Risk of severe infection affecting other parts of the body.

• High white blood cell counts or
• Stem-cell transplant, history of Use with caution. May increase risk for more serious side effects.

• Infection May decrease your body's ability to fight an infection.

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor while you are receiving this medicine.

A doctor or nurse will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for about 2 hours.

This medicine consists of two doses, usually given 14 days apart. You may also receive a medicine to prevent allergic reactions (such as diphenhydramine, methylprednisolone, or Benadryl®) before you receive this medicine.

Your doctor may want you to drink extra fluids so you will pass more urine while you are using this medicine. This will keep your kidneys working well and help prevent kidney problems. Talk to your doctor if you have questions about this.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests are needed to check for any unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

While you are being treated with gemtuzumab, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Gemtuzumab may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Gemtuzumab can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor or nurse right away if you have blue lips, fingernails, or skin; difficult or fast breathing; dizziness, fainting, or lightheadedness; fever or chills; rash; trouble breathing or swallowing; or any swelling of your hands, face, or mouth after receiving this medicine.

Check with your doctor immediately if you have any symptoms of liver problems including skin and eyes turning yellow, dark brown-colored urine, right-sided abdominal or stomach pain, fever, or severe tiredness.

This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount; joint pain, stiffness, or swelling; lower back, side, or stomach pain; a rapid weight gain; swelling of the feet or lower legs; or unusual tiredness or weakness.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Black, tarry stools

bloating or swelling of the face, arms, hands, lower legs, or feet

blood in the stools or urine

bluish color of the fingernails, lips, skin, palms, or nailbeds

blurred vision

burning or stinging of the skin

chest pain

chills

confusion

convulsions (seizures)

cough or hoarseness

cracked lips

decrease or increase in urine

diarrhea

difficulty with swallowing

dizziness

dry mouth

excessive sweating

fainting

fast or slow heartbeat

fever

flushed, dry skin

fruit-like breath odor

headache, sudden and severe

heavy, nonmenstrual vaginal bleeding

inability to speak

increased thirst or hunger

irregular heartbeat

large, flat, blue, or purplish patches in the skin

lightheadedness

lower back, joint, or side pain

loss of appetite

mood changes

muscle pain or cramps

muscle trembling or twitching

nausea or vomiting

numbness or tingling in the hands, feet, or lips

pain, difficulty, or burning while urinating

painful cold sores or blisters on the lips, nose, eyes, or genitals

pale skin

palpitations

persistent bleeding or oozing from puncture sites, mouth, or nose

pinpoint red spots on the skin

pounding in the ears

rapid, shallow breathing

rapid weight gain

red or purplish patches or spots on the skin

severe or continuing dull nervousness

shortness of breath

slurred speech

small red or purple spots on the skin

sneezing

sore throat

sores, ulcers, or white spots on the lips, tongue, or inside the mouth

stomachache

sweating

swelling or inflammation of the mouth, face, fingers, feet, or lower legs

swollen glands

temporary blindness

tightness in the chest

tingling of the hands or feet

troubled breathing, exertional

unexplained nosebleeds

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

weakness in the arm or leg on one side of the body, sudden and severe

wheezing

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Acid or sour stomach

belching

difficulty with moving

dry, red, hot, or irritated skin

full or bloated feeling or pressure in the stomach

heartburn

indigestion

lack or loss of strength

muscle pain or stiffness

pain, swelling, or redness in the joints

runny, stuffy nose

stomach discomfort upset

swelling of the abdominal or stomach area

trouble with sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.