GEMTUZUMAB OZOGAMICIN (Systemic)?

Some commonly used brand names are:

In the U.S.?

• Mylotarg

? Not commercially available in Canada.

Category

• Monoclonal antibody
• antineoplastic

Description

Gemtuzumab ozogamicin (gem-TOO-ze-mab oh-zoh-GAM-ih-sin)is a monoclonal antibody.It is used to treat a certain type of leukemia which has recurred in patientswho are 60 years of age or older. Gemtuzumab ozogamicin is an alternativeto chemotherapy for these patients.

This medicine is to be administered only by or under the immediate supervisionof your doctor. It is available in the following dosage form:

Parenteral
• Injection (U.S.)

Before Using This Medicine

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

Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to gemtuzumab ozogamicin, anti-CD33 antibody, or calicheamicinderivatives. Also tell your doctor and pharmacist if you are allergic to anyother substances, such as foods, preservatives, or dyes.

Pregnancy?Gemtuzumab ozogamicin may cause harm to the fetuswhen administered during pregnancy. There are no adequate, well-controlledstudies in pregnant women. You should avoid becoming pregnant while receivinggemtuzumab ozogamicin. However, this medicine may be needed in serious diseasesor other situations that threaten the mother's life. Be sure you have discussedthis with your doctor.

Breast-feeding?It is not known if gemtuzumab ozogamicin passesinto the breast milk. However, due to potential serious side effects in nursingbabies from gemtuzumab ozogamicin, a decision should be made whether to stopnursing or to stop the drug.

Children?Studies on this medicine have been done only inadult patients, and there is no specific information comparing use of gemtuzumabozogamicin in children with use in other age groups.

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults or if they cause different side effectsor problems in older people. There is no specific information comparing useof gemtuzumab ozogamicin in the elderly with use in other age groups. However,laboratory values associated with liver problems were observed more oftenin patients 60 years old or older.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takinggemtuzumab ozogamicin, it is especially important that your doctor or pharmacistknow if you are taking any of the following:

• Alpha interferons (e.g., Intron A, Roferon-A) or
• Amphotericin B by injection (e.g., Fungizone) or
• Antineoplastics, other (cancer medicine) or
• Antithyroid agents (medicine for overactive thyroid) or
• Azathioprine (e.g., Imuran) or
• Chloramphenicol (e.g., Chloromycetin) or
• Colchicine or
• Cyclophosphamide (e.g., Cytoxan) or
• Flucytosine (e.g., Ancoban) or
• Ganciclovir (e.g., Cytovene) or
• Mercaptopurine (e.g., Purinethol)
• Methotrexate (e.g., Rheumatrex)
• Plicamycin (e.g., Mithracin)
• Zidovudine (e.g., AZT, Retrovir)?Concurrent use of these agentswith gemtuzumab ozogamicin increases the risk of infection

Other medical problems?The presence of other medicalproblems may affect the use of gemtuzumab ozogamicin. Make sure you tell yourdoctor if you have any other medical problems, especially:

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)?Risk of severe disease affecting otherparts of the body

• High blood cell counts (peripheral blasts)?Risk of side effectsincreased by gemtuzumab ozogamicin

• Infection?Risk increased by gemtuzumab ozogamicin
• Liver disease?May be worsened by gemtuzumab ozogamicin
• Stem-cell transplant?Risk of side effects increased by gemtuzumabozogamicin

Proper Use of This Medicine

Dosing?The dose of gemtuzumab ozogamicin will be different for differentpatients. The dose that is used may depend on a number of things, includingyour size. Gemtuzumab ozogamicin is usually given by a doctor or nurse inthe hospital or outpatient clinic. If you have any questions about the properdose of gemtuzumab ozogamicin, ask your doctor.

Precautions While Using This Medicine

It is very important that your doctor check you at regular visits to make sure this medication is working properly and to check forany unwanted effects.

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

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

• If you can, avoid people with infections.Checkwith your doctor immediately if you think you are getting an infectionor 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 ifyou notice any unusual bleeding or bruising; black, tarry stools; blood inurine 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 yourteeth and gums. Check with your medical doctor before having any dental workdone.
• Do not touch your eyes or the inside of your nose unless you havejust washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects suchas a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injurycould occur.

Side Effects of This Medicine

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

More common

Black, tarry stools; bloating or swellingof face, arms, hands, lower legs, or feet; bloodin stools or urine; bluish color of fingernails,lips, skin, palms, or nail beds; blurred vision; burning or stinging of skin; chest pain; chills; confusion; convulsions (seizures); cough or hoarseness; cracked lips; decreaseor increase in urine; diarrhea; difficulty in swallowing; dizziness; dry mouth; excessive sweating; fainting; fast or slow heartbeat; fatigue; 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 purplishpatches in the skin; light-headedness; lower back, joint, or side pain; lossof appetite; mood changes; muscle pain or cramps; muscle trembling or twitching; nausea or vomiting; numbnessor tingling in hands, feet, or lips; pain, difficulty, or burning while urinating; painful cold sores orblisters on lips, nose, eyes, or genitals; pale skin; persistent bleeding or oozing from puncture sites,mouth, or nose; palpitations; pinpoint red spots on skin; pounding in the ears; red or purplish patches or spots on skin; rapid, shallow breathing; rapid weightgain; severe or continuing dull nervousness; shortness of breath; slurred speech; small red or purple spots on skin; sneezing; sore throat; sores, ulcers, or white spots on lips, tongue, or inside mouth; stomachache; sweating; swelling or inflammation of the mouth, face, fingers,feet, or lower legs; swollen glands; temporary blindness; tightness in chest; tingling of hands or feet; troubled breathing, exertional; unexplained nosebleeds; unusual bleeding or bruising; unusual tiredness or weakness; unusual weight gainor loss; weakness in arm and/or leg on one side ofthe body, sudden and severe; wheezing; yellow eyes or skin

Other side effects may occur that usually do not need medicalattention. These side effects may go away during treatment as your body adjuststo the medicine. However, check with your doctor if any of the following sideeffects continue or are bothersome.

More common

Acid or sour stomach; belching; difficulty in moving; dry, red, hot,or irritated skin; full or bloated feeling or pressurein the stomach; heartburn; indigestion; lack or loss of strength; muscle pain or stiffness; pain, swelling,or redness in joints; runny, stuffy nose; stomach discomfort upset; swelling ofabdominal or stomach area; trouble in sleeping

Other side effectsnot listed above may also occur in some patients. If you notice any othereffects, check with your doctor.