Gemtuzumab ozogamicin

What is Gemtuzumab ozogamicin?

• Gemtuzumab ozogamicin (Mylotarg) is a CD33-directed antibody and cytotoxic drug conjugate used to treat acute myeloid leukemia (AML) that is CD33 positive (expresses the protein CD33).

What are the uses of this medicine?

Gemtuzumab ozogamicin (Mylotarg) is used to treat:

• Acute myeloid leukemia that is CD33 positive.
• It is used in adults and children aged 1 month and older with newly-diagnosed disease.
• It is used in adults and children aged 2 years and older whose disease has relapsed or is refractory (does not respond to treatment).

How does this medicine work?

• Gemtuzumab (jem tooz’ ue mab) ozogamicin (oh” zoe ga mye’ sin) is a humanized monoclonal IgG4 antibody to the human CD33 cell surface marker which is highly expressed on acute myelogenous leukemia cells.
• The monoclonal antibody is conjugated to a cytotoxic molecule, ozogamicin.
• When gemtuzumab binds to CD33, it is internalized and the ozogamicin is released by the action of lysosomal enzymes on the linker molecule that joins the monoclonal antibody and cytotoxic molecule.
• The intracellular ozogamicin results in apoptotic cell death.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with a history of hypersensitivity to the active substance in MYLOTARG

What drug interactions can this medicine cause?

Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following:

• amiodarone (Cordarone, Nexterone, Pacerone), anagrelide (Agrylin), chloroquine, chlorpromazine, cilostazol, citalopram(Celexa), disopyramide (Norpace), dofetilide (Tikosyn), donepezil (Aricept, in Namzaric), dronedarone (Multaq), escitalopram (Lexapro), flecainide (Tambocor), fluconazole (Diflucan), haloperidol (Haldol), ibutilide (Corvert), methadone (Methadose, Dolophine), ondansetron (Zuplenz, Sofran), pimozide (Orap), procainamide, quinidine (in Nuedexta), sotalol (Betapace, Sorine, Sotylize), and thioridazine.

Is this medicine FDA approved?

• Gemtuzumab ozogamicin was approved and reintroduced as a therapy of acute myelogenous leukemia in 2017.

How should this medicine be used?

• Premedicate with a corticosteroid, antihistamine, and acetaminophen.

Recommended dosage:

Newly-diagnosed, de novo AML (combination regimen): Adults:

• Induction: 3 mg/m2 (up to one 4.5 mg vial) on Days 1, 4, and 7 in combination with daunorubicin and cytarabine.
• Consolidation: 3 mg/m2 on Day 1 (up to one 4.5 mg vial) in combination with daunorubicin and cytarabine.

Pediatric patients 1 month and older:

• 3 mg/m2 for patients with body surface area (BSA) 0.6 m2 or greater.
• 0.1 mg/kg for patients with BSA less than 0.6 m2.

Newly-diagnosed AML (single-agent regimen): Adults:

• Induction: 6 mg/m2 (not limited to one 4.5 mg vial) on Day 1 and 3 mg/m2 (not limited to one 4.5 mg vial) on Day 8.
• Continuation: For patients without evidence of disease progression following induction, up to 8 continuation courses of Mylotarg2 mg/m2 (not limited to one 4.5 mg vial) on Day 1 every 4 weeks.

Relapsed or refractory AML (single-agent regimen): Adults and pediatric patients 2 years and older:

• 3 mg/m2 (up to one 4.5 mg vial) on Days 1, 4, and 7

Administration:

• Gemtuzumab ozogamicin injection comes as a powder to be mixed with liquid and given through a needle or catheter placed into a vein.
• It is usually injected slowly over a period of 2 hours.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 4.5 mg as a lyophilized cake or powder in a single-dose vial for reconstitution and dilution

This medicine is available in fallowing brand namesː

• Mylotarg

What side effects can this medication cause?

The most common side effects of this medicine include:

• hemorrhage
• infection
• fever
• nausea
• vomiting
• constipation
• headache
• increased AST
• increased ALT
• rash
• mucositis
• febrile neutropenia
• decreased appetite

What special precautions should I follow?

• Hepatotoxicity, including life-threatening and sometimes fatal hepatic VOD events, have been reported in patients receiving Mylotargas a single agent or as part of a combination chemotherapy regimen. Manage signs or symptoms of hepatic toxicity by dose interruption or discontinuation of MYLOTARG.
• Life-threatening or fatal infusion-related-reactions can occur during or within 24 hours following infusion of MYLOTARG. Premedicate with a corticosteroid, acetaminophen, and diphenhydramine. Monitor patients during and for at least 1 hour after the end of the infusion. Interrupt the infusion, administer steroids or antihistamines, or permanently discontinue treatment as necessary.
• Mylotargis myelosuppressive and can cause fatal or life-threatening hemorrhage due to prolonged thrombocytopenia. Severe, including fatal, hemorrhage may occur when Mylotargis used at recommended doses. Monitor platelet counts frequently.
• MylotargCan cause fetal harm. Advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Based on its mechanism of action and findings from animal studies, Mylotargcan cause embryo-fetal harm when administered to a pregnant woman.

Can this medicine be used in children?

• The safety and effectiveness of Mylotargin combination with standard chemotherapy have been established in pediatric patients 1 month and older with newly-diagnosed de novo AML.
• The safety and effectiveness of Mylotargas a single agent in pediatric patients with newly-diagnosed AML have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• GEMTUZUMAB OZOGAMICIN

Inactive ingredient:

• DEXTRAN 40
• SUCROSE
• SODIUM CHLORIDE
• SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
• SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM

Who manufactures and distributes this medicine?

• Packager: Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

What should I know about storage and disposal of this medication?

• Refrigerate (2°C to 8°C; 36°F to 46°F) Mylotargvials and store in the original carton to protect from light.
• DO NOT FREEZE.
• Mylotargis a cytotoxic drug.
• Follow applicable special handling and disposal procedures.

• Dailymed label info on Gemtuzumab ozogamicin
• FDA Gemtuzumab ozogamicin

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