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Gemtuzumab Ozogamicin (Mylotarg)

Trade Name : Mylotarg

Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Strength 5 mg/5mL

GEMTUZUMAB OZOGAMICIN CD33-directed Immunoconjugate [EPC],CD33-directed Antibody Interactions [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Gemtuzumab Ozogamicin (Mylotarg) which is also known as Mylotarg and Manufactured by Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.. It is available in strength of 5 mg/5mL per ml. Read more

Gemtuzumab Ozogamicin (Mylotarg) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Hepatotoxicity, including severe or fatal hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), has been reported in association with the use of MYLOTARG as a single agent, and as part of a combination chemotherapy regimen. Monitor frequently for signs and symptoms of VOD after treatment with MYLOTARG. (5.1 and 6.1)
  • WARNING: HEPATOTOXICITY
  • See full prescribing information for complete boxed warning.
  • Hepatotoxicity, including severe or fatal hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), has been reported in association with the use of MYLOTARG. (, )
  • No data
  • MYLOTARG is a CD33-directed antibody-drug conjugate indicated for:
  • treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults ().
  • treatment of relapsed or refractory CD33-positive AMLin adults and in pediatric patients 2 years and older ().
  • No data
  • Newly-diagnosed, de novo AML (combination regimen):n
  • Newly-diagnosed AML (single-agent regimen):n
  • Relapsed or refractory AML(single-agent regimen): n
  • Premedicate with a corticosteroid, antihistamine, and acetaminophen 1 hour prior to MYLOTARG ().
  • For injection: 4.5 mg as a white to off-white lyophilized cake or powder in a single-dose vial for reconstitution and further dilution.
  • For Injection: 4.5 mg as a lyophilized cake or powder in a single-dose vial for reconstitution and dilution ().
  • MYLOTARG is contraindicated in patients with a history of hypersensitivity to the active substance in MYLOTARG or any of its components or to any of the excipients. Reactions have included anaphylaxis and .
  • Hypersensitivity to MYLOTARG or any of its components ().
  • No data
  • Infusion related reactions (including anaphylaxis): 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 (, , and ).
  • Hemorrhage: Severe, including fatal, hemorrhage may occur when MYLOTARG is used at recommended doses. Monitor platelet counts frequently ( and ).
  • Embryo-fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception (, , and ).
  • The following serious adverse reactions associated with MYLOTARG are discussed in detail in other sections of the prescribing information:
  • The most common adverse reactions (greater than 15%) were hemorrhage, infection, fever, nausea, vomiting, constipation, headache, increased AST, increased ALT, rash, and mucositis ().
  • To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Lactation: Advise not to breastfeed ().
  • Gemtuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of the CD33-directed monoclonal antibody (hP67.6; recombinant humanized immunoglobulin [Ig] G4, kappa antibody produced by mammalian cell culture in NS0 cells) that is covalently linked to the cytotoxic agent N-acetyl gamma calicheamicin. Gemtuzumab ozogamicin consists of conjugated and unconjugated gemtuzumab. The conjugated molecules differ in the number of activated calicheamicin derivative moieties attached to gemtuzumab. The number of conjugated calicheamicin derivatives per gemtuzumab molecule ranges from predominantly zero to 6, with an average of 2 to 3 moles of calicheamicin derivative per mole of gemtuzumab.
  • MYLOTARG (gemtuzumab ozogamicin) for Injection is supplied as a sterile, white to off-white, preservative-free lyophilized cake or powder for intravenous administration. Each single-dose vial delivers 4.5 mg gemtuzumab ozogamicin. Inactive ingredients are dextran 40 (41.0 mg), sodium chloride (26.1 mg), sodium phosphate dibasic anhydrous (2.7 mg), sodium phosphate monobasic monohydrate (0.45 mg), and sucrose (69.8 mg). After reconstitution with 5 mL of Sterile Water for Injection USP, the concentration is 1 mg/mL of gemtuzumab ozogamicin with a deliverable volume of 4.5 mL (4.5 mg).
  • No data
  • Formal carcinogenicity studies have not been conducted with gemtuzumab ozogamicin. In toxicity studies, rats were dosed weekly for 6 weeks with gemtuzumab ozogamicin at doses up to 7.2 mg/m/week. After 6 weeks of dosing, rats developed oval cell hyperplasia in the liver, which is considered a potentially preneoplastic finding, at 7.2 mg/m/week (approximately 16 times the exposure in patients at the maximum recommended dose, based on AUC). Other preneoplastic or neoplastic changes observed with other antibody-calicheamicin conjugates in rats included basophilic and/or eosinophilic altered cell foci and hepatocellular adenomas. The relevance of these animal findings to humans is uncertain.
  • Gemtuzumab ozogamicin was clastogenic in vivo in the bone marrow of mice that received single doses greater than or equal to 22.1 mg/m. This is consistent with the known induction of DNA breaks by calicheamicin. N-acetyl gamma calicheamicin dimethyl hydrazide (the released cytotoxic agent) was mutagenic in the bacterial reverse mutation assay and clastogenic in the in vitro micronucleus assay in human TK6 cells.
  • In a female fertility study, female rats were administered daily intravenous doses of gemtuzumab ozogamicin up to 1.08 mg/m for 14 days before mating with untreated male rats. Significant decreases in the numbers of corpora lutea and implants were observed at 1.08 mg/m, and dose-related decreases and increases in the number of live and dead embryos were observed at doses tested (approximately 0.4 times the exposure in patients at the maximum recommended dose, based on AUC). Increased embryofetal lethality at u22650.36 mg/m was observed in the presence of maternal toxicity that included decreases in gestational body weight and food consumption. Additional findings in female reproductive organs (ovarian atrophy and decreased numbers of follicles associated with atrophy of the uterus, vagina and mammary glands) occurred in rats and monkeys after dosing with other antibody-calicheamicin conjugates.
  • Fertility was assessed in male rats administered daily intravenous doses of gemtuzumab ozogamicin from 0.12 to 1.08 mg/m for 28 days, followed by mating with untreated females, either at the end of the dosing period or after a 9-week drug-free period. Male fertility index was decreased at doses u22650.12 mg/m (approximately 1.2 times the exposure in patients at the maximum recommended dose, based on AUC). Effects on testes and epididymides occurred at u22650.12 mg/m, including smaller size and lower weights in addition to adverse effects on sperm. Partial recovery was noted for some effects. Additional effects in male reproductive organs occurred in repeat-dose toxicology studies and included effects on mammary gland, testes, and epididymides in rats at u22652.4 mg/m/week and effects on testes and epididymides in monkeys at 21.6 mg/m/week. Testicular effects in male monkeys with other antibody-calicheamicin conjugates included degeneration of seminiferous tubules and decreased epididymidal sperm, which did not reverse following a 6-week drug-free period.
  • No data
  • No data
  • MYLOTARG (gemtuzumab ozogamicin) for Injection is a white to off-white lyophilized cake or powder supplied in a carton (NDC 0008-4510-01) containing one 4.5 mg single-dose vial .
  • Refrigerate (2u20138u00b0C; 36u201346u00b0F) MYLOTARG vials and store in the original carton to protect from light. DO NOT FREEZE.
  • MYLOTARG is a cytotoxic drug. Follow applicable special handling and disposal procedures.n
  • No data
  • This product's label may have been updated. For full prescribing information, please visit .
  • US License No. 003
  • LAB-0868-2.0
  • Pfizer
  • NDC 0008-4510-01n n
  • MYLOTARGn- for Injection
  • 4.5 mg/vial
  • For Intravenous Infusion Only
  • Single-dose vial.
  • No PreservativesDiscard unused portion.
  • Pfizer
  • NDC 0008-4510-01
  • MYLOTARGn- for Injection
  • 4.5 mg/vial
  • For Intravenous Infusion Only
  • Reconstitution and dilutionrequired
  • No Preservatives
  • One Single-Dose Vial.Discard unused portion.
  • Rx only

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