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Mylotarg

(gemtuzumab ozogamicin)

gemtuzumab ozogamicin 4.5 MG Injection [Mylotarg]

Dosage & administration

* 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 .
* See Full Prescribing Information for complete dosing information .

* 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 MYLOTARG 2 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 .

* Premedicate with a corticosteroid, antihistamine, and acetaminophen .

Mylotarg clinical details

Mechanism of Action (MOA)

Dosing: Adult AML (Combination Regimen)

Preparation & Administration: Adult AML (Combination Regimen)

Efficacy: Adult AML (Combination Regimen)

Safety Profile: Adult AML (Combination Regimen)

Clinical Trials: Adult AML (Combination Regimen)

Dosing: Pediatric AML (Combination Regimen)

Preparation & Administration: Pediatric AML (Combination Regimen)

Efficacy: Pediatric AML (Combination Regimen)

Safety Profile: Pediatric AML (Combination Regimen)

Clinical Trials: Pediatric AML (Combination Regimen)

Dosing: Adult AML (Single-Agent Regimen)

Preparation & Administration: Adult AML (Single-Agent Regimen)

Efficacy: Adult AML (Single-Agent Regimen)

Safety Profile: Adult AML (Single-Agent Regimen)

Clinical Trials: Adult AML (Single-Agent Regimen)

Dosing: Relapsed or Refractory AML (Single-Agent Regimen)

Preparation & Administration: Relapsed or Refractory AML (Single-Agent Regimen)

Efficacy: Relapsed or Refractory AML (Single-Agent Regimen)

Safety Profile: Relapsed or Refractory AML (Single-Agent Regimen)

Clinical Trials: Relapsed or Refractory AML (Single-Agent Regimen)

drug label

Mylotarg prescribing information

Have more Mylotarg questions?

Submit MSL Request

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Need to report a Mylotarg issue?

ONLINE FORMReport adverse event

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prior authorization

Mylotarg Prior authorization resources

Complete Letter of Medical Necessity

NOT PROVIDED BY BRANDCoverage Authorization Request

NOT PROVIDED BY BRANDComplete Coverage Authorization appeals

Coverage Authorization Appeal

Formulary Exception Letter

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Benefits investigation

Pfizer Oncology Together Form

Pfizer Oncology Together Form - Spanish

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Reimbursement help (FRM)

Receive Assistance from an FRM Regarding Reimbursement Information

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financial assistance

Mylotarg Financial assistance options

Co-pay savings program

commercial only

Pfizer Oncology Together Form

Pfizer Oncology Together Form - Spanish

Enroll in Patient Savings Program

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Overview

Reduce patient OOP costs for drug (and occasionally for drug administration/infusion costs or drug-related test costs)

Patient benefit

A portion (or all) of patient OOP (deductible, copay), typically up to monthly and/or annual max

Patient eligibility

Patient must enroll or activate (may permit HCPs to enroll on patient’s behalf for HCP-administered drugs)
Generally, must have commercial insurance (rarely, may permit uninsured patients to use)
May never be used with government insurance

How to sign up

Cards may be downloadable digital cards or hard copies
Some pharmacos offer debit cards with pre-loaded copay benefit
Typically, available through multiple channels (e.g., rep to HCP to patient; pharmacy to patient; patient via website, Hub live agent, or copay vendor (live agent or IVR); patient and HCP via Hub enrollment form)
Some HCP-administered product programs permit HCPs to enroll on a patient’s behalf through via Hub form

Bridge program

commercial only

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Overview

Provide patient immediate access to therapy during an insurance delay (typically new starts; some may cover change in insurance)
Limited time/ fill (typically 7-30 days; some may offer additional fill for continued delay up to certain limit)

Patient benefit

100% free (outside of insurance)

Patient eligibility

HCP must enroll patient
May be limited to commercially insured patients (i.e., no government beneficiaries); some programs may allow government beneficiaries

How to sign up

Typically HCP assisted enrollment (via form)

Foundation programs

under insured

no insurance

goverment insurance

65+

Pfizer Oncology Together Form

Pfizer Oncology Together Form - Spanish

Pfizer Patient Assistance Program

Learn More

Overview

Charitable 501(c)(3) organizations provide direct cost-sharing and other support (e.g., travel, counseling) through disease-state funds to indigent patients on first-come first-served basis
These organizations may receive financial contributions from drug manaufacturers for particular disease-state funds that cannot provide funds directly to patients - the foundation must be independent/unaligned

Patient benefit

Patients apply for grants that cover a portion (or all) of their out-of-pocket costs (deductibles and co-pays) until the grant is exhausted

Patient eligibility

Patients must apply and meet eligibility criteria including income level (typically a multiple of federal poverty line), specific diagnosis, insurance status, etc.

How to sign up

Patients submit proof of out-of-pocket drug costs to charities for reimbursement

patient education

Mylotarg Patient education

Getting started on Mylotarg

NOT PROVIDED BY BRANDInstructions For Use: Adult AML (Combination Regimen)

NOT PROVIDED BY BRANDInstructions For Use: Adult AML (Single-Agent Regimen)

Patient toolkit

Comprehensive Support Program - Care Champion Program

ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link

Pfizer Oncology Patient Access Guide

ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link

Pfizer Oncology Patient Access Guide - Spanish

ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link

NOT PROVIDED BY BRANDInstructions For Use: Pediatric AML (Combination Regimen)

NOT PROVIDED BY BRANDInstructions For Use: Relapsed or Refractory AML (Single-Agent Regimen)

Learn More

Mylotarg FAQs

FAQ Data Source

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Please note:

Access to a Field Reimbursement Manager (FRM) or Medical Science Liaison (MSL) varies by brand and may require talking with your rep first.
Samples are provided at the discretion of the brand.
We are unable to collect Protected Health Information (PHI), fill out forms, or submit them on your behalf.

Mylotarg

Dosage & administration

Most viewed Mylotarg resources

eficacy, safety & testing

Mylotarg clinical details

drug label

Mylotarg prescribing information

Have more Mylotarg questions?

Need to report a Mylotarg issue?

prior authorization

Mylotarg Prior authorization resources

Benefits investigation

Reimbursement help (FRM)

financial assistance

Mylotarg Financial assistance options

Co-pay savings program

Overview

Patient benefit

Patient eligibility

How to sign up

Bridge program

Overview

Patient benefit

Patient eligibility

How to sign up

Foundation programs

Overview

Patient benefit

Patient eligibility

How to sign up

patient education

Mylotarg Patient education

Getting started on Mylotarg

Patient toolkit

people also ask

Mylotarg FAQs

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