What is the dosage of Danyelza?

Danyelza is available in 1 dosages, including 4 mg/ml Injection 10 ml

What is Danyelza made of?

Danyelza contains naxitamab which is a undefined

How is Danyelza administered?

Danyelza is administered as a Injectable

What is Danyelza mechanism of action?

Danyelza mechanism of action is

Dosage & Administration Drug label Prior authorization Financial assistance

Patient education

Danyelza

(naxitamab)

10 ML naxitamab-gqgk 4 MG/ML Injection [Danyelza]

BLACK BOX WARNING

Dosage & administration

The recommended dosage of DANYELZA is 3 mg/kg/day (up to 150 mg/day), administered as an intravenous infusion after dilution on Days 1, 3, and 5 of each treatment cycle. Treatment cycles are repeated every 4 weeks until complete response or partial response, followed by 5 additional cycles every 4 weeks. Subsequent cycles may be repeated every 8 weeks.

Discontinue DANYELZA and GM-CSF for disease progression or unacceptable toxicity. Administer GM-CSF subcutaneously prior to and during each treatment cycle as recommended.

drug label

Danyelza prescribing information

Have more Danyelza questions?

Submit MSL Request

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Need to report a Danyelza issue?

ONLINE FORMReport adverse event

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prior authorization

Danyelza Prior authorization resources

Complete Letter of Medical Necessity

NOT PROVIDED BY BRANDCoverage Authorization Request

Coverage Authorization Appeals

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Benefits investigation

Y-mAbs Connect Enrollment Form

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Reimbursement help (FRM)

Receive Assistance from an FRM Regarding Reimbursement Information

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financial assistance

Danyelza Financial assistance options

Co-pay savings program

commercial only

Y-mAbs Connect Enrollment Form

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+

Y-mAbs Connect Patient Assistance Program

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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

Danyelza Patient education