What is the dosage of Hizentra?

Hizentra is available in 7 dosages, including 200 mg/ml Injection 10 ml, 200 mg/ml Injection 20 ml, 200 mg/ml Injection 5 ml, 200 mg/ml Injection 50 ml, 200 mg/ml Prefilled Syringe 10 ml, 200 mg/ml Prefilled Syringe 20 ml and 200 mg/ml Prefilled Syringe 5 ml

What does Hizentra treat?

Hizentra treats Immunologic Deficiency Syndromes

What is Hizentra made of?

Hizentra contains immunoglobulin G which is a Human Immunoglobulin G

How is Hizentra administered?

Hizentra is administered as a Injectable

What is Hizentra mechanism of action?

Hizentra mechanism of action is Antigen Neutralization

Dosage & Administration Drug label Prior authorization Financial assistance

Patient education

Hizentra

(immunoglobulin G)

10 ML immunoglobulin G, human 200 MG/ML Injection [Hizentra]10 ML immunoglobulin G, human 200 MG/ML Prefilled Syringe [Hizentra]

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BLACK BOX WARNING

Dosage & administration

For subcutaneous infusion only.

Dose

Before switching to HIZENTRA, obtain the patient's serum IgG trough level to guide subsequent dose adjustments.

* Weekly: Start HIZENTRA 1 week after last Immune Globulin Intravenous (Human) (IGIV) infusion.

Initial weekly dose =	Previous IGIV dose (in grams) × 1.37
	No. of weeks between IGIV doses

* Biweekly (every 2 weeks): Start HIZENTRA 1 or 2 weeks after the last IGIV infusion or 1 week after the last weekly IGSC infusion. Administer twice the calculated weekly dose.
* Frequent dosing (2 to 7 times per week): Start HIZENTRA 1 week after the last IGIV or IGSC infusion. Divide the calculated weekly dose by the desired number of times per week.
* Adjust the dose based on clinical response and serum IgG trough levels.

CIDP

* Initiate therapy with HIZENTRA 1 week after the last IGIV infusion.
* Recommended subcutaneous dose is 0.2 g/kg (1 mL/kg) body weight per week.
* In the clinical study after transitioning from IGIV to HIZENTRA, a dose of 0.4 g/kg (2 mL/kg) body weight per week was also safe and effective to prevent CIDP relapse.

* If CIDP symptoms worsen, on 0.2 g/kg (1 mL/kg) body weight per week, consider increasing the HIZENTRA dose from 0.2 g/kg to 0.4 g/kg body weight per week.
* If CIDP symptoms worsen on 0.4 g/kg body weight per week, consider re-initiating therapy with IGIV, while discontinuing HIZENTRA.

* Monitor patient's clinical response and adjust duration of therapy based on patient need.

Administration

* PI: Administer at regular intervals from daily up to every 2 weeks.
* CIDP: Administer weekly.
* Infusion sites – Up to 8 infusion sites are allowed simultaneously, with at least 2 inches between sites.

Administration in PI
Infusion Parameters *	1st Infusion	Subsequent Infusions
* As tolerated
Volume (mL/site)	≤15	≤25
Rate (mL/hr/site)	≤15	≤25

Administration in CIDP
Infusion Parameters *	1st Infusion	Subsequent Infusions
* As tolerated
Volume (mL/site)	≤20	≤50
Rate (mL/hr/site)	≤20	≤50

Hizentra prescribing information

Have more Hizentra questions?

Submit MSL Request

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Need to report a Hizentra issue?

ONLINE FORMReport adverse event

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prior authorization

Hizentra Prior authorization resources

NOT PROVIDED BY BRANDComplete Letter of Medical Necessity

NOT PROVIDED BY BRANDCoverage Authorization Request

NOT PROVIDED BY BRANDCoverage Authorization Appeals

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Benefits investigation

Hizentra Prescription Referral Form

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Reimbursement help (FRM)

NOT PROVIDED BY BRANDReimbursement help (FRM) resources

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financial assistance

Hizentra Financial assistance options

Co-pay savings program

commercial only

Hizentra Prescription Referral 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

Enroll in Bridge Program ( Protection if you lose insurance)

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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+

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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