ALTUVIIIO® HCP Resources | Sanofi

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ALTUVIIIO billing and coding information

The following ICD-10-CM code may be used to identify patient medical conditions typically associated with
hemophilia A.

The following miscellenous HCPCS codes can be used for ALTUVIIIO. The prescriber is advised to verify with the payer or Medicare fiscal intermediary to determine the correct code(s).

Code type	Code number	Description
ICD-10-CM	D66	Hereditary Factor VIII deficiency
HCPCS	J7214	Injection, Factor VIII/von Willebrand factor complex, recombinant (ALTUVIIIO) per Factor VIII IU
HCPCS	C9399	Unclassified drugs or biologics (Medicare hospital outpatient setting)

ALTUVIIIO National Drug Codes (NDCs)

NDCs are unique 3-segment numbers that serve as universal product identifiers for human drugs in the US.¹ The bolded "0" in the NDC column below represents the 11th digit required for filing claims. Payer requirements for NDC use and format may vary. Please contact each payer for specific coding policies.

Strength²	NDC²
250 IU	71104-0978-01
500 IU	71104-0979-01
1000 IU	71104-0981-01
2000 IU	71104-0982-01
3000 IU	71104-0983-01
4000 IU	71104-0984-01

This billing and coding information is provided for informational purposes only and does not constitute legal or reimbursement advice. It is not intended to substitute for the physician’s independent diagnosis or treatment of each patient. The information contained herein is gathered from various resources and is subject to change. Providers are solely responsible for the accuracy of all coding and claims submitted for reimbursement to any third-party payer.

Free laboratory tests for ALTUVIIIO

Sanofi has contracted with LabCorp (Esoterix) to provide a central lab to perform standardized one-stage clotting assays with a national network of local laboratories for specimen collection at no extra cost for the patient or healthcare provider.

Learn more information about monitoring with LabCorp.

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Simple dosing with ALTUVIIIO

Infused the same way as Factor VIII replacement therapies but taken less frequently.

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Resources for your patients

ALTUVIIIO offers a range of helpful resources and access programs for your patients.

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Indication

ALTUVIIIO^® [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl] is a von Willebrand Factor (VWF) independent recombinant DNA-derived, Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital factor VIII deficiency) for:

Routine prophylaxis to reduce the frequency of bleeding episodes
On-demand treatment & control of bleeding episodes
Perioperative management of bleeding

Limitation of Use

ALTUVIIIO is not indicated for the treatment of von Willebrand disease.

Important Safety Information

Contraindications

ALTUVIIIO is contraindicated in patients who have had severe hypersensitivity reactions, including anaphylaxis, to the product or its excipients.

Warnings and Precautions

Allergic-type hypersensitivity reactions, including anaphylaxis, may occur with ALTUVIIIO. Allergic-type hypersensitivity reactions were not reported in the clinical trials. Advise patients to discontinue use of ALTUVIIIO if hypersensitivity symptoms occur and contact a physician and/or seek immediate emergency care.
Formation of neutralizing antibodies (inhibitors) to Factor VIII are possible following administration of ALTUVIIIO. Neutralizing antibodies were not reported in the clinical trials. Monitor all patients for the development of Factor VIII inhibitors by appropriate clinical observations and laboratory tests.
If assessment of plasma Factor VIII activity is needed, it is recommended to use a validated one-stage clotting assay. The ALTUVIIIO Factor VIII activity level is overestimated by the chromogenic assay and a specific ellagic acid-based aPTT reagent in one-stage clotting assay by approximately 2.5-fold. If these assays are used, divide the result by 2.5 to approximate the patient's ALTUVIIIO Factor VIII activity level.

Adverse Reactions

The most common adverse reactions (>10% of subjects) reported in clinical trials were headache and arthralgia.

Please see full Prescribing Information.

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IndicationImportant Safety Information

HCPCS=Healthcare Common Procedure Coding System; IU=international unit.

Reference: 1. US Food and Drug Administration. National Drug Code Directory. Updated July 22, 2022. Accessed September 8, 2023. https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory 2. ALTUVIIIO Prescribing Information. Bioverativ Therapeutics Inc. Waltham, MA.

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