Indication and usage

Privigen is indicated for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability and impairment.

Privigen maintenance therapy in CIDP has not been studied for periods longer than 6 months. After responding during an initial treatment period, not all patients require indefinite maintenance therapy with Privigen in order to remain free of CIDP symptoms. Individualize the duration of any treatment beyond 6 months based upon the patient's response and demonstrated need for continued therapy.

Privigen has been proven effective in CIDP treatment

Largest
CIDP Trial

PATH, one of two clinical trials,* was the largest ever CIDP study, evaluating 207 patients

Proven Efficacy

Overall response rates to Privigen were 61% and 73% in PRIMA and PATH,* respectively

Rapid Response

Almost all who responded to Privigen did so after 1–2 maintenance treatments at Weeks 4 and 7*

Demonstrated Tolerability

In both studies,* 97% of adverse reactions were mild or moderate in intensity with 2 and 8 subjects experiencing serious adverse reactions in PRIMA and PATH, respectively

10 YearsUS Market Experience

Privigen was FDA approved for PI and chronic ITP in 2007

ProlineStability

Privigen is the first and only IVIg with proline, an amino acid shown to reduce IgG aggregation and dimer formation16

*In a prospective, open-label, single-arm, multicenter clinical study (Privigen Impact on Mobility and Autonomy [PRIMA]), 28 subjects with CIDP received a Privigen loading dose of 2 g/kg followed by Privigen maintenance doses of 1 g/kg every 3 weeks for up to 21 weeks with 3-week follow-up. In a second prospective, open-label Privigen prerandomization phase of a multicenter clinical study (Polyneuropathy and Treatment with Hizentra [PATH]), 207 IVIg-pretreated subjects with CIDP received a Privigen loading dose of 2 g/kg followed by up to 4 Privigen maintenance doses of 1 g/kg every 3 weeks for up to 13 weeks. Overall response rate was defined as percentage of subjects who experienced at least 1-point decrease in adjusted INCAT score. Primary immunodeficiency and chronic immune thrombocytopenic purpura.

Stay up-to-date about Privigen for CIDP

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CIDP administration

Privigen is a ready-to-use 10% liquid intravenous immunoglobulin (IVIg) with no warming or reconstitution necessary. It should be given by a separate infusion line and not mixed with other intravenous medications.§ See the chart below to find dosing for your patient.

§Privigen may be diluted with Dextrose Injection, USP (D5W).

Recommended dosing and infusion rates

Indication CIDP
Dose
Loading dose:
2 g/kg (20 mL/kg) in divided doses over 2 to 5 consecutive days

Maintenance dose: 1 g/kg (10 mL/kg) administered in 1 to 2 infusions on consecutive days, every 3 weeks
Initial infusion rate 0.5 mg/kg/min
(0.005/mL/kg/min)
Maintenance infusion rate (if tolerated) Increase to 8 mg/kg/min
(0.08 mL/kg/min)
Indication Dose Initial infusion rate Maintenance infusion rate (if tolerated)
CIDP
Loading dose: 2 g/kg (20 mL/kg) in divided doses over 2 to 5 consecutive days
Maintenance dose: 1 g/kg (10 mL/kg) administered in 1 to 2 infusions on consecutive days, every 3 weeks
0.5 mg/kg/min (0.005/mL/kg/min) Increase to 8 mg/kg/min (0.08 mL/kg/min)

Monitor the patient's vital signs throughout the infusion. Slow or stop the infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a lower rate that is comfortable for the patient.

The Privigen Reference Guide

Keep pertinent information about Privigen for CIDP handy. View and download The Privigen CIDP Reference Guide.

Billing and diagnosis codes

Coverage of Privigen for the medically necessary treatment of CIDP varies by payer plan and contract. Download the Prescription Referral Form to confirm insurance coverage options.

ICD-10-CM22 Diagnosis Code

G61.81
Chronic inflammatory demyelinating polyneuritis Chronic inflammatory demyelinating polyneuropathy Chronic inflammatory demyelinating polyradiculoneuropathy Polyneuropathy (multiple nerve disorder) Polyneuropathy, chronic inflammatory demyelinating Polyradiculoneuropathy, chronic inflammatory demyelinating Polyradiculoneuropathy, inflammatory demyelination

CPT® and HCPCS Codes (Healthcare Common Procedural Coding System) CPT/HCPCS Code Description23,24

S9338||
Home infusion therapy, immunotherapy, administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately)
J1459
Injection, immune globulin (Privigen), intravenous, non-lyophilized (eg, liquid), 500 mg
96365
Intravenous infusion, for therapy and prophylaxis or diagnosis (specify substance or drug); initial, up to 1 hour
96366
Each additional hour (list separately in addition to code for primary procedure)

This resource provides information from a complex and evolving medical coding system. The treating physician is solely responsible for diagnosis coding and determination of the appropriate ICD-10-CM codes that describe the patient's condition and are supported by the medical record. All codes listed in this guide are for informational purposes and are not an exhaustive list. The CPT®, HCPCS, and ICD-10-CM codes provided are based on AMA or CMS guidelines. The billing party is solely responsible for coding of services (eg, CPT coding). Because government and other third-party payer coding requirements change periodically, please verify current coding requirements directly with the payer being billed. Medicare coverage and billing requirements are dependent in part on where the patient is treated. CPT=Current Procedural Terminology. ||S-codes are HCPCS codes used by some private health plans for billing and reimbursement. Medicaid plans may use S-codes as well, but Medicare does not use them.25

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