know your ivig options - csl behring · know your ivig options proven igg therapy designed for...

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Chronic ITP PI CIDP Know your IVIg options Proven IgG therapy Designed for stability Please see full Important Safety Information for Privigen and Carimune NF on following pages and full prescribing information, including boxed warning, in pocket.

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Page 1: Know your IVIg options - CSL Behring · Know your IVIg options Proven IgG therapy Designed for stability Please see full Important Safety Information for Privigen and Carimune NF

Chronic ITPPI CIDP

Know your IVIg options

Proven IgG therapyDesigned for stability

Please see full Important Safety Information for Privigen and Carimune NF on following pages and full prescribing information, including boxed warning, in pocket.

Page 2: Know your IVIg options - CSL Behring · Know your IVIg options Proven IgG therapy Designed for stability Please see full Important Safety Information for Privigen and Carimune NF

Privigen is a convenient 10% liquid IVIg

Storage Privigen is ready to use

No reconstitution or warming needed

36-month room-temperature storage

5 g (50 mL) 10 g (100 mL) 20 g (200 mL) 40 g (400 mL)

Vial Sizes Multiple vial sizes to minimize waste Includes the largest vial of IVIg available

Important Safety Information for PrivigenWARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE • Thrombosis may occur with immune globulin products, including Privigen. Risk factors may include

advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.

• Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products that contain sucrose. Privigen does not contain sucrose.

• For patients at risk of thrombosis, renal dysfunction or renal failure, administer Privigen at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

See full prescribing information for complete boxed warning.

Please see full Important Safety Informationfor Privigen on adjacent page and full prescribing information, including boxed warning, in pocket.

Used inUS Hospitals Since 20101

#1IVIg

Proven effective, Privigen is the first and onlyIVIg designed with proline stabilization Privigen is approved forthe treatment of PI, CIDP,and chronic ITP

Low IgA content

Convenient, ready-to-use 10% IVIg that can be storedat room temperature

Important Safety Information for PrivigenPrivigen is indicated for the treatment of:• Primary humoral immunodeficiency (PI)• Chronic immune thrombocytopenic purpura (ITP) in patients age 15 years and older • Chronic inflammatory demyelinating polyneuropathy (CIDP) in adults

– Limitation of use: maintenance therapy in CIDP has not been studied for periods longer than 6 months. Individualize duration of treatment beyond 6 months based on patient response.

Please see full Important Safety Informationfor Privigen on adjacent page and full prescribing information, including boxed warning, in pocket.

Page 3: Know your IVIg options - CSL Behring · Know your IVIg options Proven IgG therapy Designed for stability Please see full Important Safety Information for Privigen and Carimune NF

Review your IVIg* options for PI, ITP, and CIDP

FeaturePrivigen®

Immune Globulin Intravenous (Human),10% Liquid CSL Behring AG†

Carimune® NFImmune Globulin Intravenous (Human)CSL Behring AG

Gammaked™

Immune Globulin Injection (Human)10% Caprylate/Chromatography PurifiedKedrion Biopharma, Inc.2

Gamunex®-CImmune Globulin Injection (Human), 10% Caprylate/Chromatography PurifiedGrifols Therapeutics Inc.3

Gammagard® Liquid Immune Globulin Infusion (Human), 10% Solution,for intravenous and subcutaneous administrationBaxalta Healthcare Corporation4

Gammagard® S/DImmune Globulin Intravenous (Human)Shire Healthcare Corporation5

Flebogamma® 5% DIFImmune Globulin Intravenous (Human)Instituto Grifols, S.A.6

Flebogamma® 10% DIFImmune Globulin Intravenous (Human)Instituto Grifols, S.A.7

Octagam® 5%Immune Globulin Intravenous (Human) 5% Liquid PreparationOctapharma USA Inc.8

Octagam® 10%Immune Globulin Intravenous (Human) 10% Liquid PreparationOctapharma USA Inc.9

Gammaplex® 5%Immune Globulin Intravenous (Human), 5% LiquidBio Products Laboratory Limited10

Gammaplex® 10%Immune Globulin Intravenous (Human), 10% LiquidBio Products Laboratory Limited11

Concentration/Dosage form Ready-to-use 10% liquid

• Lyophilized powder ranging from 3% to 12% concentration

• Reconstitution required prior to administration

Ready-to-use 10% liquid Ready-to-use 10% liquid Ready-to-use 10% liquid• Freeze-dried• Reconstitution required prior to administration

Ready-to-use 5% liquid Ready-to-use 10% liquid Ready-to-use 5% liquid Ready-to-use 10% liquid Ready-to-use 5% liquid Ready-to-use 10% liquid

Vial sizes, grams (mL) 5 g (50 mL), 10 g (100 mL), 20 g (200 mL), 40 g (400 mL)

6 g, 12 g white lyophilized powder for reconstitution

1 g (10 mL), 2.5 g (25 mL), 5 g (50 mL), 10 g (100 mL), 20 g (200 mL)

1 g (10 mL ), 2.5 g (25 mL), 5 g (50 mL), 10 g (100 mL), 20 g (200 mL), 40 g (400 mL)

1 g (10 mL), 2.5 g (25 mL), 5 g (50 mL), 10 g (100 mL), 20 g (200 mL ), 30 g (300 mL)

5 g, 10 g freeze-dried preparation for reconstitution 0.5 g (10 mL), 2.5 g (50 mL ), 5 g (100 mL), 10 g (200 mL), 20 g (400 mL)

5 g (50 mL), 10 g (100 mL), 20 g (200 mL) 1 g (20 mL), 2.5 g (50 mL), 5 g (100 mL), 10 g (200 mL), 25 g (500 mL)

2 g (20 mL), 5 g (50 mL), 10 g (100 mL), 20 g (200 mL)2.5 g (50 mL), 5 g (100 mL), 10 g (200 mL), 20 g (400mL)

5 g (50 mL), 10 g (100 mL), 20 g (200 mL)

Storage requirement 36 months at room-temperature storage up to 25°C (77°F). Do not freeze

Store at <30°C (86°F) until expiration date. Do not freeze

• 36 months at refrigerated temperature 2°–8°C (36°–46°F). Do not freeze

• Up to 6 months at temperatures not to exceed 25°C (77°F) anytime during the 36-month shelf life. Must be discarded after 6 months

• 36 months at refrigerated temperature 2°–8°C (36°–46°F). Do not freeze

• Up to 6 months at temperatures not to exceed 25°C (77°F) anytime during the 36-month shelf life. Must be discarded after 6 months

• Store Gammagard Liquid in the refrigerator or at room temperature

• Refrigeration: 2°–8°C (36°–46°F) for up to 36 months. Do not freeze

• Room temperature: Up to 25°C (77°F) for up to24 months

24 months unreconstituted; temperature not to exceed 25°C (77°F). Do not freeze

24 months from date of manufacture at room temperature 2°–25°C (36°–77°F). Do not freeze

Up to 24 months from date of manufacture at room temperature 2°–25°C (36°–77°F). Do not freeze

24 months from date of manufacture at 2°–25°C (36°–77°F). Do not freeze

24 months from date of manufacture at 2°C–8°C (36°F–46°F). Within the first 12 months of shelf-life, may be stored up to 9 months at ≤ + 25°C (77°F), after which the product must be used or discarded. Do not freeze

36 months at 2°–25°C (36°–77°F) until expiration date. Protect from light; do not freeze

36 months at 2°–25°C (36°–77°F) until expiration date. Protect from light; do not freeze

Sucrose/Sugars None 1.67 g sucrose per gram of protein Not mentioned Not mentioned None 20 mg/mL glucose in a 5% solution Contains D-sorbitol Contains D-sorbitol 100 mg/mL maltose 90 mg/mL maltose 5 g D-sorbitol in 100 mL of buffer solution None

IgA content ≤25 µg/mL Trace amounts Trace amounts of IgA (average 46 µg/mL) Trace amounts of IgA (average 46 µg/mL) Average 37 µg/mL <1 µg/mL in a 5% solution <50 µg/mL <100 µg/mL ≤200 µg/mL 106 µg/mL <10 µg/mL <20 µg/mL

Stabilizer Proline‡: ~250 mmol/L (range 210–290) Sucrose Glycine Glycine Glycine Glycine, glucose, and polysorbate 80 D-sorbitol D-sorbitol Maltose Maltose Sorbitol, glycine, and polysorbate 80 Glycine, and polysorbate 80

IgG purity ≥98% ≥96% ≥98% ≥98% ≥98% ≥90% ≥97% ≥97% ≥96% ≥96% >95% ≥98%

Half-life 36.6 days (median) 21 days (not specified)30–43 days (mean, dependent on patient age)

30–43 days (mean, dependent on patient age)

35 days (median) 37.7 days (not specified)• 30 days (mean) for patients on 3-week dosing schedule• 32 days (mean) for patients on 4-week dosing schedule

• 34 days (mean) for patients on 3-week dosing schedule• 37 days (mean) for patients on 4-week dosing schedule

36 days (median) Not studied• 6.06 days (mean) for 21-day dosing interval• 5.79 days (mean) for 28-day dosing interval

• 4.92 days (mean) for 21-day dosing interval• 5.12 days (mean) for 28-day dosing interval

Sodium Trace amounts <20 mg NaCI/g of protein Not mentioned Not mentioned No sodium added ~8.5 mg/mL sodium chloride in a 5% solution Trace amounts Trace amounts ≤30 mmol/L ≤30 mmol/L0.2 g sodium acetate and 0.3 g sodium chloride in 100 mL of buffer solution

<30 mM sodium chloride

Osmolality ~320 mOsmol/kg (range 240–440)

• In sterile water—3%: 192 mOsm/kg; 6%: 384 mOsm/kg; 9%: 576 mOsm/kg; 12%: 768 mOsm/kg

• In 5% dextrose—3%: 444 mOsm/kg; 6%: 636 mOsm/kg; 9%: 828 mOsm/kg; 12%: 1020 mOsm/kg

• In 0.9% saline—3%: 498 mOsm/kg; 6%: 690 mOsm/kg; 9%: 882 mOsm/kg; 12%: 1074 mOsm/kg

258 mOsmol/kg 258 mOsmol/kg 240–300 mOsmol/kg Not mentioned 240–370 mOsm/kg 240–370 mOsm/kg 310–380 mOsmol/kg 310–380 mOsmol/kg Typically 420–500 mOsmol/kg Typically 280 mOsmol/kg

Latex content Packaging components are not made with natural rubber latex

Not made with natural rubber latex Not made with natural rubber latex Not made with natural rubber latexPackaging of this product is not made with natural rubber latex

Not made with natural rubber latex Not made with natural rubber latex Not made with natural rubber latex Components used in the packaging are latex-freeComponents used in packaging are not made with natural rubber latex

Components used in the packaging are not made with natural rubber latex

Components used in the packaging are latex free

Diluent May be diluted with dextrose injection Sodium chloride, dextrose, or sterile waterIf dilution is required, may be diluted with 5% dextrose in water

If dilution is required, may be diluted with 5% dextrose in water

If dilution is desired, may be diluted with 5% dextrose in water

Sterile water for injection Do not dilute Do not dilute Should not be diluted Do not dilute Do not mix Do not mix

Dimers ≤12% Not mentioned Not mentioned Not mentioned Not mentioned Not mentioned Not mentioned Not mentioned Not <90% monomers and dimers Not <94% monomers and dimers Not mentioned Not mentioned

Pathogen safety§

• pH 4 incubation• Depth filtration—a virus partitioning

process• Nanofiltration (to ~20 nm)• Validated Transmittable Spongiform

Encephalopathy reduction steps

• Fractionation and depth filtration• pH 4/pepsin treatment• Nanofiltration • Validated Transmittable Spongiform

Encephalopathy reduction steps

• Caprylate precipitation/Depth filtration• Caprylate incubation• Depth filtration• Column chromatography• Nanofiltration• Low pH incubation• Validated Transmittable Spongiform

Encephalopathy reduction steps

• Caprylate precipitation/Depth filtration• Caprylate incubation• Depth filtration• Column chromatography• Nanofiltration• Low pH incubation• Validated Transmittable Spongiform

Encephalopathy reduction steps

• Solvent/detergent (S/D) treatment• 35 nm nanofiltration• Low pH incubation at elevated temperature

• Processing of cryo-poor plasma to Fraction I+II+III precipitate

• Processing of resuspended suspension A precipitate to suspension B Cuno 70 filtrate

• Solvent/detergent treatment

• Pasteurization• S/D treatment• Nanofiltration using 20 nm Planova filters• Fraction I precipitation• Fraction II+III precipitation• 4% PEG precipitation• Acid pH treatment• Validated Transmittable Spongiform

Encephalopathy reduction steps

• Pasteurization• S/D treatment• Nanofiltration using 20 nm Planova filters• Fraction I precipitation• Fraction II+III precipitation• 4% PEG precipitation• Acid pH treatment• Validated Transmittable Spongiform

Encephalopathy reduction steps

• Cold ethanol fractionation• S/D treatment• pH 4 treatment

• Cold ethanol fractionation• S/D treatment• pH 4 treatment

• S/D treatment• Virus filtration• pH incubation

• S/D treatment• Virus filtration• pH incubation

Initial infusion rate(s)(Minimum rate practicable in high-risk patients)

PI, chronic ITP, and CIDP• 0.5 mg/kg/min (0.005 mL/kg/min)

PI and acute/chronic ITP• 0.5 mg/kg/min (0.005 mL/kg/min at

10% concentration)• After 30 min, increase to 1 mg/kg/min

(0.01 mL/kg/min at 10%) as tolerated

PI and acute/chronic ITP• 1 mg/kg/min (0.01 mL/kg/min)CIDP• 2 mg/kg/min (0.02 mL/kg/min)

PI and chronic ITP• 1 mg/kg/min (0.01 mL/kg/min)CIDP• 2 mg/kg/min (0.02 mL/kg/min)

PI• 0.8 mg/kg/min (0.008 mL/kg/min) for 30 min

PI and chronic ITP• 0.4 mg/kg/min (0.008 mL/kg/min) for 5% dilution

PI• 0.5 mg/kg/min (0.01 mL/kg/min)

PI and chronic ITP• 1 mg/kg/min (0.01 mL/kg/min)

PI• 0.5 mg/kg/min (0.01 mL/kg/min)

Chronic ITP• 1.0 mg/kg/min (0.01 mL/kg/min)

PI and chronic ITP• 0.5 mg/kg/min (0.01 mL/kg/min)

for 15 minutes

PI and chronic ITP• 0.5 mg/kg/min (0.005 mL/kg/min)

for 15 minutes

Maximum infusion rate(s)(Administer at the minimum rate of infusion for those at risk of thrombosis, renal dysfunction/failure, and other high-risk patients.)

PI and CIDP• Gradually increase to 8 mg/kg/min

(0.08 mL/kg/min) as toleratedChronic ITP• Increase to 4 mg/kg/min (0.04 mL/kg/min)

PI and acute/chronic ITP• Gradually increase as tolerated—not to

exceed 3 mg/kg/min (0.03 mL/kg/min at 10%); 2 mg/kg/min (0.02 mL/kg/min at 10%) for high-risk patients

PI, acute/chronic ITP, and CIDP• Gradually increase to 8 mg/kg/min

(0.08 mL/kg/min) as tolerated

PI and chronic ITP• Gradually increase to 8 mg/kg/min

(0.08 mL/kg/min) as toleratedCIDP• Gradually increase to 8 mg/kg/min

(0.08 mL/kg/min) as tolerated every 3 weeks

PI IV administration:• Increase every 30 minutes (if tolerated) up to

8 mg/kg/min (0.08 mL/kg/min)

PI and chronic ITP• Gradually increase to 3.3 mg/kg/min

(0.066 mL/kg/min) as tolerated (5%)

PI• Gradually increase to 5 mg/kg/min

(0.10 mL/kg/min) as tolerated

PI and chronic ITP• Gradually increase to 8 mg/kg/min

(0.08 mL/kg/min) as tolerated

PI• Gradually increase to <3.33 mg/kg/min

(<0.07 mL/kg/min) as tolerated

Chronic ITP• Gradually increase to 12.0 mg/kg/min (Up to

0.12 mL/kg/min) as tolerated

PI and chronic ITP• Gradually increase every 15 minutes to

4 mg/kg/min (0.08 mL/kg/min) as tolerated

PI and chronic ITP• Gradually increase every 15 minutes to

8 mg/kg/min (0.08 mL/kg/min) as tolerated

Review your IVIg* options for PI, ITP, and CIDP

FeaturePrivigen®

Immune Globulin Intravenous (Human),10% Liquid CSL Behring AG†

Carimune® NFImmune Globulin Intravenous (Human)CSL Behring AG

Gammaked™

Immune Globulin Injection (Human)10% Caprylate/Chromatography PurifiedKedrion Biopharma, Inc.2

Gamunex®-CImmune Globulin Injection (Human), 10% Caprylate/Chromatography PurifiedGrifols Therapeutics Inc.3

Gammagard® Liquid Immune Globulin Infusion (Human), 10% Solution,for intravenous and subcutaneous administrationBaxalta Healthcare Corporation4

Gammagard® S/DImmune Globulin Intravenous (Human)Shire Healthcare Corporation5

Flebogamma® 5% DIFImmune Globulin Intravenous (Human)Instituto Grifols, S.A.6

Flebogamma® 10% DIFImmune Globulin Intravenous (Human)Instituto Grifols, S.A.7

Octagam® 5%Immune Globulin Intravenous (Human) 5% Liquid PreparationOctapharma USA Inc.8

Octagam® 10%Immune Globulin Intravenous (Human) 10% Liquid PreparationOctapharma USA Inc.9

Gammaplex® 5%Immune Globulin Intravenous (Human), 5% LiquidBio Products Laboratory Limited10

Gammaplex® 10%Immune Globulin Intravenous (Human), 10% LiquidBio Products Laboratory Limited11

Concentration/Dosage form Ready-to-use 10% liquid

• Lyophilized powder ranging from 3% to 12% concentration

• Reconstitution required prior to administration

Ready-to-use 10% liquid Ready-to-use 10% liquid Ready-to-use 10% liquid• Freeze-dried• Reconstitution required prior to administration

Ready-to-use 5% liquid Ready-to-use 10% liquid Ready-to-use 5% liquid Ready-to-use 10% liquid Ready-to-use 5% liquid Ready-to-use 10% liquid

Vial sizes, grams (mL) 5 g (50 mL), 10 g (100 mL), 20 g (200 mL), 40 g (400 mL)

6 g, 12 g white lyophilized powder for reconstitution

1 g (10 mL), 2.5 g (25 mL), 5 g (50 mL), 10 g (100 mL), 20 g (200 mL)

1 g (10 mL ), 2.5 g (25 mL), 5 g (50 mL), 10 g (100 mL), 20 g (200 mL), 40 g (400 mL)

1 g (10 mL), 2.5 g (25 mL), 5 g (50 mL), 10 g (100 mL), 20 g (200 mL ), 30 g (300 mL)

5 g, 10 g freeze-dried preparation for reconstitution 0.5 g (10 mL), 2.5 g (50 mL ), 5 g (100 mL), 10 g (200 mL), 20 g (400 mL)

5 g (50 mL), 10 g (100 mL), 20 g (200 mL) 1 g (20 mL), 2.5 g (50 mL), 5 g (100 mL), 10 g (200 mL), 25 g (500 mL)

2 g (20 mL), 5 g (50 mL), 10 g (100 mL), 20 g (200 mL)2.5 g (50 mL), 5 g (100 mL), 10 g (200 mL), 20 g (400mL)

5 g (50 mL), 10 g (100 mL), 20 g (200 mL)

Storage requirement 36 months at room-temperature storage up to 25°C (77°F). Do not freeze

Store at <30°C (86°F) until expiration date. Do not freeze

• 36 months at refrigerated temperature 2°–8°C (36°–46°F). Do not freeze

• Up to 6 months at temperatures not to exceed 25°C (77°F) anytime during the 36-month shelf life. Must be discarded after 6 months

• 36 months at refrigerated temperature 2°–8°C (36°–46°F). Do not freeze

• Up to 6 months at temperatures not to exceed 25°C (77°F) anytime during the 36-month shelf life. Must be discarded after 6 months

• Store Gammagard Liquid in the refrigerator or at room temperature

• Refrigeration: 2°–8°C (36°–46°F) for up to 36 months. Do not freeze

• Room temperature: Up to 25°C (77°F) for up to24 months

24 months unreconstituted; temperature not to exceed 25°C (77°F). Do not freeze

24 months from date of manufacture at room temperature 2°–25°C (36°–77°F). Do not freeze

Up to 24 months from date of manufacture at room temperature 2°–25°C (36°–77°F). Do not freeze

24 months from date of manufacture at 2°–25°C (36°–77°F). Do not freeze

24 months from date of manufacture at 2°C–8°C (36°F–46°F). Within the first 12 months of shelf-life, may be stored up to 9 months at ≤ + 25°C (77°F), after which the product must be used or discarded. Do not freeze

36 months at 2°–25°C (36°–77°F) until expiration date. Protect from light; do not freeze

36 months at 2°–25°C (36°–77°F) until expiration date. Protect from light; do not freeze

Sucrose/Sugars None 1.67 g sucrose per gram of protein Not mentioned Not mentioned None 20 mg/mL glucose in a 5% solution Contains D-sorbitol Contains D-sorbitol 100 mg/mL maltose 90 mg/mL maltose 5 g D-sorbitol in 100 mL of buffer solution None

IgA content ≤25 µg/mL Trace amounts Trace amounts of IgA (average 46 µg/mL) Trace amounts of IgA (average 46 µg/mL) Average 37 µg/mL <1 µg/mL in a 5% solution <50 µg/mL <100 µg/mL ≤200 µg/mL 106 µg/mL <10 µg/mL <20 µg/mL

Stabilizer Proline‡: ~250 mmol/L (range 210–290) Sucrose Glycine Glycine Glycine Glycine, glucose, and polysorbate 80 D-sorbitol D-sorbitol Maltose Maltose Sorbitol, glycine, and polysorbate 80 Glycine, and polysorbate 80

IgG purity ≥98% ≥96% ≥98% ≥98% ≥98% ≥90% ≥97% ≥97% ≥96% ≥96% >95% ≥98%

Half-life 36.6 days (median) 21 days (not specified)30–43 days (mean, dependent on patient age)

30–43 days (mean, dependent on patient age)

35 days (median) 37.7 days (not specified)• 30 days (mean) for patients on 3-week dosing schedule• 32 days (mean) for patients on 4-week dosing schedule

• 34 days (mean) for patients on 3-week dosing schedule• 37 days (mean) for patients on 4-week dosing schedule

36 days (median) Not studied• 6.06 days (mean) for 21-day dosing interval• 5.79 days (mean) for 28-day dosing interval

• 4.92 days (mean) for 21-day dosing interval• 5.12 days (mean) for 28-day dosing interval

Sodium Trace amounts <20 mg NaCI/g of protein Not mentioned Not mentioned No sodium added ~8.5 mg/mL sodium chloride in a 5% solution Trace amounts Trace amounts ≤30 mmol/L ≤30 mmol/L0.2 g sodium acetate and 0.3 g sodium chloride in 100 mL of buffer solution

<30 mM sodium chloride

Osmolality ~320 mOsmol/kg (range 240–440)

• In sterile water—3%: 192 mOsm/kg; 6%: 384 mOsm/kg; 9%: 576 mOsm/kg; 12%: 768 mOsm/kg

• In 5% dextrose—3%: 444 mOsm/kg; 6%: 636 mOsm/kg; 9%: 828 mOsm/kg; 12%: 1020 mOsm/kg

• In 0.9% saline—3%: 498 mOsm/kg; 6%: 690 mOsm/kg; 9%: 882 mOsm/kg; 12%: 1074 mOsm/kg

258 mOsmol/kg 258 mOsmol/kg 240–300 mOsmol/kg Not mentioned 240–370 mOsm/kg 240–370 mOsm/kg 310–380 mOsmol/kg 310–380 mOsmol/kg Typically 420–500 mOsmol/kg Typically 280 mOsmol/kg

Latex content Packaging components are not made with natural rubber latex

Not made with natural rubber latex Not made with natural rubber latex Not made with natural rubber latexPackaging of this product is not made with natural rubber latex

Not made with natural rubber latex Not made with natural rubber latex Not made with natural rubber latex Components used in the packaging are latex-freeComponents used in packaging are not made with natural rubber latex

Components used in the packaging are not made with natural rubber latex

Components used in the packaging are latex free

Diluent May be diluted with dextrose injection Sodium chloride, dextrose, or sterile waterIf dilution is required, may be diluted with 5% dextrose in water

If dilution is required, may be diluted with 5% dextrose in water

If dilution is desired, may be diluted with 5% dextrose in water

Sterile water for injection Do not dilute Do not dilute Should not be diluted Do not dilute Do not mix Do not mix

Dimers ≤12% Not mentioned Not mentioned Not mentioned Not mentioned Not mentioned Not mentioned Not mentioned Not <90% monomers and dimers Not <94% monomers and dimers Not mentioned Not mentioned

Pathogen safety§

• pH 4 incubation• Depth filtration—a virus partitioning

process• Nanofiltration (to ~20 nm)• Validated Transmittable Spongiform

Encephalopathy reduction steps

• Fractionation and depth filtration• pH 4/pepsin treatment• Nanofiltration • Validated Transmittable Spongiform

Encephalopathy reduction steps

• Caprylate precipitation/Depth filtration• Caprylate incubation• Depth filtration• Column chromatography• Nanofiltration• Low pH incubation• Validated Transmittable Spongiform

Encephalopathy reduction steps

• Caprylate precipitation/Depth filtration• Caprylate incubation• Depth filtration• Column chromatography• Nanofiltration• Low pH incubation• Validated Transmittable Spongiform

Encephalopathy reduction steps

• Solvent/detergent (S/D) treatment• 35 nm nanofiltration• Low pH incubation at elevated temperature

• Processing of cryo-poor plasma to Fraction I+II+III precipitate

• Processing of resuspended suspension A precipitate to suspension B Cuno 70 filtrate

• Solvent/detergent treatment

• Pasteurization• S/D treatment• Nanofiltration using 20 nm Planova filters• Fraction I precipitation• Fraction II+III precipitation• 4% PEG precipitation• Acid pH treatment• Validated Transmittable Spongiform

Encephalopathy reduction steps

• Pasteurization• S/D treatment• Nanofiltration using 20 nm Planova filters• Fraction I precipitation• Fraction II+III precipitation• 4% PEG precipitation• Acid pH treatment• Validated Transmittable Spongiform

Encephalopathy reduction steps

• Cold ethanol fractionation• S/D treatment• pH 4 treatment

• Cold ethanol fractionation• S/D treatment• pH 4 treatment

• S/D treatment• Virus filtration• pH incubation

• S/D treatment• Virus filtration• pH incubation

Initial infusion rate(s)(Minimum rate practicable in high-risk patients)

PI, chronic ITP, and CIDP• 0.5 mg/kg/min (0.005 mL/kg/min)

PI and acute/chronic ITP• 0.5 mg/kg/min (0.005 mL/kg/min at

10% concentration)• After 30 min, increase to 1 mg/kg/min

(0.01 mL/kg/min at 10%) as tolerated

PI and acute/chronic ITP• 1 mg/kg/min (0.01 mL/kg/min)CIDP• 2 mg/kg/min (0.02 mL/kg/min)

PI and chronic ITP• 1 mg/kg/min (0.01 mL/kg/min)CIDP• 2 mg/kg/min (0.02 mL/kg/min)

PI• 0.8 mg/kg/min (0.008 mL/kg/min) for 30 min

PI and chronic ITP• 0.4 mg/kg/min (0.008 mL/kg/min) for 5% dilution

PI• 0.5 mg/kg/min (0.01 mL/kg/min)

PI and chronic ITP• 1 mg/kg/min (0.01 mL/kg/min)

PI• 0.5 mg/kg/min (0.01 mL/kg/min)

Chronic ITP• 1.0 mg/kg/min (0.01 mL/kg/min)

PI and chronic ITP• 0.5 mg/kg/min (0.01 mL/kg/min)

for 15 minutes

PI and chronic ITP• 0.5 mg/kg/min (0.005 mL/kg/min)

for 15 minutes

Maximum infusion rate(s)(Administer at the minimum rate of infusion for those at risk of thrombosis, renal dysfunction/failure, and other high-risk patients.)

PI and CIDP• Gradually increase to 8 mg/kg/min

(0.08 mL/kg/min) as toleratedChronic ITP• Increase to 4 mg/kg/min (0.04 mL/kg/min)

PI and acute/chronic ITP• Gradually increase as tolerated—not to

exceed 3 mg/kg/min (0.03 mL/kg/min at 10%); 2 mg/kg/min (0.02 mL/kg/min at 10%) for high-risk patients

PI, acute/chronic ITP, and CIDP• Gradually increase to 8 mg/kg/min

(0.08 mL/kg/min) as tolerated

PI and chronic ITP• Gradually increase to 8 mg/kg/min

(0.08 mL/kg/min) as toleratedCIDP• Gradually increase to 8 mg/kg/min

(0.08 mL/kg/min) as tolerated every 3 weeks

PI IV administration:• Increase every 30 minutes (if tolerated) up to

8 mg/kg/min (0.08 mL/kg/min)

PI and chronic ITP• Gradually increase to 3.3 mg/kg/min

(0.066 mL/kg/min) as tolerated (5%)

PI• Gradually increase to 5 mg/kg/min

(0.10 mL/kg/min) as tolerated

PI and chronic ITP• Gradually increase to 8 mg/kg/min

(0.08 mL/kg/min) as tolerated

PI• Gradually increase to <3.33 mg/kg/min

(<0.07 mL/kg/min) as tolerated

Chronic ITP• Gradually increase to 12.0 mg/kg/min (Up to

0.12 mL/kg/min) as tolerated

PI and chronic ITP• Gradually increase every 15 minutes to

4 mg/kg/min (0.08 mL/kg/min) as tolerated

PI and chronic ITP• Gradually increase every 15 minutes to

8 mg/kg/min (0.08 mL/kg/min) as tolerated

*All listed IVIg products have a boxed warning for administration in patients at risk of thrombosis, renal dysfunction, or renal failure.†Limitation of use: maintenance therapy in CIDP has not been studied for periods longer than 6 months. Individualize duration of treatment beyond 6 months based on patient response.‡ Proline is 1 of the 20 naturally occurring amino acids that form human proteins. It can be synthesized by the human body or obtained from dietary sources. CSL Behring chose proline as the stabilizer for Privigen after extensive testing and analysis. Privigen is contraindicated in patients with hyperprolinemia.

§The risk of transmission of infectious agents cannot be completely eliminated.

Please see full Important Safety Information for Privigen and Carimune NF on back cover and full prescribing information,including boxed warning, in pocket. All information provided above comes directly from the prescribing information as of September 14, 2017, for each product.

Review your IVIg* options for PI, ITP, and CIDP

FeaturePrivigen®

Immune Globulin Intravenous (Human),10% Liquid CSL Behring AG†

Carimune® NFImmune Globulin Intravenous (Human)CSL Behring AG

Gammaked™

Immune Globulin Injection (Human)10% Caprylate/Chromatography PurifiedKedrion Biopharma, Inc.2

Gamunex®-CImmune Globulin Injection (Human), 10% Caprylate/Chromatography PurifiedGrifols Therapeutics Inc.3

Gammagard® Liquid Immune Globulin Infusion (Human), 10% Solution,for intravenous and subcutaneous administrationBaxalta Healthcare Corporation4

Gammagard® S/DImmune Globulin Intravenous (Human)Shire Healthcare Corporation5

Flebogamma® 5% DIFImmune Globulin Intravenous (Human)Instituto Grifols, S.A.6

Flebogamma® 10% DIFImmune Globulin Intravenous (Human)Instituto Grifols, S.A.7

Octagam® 5%Immune Globulin Intravenous (Human) 5% Liquid PreparationOctapharma USA Inc.8

Octagam® 10%Immune Globulin Intravenous (Human) 10% Liquid PreparationOctapharma USA Inc.9

Gammaplex® 5%Immune Globulin Intravenous (Human), 5% LiquidBio Products Laboratory Limited10

Gammaplex® 10%Immune Globulin Intravenous (Human), 10% LiquidBio Products Laboratory Limited11

Concentration/Dosage form Ready-to-use 10% liquid

• Lyophilized powder ranging from 3% to 12% concentration

• Reconstitution required prior to administration

Ready-to-use 10% liquid Ready-to-use 10% liquid Ready-to-use 10% liquid• Freeze-dried• Reconstitution required prior to administration

Ready-to-use 5% liquid Ready-to-use 10% liquid Ready-to-use 5% liquid Ready-to-use 10% liquid Ready-to-use 5% liquid Ready-to-use 10% liquid

Vial sizes, grams (mL) 5 g (50 mL), 10 g (100 mL), 20 g (200 mL), 40 g (400 mL)

6 g, 12 g white lyophilized powder for reconstitution

1 g (10 mL), 2.5 g (25 mL), 5 g (50 mL), 10 g (100 mL), 20 g (200 mL)

1 g (10 mL ), 2.5 g (25 mL), 5 g (50 mL), 10 g (100 mL), 20 g (200 mL), 40 g (400 mL)

1 g (10 mL), 2.5 g (25 mL), 5 g (50 mL), 10 g (100 mL), 20 g (200 mL ), 30 g (300 mL)

5 g, 10 g freeze-dried preparation for reconstitution 0.5 g (10 mL), 2.5 g (50 mL ), 5 g (100 mL), 10 g (200 mL), 20 g (400 mL)

5 g (50 mL), 10 g (100 mL), 20 g (200 mL) 1 g (20 mL), 2.5 g (50 mL), 5 g (100 mL), 10 g (200 mL), 25 g (500 mL)

2 g (20 mL), 5 g (50 mL), 10 g (100 mL), 20 g (200 mL)2.5 g (50 mL), 5 g (100 mL), 10 g (200 mL), 20 g (400mL)

5 g (50 mL), 10 g (100 mL), 20 g (200 mL)

Storage requirement 36 months at room-temperature storage up to 25°C (77°F). Do not freeze

Store at <30°C (86°F) until expiration date. Do not freeze

• 36 months at refrigerated temperature 2°–8°C (36°–46°F). Do not freeze

• Up to 6 months at temperatures not to exceed 25°C (77°F) anytime during the 36-month shelf life. Must be discarded after 6 months

• 36 months at refrigerated temperature 2°–8°C (36°–46°F). Do not freeze

• Up to 6 months at temperatures not to exceed 25°C (77°F) anytime during the 36-month shelf life. Must be discarded after 6 months

• Store Gammagard Liquid in the refrigerator or at room temperature

• Refrigeration: 2°–8°C (36°–46°F) for up to 36 months. Do not freeze

• Room temperature: Up to 25°C (77°F) for up to24 months

24 months unreconstituted; temperature not to exceed 25°C (77°F). Do not freeze

24 months from date of manufacture at room temperature 2°–25°C (36°–77°F). Do not freeze

Up to 24 months from date of manufacture at room temperature 2°–25°C (36°–77°F). Do not freeze

24 months from date of manufacture at 2°–25°C (36°–77°F). Do not freeze

24 months from date of manufacture at 2°C–8°C (36°F–46°F). Within the first 12 months of shelf-life, may be stored up to 9 months at ≤ + 25°C (77°F), after which the product must be used or discarded. Do not freeze

36 months at 2°–25°C (36°–77°F) until expiration date. Protect from light; do not freeze

36 months at 2°–25°C (36°–77°F) until expiration date. Protect from light; do not freeze

Sucrose/Sugars None 1.67 g sucrose per gram of protein Not mentioned Not mentioned None 20 mg/mL glucose in a 5% solution Contains D-sorbitol Contains D-sorbitol 100 mg/mL maltose 90 mg/mL maltose 5 g D-sorbitol in 100 mL of buffer solution None

IgA content ≤25 µg/mL Trace amounts Trace amounts of IgA (average 46 µg/mL) Trace amounts of IgA (average 46 µg/mL) Average 37 µg/mL <1 µg/mL in a 5% solution <50 µg/mL <100 µg/mL ≤200 µg/mL 106 µg/mL <10 µg/mL <20 µg/mL

Stabilizer Proline‡: ~250 mmol/L (range 210–290) Sucrose Glycine Glycine Glycine Glycine, glucose, and polysorbate 80 D-sorbitol D-sorbitol Maltose Maltose Sorbitol, glycine, and polysorbate 80 Glycine, and polysorbate 80

IgG purity ≥98% ≥96% ≥98% ≥98% ≥98% ≥90% ≥97% ≥97% ≥96% ≥96% >95% ≥98%

Half-life 36.6 days (median) 21 days (not specified)30–43 days (mean, dependent on patient age)

30–43 days (mean, dependent on patient age)

35 days (median) 37.7 days (not specified)• 30 days (mean) for patients on 3-week dosing schedule• 32 days (mean) for patients on 4-week dosing schedule

• 34 days (mean) for patients on 3-week dosing schedule• 37 days (mean) for patients on 4-week dosing schedule

36 days (median) Not studied• 6.06 days (mean) for 21-day dosing interval• 5.79 days (mean) for 28-day dosing interval

• 4.92 days (mean) for 21-day dosing interval• 5.12 days (mean) for 28-day dosing interval

Sodium Trace amounts <20 mg NaCI/g of protein Not mentioned Not mentioned No sodium added ~8.5 mg/mL sodium chloride in a 5% solution Trace amounts Trace amounts ≤30 mmol/L ≤30 mmol/L0.2 g sodium acetate and 0.3 g sodium chloride in 100 mL of buffer solution

<30 mM sodium chloride

Osmolality ~320 mOsmol/kg (range 240–440)

• In sterile water—3%: 192 mOsm/kg; 6%: 384 mOsm/kg; 9%: 576 mOsm/kg; 12%: 768 mOsm/kg

• In 5% dextrose—3%: 444 mOsm/kg; 6%: 636 mOsm/kg; 9%: 828 mOsm/kg; 12%: 1020 mOsm/kg

• In 0.9% saline—3%: 498 mOsm/kg; 6%: 690 mOsm/kg; 9%: 882 mOsm/kg; 12%: 1074 mOsm/kg

258 mOsmol/kg 258 mOsmol/kg 240–300 mOsmol/kg Not mentioned 240–370 mOsm/kg 240–370 mOsm/kg 310–380 mOsmol/kg 310–380 mOsmol/kg Typically 420–500 mOsmol/kg Typically 280 mOsmol/kg

Latex content Packaging components are not made with natural rubber latex

Not made with natural rubber latex Not made with natural rubber latex Not made with natural rubber latexPackaging of this product is not made with natural rubber latex

Not made with natural rubber latex Not made with natural rubber latex Not made with natural rubber latex Components used in the packaging are latex-freeComponents used in packaging are not made with natural rubber latex

Components used in the packaging are not made with natural rubber latex

Components used in the packaging are latex free

Diluent May be diluted with dextrose injection Sodium chloride, dextrose, or sterile waterIf dilution is required, may be diluted with 5% dextrose in water

If dilution is required, may be diluted with 5% dextrose in water

If dilution is desired, may be diluted with 5% dextrose in water

Sterile water for injection Do not dilute Do not dilute Should not be diluted Do not dilute Do not mix Do not mix

Dimers ≤12% Not mentioned Not mentioned Not mentioned Not mentioned Not mentioned Not mentioned Not mentioned Not <90% monomers and dimers Not <94% monomers and dimers Not mentioned Not mentioned

Pathogen safety§

• pH 4 incubation• Depth filtration—a virus partitioning

process• Nanofiltration (to ~20 nm)• Validated Transmittable Spongiform

Encephalopathy reduction steps

• Fractionation and depth filtration• pH 4/pepsin treatment• Nanofiltration • Validated Transmittable Spongiform

Encephalopathy reduction steps

• Caprylate precipitation/Depth filtration• Caprylate incubation• Depth filtration• Column chromatography• Nanofiltration• Low pH incubation• Validated Transmittable Spongiform

Encephalopathy reduction steps

• Caprylate precipitation/Depth filtration• Caprylate incubation• Depth filtration• Column chromatography• Nanofiltration• Low pH incubation• Validated Transmittable Spongiform

Encephalopathy reduction steps

• Solvent/detergent (S/D) treatment• 35 nm nanofiltration• Low pH incubation at elevated temperature

• Processing of cryo-poor plasma to Fraction I+II+III precipitate

• Processing of resuspended suspension A precipitate to suspension B Cuno 70 filtrate

• Solvent/detergent treatment

• Pasteurization• S/D treatment• Nanofiltration using 20 nm Planova filters• Fraction I precipitation• Fraction II+III precipitation• 4% PEG precipitation• Acid pH treatment• Validated Transmittable Spongiform

Encephalopathy reduction steps

• Pasteurization• S/D treatment• Nanofiltration using 20 nm Planova filters• Fraction I precipitation• Fraction II+III precipitation• 4% PEG precipitation• Acid pH treatment• Validated Transmittable Spongiform

Encephalopathy reduction steps

• Cold ethanol fractionation• S/D treatment• pH 4 treatment

• Cold ethanol fractionation• S/D treatment• pH 4 treatment

• S/D treatment• Virus filtration• pH incubation

• S/D treatment• Virus filtration• pH incubation

Initial infusion rate(s)(Minimum rate practicable in high-risk patients)

PI, chronic ITP, and CIDP• 0.5 mg/kg/min (0.005 mL/kg/min)

PI and acute/chronic ITP• 0.5 mg/kg/min (0.005 mL/kg/min at

10% concentration)• After 30 min, increase to 1 mg/kg/min

(0.01 mL/kg/min at 10%) as tolerated

PI and acute/chronic ITP• 1 mg/kg/min (0.01 mL/kg/min)CIDP• 2 mg/kg/min (0.02 mL/kg/min)

PI and chronic ITP• 1 mg/kg/min (0.01 mL/kg/min)CIDP• 2 mg/kg/min (0.02 mL/kg/min)

PI• 0.8 mg/kg/min (0.008 mL/kg/min) for 30 min

PI and chronic ITP• 0.4 mg/kg/min (0.008 mL/kg/min) for 5% dilution

PI• 0.5 mg/kg/min (0.01 mL/kg/min)

PI and chronic ITP• 1 mg/kg/min (0.01 mL/kg/min)

PI• 0.5 mg/kg/min (0.01 mL/kg/min)

Chronic ITP• 1.0 mg/kg/min (0.01 mL/kg/min)

PI and chronic ITP• 0.5 mg/kg/min (0.01 mL/kg/min)

for 15 minutes

PI and chronic ITP• 0.5 mg/kg/min (0.005 mL/kg/min)

for 15 minutes

Maximum infusion rate(s)(Administer at the minimum rate of infusion for those at risk of thrombosis, renal dysfunction/failure, and other high-risk patients.)

PI and CIDP• Gradually increase to 8 mg/kg/min

(0.08 mL/kg/min) as toleratedChronic ITP• Increase to 4 mg/kg/min (0.04 mL/kg/min)

PI and acute/chronic ITP• Gradually increase as tolerated—not to

exceed 3 mg/kg/min (0.03 mL/kg/min at 10%); 2 mg/kg/min (0.02 mL/kg/min at 10%) for high-risk patients

PI, acute/chronic ITP, and CIDP• Gradually increase to 8 mg/kg/min

(0.08 mL/kg/min) as tolerated

PI and chronic ITP• Gradually increase to 8 mg/kg/min

(0.08 mL/kg/min) as toleratedCIDP• Gradually increase to 8 mg/kg/min

(0.08 mL/kg/min) as tolerated every 3 weeks

PI IV administration:• Increase every 30 minutes (if tolerated) up to

8 mg/kg/min (0.08 mL/kg/min)

PI and chronic ITP• Gradually increase to 3.3 mg/kg/min

(0.066 mL/kg/min) as tolerated (5%)

PI• Gradually increase to 5 mg/kg/min

(0.10 mL/kg/min) as tolerated

PI and chronic ITP• Gradually increase to 8 mg/kg/min

(0.08 mL/kg/min) as tolerated

PI• Gradually increase to <3.33 mg/kg/min

(<0.07 mL/kg/min) as tolerated

Chronic ITP• Gradually increase to 12.0 mg/kg/min (Up to

0.12 mL/kg/min) as tolerated

PI and chronic ITP• Gradually increase every 15 minutes to

4 mg/kg/min (0.08 mL/kg/min) as tolerated

PI and chronic ITP• Gradually increase every 15 minutes to

8 mg/kg/min (0.08 mL/kg/min) as tolerated

Page 4: Know your IVIg options - CSL Behring · Know your IVIg options Proven IgG therapy Designed for stability Please see full Important Safety Information for Privigen and Carimune NF

Important Safety Information for PrivigenPrivigen is indicated for the treatment of:• Primary humoral immunodeficiency (PI)• Chronic immune thrombocytopenic purpura (ITP) in patients

age 15 years and older • Chronic inflammatory demyelinating polyneuropathy (CIDP)

in adults – Limitation of use: maintenance therapy in CIDP has not

been studied for periods longer than 6 months. Individualize duration of treatment beyond 6 months based on patient response.

WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE • Thrombosis may occur with immune globulin

products, including Privigen. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.

• Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products that contain sucrose. Privigen does not contain sucrose.

• For patients at risk of thrombosis, renal dysfunction or renal failure, administer Privigen at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

See full prescribing information for complete boxed warning. Privigen is contraindicated in patients with history of anaphylactic or severe systemic reaction to human immune globulin, in patients with hyperprolinemia, and in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity.In patients at risk of developing acute renal failure, monitor urine output and renal function, including blood urea nitrogen and serum creatinine. Hyperproteinemia, increased serum viscosity, or hyponatremia can occur with Privigen. Infrequently, aseptic meningitis syndrome (AMS) may occur—especially with high doses or rapid infusion. Hemolysis, either intravascular or due to enhanced red blood cell sequestration, may occur. Risk factors include non-O blood group and high doses. Closely monitor patients for hemolysis and hemolytic anemia.

During and shortly following Privigen infusion, elevations of systolic and diastolic blood pressure (including cases of hypertensive urgency) have been observed. These elevations resolved or significantly improved within hours with oral anti-hypertensive therapy or observation alone. Check patients for a history of hypertension and monitor blood pressure during this period. Consider relative risks and benefits before prescribing high-dose regimen for chronic ITP and CIDP in patients at increased risk of thrombosis, hemolysis, acute kidney injury or volume overload. Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]). Privigen is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated. In clinical studies of patients with PI, the most common adverse reactions to Privigen, observed in >5% of subjects, were headache, fatigue, nausea, chills, vomiting, back pain, pain, elevated body temperature, abdominal pain, diarrhea, cough, stomach discomfort, chest pain, joint swelling/effusion, influenza-like illness, pharyngolaryngeal pain, urticaria, and dizziness. Serious adverse reactions were hypersensitivity, chills, fatigue, dizziness, and increased body temperature. In clinical studies of patients being treated for chronic ITP, the most common adverse reactions, seen in >5% of subjects, were laboratory findings consistent with hemolysis, headache, elevated body temperature, anemia, nausea, and vomiting. A serious adverse reaction was aseptic meningitis syndrome. In clinical studies of patients being treated for CIDP, the most common reactions, observed in >5% of subjects, were headache, asthenia, hypertension, nausea, pain in extremity, hemolysis, influenza-like illness, leukopenia, and rash. Serious adverse reactions were hemolysis, exacerbation of CIDP, acute rash, increased diastolic blood pressure, hypersensitivity, pulmonary embolism, respiratory failure, and migraine. Treatment with Privigen might interfere with a patient’s response to live virus vaccines and could lead to misinterpretation of serologic testing. In patients over 65 and those at risk of renal insufficiency, do not exceed recommended dose and infuse at the minimum rate practicable. Please see full prescribing information for Privigen.

Important Safety Information for Carimune NFCarimune® NF, Nanofiltered Immune Globulin Intravenous (Human) is indicated for the maintenance treatment of patients with primary immunodeficiencies (PI), such as common variable immunodeficiency, X-linked agammaglobulinemia, and severe combined immunodeficiency, as well as for acute and chronic immune thrombocytopenic purpura (ITP).WARNING: THROMBOSIS, RENAL DYSFUNCTION or ACUTE RENAL FAILURE• Thrombosis may occur with immune globulin

products, including Carimune NF. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis might occur in absence of known risk factors.

• Renal dysfunction, acute renal failure, osmotic nephrosis, and death can occur in predisposed patients with immune globulin intravenous (IGIV) products, including Carimune NF. Patients predisposed to renal dysfunction include those with any degree of preexisting renal insufficiency, diabetes mellitus, age over 65, volume depletion, sepsis, paraproteinemia, and those receiving known nephrotoxic drugs. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. Carimune NF contains sucrose.

• For patients at risk of thrombosis, renal dysfunction or acute renal failure, administer Carimune NF at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

• See full prescribing information for full boxed warning.

Carimune NF is contraindicated in patients who have had anaphylactic or severe systemic reactions to the administration of human immune globulin. Individuals with selective IgA deficiency who possess antibody to IgA should only receive Carimune NF with utmost caution due to risk of severe, immediate hypersensitivity reactions, including anaphylaxis.Increases in creatinine and blood urea nitrogen with progression to oliguria or anuria requiring dialysis have been observed as soon as one to two days following IGIV infusion. Severe renal adverse events have included acute renal failure, acute tubular nephrosis, proximal tubular nephropathy, and osmotic nephrosis.Patients receiving Carimune NF should be monitored for clinical signs and symptoms of hemolysis, as well pulmonary adverse reactions, including TRALI. An aseptic meningitis syndrome (AMS) has been reported to occur infrequently with IVIG—more frequently in association with high dose (2 g/kg) treatment.Inflammatory adverse reactions have been observed; they may become apparent within 30 minutes to an hour after beginning infusion. Slow or temporarily stop infusion if patient experiences facial flushing, tightness in chest, chills, fever, nausea, dizziness or other unusual response; stop infusion immediately if anaphylaxis or severe reaction occurs. Headache, usually mild, is the most common adverse reaction; mild hemolysis, arthralgia, myalgia, and transient skin reactions have also been reported.Carimune NF is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated.Carimune NF should be given to a pregnant woman only if clearly needed.Please see full prescribing information for Carimune, including boxed warning on thrombosis and renal dysfunction/failure, in pocket.

References: 1. Data on File. Available from CSL Behring as DOF PVG-002. 2. Gammaked [package insert]. Fort Lee, NJ: Kedrion Biopharma, Inc.; 2013. 3. Gamunex-C [package insert]. Research Triangle Park, NC: Grifols Therapeutics Inc.; 2016. 4. Gammagard Liquid [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; 2016. 5. Gammagard S/D [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; 2016. 6. Flebogamma 5% DIF [package insert]. Barcelona, Spain: Instituto Grifols, S.A.; 2015.7. Flebogamma 10% DIF [package insert]. Barcelona, Spain: Instituto Grifols, S.A.; 2016. 8. Octagam 5% [package insert]. Hoboken, NJ: Octapharma USA Inc.; 2014. 9. Octagam 10% [package insert]. Hoboken, NJ; Octapharma USA Inc., 2015. 10. Gammaplex 5% [package insert]. Hertfordshire, UK: Bio Products Laboratory Limited; 2016. 11. Gammaplex 10% [package insert]. Hertfordshire, UK: Bio Products Laboratory Limited; 2017.

Privigen and Carimune NF are manufactured by CSL Behring AG and distributed by CSL Behring LLC. Privigen® and Carimune® NF are registered trademarks of CSL Behring AG. Biotherapies for Life® and IgIQ® are registered trademarks of CSL Behring LLC. CSL Behring AssuranceSM is a service mark of CSL Behring LLC. Other brands listed are the registered trademarks of their respective owners.©2017 CSL Behring LLC www.Privigen.com PVG-0040-OCT17

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