O10

Preserving Immunoglobulin Integrity Octagam ® 10% is an immune globulin intravenous (human) liquid preparation indicated for the treatment of chronic immune thrombocytopenic purpura (ITP) in adults. Octagam ® 10% is also indicated for the treatment of dermatomyositis (DM) in adults.

WARNING: THROMBOSIS, RENAL DYSFUNCTION, and ACUTE RENAL FAILURE Please see accompanying Full Prescribing Information for complete boxed warnings and additional important information.

Thrombosis may occur with immune globulin intravenous (IGIV) products, including octagam® 10%. 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 nephropathy, and death may occur with the administration of Immune Globulin Intravenous (Human) (IGIV) products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. Octagam® 10% does not contain sucrose.

For patients at risk of thrombosis, renal dysfunction or renal failure, administer octagam® 10% at the minimum 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.

Please see page 7 for additional Important Safety Information.

Please see accompanying full Prescribing Information.

Octapharma Has Pioneered A Number of Safety Innovations That Have Set the Standard For the Protein Products Industry Octagam® 10% Manufacturing and Purification Process1-3

Formulated to Help Mitigate Tolerability Issues in Adults With Chronic ITP1,2,4

• pH of 4.5 – 5.0 to stabilize IgG molecules and avoid IgG aggregation • Free of sucrose, fructose, and preservatives • Low sodium (≤30 mmol/L) • Trace amounts of IgA (on average 106 µg/mL) 1

3

Separate coagulation factors Centrifugation

Gather IgG antibodies & remove impurities (ie, plasma proteins, hemagglutinins [anti-A/B]) Cold-ethanol fractionation, precipitate II only

5

Inactivate enveloped viruses Solvent/detergent (S/D) treatment

7

Inactivate both enveloped and nonenveloped viruses Incubation at low pH

Biochemical Profile That Resembles Native IgG1 2

Remove additional thrombogenic factors Heparin-sepharose chromatography

• All 4 IgG subclasses are fully represented • Physiologic Fc portion of IgG is maintained intact Validated Viral Removal and Inactivation1,5,6

4

Adjust IgG concentration Ultrafiltration/diafiltration (UF/DF)

6

Remove S/D chemicals Cation exchange chromatography

The manufacturing process has been validated for its capacity to remove and inactivate both enveloped and nonenveloped viruses.

Global Reduction Factor [log10] ENVELOPED VIRUSES

8

Prevent aggregation, stabilize, and sterilize product UF/DF, maltose, bulk filtration

NONENVELOPED VIRUSES

HIV-1

PRV

SBV

MEV

PPV

≥14.07

≥18.22

≥20.61

≥12.20

≥6.53

HIV-1 = human immunodeficiency virus-1; PRV = pseudorabies virus; SBV = sindbis virus; MEV = mouse encephalomyelitis virus; PPV = porcine parvovirus.

2

Contraindications Octagam® 10% is contraindicated in patients who have a history of severe systemic hypersensitivity reactions, such as anaphylaxis, to human immunoglobulin. Octagam® 10% contains trace amounts of IgA (average 106 µg/mL in a 10% solution). It is contraindicated in IgA-deficient patients with antibodies against IgA and history of hypersensitivity.

Dosing and Administration Patients with dermatomyositis are at increased risk for thromboembolic events; monitor carefully and do not exceed an infusion rate of 0.04 mL/kg/min.

Warnings and Precautions IgA-deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions to octagam® 10%. Epinephrine should be available immediately to treat any severe acute hypersensitivity reactions.

Monitor renal function, including blood urea nitrogen and serum creatinine, and urine output in patients at risk of developing acute renal failure.

Falsely elevated blood glucose readings may occur during and after the infusion of octagam® 10% with testing by some glucometers and test strip systems.

Hyperproteinemia, increased serum osmolarity and hyponatremia may occur in patients receiving octagam® 10%.

Please see page 7 for additional Important Safety Information.

Please see accompanying full Prescribing Information.

3

In a Pivotal Study of Adults With Chronic ITP,

Octagam® 10% Liquid Delivered Rapid and Sustained Results With A Proven Tolerability Profile Clinical Response Within 7 Days After Initial Infusion (Mean, 1.8 Days)1-3* 50

200 50

200

180

180

45

160

35

140

35 Bleedings (n)

30 25 20

120

30 25

100

20

80

15

15

60 40

5

5

2

Baseline

Baseline

2

120 100 80 60

Bleeding Bleeding PlateletPlatelet CountCount Clinical Endpoint (50 x 10 /L)

Clinical Endpoint (50 x 109/L)

9

20

20

0

0

140

40

10

10

3

4

3

5

4

5

Days

6

6

7

350

350

300

300

250

250

200

200

150

150

100

100

160

7

Platelet Count (50 x 109/L)

40

Platelet Count x 109/L

40

Platelet Count x 109/L

45

Bleedings (n)

A Sustained Clinical Response1,2,4

(50 x 109/L) 0 0

0

0

50

50

7

14

21

63

0 -50

-50 Days

Days

The figure depicts the mean platelet count and the number of patients with bleeds reported during the first 7 days post initial treatment with octagam® 10% (n=66).

The figure depicts the duration of response in patients that reached the clinical endpoint (50 x 109/L) within the first 7 days (54 of 66).

• 82% of patients (54 of 66) reached the clinical endpoint

• Mean duration of the clinical response was 20.9 days • At day 63, mean platelet count in 54 responders was 88 x109/L

– Mean time to reach clinical endpoint was 1.8 days after initial infusion

• 78% of patients (35 of 45) with bleeding at baseline reported no bleeding on day 7 – A decrease in severity of bleeding by day 7 was seen in 84% of patients (38 of 45)

A Rapid Infusion Rate Without Compromising Tolerability1,4

• 92% of the initial study phase patients (24 of 26) were titrated to initial maximum infusion rate of 6 mg/kg/min (360 mg/kg/hour)

• 60% of the subsequent patients (54 of 90) were titrated to the amended maximum

Established Tolerability Profile1,2,4

• Premedication to alleviate potential infusion reactions was only used in one patient (0.9%) • All drug-related adverse events (AEs) were mild or moderate in intensity and they all resolved • One serious drug-related AE of a moderate headache (0.9% of subjects) was reported • No cases of drug-related hemolysis, anaphylactic, or anaphylactoid reactions were reported

infusion rate of 12 mg/kg/min (720 mg/kg/hour)

* In an open-label, phase 3 clinical trial, 66 adult patients (ages 17- 88) with chronic ITP were treated with octagam® 10% liquid 1 g/kg/day on 2 consecutive days.

Infusion rate was adjusted according to tolerability up to a maximum of 12 mg/kg/min (720 mg/kg/hour) and then evaluated during a 21-day study period and at a 63-day follow-up visit.

4

Warnings and Precautions (continued) Hemolysis that is either intravascular or due to enhanced red blood cell sequestration can develop subsequent to octagam® 10% treatments. Risk factors for hemolysis include high doses and non-O-blood group. Closely monitor patients for hemolysis and hemolytic anemia.

Warnings and Precautions (continued) Aseptic meningitis syndrome may occur in patients receiving octagam® 10%, especially with high doses or rapid infusion.

Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]).

Octagam® 10% is made from human plasma and may contain infectious agents, e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease agent.

Please see page 7 for additional Important Safety Information.

Please see accompanying full Prescribing Information.

5

Convenient, Ready-to-Use Liquid Formulation

Important Safety Information

• Does not need to be reconstituted • Tamper-evident packaging • Latex free • 36-month shelf-life when kept refrigerated (+2°C to + 8°C [36°F to 46°F]) from date of manufacture

1

– Within this shelf-life, the product may be stored up to 9 months at room temperature (≤+25°C [77°F]) – After storage at ≤+25°C (77°F) the product must be used or discarded – Do not use after expiration date – Do not freeze. Do not use frozen product

• Choice of filling sizes to meet individual needs

Contraindications Octagam® 10% is contraindicated in patients who have a history of severe systemic hypersensitivity reactions, such as anaphylaxis, to human immunoglobulin. Octagam® 10% contains trace amounts of IgA (average 106 µg/mL in a 10% solution). It is contraindicated in IgA-deficient patients with antibodies against IgA and history of hypersensitivity.

Dosing and Administration Patients with dermatomyositis are at increased risk for thromboembolic events; monitor carefully and do not exceed an infusion rate of 0.04 mL/kg/min.

Warnings and Precautions IgA-deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions to octagam® 10%. Epinephrine should be available immediately to treat any severe acute hypersensitivity reactions.

Monitor renal function, including blood urea nitrogen and serum creatinine, and urine output in patients at risk of developing acute renal failure.

Falsely elevated blood glucose readings may occur during and after the infusion of octagam® 10% with testing by some glucometers and test strip systems.

Hyperproteinemia, increased serum osmolarity and hyponatremia may occur in patients receiving octagam® 10%.

Available In 5 Vial Sizes to Meet Individual Needs VIAL SIZES

2g (20 mL)

5g (50 mL)

10 g (100 mL)

20 g (200 mL)

30 g (300 mL)

NDC #

68982-850-01

68982-850-02

68982-850-03

68982-850-04

68982-850-05

WARNING: THROMBOSIS, RENAL DYSFUNCTION, and ACUTE RENAL FAILURE Please see accompanying Full Prescribing Information for complete boxed warnings and additional important information.

Thrombosis may occur with immune globulin intravenous (IGIV) products, including octagam® 10%. 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 nephropathy, and death may occur with the administration of Immune Globulin Intravenous (Human) (IGIV) products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. Octagam® 10% does not contain sucrose.

For patients at risk of thrombosis, renal dysfunction or renal failure, administer octagam® 10% at the minimum 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.

6

Please see adjacent page for additional Important Safety Information.

Hemolysis that is either intravascular or due to enhanced red blood cell sequestration can develop subsequent to octagam® 10% treatments. Risk factors for hemolysis include high doses and non-O-blood group. Closely monitor patients for hemolysis and hemolytic anemia.

Aseptic meningitis syndrome may occur in patients receiving octagam® 10%, especially with high doses or rapid infusion.

Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]).

Octagam® 10% is made from human plasma and may contain infectious agents, e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease agent.

Adverse Reactions (observed in >5% of clinical study subjects) Chronic Immune Thrombocytopenic Purpura: headache, fever, increased heart rate.

Dermatomyositis: headache, fever, nausea, vomiting, increased blood pressure, chills, musculoskeletal pain, increased heart rate, dyspnea, infusions site reactions.

References: 1. Octagam® 10% Full Prescribing Information. Paramus, NJ: Octapharma USA Inc; rev March 2022. 2. Octapharma, Data on File. 2014.

3. Buchacher A, Kaar W. Intravenous immunoglobin G from human plasma—purification concepts and important quality criteria. In: Bertolini J, Goss N, Curling J, eds. Production of Plasma Proteins for Therapeutic Use. Paramus, NJ: John Wiley & Sons, Inc; 2013. 4. Robak T, Mainau C, Pyringer B, et al. Efficacy and safety of a new intravenous immunoglobulin 10% formulation (octagam® 10%) in patients with immune thrombocytopenia.

Hematology. 2010;15(5):351-359. 5. Dichtelmüller HO, Biesert L, Fabbrizzi F, et al. Contribution to safety of immunoglobulin and albumin from virus partitioning and inactivation by cold ethanol fractionation: a data collection of Plasma Protein Therapeutics Association member companies. Transfusion.

2011;51(7):1412-1430. 6. Dichtelmüller HO, Biesert L, Fabbrizzi F, et al. Robustness of solvent/detergent treatment of plasma derivatives: a data collection of Plasma Protein Therapeutics Association member companies. Transfusion. 2009;49(9):1931-1943.

Please see accompanying full Prescribing Information.

7

Octapharma Bringing Innovative, Lifesaving Therapies to Patients Around the World

Why Choose octagam® 10% Liquid?

• Formulated to mitigate tolerability issues in

• Convenient, ready-to-use, easy-to-store,

• Manufactured to preserve the structural and

• Flexible storage

• Rapid and sustained response in adults

– 36-month shelf-life when kept refrigerated (+2°C to + 8°C [36°F to 46°F]) from date of manufacture1

adults with chronic ITP

1,2,4

functional integrity of IgG

2,3

with chronic ITP1,4

• A high rate of infusion without compromising tolerability1,4

liquid formulation1,2

– Within this shelf-life, the product may be stored up to 9 months at room temperature (≤+25°C [77°F])

www.octagamusa.com Adverse Reactions (observed in >5% of clinical study subjects) Chronic Immune Thrombocytopenic Purpura: headache, fever, increased heart rate.

Dermatomyositis: headache, fever, nausea, vomiting, increased blood pressure, chills, musculoskeletal pain, increased heart rate, dyspnea, infusions site reactions.

Please see page 7 for additional Important Safety Information.

Please see accompanying full Prescribing Information.

Octapharma USA, Inc. 117 W. Century Road Paramus, NJ 07652 Tel: 201-604-1130

IgCares/Reimbursement Assistance usreimbursement@octapharma.com Tel: 800-554-4440

Medical Affairs usmedicalaffairs@octapharma.com

For all inquiries relating to drug safety, or to report adverse events, please contact our local Drug Safety Officer: Tel: 201-604-1137 | Cell: 201-772-4546 | Fax: 201-604-1141 or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

©2023. Octapharma USA, Inc. All rights reserved.

Date of preparation: 8/2023. GAM10-0407-PSA