The first and only IVIg with two FDA-approved maintenance dosing options for CIDP in adults1

Dosing and Rate of Administration for Adult Patients With CIDP1

Loading Dose

2 g/kg (20 mL/kg)

Divided into 2 daily doses

(1 g/kg [10 mL/kg] on 2 consecutive days)

Maintenance Dose

1 g/kg or 2 daily doses

(10 20 mL/kg) every 3 weeks

Divided into 2 doses given over 2 consecutive days

Initial Infusion Rate

(first 30 minutes)

1 mg/kg/min

(0.01 mL/kg/min)

Maximum Infusion Rate

(as tolerated)

12 mg/kg/min

(0.12 mL/kg/min)

  • In the CIDP study, a loading dose of 2 g/kg of PANZYGA was given followed by seven maintenance infusions every three weeks over a period of six months1
  • The initial infusion rate should be maintained for 30 minutes, and if tolerated, the infusion rate may be gradually increased every 15 to 30 minutes to a maximum of 12 mg/kg/min (0.12 mL/kg/min) as tolerated1
  • 94% of patients tolerated the maximum infusion rate of 12 mg/kg/min without premedication2

Download Panzyga CIDP Dosing Chart

Example Ramp-Up Schedule for an Adult Patient With CIDP

Total PANZYGA Infusion Time for an Adult Patient with CIDP1

Recommended ramp-up infusion rate if previous rate is tolerated

Maintenance dose options for 80-kg patient with CIDP at 2 different doses:

1 g/kg total dose divided in 2 daily doses
2 g/kg total dose divided in 2 daily doses

PANZYGA Infusion Rate Chart for CIDP

Patient Weight mL/hr

In kg

In lb

First 30 minutes
(0.01 mL/kg/min)

Next 15-30 minutes
if previous rate tolerated
(0.02 mL/kg/min)

Next 15-30 minutes
if previous rate tolerated
(0.04 mL/kg/min)

Next 15-30 minutes
if previous rate tolerated
(0.08 mL/kg/min)

Maximum
if previous rate tolerated
(0.12 mL/kg/min)
40 88 24 48 96 192 288
45 99 27 54 108 216 324
50 110 30 60 120 240 360
55 121 33 66 132 264 396
60 132 36 72 144 288 432
65 143 39 78 156 312 468
70 154 42 84 168 336 504
75 165 45 90 180 360 540
80 176 48 96 192 384 576
85 187 51 102 204 408 612
90 198 54 108 216 432 648
95 209 57 114 228 456 684
100 220 60 120 240 480 720
105 231 63 126 252 504 756
110 242 66 132 264 528 792
115 253 69 138 276 552 828
120 264 72 144 288 576 864
125 276 75 150 300 600 900
130 287 78 156 312 624 936
135 298 81 162 324 648 972
140 309 84 168 336 672 1008
Download Panzyga CIDP Dosing Chart

Loading Dose: 2 g/kg (20 mL/kg), divided into 2 daily doses of 1 g/kg (10 mL/kg) given on 2 consecutive days 1

Maintenance Dose: 1 g/kg or 2 g/kg (10 20 mL/kg) every 3 weeks divided in 2 doses given over 2 consecutive days 1
The initial infusion rate should be maintained for 30 minutes. Following the initial infusion, and if tolerated, the infusion rate 
may be gradually increased every 15 to 30 minutes, as tolerated, to the maximum infusion rate of 12 mg/kg/min (0.12 mL/kg/min)1

Patient Weight mL/hr
In kg In lb First 30 minutes
(0.01 mL/kg/min)		 Next 15-30 minutes
if previous rate tolerated
(0.02 mL/kg/min)		 Next 15-30 minutes
if previous rate tolerated
(0.04 mL/kg/min)		 Maximum
if previous rate tolerated
(0.12 mL/kg/min)
Patients with CIDP

Patients with CIDP

CIDP Patient Profile

CIDP = chronic inflammatory demyelinating polyneuropathy;
FDA = Food and Drug Administration;
IVIg = intravenous immunoglobulin.

Reference: 1. Panzyga. Prescribing information. Octapharma USA, Inc.; 2021.

INDICATIONS & IMPORTANT SAFETY INFORMATION FOR PANZYGA® IMMUNE GLOBULIN INTRAVENOUS (HUMAN) – IFAS 10% LIQUID PREPARATION

BOXED WARNING: THROMBOSIS, RENAL DYSFUNCTION, AND ACUTE RENAL FAILURE

Please click here for Full Prescribing Information, including BOXED WARNING.

  • Thrombosis may occur with immune globulin intravenous (IVIg) products, including Panzyga. 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 may occur in the absence of known risk factors.
  • Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients who receive IVIg products, including Panzyga. 
Patients predisposed to renal dysfunction include those with a degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, 
volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Renal dysfunction and acute renal failure occur more commonly in patients receiving IVIg products containing sucrose. Panzyga does not contain sucrose.
  • For patients at risk of thrombosis, renal dysfunction, or acute renal failure, administer Panzyga 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, Warnings and Precautions (5.2, 5.4)

Indications and Usage

Panzyga (Immune Globulin Intravenous [Human] – ifas) is indicated for the treatment of primary humoral immunodeficiency (PI) in patients 2 years of age 
and older; this includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, 
Wiskott-Aldrich syndrome, and severe combined immunodeficiencies; chronic immune thrombocytopenia (cITP) in adults to raise platelet counts to control 
or prevent bleeding; and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults to improve neuromuscular disability and impairment.

Contraindications

Panzyga is contraindicated in patients who have a history of severe systemic hypersensitivity reactions, such as anaphylaxis, to human immunoglobulin 
and in IgA-deficient patients with antibodies against IgA and history of hypersensitivity.

Warnings and Precautions

  • Monitor renal function, including blood urea nitrogen and serum creatinine, and urine output in patients at risk of developing acute renal failure.
  • Hyperproteinemia, increased serum osmolarity, and hyponatremia may occur in patients receiving Panzyga.
  • Aseptic meningitis syndrome may occur in patients receiving Panzyga, especially with high doses or rapid infusion.
  • Hemolysis that is either intravascular or due to enhanced red blood cell sequestration can develop subsequent to Panzyga treatments. Risk factors for hemolysis include high doses and non-O-blood group. Closely monitor patients for hemolysis and hemolytic anemia.
  • Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]).
  • Monitor blood pressure prior to, during, and following Panzyga infusion.
  • Carefully consider the relative risks and benefits before prescribing the high dose regimen (for cITP) in patients at increased risk of volume overload.
  • Panzyga is made from human plasma and may contain infectious agents, e.g. viruses and theoretically, the Creutzfeldt-Jakob disease agent.

Adverse Reactions

  • PI – The most common adverse reactions reported in greater than 5% of subjects were: headache, nausea, fever, fatigue, and abdominal pain.
  • cITP in adults – The most common adverse reactions reported in greater than 5% of subjects were: headache, fever, nausea, vomiting, dizziness, and anemia.
  • CIDP in adults – The most common adverse reactions reported in greater than 5% of subjects were: headache, fever, dermatitis, and blood pressure increase.

The risk information provided here is not comprehensive; See full Prescribing Information and Boxed Warning for Panzyga.

To report suspected adverse reactions, contact Octapharma USA, Inc. at 1-866-766-4860 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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