Panzyga® has the only
FDA-approved infusion rate of 14 mg/kg/min for PI, as tolerated1

Dosing and Rate of Administration for Patients With PI1

Dose

300 mg/kg
to 600 mg/kg

Body weight (3 to 6 mL/kg) administered every 3 to 4 weeks

Initial Infusion Rate

(first 30 minutes)

1 mg/kg/min

(0.01 mL/kg/min)

Maximum Infusion Rate

(as tolerated)

14 mg/kg/min

(0.14 mL/kg/min)

90% of patients (n=19) with PI in an extension study achieved the maximum infusion rate of 14 mg/kg/min1,a

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 to a maximum of 14 mg/kg/min (0.14 mL/kg/min) as tolerated1,b

Download Panzyga® PI Dosing Chart

Example Ramp-Up Schedule for an 80 kg Patient with PI

Total Panzyga® Infusion Time for an Adult Patient with PI1

Recommended ramp-up infusion rate if previous rate is tolerated

  • Panzyga® should be started at 1 mg/kg/min and continued at the infusion rates stated here, if tolerated.1
  • The example shown above follows a ramp-up of 1, 4, 8, and 14 mg/kg/min.
  • For patients at risk of renal dysfunction or thromboembolic events, administer panzyga® at the minimum infusion rate practicable. Do not exceed 3.3 mg/kg/min (0.033 mL/kg/min). Discontinue if renal function deteriorates.1

Example for 80-kg patient with PI at 2 different doses:

30-g dose (375 mg/kg)
40-g dose (500 mg/kg)

Panzyga® Infusion Rate Chart for PI

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)
10 22 6 24 48 84
15 33 9 36 72 126
20 44 12 48 96 168
25 55 15 60 120 210
30 66 18 72 144 252
35 77 21 84 168 294
40 88 24 96 192 336
45 99 27 108 216 378
50 110 30 120 240 420
55 121 33 132 264 462
60 132 36 144 288 504
65 143 39 156 312 546
70 154 42 168 336 588
75 165 45 180 360 630
80 176 48 192 384 672
85 187 51 204 408 714
90 198 54 216 432 756
95 209 57 228 456 798
100 220 60 240 480 840
105 231 63 252 504 882
110 242 66 264 528 924
115 253 69 276 552 966
120 264 72 288 576 1008
125 276 75 300 600 1050
130 287 78 312 624 1092
135 298 81 324 648 1134
140 309 84 336 672 1176
Download Panzyga® PI Dosing Chart
  • 300 mg/kg to 600 mg/kg of body weight (3-6 mL/kg) administered every 3 to 4 weeks1
  • 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 of 14 mg/kg/min (0.14 mL/kg/min)1

PI = primary immunodeficiency

a 19 of the 21 enrolled patients received panzyga® up to the maximum allowed infusion rate of 14 mg/kg/min.

b Significant differences in the half-life of IgG among patients with PI may require the dose and frequency of immunoglobulin therapy to vary from patient to patient. Determine the proper dose and frequency by monitoring the patient’s clinical response. Adjust the dose over time to achieve the desired levels of IgG and clinical responses.

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

Indications & Important Safety Information
for panzyga® Immune Globulin Intravenous (Human) – IFAS 10% Liquid Preparation

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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