PANZYGA- immune globulin intravenous (human) solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
HUMAN IMMUNOGLOBULIN G (UNII: 66Y330CJHS) (HUMAN IMMUNOGLOBULIN G - UNII:66Y330CJHS)
Available from:
Pfizer Laboratories Div Pfizer Inc
Administration route:
Intravenous
Therapeutic indications:
PANZYGA is indicated for 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. PANZYGA is indicated for the treatment of adult patients with ITP to raise platelet counts to control or prevent bleeding. - PANZYGA is contraindicated in patients who have a history of severe systemic hypersensitivity reactions, such as anaphylaxis, to human immunoglobulin. - PANZYGA is contraindicated in IgA-deficient patients with antibodies against IgA and history of hypersensitivity . Risk Summary No human data are available to indicate the presence or absence of drug-associated risk. Animal reproduction studies have not been conducted with PANZYGA. It is also not known whether PANZYGA can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Immune globulins
Product summary:
PANZYGA is supplied in 1 g, 2.5 g, 5 g, 10 g, 20 g, and 30 g single-use bottles. The table below shows the details of available presentations of PANZYGA. PANZYGA is not supplied with an infusion set. If a filtered infusion set is used (not mandatory), choose a filter size of 0.2-200 microns. Components used in the packaging of PANZYGA are not made with natural rubber latex. Store PANZYGA for 24 months at +2°C to +8°C (36°F to 46°F) from the date of manufacture. Within its shelf-life, the product may be stored at ≤ +25°C (77°F) for up to 9 months. After storage at ≤ +25°C (77°F), either use immediately or discard the product. Do not use after expiration date. Do not freeze. Do not use frozen product. PANZYGA contains no preservatives. The PANZYGA bottle is for single use only. Use promptly any bottle that has been entered or opened, and discard partially used bottles. Dispose of any unused product or waste material in accordance with local requirements.
Authorization status:
Biologic Licensing Application
Authorization number:
0069-1011-01, 0069-1011-02, 0069-1109-01, 0069-1109-02, 0069-1224-01, 0069-1224-02, 0069-1312-01, 0069-1312-02, 0069-1415-01, 0069-1415-02, 0069-1558-01, 0069-1558-02

PANZYGA- immune globulin intravenous (human) solution

Pfizer Laboratories Div Pfizer Inc

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use PANZYGA safely and effectively. See full

prescribing information for PANZYGA.

PANZYGA, (immune globulin intravenous, human - ifas)

10% Liquid Preparation

Initial U.S. Approval: 2018

WARNING: THROMBOSIS, RENAL DYSFUNCTION, and ACUTE RENAL FAILURE

See full prescribing information for complete boxed warning

- Thrombosis may occur with immune globulin intravenous (IGIV) products, including PANZYGA. 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 IGIV products in predisposed patients. Renal dysfunction and acute renal failure occur

more commonly in patients receiving IGIV products containing sucrose. PANZYGA does not contain

suc ro se .

-For patients at risk of thrombosis, renal dysfunction, or renal failure, administer PANZYGA 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

hype rvisc o sity.

INDICATIONS AND USAGE

PANZYGA is an immune globulin intravenous (human) - ifas 10% liquid preparation indicated for the treatment of:

Primary humoral immunodeficiency (PI) in patients 2 years of age and older ( 1.1 ).

Chronic immune thrombocytopenia (ITP) in adults ( 1.2 ).

DOSAGE AND ADMINISTRATION

For intravenous use only ( 2 ).

Indic atio n

Do se

I nitial

Infusio n

Rate

Maximum Infusion Rate in

PANZYGA New Patients (as

to le rate d)

Maximum Infusion Rate in

PANZYGA Experienced Patients(as

to le rate d)

300-600 mg/kg

(3-6 mL/kg)every 3-4

weeks

1 mg/kg/min

(0.01

mL/kg/min)

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

12 or 14 mg/kg/min

(0.12 or 0.14 mL/kg/min)

Chronic

ITP in

adults

1 g/kg (10 mL/kg)

daily for 2

consecutive days

1 mg/kg/min

(0.01

mL/kg/min)

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

Ensure that patients with pre-existing renal insufficiency are not volume depleted; discontinue PANZYGA if renal function

deteriorates ( 2 , 5.2 ).

For patients at risk of renal dysfunction or thrombotic events, administer PANZYGA at the minimum dose and infusion

rate practicable ( 5.2 , 5.4 ).

DOSAGE FORMS AND STRENGTHS

Solution containing 10% IgG (100 mg/mL) ( 3 , 16 )

CONTRAINDICATIONS

History of anaphylactic or severe systemic reactions to human immune globulin ( 4 )

IgAdeficient patients with antibodies against IgA and a history of hypersensitivity ( 4 )

WARNINGS AND PRECAUTIONS

IgA-deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and

anaphylactic reactions to PANZYGA. Epinephrine should be available immediately to treat any severe acute

hypersensitivity reactions ( 5.1 ).

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

developing acute renal failure ( 5.2 ).

Hyperproteinemia, increased serum osmolarity and hyponatremia may occur in patients receiving PANZYGA ( 5.3 ).

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 ( 5.6 ).

Aseptic Meningitis Syndrome may occur in patients receiving PANZYGA, especially with high doses or rapid infusion (

5.5 ).

Monitor patients for pulmonary adverse reactions [transfusion-related acute lung injury (TRALI)] ( 5.7 ).

PANZYGA is made from human plasma and may contain infectious agents, e.g., viruses, variant Creutzfeldt-Jakob disease

[vCJD] agent and, theoretically, the Creutzfeldt-Jakob disease agent ( 5.10 ).

ADVERSE REACTIONS

PI - The most common adverse reactions reported in greater than 5% of subjects during a clinical trial were: headache,

nausea, fever, fatigue, and abdominal pain ( 6 ).

Chronic ITP in adults - The most common adverse reactions reported in greater than 5% of subjects during a clinical trial

were: headache, fever, nausea, vomiting, dizziness, and anemia ( 6 ).

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-

1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

The passive transfer of antibodies may confound the results of serological testing ( 7 ).

The passive transfer of antibodies may interfere with the immune response to live viral vaccines, such as measles,

mumps, and rubella ( 7 ).

USE IN SPECIFIC POPULATIONS

Geriatric Use: In patients over age 65 years and in any patient at risk of developing renal insufficiency, infuse PANZYGA

at the minimum infusion rate practicable and do not exceed the recommended dose PANZYGA ( 8.5 ).

_______________________________________________________________________________________________________________________________________

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 4/2019

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: THROMBOSIS, RENAL DYSFUNCTION, and ACUTE RENAL FAILURE

1 INDICATIONS AND USAGE

1.1 Primary Humoral Immunodeficiency Diseases (PI)

1.2 Chronic Immune Thrombocytopenia (ITP)

2 DOSAGE AND ADMINISTRATION

2.1 Dose

2.2 Administration

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity

5.2 Renal Failure

5.3 Hyperproteinemia, Increased Serum Viscosity and Hyponatremia

5.4 Thrombotic Events

5.5 Aseptic Meningitis Syndrome

5.6 Hemolysis

5.7 Transfusion-Related Acute Lung Injury (TRALI)

5.8 Hypertension

5.9 Volume Overload

5.10 Transmission of Infectious Agents

5.11 Monitoring Laboratory Tests

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

13.2 Animal Toxicology and/or Pharmacology

14 CLINICAL STUDIES

14.1 Treatment of Primary Humoral Immunodeficiency (PI)

14.2 Treatment of Chronic Immune Thrombocytopenia (ITP) in Adults

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

FULL PRESCRIBING INFORMATION

PANZYGA, Immune Globulin Intravenous (Human) - ifas

10% Liquid Preparation

Sections or subsections omitted from the full prescribing information are not listed.

WARNING: THROMBOSIS, RENAL DYSFUNCTION, and ACUTE RENAL FAILURE

Thrombosis may occur with immune globulin intravenous (IGIV) 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. (See WARNING and

PRECAUTIONS [ 5.4 ], PATIENT COUNSELING INFORMATION [ 17 ])

Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in

predisposed patients who receive IGIV 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 IGIV product 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 DOSAGE and

ADMINISTRATION [ 2.3 ], WARNINGS and PRECAUTIONS [ 5.2 , 5.4 ])

1 INDICATIONS AND USAGE

1.1 Primary Humoral Immunodeficiency Diseases (PI)

PANZYGA is indicated for 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.

1.2 Chronic Immune Thrombocytopenia (ITP)

PANZYGA is indicated for the treatment of adult patients with ITP to raise platelet counts to control or

prevent bleeding.

2 DOSAGE AND ADMINISTRATION

For intravenous use only.

2.1 Dose

Indication

Dos e

Initial

Infus ion

Rate (first

30 min)

Maximum

Infusion Rate in

New Patients**

(as tolerated)

Maximum Infusion

Rate in Experienced

Patients*** (as

tolerated)

Treatment of

Primary Humoral

Immunodeficiency

(PI)*

300 to 600 mg/kg body

weight (3-6 mL/kg)

administered every 3 to 4

weeks

mg/kg/min

(0.01

mL/kg/min)

8 mg/kg/min

(0.08 mL/kg/min)

12 or 14 mg/kg/min

(0.12 or 0.14

mL/kg/min)

Treatment of

Chronic Immune

Thrombocytopenia

(ITP)

2 g/kg, divided into two daily

doses of 1 g/kg (10 mL/kg)

given on two consecutive

days

mg/kg/min

(0.01

mL/kg/min)

8 mg/kg/min

(0.08 mL/kg/min)

*Significant differences in the half-life of IgG among patients with PI may necessitate the dose and

frequency of immunoglobulin therapy to vary from patient to patient. Determine the proper dose and

frequency by monitoring the clinical response. Adjust dose over time to achieve the desired trough

levels of IgG and clinical responses.

**Patients receiving PANZYGA (or another IGIV) for the first time or more than 8 weeks since a prior

treatment.

*** Experienced patients received greater than 3 (12 mg/kg/min) to 6 (14 mg/kg/min) infusions every 3-4

weeks.

Following the initial infusion, the infusion rate may be gradually increased every 15-30 minutes to a

maximum of 14 mg/kg/min (0.14 mL/kg/min) in PI and to 8 mg/kg/min (0.08 mL/kg/min) in chronic ITP in

adults, as tolerated. The recommended ramp-up for an infusion is 1, 2, 4, and 8 mg/kg/min (0.01, 0.02,

0.04, and 0.08 mL/kg/min) in new PI and ITP patients (i.e., patients who have not previously received

any IGIV product), and 1, 4, 8, and 12 or 14 mg/kg/min (0.01, 0.04, 0.08, and 0.12 or 0.14 mL/kg/min) in

experienced PI patients (i.e., patients who have previously received any IGIV product).

Measles Exposure

If a patient with primary humoral immunodeficiency has been exposed to measles, it may be prudent to

administer an extra dose of IGIV as soon as possible and within 6 days of exposure. A dose of 400

mg/kg should provide a serum level > 240 mIU/mL of measles antibodies for at least two weeks.

If a patient with primary humoral immunodeficiency is at risk of future measles exposure and receives a

dose of less than 530 mg/kg every 3-4 weeks, the dose should be increased to at least 530 mg/kg. This

should provide a serum level of 240 mIU/mL of measles antibodies for at least 22 days after infusion.

2.2 Administration

Inspect parenteral products visually for particulate matter and discoloration prior to administration,

whenever solution and container permit. Do not use PANZYGA if it is turbid and/or if discoloration

is observed. Using a needle, no larger than a 16-gauge needle, insert the needle only once within the

stopper area (delineated by the raised ring for penetration). Penetrate the stopper perpendicularly to

its plane and within the ring.

PANZYGA bottles may be pooled under aseptic conditions into sterile infusion bags. Infuse within

8 hours after pooling.

Administer at room or body temperature only by the intravenous route, using an in-line filter with

pore size 0.2-200 microns.

Do not administer PANZYGA simultaneously with another intravenous preparation in the same

infusion set, including immune globulin products from another manufacturer.

After administration, flush the infusion line with either normal saline or 5% dextrose in water.

Monitor the patient carefully throughout the infusion. Certain adverse drug reactions are related to

the rate of infusion, and will disappear promptly after slowing or stopping the infusion. In such

cases, after symptoms subside, resume the infusion at a lower rate. Ensure that patients with pre-

existing renal insufficiency are not volume depleted. 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.

3 DOSAGE FORMS AND STRENGTHS

Solution containing 10% IgG (100 mg/mL) (See How Supplied/Storage and Handling ( 16 )).

4 CONTRAINDICATIONS

PANZYGA is contraindicated in patients who have a history of severe systemic hypersensitivity

reactions, such as anaphylaxis, to human immunoglobulin.

PANZYGA is contraindicated in IgA-deficient patients with antibodies against IgA and history of

hypersensitivity .

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity

Severe hypersensitivity reactions may occur (See Contraindications ( 4 )) . [ 1 ] In case of

hypersensitivity, discontinue PANZYGA infusion immediately and institute appropriate treatment. Have

epinephrine available for immediate treatment of severe acute hypersensitivity reactions.

PANZYGA contains trace amounts of IgA (average 100 µg/mL in a 10% solution). IgA-deficient

patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and

anaphylactoid reactions when administered PANZYGA (See Contraindications ( 4 )) .

5.2 Renal Failure

Renal dysfunction, acute renal failure, osmotic nephropathy, and death may occur upon use of

PANZYGA in predisposed patients.

Ensure that patients are not volume depleted prior to the initiation of the infusion of PANZYGA.

For patients at risk of renal dysfunction because of pre-existing renal insufficiency or predisposition to

acute renal failure (such as individuals with diabetes mellitus, age greater than 65 years, volume

depletion, sepsis, paraproteinemia, or those receiving known nephrotoxic drugs), administer PANZYGA

at the minimum infusion rate practicable (See Boxed Warning, and Dosage and Administration ( 2 )).

Periodic monitoring of renal function tests and urine output is particularly important in patients judged to

be at risk of developing acute renal failure. Assess renal function, including a measurement of blood

urea nitrogen (BUN)/serum creatinine, prior to the initial infusion of PANZYGA and again at

appropriate intervals thereafter. If renal function deteriorates, consider discontinuation of the product.

5.3 Hyperproteinemia, Increased Serum Viscosity and Hyponatremia

Hyperproteinemia, increased serum viscosity and hyponatremia may occur in patients receiving

PANZYGA therapy. It is clinically critical to distinguish true hyponatremia from pseudohyponatremia

related to hyperproteinemia with concomitant decreased calculated serum osmolality or elevated

osmolar gap, because treatment aimed at decreasing serum free water in patients with

pseudohyponatremia may lead to volume depletion, a further increase in serum viscosity and a higher

risk of thromboembolic events.[ 2 ]

5.4 Thrombotic Events

Thrombosis may occur following treatment with immune globulin products, including PANZYGA. Risk

factors 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.

Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including those

with cryoglobulins, fasting chylomicronemia / markedly high triacylglycerols (triglycerides), or

monoclonal gammopathies. For patients at risk of thrombotic events, 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.[ 3-5 ] (See BOXED WARNING, DOSAGE and ADMINSTRATION [ 2.3 ], PATIENT

COUNSELING INFORMATION [ 17 ])

5.5 Aseptic Meningitis Syndrome

Aseptic meningitis syndrome (AMS) may occur with PANZYGA treatment. Discontinuation of treatment

has resulted in remission of AMS within several days without sequelae. The syndrome usually begins

within several hours to two days following infusion with PANZYGA. It is characterized by symptoms

and signs including severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye

movements, nausea, and vomiting. Cerebrospinal fluid (CSF) studies frequently reveal pleocytosis up to

several thousand cells per cubic millimeter, predominantly from the granulocytic series, and elevated

protein levels up to several hundred mg/dl, but negative culture results. Conduct a thorough

neurological examination in patients exhibiting such symptoms and signs, including CSF studies, to rule

out other causes of meningitis. Patients with a history of migraine may be more susceptible.[ 6 ]

AMS may occur more frequently following high doses (≥ 2 g/kg) and/or rapid infusion of IGIV.

5.6 Hemolysis

PANZYGA may contain blood group antibodies that can act as hemolysins and induce in vivo coating of

red blood cells (RBCs) with immunoglobulin, causing a positive direct antiglobulin test (DAT)

(Coombs’ test) result and hemolysis. Delayed hemolytic anemia can develop subsequent to IGIV therapy

due to enhanced RBC sequestration and acute hemolysis, consistent with intravascular hemolysis, has

been reported. Cases of severe hemolysis-related renal dysfunction/failure or disseminated

intravascular coagulation have occurred following infusion of IGIV.

The following risk factors may be associated with the development of hemolysis following IGIV

administration: high doses (e.g., 2 g/kg or more), given either as a single administration or divided over

several days, and non-O blood group.[ 7 ] Other individual patient factors, such as an underlying

inflammatory state (as may be reflected by, for example, elevated C-reactive protein or erythrocyte

sedimentation rate), have been hypothesized to increase the risk of hemolysis following administration

of IGIV [ 8 ], but their role is uncertain. Hemolysis has been reported following administration of IGIV

for a variety of indications, including ITP.

Closely monitor patients for clinical signs and symptoms of hemolysis, particularly patients with risk

factors noted above. Consider appropriate laboratory testing in higher risk patients, including

measurement of hemoglobin or hematocrit prior to infusion and within approximately 36 to 96 hours

post-infusion. If clinical signs and symptoms of hemolysis or a significant drop in hemoglobin or

hematocrit have been observed, perform confirmatory laboratory testing, including direct antiglobulin

test. If transfusion is indicated for patients who develop hemolysis with clinically compromising anemia

after receiving IGIV, perform adequate cross-matching to avoid exacerbating on-going hemolysis.

5.7 Transfusion-Related Acute Lung Injury (TRALI)

Noncardiogenic pulmonary edema [Transfusion-Related Acute Lung Injury (TRALI)] may occur in

patients administered IGIV.[ 9 ] TRALI is characterized by severe respiratory distress, pulmonary

edema, hypoxemia, normal left ventricular function, and fever. Signs and symptoms typically appear

within 1 to 6 hours after transfusion. Patients with TRALI may be managed using oxygen therapy with

adequate ventilatory support.

Monitor recipients for pulmonary adverse reactions. If TRALI is suspected, perform appropriate tests

for the presence of anti-HLA and anti-neutrophil antibodies in both the product and patient’s serum.

5.8 Hypertension

Elevations of systolic blood pressure to 180 mm Hg or more and/or of diastolic blood pressure to

more than 120 mm Hg (hypertensive urgency) can be observed during and/or shortly following infusion

of IVIG. Such elevations are reported more often among patients with a history of hypertension. Check

patients for a history of hypertension and current antihypertensive medication use. Monitor blood

pressure prior to, during, and following PANZYGA infusion.

5.9 Volume Overload

Carefully consider the relative risks and benefits before prescribing the high dose regimen (for chronic

ITP) in patients at increased risk of volume overload.

5.10 Transmission of Infectious Agents

Because PANZYGA is made from human blood, it may carry a risk of transmitting infectious agents,

e.g., viruses and theoretically, the variant Creutzfeldt-Jakob disease and Creutzfeldt-Jakob disease

(CJD) agent. The risk of infectious agent transmission has been reduced by screening plasma donors and

by including virus inactivation/removal steps in the manufacturing process of PANZYGA. Report all

infections thought by a physician or other healthcare provider to have been possibly transmitted by this

product to Pfizer Inc. at 1-800-438-1985. Discuss the risks and benefits of PANZYGA with the patient

before prescribing or administering this product.

5.11 Monitoring Laboratory Tests

After infusion of immunoglobulin, the transitory rise of the passively transferred antibodies in the

patient’s blood may yield positive serological testing results, with the potential for misleading

interpretation.

Passive transmission of antibodies to erythrocyte antigens (e.g., A, B, and D) may cause a positive

direct or indirect antiglobulin (Coombs’) test. Clinically assess patients with known renal

dysfunction, diabetes mellitus, age greater than 65 years, volume depletion, sepsis, paraproteinemia,

or those receiving nephrotic agents, and monitor as appropriate (BUN; serum creatinine, urine

output) during therapy with PANZYGA.

Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including

those with polycythemia, cryoglobulins, fasting chylomicronemia/markedly high triglycerides, or

monoclonal gammopathies.

Consider measuring hemoglobin or hematocrit at baseline and approximately 36 to 96 hours post-

infusion in patients at higher risk of hemolysis. If signs and/or symptoms of hemolysis are present

after an infusion of PANZYGA, perform appropriate laboratory testing for confirmation.

If TRALI is suspected, perform appropriate tests for the presence of anti-neutrophil antibodies in

both the product and patient’s serum.

6 ADVERSE REACTIONS

PI: The most common adverse reactions observed at a rate of more than 5% in subjects in clinical trials

were: headache, abdominal pain, fever, nausea, and fatigue.

Chronic ITP in adults: The most common adverse reactions observed at a rate of more than 5% in

subjects in clinical trials were: headache, fever, nausea, vomiting, dizziness, and anemia.

The most serious adverse reaction observed with PANZYGA treatment during clinical trials was an

aseptic meningitis in one subject.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the

clinical trials of a product cannot be directly compared to rates in the clinical trials of another product and

may not reflect the rates observed in clinical practice.

Treatment of Primary Humoral Immunodeficiency (PI)

In a prospective, open-label, single-arm, multicenter study in 51 children and adults with PI, subjects

received PANZYGA at a dose between 200 to 800 mg/kg body weight every 3 or 4 weeks. Subjects

participated in the study for a mean of 360 days. Infusions were initiated at a rate of 1 mg/kg/minute for

the first 30 minutes, and, if tolerated, could be advanced to a maximum tolerated rate not exceeding

8 mg/kg/minute. The mean age of subjects was 26.8 years (range: 2 to 65 years).

This study was followed by an extension study that evaluated the safety of PANZYGA administered at

higher infusion rates in 21 subjects that successfully had completed the first study. Nineteen of the 21

enrolled patients received PANZYGA up to the maximum allowed infusion rate of 14 mg/kg/minute.

In the study in PI, infusion-related adverse events (during or within 72 hours after the end of infusion)

were reported in 16 patients (76%) enrolled in the 3-weeks treatment schedule and in 22 patients (73%)

in the 4-weeks treatment schedule. Overall, 38 infusions (5%) had at least one adverse event considered

related to study medication: 5 infusions (3%) in children, 4 infusions in adolescents (2%), and 29

infusions (8%) in adults. Study medication-related (possible or probable) infusion-related adverse

reactions were associated with 35 infusions (5%) (overall); study medication-related headache was

noted in 21 infusions (3%).

Table 1: Adverse Reactions* Occurring in more than 5% of Subjects with PI

Adverse Reaction

No. of Subjects with Adverse Reaction(percentage of subjects)

Headache

11 (22%)

Abdominal pain (upper)

7 (14%)

Fever

7 (14%)

Nausea

5 (10%)

Sinusitis

4 (8%)

Fatigue

3 (6%)

Bronchitis

3 (6%)

* Any infusional and any study medication related adverse events.

Treatment of Chronic Immune Thrombocytopenia (ITP) in Adults

In a prospective, open-label, single-arm, multicenter study, 40 adult subjects with chronic ITP received

PANZYGA at a dose of 2 g/kg, administered daily as 1 g/kg intravenous infusions on 2 consecutive

days. 3/40 subjects did not receive a second infusion of PANZYGA due to infusion reactions, including

chills, headache, fever and nausea. All subjects except 1 received at least 1 infusion with the highest

rate of 8 mg/kg/minute. Pre-medication to alleviate potential adverse drug reactions was not allowed in

the study.

There were 67 treatment emergent adverse events (TEAEs) reported in 24 (60%) subjects that were

related to administration of PANZYGA. 55 of these adverse events ( 82%) were infusional adverse

events that occurred within 72 hours after start of the infusion. Seven of these adverse events in 2

subjects were severe. These included headache, nausea, vomiting and chills.

When analyzed by infusion, infusion-related adverse events were reported in 33 of the 77 infusions

(43%),

Table 2: Adverse Reactions* Occurring in more than 5% of Subjects with Chronic ITP in Adults

Adverse Reaction No. of Subjects with Adverse Reaction(percentage of subjects)

Headache

20 (50%)

Fever

9 (23%)

Nausea

7 (18%)

Vomiting

4 (10%)

Dizziness

4 (10%)

Anemia

4(10%)

* Any infusional and any study medication related adverse events.

One out of 40 subjects with ITP treated with PANZYGA developed aseptic meningitis on Day 2 of the

infusion. This subject was managed with antibiotics and supportive care with recovery.

Baseline direct Coomb’s test was performed in 39/40 subjects that were treated with PANZYGA. 10/39

(26%) subjects subsequently developed positive Coomb’s test. One subject was not tested at baseline

but had positive results on all 3 subsequent visits. Four of these subjects (10%) developed hemolytic

anemia after receiving PANZYGA. These resolved spontaneously without any intervention.

6.2 Postmarketing Experience

Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it

is not always possible to reliably estimate the frequency of these reactions or establish a causal relationship

to product exposure. The following adverse reactions have been identified during post-approval use of IGIV

products. Because these reactions are reported voluntarily from a population of uncertain size, it is not

always possible to reliably estimate their frequency or to establish a causal relationship to IGIV products:

Blood and lymphatic system disorders

Leucopenia, hemolysis, pancytopenia

Immune system disorders

Hypersensitivity (e.g., anaphylaxis), anaphylactic shock, anaphylactic reaction, anaphylactoid reaction,

allergic reaction, angioedema, face edema

Metabolic and nutritional disorders

Fluid overload, (pseudo)hyponatremia

Psychiatric disorders

Agitation, confusional state, anxiety, nervousness

Nervous system disorders

Coma, loss of consciousness, seizures, (acute) encephalopathy, cerebrovascular accident, stroke,

aseptic meningitis, migraine, speech disorder, paraesthesia, hypoesthesia, photophobia, tremor

Cardiac disorders

Myocardial infarction, cardiac arrest, angina pectoris, tachycardia, bradycardia, palpitations, cyanosis

Vascular disorders

Hypotension, (deep vein) thrombosis, peripheral circulatory failure/collapse, hypertension, phlebitis,

pallor

Respiratory, thoracic and mediastinal disorders

Apnea, Acute Respiratory Distress Syndrome (ARDS), TRALI, respiratory failure, pulmonary

embolism, pulmonary edema, bronchospasm, dyspnea, hypoxia, wheezing, cough

Gastrointestinal disorders

Diarrhea, hepatic dysfunction, abdominal discomfort

Skin and subcutaneous tissue disorders

Eczema, urticaria, rash (erythematous), dermatitis, pruritus, alopecia, Stevens-Johnson syndrome,

epidermolysis, skin exfoliation, erythema (multiforme), dermatitis (e.g., bullous dermatitis)

Musculoskeletal and connective tissue disorders

Back pain, arthralgia, myalgia, musculoskeletal pain, muscle stiffness, pain in extremity, neck pain,

muscle spasm

Renal and urinary disorders

Acute renal failure, osmotic nephropathy, renal pain

General disorders and administration site conditions

Injection site reaction, chills, chest pain or discomfort, hot flush, flushing, flu-like illness, feeling cold

or hot, edema, hyperhidrosis, malaise, asthenia, lethargy, burning sensation

Investigations

Hepatic enzymes increased, oxygen saturation decreased, falsely elevated erythrocyte sedimentation

rate, positive direct antiglobulin (Coombs’) test

7 DRUG INTERACTIONS

Clinical studies have not evaluated mixtures of PANZYGA with other drugs and intravenous solutions.

It is recommended that PANZYGA is administered separately from other drugs or medications which

the patient may be receiving. Do not mix the product.

Do not mix PANZYGA with IGIVs from other manufacturers.

Passively transferred antibodies in immunoglobulin preparations can confound the results of

serological testing, e.g. false positive Treponema pallidum testing might occur.

Antibodies in PANZYGA may interfere with the response to live viral vaccines, such as measles,

mumps, and rubella. Inform physicians of recent therapy with PANZYGA, so that administration of live

viral vaccines, if indicated, can be appropriately delayed for 3 or more months from the time of

PANZYGA administration.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

No human data are available to indicate the presence or absence of drug-associated risk. Animal

reproduction studies have not been conducted with PANZYGA. It is also not known whether PANZYGA

can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Immune globulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in

clinically recognized pregnancies is 2-4% and 15-20%, respectively.

8.2 Lactation

Risk summary

No human data are available to indicate the presence or absence of drug-associated risk. The

developmental and health benefits of breastfeeding should be considered along with the mother’s

clinical need for PANZYGA and any potential adverse effects on the breastfed infant from PANZYGA

or from the underlying maternal condition.

8.4 Pediatric Use

Treatment of Primary Humoral Immunodeficiency (PI)

PANZYGA was evaluated in 25 pediatric subjects (age range: 2-15 years). Twenty-five percent of PI

subjects exposed to PANZYGA were children (between 2 and 12 years of age). Pharmacokinetics,

efficacy and safety were similar to those in adults. No specific dose requirements were necessary to

achieve the targeted serum IgG levels in the pediatric subjects.

Treatment of Immune Thrombocytopenia (ITP) in children

The safety and effectiveness of PANZYGA have not been established in pediatric patients with ITP.

8.5 Geriatric Use

Clinical studies of PANZYGA did not include sufficient numbers of subjects older than 65 years to

determine whether they respond differently from younger subjects. Patients older than 65 years of age

may be at increased risk for developing adverse reactions such as thromboembolic events and acute

renal failure (See Boxed Warnings and Thrombotic Events ( 5.4 ) and Renal Failure ( 5.2 ) . Do not exceed

recommended doses in this population, and apply the minimum practicable infusion rate.

10 OVERDOSAGE

With intravenous administration, overdose may lead to fluid overload and hyperviscosity. Patients at risk

of complications of fluid overload and hyperviscosity include elderly patients and those with cardiac or

renal impairment.

11 DESCRIPTION

Immune Globulin Intravenous (Human), PANZYGA, is a solvent/detergent (S/D)-treated, sterile

preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma.

PANZYGA is a solution for infusion to be administered intravenously.

This preparation contains approximately 100 mg of protein per mL (10%), of which not less than 96% is

normal human immunoglobulin G. PANZYGA contains not more than 3% aggregates, not less than 90%

monomers and dimers, and not more than 3% fragments. On average, the product contains 100 µg/mL of

IgA, and lower amounts of IgM.

PANZYGA contains only trace amounts of sodium, and the pH is between 4.5 and 5.0. The osmolality is

in the range of 240-310 mosmol/kg.

The manufacturing process for PANZYGA isolates IgG without additional chemical or enzymatic

modification, and the Fc portion is maintained intact. PANZYGA contains the IgG antibody activities

present in the donor population. IgG subclasses are fully represented with the following approximate

percents of total IgG: IgG is 65%, IgG is 28%, IgG is 3% and IgG is 4%.

PANZYGA contains a broad spectrum of IgG antibodies against bacterial and viral agents that are

capable of opsonization and neutralization of microbes and toxins. PANZYGA contains glycine (15.0-

19.5 mg/mL), but no preservatives or sucrose.

All units of human plasma used in the manufacture of PANZYGA are provided by FDA-approved blood

and plasma establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to

HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV1 and found to be non-reactive

(negative).

The product is manufactured by the cold ethanol fractionation process followed by purification

methodologies, as well as S/D treatment and nanofiltration (20 nm). The S/D mixture used is composed

of tri-n-butyl phosphate (TNBP, solvent) and Triton X-100 (Octoxynol, detergent). The PANZYGA

manufacturing process shows significant viral reduction and inactivation, demonstrated by in vitro

infectivity studies (Table 3). The virus safety of PANZYGA is achieved through a combination of

various process steps, including S/D treatment, ion-exchange chromatography, and nanofiltration (20

nm).

Table 3 shows the virus clearance during the manufacturing process for PANZYGA, expressed as the

mean log

reduction factor (LRF).

Table 3: Virus Reduction by PANZYGA Manufacturing Process

HIV-1: Human Immunodeficiency Virus – 1, a model for HIV-1 and HIV-2;

PRV: Pseudorabies Virus, a model for large enveloped DNA viruses (eg, herpes virus);

BVDV: Bovine Viral Diarrhea Virus, a model for e.g., Hepatitis C virus (HCV) and West-Nile virus

(WNV);

MEV: Mouse Encephalomyelitis virus, a model for Hepatitis A virus (HAV);

PPV: Porcine Parvovirus, a model for Human Parvovirus B19;

n.a.: not applicable;

n.d: not done.

Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of

an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the

vCJD and CJD agents. [ 10 ]

Several of the individual production steps in the PANZYGA manufacturing process were shown to

decrease TSE infectivity of that experimental model agent. TSE reduction steps include ion-exchange

chromatography and nanofiltration, which together give a total of at least 10.4 log10 decrease of

infectivity. These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity,

if present in the starting material, would be removed.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Treatment of Primary Humoral Immunodeficiency (PI)

PANZYGA supplies a broad spectrum of opsonic and neutralizing IgG antibodies against bacteria or

their toxins. The mechanism of action in PI has not been fully elucidated.

Treatment of Chronic Immune Thrombocytopenia (ITP) in Adults

The mechanism of action of immunoglobulins in the treatment of chronic ITP in adults has not been fully

elucidated.

12.2 Pharmacodynamics

PANZYGA contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against

various infectious agents reflecting the IgG activity found in the donor population. PANZYGA which is

prepared from pooled material from not less than 1000 donors, has an IgG subclass distribution similar

to that of native human plasma. Adequate doses of IGIV can restore abnormally low IgG level to the

normal range. Standard pharmacodynamic studies were not performed.

12.3 Pharmacokinetics

Treatment of Primary Humoral Immunodeficiency (PI)

In the PI study, 50 pediatric and adult subjects underwent pharmacokinetic assessments. Subjects

received infusions of PANZYGA (200 to 800 mg/kg body weight) every 3 or 4 weeks for 12 months.

Blood samples for PK study were collected between the 7

and 9

PANZYGA infusion, depending on

the individual treatment schedule.

Table 4a and 4b summarize the pharmacokinetic parameters of PANZYGA, based on serum

concentrations of total IgG, in subjects receiving infusions every 3, or 4 weeks, respectively.

Table 4: PI Study- Pharmakokinetic Parameters of PANZYGA in Subjects

a) PK Parameters: IGG Arm: 3-weeks

b) PK Parameters: IGG Arm: 4-weeks

Treatment of Chronic Immune Thrombocytopenia (ITP) in Adults

Pharmacokinetic studies with PANZYGA have not been performed in patients with chronic ITP in

adults.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

No animal studies were conducted on carcinogenesis, mutagenesis, or impairment of fertility with

PANZYGA.

13.2 Animal Toxicology and/or Pharmacology

Several standard nonclinical proof-of-concept and safety studies were performed with PANZYGA in

animals. These included acute toxicity, pharmacokinetic, local tolerance, and safety pharmacology

studies. PANZYGA. There were no adverse effects attributed to PANZYGA in the animal studies.

TNBP and Octoxynol-9 may be found in PANZYGA in trace amounts. In single- and repeated-dose

toxicity studies in animals, these impurities caused no adverse effects when administered (alone or in

combination) at doses multiple times higher than the equivalent human dose. A mixture of these

compounds did not show teratogenic effects when administered to pregnant rabbits and rats during

organogenesis.

14 CLINICAL STUDIES

14.1 Treatment of Primary Humoral Immunodeficiency (PI)

Study 1: In a prospective, open-label, single-arm, multicenter study in 51 children and adults with PI,

subjects received PANZYGA at a dose between 200 to 800 mg/kg body weight every 3 or 4 weeks.

Subjects participated in the study for a mean of 360 days. Infusions were initiated at a rate of 1

mg/kg/min for the first 30 minutes, and, if tolerated, could be advanced to a maximum tolerated rate not

exceeding 8 mg/kg/min. The mean age of subjects was 26.8 years (range: 2 to 65 years).

The primary efficacy endpoint was the number of episodes of serious bacterial infections per patient

per year. Serious infection included pneumonia, bacteremia or sepsis, osteomyelitis/septic arthritis,

visceral abscesses, or bacterial meningitis. Secondary efficacy variables included: occurrence of any

infection of any kind or seriousness; time to resolution of infections; use of antibiotics; the number of

days of work/school missed; the number and days of hospitalizations; and the number of episodes of

fever.

For the primary endpoint, the observed rate was 0.08 serious bacterial infections per patient per year (4

infections over 50.2 patient-years).

Only 1 adult patient was hospitalized due to an infection for 4 days (overall rate of days in hospital per

person-year: 0.080). Episodes of fever were observed for less than 25% of all patients. The mean

resolution time was 14 days for serious bacterial infections and 18 days for other infections.

Approximately 50% of all patients missed at least 1 day of work or school due to infections, with an

annual rate of less than 4 days/person-year.

Table 5 summarizes the efficacy results for all 51 subjects.

Table 5: Study 1 – Summary of Efficacy Results for subjects with PI

Category

Result Unit

Number of subjects

51 Subjects

Total number of subject days

18,349 Days

Annual rate of confirmed serious bacterial infections (SBIs)*

0.080 SBIs/person-year **

Annual rate of other infections

3.682 Inf./person-year

Number of subjects (%) with use of antibiotics

42 (82.4%)Subjects(%)

Annual rate of use of antibiotics

87 Days/person-year

Absences from work or school due to Infection, number of days (%) 183 (1.0%)Days (%)

Annual rate of absences from work or school due to infection

3.6 Days/person-year

Hospitalization due to infection, number of days

4 Days

Annual rate of hospitalizations due to infection

0.1 Day/person-year

* Defined as bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia

and visceral abscess

** Upper 1-sided 99% confidence interval: 0.503

Throughout the entire study, the serum IgG trough levels were nearly constant for both treatment

schedules and were above the required trough levels of about 5-6 g/L. The calculated pharmacokinetic

parameters showed that the minimum concentration of IgG was at least 6.8 g/L for both treatment

intervals.

14.2 Treatment of Chronic Immune Thrombocytopenia (ITP) in Adults

A prospective, open-label, single-arm, multicenter study assessed the efficacy, safety, and tolerability

of PANZYGA in 40 subjects with chronic ITP and a platelet count of 20 x 10

/L or less. Subjects

ranged in age from 18 to 72 years (median: 32 years); 43% were female and 57% were male. Ninety

percent of the subjects were Caucasian and 10% were Asian.

Subjects received a 2 g/kg dose of PANZYGA administered as two daily 1 g/kg intravenous doses,

given on 2 consecutive days. All but one patient received the maximum infusion rate of 8 mg/kg/minute,

starting at 1 mg/kg/minute. Platelet counts were measured on Days 1 to 8, 15, and 22.

The study was designed to determine the response rate, defined as the percentage of subjects with an

increase in platelet count to at least 50 x 10

/L within 7 days after the first infusion (responders).

Additionally, maximum platelet count, the time to reach a platelet count of at least 50 x 10

/L within the

first 7 days, the duration of that response (i.e., the number of days the platelet count remained in excess

of 50 x 10

/L), and the regression of hemorrhages in subjects who had bleeding at baseline were

observed.

Of the 36 subjects in the full analysis set, 29 (81%: 95% CI: 64%- 92%).) responded to PANZYGA

with a rise in platelet count to at least 50 x 10

/L within 7 days after the first infusion. The lower bound

of the overall 95% confidence interval for the response rate in all 36 subjects (64%) is above the

predefined response rate of 60%.

Table 6 shows the median and mean of the maximum platelet count.

Table 6: Maximum Platelet Count (x10

/L)

ITP subjects (n=36)

Median and range

196 (8 to 1067)

Mean ± standard deviation

237 ± 205

Table 7 shows the median and mean of the time to and duration of platelet response.

Table 7: Time to and Duration of Platelet Response (Responders Only).

Time to Platelet Response (at least 50x10

/L) (Days)

Duration of Platelet Response

(Days )

ITP Subjects Responders (n=29)

ITP Subjects Responders

(n=29)

Median and range

2 (1 to 4)

14 (1 to 20)

Mean ± standard

deviation

1.8 ± 0.8

12.4 ± 5.8

Of the 36 subjects, 23 (64%) subjects had bleeding at baseline. Bleeding was minor in 14 subjects

(39%), mild in 2 subjects (6%) and moderate in 7 subjects (19%). On Day 7, only 14% of subjects were

bleeding (5/36). Persistent bleeding was mild in 1 and minor in 2 subjects. Information regarding

bleeding resolution was missing in 2 subjects with moderate bleeding.

15 REFERENCES

1. Duhem C, Dicato MA, Ries F: Side-effects of intravenous immune globulins. Clin.Exp.Immunol.

1994;97 Suppl 1:79-83.

2. Steinberger BA, Ford SM, Coleman TA: Intravenous immunoglobulin therapy results in post-

infusional hyperproteinemia, increased serum viscosity, and pseudohyponatremia. Am.J Hematol.

2003;73:97-100.

3. Dalakas MC: High-dose intravenous immunoglobulin and serum viscosity: risk of precipitating

thromboembolic events. Neurology 1994;44:223-226.

4. Go RS, Call TG: Deep venous thrombosis of the arm after intravenous immunoglobulin infusion:

case report and literature review of intravenous immunoglobulin-related thrombotic complications.

Mayo Clin Proc 2000;75:83-85.

5. Wolberg AS, Kon RH, Monroe DM, et al: Coagulation factor XI is a contaminant in intravenous

immunoglobulin preparations. Am.J.Hematol. 2000;65:30-34.

6. Sekul EA, Cupler EJ, Dalakas MC: Aseptic meningitis associated with high-dose intravenous

immunoglobulin therapy: frequency and risk factors. Ann Intern.Med 1994;121:259-262.

7. Kahwaji J, Barker E, Pepkowitz S, et al: Acute Hemolysis After High-Dose Intravenous

Immunoglobulin Therapy in Highly HLA Sensitized Patients. Clin J Am Soc Nephrol 2009;4:1993-

1997.

8. Daw Z, Padmore R, Neurath D, et al: Hemolytic transfusion reactions after administration of

intravenous immune (gamma) globulin: A case series analysis. Transfusion 2008;48:1598-1601.

9. Rizk A, Gorson KC, Kenney L, et al: Transfusion-related acute lung injury after the infusion of

IVIG. Transfusion 2001;41:264-268.

10. Radomski KU, Lattner G, Schmidt T, Römisch J: Pathogen Safety of a New Intravenous Immune

Globulin 10% Liquid. BioDrugs 2017(2): 125-134

9

9

16 HOW SUPPLIED/STORAGE AND HANDLING

PANZYGA is supplied in 1 g, 2.5 g, 5 g, 10 g, 20 g, and 30 g single-use bottles.

The table below shows the details of available presentations of PANZYGA.

Carton NDC NumberContainer NDC Number

Size Grams Protein

0069-1011-02

0069-1011-01

10 mL

1

0069-1109-02

0069-1109-01

25 mL

2.5

0069-1224-02

0069-1224-01

50 mL

5

0069-1312-02

0069-1312-01

100 mL

10

0069-1415-02

0069-1415-01

200 mL

20

0069-1558-02

0069-1558-01

300 mL

30

PANZYGA is not supplied with an infusion set. If a filtered infusion set is used (not mandatory), choose

a filter size of 0.2-200 microns.

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

Store PANZYGA for 24 months at +2°C to +8°C (36°F to 46°F) from the date of manufacture. Within

its shelf-life, the product may be stored at ≤ +25°C (77°F) for up to 9 months. After storage at ≤ +25°C

(77°F), either use immediately or discard the product.

Do not use after expiration date.

Do not freeze. Do not use frozen product.

PANZYGA contains no preservatives. The PANZYGA bottle is for single use only. Use promptly any

bottle that has been entered or opened, and discard partially used bottles.

Dispose of any unused product or waste material in accordance with local requirements.

17 PATIENT COUNSELING INFORMATION

Inform patients of the signs and symptoms of hypersensitivity reactions including urticaria, generalized

urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis, and to contact their physicians

immediately if allergic symptoms occur.

Inform patients to immediately report the signs and symptoms of the following conditions to their

physician:

Decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath,

which may suggest kidney problems (see Renal Failure ( 5.2 )) .

Symptoms of thrombosis which may include: pain and/or swelling of an arm or leg with warmth over

the affected area, discoloration of an arm or leg, unexplained shortness of breath, chest pain or

discomfort that worsens on deep breathing, unexplained rapid pulse, numbness or weakness on one

side of the body (see Thrombosis ( 5.4 ))

Severe headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements,

nausea and vomiting (see Aseptic Meningitis Syndrome ( 5.5 ))

Increased heart rate, fatigue, yellowing of skin or eyes and dark-colored urine (see Hemolysis ( 5.6 ))

Trouble breathing, chest pain, blue lips or extremities, fever (see TRALI ( 5.7 ))

Inform patients that PANZYGA is made from human plasma and may contain infectious agents that can

cause disease (e.g., viruses, and theoretically, the CJD agent), and that the risk of infectious agent

transmission has been reduced by (a) screening plasma donors for prior exposure to viruses, (b) testing

the donated plasma for viral infections and (c) inactivating and/or removing viruses during manufacture.

Inform patients that administration of PANZYGA may interfere with the response to live viral vaccines

such as measles, mumps and rubella, and to notify their immunizing physician of their therapy with

PANZYGA.

Manufactured by:

Octapharma Pharmazeutika Produktionsges.m.b.H.

Oberlaaer Strasse 235

1100 Vienna, Austria

Distributed by:

Pfizer Labs

Division of Pfizer Inc

NY, NY 10017

18 PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL

Immune Globulin Intravenous (Human) - ifas, 10%

Panzyga

10 mL

NDC 0069-1011-02

Carton

Panzyga

25 mL

NDC 0069-1109-02

Carton

Panzyga

50 mL

NDC 0069-1224-02

Carton

Panzyga

100 mL

NDC 0069-1312-02

Carton

Panzyga

200 mL

NDC 0069-1415-02

Carton

Panzyga

300 mL

NDC 0069-1558-02

Carton

PANZYGA

immune globulin intravenous (human) solution

Product Information

Product T ype

PLASMA DERIVATIVE

Ite m Code (Source )

NDC:0 0 6 9 -10 11

Route of Administration

Intra ve no us

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HUMAN IMMUNO GLO BULIN G (UNII: 6 6 Y330 CJHS) (HUMAN IMMUNOGLOBULIN G -

UNII:6 6 Y330 CJHS)

HUMAN

IMMUNOGLOBULIN G

10 0 mg

in 1 mL

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:0 0 6 9 -10 11-

1 in 1 CARTON

1

NDC:0 0 6 9 -10 11-

10 mL in 1 BOTTLE, GLASS; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

BLA12558 7

0 8 /0 9 /20 19

PANZYGA

immune globulin intravenous (human) solution

Product Information

Product T ype

PLASMA DERIVATIVE

Ite m Code (Source )

NDC:0 0 6 9 -110 9

Route of Administration

INTRAVENOUS

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HUMAN IMMUNO GLO BULIN G (UNII: 6 6 Y330 CJHS) (HUMAN IMMUNOGLOBULIN G -

UNII:6 6 Y330 CJHS)

HUMAN

IMMUNOGLOBULIN G

10 0 mg

in 1 mL

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:0 0 6 9 -110 9 -

1 in 1 CARTON

1

NDC:0 0 6 9 -110 9 -

25 mL in 1 BOTTLE, GLASS; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

BLA12558 7

0 8 /0 9 /20 19

PANZYGA

immune globulin intravenous (human) solution

Product Information

Product T ype

PLASMA DERIVATIVE

Ite m Code (Source )

NDC:0 0 6 9 -1224

Route of Administration

INTRAVENOUS

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HUMAN IMMUNO GLO BULIN G (UNII: 6 6 Y330 CJHS) (HUMAN IMMUNOGLOBULIN G -

UNII:6 6 Y330 CJHS)

HUMAN

IMMUNOGLOBULIN G

10 0 mg

in 1 mL

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:0 0 6 9 -1224-

1 in 1 CARTON

1

NDC:0 0 6 9 -1224-

50 mL in 1 BOTTLE, GLASS; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

BLA12558 7

0 8 /0 9 /20 19

PANZYGA

immune globulin intravenous (human) solution

Product Information

Product T ype

PLASMA DERIVATIVE

Ite m Code (Source )

NDC:0 0 6 9 -1312

Route of Administration

INTRAVENOUS

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HUMAN IMMUNO GLO BULIN G (UNII: 6 6 Y330 CJHS) (HUMAN IMMUNOGLOBULIN G -

UNII:6 6 Y330 CJHS)

HUMAN

IMMUNOGLOBULIN G

10 0 mg

in 1 mL

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:0 0 6 9 -1312-

1 in 1 CARTON

1

NDC:0 0 6 9 -1312-

10 0 mL in 1 BOTTLE, GLASS; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

BLA12558 7

0 8 /0 9 /20 19

PANZYGA

immune globulin intravenous (human) solution

Product Information

Product T ype

PLASMA DERIVATIVE

Ite m Code (Source )

NDC:0 0 6 9 -1415

Route of Administration

INTRAVENOUS

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HUMAN IMMUNO GLO BULIN G (UNII: 6 6 Y330 CJHS) (HUMAN IMMUNOGLOBULIN G -

UNII:6 6 Y330 CJHS)

HUMAN

IMMUNOGLOBULIN G

10 0 mg

in 1 mL

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:0 0 6 9 -1415-

1 in 1 CARTON

1

NDC:0 0 6 9 -1415-

20 0 mL in 1 BOTTLE, GLASS; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

BLA12558 7

0 8 /0 9 /20 19

PANZYGA

immune globulin intravenous (human) solution

Product Information

Product T ype

PLASMA DERIVATIVE

Ite m Code (Source )

NDC:0 0 6 9 -1558

Route of Administration

INTRAVENOUS

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HUMAN IMMUNO GLO BULIN G (UNII: 6 6 Y330 CJHS) (HUMAN IMMUNOGLOBULIN G -

UNII:6 6 Y330 CJHS)

HUMAN

IMMUNOGLOBULIN G

10 0 mg

in 1 mL

Pfizer Laboratories Div Pfizer Inc

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:0 0 6 9 -1558 -

1 in 1 CARTON

1

NDC:0 0 6 9 -1558 -

30 0 mL in 1 BOTTLE, GLASS; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

BLA12558 7

0 8 /0 9 /20 19

Labeler -

Pfizer Laboratories Div Pfizer Inc (134489525)

Revised: 4/2019

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