PANZYGA Solution for injection (2021)

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Pfizer Laboratories Div Pfizer Inc

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BOXED WARNING SECTION

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, ...

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, ...

2. Dosage and Administration

For intravenous use only. 2.1 Dose Indication Dose Initial Infusion Rate (first 30 min) Maximum Infusion Rate (as tolerated) Treatment of Primary Humoral Immunodeficiency (PI)* 300 to 600 mg/kg body ...

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 ...

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 ...

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: ...

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 ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post-approval use of PANZYGA. Because these adverse reactions are reported voluntarily from a population of uncertain size, it is not always ...

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 ...

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 ...

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 mothers ...

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 ...

8.5. Geriatric Use

Clinical studies of PANZYGA in PID and ITP did not include sufficient numbers of subjects older than 65 years to determine whether they respond differently from younger subjects. In the clinical study ...

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 ...

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 ...

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 ...

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 ...

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 ...

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. ...

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 ...

15. References

Duhem C, Dicato MA, Ries F: Side-effects of intravenous immune globulins. Clin.Exp.Immunol. 1994;97 Suppl 1:79-83. Steinberger BA, Ford SM, Coleman TA: Intravenous immunoglobulin therapy results in post-infusional ...

16.1. How Supplied

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 Number Container NDC Number Size Grams ...

16.2. Storage and Handling

Store PANZYGA for 36 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 12 months. After storage at ≤ +25°C ...

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 ...