CUTAQUIG Solution for infusion (2020)

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Pfizer Laboratories Div Pfizer Inc

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BOXED WARNING SECTION

WARNING: THROMBOSIS Thrombosis may occur with immune globulin products, including CUTAQUIG. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history ...

1. Indications and Usage

CUTAQUIG (Immune Globulin Subcutaneous (Human) - hipp) is a 16.5% immune globulin solution for subcutaneous infusion (IGSC), indicated as replacement therapy for primary humoral immunodeficiency (PI) in ...

2. Dosage and Administration

For subcutaneous use only. Before receiving treatment with CUTAQUIG: Obtain the patients serum Immunoglobulin G (IgG) trough level to guide subsequent dose adjustments (see Dose Adjustment). 2.1 ...

3. Dosage Forms and Strengths

CUTAQUIG is a solution containing 16.5% IgG (165 mg/mL).

4. Contraindications

CUTAQUIG is contraindicated: In patients who have had an anaphylactic or severe systemic reaction to the subcutaneous administration of human immune globulin or to any of the components of CUTAQUIG such ...

5. Warnings and Precautions

5.1 Hypersensitivity Severe hypersensitivity reactions may occur with CUTAQUIG, even in patients who tolerated previous treatment with human immune globulin. If a hypersensitivity reaction occurs, discontinue ...

6. Adverse Reactions

The most common adverse reactions (AR) observed in ≥ 5% of study subjects were local infusion site adverse reactions (such as redness, swelling, and itching), and, as systemic adverse reactions, headache, ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.3. Postmarketing Experience

There is no post-marketing experience with CUTAQUIG. The following adverse reactions have been identified during post-approval use of immune globulins. Because these reactions are reported voluntarily ...

7. Drug Interactions

7.1 Serological Testing Various passively transferred antibodies in immunoglobulin preparations may lead to misinterpretation of results of serological testing. 7.2 Live Virus Vaccines The passive transfer ...

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 CUTAQUIG. It is not known whether CUTAQUIG ...

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

The safety and efficacy of CUTAQUIG have not been established in patients under 17 years of age. There are only limited data available on the safety and efficacy of CUTAQUIG administration in pediatric ...

8.5. Geriatric Use

Clinical studies of CUTAQUIG did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Three study subjects enrolled in the clinical ...

11. Description

CUTAQUIG (Immune Globulin Subcutaneous (Human) - hipp), is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. CUTAQUIG ...

12.1. Mechanism of Action

CUTAQUIG supplies a broad spectrum of opsonizing and neutralizing Immunoglobulin G (IgG) antibodies against a wide variety of bacterial and viral agents. It has a distribution of immune globulin subclasses ...

12.2. Pharmacodynamics

CUTAQUIG contains mainly IgG with a broad spectrum of antibodies against various infectious agents reflecting the IgG activity found in the donor population. CUTAQUIG which is prepared from pooled material ...

12.3. Pharmacokinetics

A pharmacokinetic (PK) sub-study was conducted in 18 adult subjects who were enrolled in the 61-subject safety and efficacy study. Blood samples for PK study were collected prior to switching to CUTAQUIG ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

No animal studies were conducted with CUTAQUIG to assess carcinogenesis, mutagenesis or impairment of fertility.

13.2. Animal Toxicology and/or Pharmacology

Safety of CUTAQUIG has been demonstrated in several standard nonclinical toxicology studies (local tolerance in rabbits, cardiovascular and respiratory effects in dogs, thrombogenic potential in rabbits). ...

14. Clinical Studies

The study was a prospective, open-label, non-controlled, single-arm, multicenter study to evaluate the pharmacokinetics (PK), efficacy, tolerability and safety of subcutaneous human immunoglobulin (CUTAQUIG) ...

16.1. How Supplied

CUTAQUIG is supplied in 1 g, 1.65 g, 2 g, 3.3 g, 4 g or 8 g single-use vials. Carton NDC Number Container NDC Number Size Grams Protein 0069-1061-02 0069-1802-02 0069-1476-02 0069-1960-02 ...

16.2. Storage and Handling

Components used in the packaging of CUTAQUIG are not made with natural rubber latex. Store at +2°C to +8°C (36°F to 46°F) for up to 36 months from the date of manufacture. Within its shelf-life, the product ...

17. Patient Counseling Information

Advise the patients to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Inform patients to immediately report the following signs and symptoms to their healthcare ...