Pediarix: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine: patient information, prescribing information, ingredients, manufacturer, adverse reactions and side effects

HIGHLIGHTS OF PRESCRIBING INFORMATION

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

See full insert sheet at this link at the Natural News Reference website.

PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine]

Suspension for Intramuscular Injection

Initial U.S. Approval: 2002

INGREDIENTS AND EXCIPIENTS

PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] is a noninfectious, sterile vaccine for intramuscular administration. Each 0.5-mL dose is formulated to contain 25 Lf of diphtheria toxoid, 10 Lf of tetanus toxoid, 25 mcg of inactivated pertussis toxin (PT), 25 mcg of filamentous hemagglutinin (FHA), 8 mcg of pertactin (69 kiloDalton outer membrane protein), 10 mcg of HBsAg, 40 D-antigen Units (DU) of Type 1 poliovirus (Mahoney), 8 DU of Type 2 poliovirus (MEF-1), and 32 DU of Type 3 poliovirus (Saukett). The diphtheria, tetanus, and pertussis components are the same as those in INFANRIX and KINRIX. The hepatitis B surface antigen is the same as that in ENGERIX-B.

The diphtheria toxin is produced by growing Corynebacterium diphtheriae in Fenton medium containing a bovine extract. Tetanus toxin is produced by growing Clostridium tetani in a modified Latham medium derived from bovine casein. The bovine materials used in these extracts are sourced from countries which the United States Department of Agriculture (USDA) has determined neither have nor present an undue risk for bovine spongiform encephalopathy (BSE). Both toxins are detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration.

The acellular pertussis antigens (PT, FHA, and pertactin) are isolated from Bordetella pertussis culture grown in modified Stainer-Scholte liquid medium. PT and FHA are isolated from the fermentation broth; pertactin is extracted from the cells by heat treatment and flocculation. The antigens are purified in successive chromatographic and precipitation steps. PT is detoxified using glutaraldehyde and formaldehyde. FHA and pertactin are treated with formaldehyde.

The hepatitis B surface antigen is obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus, in synthetic medium. The surface antigen expressed in the S. cerevisiae cells is purified by several physiochemical steps, which include precipitation, ion exchange chromatography, and ultrafiltration.

The inactivated poliovirus component is an enhanced potency component. Each of the 3 strains of poliovirus is individually grown in VERO cells, a continuous line of monkey kidney cells, cultivated on microcarriers. Calf serum and lactalbumin hydrolysate are used during VERO cell culture and/or virus culture. Calf serum is sourced from countries the USDA has determined neither have nor present an undue risk for BSE. After clarification, each viral suspension is purified by ultrafiltration, diafiltration, and successive chromatographic steps, and inactivated with formaldehyde. The 3 purified viral strains are then pooled to form a trivalent concentrate.

Diphtheria and tetanus toxoids and pertussis antigens (inactivated PT, FHA, and pertactin) are individually adsorbed onto aluminum hydroxide. The hepatitis B component is adsorbed onto aluminum phosphate.

Diphtheria and tetanus toxoid potency is determined by measuring the amount of neutralizing antitoxin in previously immunized guinea pigs. The potency of the acellular pertussis component (inactivated PT, FHA, and pertactin) is determined by enzyme-linked immunosorbent assay (ELISA) on sera from previously immunized mice. Potency of the hepatitis B component is established by HBsAg ELISA. The potency of the inactivated poliovirus component is determined by using the D-antigen ELISA and by a poliovirus neutralizing cell culture assay on sera from previously immunized rats.

Each 0.5-mL dose contains aluminum salts as adjuvant (not more than 0.85 mg aluminum by assay) and 4.5 mg of sodium chloride. Each dose also contains ≤100 mcg of residual formaldehyde and ≤100 mcg of polysorbate 80 (Tween 80). Neomycin sulfate and polymyxin B are used in the poliovirus vaccine manufacturing process and may be present in the final vaccine at ≤0.05 ng neomycin and ≤0.01 ng polymyxin B per dose. The procedures used to manufacture the HBsAg antigen result in a product that contains ≤5% yeast protein. The tip caps of the prefilled syringes contain natural rubber latex; the plungers are not made with natural rubber latex.

PEDIARIX is formulated without preservatives.

INDICATIONS AND USAGE

PEDIARIX is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis. PEDIARIX is approved for use as a three-dose series in infants born of hepatitis B surface antigen (HBsAg)-negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the 7th birthday). (1)

DOSAGE AND ADMINISTRATION

Three doses (0.5-mL each) by intramuscular injection at 2, 4, and 6 months of age. (2.2)

DOSAGE FORMS AND STRENGTHS

Single-dose prefilled syringes containing a 0.5-mL suspension for injection. (3)

CONTRAINDICATIONS

– Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis-, hepatitis B-, or polioviruscontaining vaccine, or to any component of PEDIARIX. (4.1)

– Encephalopathy within 7 days of administration of a previous pertussiscontaining vaccine. (4.2)

– Progressive neurologic disorders. (4.3)

WARNINGS AND PRECAUTIONS

– In clinical trials, PEDIARIX was associated with higher rates of fever, relative to separately administered vaccines. (5.1)

– If Guillain-Barré syndrome occurs within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the decision to give PEDIARIX should be based on potential benefits and risks. (5.2)

– The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions. (5.3)

– Syncope (fainting) can occur in association with administration of injectable vaccines, including PEDIARIX. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope. (5.4)

– If specified adverse events (i.e., temperature ≥105o F, collapse or shocklike state, or inconsolable crying lasting ≥3 hours, within 48 hours after vaccination; seizures within 3 days after vaccination) have occurred following a pertussis-containing vaccine, the decision to give PEDIARIX should be based on potential benefits and risks. (5.5)

– For children at higher risk for seizures, an antipyretic may be administered at the time of vaccination with PEDIARIX. (5.6)

– Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including PEDIARIX, to infants born prematurely should be based on consideration of the individual infant’s medical status, and the potential benefits and possible risks of vaccination. (5.7)

ADVERSE REACTIONS

Common solicited adverse events following any dose (≥25%) included local injection site reactions (pain, redness, and swelling), fever (≥100.4°F), drowsiness, irritability/fussiness, and loss of appetite. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

DRUG INTERACTIONS

Do not mix PEDIARIX with any other vaccine in the same syringe or vial. (7.1)

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category C : Animal reproduction studies have not been conducted with PEDIARIX. It is not known whether PEDIARIX can cause fetal harm when administered to a pregnant woman or if PEDIARIX can affect reproduction capacity.

Pediatric Use

Safety and effectiveness of PEDIARIX were established in the age group 6 weeks through 6 months on the basis of clinical studies [see Adverse Reactions (6.1), Clinical Studies (14.1, 14.2)]. Safety and effectiveness of PEDIARIX in the age group 7 months through 6 years are supported by evidence in infants 6 weeks through 6 months of age. Safety and effectiveness of PEDIARIX in infants younger than 6 weeks of age and children 7 to 16 years of age have not been evaluated.

Revised: 10/2016

https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Pediarix/pdf/PEDIARIX.PDF

http://naturalnewsreference.com/vaccine-insert-sheets/Pediarix-Diphtheria-Tetanus-Toxoids-Acellular-Pertussis-Adsorbed-Hepatitis-B.PDF