Drug: Daptacel

DAPTACEL vaccine is a sterile isotonic suspension of pertussis antigens and diphtheria and tetanus toxoids adsorbed on aluminum phosphate, for intramuscular injection. Each 0.5 mL dose contains 15 Lf diphtheria toxoid, 5 Lf tetanus toxoid and acellular pertussis antigens [10 mcg detoxified pertussis toxin (PT), 5 mcg filamentous hemagglutinin (FHA), 3 mcg pertactin (PRN), and 5 mcg fimbriae types 2 and 3 (FIM)]. Other ingredients per 0.5 mL dose include 1.5 mg aluminum phosphate (0.33 mg of aluminum) as the adjuvant, ≤ 5 mcg residual formaldehyde, < 50 ng residual glutaraldehyde and 3.3 mg (0.6% v/v) 2-phenoxyethanol (not as a preservative). The acellular pertussis vaccine components are produced from Bordetellapertussis cultures grown in Stainer-Scholte medium (2) modified by the addition of casamino acids and dimethyl-beta-cyclodextrin. PT, FHA and PRN are isolated separately from the supernatant culture medium. The FIM components are extracted and co-purified from the bacterial cells. The pertussis antigens are purified by sequential filtration, salt-precipitation, ultrafiltration and chromatography. PT is detoxified with glutaraldehyde. FHA is treated with formaldehyde, and the residual aldehydes are removed by ultrafiltration. The individual antigens are adsorbed separately onto aluminum phosphate. Corynebacterium diphtheriae is grown in modified Mueller's growth medium. (3) After purification by ammonium sulfate fractionation, diphtheria toxin is detoxified with formaldehyde and diafiltered. Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. (4) Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration. Diphtheria and tetanus toxoids are individually adsorbed onto aluminum phosphate. The adsorbed diphtheria, tetanus and acellular pertussis components are combined with aluminum phosphate (as adjuvant), 2-phenoxyethanol (not as a preservative) and water for injection. Both diphtheria and tetanus toxoids induce at least 2 units of antitoxin per mL in the guinea pig potency test. The potency of the acellular pertussis vaccine components is determined by the antibody response of immunized mice to detoxified PT, FHA, PRN and FIM as measured by enzyme-linked immunosorbent assay (ELISA). Last reviewed on RxList: 8/18/2014
This monograph has been modified to include the generic and brand name in many instances.

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Data from Clinical Studies Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to vaccine use and for approximating rates of those events. Approximately 18,000 doses of DAPTACEL vaccine have been administered to infants and children in 9 clinical studies. Of these, 3 doses of DAPTACEL vaccine were administered to 4,998 children, 4 doses of DAPTACEL vaccine were administered to 1,725 children, and 5 doses of DAPTACEL vaccine were administered to 485 children. A total of 989 children received 1 dose of DAPTACEL vaccine following 4 prior doses of Pentacel vaccine. In a randomized, double-blinded pertussis vaccine efficacy trial, the Sweden I Efficacy Trial, conducted in Sweden during 1992-1995, the safety of DAPTACEL vaccine was compared with DT and a whole-cell pertussis DTP vaccine. A standard diary card was kept for 14 days after each dose and follow-up telephone calls were made 1 and 14 days after each injection. Telephone calls were made monthly to monitor the occurrence of severe events and/or hospitalizations for the 2 months after the last injection. There were fewer of the solicited common local and systemic reactions following DAPTACEL vaccine than following the whole-cell pertussis DTP vaccine. As shown in Table 1, the 2,587 infants who received DAPTACEL vaccine at 2, 4 and 6 months of age had similar rates of reactions within 24 hours as recipients of DT and significantly lower rates than infants receiving whole-cell pertussis DTP. Table 1: Percentage of Infants from Sweden I Efficacy Trial with Local or Systemic Reactions within 24 Hours Post-Dose 1, 2 and 3 of DAPTACEL vaccine compared with DT and Whole-Cell Pertussis DTP Vaccines
EVENT Dose 1 (2 MONTHS) Dose 2 (4 MONTHS) Dose 3 (6 MONTHS) DAPTACEL vaccine
N = 2,587 DT
N = 2,574 DTP
N = 2,102 DAPTACEL vaccine
N = 2,563 DT
N = 2,555 DTP
N = 2,040 DAPTACEL vaccine
N = 2,549 DT
N = 2,538 DTP
N = 2,001 Local Tenderness(Any) 8.0*

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Immunization Series DAPTACEL vaccine is to be administered as a 5 dose series at 2, 4 and 6 months of age (at intervals of 6-8 weeks), at 15-20 months of age and at 4-6 years of age. The first dose may be given as early as 6 weeks of age. Four doses of DAPTACEL vaccine constitute a primary immunization course for pertussis. The fifth dose is a booster for pertussis immunization. Three doses of DAPTACEL vaccine constitute a primary immunization course for diphtheria and tetanus. The fourth and fifth doses are boosters for diphtheria and tetanus immunization. [See Clinical Studies] DAPTACEL vaccine should be used as the fifth dose of the DTaP series in children who initially received 4 doses of Pentacel® [(Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) vaccine, Sanofi Pasteur Limited]. Pentacel and DAPTACEL vaccines contain the same pertussis antigens, manufactured by the same process, although Pentacel vaccine contains twice the amount of detoxified pertussis toxin (PT) and four times the amount of filamentous hemagglutinin (FHA) as DAPTACEL vaccine. Data are not available on the safety and effectiveness of using mixed sequences of DAPTACEL vaccine and DTaP vaccines from different manufacturers for successive doses of the DTaP vaccination series. DAPTACEL vaccine may be used to complete the immunization series in infants who have received 1 or more doses of whole-cell pertussis DTP. However, the safety and efficacy of DAPTACEL vaccine in such infants have not been fully demonstrated. If a decision is made to withhold any recommended dose of pertussis vaccine, [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS], Diphtheria and Tetanus Toxoids Adsorbed For Pediatric Use (DT) should be administered. Administration Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exist, the product should not be administered. After removing the “flip-off' cap, cleanse the vaccine vial stopper with a suitable germicide. Do not remove either the rubber stopper or the metal seal holding it in place. Just before use, shake the vial well, until a uniform, white, cloudy suspension results. Using a sterile needle and syringe and aseptic technique, withdraw and administer a single 0.5 mL dose of DAPTACEL vaccine intramuscularly. Use a separate sterile needle and syringe for each injection. Changing needles between withdrawing the vaccine from the vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated. In infants younger than 1 year, the anterolateral aspect of the thigh provides the largest muscle and is the preferred site of injection. In older children, the deltoid muscle is usually large enough for injection. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk. Do not administer this product intravenously or subcutaneously. DAPTACEL vaccine should not be combined through reconstitution or mixed with any other vaccine.

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Concomitant Administration With Other Vaccines In clinical trials, DAPTACEL vaccine was administered concomitantly with one or more of the following US licensed vaccines: Hib conjugate vaccine, IPV, hepatitis B vaccine, pneumococcal conjugate vaccine, MMR vaccine, and varicella vaccine. [See ADVERSE REACTIONS and Clinical Studies] When DAPTACEL vaccine is given at the same time as another injectable vaccine(s), the vaccines should be administered with different syringes and at different injection sites. Immunosuppressive Treatments Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to DAPTACEL vaccine. Last reviewed on RxList: 8/18/2014
This monograph has been modified to include the generic and brand name in many instances.

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DAPTACEL® is a vaccine indicated for active immunization against diphtheria, tetanus and pertussis as a five-dose series in infants and children 6 weeks through 6 years of age (prior to seventh birthday).

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Hypersensitivity A severe allergic reaction (eg, anaphylaxis) after a previous dose of DAPTACEL vaccine or any other tetanus toxoid, diphtheria toxoid, or pertussis-containing vaccine, or any other component of this vaccine is a contraindication to administration of DAPTACEL vaccine. [See DESCRIPTION] Because of uncertainty as to which component of the vaccine may be responsible, none of the components should be administered. Alternatively, such individuals may be referred to an allergist for evaluation if further immunizations are to be considered. Encephalopathy Encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis-containing vaccine, including DAPTACEL vaccine. Progressive Neurologic Disorder Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy is a contraindication to administration of any pertussis-containing vaccine, including DAPTACEL vaccine. Pertussis vaccine should not be administered to individuals with such conditions until a treatment regimen has been established and the condition has stabilized. Last reviewed on RxList: 8/18/2014
This monograph has been modified to include the generic and brand name in many instances.

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No information provided.

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Dosage Forms And Strengths DAPTACEL vaccine is a suspension for injection in 0.5 mL single dose vials. See DESCRIPTION for a complete listing of ingredients. Storage And Handling The vial stopper for this product is not made with natural rubber latex. DAPTACEL vaccine is supplied in a single dose vial (NDC No. 49281-286-58):
in packages of 1 vial: NDC No. 49281-286-01;
in packages of 5 vials: NDC No. 49281-286-05;
in packages of 10 vials: NDC No. 49281-286-10. DAPTACEL vaccine should be stored at 2° to 8°C (35° to 46°F). DO NOT FREEZE. Product which has been exposed to freezing should not be used. Do not use after expiration date shown on the label. Manufactured by: Sanofi Pasteur Limited, Toronto Ontario Canada. Distributed by: Sanofi Pasteur Inc., Swiftwater PA 18370 USA Last reviewed on RxList: 8/18/2014
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Management Of Acute Allergic Reactions Epinephrine hydrochloride solution (1:1,000) and other appropriate agents and equipment must be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs. Adverse Reactions Following Prior Pertussis Vaccination If any of the following events occur within the specified period after administration of a whole-cell pertussis vaccine or a vaccine containing an acellular pertussis component, the decision to administer DAPTACEL vaccine should be based on careful consideration of potential benefits and possible risks. [See DOSAGE AND ADMINISTRATION]
  • Temperature of ≥ 40.5°C (105°F) within 48 hours, not attributable to another identifiable cause.
  • Collapse or shock-like state (hypotonic-hyporesponsive episode (HHE)) within 48 hours.
  • Persistent, inconsolable crying lasting ≥ 3 hours within 48 hours.
  • Seizures with or without fever within 3 days.
Guillain-Barre Syndrome And Brachial Neuritis A review by the Institute of Medicine found evidence for a causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barre syndrome. (1) If Guillain-Barre syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk for Guillain-Barre syndrome may be increased following DAPTACEL vaccine. Infants And Children With A History Of Previous Seizures For infants or children with a history of previous seizures, an appropriate antipyretic may be administered (in the dosage recommended in its prescribing information) at the time of vaccination with a vaccine containing an acellular pertussis component (including DAPTACEL vaccine) and for the following 24 hours, to reduce the possibility of post-vaccination fever. Limitations Of Vaccine Effectiveness Vaccination with DAPTACEL vaccine may not protect all individuals. Altered Immunocompetence If DAPTACEL vaccine is administered to immunocompromised persons, including persons receiving immunosuppressive therapy, the expected immune response may not be obtained. [See Immunosuppressive Treatments] Apnea In Premature Infants Apnea following intramuscular vaccination has been observed in some infants born prematurely. The decision about when to administer an intramuscular vaccine, including DAPTACEL, to an infant born prematurely should be based on consideration of the individual infant's medical status and the potential benefits and possible risks of vaccination. Syncope Syncope (fainting) has been reported following vaccination with DAPTACEL. Procedures should be in place to prevent falling injury and manage syncopal reactions. Non-Clinical Toxicology Carcinogenesis, Mutagenesis, Impairment Of Fertility DAPTACEL vaccine has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility. Use In Specific Populations Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with DAPTACEL vaccine. It is also not known whether DAPTACEL vaccine can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Pediatric Use DAPTACEL vaccine is not indicated for infants below 6 weeks of age or children 7 years of age or older. Safety and effectiveness of DAPTACEL vaccine in these age groups have not been established. Last reviewed on RxList: 8/18/2014
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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