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PRODUCT: KinrixCOMPANY: GlaxoSmithKline PHARMACOLOGIC CLASS: Vaccine (DTaP + IPV) ACTIVE INGREDIENTS: Diphtheria and tetanus toxoids, acellular pertussis vaccine, aluminum hydroxide adsorbed; inactivated polio vaccine; susp for IM inj; preservative-free; may contain trace formaldehyde, neomycin, polymixin B, polysorbate 80. INDICATION: Immunization against diphtheria, tetanus, pertussis, and polio: As the 5th dose in the DTaP immunization series and the 4th dose in the inactivated poliovirus vaccine (IPV) series in children 4–6 years of age (before 7th birthday) who previously received Infanrix (DTaP) and/or Pediarix (DTaP, HB, IPV) for the first 3 doses and Infanrix for the 4th dose. PHARMACOLOGY: Kinrix is a combination vaccine for children intended to provide protection against diphtheria, tetanus, pertussis and polio in one injection. The diphtheria, tetanus, and pertussis components of Kinrix are the same as those in Infanrix and Pediarix (also from GSK), and the poliovirus component is the same as that in Pediarix. CLINICAL TRIALS: In a randomized, controlled study conducted in the US, 3,156 children 4 to 6 years of age who were previously immunized with four doses of DTaP and 3 doses of IPOL (from Sanofi Pasteur) were immunized with Kinrix. All children also were given the 2nd dose of MMR II (from Merck) concomitantly administered at separate sites. The control group was given Infanrix and IPOL vaccines. Levels of antibodies to the diphtheria, tetanus, pertussis and poliovirus antigens were measured in sera obtained immediately prior to immunization and one month after vaccination. Kinrix offered similar protection to its component vaccines given separately with a similar safety profile. It was non-inferior to Infanrix and IPV given separately, in terms of booster responses to DTaP antigens and post-vaccination antibody titers for anti-polio antibodies. ADULTS: Not applicable. CHILDREN: <4 years or ≥7 years: not recommended. 4–6 years: One dose of 0.5mL in deltoid muscle. CONTRAINDICATIONS: Anaphylaxis associated with previous diphtheria, tetanus, pertussis, or polio vaccine. Encephalopathy within 7 days of previous pertussis vaccine. Progressive neurological disorders (eg, infantile spasms, uncontrolled epilepsy). PRECAUTIONS: Guillain-Barre syndrome within 6 weeks of previous tetanus vaccination. Fever (≥105°F within 48 hours), persistent inconsolable crying (≥3 hours within 48 hours), shock (within 48 hours), or seizures (within 3 days) after previous pertussis vaccine: see literature. Seizure risk: may pretreat with antipyretic. Latex allergy (prefilled syringes). Have epinephrine available. Pregnancy (Cat.C): not applicable. INTERACTIONS: May give with concomitant vaccines (eg, MMR). Immunosuppressants (eg, radiation, chemotherapy, high-dose steroids): may get suboptimal response. ADVERSE REACTIONS: Injection site pain, redness, local swelling, increase in arm circumference, drowsiness, fever, appetite loss. NOTE: Report adverse events to VAERS at (800) 822-7967 and to GlaxoSmithKline at (888) 825-5249. HOW SUPPLIED: Single-dose vials—10 Single-dose prefilled syringes—5 (without needles) Facts about vaccine-preventable diseasesDiphtheria • Respiratory diphtheria, caused by Corynebacterium diphtheriae, manifests as a sore throat with low-grade fever and an adherent membrane of the tonsils, pharynx, or nose. Neck swelling is usually present in severe disease. Transmission occurs by intimate respiratory and physical contact. • There have been approximately 0.001 cases of diphtheria per 100,000 population in the United States since 1980. Myocarditis, polyneuritis, and airway obstruction are common complications of respiratory diphtheria; death occurs in 5% to 10% of respiratory cases. Tetanus • Tetanus is an acute, often fatal, disease caused by an exotoxin produced by the bacterium Clostridium tetani. It is characterized by generalized rigidity and convulsive spasms of skeletal muscles. The muscle stiffness usually involves the jaw (lockjaw) and neck and then becomes generalized. C tetani usually enters the body through a wound. • Since the mid-1970s, 50 to 100 cases have been reported annually. The death-to-case ratio has declined from 30% to 10% in recent years. Almost all reported cases of tetanus are in persons who have never been vaccinated or who completed a primary series but have not had a booster vaccination in the preceding 10 years. Pertussis • Pertussis, caused by Bordetella pertussis, is a highly contagious illness that typically manifests in children with paroxysmal spasms of severe coughing, whooping, and posttussive vomiting. • In the United States, 5,000 to 7,000 cases are reported each year, and incidence has increased steadily since the 1980s, particularly among adolescents and adults. Epidemics occur every 3 to 5 years. • Major complications are most common among infants and young children. Young children can die from pertussis; 13 children died in the United States in 2003. Most deaths occur among unvaccinated children or children too young to be vaccinated. Hib disease • Due to routine use of the Haemophilus influenzae type b (Hib) conjugate vaccine since 1990, the incidence of Hib disease in infants and young children has decreased by 99% to fewer than 1 case per 100,000 children younger than 5 years. • In the United States, Hib disease occurs primarily in underimmunized children and among infants too young to have completed the primary immunization series; 3% to 6% of cases are fatal, and up to 20% of surviving patients have permanent hearing loss or other long-term sequelae. Data from the CDC’s Vaccines & Immunizations Web page, www.cdc.gov/vaccines. Accessed August 6, 2008. PRODUCT: PentacelCOMPANY: Sanofi Pasteur PHARMACOLOGIC CLASS: Vaccine (DTaP-IPV + Hib/PRP-T) ACTIVE INGREDIENTS: Diphtheria and tetanus toxoids + acellular pertussis adsorbed + inactivated poliovirus vaccine (susp); Hib conjugate (tetanus toxoid conjugate, PRP) (lyophilized pwd); 0.5mL/dose; for IM inj after mixing; contains residual trace amounts of formaldehyde, 2-phenoxyethanol, neomycin, polymyxin B. INDICATION: Active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b in infants and children 6 weeks through 4 years of age (prior to 5th birthday). PHARMACOLOGY: Pentacel is a combination vaccine that can replace the separate injections of DTaP, IPV and Hib conjugate vaccines that are recommended for children through 2 years of age. It was developed to align well with the existing childhood vaccination schedule. Pentacel contains the same five acellular pertussis antigens as Daptacel (DTaP, also from Sanofi Pasteur), but Pentacel has a higher concentration of two of the antigens. CLINICAL TRIALS: Pentacel was approved based on studies that established its immunogenicity for the five separate components compared to those of the separately-administered vaccines that are the current standard of care in the US: Daptacel (DTaP), IPOL (trivalent inactivated polio-virus vaccine), and ActHIB (Hib/PRP-T). A bridging study was also used to support the conclusion that Pentacel will provide protection against pertussis disease comparable to that established for Daptacel. Pentacel may be given concurrently with other vaccines (eg, MMR, varicella, hepatitis B, 7-valent pneumococcal conjugate vaccines). ADULTS: Not recommended. CHILDREN: Each dose is 0.5mL IM, in anterolateral thigh (infants) or deltoid muscle. Give as a 4 dose series at 2 months, 4 months, 6 months, and 15–18 months of age. May give 1st dose as early as 6 weeks of age. Previously vaccinated with ≥1 dose of Daptacel, IPV, or Hib conjugate vaccine: Pentacel may be used to complete vaccination series; see literature. May give other vaccines concurrently (use separate inj site). CONTRAINDICATION: Anaphylaxis associated with previous dose or component. Encephalopathy within 7 days of a previous dose of a pertussis-containing vaccine. Progressive neurological disorder (eg, infantile spasms, uncontrolled epilepsy, progressive encephalopathy). PRECAUTIONS: Fever (≥105°F within 48hrs), persistent inconsolable crying (lasting ≥3hrs within 48hrs), shock (within 48hrs), convulsions (within 3 days), or Guillain-Barre syndrome (within 6 weeks) of previous pertussis vaccine. Seizure risk (may pretreat with antipyretics, eg, acetaminophen). May defer in acute febrile illness. Have epinephrine (1:1000) available. Immune deficiency. Pregnancy (Cat.C): not recommended. INTERACTIONS: Immunosuppressants: may get suboptimal response. ADVERSE REACTIONS: Local reactions: inj site erythema, swelling, tenderness. Systemic reactions: fever, crying, fussiness. NOTE: Report adverse events to VAERS at (800) 822-7967 and to Sanofi Pasteur at (800) 822-2463. HOW SUPPLIED: Doses—5 (2 vials/dose) |
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