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diphtheria and tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine (Kinrix, Quadracel, DTaP/ IPV)

 

Classes: Vaccines, Combos

Dosing and uses of Kinrix, Quadracel (diphtheria and tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine)

 

Adult dosage forms and strengths

Not indicated for adults

 

Pediatric dosage forms and strengths

diphtheria toxoid/tetanus toxoid/inactivated pertussis toxin (PT)/filamentous hemagglutinin (FHA)/pertactin, type 1 poliovirus (Mahoney)/type 2 poliovirus (MEF-1)/type 3 poliovirus (Saukett)

suspension for IM injection

  • Kinrix: (25 Lf/10 Lf/25 mcg/25 mcg/8 mcg/40 D-antigen units/8 D-antigen units/32 D-antigen units)/0.5mL
  • Quadracel: (15 Lf/5 Lf/20 mcg/25 mcg/8 mcg/40 D-antigen units/8 D-antigen units/32 D-antigen units)/0.5mL
  • Lf = limits of flocculation

 

Immunization

For use as the 5th dose in the DTaP series and the 4th or 5th dose in the IPV series

<4 years: Safety and efficacy not established

4-6 years: 0.5 mL IM x 1 dose

 

Kinrix, Quadracel (diphtheria and tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine) adverse (side) effects

Suspected adverse events after administration of any vaccine may be reported to Vaccine Adverse Events Reporting System (VAERS), 1-800-822-7967

 

>10%

Injection site reactions including pain, redness, swelling (57%)

Drowsiness (19%)

Fever (16%)

Appetite loss (16%)

Redness (37%)

Swelling (26%)

 

Frequency not defined

Cerebrovascular accident

Cellulitis

Hypernatremia

Pruritus

Dehydration

Constipation

Angioedema

Seizures

Thrombocytopenia

Urticaria

Apnea

Lymphodenopathy

 

Warnings

Contraindications

Documented hypersensitivity

History of Arthus reaction to prior tetanus vaccination (unless 10 yr have elapsed)

History of encephalopathy (within 7 days of administration not attributable to other causes), progressive neurologic disorder with pertussis-containing vaccine

 

Progressive Neurologic Disorder

Infantile spasms, uncontrolled epilepsy, progressive encephalopathy

Do not administer pertussis vaccine until neurologic status is stabilized

 

Cautions

Tetanus toxoid carries risk for brachial neuritis, Guillain-Barre syndrome and anaphylaxis

Caution in Guillain-Barre syndrome within 6 wk of prior tetanus toxoid vaccine

Use caution in patients with history of seizure disorders, progressive neurologic disease, or conditions predisposing to seizures

Consider postponing administration iin patients with moderate or severe acute illness (with or without fever)

Use caution in severely immunocompromised patients

 

Pregnancy and lactation

Pregnancy category: C

Lactation: Excretion in milk unknown; use caution

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Kinrix, Quadracel (diphtheria and tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine)

Mechanism of action

Production of specific antibodies to tetanus, diphtheria, and pertusis (active immunity)

Conveys active immunity via stimulation of production of endogenously produced antibodies