diphtheria and tetanus toxoids/ acellular pertussis vaccine (Infanrix, Daptacel)

Dosing and uses of Infanrix, Daptacel (diphtheria and tetanus toxoids/ acellular pertussis vaccine)

• Adult
• Pediatric

 

Immunization

Not indicated for adults

 

Pediatric dosage forms and strengths

Lf = limits of flocculation

pertussis/diphtheria/tetanus

DTaP suspension

• (10mcg/15Lf/5Lf)/0.5mL (Daptacel)
• (58mcg/25Lf/10Lf)/0.5mL (Infanrix)

 

Primary Immunization

DTap

6 weeks-7 years

• 0.5 mL IM x 3 at 2, 4, 6 months of age; may administer as early as six weeks of age and repeated every 4-8 weeks; THEN 4th dose at 15-20 months of age but at least 6 months after the third dose & 5th dose at 4-6 years of age, prior to starting school or kindergarten; if fourth dose given at >4 years of age, may omit fifth dose;
• For children <7 years who didn't receive DTaP at early infancy, give first 3 doses q1Month, THEN 4th dose at least 6 months later

>7 years

• Not approved for use; use tetanus and diphtheria toxoids vaccine instead

 

Infanrix, Daptacel (diphtheria and tetanus toxoids/ acellular pertussis 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

 

Frequency not defined

Swelling

Erythema

Fever

Drowsiness

Fussiness

Irritability

Anorexia

Lethargi

Swelling

Tenderness

Angioedema

Apnea

Cellulitis

Cough

Cyanosis

Ear pain

Headache

Hypotonia

Limb swelling

Pruritus

 

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 including uncontrolled or progressive epilepsy, infantile spasms, with pertussis-containing vaccine

 

Cautions

DTaP (Tripedia) now contains <0.5 mcg thimerosal; Daptacel, Infanrix are thimerosal-free

Do not use DTaP with HIB (TriHIBit) for primary immunization of infants; only use for booster shots

Caution in patients with neurological disorders

Apnea reported in premature infants following IM vaccine administration; weigh risk/benefit

Syncope accompanied by transient disturbances , tonic-clonic movements, or weakness reported

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

Use caution in patients with a history of bleeding disorders (including thrombocytopenia) and or patients on anticoagulants

History of Guillain-Barre syndrome with prior tetanus vaccine; weigh risk/benefit

 

Pregnancy and lactation

Pregnancy category: C

Lactation: Excretion in milk unknown; use with 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 Infanrix, Daptacel (diphtheria and tetanus toxoids/ acellular pertussis 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

 

Pharmacokinetics

The onset of protection from disease is relatively slow, but duration is long lasting (years)

Duration: Variable, possibly >10 yr; Tdap maternal pertussis antibodies appear to wane greatly between subsequent pregnancies