ACTHIB Dosage & Rx Info | Uses, Side Effects

Acthib Generic Name & Formulations

Legal Class

General Description

Haemophilus b conjugate 10mcg (tetanus toxoid conjugate) per 0.5mL; pwd for IM inj after reconstitution with saline.

Pharmacological Class

Hib (PRP-T).

How Supplied

Single-dose vials—5 (w. saline diluent)

Storage

Store lyophilized ActHIB vaccine packaged with saline diluent (0.4% Sodium Chloride) at 2° to 8°C (35° to 46°F); do not freeze.

Manufacturer

Sanofi Pasteur, Inc.

Mechanism of Action

Haemophilus influenzae (H. influenzae) is a gram-negative coccobacillus. Most strains of H. influenzae that cause invasive disease (eg, sepsis and meningitis) are H. influenzae type b. The response to ActHIB vaccine is typical of a T-dependent immune response to antigens. The prominent isotype of anti-capsular PRP antibody induced by ActHIB vaccine is IgG. Bactericidal activity against H. influenzae type b was demonstrated in serum after immunization and correlated with the anti-PRP antibody response induced by ActHIB.

Acthib Indications

Indications

For the prevention of invasive disease caused by Haemophilus influenzae (H. influenzae) type b. Approved for use in children 2 months through 5 years of age.

Acthib Dosage and Administration

Children

Inject IM in thigh or deltoid. <2months: not recommended. As 1^st, 2^nd, 3^rd dose in series: 0.5mL at 2, 4, and 6 months of age. As 4^th (booster) dose in series: 0.5mL at 15-18months of age.

Administration

Reconstitute only with the accompanying saline diluent (0.4% Sodium Chloride). If not administered promptly after reconstitution, store at 2° to 8°C (35° to 46°F) and administer within 24 hours. Stored vaccine should be re-agitated prior to injection.

Administer by intramuscular (IM) injection into the anterolateral aspect of the thigh or deltoid.

Record the date, lot number, and manufacturer of the administered vaccine in the child’s immunization record.

Acthib Contraindications

Not Applicable

Acthib Boxed Warnings

Not Applicable

Acthib Warnings/Precautions

Warnings/Precautions

Not a substitute for routine tetanus immunization. Immunodeficiency/suppression: may get suboptimal response. Have epinephrine available to manage acute anaphylactic reaction. Guillain-Barré syndrome with prior vaccine containing tetanus toxoid; consider benefits and risks.

Acthib Pharmacokinetics

See Literature

Acthib Interactions

Interactions

Urine antigen detection may not have a diagnostic value in suspected disease due to H. influenzae type b within 1 to 2 weeks after receipt of a H. influenzae type b-containing vaccine.

Acthib Adverse Reactions

Adverse Reactions

Children 2 months to 16 months: Fussiness/irritability, inconsolable crying, decreased activity/lethargy. Children 15-20 months: Tenderness at the injection site.

Acthib Clinical Trials

Clinical Trials

Two clinical trials have compared the anti-PRP antibody responses to 3 Haemophilus influenzae type b conjugate vaccines in children. Infants were immunized with ActHIB vaccine and other Haemophilus influenzae type b conjugate vaccines at 2, 4, and 6 months of age. In one study, 83% of patients administered ActHIB achieved an anti-PRP antibody titer of ≥1.0mcg/mL after the third dose. In the second study, 97% of children administered ActHIB achieved an anti-PRP antibody titer of ≥1.0mcg/mL after the third dose.

Among Native American children, the administration of a 3-dose series of ActHIB vaccine at 6 weeks, 4 months, and 6 months of age resulted in 75% of patients achieving an anti-PRP antibody titer of ≥1.0mcg/mL at 7 months of age. Native American populations have had high rates of H. influenzae type b disease and have been observed to have low immune responses to Haemophilus influenzae type b conjugate vaccines.

The immunogenicity of ActHIB was evaluated In 4 separate studies in children 12 to 24 months of age who had not previously received Haemophilus influenzae type b conjugate vaccination. Study participants were administered a single dose of ActHIB vaccine. Among 12 to 15 month old patients, 90.2% achieved an anti-PRP antibody titer of ≥1.0mcg/mL. Among 17 to 24 month olds, 81.5% achieved an anti-PRP antibody titer of ≥1.0mcg/mL. Post immunization responses were measured at approximately 1 month after vaccination.

ActHIB has been found to be immunogenic in patients with sickle cell disease. Following 2 doses, given at 2-month intervals, 89% of children with sickle cell disease were reported to have anti-PRP antibody titers of ≥1.0mcg/mL.

Acthib

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