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ActHIB

ActHIB

Acthib Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

ActHIB (haemophilus b conjugate vaccine) is used to prevent infection caused by haemophilus B bacteria, and is sometimes combined with vaccines to protect against other diseases. This vaccine will not protect against other types of influenza. It is an immunization. Common side effects include redness, pain, swelling, or a lump where the shot was given, low fever, mild fussiness or crying, joint pain, body aches, drowsiness, or diarrhea.

The number of doses of ActHIB Vaccine indicated depends on the age at which immunization is begun. A child 7 to 11 months of age should receive 2 doses of ActHIB Vaccine at 8-week intervals and a booster dose at 15 to 18 months of age. A child 12 to 14 months of age should receive 1 dose of ActHIB Vaccine followed by a booster 2 months later. Consult your doctor for the immunization schedule. ActHIB may interact with steroids, medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, or medicines to treat or prevent organ transplant rejection. Tell your doctor all medications and supplements you use, and all vaccines you have recently received. Before you receive the ActHIB vaccine, tell your doctor if you are pregnant. This vaccine should not be given to a woman who is breastfeeding.

Our ActHIB (haemophilus b conjugate vaccine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Acthib in Detail - Patient Information: Side Effects

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives another haemophilus B vaccine in the future, you will need to tell the child's doctor if the first shot caused any side effects.

Becoming infected with haemophilus B is much more dangerous to your child's health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if your child has any of these serious side effects:

  • extreme drowsiness, fainting;
  • fussiness, irritability, crying for an hour or longer;
  • seizure (black-out or convulsions); or
  • high fever (within a few hours or a few days after the vaccine).

Less serious side effects may include:

  • redness, pain, swelling, or a lump where the shot was given;
  • low fever;
  • mild fussiness or crying;
  • joint pain, body aches;
  • drowsiness; or
  • diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

Read the entire detailed patient monograph for Acthib (Haemophilus b Conjugate Vaccine) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Acthib FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

More than 7,000 infants and young children (<2 years of age) have received at least one dose of ActHIB (haemophilus b conjugate vaccine) ® during US clinical trials. Of these, 1,064 subjects 12 to 24 months of age who received ActHIB (haemophilus b conjugate vaccine) ® alone reported no serious or life threatening adverse reactions.

Adverse reactions commonly associated with a first ActHIB (haemophilus b conjugate vaccine) ® immunization of children 12 to 15 months of age who were previously unimmunized with any Haemophilus b conjugate vaccine, include local pain, redness and swelling at the injection site. Systemic reactions include fever, irritability and lethargy. 14,18

In a multicenter trial, ActHIB (haemophilus b conjugate vaccine) ® was administered to US infants at 2, 4, and 6 months of age concomitantly, at separate sites, with AvP D.P. The adverse events observed are summarized in Table 5.

TABLE 5 14

PERCENTAGE OF INFANTS PRESENTING WITH LOCAL OR SYSTEMIC REACTIONS

AT 6, 24, AND 48 HOURS OF IMMUNIZATION WITH ActHIB (haemophilus b conjugate vaccine) ® ADMINISTERED

SIMULTANEOUSLY, AT SEPARATE SITES, WITH AvP DTP VACCINE

AGE AT IMMUNIZATION

REACTION

2 Months

(n= 365)

4 Months

(n= 364)

6 Months

(n= 365)

6 Hrs.

24 Hrs.

48 Hrs.

6 Hrs.

24 Hrs.

48 Hrs.

6 Hrs.

24 Hrs.

48 Hrs.

Local §
Tenderness

46.3%

11.5%

2.2%

23.4%

7.4%

1.1%

19.2%

6.0%

1.1%

Erythema

14.3%

4.1%

0.3%

8.8%

5.8%

0.6%

11.5%

6.9%

1.6%

Induration

22.5%

6.3%

1.9%

12.4%

4.7%

0.8%

9.6%

3.8%

1.1%

Systemic*
Fever>100.8° F

20.1%

1.3%

0.6%

14.6%

6.6%

1.4%

15.7%

8.8%

0.8%

Irritability

72.6%

21.9%

12.6%

48.4%

25.0%

13.2%

44.1%

25.2%

10.1%

Drowsiness

57.5%

29.9%

10.4%

44.2%

18.1%

7.4%

32.6%

13.4%

2.5%

Anorexia

15.3%

5.8%

4.9%

8.0%

5.0%

3.0%

5.5%

4.9%

2.2%

Diarrhea

4.4%

6.6%

5.2%

5.0%

4.7%

4.7%

4.7%

6.3%

3.6%

Vomiting

2.7%

4.1%

2.7%

2.5%

3.3%

2.8%

2.2%

2.7%

1.9%

Persistent Crying Percentage of infants within 72 hours after immunization was 1.6% after dose one, 0.6%

after dose two, and 0.3% after dose three.

§ Local reactions were evaluated at the ActHIB (haemophilus b conjugate vaccine) ® injection site.

* The adverse reaction profile is defined by the concomitant use of AvP DTP vaccine.

The number of individuals observed at each time point for fever varied from 357 to 363.

In general, the rates of minor systemic reactions after ActHIB (haemophilus b conjugate vaccine)
® and DTP immunization were comparable to those usually reported after DTP vaccine alone. 30,31,32,33

When ActHIB (haemophilus b conjugate vaccine) ® reconstituted with AvP whole-cell DTP was administered in infants at 2, 4, and 6 months of age, the systemic adverse experience profile (Table 6) was comparable to that observed when the two vaccines were given separately (Table 5). An increase in the rates of local reactions was observed within the 24- hour period after immunization. 18

TABLE 6 18

PERCENTAGE OF INFANTS PRESENTING WITH LOCAL OR SYSTEMIC REACTIONS

AT 6, 24, AND 48 HOURS OF IMMUNIZATION WITH ActHIB (haemophilus b conjugate vaccine) ® COMBINED

WITH CLI DTP VACCINE BY RECONSTITUTION

AGE AT IMMUNIZATION

REACTION

2 Months

(n= 204)

4 Months

(n= 199)

6 Months

(n= 200)

6 Hrs.

24 Hrs.

48 Hrs.

6 Hrs.

24 Hrs.

48 Hrs.

6 Hrs.

24 Hrs.

48 Hrs.

Local
Tenderness

47.1%

18.6%

3.4%

33.2%

17.6%

4.0%

25.0%

17.0%

3.5%

Erythema > 1"

11.8%

2.5%

0.0%

11.6%

9.1%

2.5%

10.5%

13.5%

3.5%

Induration

31.4%

17.2%

3.9%

26.1%

20.1%

7.5%

28.5%

22.5%

10.0%

Systemic
Fever > 100.4° F

24.6%

2.0%

0.5%

15.8%

6.1%

3.6%

13.0%

10.3%

3.1%

Irritability

70.6%

22.1%

12.8%

56.8%

31.2%

19.1%

40.5%

28.2%

15.9%

Drowsiness

60.3%

23.5%

11.3%

42.2%

20.6%

9.6%

30.3%

12.3%

5.6%

Anorexia

17.7%

6.4%

2.9%

10.1%

7.5%

5.5%

5.1%

4.6%

4.1%

Diarrhea

2.5%

5.4%

1.5%

3.5%

3.5%

2.5%

2.6%

4.1%

5.6%

Vomiting

2.9%

5.4%

2.9%

3.0%

5.0%

3.0%

3.6%

3.6%

1.5%

Persistent Crying Percentage of infants within 72 hours after immunization was 0.0% after dose one, 0.0%

after dose two, and 0.005% after dose three.

In a third US trial when ActHIB (haemophilus b conjugate vaccine) ® was combined with DTP by reconstitution, approximately 1,450 doses were administered to infants starting at 2 months of age. Adverse reactions observed at 6 and 24 hours respectively after the first immunization (n=498) were tenderness 66.9% and 30.7%; erythema (>1") 8.6% and 2.2%; induration 38.2% and 21.7%; irritability 77.9% and 35.7%; drowsiness 63.7% and 34.1%; anorexia 26.1% and 12.9%; diarrhea 6.8% and 9.0%; and vomiting 3.4% and 3.8%. 18 One hypotonic hyporesponsive episode (HHE) was seen in an infant following the second dose in this trial. This is consistent with the HHE incidence rate observed with DTP vaccination alone. 4

Adverse reactions associated with ActHIB (haemophilus b conjugate vaccine) ® generally subsided after 24 hours and usually do not persist beyond 48 hours after immunization.

No data are available on the safety of a booster dose of ActHIB (haemophilus b conjugate vaccine) ® combined with AvP DTP vaccine by reconstitution given in 15 to 20 month old children.

In a US trial, safety of TriHIBit®,ActHIB (haemophilus b conjugate vaccine) ® combined with Tripedia® by reconstitution, in 110 children aged 15 to 20 months was compared to ActHIB (haemophilus b conjugate vaccine) ® given with Tripedia® at separate sites to 110 children. All children received three doses of Haemophilus b conjugate vaccine (ActHIB (haemophilus b conjugate vaccine) ® or HibTITER® )and three doses of whole-cell DTP at approximately 2, 4 and 6 months of age.



TABLE 7 18

PERCENTAGE OF 15 TO 20-MONTH-OLD CHILDREN PRESENTING WITH LOCAL

OR SYSTEMIC REACTIONS AT 6, 24 AND 48 HOURS OF IMMUNIZATION WITH TriHIBit®

COMPARED TO ActHIB (haemophilus b conjugate vaccine) ® AND TRIPEDIA® GIVEN CONCOMITANTLY AT SEPARATE SITES

 

6 Hrs. Post- dose

24 Hrs. Post- dose

48 Hrs. Post- dose

REACTION

Separate

Injections*

TriHIBit®

Separate

Injections*

TriHIBit®

Separate

Injections*

TriHIBit®

 
Local

n= 110

n= 110

n= 110

n= 110

n= 110

n= 110

Tenderness

17.3/ 20.0

19.1

8.2/ 8.2

10.0

1.8/ 0.9

1.8

Erythema > 1"

0.9/ 0.0

3.6

2.7/ 0.9

3.6

0.9/ 0.0

1.8

Induration**

3.6/ 5.5

2.7

2.7/ 3.6

8.2

4.5/ 0.9

3.6

Swelling

3.6/ 3.6

3.6

2.7/ 1.8

5.5

0.9/ 0.0

4.5

Systemic

n= 103-110

n= 102-109

n= 105-110

n= 103-108

n= 104-110

n= 103-109

Fever > 102.2° F

0

2.0

1.0

1.9

1.9

0

Irritability

27.3

22.9

20.9

17.6

12.7

10.1

Drowsiness

36.4

30.3

17.3

13.9

12.7

11.0

Anorexia

12.7

9.2

10.0

6.5

6.4

2.8

Vomiting

0.9

1.8

0.9

1.9

0.9

2.8

Persistent Cry

0

0

0

0

0

0

Unusual Cry

0

0

0

0

0

0.9

* Tripedia injection site ActHIB (haemophilus b conjugate vaccine) ® injection site.

** Induration is defined as hardness with or without swelling.

TriHIBit® ActHIB (haemophilus b conjugate vaccine) ® combined with Tripedia® by reconstitution, was administered to approximately 850 children, aged 15 to 20 months. All children received three doses of a Haemophilus b conjugate vaccine (ActHIB (haemophilus b conjugate vaccine) ® or HibTITER®)and three doses of whole-cell DTP at approximately 2, 4 and 6 months of age .Local reactions were typically mild and usually resolved within the 24 to 48 hour period after immunization. The most common local reactions were pain and tenderness at the injection site. Systemic reactions occurring were usually mild and resolved within 72 hours of immunization. The reaction rates were similar to those observed in Table 7 when TriHIBit® ,ActHIB (haemophilus b conjugate vaccine) ® reconstituted with Tripedia® was administered and when Tripedia® was administered alone as a booster. 18

In a randomized, double-blind US clinical trial, ActHIB (haemophilus b conjugate vaccine) ® was given concomitantly with DTP to more than 5,000 infants and hepatitis B vaccine was given with DTP to a similar number. In this large study, deaths due to sudden infant death syndrome (SIDS) and other causes were observed but were not different in the two groups. In the first 48 hours following immunization, two definite and three possible seizures were observed after ActHIB (haemophilus b conjugate vaccine) and DTP in comparison with none after hepatitis B vaccine and DTP 18 This rate of seizures following ActHIB (haemophilus b conjugate vaccine) ® and DTP was not greater than previously reported in infants receiving DTP alone. (Refer to product insert for AvP DTP.) Other adverse reactions reported with administration of other Haemophilus b conjugate vaccines include urticaria, seizures, hives, renal failure and Guillain-Barré syndrome (GBS). 18,34 A cause and effect relationship among any of these events and the vaccination has not been established.

When ActHIB (haemophilus b conjugate vaccine) ® was given with DTP and inactivated poliovirus vaccine to more than 100,000 Finnish infants, the rate and extent of serious adverse reactions were not different from those seen when other Haemophilus b conjugate vaccines were evaluated in Finland (i.e. HibTITER®,ProHIBiT®)18

However, the number of subjects studied with TriHIBit®,ActHIB (haemophilus b conjugate vaccine) ® combined with Tripedia® by reconstitution was inadequate to detect rare serious adverse events.

Reporting of Adverse Events

Reporting by the parent or guardian of all adverse events occurring after vaccine administration should be encouraged. Adverse events following immunization with vaccine should be reported by the health-care provider to the US Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS). Reporting forms and information about reporting requirements or completion of the form can be obtained from VAERS through a toll-free number 1-800-822-7967. 26,27,28

Health-care providers also should report these events to the Director of Medical Affairs, Connaught Laboratories, Inc., Route 611, PO Box 187, Swiftwater, PA 18370 or call 1-800-822-2463.

Read the entire FDA prescribing information for Acthib (Haemophilus b Conjugate Vaccine) »

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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