Recommended Topic Related To:

Prohibit

"Potential drug treatments are tested on paper, in laboratories and eventually in thousands of people. But every drug that goes through this cycle “ every drug that FDA approves “ carries some risk. One of the first lines of defense against "...

Prohibit

Prohibit Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

ProHIBiT Haemophilus b Conjugate Vaccine (Diphtheria Toxoid-Conjugate) is a vaccine used to help prevent Haemophilus influenza, a serious disease caused by bacteria. This medication may be available in generic form. Common side effects include fever over 101 degrees Fahrenheit (about up to 1 child in 20), or redness, warmth, or swelling where the shot was given (up to about 1 child in 4). If these problems happen, they usually start within a day of vaccination and may last 2-3 days.

The immunizing dose of ProHIBiT vaccine is a single injection of 0.5 mL given intramuscularly in the outer area of the mid-thigh or deltoid. ProHIBiT may interact with steroids, cancer treatment (chemotherapy, radiation, x-rays), azathioprine, basiliximab, cyclosporine, etanercept, leflunomide, muromonab-CD3, mycophenolate mofetil, sirolimus, or tacrolimus. Tell your doctor all medications and supplements you use and all vaccines you recently received. Consult your doctor before receiving ProHIBiT (Hib) vaccine if you are pregnant or breastfeeding.

Our ProHIBiT Haemophilus b Conjugate Vaccine (Diphtheria Toxoid-Conjugate) 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 Prescribing information?

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

Prohibit FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

When ProHIBiT (haemophilus b conjugate vaccine) ® alone was given to over 1,000 adults and children, no serious adverse reactions were observed.15,20,25,34 Thrombocytopenia was seen in one adult but a causative relationship was not established.

When ProHIBiT (haemophilus b conjugate vaccine) ® was given with DTP and Inactivated Poliovirus Vaccine (IPV) to 55,000 Finnish children, the rate and extent of serious adverse reactions were not different from those seen when DTP or IPV were administered alone.25,35 Allergic reactions such as urticaria were infrequently observed.15,35

Adverse reactions following vaccination with ProHIBiT (haemophilus b conjugate vaccine) ® (without DTP) in subjects 15 to 24 months of age are summarized in Table 6.34

TABLE 634: Percentage of Subjects 15 to 24 Months of Age Developing Local or Systemic Reactions to One Dose of Haemophilus b Conjugate Vaccine (Diphtheria Toxoid-Conjugate)

  No. of Subjects* 6 Hours Reaction 24 Hours 48 Hours
Fever > 38.3°C 281 1.1 2.1 1.8
Erythema 285 - 2.5 0.4
Induration 285 - 1.0 0.4
Tenderness 285 - 4.6 0.7
* Not all subjects had measurements at all time periods.

Other adverse reactions temporally associated with administration of ProHIBiT (haemophilus b conjugate vaccine) ® including diarrhea, vomiting, and crying were reported at a frequency of ≤ 1.2%. Fever of 39°C or more occurred in < 1%, while irritability, sleepiness, or anorexia were reported in 16.1%.34

Adverse reactions in clinical evaluations among 689 children, 7 to 14 months of age, 24 hours after receiving a single dose of ProHIBiT (haemophilus b conjugate vaccine) ® , were observed and compared to 139 children who received a saline placebo. There were no significant differences in the reaction rates for fever, erythema, induration, and tenderness between the two groups.15

A post-marketing surveillance study was conducted between April 1988 and July 1989 in the United States in 50,007 children 16 to 60 months of age. At Southern California Kaiser Permanente, 29,309 of these children were followed closely to determine the number of systemic and local reactions occurring within 6, 24, and 48 hours post-vaccination with ProHIBiT (haemophilus b conjugate vaccine) ® alone. These reactions are summarized in Table 7.15

TABLE 715: Post-Marketing Surveillance Study in Subjects 16-60 Months of Age Experiencing Adverse Reactions (n=29,309)

  6 Hours Reaction % 24 Hours 48 Hours
Fever > 38.9°C 2 2 2
Analgesic Given 23 12 8
Irritability 17 14 10
Drowsiness 13 8 5
Unusual Crying 2 2 2
Vomiting/Poor Eating 7 7 7
Redness 2 1 1
Swelling 2 2 1
Tenderness 25 12 5

In 50 children who had received licensed Haemophilis b Conjugate Vaccine in infancy and a booster dose of ProHIBiT (haemophilus b conjugate vaccine) ® at 12 months of age, the adverse experience profile was similar as summarized in Table 8.15

TABLE 815: Adverse Experiences with ProHIBiT (haemophilus b conjugate vaccine) ® given as a Booster at 12 to 15 Months of Age Primary Series either with Haemophilus b Conjugate Vaccine (Diphtheria CRM197Protein Conjugate) or Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (n=50)

  6 Hours Reaction % 24 Hours 48 Hours
Fever > 38.9°C 0 0 2
Analgesic Given 14 8 6
Irritability 28 18 14
Drowsiness 20 4 6
Unusual Crying 0 0 0
Vomiting/Poor Eating 10 10 6
Hypotonic/Hyporesponsive 0 0 0
Redness 4 6 4
Swelling 4 0 0
Tenderness 4 0 0

Other adverse reactions reported with administration of ProHIBiT (haemophilus b conjugate vaccine) ®  included urticaria, seizure, and renal failure.15,34 Guillain-Barré syndrome (GBS) rarely has been reported.36 However, a cause and effect relationship for these adverse events has not been established.

Reporting of Adverse Events

Reporting by parents or guardians 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 1-800-822-7967.32,33,37

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

Read the entire FDA prescribing information for Prohibit (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.


Women's Health

Find out what women really need.