Tenivac

Name: Tenivac

How supplied

Dosage Forms And Strengths

TENIVAC vaccine is a suspension for injection available in 0.5 mL single-dose vials or syringes. [See DESCRIPTION]

Storage And Handling

Vial, 1 dose - NDC No. 49281-215-58; in package of 10 vials, NDC No. 49281-215-10. Contains no latex.

Syringe, 1 dose- NDC No. 49281-215-88; in package of 10 syringes, NDC No. 49281-215-15. The tip caps of the prefilled syringes may contain natural rubber latex. No other components contain latex.

TENIVAC vaccine should be stored at 2° to 8°C (35° to 46°F). DO NOT FREEZE. Product which has been exposed to freezing should not be used. Do not use after expiration date shown on the label.

REFERENCES

1 CDC. Diphtheria, tetanus and pertussis: recommendations for vaccine use and other preventive measures. Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1991;40(RR-10):1-28.

Manufactured by: Sanofi Pasteur Limited, Toronto Ontario Canada. Distributed by: Sanofi Pasteur Inc., Swiftwater PA 18370 USA. Revised: Apr 2013

Side effects

Data From Clinical Studies

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to vaccine use and for approximating rates of those events.

In a primary immunization study conducted in Canada, 18 participants, 8 of whom were 6 to 9 years of age and 10 of whom were 17 to 56 years of age, received three doses of TENIVAC vaccine. In four booster immunization studies conducted in either the US or Canada, TENIVAC vaccine was administered to 3,723 participants overall, ranging in age from 11 to 93 years.

In one of these studies, a US multi-center booster immunization study (TDC01), 2,250 adolescents and adults ages 11-59 years of age received TENIVAC vaccine in an open-label design and adults 60 years of age and over were randomized to receive either TENIVAC vaccine (N = 700) or DECAVAC vaccine (US licensed Td manufactured by Sanofi Pasteur Inc.) (N = 701). Vaccine assignment for participants ≥ 60 years of age was unblinded to pharmacists and vaccination nurses, but was blinded to other study personnel and participants. Among participants who received TENIVAC vaccine, overall, 80.4% were Caucasian, 3.3% Black, 5.1% Hispanic, 4.5% Asian and 6.6% other races. Among participants ≥ 60 years of age, the racial distribution was similar for the TENIVAC vaccine and DECAVAC vaccine groups. Among participants who received TENIVAC vaccine, the proportion of participants who were female varied by age group (44.4% of participants 11-18 years of age, 70.1% of participants 19-59 years of age and 62.4% of participants ≥ 60 years of age). Among participants ≥ 60 years of age who received DECAVAC vaccine, 57.6% were female. Nearly all (99.8%) enrolled participants and all participants in the per-protocol immunogenicity population had a reported or documented history of previous immunization against tetanus and diphtheria and, by report, had not received a vaccine containing tetanus or diphtheria toxoid within 5 years prior to enrollment.

In the US multi-center booster immunization study, solicited injection site reactions and systemic adverse events were monitored on diary cards for a subset of participants 11-59 years of age and for all participants ≥ 60 years of age. The incidence and severity of solicited injection site reactions and selected solicited systemic adverse events that occurred within 3 days following vaccination are shown in Table 2.

Table 2: Frequency and Severity of Selected Solicited Adverse Events Within 0-3 Days Following TENIVAC Vaccine or DECAVAC Vaccine in a US Study

  TENIVAC Vaccine DECAVAC Vaccine
Adolescents 11 to 18 years
N = 491-492 %
Adults 19 to 59 years
N = 247 %
Adults ≥ 60 years
N = 688-695 %
Adults ≥ 60 years
N = 686-693 %
Injection Site AdverseReactions
Pain
  Any 80.1 74.9 35.3 29.4
  Moderate * 15.0 18.2 2.9 2.3
  Severe† 0.2 0.4 0.6 0.7
Redness
  Any 25.6 15.8 18.1 18.0
   ≥ 35 mm to < 50 mm 1.2 2.4 0.7 1.3
   ≥ 50 mm 0.4 0.4 2.3 1.9
Swelling
  Any 15.0 17.0 12.1 13.0
   ≥ 35 mm to < 50 mm 1.2 2.8 1.0 1.3
   ≥ 50 mm 1.8 2.8 1.7 1.3
Systemic Adverse Events
Fever
   ≥ 37.5°C 4.3 5.7 2.5 3.8
   ≥ 38.0°C to < 39°C 0.8 1.6 0.6 0.9
   ≥ 39°C 0.0 0.0 0.1 0.1
Headache
  Any 23.0 25.1 11.7 10.8
  Moderate* 4.3 7.3 1.6 1.4
  Severe† 0.6 0.8 0.0 0.3
Muscle Weakness
  Any 32.3 17.4 4.9 5.9
  Moderate* 7.3 3.2 1.3 1.0
  Severe† 0.6 0.4 0.1 0.1
Malaise
  Any 14.5 17.0 8.9 8.8
  Moderate* 3.5 3.2 2.4 1.2
  Severe† 0.8 0.4 0.1 0.4
Pain in Joints
  Any 15.7 10.9 8.5 7.4
  Moderate* 2.8 1.6 2.2 1.4
  Severe† 0.6 0.4 0.1 0.0
* Moderate: interfered with activities, but did not require medical care or absenteeism.
† Severe: incapacitating, unable to perform usual activities, may have/or required medical care or absenteeism.

In the US booster immunization study, among participants ≥ 60 years of age, 7 (1.0%) participants in the TENIVAC vaccine group and 10 (1.4%) participants in the DECAVAC vaccine group experienced a serious adverse event within 30 days following vaccination. During this period, 2 (0.3%) participants 19-59 years of age and no participants 11-18 years of age experienced a serious adverse event following TENIVAC vaccine. Serious adverse events within 30 days following TENIVAC vaccine included localized infection, asthma, colonic polyp, cellulitis, angina pectoris, hip and wrist fracture, cholecystitis, chest pain and cerebrovascular accident.

There were five deaths reported during the study. All of the reported deaths were in participants ≥ 60 years of age and occurred > 30 days post-vaccination: three in the TENIVAC vaccine group (cardiopulmonary arrest; myocardial infarction and septic shock; and unknown cause) and two in the DECAVAC vaccine group (myocardial infarction and congestive heart failure; and liver cancer).

In the primary immunization study (N = 18) in which serious adverse events were monitored for 3 days following each vaccination and in three other booster immunization studies in which serious adverse events were monitored for either four days (N = 347) or one month (N = 426) following vaccination, no serious adverse events were reported.

Data From Post-marketing Experience

The following adverse events have been spontaneously reported during the post-marketing use of TENIVAC vaccine. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.

The following adverse events were included based on severity, frequency of reporting or the strength of causal association to TENIVAC vaccine:

Blood And Lymphatic System Disorders

Lymphadenopathy

Immune System Disorders

Allergic reactions (such as erythematous rash, maculopapular rash, urticaria and pruritus); anaphylactic reaction (bronchospasm and angioedema).

Nervous System Disorders

Paresthesia, dizziness, syncope

Guillain Barre syndrome

Gastrointestinal Disorders

Vomiting

Musculoskeletal, Connective Tissue And Bone Disorders

Myalgia, pain in extremities

General Disorders And Administration Site Conditions

Injection site reactions (including inflammation, mass, edema, induration, warmth, pruritus, cellulitis, discomfort)

Fatigue, edema peripheral

Overdose

No information provided.

Tenivac Food Interactions

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Tenivac, there are no specific foods that you must exclude from your diet when receiving this medication. 

Before Using Tenivac

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of Diphtheria and Tetanus Toxoids Vaccine for Pediatric Use in children 7 years of age and older. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of Decavac® vaccine in children younger than 7 years of age. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of Decavac® vaccine have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Receiving this vaccine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Meningococcal Vaccine, Tetanus Toxoid Conjugate Quadrivalent

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Allergic reaction to a tetanus vaccine (eg, Arthus-type reaction) or
  • Guillain-Barré syndrome (nerve disease that causes paralysis) after a tetanus vaccine, history of—Your doctor will decide if you should receive this vaccine.
  • Immunodeficiency disorder (low blood counts for white cells or platelets) or
  • Weakened immune system—May not work as well in patients with these conditions.

Proper Use of diphtheria and tetanus vaccine

This section provides information on the proper use of a number of products that contain diphtheria and tetanus vaccine. It may not be specific to Tenivac. Please read with care.

A nurse or other trained health professional will give you or your child this vaccine. This vaccine is given as a shot into one of your muscles, usually in the upper leg for infants or in the shoulder for older children, teenagers, and adults.

Depending on the age of the child, this vaccine is given as a series of 3 or 4 doses. Teenagers and adults will receive a total of 3 doses.

After the first set of shots, you or your child should get a booster shot every 10 years.

It is important that you or your child receive all of the doses of vaccine in this series. Try to keep all of your scheduled appointments. If you miss a dose, make another appointment as soon as possible.

What do I need to tell my doctor BEFORE I take Tenivac?

  • If you have an allergy to any part of Tenivac (diphtheria and tetanus toxoids).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Feeling confused.
  • Very bad dizziness or passing out.
  • Change in eyesight.
  • Seizures.
  • A burning, numbness, or tingling feeling that is not normal.
  • Trouble controlling body movements.
  • Very bad irritation where the shot was given.

What are some other side effects of Tenivac?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

For all patients taking this medicine:

  • Pain where the shot was given.
  • Redness or swelling where the shot is given.
  • Headache.
  • Muscle weakness.
  • Feeling tired or weak.
  • Joint pain.

Young children:

  • Crying that is not normal.
  • Not hungry.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

How do I store and/or throw out Tenivac?

  • If you need to store Tenivac at home, talk with your doctor, nurse, or pharmacist about how to store it.
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