Diphtheria, tetanus, and acellular pertussis booster vaccine (Intramuscular)

Diphtheria, tetanus, and acellular pertussis booster vaccine (also known as Tdap) is a combination vaccine used to protect against infections from diphtheria, tetanus (lockjaw), and pertussis (whooping cough). This vaccine is given to children 10 years of age and older, to women in their third trimester of pregnancy to help prevent pertussis in babies younger than 2 months, and to adults who have previously received this vaccine. The vaccine will "boost" or increase the protection that the patient had from an earlier dose.

Diphtheria is a serious illness that can lead to breathing problems, heart issues, nerve damage, pneumonia, and possibly death. The risk of serious complications and death is higher in very young children and in older adults.

Tetanus (also known as lockjaw) is a serious illness that causes convulsions (seizures) and intense muscle spasms that can be strong enough to result in spine fractures. Tetanus has a death rate of 30 to 40 percent in cases.

Pertussis (also known as whooping cough) is a serious disease that leads to severe coughing spells that may disrupt breathing. Pertussis can also result in pneumonia, long-lasting bronchitis, seizures, brain damage, and death.

Children 10 years of age and older, and adults, may need an additional vaccine called a booster against diphtheria, tetanus, and pertussis. Adults and teenagers should receive Tdap instead of the tetanus-diphtheria (Td) injection if it has been 10 years or more since their last tetanus-diphtheria vaccine. The Tdap vaccine is recommended for adults who are in close contact with a baby who is less than a year old and for adults who work in healthcare.

Diphtheria, tetanus, and pertussis are serious diseases that can cause life-threatening illnesses. While some serious side effects can occur after a dose of Tdap (usually from the pertussis part of the vaccine), this is rare. The likelihood of your child contracting one of these diseases and suffering permanent injury or death is much higher than the chance of your child experiencing a serious side effect from the Tdap vaccine.

This vaccine should be given only by or under the direct supervision of your doctor.

It is very important to call the doctor right away if you or your child have any unwanted effects after getting the vaccine. This may include fainting, seizures, a high fever, crying that will not stop, or severe redness or swelling at the injection site.

This vaccine may cause a serious allergic reaction called anaphylaxis, which can be life-threatening and needs immediate medical help. Tell your doctor right away if you have a rash, itching, swelling of the tongue and throat, or trouble breathing after the injection.

Fainting may happen after you get this vaccine. You may also experience changes in vision, numbness or tingling in your arms, hands, or feet, or jerky movements in the arms and legs. Call the doctor right away if you or your child have any of these symptoms.

It is very important to inform the doctor if you or your child are allergic to rubber. The tip caps of the prefilled syringes may have dry natural latex rubber. This could cause an allergic reaction if you have a latex allergy.

This vaccine will not treat an active infection. If you or your child have a diphtheria, tetanus, or pertussis infection, you will need medication to treat the infection.

Do not take other medicines unless you have discussed it with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a vaccine, you and your doctor should consider the risks and benefits. Here are some important points to think about for this vaccine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this vaccine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For over-the-counter products, check the label or package ingredients carefully.

Pediatric

Adacel® and Boostrix® are not for use in children younger than 10 years old. Their safety and effectiveness have not been established for this age group.

The Advisory Committee on Immunization Practices (ACIP) recommends that teenagers receive a Tdap vaccine instead of the tetanus-diphtheria (Td) vaccine. The committee also encourages all teenagers, even those who have had Td before, to get a Tdap booster to help protect against pertussis (whooping cough). If you have questions about whether your teenager should get the Tdap vaccine, contact your doctor.

Geriatric

Adacel® is not for use in adults 65 years old and older.

Current studies have not shown any specific problems for older adults that would limit the effectiveness of Boostrix®.

Breast Feeding

There are no sufficient studies on women to determine the risk to infants when using this vaccine while breastfeeding. Weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be combined with caution. If you are receiving this vaccine, it’s very important for your healthcare professional to know if you are taking any of the following medicines. The interactions listed below are based on their potential significance and are not all-inclusive.

Using this vaccine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both are prescribed together, your doctor may adjust the dose or how often you use one or both medicines.

• Elivaldogene Autotemcel
• Teplizumab-mzwv
• Ublituximab-xiiy

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken with food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may affect the use of this vaccine. You should inform your doctor about any other medical problems, especially:

• Brachial neuritis (nerve problem) or
• Brain or nerve disorder, unstable or progressive or
• Epilepsy (seizures or convulsions), uncontrolled or
• Guillain-Barré syndrome (nerve disorder with paralysis), history of after a vaccine with tetanus or
• Severe infection or
• Progressive encephalopathy (brain disease) or
• Active stroke—Your doctor will determine if you or your child should receive this vaccine.

• History of encephalopathy (brain disease) within 7 days after a pertussis vaccine—Should not be used in patients with this condition.

• Immunodeficiency disorder (weak immune system)—May not be as effective in patients with this condition.

Along with its intended effects, this medicine may cause some unwanted effects. Not all of these side effects will happen, but if they do, they may need medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

Less common

• Crying for 3 or more hours
• Fainting

Rare

• Blurred vision
• Confusion
• Difficulty with breathing or swallowing
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Fever of 102.2 degrees F or more
• Severe or continuing headache
• Hives or welts
• Itching, especially of the feet or hands
• Reddening of the skin, especially around the ears
• Seizures
• Unusual and continuing sleepiness
• Sweating
• Swelling of the eyes, face, or inside of the nose
• Sudden and severe unusual tiredness or weakness
• Severe or continuing vomiting

Incidence not known

• Blood in the urine
• Bloody or black, tarry stools
• Burning, crawling, itching, numbness, prickling, "pins and needles," or tingling feelings
• Chest pain, discomfort, or tightness
• Chills
• Cough
• Dizziness
• Dry mouth
• Fast heartbeat
• Flushed, dry skin
• Fruit-like breath odor
• Inability to move the arms and legs
• Increased hunger
• Increased thirst
• Increased urination
• Large, flat, blue or purplish patches on the skin
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• Loss of consciousness
• Muscle pain or spasms
• Nausea
• Painful knees and ankles
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Redness and swelling on the skin, buttocks, legs, or ankles
• Skin rash
• Stiff neck
• Stomach pain
• Sudden numbness and weakness in the arms and legs
• Swollen, painful, or tender lymph glands in the neck, armpit, or groin
• Unexplained weight loss

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also tell you how to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Body aches
• Diarrhea
• Fever of 99.5 degrees F or more
• Redness, swelling, tenderness, pain, or a lump at the injection site
• Tiredness

Incidence not known

• Back pain
• Injection site bruising
• Muscle or joint pain
• Weakness of the muscles in the face

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Adacel
• Boostrix

Available Dosage Forms:

• Suspension

Therapeutic Class: Vaccine

A nurse or other trained health professional will give you or your child this vaccine. It is given as a shot into one of your muscles.

This vaccine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You will receive the first dose of Adacel® or Boostrix® 5 years or more after the last dose of a DTaP series or tetanus toxoid vaccine. The second dose may be given 8 years or more for Adacel® or 9 years or more for Boostrix® after the first dose of Tdap vaccine.

To prevent tetanus, a booster dose of Adacel® or Boostrix® may be given if it has been at least 5 years after you have received a tetanus toxoid vaccine.

To prevent pertussis in babies younger than 2 months of age, Adacel® or Boostrix® is given to women in their third trimester of pregnancy.

You or your child may receive other vaccines at the same time as this one, but in a different body area. You should receive patient instructions for all of the vaccines. Make sure you understand all of the information and talk to your doctor or nurse if you have questions.

It is important that you or your child receive all of the shots. Try to keep all scheduled appointments. Make another appointment as soon as possible if you or your child misses a dose of this vaccine.