Pronunciation:

dif-THEER-ee-a TOX-oyd, ad-SORBD, TET-a-nus TOX-oyd

Brand Names:

• Decavac
• Tenivac

Dosage Forms:

• Suspension

Classifications:

Therapeutic—

Toxoid

Uses of This Medicine:

Diphtheria and tetanus vaccine is a combination vaccine that is given to protect against infections caused by diphtheria and tetanus (lockjaw). The vaccine works by causing the body to produce its own protection (antibodies) against these diseases. This vaccine is given to children 6 weeks of age and older, teenagers, and adults.

Diphtheria is a serious illness that can cause breathing problems, heart problems, nerve damage, pneumonia, and possibly death. The risk for serious illness is greater in very young children and the elderly.

Tetanus (also known as lockjaw) is a very serious illness that causes severe muscle spasms that make the muscles very rigid or stiff. The muscle spasms can be strong enough to cause bone fractures in the spine. The disease can also cause breathing problems, swallowing problems, seizures, and possibly death.

This vaccine is to be administered only by or under the direct supervision of a doctor.

Before Using This Medicine:

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.

Children—

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.

Older adults—

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.

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.

Other 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 is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Elivaldogene Autotemcel
• Teplizumab-mzwv
• Ublituximab-xiiy

Other interactions—

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 This Medicine:

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.

Precautions While Using This Medicine:

It is very important that you or your child return to your doctor’s office at the right time for the next dose. Be sure to notify your doctor of any unwanted effects that occur after you receive the vaccine.

If you or your child develop a skin rash, hives, or any allergic reaction after receiving this vaccine, tell your doctor right away.

Tell your doctor right away if you or your child are allergic to latex rubber. The prefilled syringes or bottle of vaccine may contain natural rubber latex. This may cause an allergic reaction in patients who are sensitive to latex.

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

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

Less common

Fever

general feeling of discomfort or illness

unusual tiredness or weakness

Incidence not known

Bloating or swelling of the face, arms, hands, lower legs, or feet

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chills

convulsions

cough

difficulty with swallowing

dizziness

fainting

fast heartbeat

hives

itching

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

rapid weight gain

shortness of breath

skin rash

swelling or puffiness of the face

swollen, painful, or tender lymph glands in the neck, armpit, or groin

tightness in the chest

tingling of the hands or feet

unusual weight gain or loss

wheezing

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

More common

Hard lumps, redness, tenderness, or warmth at the injection site

Less common

Headache

Incidence not known

Difficulty with moving

joint pain

lack or loss of strength

muscle aching or cramping

muscle stiffness

nausea

pain in the arms or legs

swollen joints

vomiting

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

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