Diphtheria and tetanus vaccine (Intramuscular)

Diphtheria and tetanus vaccine is a combination vaccine that protects against infections from diphtheria and tetanus (lockjaw). It helps the body 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 lead to breathing problems, heart issues, nerve damage, pneumonia, and possibly death. The risk of serious illness is higher in very young children and the elderly.

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

This vaccine must be given only by or under the direct supervision of a doctor.

It is very important that you or your child go back to your doctor’s office on time for the next dose. Make sure to inform your doctor of any side effects that happen after you receive the vaccine.

If you or your child get a skin rash, hives, or any allergic reaction after receiving this vaccine, contact your doctor immediately.

Let your doctor know 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 can cause an allergic reaction in people who are sensitive to latex.

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

In deciding to take a vaccine, you and your doctor need to consider the risks of the vaccine against the benefits it offers. Here are some important points to think about:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies have not been done to determine how age affects the effects of Diphtheria and Tetanus Toxoids Vaccine for Pediatric Use in children 7 years of age and older. Safety and effectiveness have not been established.

Studies have not been done to determine how age affects the effects of Decavac® vaccine in children younger than 7 years of age. Safety and effectiveness have not been established.

Geriatric

While studies on the effects of Decavac® vaccine in older adults have not been conducted, there are currently no known problems specific to older patients.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while in some cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below when you receive this vaccine. The following interactions are based on their potential significance and may not include all possible interactions.

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

• Elivaldogene Autotemcel
• Teplizumab-mzwv
• Ublituximab-xiiy

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken near mealtime or with specific foods due to potential interactions. Drinking alcohol or using 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. Make sure to tell your doctor if you have any other medical problems, especially:

• An allergic reaction to a tetanus vaccine (for example, an Arthus-type reaction) or
• A history of Guillain-Barré syndrome (a nerve disease that can cause paralysis) after a tetanus vaccine. Your doctor will determine if you should receive this vaccine.

• An immunodeficiency disorder (low blood counts for white cells or platelets) or
• A weakened immune system may mean the vaccine does not work as well in these patients.

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

In the U.S.

• Decavac
• Tenivac

Available Dosage Forms:

• Suspension

Therapeutic Class: Toxoid

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.