Tenivac (Intramuscular)

Diphtheria and tetanus vaccine is a combination vaccine that protects against infections caused by diphtheria and tetanus (lockjaw). The vaccine 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 very rigid or stiff. The muscle spasms can be strong enough to cause bone fractures in the spine. This disease can also cause breathing problems, swallowing difficulties, seizures, and possibly death.

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

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 inform your doctor about any side effects that happen after receiving the vaccine.

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

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 caused by diphtheria or tetanus, you will need medicine to treat the infection.

In deciding to use a vaccine, it's important to weigh the risks against the benefits. This is a choice you will make with your doctor. For this vaccine, consider the following:

Allergies

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

Pediatric

Appropriate studies have not been done on 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.

Appropriate studies have not been done on the effects of Decavac® vaccine in children younger than 7 years of age. Safety and effectiveness have not been established.

Geriatric

While appropriate studies on the effects of Decavac® vaccine in older adults have not been performed, no specific problems related to aging have been documented so far.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during 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 used together even if an interaction could happen. In these cases, your doctor may need to adjust the dose, or take other precautions. When receiving this vaccine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their possible significance and may not include all potential interactions.

Receiving 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 change the dose or frequency of use for one or both medicines.

• Elivaldogene Autotemcel
• Teplizumab-mzwv
• Ublituximab-xiiy

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this vaccine. Be sure to inform 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 causes 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—This vaccine may not work as well in patients with these conditions.

Along with its necessary 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 you notice any of the following side effects:

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. Your health care professional may also have ways to prevent or lessen 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 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.

• 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.