Pronunciation:

tel-BI-vyoo-deen

Brand Names:

• Tyzeka

Dosage Forms:

• Tablet

Warnings:

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with antiretrovirals.

Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including telbivudine. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, resumption of anti-hepatitis B therapy may be warranted .

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with other antiretrovirals. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued telbivudine; monitor hepatic function closely for several months following discontinuation of therapy .

Classifications:

Therapeutic—

Antiviral

Chemical—

Thymidine Nucleoside Analog

Uses of This Medicine:

Telbivudine is used to treat chronic infections with the hepatitis B virus. Telbivudine is not a cure for the hepatitis B virus, but it may lower the amount of virus in your body and may decrease the ability of the virus to multiply .

This medicine is available only with your doctor's prescription .

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, 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 telbivudine in the pediatric population. Safety and efficacy have not been established .

Older adults—

Although appropriate studies on the relationship of age to the effects of telbivudine have not been performed in the geriatric population, geriatrics-specific problems are not expected to limit the usefulness of telbivudine in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving telbivudine .

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease—May cause side effects to become worse .

Proper Use of This Medicine:

You may take this medicine with or without food .

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For hepatitis B infection:
    • Adults and adolescents 16 years of age and older—600 milligrams (mg) once a day.
    • Children—Use and dose must be determined by your doctor .

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood or urine tests may be needed to check for unwanted effects .

A rare but serious reaction to this medicine is lactic acidosis (too much acid in the blood). Call your doctor right away if you have abdominal discomfort, a decreased appetite, diarrhea, fast or shallow breathing, a general feeling of discomfort, muscle pain or cramping, nausea, shortness of breath, sleepiness, or unusual tiredness or weakness .

Some patients who have used this medicine had serious liver problems, including an enlarged liver. Tell your doctor right away if you start having severe pain in your upper stomach, nausea, vomiting, loss of appetite, dark-colored urine, pale-colored stools, or yellowish skin or eyes .

Some patients who have used telbivudine had unexplained muscle aches, pain, tenderness, or weakness. If you notice any of these symptoms, call your doctor right away .

Hepatitis B infection may become worse if treatment with telbivudine is stopped. Do not stop taking this medicine without first checking with your doctor .

This medicine will not keep you from giving the hepatitis B virus to your partner during sex. Make sure you understand and practice safe sex, even if your partner also has hepatitis B. Do not share needles and personal items that can have blood or body fluids on them with anyone, such as toothbrushes or razor blades .

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 immediately if any of the following side effects occur:

More common

Chills

cough

diarrhea

fever

general feeling of discomfort or illness

headache

joint pain

loss of appetite

muscle aches and pains

nausea

runny nose

shivering

sore throat

stomach pain

sweating

trouble sleeping

unusual tiredness or weakness

vomiting

Less common

Back pain

chest pain

difficulty in moving

muscle cramping

muscle stiffness

muscle tenderness, wasting, or weakness

pain

pain in extremity

swollen joints

Rare

Burning feeling in chest or stomach

indigestion

loose stools

stomach upset

tenderness in stomach area

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

Body aches or pain

difficulty in breathing

ear congestion

loss of voice

nasal congestion

sneezing

stuffy nose

Less common

Acid or sour stomach

belching

dizziness

heartburn

rash

sleeplessness

stomach discomfort

unable to sleep

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