Pronunciation:

tel-BIV-ue-deen

Brand Names:

• Tyzeka

Warnings:

Warning: Severe Acute Exacerbations of Hepatitis BSevere 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 .

Classifications:

Chemical—

Thymidine Nucleoside Analog

Uses of This Medicine:

Telbivudine is used to treat chronic hepatitis B infection. Telbivudine is not a cure for hepatitis B infection, 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, geriatric-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 caution and an adjustment in the dose for patients receiving telbivudine.

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 taking this medicine, 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.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Peginterferon Alfa-2a

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—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Myopathy (muscle aches, pain, weakness) or
• Peripheral neuropathy (nerve disorder with numbness, tingling)—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of this medicine and do not take it more often than your doctor ordered. This medicine works best if there is a constant amount in the blood. To keep blood levels constant, take this medicine at the same time each day and do not miss any doses.

This medicine should come with a Medication Guide and patient information insert. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

Measure the oral liquid correctly using the marked dosing cup that comes with the package. Rinse the dosing cup with water after each use.

The oral liquid contains sodium. Ask your doctor for advice if you are on a low sodium diet.

When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.

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 forms (solution or tablets):
  • For hepatitis B infection:
    • Adults and teenagers 16 years of age and older—600 milligrams (mg) or 30 milliliters (mL) 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.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Throw away any unused oral liquid 60 days after opening the bottle. Unused or outdated medicine should not be put directly in the trash can. Place it in a closed container first, such as a sealed bag, then into the household trash. You may also take it to a community take-back program when available.

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.

Do not use this medicine if you are also using pegylated interferon alfa-2a (Pegasys®). Using these medicines together may increase your risk of having peripheral neuropathy.

Two rare but serious reactions to this medicine are lactic acidosis (too much acid in the blood) and liver toxicity, which includes an enlarged liver. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Call your doctor right away if you have more than one of these symptoms: abdominal or stomach discomfort or cramping; dark urine; decreased appetite; diarrhea; a general feeling of discomfort; light-colored stools; muscle cramping or pain; nausea; unusual tiredness or weakness; trouble with breathing; vomiting; or yellow eyes or skin.

If you have muscle aches, pain, tenderness, or weakness after using this medicine, call your doctor right away. These could be symptoms of a condition called myopathy.

Stop using this medicine and check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

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

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

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. The male partner should use a latex condom during sex. Do not share needles and personal items, such as toothbrushes or razor blades, that can have blood or body fluids on them with anyone.

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

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 with sleeping

unusual tiredness or weakness

vomiting

Less common

Back pain

chest pain

difficulty with moving

muscle cramping

muscle stiffness

muscle tenderness, wasting, or weakness

pain

pain in the extremity

swollen joints

Rare

Burning feeling in the chest or stomach

indigestion

loose stools

stomach upset

tenderness in the stomach area

Incidence not known

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

dark-colored urine

decreased appetite

fast, shallow breathing

muscle pain or spasms

shortness of breath

sleepiness

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 with 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.

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