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Tyzeka

Tyzeka - General Information

Tyzeka is a drug with specific activity against the hepatitis B virus. Tyzeka is orally administered, with good tolerance, lack of toxicity and no dose-limiting side effects.

 

Pharmacology of Tyzeka

Tyzeka is a synthetic thymidine nucleoside analogue with activity against hepatitis B virus (HBV). Tyzeka is the unmodified β–L enantiomer of the naturally occurring nucleoside, thymidine.

 

Tyzeka for patients

Rx only

Tyzeka ™ (Tie–zee–ka)
(generic name = telbivudine )
Tablets

Read this Patient Information that comes with Tyzeka before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

What is the most important information I should know about TYZEKA?

1. Some people who have taken medicines like TYZEKA (a nucleoside analogue) have developed a serious condition called lactic acidosis(buildup of an acid in the blood). Lactic acidosis is a medical emergency and must be treated in the hospital. Call your healthcare provider right away if you get any of the following signs of lactic acidosis.

  • You feel very weak or tired.
  • You have unusual (not normal) muscle pain.
  • You have trouble breathing.
  • You have stomach pain with nausea and vomiting.
  • You feel cold, especially in your arms and legs.
  • You feel dizzy or light–headed.
  • You have a fast or irregular heartbeat.

2. Some people who have taken medicines like TYZEKA have developed serious liver problems called hepatotoxicity, with liver enlargement (hepatomegaly) and fat in the liver (steatosis). Call your healthcare provider right away if you get any of the following signs of liver problems.

  • Your skin or the white part of your eyes turns yellow (jaundice).
  • Your urine turns dark.
  • Your bowel movements (stools) turn light in color.
  • You don't feel like eating food for several days or longer.
  • You feel sick to your stomach (nausea).
  • You have lower stomach pain.

3. Some people who have taken medicines like TYZEKA have developed persistent unexplained muscle pain, muscle weakness or muscle tenderness. If you develop any of these symptoms, call your healthcare provider right away.

4. Your hepatitis B infection may get worse or become very serious if you stop taking TYZEKA.

  • Take your TYZEKA exactly as prescribed.
  • Be sure to refill your prescription or talk to your healthcare provider if you are running low on Tyzeka. Do not run out of TYZEKA.
  • Do not stop taking your TYZEKA without talking to your healthcare provider.

Your health care provider will need to monitor your health and do regular blood tests to check your liver if you stop taking Tyzeka. Tell your healthcare provider right away about any new or unusual symptoms that you notice after you stop taking Tyzeka.

What is TYZEKA?

TYZEKA is a prescription medicine used for chronic infection with hepatitis B virus (HBV) in adults who also have active liver damage.

  • TYZEKA will not cure HBV.
  • TYZEKA may lower the amount of HBV in the body.
  • TYZEKA may lower the ability of HBV to multiply and infect new liver cells.
  • TYZEKA may improve the condition of your liver.

It is important to stay under your healthcare provider's care while taking TYZEKA. Your healthcare provider will test the level of the hepatitis B virus in your blood regularly.

Does TYZEKA lower the risk of passing HBV to others?

TYZEKA does not stop you from spreading HBV to others by sex, sharing needles, or being exposed to your blood. Talk with your healthcare provider about safe sexual practices that protect your partner. Never share needles. Do not share personal items that can have blood or body fluids on them, like toothbrushes or razor blades. A shot (vaccine) is available to protect people at risk from becoming infected with HBV.

Who should not take TYZEKA (telbivudine)?

Do not take TYZEKA if you are allergic to any of its ingredients. The active ingredient in TYZEKA is telbivudine. See the end of this leaflet for a complete list of ingredients in TYZEKA. Tell your healthcare provider if you think you have had an allergic reaction to any of these ingredients.

TYZEKA has not been studied in children and is not recommended for anyone less than 16 years old.

What should I tell my healthcare provider before I take TYZEKA?

Tell your healthcare provider about all of your medical conditions, including if you:

  • have kidney problems. You may need a lower dose of TYZEKA.
  • are pregnant or planning to become pregnant. It is not known if TYZEKA is safe to use during pregnancy. It is not known whether TYZEKA helps prevent a pregnant mother from passing HBV to her baby. You and your healthcare provider will need to decide if TYZEKA is right for you. If you use TYZEKA while you are pregnant, talk to your healthcare provider.
  • are breast–feeding. It is not known if TYZEKA can pass into your breast milk or if it can harm your baby. Do not breast–feed if you are taking TYZEKA.

Tell your healthcare provider about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. TYZEKA may interact with other medicines that leave the body through the kidneys.

Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist.

How should I take TYZEKA?

  • Take TYZEKA exactly as prescribed. Your healthcare provider will tell you how much TYZEKA to take. The usual dose of TYZEKA Tablets is one 600 mg tablet once daily by mouth. Your dose may be lower if you have kidney problems.
  • To help you remember to take your TYZEKA, try to take it at the same time each day.
    • Do not change your dose or stop taking TYZEKA without talking to your healthcare provider. Your hepatitis B symptoms may get worse or become very serious if you stop taking TYZEKA. After you stop taking TYZEKA, it is important to stay under your healthcare provider's care. Your healthcare provider will need to do regular blood tests to check your liver.
    • If you forget to take TYZEKA, take it as soon as you remember and then take your next dose at its regular time. If it is almost time for your next dose, skip the missed dose. Do not take two doses at the same time. Call your healthcare provider or pharmacist if you are not sure what to do.
    • When your supply of TYZEKA starts to run low, get more from your healthcare provider or pharmacy. Do not run out of TYZEKA.
    • If you take more than the prescribed dose of TYZEKA, call your healthcare provider right away.

What are the possible side effects of TYZEKA?

TYZEKA may cause the following serious side effects :

  • lactic acidosis and liver problems.
  • unexplained muscle pain, weakness or tenderness
  • a worse or very serious hepatitis if you stop taking it.

The most common side effects of TYZEKA include tiredness, headache, fever, and muscle related symptoms. Less common side effects include stomach pain, joint pain, diarrhea, and cough. In some patients the results of some blood tests may worsen.

These are not all the side effects of TYZEKA. The list of side effects is not complete at this time because TYZEKA is still under study. Report any new or continuing symptom to your healthcare provider. If you have questions about side effects, ask your healthcare provider. Your healthcare provider may be able to help you manage these side effects.

How should I store TYZEKA?

  • Store TYZEKA Tablets at room temperature, 59° to 86° F (15° to 30° C). They do not require refrigeration. Do not store TYZEKA Tablets in a damp place such as a bathroom medicine cabinet or near the kitchen sink.
  • Keep the container tightly closed.
  • Throw away TYZEKA when it is outdated or no longer needed by flushing tablets down the toilet.

Keep TYZEKA and all medicines out of the reach of children and pets.

General information about TYZEKA: Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use TYZEKA for a condition for which it was not prescribed. Do not give TYZEKA to other people, even if they have the same symptoms you have. It may harm them. This leaflet summarizes the most important information about TYZEKA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about TYZEKA that is written for healthcare professionals. You can also call 1–877–8–Tyzeka or visit the TYZEKA website at www.TYZEKA.com.

What are the ingredients in TYZEKA?

Active Ingredient: telbivudine

Inactive Ingredients in TYZEKA Tablets: microcrystalline cellulose, povidone, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, titanium dioxide, talc, macrogol, hypromellose.

 

Tyzeka Interactions

Telbivudine is excreted mainly by passive diffusion so the potential for interactions between telbivudine and other drugs eliminated by renal excretion is low. However, because telbivudine is eliminated primarily by renal excretion, co–administration of telbivudine with drugs that alter renal function may alter plasma concentrations of telbivudine.

 

Tyzeka Contraindications

Telbivudine tablets are contraindicated in patients with previously demonstrated hypersensitivity to any component of the product.

 

Additional information about Tyzeka

Tyzeka Indication: For the treatment of chronic hepatitis B in adult patients with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
Mechanism Of Action: Tyzeka 5'–triphosphate inhibits HBV DNA polymerase (reverse transcriptase) by competing with the natural substrate, thymidine 5'–triphosphate. Incorporation of telbivudine 5'–triphosphate into viral DNA causes DNA chain termination, resulting in inhibition of HBV replication.
Drug Interactions: Not Available
Food Interactions: Not Available
Generic Name: Telbivudine
Synonyms: 2'-Deoxy-L-thymidine; Beta-l-thymidine; Epavudine; L-DT; LDT; Telbivudin; L-deoxythymidine; L-thymidine
Drug Category: Antiviral Agents; Reverse Transcriptase Inhibitors
Drug Type: Small Molecule; Approved

Other Brand Names containing Telbivudine: Tyzeka; Sebivo;
Absorption: Absorbed following oral administration. Telbivudine absorption and exposure were unaffected when a single 600–mg dose was administered with a high–fat (~55 g), high–calorie (~950 kcal) meal.
Toxicity (Overdose): There is no information on intentional overdose of telbivudine, but one subject experienced an unintentional and asymptomatic overdose. Healthy subjects who received telbivudine doses up to 1800 mg/day for 4 days had no increase in or unexpected adverse events. A maximum tolerated dose for telbivudine has not been determined.
Protein Binding: In vitro binding of telbivudine to human plasma proteins is low (3.3%).
Biotransformation: No metabolites of telbivudine were detected following administration of [14C]–telbivudine in humans. Telbivudine is not a substrate, or inhibitor of the cytochrome P450 (CYP450) enzyme system.
Half Life: Approximately 15 hours.
Dosage Forms of Tyzeka: Tablet Oral
Chemical IUPAC Name: 1-[(2S,4R,5S)-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]-5-methylpyrimidine-2,4-dione
Chemical Formula: C10H14N2O5
Telbivudine on Wikipedia: Not Available
Organisms Affected: Hepatitis B virus