Tyzeka

DRUG DESCRIPTION

Tyzeka is the trade name for telbivudine, a synthetic thymidine nucleoside analogue with activity against hepatitis B virus (HBV). The chemical name for telbivudine is 1-((2S,4R,5S)-4-hydroxy-5hydroxymethyltetrahydrofuran-2-y1)-5-methyl-1H-pyrimidine-2,4-dione, or 1-(2-deoxy-?-L-ribofuranosyl)-5 -methyluracil. Telbivudine is the unmodified ?-L enantiomer of the naturally occurring nucleoside, thymidine. Its molecular formula is C10H14N2O5, which corresponds to a molecular weight of 242.23. Telbivudine has the following structural formula:

Tyzeka (telbivudine) Structural Formula Illustration

Telbivudine is a white to slightly yellowish powder. Telbivudine is sparingly soluble in water (greater than 20 mg/mL), and very slightly soluble in absolute ethanol (0.7 mg/mL) and n-octanol (0.1 mg/mL).

Tyzeka film-coated tablets are available for oral administration in 600 mg strength. Tyzeka 600 mg film-coated tablets contain the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. The tablet coating contains titanium dioxide, polyethylene glycol, talc and hypromellose.

Tyzeka oral solution is available for oral administration in 100 mg/5 mL strength. Tyzeka oral solution contains the following inactive ingredients: citric acid anhydrous, benzoic acid, passion fruit flavor, sodium saccharin, sodium hydroxide, and purified water. A 600 mg dose (30 mL) of Tyzeka oral solution contains approximately 47 mg of sodium.

What are the possible side effects of telbivudine (Tyzeka)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as:

  • muscle pain or weakness;
  • numb or cold feeling in your arms and legs;
  • trouble breathing;
  • ...

Read All Potential Side Effects and See Pictures of Tyzeka

What are the precautions when taking telbivudine (Tyzeka)?

Before taking telbivudine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, alcohol use.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.

Avoid alcohol because it may worsen dizziness and liver problems.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal...

Read All Potential Precautions of Tyzeka


Tyzeka Consumer (continued)

SIDE EFFECTS: See also Warning section.

Dizziness, tiredness, diarrhea, cough, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: unexplained muscle pain/tenderness/weakness.

Tell your doctor immediately if any of these rare but serious side effects occur: numbness/tingling/burning or weakness/pain of arms/legs, difficulty walking, signs of infection (such as fever, persistent sore throat), easy bruising/bleeding.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking telbivudine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, alcohol use.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.

Avoid alcohol because it may worsen dizziness and liver problems.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

To decrease your risk of spreading hepatitis B to others, always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity. Consult your doctor or pharmacist for more details.

During pregnancy, this medication should be used only when clearly needed. It is not known if this medication helps to prevent the hepatitis B virus from passing from the mother to the baby. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. The manufacturer states that breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Tyzeka Patient Information Including Side Effects

Brand Names: Tyzeka

Generic Name: telbivudine (Pronunciation: tel BIV yoo deen)

  • What is telbivudine (Tyzeka)?
  • What are the possible side effects of telbivudine (Tyzeka)?
  • What is the most important information I should know about telbivudine (Tyzeka)?
  • What should I discuss with my health care provider before taking telbivudine (Tyzeka)?
  • How should I take telbivudine (Tyzeka)?
  • What happens if I miss a dose (Tyzeka)?
  • What happens if I overdose (Tyzeka)?
  • What should I avoid while taking telbivudine (Tyzeka)?
  • What other drugs will affect telbivudine (Tyzeka)?
  • Where can I get more information?

What is telbivudine (Tyzeka)?

Telbivudine is an antiviral medication. It works by preventing viral cells from multiplying in the body and infecting new liver cells.

Telbivudine is used to treat chronic hepatitis B in adults. This medicine will not cure hepatitis.

Telbivudine may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of telbivudine (Tyzeka)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as:

  • muscle pain or weakness;
  • numb or cold feeling in your arms and legs;
  • trouble breathing;
  • feeling dizzy, light-headed, tired, or very weak;
  • stomach pain, nausea with vomiting; or
  • fast or uneven heart rate.

Call your doctor at once if you have any of these serious side effects:

  • muscle tenderness, or weakness (may occur several weeks or months after you start taking telbivudine);
  • fever or flu symptoms and dark colored urine;
  • burning, pain or tingly feeling in your arms or legs; or
  • liver symptoms - pain in your upper stomach with low fever, loss of appetite, dark urine, clay-colored stools, and/or jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • cough, sore throat;
  • headache, tired feeling;
  • dizziness;
  • muscle aches;
  • low fever;
  • bloating, mild nausea, vomiting, diarrhea;
  • itching or mild skin rash;
  • joint pain, back pain; or
  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about telbivudine (Tyzeka)?

Some people have developed a life-threatening condition called lactic acidosis while taking telbivudine. Get emergency medical help if you have any of these symptoms of lactic acidosis: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

If you have hepatitis B you may develop liver symptoms after you stop taking telbivudine, even months after stopping. Your doctor may want to check your liver function on a regular basis for several months after you stop using this medication. Do not miss any scheduled visits.

Avoid having unprotected sex or sharing needles, razors, or toothbrushes. Taking this medication will not prevent you from passing hepatitis B to other people. Talk with your doctor about safe methods of preventing hepatitis transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

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