Tyzeka

Tyzeka Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Tyzeka (telbivudine) is an antiviral medication used to treat chronic hepatitis B in adults. It will not cure hepatitis. Common side effects include dizziness, tiredness, diarrhea, cough, or headache.

The recommended dose of Tyzeka for the treatment of chronic hepatitis B is 600 mg once daily, taken orally, with or without food. Tyzeka may interact with cyclosporine, erythromycin, penicillamine, zidovudine, antifungals, anti-malaria drugs, cholesterol-lowering medicines, interferon, or steroids. Tell your doctor all medications and supplements you use. During pregnancy, Tyzeka should be used only when prescribed. It is unknown if this drug helps to prevent the hepatitis B virus from passing from the mother to the baby. Consult your doctor. It is unknown if this drug passes into breast milk. Breastfeeding while using this drug is not recommended.

Our Tyzeka (telbivudine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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 Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Tyzeka in Detail - Patient Information: Side Effects

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 other serious side effects, such as:

  • 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 - nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, 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.

Read the entire detailed patient monograph for Tyzeka (Telbivudine) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Tyzeka Overview - Patient Information: Side Effects

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.

Read the entire patient information overview for Tyzeka (Telbivudine)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Tyzeka FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are discussed in other sections of the labeling:

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Assessment of adverse reactions is primarily based on two trials (007 GLOBE and NV-02B-015) in which 1,699 subjects with chronic hepatitis B received double-blind treatment with Tyzeka 600 mg per day (n=847 subjects) or lamivudine (n=852 subjects) for 104 weeks. The median duration of therapy was 104 weeks for both treatment groups.

In the 104 week clinical trials, most adverse experiences reported with Tyzeka were classified as mild or moderate in severity and were not attributed to Tyzeka. Selected adverse events of any severity which were reported in greater than or equal to 3% of Tyzeka and lamivudine recipients are shown in Table 2. With the exception of increased creatine kinase (CK), which was reported more frequently among Tyzeka recipients, the adverse event profile was similar for the two drugs.

Table 2 : Selected Common Adverse Eventsa in Pooled Trials 007 GLOBE and NV-02B-015

Adverse Event (Preferred Term) Tyzeka
N=847
n (%)b
Lamivudine
N=852
n (%)b
Fatigue 106 (13) 95 (11)
CK increased 90 (11) 52 (6)
Headache 83 (10) 95 (11)
Cough 52 (6) 45 (5)
Diarrhea 50 (6) 46 (5)
Abdominal pain, upper 49 (6) 52 (6)
Nausea 45 (5) 40 (5)
Pharyngolaryngeal pain 38 (5) 31 (4)
Arthralgia 37 (4) 38 (5)
Pyrexia 34 (4) 27 (3)
Rash 33 (4) 21 (3)
Back pain 33 (4) 32 (4)
Dizziness 32 (4) 43 (5)
Abdominal pain 29 (3) 31 (4)
Myalgia 27 (3) 17 (2)
ALT increased 27 (3) 31 (4)
Dyspepsia 24 (3) 39 (5)
Insomnia 24 (3) 22 (3)
Abdominal distension 22 (3) 19 (2)
Pruritus 18 (2) 23 (3)
Hepatitis B exacerbation 17 (2) 36 (4)
aAdverse events reported in greater than or equal to 3% subjects in either treatment group
bn (%) = the number and proportion of subjects in whom adverse event was reported

Moderate to severe (Grade 2-4) adverse events were reported in 239/847 (28%) of Tyzeka recipients and 229/852 (27%) of lamivudine recipients. The profile of adverse events of moderate to severe intensity was similar in both treatment groups and no individual adverse event was reported in greater than 2% of subjects in either treatment group.

Discontinuations due to adverse events were reported in 4% of Tyzeka recipients and 4% of lamivudine recipients. The most common adverse events resulting in Tyzeka discontinuation included increased CK, nausea, diarrhea, fatigue, myalgia, and myopathy.

Peripheral neuropathy was reported as an adverse event in less than 1% (2/847) of subjects receiving Tyzeka monotherapy [see WARNINGS AND PRECAUTIONS]. Of Tyzeka-treated subjects less than 1% (5/847) were diagnosed with myopathy/myositis (presenting with muscular weakness) [see WARNINGS AND PRECAUTIONS].

Laboratory Abnormalities

Frequencies of selected treatment-emergent laboratory abnormalities in the 007 GLOBE and NV-02B-015 trials are listed in Table 3.

Table 3 : Selected Treatment-Emergent Grade 3-4 Laboratory Abnormalitiesa in Patients with Chronic Hepatitis B in the 104-Week Pooled 007 GLOBE and NV-02B-015 Trials

Test Tyzeka 600 mg
(n=847)
Lamivudine 100
mg (n=852)
Creatine Kinase (CK) greater than 7.0 x ULN 13% 4%
ALT greater than 10.0 x ULN and 2.0 x baselineb 5% 8%
ALT greater than 3 x baseline 7% 13%
AST (SGOT) greater than 3.0 x baseline 6% 10%
Lipase greater than 2.5 x ULN 2% 4%
Amylase greater than 3.0 x ULN less than 1% less than 1%
Total Bilirubin greater than 5.0 x ULN less than 1% less than 1%
Neutropenia (ANC less than or equal to 749/mm³) 2% 2%
Thrombocytopenia (Platelets less than or equal to 49,999/mm³) less than 1% less than 1%
a On-treatment value worsened from baseline to Grade 3 or Grade 4 during therapy
b American Association for the Study of Liver Diseases (AASLD) definition of acute hepatitis flare

Creatine Kinase (CK) Elevations

Creatine kinase (CK) elevations were more frequent among subjects on Tyzeka treatment. By 104 weeks of treatment, Grade 1-4 CK elevations occurred in 79% of Tyzeka-treated subjects and 47% of lamivudine-treated subjects. Grade 3 or 4 CK elevations occurred in 13% of Tyzeka-treated subjects and 4% of lamivudine-treated subjects. Most CK elevations were asymptomatic, but the mean recovery time was longer for subjects on Tyzeka than subjects on lamivudine.

Among Tyzeka-treated subjects with Grade 1-4 CK elevations, 10% developed a musculoskeletal adverse event compared to 5% of lamivudine-treated subjects. A total of 2% (13/847) Tyzeka-treated subjects interrupted or discontinued trial drug due to CK elevation or musculoskeletal adverse events1.

ALT Flares During Treatment

The incidence of ALT flares, defined as ALT greater than 10 x ULN and greater than 2 x baseline, was similar in the two treatment arms (3%) in the first six months. After week 24, ALT flares were reported less frequently in the Tyzeka arm (2%) compared to the lamivudine arm (5%). Periodic monitoring of hepatic function is recommended during chronic hepatitis B treatment.

Exacerbations of Hepatitis after Discontinuation of Treatment

In the subset of subjects who discontinued treatment prematurely for reasons other than efficacy, or who elected not to continue Tyzeka in another clinical trial, 9/154 (6%) Tyzeka-treated and 10/180 (6%) lamivudine-treated subjects experienced an exacerbation of hepatitis (ALT elevation greater than 2 x baseline and greater than 10 x ULN) in the 4-month post-treatment period.

Results at 208 Weeks

After 104 weeks of blinded therapy in trials 007 GLOBE and NV-02B-015, 667 subjects received Tyzeka in an open-label extension trial, CLDT600A2303. Of those initially randomized to Tyzeka therapy, 78% of subjects (530/680) from trial 007 GLOBE and 82% (137/167) of subjects from trial NV-02B-015 enrolled into the extension trial and continued Tyzeka treatment for up to 208 weeks. The long-term Tyzeka safety population in trial CLDT600A2303 consisted of 655 subjects, including 518 subjects from trial 007 GLOBE and 137 subjects from trial NV-02B-015.

The overall safety profile from the pooled analysis up to 104 and 208 weeks was similar. Grade 3/4 CK elevations occurred in 16% of subjects (104/655) treated with Tyzeka in trial CLDT600A2303. Most grade 3/4 CK elevations were asymptomatic (74% of subjects without any muscle related adverse reaction) and transient (98% of episodes lasted one or two visits (visit interval 2 - 12 weeks) and 87% of subjects had one or two episodes). Most grade 3/4 CK elevations (93%) resolved spontaneously or returned to baseline levels. Two cases of myopathy and two cases of myositis were reported in the 655 Tyzeka-treated subjects.

Among the cohort of 655 subjects continuing Tyzeka for up to 208 weeks in trial CLDT600A2303, including the subgroup of patients (n=223) with mild renal impairment (eGFR 60-90 mL per min) at baseline, mean estimated GFR assessed by MDRD did not decline.

Postmarketing Experience

The following adverse reactions have been reported during post approval use of Tyzeka. Because these reactions were reported voluntarily from a population of unknown size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Musculoskeletal and Connective Tissue Disorders

Rhabdomyolysis

Nervous System Disorders

Paraesthesia, hypoaesthesia

Metabolism and Nutrition Disorders

Lactic acidosis

1Includes the Preferred Terms: back pain, chest wall pain, non-cardiac chest pain, chest discomfort, flank pain, muscle cramp, muscular weakness, musculoskeletal pain, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal stiffness, myalgia, myofascial pain syndrome, myopathy, myositis, neck pain, and pain in extremity.

Read the entire FDA prescribing information for Tyzeka (Telbivudine) »

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Tyzeka - User Reviews

Tyzeka User Reviews

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Here is a collection of user reviews for the medication Tyzeka sorted by most helpful. Patient Discussions FAQs

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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