Tyzeka Side Effects

Generic name: telbivudine

Note: This document contains side effect information about telbivudine. Some of the dosage forms listed on this page may not apply to the brand name Tyzeka.

Some side effects of Tyzeka may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to telbivudine: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking telbivudine (the active ingredient contained in Tyzeka) 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 of telbivudine 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.

For Healthcare Professionals

Applies to telbivudine: oral solution, oral tablet

General

In general, telbivudine (the active ingredient contained in Tyzeka) was usually well tolerated in clinical studies, with most side effects described as mild or moderate and not ascribed to telbivudine. Discontinuations due to adverse events were reported in 4% of telbivudine recipients and 4% of lamivudine recipients. The most common side effects leading to discontinuation of telbivudine included elevated creatine kinase (CK), nausea, diarrhea, fatigue, myalgia, and myopathy.

Musculoskeletal

Increased CK occurred more frequently during telbivudine (the active ingredient contained in Tyzeka) treatment during clinical trials. By 104 weeks of treatment, 79% of telbivudine-treated patients and 47% of lamivudine-treated patients reported Grade 1 to 4 CK elevations. Thirteen percent and 4% of telbivudine- and lamivudine-treated patients reported Grade 3 or 4 CK elevations, respectively. Most patients with CK elevations did not exhibit symptoms, but the average recovery time was longer in telbivudine-treated patients versus lamivudine-treated patients. Of the telbivudine-treated patients with Grade 1 to 4 CK elevations, 10% experienced a musculoskeletal side effect compared to 5% of lamivudine-treated patients. By 208 weeks of treatment, 16% of telbivudine-treated patients reported Grade 3 or 4 CK elevations, most of which were asymptomatic (74%), transient (98% lasted 1 or 2 visits), and resolved spontaneously or returned to baseline levels (93%).

Cases of myopathy/myositis have been reported with telbivudine use several weeks to months following treatment initiation.

Very common (10% or more): CK greater than 7 times ULN (13%), increased CK (11%)
Common (1% to 10%): Arthralgia (4%), back pain (4%), myalgia (3%)
Uncommon (0.1% to 1%): Myopathy/myositis (presenting with muscular weakness; less than 1%)
Frequency not reported: Fibromyalgia, muscle strain, chest wall pain, noncardiac chest pain, chest discomfort, flank pain, muscle cramp, musculoskeletal chest pain, musculoskeletal pain, musculoskeletal discomfort, musculoskeletal stiffness, myofascial pain syndrome, neck pain, pain in extremity, tenderness
Postmarketing reports: Rhabdomyolysis

Other

Very common (10% or more): Fatigue (13%)
Common (1% to 10%): Pyrexia (4%)
Frequency not reported: Malaise, vertigo, influenza and influenza-like symptoms, postprocedural pain

Nervous system

Very common (10% or more): Headache (10%)
Common (1% to 10%): Dizziness (4%), insomnia (3%)
Uncommon (0.1% to 1%): Peripheral neuropathy (less than 1%)
Frequency not reported: Migraine, sinus headache, tension headache
Postmarketing reports: Paresthesia, hypoesthesia

Hepatic

Common (1% to 10%): ALT greater than 3 times baseline (7%), AST (SGOT) greater than 3 times baseline (6%), ALT greater than 10 times ULN and 2 times baseline (i.e., acute hepatitis flare; 5%), increased ALT (3%), hepatitis B exacerbation (2%)
Uncommon (0.1% to 1%): Total bilirubin greater than 5 times ULN (less than 1%)
Frequency not reported: Lactic acidosis and severe hepatomegaly with steatosis, hypercholesterolemia, posttreatment exacerbations of hepatitis

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of telbivudine and other nucleoside analogs alone or in combination with other antiretroviral agents.

The incidence of ALT flares (ALT greater than 10 times ULN and greater than 2 times baseline) was similar (3%) in the two treatment arms in the first 6 months. After week 24, ALT flares were reduced to 2% in telbivudine-treated patients versus 5% in lamivudine-treated patients.

Posttreatment exacerbations of hepatitis have occurred after discontinuation of telbivudine.

Gastrointestinal

Common (1% to 10%): Diarrhea (6%), upper abdominal pain (6%), nausea (5%), abdominal pain (3%), abdominal distension (3%), dyspepsia (3%), lipase greater than 2.5 times ULN (2%)
Uncommon (0.1% to 1%): Amylase greater than 3 times ULN (less than 1%)
Frequency not reported: Gastritis, sore throat, dry mouth, decreased appetite, abdominal discomfort, lower abdominal pain, gastrointestinal pain

Respiratory

Common (1% to 10%): Cough (6%), pharyngolaryngeal pain (5%)
Frequency not reported: Upper respiratory tract infection, nasopharyngitis

Dermatologic

Common (1% to 10%): Rash (4%), pruritus (2%)
Frequency not reported: Acne

Hematologic

Common (1% to 10%): Neutropenia (absolute neutrophil count less than or equal to 749/mm3; 2%)
Uncommon (0.1% to 1%): Thrombocytopenia (platelets less than or equal to 49,999/mm3; less than 1%)

Metabolic

Postmarketing reports: Lactic acidosis

Renal

At least one patient reporting polyuria was receiving a diuretic for ascites.

Rare (less than 0.1%): Polyuria

Genitourinary

Frequency not reported: Hematuria, irregular menstruation

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