Telbivudine Side Effects

Brand Names: Tyzeka

Please note - some side effects for Telbivudine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Telbivudine - for the Consumer

Telbivudine

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Telbivudine:

Back pain; cough; diarrhea; dizziness; headache; joint pain; mild stomach pain or upset; tiredness; trouble sleeping.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; decreased coordination or trouble walking; fainting; fast or irregular heartbeat; fever or persistent sore throat; loss of appetite; numbness, tingling, or burning in the arms or legs; pale stools; severe or persistent dizziness or lightheadedness; severe or persistent nausea or vomiting; severe or persistent tiredness or weakness; severe, persistent, or unusual stomach pain; stomach swelling; unusual cold feeling, especially in the arms or legs; unusual muscle pain, ache, tenderness, or weakness; yellowing of the skin or eyes.

Side Effects by Body System

General

In general, telbivudine 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 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.

Myopathy has been reported with telbivudine use several weeks to months following treatment initiation.

Musculoskeletal side effects have included increased CK (11%), arthralgia (4%), back pain (4%), myalgia (3%), myopathy, myositis, and muscular weakness. CK greater than 7 times upper limit of normal (ULN) has been reported in 13% of patients. 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, and tenderness have been reported. Rhabdomyolysis has been reported during postmarketing experience.

Gastrointestinal

Gastrointestinal side effects have included diarrhea (6%), upper abdominal pain (6%), nausea (5%), abdominal pain (3%), abdominal distension (3%), and dyspepsia (3%). Lipase greater than 2.5 times ULN (2%) and amylase greater than 3 times ULN (less than 1%) have been reported. Gastritis, sore throat, dry mouth, decreased appetite, abdominal discomfort, lower abdominal pain, and gastrointestinal pain have been reported.

Nervous system

Nervous system side effects have included headache (10%), dizziness (4%), insomnia (3%), and peripheral neuropathy. Migraine, sinus headache, and tension headache have been reported. Paresthesia and hypoesthesia have been reported during postmarketing experience.

Hepatic

Hepatic side effects have included increased ALT (3%), hepatitis B exacerbation (2%), and lactic acidosis and severe hepatomegaly with steatosis. ALT greater than 10 times ULN and 2 times baseline (5%), ALT greater than 3 times baseline (7%), AST (SGOT) greater than 3 times baseline (6%), and total bilirubin greater than 5 times ULN (less than 1%) have been reported. Hypercholesterolemia has been reported. Posttreatment exacerbations of hepatitis have occurred after discontinuation of telbivudine.

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.

Metabolic

Metabolic side effects have included lactic acidosis during postmarketing experience.

Hematologic

Hematologic side effects have included neutropenia (absolute neutrophil count less than or equal to 749/mm3; 2%) and thrombocytopenia (platelets less than or equal to 49,999/mm3; less than 1%).

Other

Other side effects have included fatigue (13%) and pyrexia (4%). Malaise, vertigo, influenza and influenza-like symptoms, and postprocedural pain have been reported.

Respiratory

Respiratory side effects have included cough (6%) and pharyngolaryngeal pain (5%). Upper respiratory tract infection and nasopharyngitis have been reported.

Dermatologic

Dermatologic side effects have included rash (4%), pruritus (2%), and acne.

Renal

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

Renal side effects have included polyuria.

Genitourinary

Genitourinary side effects have included hematuria and irregular menstruation.

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