telbivudine


Also found in: Dictionary, Wikipedia.

telbivudine

(tel-bi-vu-deen) ,

Sebivo

(trade name),

Tyzeka

(trade name)

Classification

Therapeutic: antivirals
Pharmacologic: nucleoside analogues
Pregnancy Category: B

Indications

Management of chronic hepatitis B with evidence of currently active disease.

Action

Converted intracellularly to the triphosphate active metabolite which inhibits DNA polymerase by acting as a nucleoside analogue. Result is inhibition of viral replication.

Therapeutic effects

Decreased progression of chronic hepatitis B infection.

Pharmacokinetics

Absorption: Rapidly absorbed following oral administration; bioavailability unknown.
Distribution: Widely distributed into tissues.
Metabolism and Excretion: Excreted entirely as unchanged drug; no metabolism.
Half-life: Effective—15 hr; elimination half–life—40–49 hr.

Time/action profile (blood levels)

ROUTEONSETPEAKDURATION*
POunknown1–4 hr24 hr
*Patients with normal renal function.

Contraindications/Precautions

Contraindicated in: Hypersensitivity; Concurrent use of pegylated interferon alfa-2a Lactation: Lactation.
Use Cautiously in: Moderate to severe renal impairment (dosage modification recommended for CCr <50 mL/min); Discontinuation of medication (may result in exacerbation of hepatitis B); Geriatric: Consider age-related ↓ in renal function; Obstetric: Use only if maternal benefit outweighs fetal risk; Pediatric: Children <16 yr (safety not established).

Adverse Reactions/Side Effects

Cardiovascular

  • fatigue
  • headache

Gastrointestinal

  • hepatomegaly

Hematologic

  • neutropenia

Metabolic

  • lactic acidosis (life-threatening)

Musculoskeletal

  • myopathy

Neurologic

  • peripheral neuropathy

Miscellaneous

  • fever

Interactions

Drug-Drug interaction

↑ risk of peripheral neuropathy when used with pegylated interferon alfa-2a ; concurrent use contraindicated.Drugs that alter renal function may alter blood levels and effectiveness.

Route/Dosage

Oral (Adults and Children ≥16 yr) 600 mg daily.

Renal Impairment

Oral (Adults and Children ≥16 yr) CCr 30–49 mL/min—600 mg every 48 hr; CCr <30 mL/min (not on dialyis)—600 mg every 72 hr; End stage renal disease—600 mg every 96 hr.

Availability

Tablets: 600 mg

Nursing implications

Nursing assessment

  • Monitor signs of hepatitis (jaundice, fatigue, anorexia, pruritus) during therapy.
  • Assess for signs of myopathy (diffuse myalgias, muscle tenderness or muscle weakness with increases in creatine kinase). Interrupt therapy if myopathy is suspected and discontinue therapy if myopathy is diagnosed.
  • Lab Test Considerations: Monitor liver function tests during and for at least several months following discontinuation of therapy. May cause ↑ serum CPK, ALT, AST, lipase, amylase, and total bilirubin.
    • May cause neutropenia and thrombocytopenia.
    • Monitor HBV DNA every 6 mo to determine response to therapy.

Potential Nursing Diagnoses

Risk for infection (Indications)

Implementation

  • Oral: Administer without regard to food.

Patient/Family Teaching

  • Instruct patient to take telbivudine as directed and not to discontinue therapy without consulting health care professional. Severe acute exacerbations of hepatitis B have occurred when therapy was discontinued. Take missed doses as soon as remembered unless almost time for next dose; do not double doses. Advise patients to read the patient package insert prior to therapy and with each prescription refill.
  • Advise patient to notify health care professional promptly if signs of lactic acidosis (weakness or tiredness, unusual muscle pain, trouble breathing, nausea and vomiting, feeling cold, especially in arms or legs, dizziness, fast or irregular heart beat), hepatotoxicity (yellow skin or eyes, dark urine, light colored stools, lack or appetite, nausea, lower stomach pain) or myopathy (unexplained muscle aches, pain, tenderness or weakness) occur or if new symptoms occur.
  • Inform patient that telbivudine does not cure hepatitis B. Telbivudine does not reduce the risk of transmission of hepatitis B to others through sexual contact or blood contamination. Caution patient to use a condom during sexual contact and avoid sharing needles or donating blood to prevent spreading hepatitis B to others. Advise patient that the long-term effects of telbivudine are unknown.
  • Encourage pregnant female patients to register in the AntiRetroviral Pregnancy Registry at 1-800-258-4263 to monitor fetal outcomes. Advise patients not to breastfeed during therapy.

Evaluation/Desired Outcomes

  • Decreased progression of chronic hepatitis B infection. For patients with incomplete viral suppression (HBV DNA ≥300 copies/mL) after 24 wk of treatment, alternate therapy should be instituted. HBV DNA should be monitored every 6 mo to assure continued response. If patients test positive for HBV DNA at any time after their initial response, alternate treatment should be instituted.

telbivudine

an antiretroviral.
indication This drug is used in the treatment of hepatitis B.
contraindications Lactation and known hypersensitivity to this drug prohibit its use.
adverse effects Adverse effects of this drug include weakness, taste change, hearing loss, photophobia, abdominal pain, hepatomegaly, lactic acidosis, myalgia, arthralgia, muscle cramps, and cough. Common side effects include fever, headache, malaise, dizziness, insomnia, nausea, vomiting, diarrhea, anorexia, and rash.
References in periodicals archive ?
The authors described their study as the first to examine telbivudine therapy in such patients.
Overall, 42% of the patients had received lamivudine (Epivir), 32% had received adefovir (Hepsera), 10% had received tenofovir (Viread), 9% had received telbivudine (Tyzeka), and 7% had received entecavir (Baraclude).
Telbivudine (LdT) is a thymidine analogue, with a long half-life and anti-HBV potency greater than 3TC or FTC [29].
We are committed to improving the therapeutic options for patients with viral diseases with new drugs, such as telbivudine," said Jean-Pierre Sommadossi, chairman and chief executive officer of Idenix.
We look forward to continuing the phase III clinical trial of telbivudine and initiating phase IIb clinical trials for NM 283 and valtorcitabine later this year.
Changes have been made to the labeling of the antiviral drug telbivudine that are "related to a higher risk of developing resistance-associated substitutions in treated patients," according to the FDA.
BOSTON -- Limited use of the antiviral drug telbivudine is safe and effective for pregnant women with active hepatitis B virus infection and reduces perinatal transmission of the virus to their infants, Dr.
Treatment of hepatitis B e antigen positive chronic hepatitis with telbivudine or adefovir: a randomized trial.
True (A) or false (B)--click on the correct answer: Other agents active against hepatitis B mono-infection include entecavir, adefovir and telbivudine.
Following on from the revelation that entecavir may have anti-HIV activity and may jeopardise the future use of lamivudine against HIV, interest is now focused on telbivudine and its potential use in patients not requiring CART.
The companies report the trial, which is an ongoing two-year treatment study, found that after one year of treatment the telbivudine group showed greater anti-viral and clinical efficacy than the Epivir group.
There are several drugs available for treatment of hepatitis B mono-infection: interferon-alpha, lamivudine, adefovir, tenofovir, emotricitabine, entecavir, telbivudine and interferon.