telbivudine

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Related to Sebivo: telbivudine

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 ?
In the European Union, SEBIVO is indicated for the treatment of chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.
There can be no guarantees that SEBIVO or other development product candidates will be brought to market in the European Union or in any other markets, or that TYZEKA/SEBIVO will achieve any particular level of sales, or that our development product candidates will ever achieve any sales.
These new findings come from a trial comparing the efficacy of SEBIVO and adefovir in 135 HBeAg-positive patients with CHB over one year.
At one year, patients had the option of continuing on or switching to SEBIVO treatment in an ongoing follow-on study.
Two patients experienced grade 3 or 4 neutropenia - one SEBIVO recipient and one patient in the switch group; both events resolved at follow-up six days later, with continued treatment.
We are excited by the continued success of SEBIVO in clinical trials, as it further demonstrates SEBIVO's potential to fill an unmet need in chronic hepatitis B treatment and provide rapid, profound and sustained viral suppression," said Douglas Mayers, M.
On February 23, 2007, SEBIVO was recommended for approval by the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP), which reviews drug applications for all 27 countries in the European Union as well as Iceland and Norway.
The positive opinion from CHMP follows earlier approvals in the United States, where SEBIVO is marketed as TYZEKA(R) (telbivudine) 600 mg tablets; Canada; Switzerland; and various other countries in Asia and Latin America.
In HBeAg-positive patients, therapeutic response was 75 percent (n=345/458) among patients treated with SEBIVO and 67 percent (n=310/463) for those patients treated with lamivudine, while the response for HBeAg-negative patients after one year was 75 percent (n=167/222) vs.
In clinical studies SEBIVO was generally well tolerated with most adverse experiences classified as mild or moderate in severity.
Idenix and Novartis Pharma AG are co-promoting SEBIVO, for the treatment of hepatitis B, and co-developing valtorcitabine, a second hepatitis B compound, and valopicitabine, a hepatitis C compound, under a development and commercialization arrangement established in May 2003.
Such forward-looking statements can be identified by the use of forward-looking terminology such as "expected," "will," "goal," "treatment option," "look forward to," or similar expressions, or by express or implied discussions regarding potential approvals of SEBIVO by the European Commission or in additional markets, or potential future revenues from SEBIVO.