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telbivudine (Rx)Brand and Other Names:Tyzeka

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 600mg
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Chronic Hepatitis B

600 mg PO qDay

Administration: with or without food

Renal Impairment

CrCl 50 mL/min or higher: normal dose

CrCl 30-49 mL/min: 600 mg PO q48hr

CrCl <30 mL/min: 600 mg PO q72hr

ESRD: 600 mg PO q96hr

Safety and efficacy not established

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Adverse Effects

Well tolerated, most AEs comparable to lamivudine

>10%

Fatigue (13%)

Elevated serum creatinine kinase (11%); higher incidence than lamivudine

1-10%

Headache (10%)

Cough (6%)

Diarrhea (6%)

Abdominal pain, upper (6%)

Nausea (5%)

Pharyngolaryngeal pain (5%)

Arthralgia (4%)

Pyrexia (4%)

Rash (4%)

Back pain (4%)

Dizziness (4%)

Abdominal pain (3%)

Myalgia (3%)

ALT increased (3%)

Dyspepsia (3%)

Insomnia (3%)

Abdominal distension (3%)

Pruritus (2%)

Hepatitis B exacerbation (2%)

<1%

Peripheral neuropathy

Myopathy/myositis

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Warnings

Black Box Warnings

Hepatitis B Treatment

  • Severe acute exacerbations of hepatitis B reported in patients who have discontinued therapy for hepatitis B
  • Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue therapy
  • Resumption of therapy for hepatitis B may be warranted

Lactic Acidosis

  • Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) reported with use of nucleoside analogues alone or in combination

Contraindications

Hypersensitivity

Coadministration with pegylated interferon alfa-2a is contraindicated because of increased risk of peripheral neuropathy

Cautions

Discontinuation may result in acute exacerbation of hepatitis B

Renal impairment

Risk of lactic acidosis, severe hepatomegaly with steatosis

Risk of peripheral neuropathy alone or in combination with pegylated interferon alfa-2a and other interferons (see Contraindications)

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Pregnancy & Lactation

Pregnancy Category: B (to register pregnant patients, call 1-800-258-4263)

Lactation: not known if distributed in breast milk, do not nurse

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Thymidine nucleoside analog; inhibits HBV DNA polymerase, which blocks reverse transcriptase activity and in turn reduces viral DNA replication.

Pharmacokinetics

Half-life, elimination: 40-49 hr

Peak plasma time: 1-4 hr

Concentration: 3.7±1.25 mcg/mL

AUC: 26.1±7.2 mcg/mL

Trough: 0.2-0.3 mcg/mL

Protein bound: 3.3%

Renal clearance: 7.6±2.9 mL/min

Metabolism: None detected in studies

Excretion: urine 42% (passive diffusion)

Dialyzable: 23% (HD)

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Images

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Formulary

FormularyPatient Discounts

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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