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RX ITEM-Tyzeka 600Mg Tab 30 By Novartis

NDC 00078-0538-15 UPC/GTIN No.3-00780-53815-2 Mfg.Part No.53815 TELBIVUDINE ORALBRAND: TYZEKA NDC: 00078-0538-15,78053815 UPC: 3-00780-53815-2,300780538152 Novartis Pharma CorpOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

RX ITEM-Tyzeka 600Mg Tab 30 By Novartis

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Item No.: RX829080 NDC No.78053815 UPC No.:300780538152 NDC No.00078-0538-15 UPC/GTIN No.3-00780-53815-2 MPN 53815 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX item. Rx Item No.Rx829080 Tyzeka 600mg Tab 30 by Novartis Item No.3829080 NDC No.00078053815 UPC No.300780538152 Other Name Tyzeka, TELBIVUDINE ORAL Thera

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TYZEKA- telbivudine tablet, film coated
TYZEKA- telbivudine solution
Novartis Pharmaceuticals Corporation

WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS AND SEVERE ACUTE EXACERBATIONS OF HEPATITIS B

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogue s alone or in combination with antiretrovirals [ s ee Warnings and Precautions (5.1) ] .



Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti - hepatitis B therapy, including Tyzeka. Hepatic function should be monitored closely with both clinical and laboratory follow -up for at least several months in patients who discontinue anti - hepatitis B therapy. If appropriate, resumption of anti - hepatitis B therapy may be warranted [ see Warnings and Precautions (5 .2 ) ].

1 INDICATIONS AND USAGE

1.1 Chronic Hepatitis B
Tyzeka is indicated for the treatment of chronic hepatitis B in adult patients with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

The following points should be considered when initiating therapy with Tyzeka:

This indication is based on virologic, serologic, biochemical and histologic responses in nucleoside treatment na�ve adult patients with HBeAg positive and HBeAg negative chronic hepatitis B with compensated liver disease [see Clinical Studies (14) ].
For HBeAg-positive patients, Tyzeka should only be initiated in patients with HBV DNA less than 9 log10 copies per mL and ALT greater than or equal to 2x Upper Limit of Normal (ULN) prior to treatment.
For HBeAg-negative patients, Tyzeka should only be initiated in patients with HBV DNA less than 7 log10 copies per mL prior to treatment.
On-treatment response should guide continued therapy [see Dosage and Administration (2.1) and Microbiology (12.4) ].
Tyzeka has not been evaluated in patients co-infected with HIV, HCV, or HDV.
Tyzeka has not been evaluated in liver transplant recipients or in patients with decompensated liver disease.
Tyzeka has not been studied in well-controlled trials for the treatment of patients with established nucleoside analog reverse transcriptase inhibitor-resistant hepatitis B virus infection, but is expected to be cross-resistant to lamivudine [see Microbiology (12.4) ].
The safety and efficacy of Tyzeka have not been evaluated in Black/African American or Hispanic patients [see Use in Specific Populations (8.9) ].
2 DOSAGE AND ADMINISTRATION

2.1 Adults and Adolescents (16 years of age and older)
Due to higher rates of resistance that may develop with longer term treatment among patients with incomplete viral suppression, treatment should only be initiated, if pre-treatment HBV DNA and ALT measurements are known, in the following patient populations:

For HBeAg-positive patients, HBV DNA should be less than 9 log10 copies per mL and ALT should be greater than or equal to 2x ULN prior to treatment with Tyzeka.

For HBeAg-negative patients, HBV DNA should be less than 7 log10 copies per mL prior to treatment with Tyzeka.

HBV DNA levels should be monitored at 24 weeks of treatment to assure complete viral suppression (HBV DNA less than 300 copies per mL). Alternate therapy should be initiated for patients who have detectable HBV DNA after 24 weeks of treatment. Optimal therapy should be guided by further resistance testing.

The recommended dose of Tyzeka for the treatment of chronic hepatitis B is 600 mg once daily, taken orally, with or without food.

Tyzeka oral solution (30 mL) may be considered for patients who have difficulty with swallowing tablets.
DOSAGE FORMS AND STRENGTHS

3.1 Tablets
Tyzeka (telbivudine) 600 mg tablets are white to slightly yellowish film-coated, ovaloid-shaped tablets, imprinted with "LDT" on one side.

3.2 Oral Solution
Tyzeka (telbivudine) oral solution is a clear, colorless to pale yellow, passion fruit flavored liquid. Tyzeka oral solution contains 100 mg of telbivudine per 5 milliliters. Therefore, 30 mL of the oral solution provides a 600 mg dose of telbivudine.

4 CONTRAINDICATIONS

Combination of Tyzeka with pegylated interferon alfa-2a is contraindicated because of increased risk of peripheral neuropathy [see Warnings and Precautions (5.4) and Drug Interactions (7) ].

5 WARNINGS AND PRECAUTIONS

5.1 Lactic Acidosis
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with antiretrovirals. Female gender, obesity, and prolonged nucleoside exposure may be risk factors. Particular caution should be exercised when administering HBV nucleoside analogue reverse transcriptase inhibitors to patients with known risk factors for liver disease; however, cases have also been reported in patients with no known risk factors. Treatment with Tyzeka should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations).

5.2 Exacerbations of Hepatitis B after Discontinuation of Treatment
Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including Tyzeka. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, resumption of anti-hepatitis B therapy may be warranted [see Adverse Reactions (6. 1 ) ].

5.3 Myopathy
Cases of myopathy/myositis have been reported with Tyzeka use several weeks to months after starting therapy. Myopathy has also been reported with some other drugs in this class. Rhabdomyolysis has been reported during postmarketing use of Tyzeka [see Adverse Reactions (6.2) ].

Uncomplicated myalgia has been reported in Tyzeka-treated patients [see Adverse Reactions (6 .1 ) ]. Myopathy, defined as persistent unexplained muscle aches and/or muscle weakness in conjunction with increases in creatine kinase (CK) values, should be considered in any patient with diffuse myalgias, muscle tenderness, or muscle weakness. Among patients with Tyzeka-associated myopathy, no pattern with regard to the degree or timing of CK elevations has been observed. In addition, the predisposing factors for the development of myopathy among Tyzeka recipients are unknown. Patients should be advised to report promptly unexplained muscle aches, pain, tenderness, or weakness. Tyzeka therapy should be interrupted if myopathy is suspected, and discontinued if myopathy is confirmed. It is unknown whether the risk of myopathy during treatment with drugs in this class is increased with concurrent administration of other drugs associated with myopathy, including but not limited to: corticosteroids, chloroquine, hydroxychloroquine, certain HMGCoA reductase inhibitors, fibric acid derivatives, penicillamine, zidovudine, cyclosporine, erythromycin, niacin, and certain azole antifungals. Physicians initiating concomitant treatment with any drug associated with myopathy should monitor patients closely for any signs or symptoms of unexplained muscle pain, tenderness, or weakness.

5.4 Peripheral Neuropathy
Peripheral neuropathy has been reported with Tyzeka alone or in combination with pegylated interferon alfa-2a and other interferons. In one clinical trial, an increased risk and severity of peripheral neuropathy was observed with the combination use of Tyzeka 600mg daily and pegylated interferon alfa-2a 180 micrograms once weekly compared to Tyzeka or pegylated interferon alfa-2a alone [see Contraindications (4) and Drug Interactions (7) ]. Such risk cannot be excluded for other dose regimens of pegylated interferon alfa-2a, or other alfa interferons (pegylated or standard). The safety and efficacy of Tyzeka in combination with pegylated interferons or other interferons for the treatment of chronic hepatitis B have not been demonstrated. Patients should be advised to report any numbness, tingling, and/or burning sensations in the arms and/or legs, with or without gait disturbance. Tyzeka therapy should be interrupted if peripheral neuropathy is suspected, and discontinued if peripheral neuropathy is confirmed [see Adverse Reactions (6. 1 ) ].

6 ADVERSE REACTIONS

The following adverse reactions are discussed in other sections of the labeling:

Lactic acidosis and severe hepatomegaly with steatosis [see Boxed Warning, Warnings and Precautions (5.1) ]
Severe acute exacerbations of hepatitis after discontinuation of treatment [see Boxed Warning, Warnings and Precautions (5.2) ]
Myopathy [see Warnings and Precautions (5.3) ]
Peripheral Neuropathy [see Warnings and Precautions (5.4) ]
DESCRIPTION

Tyzeka is the trade name for telbivudine, a synthetic thymidine nucleoside analogue with activity against hepatitis B virus (HBV). The chemical name for telbivudine is 1-((2S,4R,5S)-4-hydroxy-5-hydroxymethyltetrahydrofuran-2-y1)-5-methyl-1H-pyrimidine-2,4-dione, or 1-(2-deoxy-β-L-ribofuranosyl)-5-methyluracil. Telbivudine is the unmodified β-L enantiomer of the naturally occurring nucleoside, thymidine. Its molecular formula is C10 H14 N2 O5 , which corresponds to a molecular weight of 242.23.
Telbivudine is a white to slightly yellowish powder. Telbivudine is sparingly soluble in water (greater than 20 mg per mL), and very slightly soluble in absolute ethanol (0.7 mg per mL) and n-octanol (0.1 mg per mL).

Tyzeka film-coated tablets are available for oral administration in 600 mg strength. Tyzeka 600 mg film-coated tablets contain the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. The tablet coating contains titanium dioxide, polyethylene glycol, talc, and hypromellose.

Tyzeka oral solution is available for oral administration in 100 mg per 5 mL strength. Tyzeka oral solution contains the following inactive ingredients: citric acid anhydrous, benzoic acid, passion fruit flavor, sodium saccharin, sodium hydroxide, and purified water. A 600 mg dose (30 mL) of Tyzeka oral solution contains approximately 47 mg of sodium.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action
Tyzeka is an antiviral drug
Microbiology
Mechanism of Action

Telbivudine is a synthetic thymidine nucleoside analogue with activity against HBV DNA polymerase. It is phosphorylated by cellular kinases to the active triphosphate form, which has an intracellular half-life of 14 hours. Telbivudine 5′-triphosphate inhibits HBV DNA polymerase (reverse transcriptase) by competing with the natural substrate, thymidine 5′-triphosphate. Incorporation of telbivudine 5′-triphosphate into viral DNA causes DNA chain termination. Telbivudine is an inhibitor of both HBV first strand (EC50 value = 1.3 � 1.6 micromolar) and second strand synthesis (EC50 value = 0.2 � 0.2 micromolar). Telbivudine 5′-triphosphate at concentrations up to 100 micromolar did not inhibit human cellular DNA polymerases α, β, or γ. No appreciable mitochondrial toxicity was observed in HepG2 cells treated with telbivudine at concentrations up to 10 micromolar.

Antiviral Activity

The antiviral activity of telbivudine was assessed in the HBV-expressing human hepatoma cell line 2.2.15, as well as in primary duck hepatocytes infected with duck hepatitis B virus. The concentration of telbivudine that effectively inhibited 50% of viral DNA synthesis (EC50 ) in both systems was approximately 0.2 micromolar. The anti-HBV activity of telbivudine was additive with adefovir in cell culture, and was not antagonized by the HIV NRTIs didanosine and stavudine. Telbivudine was not antagonistic to the anti-HIV activity of abacavir, didanosine, emtricitabine, lamivudine, stavudine, tenofovir, or zidovudine. Transient reductions in HIV-1 RNA have been seen in some patients after administration of telbivudine in the absence of antiretroviral therapy. The clinical significance of these reductions has not been determined.

NDC 00078-0538-15 UPC/GTIN No.3-00780-53815-2 Mfg.Part No.53815 TELBIVUDINE ORAL
RX ITEM-Tyzeka 600Mg Tab 30 By Novartis
NDC 00078-0538-15 UPC/GTIN No.3-00780-53815-2 Mfg.Part No.53815 TELBIVUDINE ORAL

BRAND: TYZEKA NDC: 00078-0538-15,78053815 UPC: 3-00780-53815-2,300780538152 Novartis Pharma Corp
Tyzeka 600Mg Tab 30 By Novartis
BRAND: TYZEKA NDC: 00078-0538-15,78053815 UPC: 3-00780-53815-2,300780538152 Novartis Pharma Corp

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
TELBIVUDINE ORAL TABLET 6
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
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Want to do Research on this Med or need a large quantity? Email Details with quantity required to:[email protected]

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
AmericanPharmaWholesale.com
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.