Lamivudine And Tenofovir Disoproxil Fumarate
Generic Name: lamivudine and tenofovir disoproxil fumarate
Brand Names:
Cimduo
11 DESCRIPTION CIMDUO tablets contain lamivudine (also known as 3TC), a synthetic nucleoside analogue with activity against HIV-1 and tenofovir disoproxil fumarate or tenofovir DF, a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester prodrug of tenofovir. In vivo tenofovir DF is converted to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5’-monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase.
Overview
11 DESCRIPTION CIMDUO tablets contain lamivudine (also known as 3TC), a synthetic nucleoside analogue with activity against HIV-1 and tenofovir disoproxil fumarate or tenofovir DF, a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester prodrug of tenofovir. In vivo tenofovir DF is converted to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5’-monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase.
Uses
1 INDICATIONS AND USAGE CIMDUO ® (lamivudine and tenofovir disoproxil fumarate) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg. CIMDUO is a two-drug combination of lamivudine (3TC) and tenofovir disoproxil fumarate (TDF), both nucleo(t)side reverse transcriptase inhibitors and is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION • Testing: Prior to initiation and during treatment with CIMDUO, patients should be tested for hepatitis B virus infection, and estimated creatinine clearance, urine glucose, and urine protein should be obtained. ( 2.1 ) • Recommended dose: One tablet taken orally once daily with or without food. ( 2.2 ) • Renal Impairment: Not recommended in patients with CrCL less than 50 mL/min or patients with end-stage renal disease requiring hemodialysis. ( 2.3 ) 2.1 Testing Prior to Initiation and During Treatment with CIMDUO Prior to initiation of CIMDUO, test patients for hepatitis B virus infection [see Warnings and Precautions (5.2) ] .
Side Effects
6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: • Lactic Acidosis/Severe Hepatomegaly with Steatosis [see Warnings and Precautions (5.1) ] . • Exacerbations of Hepatitis B [see Boxed Warning , Warnings and Precautions (5.2) ] . • New Onset or Worsening Renal Impairment [see Warnings and Precautions (5.3) ] . • Hepatic Decompensation in Patients Co-infected with HIV-1 and Hepatitis C [see Warnings and Precautions (5.4) ] . • Pancreatitis [see Warnings and Precautions (5.5) ] . • Decreases in Bone Mineral Density [see Warnings and Precautions (5.6) ] . • Immune Reconstitution Syndrome [see Warnings and Precautions (5.7) ] . • Fat Redistribution [see Warnings and Precautions (5.8) ] .
Interactions
7 DRUG INTERACTIONS • Atazanavir: Atazanavir should be coadministered with ritonavir when coadministered with CIMDUO. ( 7.2 ) • HIV-1 Protease Inhibitors: Monitor for evidence of tenofovir toxicity when CIMDUO is coadministrated with atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir. ( 7.2 ) • Sorbitol: Avoid chronic administration of sorbitol with CIMDUO.( 7.5 ) 7.1 Drugs Affecting Renal Function Since tenofovir is primarily eliminated by the kidneys [see Clinical Pharmacology (12.3) ] , coadministration of CIMDUO with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of tenofovir and/or increase the concentrations of other renally eliminated drugs.
Warnings
WARNING: POST TREATMENT ACUTE EXACERBATIONS OF HEPATITIS B Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued lamivudine or tenofovir disoproxil fumarate, components of CIMDUO. Monitor hepatic function closely in these patients and, if appropriate, initiate anti-hepatitis B treatment [see Warnings and Precautions (5.2) ]. 5 WARNINGS AND PRECAUTIONS • Lactic Acidosis/Severe Hepatomegaly with Steatosis: Discontinue treatment in patients who develop symptoms or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity. ( 5.1 ) • New Onset or Worsening Renal Impairment: Can include acute renal failure and Fanconi syndrome. Assess estimated creatinine clearance before initiating treatment with tenofovir disoproxil fumarate, a component of CIMDUO. In patients at risk for renal dysfunction, assess estimated creatinine clearance, serum phosphorus, urine glucose and urine protein before initiating treatment with tenofovir and periodically during treatment. Avoid administering CIMDUO with concurrent or recent use of nephrotoxic drugs. 4 CONTRAINDICATIONS CIMDUO is contraindicated in patients with a previous hypersensitivity reaction to any of the components contained in the formulation. • CIMDUO is contraindicated in patients with previous hypersensitivity to any of the components of this product. ( 4 )
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to CIMDUO during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from the APR show no difference in the risk of overall major birth defects for 3TC compared to the background rate for major birth defects of 2.7% in the U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP) (see Data ) .
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING CIMDUO (lamivudine and tenofovir disoproxil fumarate) tablets 300 mg/300 mg are white to off-white, film-coated, oval tablets debossed with “ M112 ” on one side and plain on the other side.
Frequently Asked Questions
What is Lamivudine And Tenofovir Disoproxil Fumarate used for?▼
1 INDICATIONS AND USAGE CIMDUO ® (lamivudine and tenofovir disoproxil fumarate) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg. CIMDUO is a two-drug combination of lamivudine (3TC) and tenofovir disoproxil fumarate (TDF), both nucleo(t)side reverse transcriptase inhibitors and is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg. ( 1 )
What are the side effects of Lamivudine And Tenofovir Disoproxil Fumarate?▼
6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: • Lactic Acidosis/Severe Hepatomegaly with Steatosis [see Warnings and Precautions (5.1) ] . • Exacerbations of Hepatitis B [see Boxed Warning , Warnings and Precautions (5.2) ] . • New Onset or Worsening Renal Impairment [see Warnings and Precautions (5.3) ] . • Hepatic Decompensation in Patients Co-infected with HIV-1 and Hepatitis C [see Warnings and Precautions (5.4) ] . • Pancreatitis [see Warnings and Precautions (5.5) ] . • Decreases in Bone Mineral Density [see Warnings and Precautions (5.6) ] . • Immune Reconstitution Syndrome [see Warnings and Precautions (5.7) ] . • Fat Redistribution [see Warnings and Precautions (5.8) ] .
Can I take Lamivudine And Tenofovir Disoproxil Fumarate during pregnancy?▼
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to CIMDUO during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from the APR show no difference in the risk of overall major birth defects for 3TC compared to the background rate for major birth defects of 2.7% in the U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP) (see Data ) .
What are the important warnings for Lamivudine And Tenofovir Disoproxil Fumarate?▼
WARNING: POST TREATMENT ACUTE EXACERBATIONS OF HEPATITIS B Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued lamivudine or tenofovir disoproxil fumarate, components of CIMDUO. Monitor hepatic function closely in these patients and, if appropriate, initiate anti-hepatitis B treatment [see Warnings and Precautions (5.2) ]. 5 WARNINGS AND PRECAUTIONS • Lactic Acidosis/Severe Hepatomegaly with Steatosis: Discontinue treatment in patients who develop symptoms or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity. ( 5.1 ) • New Onset or Worsening Renal Impairment: Can include acute renal failure and Fanconi syndrome. Assess estimated creatinine clearance before initiating treatment with tenofovir disoproxil fumarate, a component of CIMDUO. In patients at risk for renal dysfunction, assess estimated creatinine clearance, serum phosphorus, urine glucose and urine protein before initiating treatment with tenofovir and periodically during treatment. Avoid administering CIMDUO with concurrent or recent use of nephrotoxic drugs. 4 CONTRAINDICATIONS CIMDUO is contraindicated in patients with a previous hypersensitivity reaction to any of the components contained in the formulation. • CIMDUO is contraindicated in patients with previous hypersensitivity to any of the components of this product. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.