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Rx Item-Symfi Lo Tab 30 By Mylan Specialty

SYMFI LO- efavirenz, lamivudine and tenofovir disoproxil fumarate tablet, film coated Rx Item-Symfi Lo Lamivud/Tenofovir Df/Efavir Tab 30 By Mylan Specialty Item No.:3733845 Rx733845 NDC No.: 49502-0425-93 49502-425-93 4950242593 49502042593 UPC No.: 3-49502-42593-6 349502-425936 34950Fexofenadine 60 Mg Tab 100 Ud By Mylan Institutional/PgnFEXOFENADINE 60 MG TAB 100 UD

Rx Item-Symfi Lo Tab 30 By Mylan Specialty

$1961.33$1649.00

Rx Item-Symfi Lo Lamivud/Tenofovir Df/Efavir Tab 30 By Mylan Specialty Item No.:3733845 Rx733845 NDC No.: 49502-0425-93 49502-425-93 4950242593 49502042593 UPC No.: 3-49502-42593-6 349502-425936 349502425936 1 Item Description: Gnrc Other Name: Therapeutic Code: Therapeutic Class: DEA Class: Zero, Non Controlled Category: Rx Item-Symfi Lo Tab 30 By Mylan Specialty Common Group: Gnrc Item Form:Tab MPN No.:593 Generic Str Code: More Detail: Tab Item Ext Desc:

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For: HIV Infection

Symfi (efavirenz, lamivudine and tenofovir disoproxil fumarate) is a three-drug combination of a non-nucleoside reverse transcriptase inhibitor (efavirenz), and two nucleo(t)side reverse transcriptase inhibitors (lamivudine and tenofovir disoproxil fumarate) indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. SYMFI LO- efavirenz, lamivudine and tenofovir disoproxil fumarate tablet, film coated
BOXED WARNING(WHAT IS THIS?)
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, two components of SYMFI LO. Monitor hepatic function closely in these patients and, if appropriate, initiate anti-hepatitis B treatment [see WARNINGS AND PRECAUTIONS (5.2)].

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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use SYMFI LO safely and effectively. See full prescribing information for SYMFI LO.

SYMFI LO� (efavirenz, lamivudine and tenofovir disoproxil fumarate) tablets, for oral use
Initial U.S. Approval: 2018
WARNING: POST TREATMENT ACUTE EXACERBATONS OF HEPATITIS B SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.

Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with HBV and human immunodeficiency virus (HIV-1) and have discontinued lamivudine and tenofovir disoproxil fumarate. Monitor hepatic function closely in these patients and, if appropriate, initiate anti-hepatitis B treatment. (5.2)
INDICATIONS AND USAGE
SYMFI LO is three-drug combination of efavirenz (EFV), a non-nucleoside reverse transcriptase inhibitor, and lamivudine (3TC) and tenofovir disoproxil fumarate (TDF), both nucleo(t)side reverse transcriptase inhibitors and is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg. (1)

DOSAGE AND ADMINISTRATION

Testing: Prior to initiation and during treatment with SYMFI LO, 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 on an empty stomach, preferably at bedtime. ( 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)

Hepatic Impairment: Not recommended for patients with moderate or severe hepatic impairment. Use caution in patients with mild hepatic impairment. ( 2.4)
DOSAGE FORMS AND STRENGTHS
Tablets: 400 mg efavirenz, 300 mg lamivudine and 300 mg tenofovir disoproxil fumarate (equivalent to 245 mg of tenofovir disoproxil). (3)

CONTRAINDICATIONS

SYMFI LO is contraindicated in patients with previous hypersensitivity (e.g., Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of this product. ( 4)

Coadministration with elbasvir/grazoprevir. ( 4)
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 SYMFI LO. 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 SYMFI LO with concurrent or recent use of nephrotoxic drugs. ( 5.4)

Serious Psychiatric Symptoms: Immediate medical evaluation is recommended for serious psychiatric symptoms such as severe depression or suicidal ideation. ( 5.5)

Nervous System Symptoms (NSS): NSS are frequent, usually begin 1 to 2 days after initiating therapy and resolve in 2 to 4 weeks. Dosing at bedtime may improve tolerability. NSS are not predictive of onset of psychiatric symptoms. ( 5.6)

Rash: Rash usually begins within 1 to 2 weeks after initiating therapy and resolves within 4 weeks. Discontinue if severe rash develops. ( 5.9)

Hepatotoxicity: Monitor liver function tests before and during treatment in patients with underlying hepatic disease, including hepatitis B or C coinfection, marked transaminase elevations, or who are taking medications associated with liver toxicity. Among reported cases of hepatic failure, a few occurred in patients with no pre-existing hepatic disease. ( 5.9, 8.7)

Hepatic decompensation, some fatal, has occurred in HIV-1/HCV co-infected patients receiving combination antiretroviral therapy and interferon and ribavirin-based regimens. Monitor for treatment-associated toxicities. Discontinue SYMFI LO, as medically appropriate, and consider dose reduction or discontinuation of interferon alfa, ribavirin, or both. ( 5.10)

Pancreatitis: Use with caution in pediatric patients with a history of pancreatitis or other significant risk factors for pancreatitis. Discontinue SYMFI LO as clinically appropriate. ( 5.11)

Convulsions: Use caution in patients with a history of seizures. ( 5.12)

Lipids: Total cholesterol and triglyceride elevations. Monitor before therapy and periodically thereafter. ( 5.13)

Decreases in Bone Mineral Density (BMD): Observed in HIV-infected patients. Consider assessment of BMD in patients with a history of pathologic fracture or other risk factors for osteoporosis or bone loss. ( 5.14)

Immune Reconstitution Syndrome: Observed in HIV-infected patients. May necessitate further evaluation and treatment. ( 5.15)

Redistribution/Accumulation of Body Fat: Observed in HIV-infected patients receiving antiretroviral combination therapy. ( 5.16)
ADVERSE REACTIONS

Most common adverse reactions (> 5% with SYMFI LO) are rash and dizziness. ( 6)
To report SUSPECTED ADVERSE REACTIONS, contact Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or WWW.FDA.GOV/MEDWATCH.

DRUG INTERACTIONS

SYMFI LO should not be administered with other antiretroviral medications for the treatment of HIV-1 infection. ( 7.1)

Coadministration of SYMFI LO can alter the concentrations of other drugs and other drugs may alter the concentration of SYMFI LO. The potential for drug-drug interactions should be considered before and during therapy. ( 5.3, 7)
USE IN SPECIFIC POPULATIONS

Pregnancy: Women should avoid pregnancy during EFV therapy, a component of SYMFI LO, and for 12 weeks after discontinuation. ( 5.7, 8.1, 8.3)

Lactation: Breastfeeding not recommended due to potential for HIV transmission. ( 8.2)

Females and Males of Reproductive Potential: Pregnancy testing and contraception are recommended. ( 8.3)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 2/2018

SYMFI LO- efavirenz, lamivudine and tenofovir disoproxil fumarate tablet, film coated
SYMFI LO- n
SYMFI LO- efavirenz, lamivudine and tenofovir disoproxil fumarate tablet, film coated

Rx Item-Symfi Lo Lamivud/Tenofovir Df/Efavir Tab 30 By Mylan Specialty Item No.:3733845 Rx733845 NDC No.: 49502-0425-93 49502-425-93 4950242593 49502042593 UPC No.: 3-49502-42593-6 349502-425936 34950
SYMFI LO- n
Rx Item-Symfi Lo Lamivud/Tenofovir Df/Efavir Tab 30 By Mylan Specialty Item No.:3733845 Rx733845 NDC No.: 49502-0425-93 49502-425-93 4950242593 49502042593 UPC No.: 3-49502-42593-6 349502-425936 34950

Fexofenadine 60 Mg Tab 100 Ud By Mylan Institutional/Pgn
Fexofenadine 60 Mg Tab 100 Ud
Fexofenadine 60 Mg Tab 100 Ud By Mylan Institutional/Pgn

FEXOFENADINE 60 MG TAB 100 UD
FEXOFENADINE 60 MG TAB 100 UD
FEXOFENADINE 60 MG TAB 100 UD