Please email us at Sales@AmericanPharmaWholesale.com with our item No, NDC#,UPC#or best is product link. We are located in Oceanside, California. Search over 100,000 items by Name, Item No., NDC, UPC (without dashes) or by Mfg.Name.
Menu

Rx Item-Symfi 600Mg/300Mg/300mg Tab 30 By Mylan Specialty

SYMFI 600MG/300MG/300MG TAB 30 BY MYLAN SPECIALTY NDC Code(s): 49502-475-93
Packager: Mylan Specialty L.P.
Category: HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule: None
Marketing Status: New Drug AppSYMFI LO- efavirenz, lamivudine and tenofovir disoproxil fumarate tablet, film coated Rx Item-Symfi 600Mg/300Mg/300mg Tab 30 By Mylan Specialty Item No.:3744854 Rx744854 NDC No.: 49502-0475-93 49502-475-93 49502047593 4950247593 UPC No.: 3-49502-47593-1 349502-475931 349502475931 Item Symfi 600Mg/300Mg/300mg Tab 30 By Mylan SpecialtySYMFI LO- efavirenz, lamivudine and tenofovir disoproxil fumarate tablet, film coated

Rx Item-Symfi 600Mg/300Mg/300mg Tab 30 By Mylan Specialty

$1961.33$1649.00

Rx Item-Symfi 600Mg/300Mg/300mg Tab 30 By Mylan Specialty Item No.:3744854 Rx744854 NDC No.: 49502-0475-93 49502-475-93 49502047593 4950247593 UPC No.: 3-49502-47593-1 349502-475931 349502475931 Item Description: Gnrc Other Name:Therapeutic Code: 040800 Therapeutic Class: DEA Class: Zero, Non Controlled Category: Rx Item- Common Group: Gnrc Item Form:Tab MPN No.:5931 Generic Str Code: More Detail: Tab Item Ext Desc:

Have a question?

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. Generic Name: LAMIVUD/TENOFOVIR DF/EFAVIR
Description: SYMFI TB 300-300-600MG 30 CPLT
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. Monitor hepatic function closely in these patients and, if appropriate, initiate anti-hepatitis B treatment [see WARNINGS AND PRECAUTIONS (5.2)].

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

SYMFI� (efavirenz, lamivudine and tenofovir disoproxil fumarate) tablets, for oral use
Initial U.S. Approval: 2018
WARNING: POST TREATMENT ACUTE EXACERBATIONS 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 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 40 kg. (1)

DOSAGE AND ADMINISTRATION

Testing: Prior to initiation and during treatment with SYMFI, 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: 600 mg efavirenz, 300 mg lamivudine and 300 mg tenofovir disoproxil fumarate (equivalent to 245 mg of tenofovir disoproxil). (3)

CONTRAINDICATIONS

SYMFI 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. 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 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. ( 5.8)

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, 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 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 are impaired concentration, abnormal dreams, headache, nausea, malaise and fatigue, nasal signs and symptoms, diarrhea, rash, dizziness, insomnia, pain, depression, asthenia, and cough. ( 6)
To report SUSPECTED ADVERSE REACTIONS, contact Mylan 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 should not be administered with other antiretroviral medications for the treatment of HIV-1 infection. ( 7.1)

Coadministration of SYMFI can alter the concentrations of other drugs and other drugs may alter the concentration of SYMFI. 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, 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: 3/2018

SYMFI 600MG/300MG/300MG TAB 30 BY MYLAN SPECIALTY NDC Code(s): 49502-475-93
Packager: Mylan Specialty L.P.
Category: HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule: None
Marketing Status: New Drug App
SYMFI 600MG/300MG/300MG TAB 30
SYMFI 600MG/300MG/300MG TAB 30 BY MYLAN SPECIALTY NDC Code(s): 49502-475-93 Packager: Mylan Specialty L.P. Category: HUMAN PRESCRIPTION DRUG LABEL DEA Schedule: None Marketing Status: New Drug App

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 600Mg/300Mg/300mg Tab 30 By Mylan Specialty Item No.:3744854 Rx744854 NDC No.: 49502-0475-93 49502-475-93 49502047593 4950247593 UPC No.: 3-49502-47593-1 349502-475931 349502475931 Item
SYMFI 600MG/300MG/300MG TAB 30
Rx Item-Symfi 600Mg/300Mg/300mg Tab 30 By Mylan Specialty Item No.:3744854 Rx744854 NDC No.: 49502-0475-93 49502-475-93 49502047593 4950247593 UPC No.: 3-49502-47593-1 349502-475931 349502475931 Item

Symfi 600Mg/300Mg/300mg Tab 30 By Mylan Specialty
Symfi 600Mg/300Mg/300mg Tab 30
Symfi 600Mg/300Mg/300mg Tab 30 By Mylan Specialty

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