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INDICATIONS
ARBLI is an angiotensin II receptor blocker (ARB) indicated for:

• Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
• Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients.
• Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension.

CONTRAINDICATIONS
ARBLI is contraindicated in patients who are hypersensitive to any component of this product.  ARBLI is also contraindicated for co-administration with aliskiren in patients with diabetes. 

WARNINGS AND PRECAUTIONS
Fetal Toxicity: ARBLI can cause fetal harm when administered to a pregnant woman. When pregnancy is detected, discontinue ARBLI as soon as possible
Hypotension: In patients with an activated renin-angiotensin system, such as volume- or salt-depleted patients, symptomatic hypotension may occur after initiation of treatment with ARBLI.  Correct volume or salt depletion prior to administration of ARBLI.
Renal Function Deterioration:  Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute renal failure on ARBLI.  Monitor renal function and potassium in susceptible patients.
Hyperkalemia: Monitor serum potassium periodically and treat appropriately. Dosage reduction or discontinuation of ARBLI may be required.  Concomitant use of other drugs that may increase serum potassium may lead to hyperkalemia.

ADVERSE REACTIONS
The most common adverse reactions (incidence ≥2% and greater than placebo) are: dizziness, upper respiratory infection, nasal congestion, and back pain.

DRUG INTERACTIONS
Agents Increasing Serum Potassium: Risk of hyperkalemia; monitor serum potassium.
Lithium: Risk of lithium toxicity.
NSAIDs Including COX-2 Inhibitors: Increased risk of renal impairment and reduced diuretic, natriuretic, and antihypertensive effects.
Dual Blockade of the Renin-Angiotensin System: Increased risk of renal impairment, hypotension, syncope, and hyperkalemia. Do not co-administer aliskiren with losartan in patients with diabetes or renal impairment.

USE IN SPECIFIC POPULATIONS

Pregnancy
ARBLI can cause fetal harm when administered to a pregnant woman. Use of drugs that act directly on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. When pregnancy is detected, discontinue losartan as soon as possible.

Lactation
Advise not to breastfeed during treatment with ARBLI and for 2 days after the last dose.

Pediatric Patients
Antihypertensive effects of ARBLI have been established in hypertensive pediatric patients aged 6 to 16 years. ARBLI is not recommended in pediatric patients less than 2 years of age or in pediatric patients with glomerular filtration rate less than 30 mL/min/1.73 m².

Hepatic Impairment
For patients with mild-to-moderate hepatic impairment the recommended starting dose is 25 mg once daily. Not studied in patients with severe hepatic impairment.

This Important Safety Information does not include all of the information needed to use ARBLI safely and effectively.  Please see Full Prescribing Information, including BOXED WARNING.

To report SUSPECTED ADVERSE REACTIONS, contact Scienture, LLC at 1-833-754-4917 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.