Natalvirt FLT

Virtus Pharmaceuticals LLC

NATALVIRT™ FLT

FULL PRESCRIBING INFORMATION: CONTENTS*

• NATALVIRT FLT DESCRIPTION
• CLINICAL PHARMACOLOGY
• NATALVIRT FLT INDICATIONS AND USAGE
• NATALVIRT FLT CONTRAINDICATIONS
• WARNING
• PRECAUTIONS
• NATALVIRT FLT ADVERSE REACTIONS
• DRUG INTERACTIONS
• OVERDOSAGE
• NATALVIRT FLT DOSAGE AND ADMINISTRATION
• NOTICE
• HOW SUPPLIED
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

90 mg Dual-Iron Delivery

NATALVIRT FLT DESCRIPTION

Each green film-coated tablet for oral administration contains:

Inactive Ingredients: Citric Acid, Croscarmellose Sodium, Fumed Silica, Green Color Coating (FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Yellow #5 Aluminum Lake, Hydroxypropylmethyl Cellulose, Polyvinyl Alcohol, Talc, Titanium Dioxide, Triacetin), Magnesium Stearate, Microcrystalline Cellulose, Pregelatinized Starch, Stearic Acid and TriPotassium Citrate.

This product contains FD&C Yellow No. 5 (tartrazine) Aluminum Lake.

This product has been manufactured in a facility that also manufactures products containing tree nuts, peanuts, fish, shellfish, milk, eggs, wheat, and soy. Individuals with allergic tendencies to these substances should use discretion.

CLINICAL PHARMACOLOGY

Oral iron is absorbed most efficiently when administered between meals. Iron is critical for normal hemoglobin synthesis, to maintain oxygen transport, energy production and proper function of cells. Adequate amounts of iron are necessary for effective erythropoiesis. Iron also serves as a cofactor of several essential enzymes, including cytochromes, which are involved in electron transport. Folic acid is required for nucleoprotein synthesis and the maintenance of normal erythropoiesis. Folic acid is the precursor of tetrahydrofolic acid, which is involved as a cofactor for transformylation reactions in the biosynthesis of purines and thymidylates of nucleic acids. Deficiency of folic acid may account for the defective deoxyribonucleic acid (DNA synthesis) that leads to megaloblast formation and megaloblastic macrocytic anemias. Vitamin B12 is essential to growth, cell reproduction, hematopoiesis, nucleic acid, and myelin synthesis. Deficiency may result in megaloblastic anemia or pernicious anemia.

NATALVIRT FLT INDICATIONS AND USAGE

NATALVIRT™ FLT is indicated for the treatment of all anemias that are responsive to oral iron therapy. These include: hypochromic anemia associated with pregnancy, chronic and/or acute blood loss, metabolic disease, post-surgical convalescence, and dietary needs.

NATALVIRT FLT CONTRAINDICATIONS

Hypersensitivity to any of the ingredients. Hemolytic anemia, hemochromatosis, and hemosiderosis are contraindications to iron therapy.

WARNING

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B₁₂ is deficient.

PRECAUTIONS

General: Take 2 hours after meals. Do not exceed recommended dose. Discontinue use if symptoms of intolerance appear. The type of anemia and underlying cause or causes should be determined before starting therapy with NATALVIRT™ FLT tablets. Ensure Hgb, Hct, reticulocyte count are determined before starting therapy and periodically thereafter during prolonged treatment. Periodically review therapy to determine if it needs to be continued without change or if a dose change is indicated. This product contains FD&C Yellow No. 5 (tartrazine) Aluminum Lake which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons.

Although the overall incidence of FD&C Yellow No. 5 (tartrazine) Aluminum Lake sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

Folic Acid: Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Pernicious anemia should be excluded before using this product since folic acid may mask the symptoms of pernicious anemia.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: Dosing for elderly patients should be cautious. Due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy, dosing should start at the lower end of the dosing range.

NATALVIRT FLT ADVERSE REACTIONS

Adverse reactions with iron therapy may include GI irritation, constipation, diarrhea, nausea, vomiting, and dark stools. Adverse reactions with iron therapy are usually transient. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

DRUG INTERACTIONS

Prescriber should be aware of a number of iron/drug interactions, including antacids, tetracyclines, or fluoroquinolones.

OVERDOSAGE

Symptoms: abdominal pain, metabolic acidosis, anuria, CNS damage, coma, convulsions, death, dehydration, diffuse vascular congestion, hepatic cirrhosis, hypotension, hypothermia, lethargy, nausea, vomiting, diarrhea, tarry stools, melena, hematemesis, tachycardia, hyperglycemia, drowsiness, pallor, cyanosis, lassitude, seizures, and shock.

NATALVIRT FLT DOSAGE AND ADMINISTRATION

One tablet daily or as directed by a physician.

NOTICE

Contact with moisture can discolor or erode the tablet.

Do not chew tablet.

HOW SUPPLIED

NATALVIRT™ FLT (NDC 76439-247-90) is a green, rectangle shaped, film-coated tablet, debossed with “576” on one side and blank on the other, and packaged in bottles of 90. Store at 25°C (77°F). Excursions permitted to 15°- 30°C (59°-86°F). (See USP Controlled Room Temperature).

To report a serious adverse event or obtain product information, call (813) 283-1344.

KEEP THIS OUT OF REACH OF CHILDREN.

This is not an Orange Book product.

All prescriptions using this product should be pursuant to state statutes as applicable.

R_x Only

VIRTUS
PHARMACEUTICALS

Manufactured for:
Virtus Pharmaceuticals, LLC
Tampa, FL 33619

Made in Canada

Revised 4/13

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VIRTUS
PHARMACEUTICALS

NDC 76439-247-90

NATALVIRT^TM FLT
90 mg Dual-Iron Delivery

R_x Only

90 Coated Tablets