EnLyte

JayMac Pharmaceuticals

EnLyte with DeltaFolate™ ADVANCED FOLATE SUPPLEMENT

FULL PRESCRIBING INFORMATION: CONTENTS*

• ENLYTE DESCRIPTION
• INGREDIENTS
  • Other Ingredients
• FOLATE REGULATION
• ENLYTE INDICATIONS AND USAGE
• ENLYTE CONTRAINDICATIONS
• WARNING
• WARNING
• DRUG INTERACTIONS
• ENLYTE ADVERSE REACTIONS
• ENLYTE DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
  • STORAGE
• PRINCIPAL DISPLAY PANEL - 30 Capsule Label

FULL PRESCRIBING INFORMATION

R_x Only

Prescription Vitamin with other Dietary Ingredients

ENLYTE DESCRIPTION

EnLyte^® is an orally administered prescription vitamin containing other dietary ingredients specifically formulated to meet the distinct nutritional requirements of patients who are in need of increased folate levels. EnLyte^® may be administered only under the supervision of a licensed medical practitioner.

INGREDIENTS

Each annatto-colored, oval softgel capsule contains the following ingredients with piperine Piperine as BioPerine^® is a registered trademark of Sabinsa Corporation, Piscataway, NJ. It is protected and manufactured under U.S. Patent Nos. 5,536,506, 5,744,161, 5,972,382; and 6,054,585. added for bioavailability enhancement:

DeltaFolate™ Whole-B™, CitraFerr™, and DeltaFolate™ are trademarks of Captiva Pharma, LLC (Fort Myers, Florida, USA). Complex (8.73 mg total folate):
L-methylfolate glucosamine L-methylfolate as Quatrefolic® is a registered trademark of Gnosis S.p.A. (Milan, Italy). Quatrefolic® is the glucosamine salt and metabolically active pure 6(S) isomer of l-methylfolate, and has CAS #1181972-37-1, and has less than 1% d-methylfolate (inactive form). It is protected under U.S. Patent No. 7,947,662.	3.83 mg
Folinic acid calcium (formyl-THF calcium)	2.4 mg
Folacin (citrated pteroylglutamic acid)	2.5 mg
CitraFerr™Based on patient weight of 50 kg Iron Metabolite Complex:
Ferrous gluconate chelate Ferrous gluconate iron-amino acid chelate complex as AminoFerr™ is a trademark of Viva Pharmaceutical, Inc. (Richmond, BC, Canada), and is manufactured under U.S. Patent No. 7,341,708. (1.5 mg elemental iron)	13.6 mg
Calcium ascorbate (vitamin C)	21 mg
Calcium threonate (metabolite)	5 mg
Conjugated PS-DHA PS-DHA, or conjugated phosphatidylserine-docosahexaenoic acid, as Sharp-PS® GOLD is a registered trademark of Enzymotec, Ltd (Israel). It is protected under U.S. Patent Nos. 7,935,365 and 5,965,413.	40 mg
Whole-B™ Based on patient weight of 50 kg Reduced B Vitamin Complex:
Thiamine pyrophosphate (vitamin B1)	25 mcg
Flavin adenine dinucleotide (vitamin B2)	25 mcg
Nicotinamide adenine dinucleotide (vitamin B3)	25 mcg
Pyridoxal 5' phosphate (vitamin B6)	25 mcg
Adenosylcobalamin as cobamamide (vitamin B12)	25 mcg
Methylcobalamin (vitamin B12)	25 mcg

Other Ingredients

Annatto (color), Citric Acid, Gelatin (bovine), Glycerin, Lecithin, Natural Orange Flavor, Piperine, Purified Water, Soybean Oil, TriPotassium Citrate, and Yellow Bees Wax.

This product also contains fish, soy, and bovine gelatin.

This product is gluten-free. No artificial ingredients were used in flavoring. No dyes were used in coloring.

FOLATE REGULATION

The term "folate" are B vitamins that include folic acid and any forms of active pteroylglutamates regardless of the reduction state of the molecule. The folic acid in EnLyte^® is uniquely formulated with citrate buffers to achieve optimum absorption at the proximal jejunum. Folates, or vitamin B₉, are primarily hydrolyzed in the intestinal jejunum and the liver to the active circulating form of folate, l-methylfolate, with an intermediate stable form, 5,10-methylenetetrahydrofolate. Individuals with genetic polymorphisms for the genes coding methylenetetrahydrofolate reductase (MTHFR) may not be capable of utilizing or metabolizing folic acid adequately for the vitamin B₁₂ dependent methylation cycle.

Folic acid, or any form of folate other than l-methylfolate – such as folinic acid, may obscure pernicious anemia above 0.1 mg doses, and must be administered under a physician's supervision. The 1971, 1972, 1973, 1980, 1984, 2000, and 2010 Federal Register Notices addressed this concern - while establishing that increased folate was proper therapy in megoblastic anemias; specifically where homocysteine levels were elevated or risk of neural tube defects (NTDs) was at issue.

The Federal Register Notice of August 2, 1973 (38 FR 20750) states that:

•  Dietary supplement preparations are available without a prescription (21 CFR 121.1134). Levels higher than dietary supplement amounts are available only with a prescription.

Folic acid, or any form of folate other than l-methylfolate – such as folinic acid, may obscure pernicious anemia above 0.1 mg doses, and must be administered under a physician's supervision.

Folic acid may be added to medical foods – as defined in section 5(b)(3) of the Orphan Drug Act (21 USC 360ee(b)(3)), or to food (21 CFR 172.345).

ENLYTE INDICATIONS AND USAGE

EnLyte^® is indicated as adjuvant therapy for depressed patients in need of increased folate levels.

This product may be used in stand-alone therapy or alongside traditional anti-depressant therapy where increased folate levels are needed.

ENLYTE CONTRAINDICATIONS

EnLyte^® is contraindicated in patients with a known hypersensitivity to any of the ingredients.

WARNING

Daily ingestion of more than 3 grams per day of omega-3 fatty acids (ALA, EPA, and DHA) from fish oils may have potential antithrombotic activities, or effects, and may increase bleeding times. Administration of omega-3 fatty acids, including DHA, should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants. Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

Caution is recommended in patients with a history of bipolar illness. Patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder since mood elevation in this population is possible.

Formyl-THF may enhance the toxicity of fluorouracil. Deaths from severe enterocolitis, diarrhea, and dehydration have been reported in elderly patients receiving weekly formyl-THF and fluorouracil. Concomitant granulocytopenia and fever were present in some but not all of the patients. The concomitant use of formyl-THF with trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection was associated with increased rates of treatment failure and mortality in a placebo controlled study.

Folic acid has been shown to play a dual role in cancer development; low total folate Total folate includes folic acid from fortified foods and dietary supplements and naturally occurring food folates. intake increases risk of carcinogenesis, and high folic acid intake has been shown to promote carcinogenesis. Patients undergoing cancer treatment or who have a history of pre-cancerous neoplasms should consult their doctor to determine if EnLyte^® is appropriate for them.

This product contains iron.

PREGNANCY

Teratogenic Effects

Pregnancy Category C (for formyl-THF)

Animal reproduction studies have not been conducted with formyl-THF. It is also not known whether formyl-THF can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Formyl-THF is an active form of folic acid, and has vitamin B₉ activity. Folinic acid, or citrovorum factor, has been on the market since the early 1950s, and is considered generally recognized as safe and effective for the treatment of folic acid deficiency.

NURSING MOTHERS

It is not known whether formyl-THF is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when formyl-THF is administered to a nursing mother.

PRECAUTIONS

Folate alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B₁₂ is deficient. Folate in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

DRUG INTERACTIONS

Talk to your doctor and pharmacist before taking or using any other prescription or over-the-counter medicines or herbal/health supplements alongside EnLyte^®.

Formyl-THF may enhance the toxicity of fluorouracil (see WARNING ).

ENLYTE ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parenteral administration of folate.

Paresthesia, somnolence, nausea, and headaches have been reported with pyridoxal 5' phosphate. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with methylcobalamin.

These are not all of the possible side effects with EnLyte^®. It is important to always contact your doctor if you experience any side effects while on EnLyte^®.

ENLYTE DOSAGE AND ADMINISTRATION

The recommended dose is one softgel daily or as prescribed by a physician.

HOW SUPPLIED

EnLyte^® is supplied as OVAL, ANNATTO softgel capsules with imprint "ENL" on one side in bottles of 30 softgel capsules.

NDC 64661-711-30

STORAGE

Store at 20°-25°C (68°-77°F). Excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

Call your doctor about side effects. You may report side effects by calling 866-280-5961.

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

R_x Only

MANUFACTURED FOR:
JAYMAC Pharmaceuticals, LLC
Sunset, LA 70584
www.jaymacpharma.com

MADE IN CANADA
Rev. AUGUST 2011

All prescriptions using this product shall be pursuant to state statutes as applicable. This product may be administered only under a physician's supervision.

PRINCIPAL DISPLAY PANEL - 30 Capsule Label

R_x Only
30 softgels

Enlyte^®
with DeltaFolate™
advanced folate supplement

Manufactured for:

JAYMAC
Pharmaceuticals, LLC

Sunset, LA 70584

NDC 64661-711-30
Prescription Vitamin