1. No category

Possible Side Effects
Side Effect(s)
Weight Gain
Loss of libido, difficulty
achieving erections,
inability to reach orgasm
Increased thoughts of suicide
Drowsiness or confusion
Nervousness and agitation
Insomnia
Visit Us On Our Website:
www.EnlyteRX.com
11
EnLyte
No
SSRIs
Yes
SNRIs
Yes
No
Yes
Yes
No
No
No
No
Yes
Yes
Yes
Yes
Yes
Yes
YesYes
(2.5mg F-THF, 1mg PteGlu CR, 7mg Me-THF-Mg, 13.6mg FeGC, 6.4mg PS-DHA, 800mcg PS-EPA)
Plus CitraFolic®, AminoFerr®, MagnaFolTM, and Sharp-PS® GOLD
DIETARY MANAGEMENT / PRESCRIPTION (Rx) FOLATE
MULTIPHASIC SOFTGEL
PRODUCT CODE†† 64661-711 / PART-ID 711-30
CERTIFIED GLUTEN-FREE - LOW IRON
Adapted from: Consumer Reports Best Buy Drugs. Using antidepressants to treat depression: comparing efficacy, safety, and
price. 2012. Available at: http://www.consumerreports.org/health/resources/pdf/best-buy-drugs/Antidepressants_update.pdf
“Only 40% of patients complete their recommended duration
of antidepressant therapy…they don’t like the side effects.”
— Andrew Farah, MD, Chief of Psychiatry,
High Point Section of UNC Health Care, Central NC
June 19, 2013, oral communication
EnLyte helps them be happy.
Prescribe EnLyte—
Complete care to treat mild, moderate, and severe
2
Prescribe EnLyte—
depression
2
carecornerstone
to treat mild, moderate,
and severe depression
•Complete
Essential
in the treatment
of all patients
with
depression
• Essential cornerstone in the treatment of all patients with depression
• No artificial
• Stand-alone or adjunctive therapy
sweeteners
Stand-alone or adjunctive therapy
• •Contains
targeted optimal ingredients for maximal
• Dye-free
•methylation
Contains optimal ingredients
production
• Gluten-free
EnLyte helps them be happy.
– Most reduced form of folate (16 mg DeltaFolate™)
• Calcium-free
• Casein-free
– Most reduced brain-ready forms of vitamin B
EnLyte helps them be happy.
Your patients have two easy
Your
patients have
easy options EnLyte.
options
for two
obtaining
for obtaining EnLyte.
Zinc
Prescribe –EnLyte—
Complete care to treat mild, moderate, and severe depression2
• Essential cornerstone in the treatment of all patients with depression
• Stand-alone or adjunctive therapy
• Contains optimal ingredients
– Most reduced form of folate (16 mg DeltaFolate™)
– Most reduced brain-ready forms of vitamin B
(actual size)
• No artificial
sweeteners
• Dye-free
• Gluten-free
• Calcium-free
• Casein-free
EnLyte is available by prescription and can easily be filled at local pharmacies
with insurance, Medicaid, and Medicare for a reasonable co-pay.
May not be payable on all programs.
1– Zinc
(actual size)
Your patients have two easy options
for obtaining
EnLyte.
Patients
may also fill their prescription for EnLyte through Speialty Medical Drug Store
1
2

2

EnLyte is available by prescription and can easily be filled at local pharmacies
Mail Order/Cash Pay* program with no additional service or shipment fees.
with insurance, Medicaid, and Medicare for a reasonable co-pay.
Phone
Phone 1-888-795-5826 with your Rx information
Fax 1-513-576-0092 or
30-day
ePrescription to
ePrescription
to specialtymedicaldrugstore supply
Phone
of
Patients
may also fill their prescription for EnLyte through Speialty Medical Drug Store
Fax
Mail Order/Cash Pay* program with no additional service or shipment fees.
Fax
ePrescription to
For any questions regarding EnLyte, patients can call
30-day
supply of
EnLyte
EnLyte
985-788-7755
985-788-7755
For any questions regarding EnLyte, patients can call
“[EnLyte] addresses the root
for cash payment: No shipping charge when shipped via US Postal
“[EnLyte]
addresses
the rootGuarantee
cause
of depression,
not just
Service. (Please
add 3 to 4artificial
days for processing prescription orders and
•Guarantee
No
forbusiness
cash payment:
No shipping charge when shipped via US Postal
to 9 business days for shipping, depending on location.) For questions about
the symptoms
of depression…
cause of depression,
not just2ordering
through
Linden(Please
Care, call
(877-954-6336).
Service.
add877-9Linden
3 to 4 business
days for processing prescription orders and
it’s a real paradigm shift.”
sweeteners
the symptoms of depression…
it’s a real paradigm shift.”
• Artificial
Dye-free
• Gluten-free
• Calcium-free
Practice Guideline for Treatment of Patients With Major Depressive Disorder. 3rd edition. Arlington, VA: American Psychiatric Publishing; 2010.
11. Consumer Reports Best Buy Drugs. Using antidepressants to treat depression: comparing effectiveness, safety, and price (2013). Consumer
Reports website. http://www.consumerreports.org/health/resources/pdf/best-buy-drugs/Antidepressants_update.pdf. Accessed October 24,
2013. 12. Rosenberg M. Physician letters. The Physician eXchange website. (Registration required) http://www.thephysicianexchange.com/
kol_letters2.aspx. Accessed July 3, 2013. 13. Trivedi MH, Rush AJ, Wisniewski SR, et al. Evaluation of outcomes with citalopram for depression
using measurement-based care in STAR*D: implications for clinical practice. Am J Psychiatry. 2006;163:28–40. 14. Passeri M, Cucinotta
(actual size)
D, Abate G, et al. Oral 5’- methyltetrahydrofolic
acid in senile organic mental disorders with depression: results of a double-blind multicenter
study. Aging (Milano). 1993;5(1):63–71. 15. Wright CB, Lee HS, Paik MC, Stabler SP, Allen RH, Sacco RL. Total homocysteine and cognition
in a tri-ethnic cohort: the Northern Manhattan Study. Neurology. 2004;63(2):254–260. 16. Taylor MJ, Freemantle N, Geddes JR, Bhagwagar
Scan the QR code
Z. Early onset of selective serotonin reuptake inhibitor antidepressant action: systematic review and meta-analysis. Arch Gen Psychiatry.
above to watch
the full video of
AdvAnced
folAte
therApy
2006;63(11):1217–1223.
17.
WebMD.
The
truth
aboutgenerAtion
antidepressants. WebMD
website.
http://www.webmd.com/depression/antidepressants
Dr. Farah’s interview.
© 2013 JAYMAC Pharmaceuticals, LLC. All rights reserved.
-9/slideshow-antidepressants. Accessed
July 10, 2013.
• Casein-free
.com
—Andrew Farah, MD,
Chief of Psychiatry,
High Point Section of
UNC Health Care,
Central NC
June 19, 2013,
oral communication
2 to 9 business days for shipping, depending on location.) For questions about
ordering through Linden Care, call 877-9Linden (877-954-6336).
References: 1. Rosenberg I. Physician letters. The Physician Exchange website. (Registration required). http://www.thephysicianexchange.
com/kol_letters. aspx. Accessed July 16, 2013. 2. EnLyte [package insert]. Sunset, LA: JAYMAC Pharmaceuticals, LLC; 2012. 3. Gu P,
DeFina LF, Leonard D, et al. Relationship between serum homocysteine levels and depressive symptoms: the Cooper Center Longitudinal Study.
J Clin Psychiatry. 2012;73(5):691–695. 4. Stahl SM. Novel therapeutics for depression: L-methylfolate as a trimonoamine modulator and
antidepressant-augmenting agent. CNS Spectr. 2007;12(10):739–744. 5. Tanaka T, Scheet P, Giusti B, et al. Genome-wide association study
of vitamin B6, vitamin B12, folate, and homocysteine blood concentrations. Am J Hum Genet. 2009;84(4):477–482. 6. Jolliffe T. Folate levels
influence depression symptoms.
Spark
website.http://www.sparkpeople.com/blog/blog.asp?post=folate_levels_influence_depression_
References:
1.People
Rosenberg
I. Physician letters. The Physician Exchange website. (Registration required). http://www.thephysicianexchange.
symptoms. Accessed August 11, 2013. 7. Ortega RM, Lopez-Sobaler AM, Gonzalez-Gross MM, et al. Influence of smoking on folate intake and
com/kol_letters.
JulyJ 16,
2. 1994;13(1):68–72.
EnLyte [package insert].
Sunset,JA.LA:Effects
JAYMAC
LLC; 2012. 3. Gu P,
blood folate concentrations
in a group of aspx.
elderlyAccessed
Spanish men.
Am 2013.
Coll Nutr.
8. Mountifield
of oralPharmaceuticals,
contraceptive
usage on B12 and folate
levels.LF,Can
Fam Physician.
Fava M,
Mischoulon D.levels
Folateand
in depression:
safety,the Cooper Center Longitudinal Study.
DeFina
Leonard
D, et al. 1985;31:1523–1526.
Relationship between9.serum
homocysteine
depressiveefficacy,
symptoms:
differences in formulations, and clinical issues. J Clin Psychiatry. 2009;70(suppl 5):12–17. 10. Gelenberg AJ, Freeman MP, Markowitz JC, et al.
J Clin Psychiatry.
2012;73(5):691–695.
Stahl SM.
Novel therapeutics
depression:
L-methylfolate
a trimonoamine modulator and
Practice Guideline for Treatment
of Patients
With Major Depressive 4.
Disorder.
3rd edition.
Arlington, VA: for
American
Psychiatric
Publishing; as
2010.
11. Consumer Reports Best Buy Drugs. Using antidepressants to treat depression: comparing effectiveness, safety, and price (2013). Consumer
antidepressant-augmenting agent. CNS Spectr. 2007;12(10):739–744. 5. Tanaka T, Scheet
P, Giusti
B, et24,al. Genome-wide association study
Reports website. http://www.consumerreports.org/health/resources/pdf/best-buy-drugs/Antidepressants_update.pdf.
Accessed
October
2013. 12. Rosenberg of
M.vitamin
Physician
TheB12,
Physician
website. (Registration
required) http://www.thephysicianexchange.com/
B6,letters.
vitamin
folate,eXchange
and homocysteine
blood concentrations.
Am J Hum Genet. 2009;84(4):477–482. 6. Jolliffe T. Folate levels
kol_letters2.aspx. Accessed July 3, 2013. 13. Trivedi MH, Rush AJ, Wisniewski SR, et al. Evaluation of outcomes with citalopram for depression
influence
depression
symptoms.forSpark
People
website.http://www.sparkpeople.com/blog/blog.asp?post=folate_levels_influence_depression_
using measurement-based
care in
STAR*D: implications
clinical
practice.
Am J Psychiatry. 2006;163:28–40. 14. Passeri M, Cucinotta
D, Abate G, et al. Oral symptoms.
5’- methyltetrahydrofolic
acid in11,
senile
organic
mental disorders
with depression:
results of a double-blind
Accessed August
2013.
7. Ortega
RM, Lopez-Sobaler
AM, Gonzalez-Gross
MM, etmulticenter
al. Influence of smoking on folate intake and
study. Aging (Milano). 1993;5(1):63–71. 15. Wright CB, Lee HS, Paik MC, Stabler SP, Allen RH, Sacco RL. Total homocysteine and cognition
blood
folate Manhattan
concentrations
a group of2004;63(2):254–260.
elderly Spanish men.16.J Taylor
Am Coll
1994;13(1):68–72.
Mountifield JA. Effects of oral contraceptive
in a tri-ethnic cohort: the
Northern
Study.inNeurology.
MJ,Nutr.
Freemantle
N, Geddes JR, 8.
Bhagwagar
Z. Early onset of selective serotonin reuptake inhibitor antidepressant action: systematic review and meta-analysis. Arch Gen Psychiatry.
usage on B12 and folate levels. Can Fam Physician. 1985;31:1523–1526. 9. Fava M, Mischoulon D. Folate in depression: efficacy, safety,
2006;63(11):1217–1223. 17. WebMD. The truth about antidepressants. WebMD website. http://www.webmd.com/depression/antidepressants
-9/slideshow-antidepressants.
Accessed
July 10, 2013.
differences
in formulations,
and clinical issues. J Clin Psychiatry. 2009;70(suppl 5):12–17. 10. Gelenberg AJ, Freeman MP, Markowitz JC, et al.
EnlyteRx.com
—Andrew Farah, MD,
Chief of Psychiatry,
High Point Section of
UNC Health Care,
Central NC
June 19, 2013,
oral communication
DESCRIPTION: EnLyte® is an orally-administered prescription folate-containing product for the clinical dietary management of depression related to suboptimal
folate levels associated with metabolic imbalances in transformylation and/or methylation biochemistry.1-8,20
Folate appears to enhance synthesis and/or regeneration of tetrahydrobiopterin (BH4), which is an essential cofactor in the biosynthesis of monoamine
neurotransmitters serotonin, dopamine and norepinephrine.15,16,17 Additionally, folate may normalize elevated homocysteine levels and reduce the risk of
neural tube defects. Elevated homocysteine has been observed among women with neural tube defect (NTD)-affected pregnancies.36 The protective effect of
DeltaFolateTM in EnLyte® comes in supplying an array of folate-derivatives in combination with folate coenzymes, cofactors and co-metabolites that decrease
the risk of bioavailability-interference such as might occur with inborn or environmental folate-malabsorption. This allows the folate substrate, THF, to be utilized in
transformylation and/or methylation biochemistry.1-8,14
EnLyte® can be taken by women of childbearing age, pregnant women, and lactating and nonlactating mothers.
INGREDIENTSa: Each oval, annatto-colored MULTIPHASIC soft gelatin capsule contains the following 8.73 mg of active vitamin B9 moiety from 16 mg
DeltaFolate™b provided as:
Formyltetrahydrofolic acid (equiv. to 2.5 mg moiety)........................................................................................................................................................................3 mg
Controlled-release citrated-pteroylmonoglutamic acid, USP as CitraFolic®c (equiv. to 1 mg moiety).............................................................................................6 mg
Methylfolate magnesium as MagnaFol™d (equiv. to 5.23 mg moiety)............................................................................................................................................7 mg
ALSO CONTAINSa: The following distinct dietary ingredients as necessary cofactors, coenzymes and co-metabolites
for advanced folate supplementation:
FeGC as ferrous glycine cysteinate (1.5mg elemental iron) from pure amino acid chelate as AminoFerr® .................................................................................................... 13.6 mg
PS-DHA as phosphatidylserine-docosahexaenoic acid from PS-DHA-Ca as Sharp-PS® Gold..................................................................................................6.4 mg
PS-EPA as phosphatidylserine-eicosapentaenoate acid from PS-EPA-Ca as Sharp-PS® Gold............................................................................................... 800 mcg
Phosphatidylserine from Sharp-PS® GOLDf................................................................................................................................................................................ 12 mg
Ascorbates [as 24 mg magnesium ascorbate and 1 mg zinc ascorbate]..................................................................................................................................... 25 mg
Thiamine pyrophosphate............................................................................................................................................................................................................. 25 mcg
Flavin adenine dinucleotide (FAD)............................................................................................................................................................................................... 25 mcg
Nicotinamide adenine dinucleotide hydride (NADH).................................................................................................................................................................... 25 mcg
Pyridoxal 5’ phosphate (P5P)..................................................................................................................................................................................................... 25 mcg
Cobalamin................................................................................................................................................................................................................................... 50 mcg
Betaine (trimethylglycine).......................................................................................................................................................................................................... 500 mcg
L-threonate magnesium...................................................................................................................................................................................................................1 mg
a Daily Values not established for patients with unique nutritional needs who are in need of supplementation as directed by a licensed medical practitioner.
b DeltaFolateTM is a proprietary folate blend consisting of folinic acid, folic acid and methylfolic acid providing 8.73 mg of active vitamin B9 moiety.
c CitraFolic® is a controlled-release form of folic acid that is pH-specific using citrates as buffers to achieve optimal absorption for targeted-GI at the proximal
jejunum AND in order to meet USP requirements for folic acid dissolution and disintegration; it is patent pending. CitraFolic® uses only DMF-approved manufacturers
of folic acid.
d MagnaFol™ is the magnesium salt of methylfolic acid - also known as LEVOMEFOLATE MAGNESIUM, and has the Unique Ingredient Identifier (UNII) code
1VZZ62R081; the active moiety being LEVOMEFOLIC ACID, and has the UNII 8S95DH25XC. MagnaFolTM, or l-methylfolate magnesium, has the CAS #142949811-2; and has U.S. patent applications pending.
e AminoFerr® as ferrous glycine cysteinate, also known as FERROUS CYSTEINE GLYCINATE, and has the UNII code 8B4OP7RK5N. AminoFerr® is a proprietary
ingredient containing pure chelates without interfering ions -resulting in high solubility and absorption;it is the only pure amino acid iron chelate supplement on the
market, and is protected under US Patent No. 7,341,708.
f Sharp-PS® GOLD is an omega-3 derived complex comprising phospholated docosahexaenoic (DHA) and eicosapentaenoic acid (EPA), and is protected
under U.S. Patent Nos. 7,935,365 and 5,965,413. It has the following two metabolic substrates*: (1) PS-DHA as the active ingredient phosphatidylserinedocosahexaenoate calcium salt (PS-DHA-Ca) - also known as 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, and has UNII code
6WJM73T46K; the active moiety being phosphatidylserine-docosahexaenoic acid (PS-DHA) - also known as 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3PHOSPHOSERINE, and has UNII code DVY07ILF1W. AND, (2) PS-EPA as the active ingredient phosphatidylserine-eiconosapentanoate calcium salt (PSEPA-Ca) - also known as 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, and has UNII code 9ABD9DRK7B; the active moiety being
phosphatidylserine-eiconosapentanoic acid (PS-EPA) - also known as 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE, and has UNII code C3019D8IIA.
* Both di-ester salts of the omega-3 derivatives have the calcium element as CALCIUM CATION UNII code 2M83C4R6ZB.
EXCIPIENTS: Annatto (color), gelatin (bovine), glycerin, lecithin (sunflower), natural creamy orange (flavor), olive oil, piperineg (bioavailability enhancer), purified
water, r-5-formylTHF, ubidecarenone (trace amounts), yellow beeswax,....[and other ancillary ingredientsh as needed to ensure product stability] ...
g Bioavailability enhancer piperine as BioPerine® is a registered trademark of Sabinsa Corporation, Piscataway, NJ. Protected and manufactured under US Patent
Nos. 5,536,506, 5,744,161, 5,972,382; and 6,054,585.
h Since additives, preservatives, bioavailability enhancers, colors and/or flavors of natural origin, etc. are preferred over synthetics, it may be the case that product
color, appearance and/or taste may vary slightly over time; and it may be necessary to substitute excipients during the manufacturing process as needed to preserve
product appearance and continuity in order to avoid confusion in the marketplace and ensure the highest therapeutic target, safety and quality.
EnLyte® DOES NOT CONTAIN artificial dyes, artificial flavors/ sweeteners, and gluten. EnLyte® is third-partyv certified gluten-free. EnLyte® contains less than
5000 ppm alcohol.
ALLERGY STATEMENT: EnLyte® contains soy and fish (blue whiting and herring) – derived Sharp-PS® GOLD. This ingredient, however, does not contain
detectable levels of fish and soy protein due to an extensive purification process. Neverless, EnLyte® has been manufactured in a facility that also manufactures
products containing tree nuts, peanuts, fish, egg, wheat, milk, soy and shellfish. Patients with allergic tendencies to any of these substances should use discretion
and consult their healthcare practitioner for advice. EnLyte® also contains bovine gelatin.
WARNINGS:
This product contains iron. EnLyte® should not be used by individuals at risk for iron overload (including transfusional overload) or other conditions for which iron
is contraindicated. Warning: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the
reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
[PSYCHIATRIC] Caution is recommended in patients with a history of bipolar illness as mood elevation is possible following coadministration of folate with
antidepressant therapy in situations of severe folate deficiency. Caution is also recommended with schizophrenic patients as it is imperative that positive symptoms
in schizophrenia be treated with therapies (e.g., antipsychotic medications) that are accepted by licensed psychiatric professionals as being safe and effective.
EnLyte® should not be administered to patients with positive symptoms.
[NEUROCOGNITIVE] Caution is recommended in patients taking anticonvulsant medications as folate may interfere with anticonvulsant medication, and may lower
seizure threshold.9 Furthermore, it has been reported that anticonvulsant medications interfere with folate metabolism, but the exact action is unclear; therefore
caution is recommended with patients in this therapeutic group.10 Caution is likewise recommended in Parkinson’s disease patients as EnLyte® contains vitamin
B6 which may or may not interfere with levodopa (even when administered with carbidopa).
[ONCOLOGY] Folinic acid 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. Individuals
undergoing treatment for cancer or certain inflammatory conditions or who have a history of precancerous neoplasms should consult their medical practitioner to
determine if EnLyte® is appropriate for them.
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 may occur while neurological manifestations progress.
Daily ingestion of more than 3 grams per day of omega-3 fatty acids (ALA, EPA, and DHA) 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 diathesis, including those
taking anticoagulants. Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.
INTERACTIONS: Talk to your healthcare practitioner and/or pharmacist before taking or using any prescription or overthecounter medicines or herbal/health
supplements alongside EnLyte®. Folinic acid may enhance the toxicity of fluorouracil (see WARNINGS).
CONTRAINDICATIONS: EnLyte® is contraindicated in patients with a known hypersensitivity to any of the components contained in this product. EnLyte® is
contraindicated for individuals with conditions for which any of the EnLyte® ingredients are contraindicated. EnLyte® is also contraindicated for individuals who
would be negatively affected by increased monoamine neurotransmitter synthesis.
ADVERSE REACTIONS: Allergic reactions have been reported following the use of oral and parenteral folate. Paresthesia, somnolence, nausea, and headaches
have been reported with pyridoxine. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body has been
associated with cobalamin. These are not all the possible side effects associated with EnLyte®. It is important to always contact your healthcare practitioner if you
experience any side effects on EnLyte®. You may report side effects by calling (866) 280-5961.
INDICATIONS AND USAGE: EnLyte® is indicated for the distinct nutritional requirements of individuals who have suboptimal folates levels in the cerebrospinal fluid,
plasma and/or red blood cells, and require a maintenance level. Folate is effective in the treatment of hyperhomocysteinemia and/or megaloblastic anemias12 (as
may be seen in tropical or nontropical sprue) and in anemias of nutritional origin13, pregnancy, infancy, childhood or other related folate-malabsorption complications
of an inborn or environmental origin.14,43 EnLyte® is not a drug, but may be used as monotherapy (“rescue” therapy) or adjunctive therapy as determined by
your licensed medical practitioner. The adjunctive use of EnLyte® enables medical practitioners to combine therapeutic modalities (dietary management and
drug therapy).18,19 In patients with suboptimal folate levels and as determined by your licensed medical practitioner, EnLyte® may be administered as rescue or
adjunctive folate-therapy to provide a protective effect in reducing the risk of secondary/endpoints and/or disease-states of a hyperhomocysteinemia and/or vascular
nature such as may be found with depression; or EnLyte® may be administered as rescue or adjunctive folate-therapy to provide a protective effect in reducing the
risk of secondary/endpoints and/or disease-states of a hyperhomocysteinemia and/or methylation metabolic imbalance as may be found with depressed patients.
PREGNANCY AND NURSING MOTHERS: EnLyte® is a prescription (Rx)-folate containing dietary supplement (prenatal/postnatal) formulated for use by lactating
and nonlactating women who are at risk of postpartum depression, depression before or during a pregnancy, and/or women of childbearing age who may become
pregnant and/or are in need of increased folate levels in the central nervous system (CNS). EnLyte® may also be an appropriate folate supplement for those at
high risk of NTDs because of the amount and diversity of folates. EnLyte® is Pregnancy Category A; however, EnLyte® is NOT a standard complete prenatal/
postnatal supplement for the following reasons:
EnLyte® contains over 1,000% of DV of folate for pregnant and lactating women, which may or may not be important depending upon your genetic disposition and
previous pregnancies; please consult with your licensed medical practitioner on advanced folate supplementation during pregnancy for women at risk of NTDs
and/or suboptimal folate/depression/postpartum. EnLyte® contains piperine a dietary ingredient derived from pepper.9,10 EnLyte® contains a minimal amount of
iron – providing only 8% of DV of iron for pregnant and lactating women, and EnLyte® does not contain other vitamins and minerals that might be more suitable to
your specific metabolic needs or part of a standard prenatal/postnatal multivitamin/multimineral/dietary supplement.7-9,10
GERIATRICS: EnLyte® is formulated for the clinical dietary management of depression specifically related to suboptimal folate levels. EnLyte® contains 1.5 mg of
elemental iron, which is approximately 19% of the recommended dietary allowance for individuals over the age of 51.48
DOSAGE AND ADMINISTRATION: The recommended dose is one softgel daily or as directed under medical supervision to achieve a satisfactory folatemaintenance level. Some individuals may require larger doses as determined by a licensed medical practitioner.
EnLyte® is best absorbed when taken on an empty stomach. During times of medication transition, the amount of EnLyte® may be increased as per direction of
your licensed medical practitioner in order to achieve a “rescue” effect. It is important to obtain vitamin D supplementation preferably through the natural process of
sun exposure – though not to the point of skin damage, as vitamin D acts as a neuro-immunomodulator and therefore enhances the therapeutic goals of EnLyte®.
HOW SUPPLIED: EnLyte® is supplied as oval, annatto-colored soft gelatin capsules with “ENL” on one side, in bottles of 30 softgels with NDC†† 64661-711-30.
EnLyte® is also supplied to licensed healthcare practitioners as samples, 64661-711-05.
†† This product is a prescription-folate with or without other dietary ingredients that – due to increased folate levels (AUG 2 1973 FR 20750), requires an Rx on
the label because of increased risk associated with masking of B12 deficiency (pernicious anemia). Based on our assessment of the risk of obscuring pernicious
anemia, this product requires licensed medical supervision, an Rx status, and a National Drug Code (NDC) – or similarly-formatted product code, as required by
pedigree reporting requirements and supply-chain control as well as – in some cases, for insurance-reimbursement applications.
EnLyte® may – under certain circumstances, be dispensed through a certified mail-order program so long as there is record of prescription AND confirmation that
the patient is under licensed medical supervision. This product is not an Orange Book (OB) rated product, therefore all prescriptions using this
product shall be pursuant to State statutes as applicable. STORAGE: Store at 20°-25° C (68°-77° F). Excursions permitted to 15°-30° C (59°-86° F). [See USP
Controlled Room Temperature]. Protect from light and moisture. 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 PRODUCT OUT OF THE REACH OF CHILDREN.
MANUFACTURED FOR: JAYMAC Pharmaceuticals, LLC (Sunset, Louisiana, USA). EnLyteRx.com. MADE IN CANADA
PATENTS: US Patent Nos. 7,935,365; 5,965,413; 7,341,708; 6,054,585; 5,972,382; 5,744,161; 5,536,506; and other patent applications pending.
TRADEMARKS: EnLyte® is a registered trademark of JAYMAC Pharmaceuticals, LLC (Sunset, Louisiana, USA), and was co-developed by Daniels-Trezza, LLC.
CitraFolic® and MagnaFolTM are registered trademarks of Viva Pharmaceuticals, Inc. (Richmond, B.C., Canada), and was co-developed by Daniels-Trezza, LLC.
DeltaFolateTM is a use-trademark of Daniels-Trezza, LLC (Ft. Myers, FL). AminoFerr® is a registered trademark of Viva Pharmaceuticals (Richmond, BC, Canada).
Sharp-PS® GOLD is a registered trademark of Enzymotec Ltd. (Israel).
Visit Us On Our Website: www.EnlyteRX.com
Visit Us On Our Website: www.EnlyteRX.com
Patients can feel completely safe.
You want your patients with depression
to be inyour
remission.
You want
patients w
to be in remiss
EnLyte® Rx is the natural answer.
EnLyte Rx is the natu
®
EnLyte Rx is a new,
effective, safe,
and cost-effective
natural option for
depression
You want your patients with depressio
to be in remission.
EnLyte Rx is the natural answer.
®
EnLyte Rx is a new, effecti
safe, and cost-effective na
option for depression
with Complete Delta-Folate
ADVANCED GENERATION FOLATE THERAPY
““[EnLyte]…could
represent a major
[EnLyte]…could represent a
clinical
and
breakthrough.”1
major
clinical
and therapeutic
therapeutic
1
breakthrough.”
—Irwin Rosenberg, MD, Senior Scientist and Director, Nutrition and
— Irwin
Rosenberg, MD,
Senior Scientist
Neurocognition
Laboratory,
Tufts University, Boston, MA
and Director, Nutrition and Neurocognition
Laboratory, Tufts University, Boston, MA
750 mcg
B6
Organic iron–gluconate
750 mcg
B1
25 mcg
B2
25 mcg
B3
DeltaFolate™
Pyridoxal
5’ phosphate
s EnLyte
work?
Folinic
acid
Flavin
adenineingredients
dinucleotide 2
wing
optimal
NADH
Folic
Converted by MTHFR,
which is affected by
C677T polymorphism
How
does EnLyte work? maximizes
Reduces homocysteine and5-MTHF
mcg so important
Why25they’re
™
12
800 mcg
B12
B3
B2
5-,10- MTHF
Converted by MTHFR,
which is affected by
C677T polymorphism
5-MTHF
e
18 mcg
Folinic Acid
agnesium, zinc)
25 mg
s metabolite) Folic Acid1 mg
• Gluten-free
B3
• Artificial Dye-Free
DHA
B6
EPA
• Calcium-free
B12
• Casein-free
Brain-ready mineral metabolites
and vitamins
C
Zinc
Zinc
Magnesium
etaine)
92% Reduced Folate
L-Methylfolate
B1
Phospholipid (phosphatidylserine) conjugated
B2
omega 3s that mimic the structure
of fatty
acids found in the brain
Vitamin C
Omega 3s
Magnesium
Betaine
EnLyte actual ingredients:
nLyte® is indicated for depression therapy for patients at risk of folate deficiency as determined by a licensed practitioner; for obstetrics patients
ho may be at risk of postpartum depression; and as a prescription pre-natal/post-natal vitamin for women at increased risk of having offspring
B1 from advanced folate supplementation.
th neural tube defects (NTDs), and who would benefit
• Gluten-free
2
WARNING:6(S)-5-MeTHF-magnesium
Accidental overdose of iron-containing
products is a leading
cause of fatal poisoning in children under 6. Keep7
thismg
product out
of reach of children. In case of accidental overdose,
B3 call a doctor or poison
• control center immediately.
B
6(S)-5-FormylTHF sodium 3
2.5 mg
B6
mportant Safety Information
• Calcium-free
Citrated
1 mg
aily ingestion
of more than folic
3 gramsacid
per day CR-USP
of omega-3
fatty
acids
(ALA,
EPA,
and
DHA)
from
fish
oils
may
have
potential
B
Casein-free
tithrombotic activities, or effects, and may increase bleeding times.•Administration
of omega-3 fatty acids, including DHA, should be
5’-deoxyadenosylcobalamin
50 mcg
oided in individuals with inherited or acquired bleeding
Zinc diathesis, including those taking anticoagulants. Exercise caution to ensure that
e prescribed
dosageChelate
of DHA does not exceed 1 gram (1000 mg) per day.
Iron
13.6 mg
ease see full indication and prescribing information in back pocket.
Pyridoxal 5’ phosphate
25 mcg
sion therapy Thiamine
for patients at risk of pyrophosphate
folate deficiency as determined by a licensed practitioner; for obstetrics patients
25 mcg
um depression; and as a prescription pre-natal/post-natal vitamin for women at increased risk of having offspring
Flavin
adenine
dinucleotide
25 mcg
), and who would
benefit from
advanced folate
supplementation.
NADHproducts is a leading cause of fatal poisoning in children under 6. Keep this product out
25 mcg
erdose of iron-containing
of accidental overdose, call a doctor or poison control center immediately.
PS-DHA
6.4 mg
ion
3 grams perPS-EPA
day of omega-3 fatty acids (ALA, EPA, and DHA) from fish oils may have potential
800 mcg
ffects, and may increase bleeding times. Administration of omega-3 fatty acids, including DHA, should be
herited or acquired
bleeding diathesis, including those taking anticoagulants. Exercise caution to ensure that
Phosphatidylserine
12 mg
A does not exceed 1 gram (1000 mg) per day.
Magnesium
Ascorbate
24 mg
and prescribing
information in back
pocket.
Zinc Ascorbate
1 mg
Magnesium L-Theoronate
1 mg
Trimethylglycine (betaine)
500 mcg
Coenzyme Q10
500 mcg
Bioperine
500 mcg
12
EnLyte® is indicated for depression therapy for patients at risk of folate deficiency as determined
by a licensed practitioner; for obstetrics patients who may be at risk of postpartum depression;
and as a prescription pre-natal/post-natal vitamin for women at increased risk of having offspring
with neural tube defects (NTDs), and who would benefit from advanced folate supplementation.
WARNING: Accidental overdose of iron-containing products is a leading cause of
fatal poisoning in children under 6. Keep this product out of reach of children. In case of
accidental overdose, call a doctor or poison control center immediately.
Important Safety Information
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 individuals
with inherited or acquired bleeding diathesis, including those taking anticoagulants. Exercise
caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.
Please see full indication and prescribing information in back pocket.
13
Norepinephrine
single medication13
•• At
for folate
deficiency
Therisk
majority
of patients
do not achieve remission with any initial treatme
•• According
to the recent APA Practice Guidelines,
According to the recent APA Practice Guidelines, “…Considering the mo
“…Considering
the modest
evidence
thatstrategy
supports
evidence that supports
folate as an
augmentation
and its attrac
risk-benefit
folate can bestrategy
recommended
reasonable adjunct
folate
as anprofile,
augmentation
and as
itsaattractive
strategy for major depressive disorder that carries little risk…”10
risk-benefit profile, folate can be recommended as a
reasonable adjunctive strategy for major depressive
disorder that carries little risk…”10
CH
3
REDUCTION
OF
THF
DNA
HOMOCYSTEINE
Methionine
LEVELS
B1
Betaine
BH4
Folinic Acid
Exactly who
who can
can benefit
benefit from
from EnLyte?
EnLyte?
Exactly
➤
ENHANCED
Tryptophan
NEUROTRANSMITTER
hydroxylase
SAM
SYNTHESIS
Patients with mild to moderate depression
Patients with MDD
who
are MTHFRDisorder
Polymorphic,
Confirmed
or Suspected
Major
Depressive
(MDD)
who need
adjunctive th
Patients
B6
Patients with
with
DMG
B12
• 60%Zn/Mg
of the US population have polymorphisms of
the MTHFR enzyme and are unable to convert
Serotonin
Dopamine
folate/folic acid into L-methylfolate3,4 BH
Homocysteine
2
Norepinephrine
➤
L-methylfolate
6.4 mg
2
DHFR
➤ ➤
Brain-ready metabolite cofactors
25 mcg
6
PS-DHA
EPA
Folinic Acid
Folic Acid
3
25 mcg
➤Exactlywho
Exactly
whocan
canbenefit
benefitfrom
fromEnLyte?
EnLyte?
12
2
ucleotide
Betaine
Patients with Major Depressive Disorder (MDD) who need
production of
Tyrosine
B
DMG
adjunctive
with therapy
Major Depressive Disorder (MDD) who need adjunctive th
B
neurotransmitters by completely addressing
the needs ➤hydroxylase Patients
Reduces homocysteine and maximizes production of neurotransmitters
by
Serotonin
Zn/Mg
2
• 70% of patients do not achieve remission with a
L-Methylfolate
of the addressing
remethylation
and
Dopamine
completely
the needs
of transsulfuration
the remethylation andcycles
transsulfuration cycles2 BH
• 70% of patients do not achieve remission with a single medication
6
1
BH4
Tryptophan
hydroxylase
➤
25 mcg
acid
gnesium
7 mg
16 mg total folate—DeltaFolate
Brain-ready metabolite
cofactors
L-methylfolate
sodium
3 mg
PS-DHA
6.4 mg
Phospholipid
(phosphatidylserine) conjugated
6
1
B12B
B
Folinic acid
omega 3s that mimic the structure of fatty
CR PS-EPA
6 mg
800 mcg
acids found in the brain
2
3Folic acid
B B
C
Phosphatidylserine
18 mcg
DHA
Phospholipid
(phosphatidylserine)
conjugated
Brain-ready metabolite cofactors
EPA
cobalamin
25 mcg
omega 25
3smcg
that mimicB the structure of fatty
Ascorbates
magnesium,
zinc)
25 mg
Brain-ready mineral metabolites and vitamins
acids(as
found
in the
brain
B
cid chelate
750 mcg
Zinc
acid 750
(as metabolite)
1 mg
B
onateL-theronic
mcg
DHAEPA
Magnesium
(betaine)
phateTrimethylglycine
25
mcg mineral Bmetabolites and vitamins
Brain-ready
Vitamin C
B
sphate
25 mcg
Zinc
Magnesium
Vitamin C
B1
➤
L-methylfolate
Thiamine
pyrophosphate
Methionine
How does EnLyte work?
➤ ➤
What is EnLyte?
B12
B3
B2
5-,10- MTHF
Tyrosine
hydroxylase
➤
Major Depressive Disorder (MDD) who need adjunctive th
– Increases the risk of elevated homocysteine levels
Cystathionine
– Increases the need for folate
Cysteine
• An additional 12 polymorphisms related to the reduction of B cofactors put depressed patients at risk5
Glutathione
PS-DHA
EPA
REDUCTION OF
• Other
HOMOCYSTEINE
LEVELS
risk factors can increase the need for folate6–8
– Pregnancy and lactation
– Liver disease
– Malabsorption syndromes
– Certain types of anemia
•• A
double-blind
placebo
controlled
monotherapy
Enlyte 13
70%
of patients
patients do
do
not achieve
achieve
remission
with a
a single
single medication
medication
13
• 70%
of
remission
with
A double-blind
studynot
found L-methylfolate
as
effective
as
trial
in 330 patients
with
confirmed
C677T
MTHFR
SNPs
14
trazodone
(tricyclic
antidepressent
monotherapy)
The majority
majority of
of patients
patients do
do not
not achieve
remission with
with any
any initial
initial treatme
treatme
The
••• 42%
remission
in MDD
inachieve
Enlyteremission
tested group
Folatereduction
monotherapy
benefit certain
patients9compared
According
APA
“…Considering
•••• 33%
inmay
homocysteine
levels
According to
to the
the recent
recent
APA Practice
Practice Guidelines,
Guidelines,
“…Considering the
the mo
mo
evidence
that supports
supports folate
folate as
as an
an augmentation
augmentation strategy
strategy and
and its
its attrac
attrac
to evidence
placebothat
risk-benefit profile,
profile, folate
folate can
can be
be recommended
recommended as
as a
a reasonable
reasonable adjunct
adjunct
risk-benefit
10
• Side
effectmajor
profile equaldisorder
to placebocarries little risk…”10
strategy
strategy for
for major depressive
depressive disorder that
that carries little risk…”
Data available on file
– Certain Patients
medications with mild to moderate depression and cognitive decline
(lamictal and first-generation
Patients
with mild to moderate depression (mood disorder or brain fog)
anticonvulsants,
metformin,
Patients
with
dialysis
– Alcohol abuse
Patients
with mild
mild to
to moderate
moderate depression
depression
sulfasalazine,
triamterene,
methotrexate,
barbiturates,
– Age
– Smoking
oral contraceptives)
• A double-blind study found L-methylfolate as
• High levels
homocysteine
are associated
with cognitive impairment15
• 60% of the US population have polymorphisms of the MTHFR enzyme and are unable to convert
effective
asoftrazodone
(tricyclic
antidepressent
• 3,4
EnLyte contains the much-needed B12 cofactor—without it, L-methylfolate gets caught in the methyl group “trap”2
folate/folic acid into L-methylfolate
14
monotherapy)
EnLyte
addresses
distinctive
nutritional requirements
depressed patie
•
A
double-blind
study
found
L-methylfolate
as
effectivefor
as
•A
double-blind
study
found
L-methylfolate
as
as
– Increases the risk of elevated homocysteine levels
14of hyperhomocysteine
under
treatment
for early
memory
loss
andcertain
at effective
risk14
trazodone
(tricyclic
monotherapy)
• Folate
monotherapy
may benefit
patients9
trazodone
(tricyclic antidepressent
antidepressent
monotherapy)
ENHANCED
– Kidney
NEUROTRANSMITTER
SYNTHESIS
EnlyteRx.com
Pure iron–amino acid chelate
THF
➤
B12
Why do we need EnLyte?
Increases the need for folate
• –60%
of the US “population
havecombination
polymorphisms
EnLyte is that
of all(genetic
defects) of the MTHFR
enzyme and
are unable to convert
the cofactors
you need…engineered
• Other risk factors can increase the need for folate
3,4
maximize that
homocysteine cycle
folate/folic acid intoto
L-methylfolate
– Pregnancy and lactation
– Liver disease
– Certain medications
treat
depression.”
(lamictal
and first-generation
Increases
the riskand
of
elevated
homocysteine
levels
––Malabsorption
syndromes
– Certain
types of anemia
anticonvulsants,
metformin,
—Andrew Farah, MD, Chief
of Psychiatry,
– Kidney dialysis
– Alcohol abuse High Point Section of UNC
Health Care, Central
NC
sulfasalazine,
triamterene,
June 19, 2013, oral communication
–
Decreases
neurotransmitters
methotrexate, barbiturates,
– Age
– Smoking
oral contraceptives)
• An additional 12 polymorphisms (genetic defects) related to
• EnLyte contains the much-needed B cofactor—without it, L-methylfolate gets caught in the methyl group
“trap”
the reduction of B cofactors put depressed patients at risk5
• Other risk factors can increase the need for folate6–8
9
•
• Folate
Folate monotherapy
monotherapy may
may benefit
benefit certain
certain patients
patients9
• An additional 12 polymorphisms related to the reduction of B cofactors put depressed patients at risk5
6–8
2
12
“EnLyte is that combination of all
– Pregnancy
and lactation
– Liver disease
– Certain medications
the
cofactors
you need…engineered
to– Malabsorption
maximize that
homocysteine
cycle
syndromes
– Certain types
of anemia (lamictal and first-generation
and
treat
depression.”– Alcohol abuse
– Kidney
dialysis
anticonvulsants, metformin,
– Age
—Andrew Farah, MD, Chief of Psychiatry,
High Point Section of UNC Health Care, Central NC
June 19, 2013, oral communication
– Smoking
sulfasalazine, triamterene,
AdvAnced generAtion folAte therApy
methotrexate, barbiturates,
oral contraceptives)
• EnLyte contains the much-needed B12 cofactor—without it,
L-methylfolate gets caught in the methyl group “trap”2
“ EnLyte is that combination
of all the cofactors you need…
engineered to maximize
neurotransmitter production
and reduce homocysteine to
treat depression.”
— Andrew Farah, MD, Chief of Psychiatry,
High Point Section of UNC Health Care, Central NC
June 19, 2013, oral communication
Pregnant women
Patients with mild to moderate depression and cognitive
Patients
with mild
mild to
to moderate
moderate depression
depression and
and cognitive
cognitive decline
decline
declinewith
Patients
2
EnlyteRx.com
Brain-ready metabolite cofactors
25 mcg
➤
25 mcg
Methylcobalamin
➤
5’-deoxyadenosylcobalamin
• Category A for pregnancy
AdvAnced generAtion folAte therApy
•• High
of be
homocysteine
are supplement
associated
EnLytelevels
may also
an appropiate folate
forwith
those at high ris
15
cognitive
for neural impairment
tube defects regardless
of their MTHFR polymorphic genotype
15
••• EnLyte
addresses
distinctive
nutritional
High
levels
associated
with
impairment
15
EnLyte
mayof
taken before are
conception,
throughout
pregnancy,
and dur
High
levels
ofbehomocysteine
homocysteine
are
associated
with cognitive
cognitive
impairment
2
requirements
for depressed
under
the postnatal period,
regardless ofpatients
lactation status
•
EnLyte
addresses
distinctive
nutritional
requirements
for
depressed
patie
• EnLyte addresses
distinctive
nutritionaland
requirements
for depressed patie
treatment
for early
memory
risk
of
under treatment
treatment
for early
early
memoryloss
loss and
and at
atatrisk
risk
of hyperhomocysteine
hyperhomocysteine
under
for
memory
loss
of
hyperhomocysteinemia2
“I strongly recom
in
• Category A for pregnancywho are planning to
Category
A
pregnancy
•••EnLyte
taken before conception, throughout
Categorymay
A for
forbe
pregnancy
pregnant
or
are pre
pregnancy,
the postnatal
period, regardless
• EnLyte mayand
also during
be an appropiate
folate supplement
for those at high ris
Pregnant women or Post Partum Depression (PPD)
Pregnant
Pregnant women
women
use of EnLyte
2
2
2
• EnLyte may also be an appropiate folate supplement for those at high ris
—Lawrence D. Ginsberg, MD, President and
2
of for
lactation
status
for
neural tube
tube
defects
regardless of
of their
their MTHFR
MTHFR
polymorphic
genotype
Red Oak Psychiatry
Associates,
Houston,
neural
defects
regardless
polymorphic
genotype
Written
communication
••Significantly
high
homocysteine
levels
in PPD
EnLyte may
may be
be taken
taken before
before conception,
conception, throughout
throughout pregnancy,
pregnancy, and
and dur
dur
•
EnLyte
compared
to those without
PPD lactation status22
the
the postnatal
postnatal period,
period, regardless
regardless of
of lactation status
• EnLyte reduced homocysteine 33% in a large clinical study
Data available on file
Patients with MDD and Sleep Disturbance
with Complete Delta-Folate
ADVANCED GENERATION FOLATE THERAPY
Visit Us On Our Website: www.EnlyteRX.com
“I
“I strongly
strongly recom
recom
use
use of
of EnLyte
EnLyte in
in
who
who are
are planning
planning to
to
pregnant or
or are
are pre
pre
pregnant
• An open-label 60 patient Enlyte study in patients
with sleep disturbance and depression
• 80% of patients reported sleep improvement
• 22% reduction in morning fatigue
• 41% reduction in emotional dysregulation/morning
—Lawrence D. Ginsberg, MD, President and
—Lawrence D. Ginsberg, MD, President and
Red Oak Psychiatry Associates, Houston,
irratibility
Red Oak Psychiatry Associates, Houston,
Written communication
communication
• Enlyte allows serotonin to convert Written
to melatonin
supporting sleep
Data available on file