Label: ENBRACE HR- levomefolate magnesium, leucovorin, folic acid, ferrous cysteine glycinate, magnesium ascorbate, zinc ascorbate, cocarboxylase, flavin adenine dinucleotide, nadh, pyridoxal phosphate anhydrous, cobamamide, betaine, magnesium l-threonate, 1,2-docosahexanoyl-sn-glycero-3-phosphoserine calcium, 1,2-icosapentoyl-sn-glycero-3-phosphoserine calcium, and phosphatidyl serine capsule, delayed release pellets
- NDC Code(s): 64661-650-30
- Packager: JAYMAC Pharmaceuticals, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Updated June 9, 2019
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
EnBrace® HR is an orally administered prescription prenatal vitamin drug for therapeutic use formulated to meet the unique nutritional needs of pregnancy - regardless of lactation status. EnBrace® HR may be taken by female macrocytic anemia patients that are in need of treatment and are under specific direction and monitoring of vitamin B9 and vitamin B12 status by a physician.
EnBrace® HR is intended for women of childbearing age, and may be prescribed for women at risk of folate or cobalamin deficiency - including folate-induced perinatal and postpartum depression, and are at risk of folate-induced birth defects such as may be found with spina bifida and other neural tube defects (NTDs).
EnBrace® HR is intended to address the increased need for metabolically-active variants of vitamin B9-vitamers in the cerebrospinal fluid, plasma, and/or red blood cells - as may be found in the SNP (Single-Nucleotide Polymorphisms) known as MTHFR (MethyleneTetraHydroFolate Reductase). EnBrace® HR achieves this through passive diffusion of these different biologically-active vitamers.
EnBrace® HR contains a small amount of iron and may be taken concurrently with iron supplementation.
Control-release, citrated folic acid, DHF+ (B9 - Provitamin) 1 mg1 Vitamin B12 [cobamamide] 50 mcg2 FeGC [ferrous glycine cysteinate] (1.5 mg elemental iron) 13.6 mg3 ALSO CONTAINS: Folinic acid (B9-vitamer) 2.5 mg1 Levomefolic acid (B9 & B12 - cofactor) 5.23 mg4
1 6 mg DFE folate (vitamin B9)
2 The form most found in mammalian liver - adjusted for stability and pH in the presence of stomach substance, is a cobamamide, or vitamin B12
3 Pure amino acid, cysteinated iron chelate as AminoFerTM* under exclusive license
4 9 mg DFE l-methylfolate magnesium (molar equivalent)
* AminoFerTM (Viva Pharmaceuticals, Canada) U.S. Patent # 7,341,708
FUNCTIONAL EXCIPIENTS: 25 mg ascorbates5,6 (24 mg magnesium l-ascorbate, 1 mg zinc l-ascorbate) [antioxidant], at least 23.33 mg phospholipid-omega 3 complex7 [marine lipids] , 500 mcg betaine (trimethylglycine) [acidifier], 1 mg magnesium l-threonate [stabilizer].
OTHER EXCIPIENTS: "Annatto color" (as a blend of annatto with stomach substance [thickener/stabilizer]) [colorant], citrates (citric, sodium) [stabilizers], flavin adenine dinucleotide 8 (FAD), gelatin (bovine), glycerine, plant lipids (sunflower) [lecithin], natural orange flavor [masking], nicotinamide adenine dinucleotide hydride 8 (NADH), pyridoxal 5’ phosphate 8 (P5P), piperine [bioavailability enhancer], purified water, thiamine pyrophosphate 8 , ubidecarenone [antioxidant], yellow beeswax.
5 20% daily value (DV) of VITAMIN C, and 5% DV IRON for pregnancy
6 NOT a significant source of magnesium and zinc
7 Contains at least 12 mg phosphatidylserine (PS) – of which approximately 6.4 mg as PS-DHA-Ca, and less than 1% EPA (<800 mcg PS-EPA-Ca)
8 Contains less than 2% (<25 mcg/each) of vitamins B1, B2, B3 and B6
Certified 3rd-partyGLUTEN-FREE.No artificial colorants. No dairy, wheat, sugar or egg.
MECHANISM OF ACTION:
Vitamin B9[treatment]; Vitamin B12 [prevention]; and Iron [prophylactic].
Vitamin B9 deficiency results in megaloblastic anemia. Vitamin B9 stimulates specifically the production of red blood cells, white blood cells, and platelets in persons suffering from certain megaloblastic anemias.
Folic acid, folinic acid and l-methylfolate metabolism results in the creation of tetrahydrofolic acid by different pathways. Both folinic acid and levomefolic acid do not require dihydrofolate reductase (DHR), however folic acid does.
Vitamin B12 deficiency results in megaloblastic anemia, GI lesions, and neurological damage that begins with an inability to produce myelin and is followed by gradual degeneration of the axon and nerve head. Vitamin B12 has hematopoietic activity apparently identical to that of the anti-anemia factor in purified liver extract.
Inborn errors of metabolism (IEMs) - such as methyltetrahydrofolate reductase (MTHFR), may also inhibit cobalamin intracellular conversion due to impaired ability to metabolize folic acid.
EnBrace® HR is indicated in the treatment of folate-induced macrocytic anemias before, during or after pregnancy including megaloblastic anemias, and the prevention of cobalamin deficiency.
Requirements of vitamin B9 and/or vitamin B12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral supplementation.
(What is this?)
- USE OF THIS PRODUCT WITHOUT DIRECT SUPERVISION OF A PHYSICIAN IS DANGEROUS.
- Some patients afflicted with pernicious anemia may or not respond to the orally ingested vitamin B12, and there is no known way to predict which patients may respond and which patients may cease to respond.
- Periodic examination and laboratory studies of pernicious anemia patients are essential and recommended.
- The parenteral administration of (cyano)cobalamin – or vitamin B12, is generally recognized as a fully effective treatment of pernicious anemia. Parenteral alkyl-cobalamin preparations have not been and are not authorized for use except by or on the prescription of a physician.
0.1 mg or more of folic acid daily may obscure pernicious anemia in that the hematological remission may occur while neurological manifestations remain progressive. The safe tolerable limit for folic acid (in preparations) is 1 mg [emphasis added].
Folic acid is not a substitute for vitamin B12 - although it may improve vitamin B12-deficient megaloblastic anemia. Exclusive use of folic acid in treating vitamin B12-deficient megaloblastic anemia could result in progressive and irreversible neurologic damage. Specifically, vitamin B12 deficiency allowed to progress over 3 months may produce permanent degenerative lesions of the spinal cord - as observed when folate therapy is used as the only hematopoietic agent.
Doses of vitamin B12 exceeding 10 mcg daily may produce hematologic response in patients with folate deficiency. Indiscriminate administration may mask the true diagnosis.
A dietary deficiency of only vitamin B12 is rare; multiple vitamin deficiency is expected in any dietary deficiency. No single regimen fits all cases, and the status of the patient observed in follow-up is the final criterion for adequacy of therapy.
Colchicine, para-aminosalicylic acid, and heavy alcohol intake for longer than 2 weeks may produce malabsorption of vitamin B12.
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY:
There is no evidence from long-term use in patients with pernicious anemia that vitamin B12 or folate is carcinogenic. Pernicious anemia is associated with increased incidence of carcinoma of the stomach, but this is believed to be related to the underlying pathology and not to treatment with vitamin B12.
PREGNANCY, NURSING MOTHERS, PEDIATRIC USE:
Vitamin B9 and vitamin B12 are essential vitamins and requirements are increased during pregnancy. Amounts of vitamin B9 and vitamin B12 that are recommended by the Food and Nutrition Board, National Academy of Science - National Research Council for lactating women should be consumed during pregnancy.
Vitamin B12 and vitamin B9 appear in the milk of nursing mothers in concentrations which approximate the mother’s vitamin B12 and vitamin B9 blood level. Amounts of vitamin B12 that are recommended by the Food and Nutrition Board, National Academies of Science - National Research Council for lactating women should be consumed during lactation.
Intake in pediatric patients should be in the amount recommended by the Food and Nutrition Board, National Academy of Science - National Research Council.
- ADVERSE REACTIONS:
DOSAGE AND ADMINISTRATION:
The adult dose is one capsule daily preferably on an empty stomach.
As a general rule reticulocyte plasma count, folate and vitamin B12 status must be obtained prior to treatment.
Do not exceed recommended dose. Call your medical practitioner about side effects. You may report side effects by calling 337.662-5962.
- HOW SUPPLIED:
SPL UNCLASSIFIED SECTION
Rx Only [DRUG]
Caution: Federal law prohibits dispensing without a prescription.
KEEP OUT OF THE REACH OF CHILDREN.
Tamper Evident:Do not use if seal is broken or missing.
JayMac Pharmaceuticals, LLC; Sunset, LA 70584.
MANUFACTURED AND/OR PACKAGED IN USA/CANADA.
US Patent No 7,935,365; and other patent applications pending.
EnBrace® HR is a registered mark of JayMac Pharmaceuticals. DeltaFolate™ is a use-trademark of JayMac Pharmaceuticals.
Revision 3(April 2019)
- PRINCIPAL DISPLAY PANEL:
INGREDIENTS AND APPEARANCE
levomefolate magnesium, leucovorin, folic acid, ferrous cysteine glycinate, magnesium ascorbate, zinc ascorbate, cocarboxylase, flavin adenine dinucleotide, nadh, pyridoxal phosphate anhydrous, cobamamide, betaine, magnesium l-threonate, 1,2-docosahexanoyl-sn-glycero-3-phosphoserine calcium, 1,2-icosapentoyl-sn-glycero-3-phosphoserine calcium, and phosphatidyl serine capsule, delayed release pellets
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64661-650 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVOMEFOLATE MAGNESIUM (UNII: 1VZZ62R081) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID 5.23 mg LEUCOVORIN (UNII: Q573I9DVLP) (LEUCOVORIN - UNII:Q573I9DVLP) LEUCOVORIN 2.5 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg FERROUS CYSTEINE GLYCINATE (UNII: 8B4OP7RK5N) (FERROUS CATION - UNII:GW89581OWR) FERROUS CYSTEINE GLYCINATE 13.6 mg MAGNESIUM ASCORBATE (UNII: 0N1G678593) (ASCORBIC ACID - UNII:PQ6CK8PD0R) MAGNESIUM ASCORBATE 24 mg ZINC ASCORBATE (UNII: 9TI35313XW) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ZINC ASCORBATE 1 mg COCARBOXYLASE (UNII: Q57971654Y) (COCARBOXYLASE - UNII:Q57971654Y) COCARBOXYLASE 25 ug FLAVIN ADENINE DINUCLEOTIDE (UNII: ZC44YTI8KK) (FLAVIN ADENINE DINUCLEOTIDE - UNII:ZC44YTI8KK) FLAVIN ADENINE DINUCLEOTIDE 25 ug NADH (UNII: 4J24DQ0916) (NADH - UNII:4J24DQ0916) NADH 25 ug PYRIDOXAL PHOSPHATE ANHYDROUS (UNII: F06SGE49M6) (PYRIDOXAL PHOSPHATE ANHYDROUS - UNII:F06SGE49M6) PYRIDOXAL PHOSPHATE ANHYDROUS 25 ug COBAMAMIDE (UNII: F0R1QK73KB) (COBAMAMIDE - UNII:F0R1QK73KB) COBAMAMIDE 50 ug BETAINE (UNII: 3SCV180C9W) (BETAINE - UNII:3SCV180C9W) BETAINE 500 ug MAGNESIUM L-THREONATE (UNII: 1Y26ZZ0OTM) (THREONIC ACID, DL- - UNII:NTD0MI8XRT) MAGNESIUM L-THREONATE 1 mg 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM (UNII: 6WJM73T46K) (1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE - UNII:DVY07ILF1W) 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM 6.4 mg 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM (UNII: 9ABD9DRK7B) (1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE - UNII:C3019D8IIA) 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM 800 ug PHOSPHATIDYL SERINE (UNII: 394XK0IH40) (PHOSPHATIDYL SERINE - UNII:394XK0IH40) PHOSPHATIDYL SERINE 12 mg Inactive Ingredients Ingredient Name Strength ANNATTO (UNII: 6PQP1V1B6O) GELATIN (UNII: 2G86QN327L) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) PIPERINE (UNII: U71XL721QK) WATER (UNII: 059QF0KO0R) UBIDECARENONE (UNII: EJ27X76M46) YELLOW WAX (UNII: 2ZA36H0S2V) Product Characteristics Color BROWN (ANNATTO) Score no score Shape CAPSULE (oval) Size 14mm Flavor Imprint Code ENL Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64661-650-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 08/12/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 08/12/2011 Labeler - JAYMAC Pharmaceuticals, LLC (830767260) Registrant - JAYMAC Pharmaceuticals, LLC (830767260)