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.

Drug Label Information

Updated November 29, 2018

If you are a consumer or patient please visit this version.

  • BOXED WARNING(What is this?)

    WARNINGS:

    1. USE OF THIS PRODUCT WITHOUT DIRECT SUPERVISION OF A PHYSICIAN IS DANGEROUS.
    2. 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.
    3. Periodic examination and laboratory studies of pernicious anemia patients are essential and recommended
    4. 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.

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  • SPL UNCLASSIFIED SECTION

    EnBrace® HR

    with DeltaFolate™

    [1 NF Units] [15 mg DFE Folate]

    ANTI-ANEMIA PREPARATION as extrinsic/intrinsic factor concentrate plus folate.

    Prescription Prenatal/Vitamin DrugFor Therapeutic Use

    Multi-phasic Capsules (30ct bottle)

    NDC 64661-650-30

    Rx Only [DRUG]

    GLUTEN-FREE

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  • DESCRIPTION:

    EnBrace® HR is an orally administered prescription prenatal/vitamindrugfor therapeutic use formulated for female macrocytic anemia patients that are in need of treatment, and are under specific direction and monitoring of vitamin B12 and vitamin B9 status by a physician.  EnBrace® HR is intended for women of childbearing age who are – or desire to become, pregnant regardless of lactation status. EnBrace® HR may be prescribed for women at risk of depression as a result of folate or cobalamin deficiency - including folate-induced postpartum depression, or are at risk of folate-induced birth defects such as may be found with spina bifida and other neural tube defects (NTDs).

    INGREDIENTS:

    INGREDIENTS
    *
    National Formulary Units ("NF UNITS") equivalent to 50 mcg of active coenzyme cobalamin (as cobalamin (as cobamamide concentrate with intrinsic factor)
    6 mg DFE folate (vitamin B9)
    9 mg l-methylfolate (molar equivalent)
         Cobalamin intrinsic factor complex  1 NF Units*
    ALSO CONTAINS:
         Folinic acid (B9-vitamer)  2.5 mg
         Control-release, citrated folic acid, DHF+(B9-Provitamin)  1 mg
         Levomefolic acid (B​9​ & B​12​- cofactor)  5.23 mg

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  • INACTIVE INGREDIENT

    FUNCTIONAL EXCIPIENTS: 13.6 mg FeGC as ferrous glycine cysteinate (1.5 mg elemental iron3) [colorant], 25 mg ascorbates3,4 (24 mg magnesium l-ascorbate, 1 mg zinc l-ascorbate) [antioxidant], at least 23.33 mg phospholipid-omega3 complex5 [marine lipids], 500 mcg betaine (trimethylglycine) [acidifier], 1 mg magnesium l-threonate [stabilizer].

    OTHER EXCIPIENTS: Annatto [colorant], citrates (citric, sodium) [stabilizers], flavin adenine dinucleotide6 (FAD), gelatin (bovine), glycerine, plant lipids (sunflower) [lecithin], natural orange flavor [masking], nicotinamide adenine dinucleotide hydride6 (NADH), pyridoxal 5’ phosphate6 (P5P), piperine [bioavailability enhancer], purified water, thiamine pyrophosphate6, ubidecarenone [antioxidant], yellow beeswax.

    3 20% daily value (DV) of VITAMIN C, and 5% DV IRON.

    4 NOT a significant source of magnesium and zinc.

    5 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)

    6 Contains less than 2% (<25 mcg/each) of vitamins B1, B2, B3 and B6.  

    CONTAINS FISH/KRILL/SOY.

    Certified 3rd-party GLUTEN-FREE. No artificial colorants. No dairy, wheat, sugar or egg.

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  • MECHANISM OF ACTION:

    Vitamin B12 [treatment]; Vitamin B9 [prevention]; Intrinsic Factor[facilitator].

    [Vitamin B12]

    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.

    [Vitamin B12] / [Intrinsic factor]

    Gastrointestinal absorption of cobalamin depends on the presence of sufficient intrinsic factor. Intrinsic factor deficiency causes pernicious anemia - which may be associated with subacute combined degeneration of the spinal cord.

    [Vitamin B9]

    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 B9] / [Vitamin B12]

    Vitamin B12 is essential for the synthesis of methionine from homocysteine - a reaction which also requires folate. In the absence of Vitamin B12, tetrahydrofolate cannot be regenerated from 5-methyltetrahydrofolate, and a functional Vitamin B9 deficiency occurs (ie, “methyl trap hypothesis”).

    Inborn errors of metabolism (IEMs) - such as methyltetrahydrofolate reductase (MTHFR), may also inhibited cobalamin intracellular conversion due to impaired ability to metabolize folic acid.

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  • iNDICATIONS

    EnBrace® HR is indicated in the treatment of macrocytic anemias before, during or after pregnancy - including pernicious anemia and megaloblastic anemia, and the prevention of folic acid deficiency.

    Requirements of vitamin B12 and/or vitamin B9 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral supplementation.

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  • PRECAUTIONS​:

    GENERAL:

    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.

    DRUG INTERACTIONS:

    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 B12 and vitamin B9 are essential vitamins and requirements are increased during pregnancy. Amounts of vitamin B12 and vitamin B9 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.

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  • ADVERSE REACTIONS:

    Mild transient diarrhea, polycythemia vera, itching, transitory exanthema, feeling of swelling of entire body may occur with administration of vitamin B12

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

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  • DOSAGE AND ADMINISTRATION​:

    The adult dose is one capsule daily preferably on an empty stomach.

    As a general rule - in patients with Addisonian Pernicious Anemia, treatment will be required for the remainder of the patient’s life. Reticulocyte plasma count, vitamin B12 and folate 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.

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  • HOW SUPPLIED:

    Oval, brownish-orange softgel capsule with “ENL7 on one side, in bottles of 30 with NDC 64661-650-30.

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  • STORAGE:

    Oval, brownish-orange softgel capsule with “ENL7 on one side, in bottles of 30 with NDC 64661-650-30.

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  • ​STORAGE:

    Store at 20°-25°C (68°-77°F). Protect from light and moisture as contact with moisture may produce surface discoloration and/or erosion.

    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.

    7 Upper case.

    MANUFACTURED FOR:

    JayMac Pharmaceuticals, LLC; Sunset, LA 70584.

    MANUFACTURED AND/OR PACKAGED IN USA/CANADA.

    PATENTS

    US Patent No 7,935,365; and other patent applications pending.

    TRADEMARKS:

    EnBrace® HR is a registered mark of JayMac Pharmaceuticals. DeltaFolate™ is a use-trademark of JayMac Pharmaceuticals.

    Revision 3(November 14, 2018)

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  • PRINCIPAL DISPLAY PANEL:

    NDC 64661-650-30

    Rx Only

    with DeltaFolateTM

    EnBrace™HR™

    [1 NF Units]

    [15 mg DFE Folate]

    ANTI-ANEMIA PREPARATION

    as extrinsic/intrinsic factor concentrate plus folate.

    JAYMAC
    Pharmaceuticals, LLC

    SOFTGEL (30 ct BOTTLE)

    Prescription Prenatal/Vitamin Drug

    For Therapeutic Use

    Enbrace Label

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  • INGREDIENTS AND APPEARANCE
    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
    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 04/08/2015
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 04/08/2015
    Labeler - JAYMAC Pharmaceuticals, LLC (830767260)
    Registrant - JAYMAC Pharmaceuticals, LLC (830767260)
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