Prescribing information (package insert) - EnBrace HR
EnBrace HR®
with DeltaFolate™
[15 mg DFE Folate ] [50 mcg CBl] [1.5 mg Cys-Fe]
ANTI-ANEMIA PREPARATION
Low-IRON
Prescription Prenatal Vitamin For Therapeutic Use
SOFTGEL (30ct bottle)
NDC 64661-650-30
Rx Only
DESCRIPTION:
EnBrace HR® is an orally administered prescription anti-anemia preparation and prenatal vitamin softgel for therapeutic use, formulated for adult patients, to be used under the supervision of a licensed medical practitioner. A clinical trial+ evaluated EnBrace HR® in women trying to conceive or in early pregnancy who had a history of depression and were undergoing treatment for it.
+ ClinicalTrials.gov identifier: NCT02676882, "EnBrace HR for Depression Treatment and Prevention in Women Trying to Conceive and Early Pregnancy"; Sponsor: Massachusetts General Hospital.
EnBrace HR® contains a small amount of iron and may be taken concurrently with iron supplementation.
INGREDIENTS:
Folic acid, DHF+ (B9-Provitamin) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (1.7 mg DFE) 1 mg
Folinic acid (B9-vitamer). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (4.25 mg DFE) 2.5 mg
Levomefolic acid (B9 & B12- cofactor) . . . . . . . . . . . . . . . . . . . . . . . . . . (9 mg DFE) 5.23 mg
Vitamin B12 [cobamamide] . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50 mcg1
FeGC (1.5 mg elemental iron from ferrous glycine cysteinate) . . . . . . . . . . . . 13.6 mg2,3
FUNCTIONAL EXCIPIENTS: 25 mg ascorbates3,4 (24 mg magnesium l-ascorbate, 1 mg zinc l-ascorbate), 500 mcg betaine (trimethylglycine), flavin adenine dinucleotide6 (FAD), 1 mg magnesium l-threonate, 25 mcg nicotinamide adenine dinucleotide hydride6 (NADH), at least 23.33 mg phospholipid-omega 3 complex5 [marine lipids], 25 mcg pyridoxal 5’ phosphate6 (P5P), 25 mcg thiamine pyrophosphate6.
OTHER EXCIPIENTS: Annatto [colorant], citrates (citric, sodium) [stabilizers], gelatin (bovine), glycerine, plant lipids (sunflower) [lecithin], natural orange flavor [masking], piperine [bioavailability enhancer], purified water, ubidecarenone [antioxidant], yellow beeswax.
1 The form most found in mammalian liver. 2 Pure amino acid, cysteinated iron chelate. 3 20% Daily Value (DV) of VITAMIN C, and 5% DV IRON for pregnancy. 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. No artificial colorants. No dairy, wheat, sugar or egg.
MECHANISM OF ACTION:
VITAMIN B12 [TREATMENT]; FOLATE [PREVENTION]; OTHER [SUPPLEMENTATION] Vitamin B12 is essential for the synthesis of methionine from homocysteine - a reaction which also requires l-methylfolate as a necessary cofactor. In the absence of vitamin B12, tetrahydrofolate cannot be regenerated from l-methylfolic acid, and a functional folate deficiency occurs - ie, “methyl trap hypothesis”. Repletion of vitamin B12 and l-methylfolate restores the remethylation of homocysteine to methionine, thereby reducing elevated plasma homocysteine levels in patients with hyperhomocysteinemia due to vitamin B12 and/or folate deficiency. Gastrointestinal absorption of vitamin B12 depends on the presence of sufficient intrinsic factor, and lack of intrinsic factor results in vitamin B12 deficiency (ie, pernicious anemia).
INDICATIONS:
EnBrace HR® is indicated in the TREATMENT of vitamin deficiency - specifically vitamin B12 deficiency - and TREATMENT of hyperhomocysteinemia due to vitamin B12 and/or folate deficiency, and the PREVENTION of deficiency of the vitamin B12 cofactor, l-methylfolate.
Requirements of vitamin B9 and/or vitamin B12 in excess of normal due to pregnancy can usually be met with oral supplementation.
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 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:
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.
DOSAGE AND ADMINISTRATION:
The recommended dosage is one (1) capsule daily, preferably on an empty stomach. Dosage may be adjusted by a healthcare provider based on individual patient needs.
As a general rule reticulocyte plasma count, folate and vitamin B12 status must be obtained prior to treatment.
Do not exceed the recommended dose. Call your medical practitioner about side effects. You may report side effects by calling (866) 280-5961.
HOW SUPPLIED:
Oval, brownish-orange softgel capsule with imprint ENL.
STORAGE:
Store at 20°-25°C (68°-77°F). Protect from light and moisture.
Rx ONLY
MANUFACTURED FOR: JayMac Pharmaceuticals, LLC; Sunset, LA 70584.
MANUFACTURED IN INDIA / PACKAGED IN USA
PATENTS: Patent applications pending .
TRADEMARKS: EnBrace HR® is a registered mark of JayMac Pharmaceuticals. DeltaFolate™ is a use-trademark of JayMac Pharmaceuticals.
V29 (Aug 2026)