Label: BIOPAR DELTA-FORTE- 1 nf units, 50 mcg cbl, 2.5 mg f-thf, 1 mg pteglu-, 7 mg me-thf capsule

  • Category: HUMAN PRESCRIPTION DRUG LABEL

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Drug Label Information

Updated July 16, 2024

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  • DESCRIPTION

       [1 NF Units] [50 mcg CBl] [2.5 mg F-THf] [1 mg PteGlu-] [7 mg Me-THf]

       Prescription Hematopoietic Preparation For Therapeutic Use

       Multiphasic Softgels (30ct carton)

       NDC 64661-793-30
       Rx ONLY

       BioparTMdelta-FORTE is an orally administered prescription hematopoietic preparation for therapeutic use formulated for adult macrocytic anemia patients – specifically including pernicious anemia patients, ages 12 and up, who are under specific direction and monitoring of cobalamin and folate status by a physician.

  • INGREDIENTS

       Cobalamin-intrinsic factor concentrate (non-inhibitory)1 .............................................................................................. 1 NF Units§

       Adenosylcobalamin (coenzyme B12) .............................................................................................................................. 50 mcg

       Formyl folic acid, L-FTHf .............................................................................................................................................. 2.5 mg2

       Oxidized folic acid, DHf+ ................................................................................................................................................. 1 mg2

       Methyl folic acid, L-MeTHf ............................................................................................................................................... 7 mg2

          1 50 mcg Vitamin B12 (activity equivalent) and 50 mg of intrinsic factor concentrate§ from ultra-purified, porcine-derived stomach substance from a porcine, disease-free country; together these equal 1 NF Units. Cobalamin has hematopoietic activity apparently identical to that of the anti-anemia factor in purified liver-stomach extract

          2 Total folates is from l-methylfolate magnesium (molar equivalent) from amorphous, diastereoisomerically pure l-methylfolate (less than 1% d-isomer), DHF-dependent provitamin B9 (folic acid included) and the levo-isomer of folinic acid (label claim molar equivalent).

  • INACTIVES

    ALSO CONTAINS:

          25 mg ascorbates4a (24 mg magnesium l-ascorbate, 1 mg zinc l-ascorbate) [antioxidant], 13.6 mg chelates (Cys-Fe3 as cysteinated pure amino acid chelate subsisting of 1.5 mg elemental iron4a) [colorant], phospholipids (phosphatidylserine-docosahexaenoic acid complex5)


    OTHER INGREDIENTS:

          Annatto [colorant], betaine (trimethylglycine) [acidifier], citrates (citric acid, sodium citrate) [stabilizers], flavin adenine dinucleotide (B2-vitamer)4b, gelatin (bovine), glycerine, nicotinamide adenine dinucleotide hydride (B3-vitamer)4b, phospholipids (sunflower lecithin) [emulsifiers], piperine [bioavailability enhancer], purified water, pyridoxal 5’ phosphate (B6-vitamer)4bthiamine pyrophosphate (B1-vitamer)4b, ubidecarenone [antioxidant], yellow beeswax.

          3 Pure amino acid, cysteinated iron chelate.

          4a 30% daily value (DV) of VITAMIN C, and 10% DV IRON for geriatric patients.

          4b Contains less than 2% (<25 mcg/each) of vitamins B1, B2, B3 and B6.

          5 Contains at least 12 mg phosphatidylserine (PS) – of which approximately 6.4 mg as PS-DHA, and less than 1% EPA (<800 mcg PS-EPA)

  • CONTAINS

       FISH/KRILL/PORCINE (Intrinsic Factor/Cobalamin)/SOY

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

  • INDICATIONS & USAGE

    BioparTM delta-FORTE is specifically indicated as a primary and adjunctive treatment in pernicious anemia patients having idiosyncrasy or sensitivity to parenteral administration - or when parental therapy is refused;

  • MECHANISM OF ACTION

    COBALAMIN [TREATMENT]; FOLATE [PREVENTION]; INTRINSIC FACTOR [B12-ADJUVENT] -

    Cobalamin is essential for the synthesis of methionine from homocysteine - a reaction which also requires folate. In the absence of cobalamin - ie, cobalamin deficiency, tetrahydrofolate cannot be regenerated from l-methylfolic acid, and a functional folate deficiency occurs - ie, “methyl trap hypothesis”. Gastrointestinal absorption of cobalamin depends on the presence of sufficient intrinsic factor, and lack of intrinisic factor results in cobalamin deficiency.

  • DOSAGE & ADMINISTRATION

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

       A deficiency of cobalamin may present first as folate deficiency - which is why folate supplementation may mask the symptoms that would normally result and also why advanced folate supplementation requires licensed medical supervision; because of this, reticulocyte plasma count, cobalamin and folate must be obtained prior to treatmentRequirements of cobalamin and/or folate in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral supplementation. 

       As a general rule - in Pernicious Anemia patients, treatment will be required for the remainder of the patient’s life, and usually requires weekly or monthly injections at the doctor's office. Patients that are non-compliant with parenteral therapy (injections) may use this product as a substitute ONLY UNDER THE DIRECT SUPERVISION OF A LICENSED MEDICAL PRACTITIONER

  • ADVERSE REACTIONS

       Mild transient diarrhea, polycythemia vera, itching, transitory exanthema, feeling of swelling of entire body may occur with administration of cobalamin. Allergic sensitization has been reported following both oral and parenteral administration of folate.

       Sensitivity to porcine intrinsic factor derived from liver substance has been reported in patients, and may occur at any time; BioparTMdelta-FORTE contains a non-inhibitory form of intrinsic factor that is not derived from liver substance but rather just the mucosa (stomach substance) - in which such senstitivity is less likely to occur, however caution is advised and continuous monitoring under licensed medical supervision is required.

  • BOXED WARNING (What is this?)

    WARNING

    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 examinations and laboratory studies of pernicious anemia patients are essential and recommended; and -
    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.

  • 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 anemias. Exclusive use of folic acid in treating vitamin B12-deficient anemias 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; and -

          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 cobalamin.

          Epileptic, antineoplastic and Parkinson's medications are cautioned in the concimant use with folate supplementation.

  • HOW SUPPLIED

       BioparTM delta-FORTE is supplied as oval, annatto (”orangish-brown”) softgels* with imprint "7N3". Provided as a carton with 30 softgels in blister cards. NDC 64661-793-30.

  • REGULATORY

    BioparTM delta-FORTE is regulated as a drug to ensure it's use is under medical supervision, and because of this, advanced folate supplementation is possible [21 CFR 250.201]. Intrinsic Factor was first marketed as Extralin(R) in 1932, and Extralin-B(R) with B-vitamins in 1936, followed by the Becotin(R) product which contained all the equivalent vitamins as this product plus intrinsic factor. "Old" drugs, including virtamins, which were considered safe prior to 1938, were permitted to continue on the market without further review. However, FDA maintained the authority to review these old drugs if possible safety concerns became apparent. In 1951, the Durham-Humphrey Act was passed. This act formally differentiated between prescription and OTC drugs. - 44 FR 16131 (March 16, 1979).

  • STORAGE AND HANDLING

       Call your medical practitioner about side effects. You may report side effects by calling (337) 662-5962.

       KEEP THIS OUT OF THE REACH OF CHILDREN.

       (Tamper Evident: Do not use if seal is broken or missing)

    Do not exceed the recommended dose.

       STORAGE: Store at 20 ̊-25 ̊ C (68 ̊-77 ̊ F)

       CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION

       [Rx ONLY]

    PATENTS: Patent(s) pending.

    TRADEMARKS: BioparTM delta-FORTEis a registered mark of JayMac Pharmaceuticals. DeltaFolateTM is a use-trademark of Jaymac Pharmaceuticals.

       JAYMAC Pharmaceuticals, LLC

       Sunset, LA 70584

       MANUFACTURED AND/OR PACKAGED IN USA/CANADA

       Revision

       Dec 28, 2021

  • CARTON IMAGES

    carton 1

    carton 2

    carton 3

    carton 4

    carton 5

  • PACKAGE INSERT

    Package Insert

  • PILL/CAPSULE IMAGE

    Pill image

  • BLISTER CARD

    Blister card

  • INGREDIENTS AND APPEARANCE
    BIOPAR DELTA-FORTE 
    1 nf units, 50 mcg cbl, 2.5 mg f-thf, 1 mg pteglu-, 7 mg me-thf capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64661-793
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    INTRINSIC FACTOR (UNII: 70BT6OQT2Q) (INTRINSIC FACTOR - UNII:70BT6OQT2Q) INTRINSIC FACTOR50 mg
    COBALAMIN (UNII: 8406EY2OQA) (COBALAMIN - UNII:8406EY2OQA) COBALAMIN50 ug
    COBAMAMIDE (UNII: F0R1QK73KB) (COBAMAMIDE - UNII:F0R1QK73KB) COBAMAMIDE50 ug
    levoLEUCOVORIN (UNII: 990S25980Y) (LEVOLEUCOVORIN - UNII:990S25980Y) levoLEUCOVORIN2.5 mg
    DIHYDROFOLIC ACID (UNII: KXP0KNM559) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    LEVOMEFOLATE MAGNESIUM (UNII: 1VZZ62R081) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID7 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERROUS CYSTEINE GLYCINATE (UNII: 8B4OP7RK5N) 13.6 mg
    1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM (UNII: 6WJM73T46K) 6.4 mg
    1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM (UNII: 9ABD9DRK7B) 800 ug
    PHOSPHATIDYL SERINE (UNII: 394XK0IH40) 12 mg
    PYRIDOXAL PHOSPHATE ANHYDROUS (UNII: F06SGE49M6) 25 ug
    FLAVIN ADENINE DINUCLEOTIDE (UNII: ZC44YTI8KK) 25 ug
    NADH (UNII: 4J24DQ0916) 25 ug
    COCARBOXYLASE (UNII: Q57971654Y) 25 ug
    MAGNESIUM ASCORBATE (UNII: 0N1G678593) 24 mg
    ZINC ASCORBATE (UNII: 9TI35313XW) 1 mg
    RIBOFLAVIN (UNII: TLM2976OFR) 5 mg
    MAGNESIUM L-THREONATE (UNII: 1Y26ZZ0OTM) 1 mg
    BETAINE (UNII: 3SCV180C9W) 500 ug
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 1.83 mg
    SODIUM CITRATE (UNII: 1Q73Q2JULR) 3.67 mg
    ANNATTO (UNII: 6PQP1V1B6O)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PIPERINE (UNII: U71XL721QK)  
    WATER (UNII: 059QF0KO0R)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Product Characteristics
    Colorbrown (ORANGISH-BROWN) Scoreno score
    ShapeOVALSize16mm
    FlavorImprint Code 7N3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64661-793-3030 in 1 CARTON06/01/202406/01/2024
    11 in 1 BLISTER PACK; Number of Units = 3; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/01/2024
    Labeler - Jaymac Pharma (830767260)
    Registrant - Jaymac Pharma (830767260)
    Establishment
    NameAddressID/FEIBusiness Operations
    Viva Pharmaceuticals INC253288898manufacture(64661-793)