FDA Label for Biopar Delta-forte

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

   Biopar^TMdelta-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. A recent study⁺ suggested that Biopar^TM delta-FORTE was effective in lowering homocysteine levels in patients that are positive for MTHFR (methylenetetrahydrofolate reductase polymorphism). Biopar^TM delta-FORTE may be taken by women of childbearing age. Biopar^TM delta-FORTE may be taken by geriatric patients where compliance is an issue.

    ⁺ ClinicalTrials.gov identifier: NCT02709668, Correlation of Clinical Response With Homocysteine Reduction During Therapy With Reduced B Vitamins in Patients with MDD Who Are Positive for MTHFR C677T or A1298C Polymorphism.

Ingredients

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

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

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

   Reduced 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 15 mg DFE DeltaFolate™ (total folates) of which 9 mg DFE is from l-methylfolate magnesium (molar equivalent) from amorphous, diastereoisomerically pure l-methylfolate (less than 1% d-isomer)

Inactives

FUNCTIONAL EXCIPIENTS:

      25 mg ascorbates^4a (24 mg magnesium l-ascorbate, 1 mg zinc l-ascorbate) [antioxidant], 13.6 mg chelates (FeGC³ as ferrous glycine cysteinate subsisting of 1.5 mg elemental iron^4a) [colorant].

OTHER EXCIPIENTS:

      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, phosphatidylserine-docosahexaenoic acid complex⁵) [emulsifiers], piperine [bioavailability enhancer], purified water, pyridoxal 5’ phosphate (B₆-vitamer)^4b, thiamine pyrophosphate (B₁-vitamer)^4b, ubidecarenone [antioxidant], yellow beeswax.

      ³ Pure amino acid, cysteinated iron chelate as AminoFer^TM under exclusive license by Viva Pharmaceuticals, Canada, U.S. Patent #7341708

      ^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

   Biopar^TMdelta-FORTE is indicated in the treatment of pernicious anemia and the prevention of folate deficiency;

   Biopar^TM 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;

   Biopar^TM delta-FORTE is further indicated in the maintenance of normal hematologic status (hematopoiesis) in macrocytic anemia conditions which are caused by either cobalamin and/or folate deficiency, and where increased intrinsic factor is desired - including:

      1. Malabsorption of cobalamin resulting from structural or functional damage to the stomach - where intrinsic factor is secreted, or to the ileum, where intrinsic factor facilitates cobalamin absorption. Folate deficiency in these patients is usually more severe than cobalamin deficiency;

      2. Genetic polymorphisms such as MTHFR that impede folate metabolism and the effective use of synthetic folic acid (oxidized form); and

      3. Inadequate secretion of intrinsic factor, resulting from lesions that destroy the gastric mucosa (ingestion of corrosives, extensive neoplasia), and a number of conditions associated with a variable degree of gastric atrophy (certain endocrine disorders, iron deficiency, and subtotal gastrectomy). Total gastrectomy always produces cobalamin deficiency. Structural lesions leading to cobalamin deficiency include regional ileitis, ileal resections, malignancies, etc

Mechanism Of Action

COBALAMIN [treatment]; FOLATE [prevention]; INTRINSIC FACTOR [facilitator] -

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 treatment. Requirements 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; Biopar^TMdelta-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.

Warning

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

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

Regulatory

Biopar^TMdelta-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].

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: Biopar^TMdelta-FORTE is 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

   August 26, 2020