BOXED WARNING SECTION.
WARNING. USE OF THIS PRODUCT WITHOUT DIRECT SUPERVISION OF 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 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 physician.
ADVERSE REACTIONS SECTION.
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; BioparTM delta-FORTE contains 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.
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 BioparTM delta-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 physician. recent study+ suggested that BioparTM delta-FORTE was effective in lowering homocysteine levels in patients that are positive for MTHFR (methylenetetrahydrofolate reductase polymorphism). BioparTM delta-FORTE may be taken by women of childbearing age. BioparTM 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 Vitamins in Patients with MDD Who Are Positive for MTHFR C677T or A1298C Polymorphism.
DOSAGE & ADMINISTRATION SECTION.
DOSAGE ADMINISTRATION. The adult dose is one capsule daily preferably on an empty stomach. 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 general rule in Pernicious Anemia patients, treatment will be required for the remainder of the patients life, and usually requires weekly or monthly injections at the doctors office. Patients that are non-compliant with parenteral therapy (injections) may use this product as substitute ONLY UNDER THE DIRECT SUPERVISION OF LICENSED MEDICAL PRACTITIONER.
HOW SUPPLIED SECTION.
HOW SUPPLIED. BioparTM delta-FORTE is supplied as oval, annatto (orangish-brown) multiphasic softgels with imprint 7N3. Provided as carton with 30 softgels in blister cards. NDC 64661-793-30.
INDICATIONS & USAGE SECTION.
INDICATIONS USAGE. BioparTM delta-FORTE is indicated in the treatment of pernicious anemia and the prevention of folate deficiency; BioparTM delta-FORTE is specifically indicated as primary and adjunctive treatment in pernicious anemia patients having idiosyncrasy or sensitivity to parenteral administration or when parental therapy is refused; BioparTM 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 number of conditions associated with 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 SECTION.
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 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.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
CARTON IMAGES. carton 1. carton 2. carton 3. carton 4. carton 5.
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 mg [emphasis added]; Folic acid is not 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 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 weeks may produce malabsorption of cobalamin. Epileptic, antineoplastic and Parkinsons medications are cautioned in the concimant use with folate supplementation.
SPL UNCLASSIFIED SECTION.
CONTAINS. FISH/KRILL/PORCINE (Intrinsic Factor/Cobalamin)/SOY Certified 3rd-party GLUTEN-FREE. No artificial colorants. No dairy, wheat, sugar or egg.
STORAGE AND HANDLING SECTION.
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 (68 -77 F) CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION [Rx ONLY]PATENTS: Patent(s) pending.TRADEMARKS: BioparTM delta-FORTE is registered mark of JayMac Pharmaceuticals. DeltaFolateTM is use-trademark of Jaymac Pharmaceuticals. JAYMAC Pharmaceuticals, LLC Sunset, LA 70584 MANUFACTURED AND/OR PACKAGED IN USA/CANADA Revision August 26, 2020.