ENLYTE EXTRA-LN- cobalamin-intrinsic factor complex, folic acid - rx only capsule

EnLyte Extra-LN by

Drug Labeling and Warnings

EnLyte Extra-LN by is a Prescription medication manufactured, distributed, or labeled by Jaymac Pharmacueticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTI-ANEMIA PREPARATION as cobalamin-intrinsic factor concentrate plus folate

EnLyteTM Extra-LN

[1 NF Units*] [1mg PteGlu]

Prescription Hematinic Drug For Therapeutic Use

Softgel Capsules (30ct carton)

NDC 64661-117-30
Rx Only [DRUG]
GLUTEN-FREE

DESCRIPTION

EnLyteTM Extra-LN is an orally administered prescription hematinic drug for therapeutic use formulated for adult macrocytic anemia patients – specifically the treatment of pernicious anemia and the prevention of folate deficiency, ages 12 and up, who are under specific direction and monitoring of cobalamin and folate status by a physician. EnLyteTM Extra-LN may be useful in patients at risk of depression due to a deficiency of cobalamin and/or folate. EnLyteTM Extra-LN may be taken by women of childbearing age. EnLyteTM Extra-LN may be taken by geriatric patients where compliance is an issue. EnLyteTM Extra-LN may be taken in pediatric situations where age-appropriate oral ingestion is not a concern given strict monitoring of a physician but should never replace parenteral treatment - especially in that age group where the permanent effects of folate and/or cobalamin deficiency rapidly develop at a pace markedly different than adult populations.

ACTIVE INGREDIENTS

Cobalamin-intrinsic factor concentrate ....................... 1 NF Units* +

Reduced folic acid, DHF- ....................................... 1 mg ++

+ 50 mcg coenzyme-B12 (25 mcg as adenosyl cobamamide and 25 mcg as methyl cobalamin), and 25 mg of intrinsic factor concentrate from
ultra-purified, porcine-derived stomach/liver substance from a porcine, disease-free country. Together these equal 1 NF Units.

++ 15 mg DFE [Dietary Folate Equivalent] from total folates [as 15 mg DeltaFolateTM] - l-methylfolate magnesium and folinic acid, as reconstituted factions of the liver-stomach substance derived, intrinsic factor cofactors naturally present but lost in the purification process. Note: The FDA has stated there exists little evidence of doses above 1 mg of folic acid have any greater efficacy in approved indications - including megaloblastic anemias.

EXCIPIENTS

FUNCTIONAL EXCIPIENT:  25 mg ascorbates (3,4) [24 mg magnesium l-ascorbate, 1 mg zinc l-ascorbate] [antioxidant], 450 mcg cobalamin (3) [thickening agent]; methacrylic acid-divinylbenzene copolymer (3) [cobalamin carrier]; phosphatE (3) [5 mg pyridoxal 5' phosphate] [pH-adjuster]; at least 23.33 mg phospholipid-omega complex (5) [marine lipids] [blending agent]; at least 5 mg riboflavin (3) [colorant]; and 1 mg magnesium l-threonate [stabilizer].

OTHER EXCIPIENTS: "Annatto color" (as a blend of annatto with riboflavin) [colorant]; gelatin (bovine); glycerine; plant lipids (sunflower) [lecithin]; piperine [bioavailability enhancer]; purified water; yellow beeswax.

(3) 25 mg ASCORBIC ACID (21CFR182.3013), 450 mcg CYANOCOBALAMIN (21CFR184.1945), 5 mg RIBOFLAVIN (21CFR184.1695 and 21CFR73.450), 5 mg PHOSPHATE (21CFR182.1073) - as PYRIDOXAL 5' PHOSPHATE, and METHACRYLIC ACID-DIVINYLBENZENE COPOLYMER (21CFR172.775) as FUNCTIONAL EXCIPIENTS.

(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).

DOSAGE & 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, cobalamin and folate must be obtained prior to treatment.

MECHANISM OF ACTION

Cobalamin [treatment]; Folate [prevention]; Intrinsic Factor [facilitator] -

[Cobalamin]

   Cobalamin 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. cobalamin has hematopoietic activity apparently identical to that of the anti-anemia factor in purified liver extract.

[Cobalamin] / [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.

[Folate]

   Folate deficiency results in megaloblastic anemia. Folate stimulates specifically the production of red blood cells, white blood cells, and platelets in persons suffering from certain megaloblastic anemias.
Folic acid, formylfolic acid and l-methylfolic acid metabolism results in the creation of tetrahydrofolic acid by different pathways. Both formylfolic acid and l-methylfolic acid acid do not require dihydrofolate reductase (DHR), however folic acid does.

[Folate] / [Cobalamin]

   Cobalamin is essential for the synthesis of methionine from homocysteine - a reaction which also requires folate. In the absence of cobalamin, tetrahydrofolate cannot be regenerated from 5-methyltetrahydrofolate, and a functional folate 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.

INDICATIONS & USAGE

EnLyteTM Extra-LN is indicated in the treatment of macrocytic anemias resulting from cobalamin deficiency - including pernicious anemia, and the prevention of folate deficiency;

EnLyteTM Extra-LN is indicated as a primary and adjunctive treatment in megaloblastic anemia associated with tropical and non-tropical sprue, in anemias of nutritional origen, pregnancy, alcoholism, infancy and childhood as well as pernicious anemia patients having idiosyncrasy or sensitivity to parenteral administration (or when parental therapy is refused);

EnLyteTM Extra-LN is indicated in the maintenance of normal hematologic status (hematopoiesis) as well as supplement for other cobalamin deficiencies, including:

1. Dietary deficiency of cobalamin occurring in strict vegetarians;
2. 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. These conditions include HIV infections, AIDS, Crohn’s disease, tropical sprue, and nontropical sprue (idiopathic steatorrhea, gluten-induced enteropathy). Folate deficiency in these patients is usually more severe than cobalamin deficiency;
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 (such as multiple sclerosis, HIV infection, AIDS, 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;
4. Competition for cobalamin by intestinal parasites or bacteria. The fish tapeworm (Diphyllobothrium latum - usually found in raw fish such as sushi) absorbs huge quantities of cobalamin and infested patients often have associated gastric atrophy. The blind loop syndrome may produce deficiency of cobalamin or folate; and -
5. Inadequate utilization of cobalamin. This may occur if antimetabolites fo the vitamin are employed in the treatment of neoplasia.

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.

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.

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; 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.

CONTAINS

FISH/KRILL/PORCINE (INTRINSIC FACTOR)/SOY

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

BOXED WARNING

(What is this?)

WARNING

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

HOW SUPPLIED

EnLyteTMExtra-LN is supplied in oval, reddish-brown - or "annatto" color as a blend of annatto, mecobal and riboflavin, with imprint "7u2".

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

OTHER/MISC

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 (21 CFR 250.201)

Rx Only

JAYMAC Pharmaceuticals, LLC

Sunset, LA 70584

MANUFACTURED AND/OR PACKAGED IN USA/CANADA

PATENTS: 

Patent(s) pending.

TRADEMARKS: 

EnLyteTM Extra-LN is a registered mark of JayMac Pharmaceuticals. DeltaFolateTM is a use-trademark of Jaymac Pharmaceuticals.

Rev DEC 2019

PATIENT PACKAGE INSERT

package insert

SPL UNCLASSIFIED SECTION

blisters

PRINCIPAL DISPLAY PANEL

Carton

INGREDIENTS AND APPEARANCE

ENLYTE EXTRA-LN 
cobalamin-intrinsic factor complex, folic acid - rx only capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 64661-117
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIHYDROFOLIC ACID (UNII: KXP0KNM559) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
INTRINSIC FACTOR (UNII: 70BT6OQT2Q) (INTRINSIC FACTOR - UNII:70BT6OQT2Q)	INTRINSIC FACTOR	25 mg
COBAMAMIDE (UNII: F0R1QK73KB) (COBAMAMIDE - UNII:F0R1QK73KB)	COBAMAMIDE	25 ug
METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W)	METHYLCOBALAMIN	25 ug

Inactive Ingredients
Ingredient Name	Strength
PYRIDOXAL PHOSPHATE ANHYDROUS (UNII: F06SGE49M6)	5 mg
PHOSPHATIDYL SERINE (UNII: 394XK0IH40)	12 ug
1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE (UNII: C3019D8IIA)	800 ug
1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE (UNII: DVY07ILF1W)	6.4 mg
ZINC ASCORBATE (UNII: 9TI35313XW)	1 mg
MAGNESIUM ASCORBATE (UNII: 0N1G678593)	24 mg
RIBOFLAVIN (UNII: TLM2976OFR)	5 mg
MAGNESIUM L-THREONATE (UNII: 1Y26ZZ0OTM)	1 mg
LEVOMEFOLATE MAGNESIUM (UNII: 1VZZ62R081)	7 mg
LEVOLEUCOVORIN (UNII: 990S25980Y)	2.5 mg
CYANOCOBALAMIN (UNII: P6YC3EG204)	450 ug
ANNATTO (UNII: 6PQP1V1B6O)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
PIPERINE (UNII: U71XL721QK)
WATER (UNII: 059QF0KO0R)
YELLOW WAX (UNII: 2ZA36H0S2V)

Product Characteristics
Color	orange (REDISH-BROWN WITH ORANGISH-YELLOW)	Score	no score
Shape	capsule	Size	14mm
Flavor		Imprint Code	7u2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64661-117-30	30 in 1 CARTON	12/16/2019
1		1 in 1 BLISTER PACK; Number of Units = 3; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/16/2019

Labeler - Jaymac Pharmacueticals LLC (830767260)

Registrant - Jaymac Pharmacueticals LLC (830767260)