FDA Label for Foltrexyl

Description

Foltrexyl™ is an orally administered prescription folate product for the dietary management of patients with unique
nutritional needs requiring increased folate levels and Vitamin D supplementation due to Vitamin D deficiency.

Foltrexyl™ should be administered under the supervision of
a licensed medical practitioner.

Each tablet contains:
Folate (as folic acid)……………………..1700 mcg DFE†
(1000 mcg folic acid)
Vitamin D3 (cholecalciferol)………....125 mcg (5000 IU)

Each tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium
starch glycolate, stearic acid, magnesium stearate.

† Dietary Folate Equivalent

Indications And Dosage

Foltrexyl™ is indicated for dietary management of patients with unique nutritional needs requiring increased folate
levels and Vitamin D supplementation.

Foltrexyl™ can be taken by women of childbearing age, pregnant women, and lactating and nonlactating mothers.

Clinical Pharmacology

The in vivo synthesis of the major biologically active metabolites of vitamin D occurs in two steps. The first hydroxylation of ergocalciferol takes place in the liver (to 25-hydroxyvitamin D) and the second in the kidneys (to 1,25-dihydroxyvitamin D). Vitamin D metabolites promote the active absorption of calcium and phosphorus by the small intestine, thus elevating serum calcium and phosphate levels sufficiently to permit bone mineralization. Vitamin D metabolites also mobilize calcium and phosphate from bone and probably increase the reabsorption of calcium and perhaps also of phosphate by the renal tubules.

There is a time lag of 10 to 24 hours between the administration of vitamin D and the initiation of its action in the body due to the necessity of synthesis of the active metabolites in the liver and kidneys. Parathyroid hormone is responsible for the regulation of this metabolism in the kidneys.

Contraindications

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Foltrexyl™ is
contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.

Warnings And Precautions

Tell your doctor if you have: kidney problems, thyroid disease. This medication should be used as directed during pregnancy or while breast-feeding. Consult your doctor about the risks and benefits.

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

Adverse Reactions

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact PureTek Corporation, at 1-877-921-7873.

Dosage And Administration

Take one tablet daily or as directed by a healthcare practitioner.

How Supplied

Foltrexyl™ Tablets are supplied as round, light yellow tablets with one side scored, the other side plain and dispensed in child-resistant bottles of 30 tablets (NDC 59088-447-54*).

* This product is a prescription-folate with or without other dietary ingredients that – due to increased folate levels (AUG 2, 1973 FR 20750), requires an Rx on the label because of increased risk associated with masking of B12 deficiency (pernicious anemia). Based on our assessment of the risk of obscuring pernicious anemia, this product requires licensed medical supervision, an Rx status, and a National Drug Code (NDC) or similarly-formatted product code, as required by pedigree reporting requirements and supply-chain control as well as in some cases, for insurance-reimbursement applications. All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence.

Storage

KEEP OUT OF THE REACH OF CHILDREN.

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Protect from heat, light and moisture.

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

Manufactured in the USA by:

PureTek Corporation

Panorama City, CA 91402

For questions or information

call toll-free: 877-921-7873

Package Label / Principal Display Panel

Manufactured in the USA by:
PureTek Corporation
Panorama City, CA 91402
For questions or information
call toll-free: 877-921-7873

List No. 44754JPA Rev. 38198