Company:

Fleming

Hematinic

Cyanocobalamin 25micrograms/spray; nasal spray.

Maintenance of Vit. B₁₂ concentrations after normalization with IM Vit. B₁₂ therapy in patients with Vit. B₁₂ deficiency who have no nervous system involvement.

Vitamin B₁₂ is essential for cell growth and reproduction, hematopoiesis, and nucleoprotein and myelin synthesis. Rapidly dividing cells (e.g., epithelial cells, bone marrow, myeloid cells) have the greatest requirement for Vit. B₁₂. It is also essential for the conversion of methylmalonate to succinate and for the synthesis of methionine from homocysteine. In the blood, Vit. B₁₂ is bound to transcobalamin II (a carrier protein) and is distributed to tissues and stored primarily in the liver and bone marrow. A deficiency of Vit. B₁₂ in the body prevents tetrahydrofolate from being regenerated and results in functional folate deficiency. Vit. B₁₂ may also play a role in sulfhydryl-activated enzyme systems associated with fat and carbohydrate metabolism and protein synthesis.

A trial involving 25 Vit. B₁₂ deficient patients was conducted to assess the efficacy and safety of Calomist. Prior to enrollment, all subjects were required to have normal Vit. B₁₂ levels with intramuscular Vit. B₁₂ injections. One of the 25 patients dosed with Calomist was excluded from the efficacy analyses because a diagnosis of Vit. B₁₂ deficiency could not be confirmed. The 24 remaining patients were stabilized on intramuscular Vit. B₁₂ therapy and given once daily (50mcg) intranasal dosing with Calomist for 8 weeks. The serum Vit. B₁₂ concentrations were within the target range (>200ng/L) and slightly higher than those seen 2 to 4 weeks after administration of intramuscular Vit. B₁₂; the mean serum Vit. B₁₂ level was about 570ng/L at week 8 of the trial. Twenty-three of the 24 patients received 50mcg of Calomist daily for the duration of the trial and one patient required doubling of the Calomist dose from 50mcg to 100mcg daily during the last week of the study because of declining Vit. B₁₂ concentrations.

Not for newly diagnosed Vit. B₁₂ deficiency. Initially 1 spray in each nostril daily (50micrograms/day); if response inadequate, may increase to twice daily dosing (100micrograms/day). Renal or hepatic impairment: may require increased dosing or frequency.

Not recommended.

Avoid in Leber’s disease. Vit. B₁₂ concentrations should be normal prior to treatment; switch to IM injections if levels are low or decline. Nasal pathology; defer until nasal symptoms subside. Infections, uremia, concurrent iron, folic acid deficiency; may blunt therapeutic response. Obtain hematocrit, reticulocyte count, Vit. B₁₂, folate, and iron levels prior to and during treatment. Monitor potassium and platelet count during intense megaloblastic anemia treatment. Pregnancy (Cat.C). Nursing mothers.

Iron supplements or bone marrow suppressants (e.g., chloramphenicol) may blunt therapeutic response. Antibiotics, methotrexate, pyrimethamine may interfere with lab tests. Do not use for Schilling Test.

Rhinorrhea, nasopharyngitis, arthralgia, dizziness, headache, nasal discomfort, pain, bronchitis, rash.

Nasal spray—30mL (60 sprays)

1/4/08