NASCOBAL SUMMARY
Nascobal®
Nasal spray
(Cyanocobalamin, USP)
mcg/spray
2.3 mL (8 sprays)
Cyanocobalamin is a synthetic form of vitamin B12 with equivalent vitamin B12 activity.
Nascobal Nasal Spray is indicated for the maintenance of normal hematologic status in pernicious anemia patients who are in remission following intramuscular vitamin B12 therapy and who have no nervous system involvement.
Nascobal Nasal Spray is also indicated as a supplement for other vitamin B12 deficiencies, including:
I. Dietary deficiency of vitamin B12 occurring in strict vegetarians (Isolated vitamin B12 deficiency is very rare).
II. Malabsorption of vitamin B12 resulting from structural or functional damage to the stomach, where intrinsic factor is secreted, or to the ileum, where intrinsic factor facilitates vitamin B12 absorption. These conditions include HIV infection, AIDS, Crohn's disease, tropical sprue, and nontropical sprue (idiopathic steatorrhea, gluten-induced enteropathy). Folate deficiency in these patients is usually more severe than vitamin B12 deficiency.
III. 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 vitamin B12 deficiency. Structural lesions leading to vitamin B12 deficiency include regional ileitis, ileal resections, malignancies, etc.
IV. Competition for vitamin B12 by intestinal parasites or bacteria. The fish tapeworm (Diphyllobothrium latum) absorbs huge quantities of vitamin B12 and infested patients often have associated gastric atrophy. The blind loop syndrome may produce deficiency of vitamin B12 or folate.
V. Inadequate utilization of vitamin B12. This may occur if antimetabolites for the vitamin are employed in the treatment of neoplasia.
It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see Drug/Laboratory Test Interactions), use of a gluten free diet in nontropical sprue, or administration of antibiotics in tropical sprue. Such measures remove the need for long-term administration of vitamin B12.
Requirements of vitamin B12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with intranasal or oral supplementation.
Nascobal Nasal Spray is not suitable for vitamin B12 absorption test (Schilling Test).
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NEWS HIGHLIGHTSMedia Articles Related to Nascobal (Cyanocobalamin Nasal)
AHA: Correcting Iron Helps in CHF, Anemia or Not (CME/CE)
Source: MedPage Today Hematology/Oncology [2009.11.17]
ORLANDO (MedPage Today) -- Treating iron deficiency in heart failure patients makes patients feel better even in the absence of anemia, according to a randomized trial.
Anemia Drugs May Cause Deadly Blood Clots
Source: MedicineNet Anemia Specialty [2009.11.11]
Title: Anemia Drugs May Cause Deadly Blood Clots
Category: Health News
Created: 11/10/2009 4:10:00 PM
Last Editorial Review: 11/11/2009
Anemia Drugs May Cause Deadly Blood Clots (HealthDay)
Source: Y! Health News Search RSS Feed [2009.11.10]
HealthDay - TUESDAY, Nov. 10 (HealthDay News) -- New research on cancer
patients adds to the controversy surrounding anemia drugs such as Procrit
and Aranesp, concluding that they increase the risk of venous
thromboembolism, potentially fatal blood clots.
Study confirms clot risks with anti-anemia drugs (Reuters)
Source: Y! Health News Search RSS Feed [2009.11.10]
Reuters - Cancer patients who took drugs to cut the risk of anemia were twice as likely to develop blood clots in the lungs or legs as other patients, a decade-long study of more than 55,000 cancer patients has found.
Will New Anemia Drug Top Current Treatments?
Source: MedicineNet Anemia Specialty [2009.11.05]
Title: Will New Anemia Drug Top Current Treatments?
Category: Health News
Created: 11/4/2009 4:10:00 PM
Last Editorial Review: 11/5/2009
Clinical Trials Related to Nascobal (Cyanocobalamin Nasal)
Plasma Holotranscobalamin as Compared to Plasma Cobalamins for Assessment of Vitamin B12 Absorption [Completed]
In the present study the design of the vitamin B12 absorption test, CobaSorb, is further
optimised. We investigate which test – measurement of holotranscobalamin or cobalamins –
could be used for reflection of vitamin B12 absorption. Furthermore, we prolong the duration
of vitamin B12 administration in order to determine the final duration of the vitamin B12
absorption test CobaSorb.
Seventy-eight healthy individuals (age 21-81 years) are treated with three oral doses of 9
microgram cyanocobalamin per day for five successive days. Non-fasting blood samples are
collected on day 1-5 before administration of the first dose of vitamin B12 and on day 8.
Cobalamins and holotranscobalamin are measured on day 1–5 and 8. The performance of the
vitamin B12 absorption test will be evaluated in individuals with borderline or low levels of
holotranscobalamin or cobalamins (below the 75% percentiles) using a change larger than
2CV(day to day) of holotranscobalamin (22%) and cobalamins (12%) to indicate a change caused
by absorption of the administered vitamin B12.
Cobalamin Supplementation During Infancy; Effect on B-Vitamin Status, Growth and Psychomotor Development [Completed]
Adequate levels of vitamin B12 (cobalamin) is necessary for normal growth and development in
infants. We have earlier investigated cobalamin status in healthy children and we observed
metabolic evidence of impaired cobalamin status during the first 6 months, but not later in
life.
The purpose of this study is to determine if cobalamin supplementation may influence the
metabolic profile related to cobalamin status in infants.
How Many Patients Are in Need of Vitamin B12 Injections? [Recruiting]
The clinical consequences of vitamin B12 deficiency include megaloblastic anemia and
neurological disorders. Therefore, a proper and timely diagnosis and treatment is important.
The use of sensitive biochemical markers such as methylmalonic acid for the diagnosis of
vitamin B12 deficiency have increased since the 1980s. Consequently, the number of
individuals treated with vitamin B12 has increased significantly.
The objective of this project is to study the actual need for vitamin B12 injections in the
group of individuals who have already started treatment. In order to investigate this, the
investigators stop vitamin B12 treatment in this group, and look for signs of vitamin B12
deficiency by monitoring changes in biochemical and hematological markers. Furthermore, they
will test if the individuals are able to absorb a physiological dose of vitamin B12 using a
recently developed absorption test (CobaSorb). If a physiological dose can be absorbed, the
vitamin B12 injections can be replaced with tablets. In the end, the investigators hope to be
able to divide the patients into three groups:
1. need life long injections with vitamin B12,
2. only need supplementations with a small dose of oral vitamin B12, and
3. no need for further vitamin B12 treatment.
The perspective is that the new information from this study might be used for a future
strategy for vitamin B12 treatment.
Can Recombinant Human Intrinsic Factor Be Used for Evaluation of the Vitamin B12 Absorption? [Completed]
Vitamin B12 is an essential nutrient for normal DNA-synthesis and must be supplied by animal
products. Vitamin B12 deficiency may cause anemia and irreverible neurological damage.
Laboratory tests are used for diagnosis of vitamin B12 deficiency, and following the
diagnosis, the cause of the vitamin B12 deficiency has to be clarified. For years a test
called Shilling’s test has been used for evaluation of the vitamin B12 absorption. However,
the Schilling’s test is no longer easy accessible because of increasing difficulties to
obtain the radioactively labeled vitamin B12 requested, and native human intrinsic factor for
Schilling’s test II (absorption of vitamin B12 attached to intrinsic factor) is no longer
available in most countries. Recently, human intrinsic factor unsaturated with vitamin B12
has been expressed in the plant Arabidopsis thaliana. The purpose of this study was to
examine whether recombinant human intrinsic factor is able to promote the uptake of vitamin
B12 in patients with evident vitamin B12 deficiency.
Oral Vitamin B12 Supplementation and Cognitive Performance in Elderly People [Completed]
The purpose of this trial is to study the effects of oral vitamin B12 supplementation and
vitamin B12 combined with folic acid supplementation on cognitive performance for 24 weeks in
elderly people with mild vitamin B12 deficiency.
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Page last updated: 2009-11-17
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