a) (nasal spray, Nascobal(R)) 500 mcg spray INTRANASALLY into one nostril once weekly [2]

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1 CYANOCOBALAMIN DRUGDEX Evaluations OVERVIEW 1) Class a) This drug is a member of the following class(es): Diagnostic Agent, Vitamin B12 Absorption Nutritive Agent Vitamin B Vitamin B Combination 2) Dosing Information a) Adult 1) Cobalamin deficiency a) normal absorption, 1000 mcg/day ORALLY; if oral route not adequate, initial treatment same as for pernicious anemia; chronic treatment should be with oral B12 preparation b) malabsorption, 100 mcg IM or deep SC injection daily for 6 or 7 days; if clinical improvement and reticulocyte response, give same amount on alternate days for 7 doses; then every 3 to 4 days for another 2 to 3 wk; then 100 mcg monthly for life (manufacturer dosing) c) malabsorption, 1000 mcg IM daily for 10 days OR daily for 3 to 7 days followed by weekly injection for 3 to 4 weeks; then monthly have been reported in the literature [12] [13] [14] [15] [16] d) nasal spray; 500 mcg INTRANASALLY in one nostril once weekly [2] 2) Cobalamin deficiency; Prophylaxis a) (nasal spray, Nascobal(R)) 500 mcg spray INTRANASALLY into one nostril once weekly [2] b) (nasal spray, CaloMist(TM)) 25 mcg spray INTRANASALLY each nostril daily, total dose 50 mcg per day; dose may be increased to one spray each nostril twice daily when once daily is inadequate [3] c) (sublingual tablet) 2500 mcg SL once daily [4] d) (time-released tablet) 1500 mcg ORALLY once daily [5]

2 3) Hyperhomocysteinemia a) 400 mcg/day ORALLY with folic acid 4) Malabsorption of cyanocobalamin; Diagnosis - Schilling test a) 185 to 37 kbq (05 to 1 mci) cyanocobalamin Co 57 ORALLY, followed by 1000 mcg cyanocobalamin IM 2 hr later [32] b) flushing dose, 1000 mcg IM [33] 5) Pernicious anemia a) 100 mcg IM or deep SC injection daily for 6 or 7 days; if clinical improvement and reticulocyte response, give same amount on alternate days for 7 doses; then every 3 to 4 days for another 2 to 3 wk; then 100 mcg monthly for life (manufacturer dosing) [33] b) malabsorption, 1000 mcg IM daily for 10 days OR daily for 3 to 7 days followed by weekly injection for 3 to 4 weeks; then monthly have been reported in the literature [12] [13] [14] [15] [16] c) nasal spray; 500 mcg INTRANASALLY in one nostril once weekly for maintenance of normal hematologic status [2] b) Pediatric 1) Cobalamin deficiency a) 1000 mcg/day ORALLY, IM route is preferred; 30 to 50 mcg IM daily for 2 or more wk; then 100 mcg monthly to sustain remission 2) Pernicious anemia a) 30 to 50 mcg IM daily for 2 or more wk; then 100 mcg monthly to sustain remission 3) Contraindications a) hypersensitivity to cobalt, B12 products, or any component of the product [3] [48] [33] 4) Serious Adverse Effects a) Anaphylaxis b) Angioedema

3 c) Congestive heart failure d) Peripheral vascular disease e) Pulmonary edema 5) Clinical Applications a) FDA Approved Indications 1) Cobalamin deficiency 2) Cobalamin deficiency; Prophylaxis 3) Malabsorption of cyanocobalamin; Diagnosis - Schilling test 4) Pernicious anemia b) Non-FDA Approved Indications 1) Hyperhomocysteinemia DOSING INFORMATION Drug Properties A) Information on specific products and dosage forms can be obtained by referring to the Tradename List (Product Index) B) Synonyms B12 Cyanocobalamin Vitamin B12 Vit B12 Vit B 12 Storage and Stability A) Preparation 1) Nasal route a) Dispensing the Nasal Spray 1) The pharmacist should assemble the Nascobal(R) spray unit prior to dispensing First, the white cap from the spray solution bottle should be removed Next, the actuator unit should be screwed onto the bottle, keeping the clear dust cover on the pump unit tip The spray bottle should be returned to the carton; it is then ready to dispense to the patient [2] Demonstration by the pharmacist of how to prime the pump and how to administer the spray is helpful b) Priming the Spray 1) Nascobal(R): The spray pump must be primed initially and then prior to each subsequent use To prime the pump, remove the clear cover and place the nozzle between the first and second fingers with the thumb on the bottom of the bottle Pump the unit firmly and quickly by pushing down with the first and second fingers After the first appearance of spray, prime the

4 pump an additional 2 times It is then ready for use After the initial use, the pump should only be primed once immediately before each administration [2] 2) CaloMist(TM): The spray pump must be primed prior to the first use To prime the pump, remove the clear cover and place the nozzle between the index and middle fingers with the thumb on the bottom of the bottle Pump the unit by pressing the arm down firmly and quickly After the first pump, continue to prime the pump an additional 6 times for a total of 7 priming sprays It is then ready for use Re-prime with 2 sprays if the pump is not used for 5 or more days [3] c) Administration 1) After the pump is primed, the patient should insert the pump tip approximately 05 inch (1 centimeter) into one nostril, pointing the tip toward the back of the nose The head should be tilted slightly forward and the other nostril closed with the forefinger of the other hand Actuate the spray by pushing down firmly and quickly on the pump while gently sniffing (mouth closed) Afterwards, wipe the nozzle with a clean tissue and replace the clear cover [3] 2) Nascobal(R) nasal spray should be given 1 hour before or 1 hour after eating hot foods or liquids [2] 3) Separate administration of CaloMist(TM) nasal spray with other intranasal medication by several hours [3] B) Nasal route 1) Cyanocobalamin nasal spray should be stored in an upright position at controlled room temperature 15 to 30 degrees Centigrade (C) (59 to 86 degrees Fahrenheit (F)) The nasal spray should be protected from light (keep covered in the carton), and protected from freezing [108] C) Oral route 1) Cyanocobalamin tablets should be stored in a tight container at room temperature (between 59 and 86 degrees Fahrenheit) Tablets should be protected from light [107] D) Parenteral route 1) Cyanocobalamin for injection should be stored in a light-resistant container at room temperature (59 to 86 degrees Fahrenheit or 15 to 30 degrees centigrade) (Prod Info Cyanocobalamin, 1994) E) FILTRATION 1) Inline filtration of cyanocobalamin 200 micrograms/liter in Dextrose 5% in water or Sodium chloride 09% did not cause any reduction in potency (Butler et al, 1980)

5 Adult Dosage Normal Dosage Nasal route Cobalamin deficiency a) Initial recommended dose of nasal spray is one spray (500 micrograms) in ONE nostril once weekly The dose of nasal spray should be administered at least 1 hour before or after ingestion of hot foods or liquids One bottle will provide 4 doses [2] Cobalamin deficiency; Prophylaxis a) Nascobal(R) 1) Initial recommended dose of Nascobal(R) nasal spray (500 micrograms (mcg) per 01 milliliter) is one spray (500 mcg) in one nostril once weekly The dose of nasal spray should be administered at least 1 hour before or after ingestion of hot foods or liquids One bottle will provide 4 doses [2] b) CaloMist(TM) 1) The recommended initial dose of CaloMist(TM) nasal spray (25 mcg per 01 milliliter) is 25 mcg spray intranasally each nostril daily; total dose 50 mcg per day Dose may be increased to 1 spray each nostril twice daily (total daily dose of 100 mcg) for patients with inadequate response Separate other intranasal medications and CaloMist(TM) by several hours [3] Pernicious anemia a) Initial recommended dose of nasal spray is one spray (500 micrograms) in ONE nostril once weekly for maintenance of normal hematologic status The dose of nasal spray should be administered at least 1 hour before or after ingestion of hot foods or liquids One bottle will provide 4 doses [2] Oral route Cobalamin deficiency Evidence from published studies suggests the following guidelines for oral cobalamin (cyanocobalamin) treatment of PERNICIOUS ANEMIA (absence of intrinsic factor): 5 to 20 micrograms daily is ineffective 80 to 150 micrograms daily improves but does not restore circulating cobalamin or hemoglobin concentrations

6 100 to 200 micrograms daily is adequate for most patients 500 micrograms daily produces satisfactory responses; but because of individual variability in absorption, it leaves some patients with borderline cobalamin concentrations 1000 micrograms daily produces successful long-term results [26] a) Vitamin B12 oral administration of an appropriate dosage, even in the absence of intrinsic factor, can result in effective elevations of vitamin B12 in the blood Detailed analysis has shown that 2 milligrams (mg) of cyanocobalamin administered orally on a daily basis is as effective or superior to 1 mg administered intramuscularly monthly [27] ; (Lederly, 1991) b) Either sublingual or oral administration of cobalamin 500 micrograms/day, with or without supplemental thiamine and pyridoxine, raised serum vitamin B12 levels to within the normal range in patients with (n=30) with very low serum cobalamin concentrations (preclinical deficiency) Most of the increase in serum cobalamin occurred by the end of the first week [28] c) SUBLINGUAL cyanocobalamin 2000 micrograms per day for 7 to 12 days raised serum cobalamin levels as much as 4-fold compared with pretreatment levels in 18 patients with cobalamin deficiency from various causes (vegetarianism, pernicious anemia, Crohn's disease, frequent blood donation) Normalization of serum cobalamin was seen in all patients There were no side effects [29] Cobalamin deficiency; Prophylaxis a) Adequate diets containing animal foods provide amounts of vitamin B12 in excess of the Recommended Dietary Allowance (RDA) for most individuals, and dietary deficiency of vitamin B12 is rare Prophylactic administration of vitamin B12 alone or in multivitamin supplements is not generally required However, since 10 to 30 percent of older people may be unable to absorb naturally occurring vitamin B12, it is advisable that those over 50 years meet their RDA for vitamin B12 by consuming vitamin B12-fortified foods or vitamin B12 supplements [9]

7 b) Because vitamin B12 is not a component of plant foods, diets containing little or no animal food may lead to vitamin B12 deficiency [9] Vegans may benefit from vitamin B12-fortified foods or vitamin B12 supplements Pernicious anemia Evidence from published studies suggests the following guidelines for oral cobalamin (cyanocobalamin) treatment of pernicious anemia (absence of intrinsic factor): 5 to 20 micrograms daily is ineffective 80 to 150 micrograms daily improves but does not restore circulating cobalamin or hemoglobin concentrations 100 to 200 micrograms daily is adequate for most patients 500 micrograms daily produces satisfactory responses; but because of individual variability in absorption, it leaves some patients with borderline cobalamin concentrations 1000 micrograms daily produces successful long-term results [26] a) Vitamin B12 oral administration of an appropriate dosage, even in the absence of intrinsic factor, can result in effective elevations of vitamin B12 in the blood Detailed analysis has shown that 2 milligrams (mg) of cyanocobalamin administered orally on a daily basis is as effective or superior to 1 mg administered intramuscularly monthly [27] ; (Lederly, 1991) b) Either sublingual or oral administration of cobalamin 500 micrograms/day, with or without supplemental thiamine and pyridoxine, raised serum vitamin B12 levels to within the normal range in patients with (n=30) with very low serum cobalamin concentrations (pre-clinical deficiency) Most of the increase in serum cobalamin occurred by the end of the first week [28]

8 c) Sublingual cyanocobalamin 2000 micrograms per day for 7 to 12 days raised serum cobalamin levels as much as 4-fold compared with pretreatment levels in 18 patients with cobalamin deficiency from various causes (vegetarianism, pernicious anemia, Crohn's disease, frequent blood donation) Normalization of serum cobalamin was seen in all patients There were no side effects [29] Parenteral route Cobalamin deficiency a) Uncomplicated 1) Parenteral cyanocobalamin is recommended for initial treatment; oral or parenteral dosing can be used for maintenance therapy Cyanocobalamin may be administered intramuscularly or by deep subcutaneous injection In patients with uncomplicated vitamin B12 malabsorption, the initial recommended dose of cyanocobalamin is 100 micrograms daily for 5 to 10 days, followed by 100 to 200 micrograms monthly until complete remission is achieved Maintenance doses of 100 micrograms monthly should maintain remission [6] 2) An alternative regimen in patients with uncomplicated vitamin B12 malabsorption is 100 micrograms daily initially for 1 week, followed by 100 micrograms every other day for 2 weeks; doses of 100 micrograms every 3 to 4 days are then given until remission is complete This regimen should be followed by maintenance doses of 100 micrograms monthly [6] [11] 3) For the management of vitamin B12 malabsorption, a dose of at least 100 micrograms intramuscularly monthly has been recommended [30] 4) In one clinical trial comparing oral to parenteral dosing for megaloblastic anemia, 1000 micrograms intramuscularly daily for 10 days, then monthly was the parenteral dose provided for treatment [12] 5) For the treatment of pernicious anemia, an arbitrary dose of 1000 micrograms intramuscularly (IM) daily for 7 days followed by weekly IM injections for a month then monthly injections has been recommended [13] [14] 6) In one clinical trial of patients with cobalamin deficiency, the dose of cyanocobalamin was 1000 micrograms (mcg) intramuscularly (IM) for three days in the first week, followed by weekly IM injections of 1000 mcg for three weeks then monthly injections of 1000 mcg [15]

9 7) In patients with cobalamin (vitamin B12) deficiency, a recommended treatment regimen is 1000 micrograms (mcg) intramuscularly (IM) followed by 1000 mcg as 8 to 10 IM injections over 2 to 3 months then monthly injections of 1000 mcg [16] 8) Patients with vitamin B12 deficiency secondary to any other irreversible defect in absorption require continued (maintenance) cyanocobalamin treatment for life (Gilman et al, 1990) [7] [6] b) Complicated 1) In patients with severe complications of vitamin B12 malabsorption including neurologic complications, immediate parenteral therapy with cyanocobalamin is recommended [31] Cyanocobalamin 1000 micrograms intramuscularly once daily for one week then 1000 mcg intramuscularly once weekly for one month followed by 1000 mcg once monthly until cause of deficiency has been corrected or lifelong therapy in patients with pernicious anemia has been recommended [13] [14] 2) In one clinical trial comparing oral to parenteral dosing for megaloblastic anemia, 1000 micrograms intramuscularly daily for 10 days, then monthly was the parenteral dose provided for treatment [12] 3) For the treatment of pernicious anemia, an arbitrary dose of 1000 micrograms intramuscularly (IM) daily for 7 days followed by weekly IM injections for a month then monthly injections has been recommended [13] [14] 4) In one clinical trial of patients with cobalamin deficiency, the dose of cyanocobalamin was 1000 micrograms (mcg) intramuscularly (IM) for three days in the first week, followed by weekly IM injections of 1000 mcg for three weeks then monthly injections of 1000 mcg [15] 5) In patients with vitamin B12 deficiency, a recommended treatment regimen is 1000 micrograms (mcg) intramuscularly (IM) followed by 1000 mcg as 8 to 10 IM injections over 2 to 3 months then monthly injections of 1000 mcg [16] Cobalamin deficiency; Prophylaxis

10 a) For prophylaxis of anemia in patients with vitamin B12 deficiency secondary to gastrectomy or malabsorption syndromes, cyanocobalamin 250 to 1000 micrograms intramuscularly every month has been suggested [10] Disorder of vitamin B12 a) In patients with subnormal vitamin B12 utilization (eg, acquired immunodeficiency syndrome), cyanocobalamin 1000 micrograms intramuscularly or subcutaneously (deep) once a month has been recommended [6] Malabsorption of cyanocobalamin; Diagnosis - Schilling test a) The recommended flushing dose of cyanocobalamin for the Schilling test for vitamin B12 malabsorption is 1000 micrograms intramuscularly [6] [11] Pernicious anemia a) Uncomplicated 1) For the management of vitamin B12 malabsorption, a dose of at least 100 micrograms intramuscularly monthly has been recommended [30] 2) In one clinical trial comparing oral to parenteral dosing for megaloblastic anemia, 1000 micrograms intramuscularly daily for 10 days, then monthly was the parenteral dose provided for treatment [12] 3) For the treatment of pernicious anemia, an arbitrary dose of 1000 micrograms intramuscularly (IM) daily for 7 days followed by weekly IM injections for a month then monthly injections has been recommended [13] [14] 4) In one clinical trial of patients with cobalamin deficiency, the dose of cyanocobalamin was 1000 micrograms (mcg) intramuscularly (IM) for three days in the first week, followed by weekly IM injections of 1000 mcg for three weeks then monthly injections of 1000 mcg [15] 5) In patients with cobalamin (vitamin B12) deficiency, a recommended treatment regimen is 1000 micrograms (mcg) intramuscularly (IM) followed by 1000 mcg as 8 to 10 IM injections over 2 to 3 months then monthly injections of 1000 mcg [16] 6) Parenteral cyanocobalamin is recommended for initial treatment; oral or parenteral dosing can be used for maintenance therapy Cyanocobalamin may be administered intramuscularly or by deep subcutaneous injection In

11 patients with uncomplicated pernicious anemia, the initial recommended dose of cyanocobalamin is 100 micrograms daily for 5 to 10 days, followed by 100 to 200 micrograms monthly until complete remission is achieved Maintenance doses of 100 micrograms monthly should maintain remission [6] 7) An alternative regimen in patients with uncomplicated pernicious anemia is 100 micrograms daily initially for 1 week, followed by 100 micrograms every other day for 2 weeks; doses of 100 micrograms every 3 to 4 days are then given until remission is complete This regimen should be followed by maintenance doses of 100 micrograms monthly [6] [11] 8) Patients with pernicious anemia require continued (maintenance) cyanocobalamin treatment for life (Gilman et al, 1990) [7] [6] b) Complicated 1) In patients with severe complications of pernicious anemia including neurologic complications, immediate parenteral therapy with cyanocobalamin is recommended [31] 2) For the treatment of pernicious anemia, an arbitrary dose of 1000 micrograms intramuscularly (IM) daily for 7 days followed by weekly IM injections for a month then monthly injections has bee recommended [13] [14] 3) In one clinical trial comparing oral to parenteral dosing for megaloblastic anemia, 1000 micrograms intramuscularly daily for 10 days, then monthly was the parenteral dose provided for treatment [12] 4) In one clinical trial of patients with cobalamin deficiency, the dose of cyanocobalamin was 1000 micrograms (mcg) intramuscularly (IM) for three days in the first week, followed by weekly IM injections of 1000 mcg for three weeks then monthly injections of 1000 mcg [15] 5) In patients with cobalamin (vitamin B12) deficiency, a recommended treatment regimen is 1000 micrograms (mcg) intramuscularly (IM) followed by 1000 mcg as 8 to 10 IM injections over 2 to 3 months then monthly injections of 1000 mcg [16] Short bowel syndrome See Drug Consult reference:

12 VITAMIN ABSORPTION IN SHORT BOWEL SYNDROME Dosage in Renal Failure A) The clinical response to cyanocobalamin may be attenuated in the presence of renal disease [7] An increase in dose (eg, decrease in the interval between injections) may be required in vitamin B12-deficient patients with renal disease [45] B) In some patients with renal disease, it may not be possible to correct the megaloblastic anemia (Gilman et al, 1990) Dosage in Hepatic Insufficiency A) A decrease in the interval between maintenance injections of cyanocobalamin may be required in vitamin B12-deficient patients with liver disease [45] Pediatric Dosage Normal Dosage Oral route Cobalamin deficiency; Prophylaxis a) Recommended dietary allowances (RDA) of vitamin B12 in infants and children are: up to 6 months of age - 03 micrograms daily; 6 months to 1 year of age - 05 mcg daily; 1 to 3 years of age - 07 microgram daily; 4 to 6 years of age - 1 microgram daily; 7 to 10 years of age - 14 micrograms daily The RDA in children 11 years and older is 2 micrograms daily [11] b) Adequate diets provide RDA amounts of vitamin B12 for most infants and children, and dietary deficiency of vitamin B12 is rare Prophylactic administration of vitamin B12 alone or in multivitamin supplements is not generally required When vitamin B12 supplementation is deemed required for the prevention of deficiency, cyanocobalamin in doses of 03 to 3 micrograms daily has been suggested in infants up to 1 year of age; in children 1 year of age and older, recommended doses have ranged from 1 to 6 micrograms daily [6] [11] Multivitamin formulations containing vitamin B12 may be used, although this is controversial [6] c) In infants receiving commercial formulas, a daily vitamin B12 intake of 015 microgram/100 kilocalorie is required [6] Pernicious anemia

13 a) Oral cyanocobalamin in doses of up to 1000 micrograms daily may be considered as an alternative to parenteral therapy for the treatment of pernicious anemia in children and adolescents [43] [44] [6] However, parenteral administration should remain the route of choice for initial treatment in most patients, especially those with severe deficiency where rapid repletion of body stores is desired [44] Parenteral route Cobalamin deficiency a) Parenteral cyanocobalamin is recommended for initial treatment; oral or parenteral dosing can be used for maintenance therapy Cyanocobalamin may be administered intramuscularly or by deep subcutaneous injection In children with uncomplicated vitamin B12 malabsorption, the recommended dose of cyanocobalamin is 30 to 50 micrograms daily for 2 or more weeks (to a total dose of 1000 to 5000 micrograms) This is followed by maintenance doses 100 micrograms monthly to sustain remission [11] [6] b) In infants with congenital transcobalamin deficiency, the recommended dose is 1000 micrograms twice weekly [6] c) Patients with vitamin B12 deficiency secondary to any other irreversible defect in absorption require continued (maintenance) cyanocobalamin treatment for life (Gilman et al, 1990) [7] [6] Malabsorption of cyanocobalamin; Diagnosis - Schilling test a) The recommended flushing dose of cyanocobalamin for the Schilling test for vitamin B12 malabsorption is 1000 micrograms intramuscularly [6] [11] Pernicious anemia a) Parenteral cyanocobalamin is recommended for initial treatment; oral or parenteral dosing can be used for maintenance therapy Cyanocobalamin may be administered intramuscularly or by deep subcutaneous injection In children with uncomplicated pernicious anemia, the recommended dose of cyanocobalamin is 30 to 50 micrograms daily for 2 or more weeks (to a total dose of 1000 to 5000 micrograms) This is followed by maintenance doses 100 micrograms monthly to sustain remission [11] [6]

14 b) Patients with pernicious anemia require continued (maintenance) cyanocobalamin treatment for life (Gilman et al, 1990) [7] [6] Megaloblastic anemia due to folate deficiency - Sickle cell anemia See Drug Consult reference: VITAMIN TREATMENT OF SICKLE CELL DISEASE Total parenteral nutrition See Drug Consult reference: TRACE MINERAL SUPPLEMENTATION IN TPN PHARMACOKINETICS Onset and Duration A) Onset 1) Initial Response a) Megaloblastic anemia, intramuscular: 8 hours [74] [75] [76] 1) Conversion of megaloblastic to normoblastic erythroid hyperplasia within the bone marrow is evident within 8 hours of an intramuscular cyanocobalamin dose in patients with megaloblastic anemia An increase in reticulocytes usually begins after 2 to 5 days of therapy, followed by rises in hemoglobin, hematocrit, and erythrocyte count [74] [75] [76] b) Psychiatric sequelae of vitamin B12 deficiency: 24 hours [75] [74] [76] [77] 1) Psychiatric sequelae of vitamin B12 deficiency may subside within 24 hours of initiation of therapy, while neurologic complications require substantially longer periods (several months); in patients with long-standing neurologic sequelae (months to years) prior to therapy, damage may be irreversible [75] [76] [77]

15 [74] c) Thrombocytopenia: 10 days [76] d) Leukopenia: 2 weeks [76] B) Duration 1) Multiple Dose a) Vitamin B12 deficiency, intramuscular: 2 to 4 weeks [76] [78] [74] 1) Serum vitamin B12 levels are maintained above 200 pg/ml in most patients with intramuscular cyanocobalamin doses of 100 mcg every 2 to 4 weeks [76] [78] [74] 2) Slower rates of decline in vitamin B12 serum levels have been reported with hydroxocobalamin as compared with cyanocobalamin with equivalent parenteral doses [75] [79] [80] However, in other reports, reductions in plasma concentration of vitamin B12 over a 10- to 30- day period have been similar with each preparation [76] [79] 3) A depot cyanocobalamin formulation (cyanocobalamin-tannate complex in sesame oil; Betolvex(R)) is available in some countries and has been effective in maintaining adequate vitamin B12 levels when administered every 2 to 3 months [81] [82] [83] [74] b) Pernicious anemia, parenteral: 6 months to 5 years [78] [75] 1) The wide range in time to relapse is attributed to variability in the period required to deplete liver stores of vitamin B12 [78] [75]

16 Because low serum vitamin B12 levels can precede relapse for several years in pernicious anemia, without evidence of deleterious effects, some investigators have suggested a longer interval between injections of cyanocobalamin [78] Drug Concentration Levels A) Therapeutic Drug Concentration 1) Healthy adult, 200 to 900 pg/ml [75] [76] [79] a) Intramuscular doses of cyanocobalamin 100 mcg every 2 to 4 weeks are adequate to maintain therapeutic plasma levels of vitamin B12 (greater than 200 pg/ml) [76] [74] b) Serum vitamin B12 levels following administration of intramuscular hydroxocobalamin have been higher than those achieved with equivalent doses of cyanocobalamin [83] [79] [80] However, this is of doubtful significance clinically Recommended maintenance doses of cyanocobalamin and hydroxocobalamin are similar [75] c) Total vitamin B12 levels refer to methylcobalamin, adenosylcobalamin, hydroxocobalamin, and cyanocobalamin [86] d) Limited evidence suggests that increases in serum cyanocobalamin concentrations following a single 400 mg intranasal dose of Ener-B(R) (intranasal cyanocobalamin gel formulation) are similar to those achieved after a single dose of intramuscular cyanocobalamin 100 mcg [87] [88] B) Time to Peak Concentration 1) Intramuscular, injection: 30 minutes to 2 hours [84] [85] [83] 2) Subcutaneous, injection: 30 minutes to 2 hours [84] [85] [83]

17 ADME Absorption A) Bioavailability 1) Oral, tablet: poor [75] ; [76] a) The presence of intrinsic factor, calcium and the proper ph influence the absorption of vitamin B12 [76] Binding to intrinsic factor occurs during passage through the gastrointestinal tract, and the intrinsic factor-vitamin B12 complex is absorbed in the ileum in the presence of calcium Intrinsic factor, bile, and sodium bicarbonate are required for ileal transport of vitamin B12 [76] [75] Small amounts of vitamin B12 can also be absorbed independent of intrinsic factor via simple diffusion [75] [89] b) The average US diet supplies 5 to 30 micrograms of vitamin B12 daily, of which 1 to 5 micrograms is absorbed in the presence of gastric intrinsic factor [75] c) In the absence of intrinsic factor (pernicious anemia), large oral doses of cyanocobalamin (1000 mcg or more) have been effective in achieving therapeutic vitamin B12 plasma levels as sufficient vitamin is absorbed via passive diffusion [90] [89] The oral bioavailability of cyanocobalamin in pernicious anemia is reportedly 12% [90] 2) Intramuscular, injection: rapid and complete [75] a) Following 100 mcg and 1000 mcg parenteral doses of cyanocobalamin, total body retention is reportedly 55% and 15%, respectively The remainder of these doses is excreted unchanged in the urine Body retention of hydroxocobalamin has been greater than with cyanocobalamin in some reports [91] 3) Subcutaneous, injection: rapid and complete [75]

18 Distribution A) Distribution Sites 1) Vitamin B12 binds in plasma to transcobalamin II, a beta-globulin, and this complex is transported to tissues [94] [76] Hydroxocobalamin is more tightly bound than cyanocobalamin [75] [80] [74] a) OTHER DISTRIBUTION SITES 1) LIVER, 90% [76] a) Preferential distribution to hepatic parenchymal cells is observed, and the liver serves as a storage site for other tissues Up to 90% of body stores are in the liver (1 to 10 mg), where the vitamin is stored as the active coenzyme with a turnover rate of 05 to 8 micrograms daily [76] 2) TISSUES [76] [74] a) Vitamin B12 bound to transcobalamin II is rapidly cleared from plasma and transported to tissues (liver, bone marrow, endocrine glands, kidney) [76] [74] Excretion A) Kidney 1) Renal Excretion (%) a) 50% to 98% [75] ; [76] [91] 1) Between 50% and 98% of an intramuscular or subcutaneous dose (100 to 1000 mcg) of cyanocobalamin is excreted unchanged in the urine, most within the first 8 hours post injection

19 CAUTIONS [75] [76] [91] 2) Doses higher than 100 mcg will not result in greater retention of the vitamin, although stores may be replenished more quickly [75] [76] Renal clearance is more rapid with intravenous administration [75] 2) OTHER EXCRETION a) BILE [76] [74] Contraindications 1) Between 1 and 3 mcg of vitamin B12 is excreted daily in the bile Up to 50% of this amount is reabsorbed, establishing an enterohepatic recirculation of the vitamin In patients with pernicious anemia (or following total gastrectomy), enterohepatic recirculation is impaired due to lack of intrinsic factor which results in continuous depletion of hepatic stores of vitamin B12 [76] [74] A) hypersensitivity to cobalt, B12 products, or any component of the product [3] [48] [33] Precautions A) anaphylactic shock; has been reported (injection) [33] B) angioedema; has been reported (injection) [3] C) chronic nasal symptoms; potential for erratic or blunted absorption (intranasal) [3] D) concomitant intranasal medications; potential for erratic cyanocobalamin absorption (intranasal) [3]

20 E) concomitant bone marrow suppressants; may blunt therapeutic response (intranasal) [3] [48] F) folate deficiency; not indicated, may blunt therapeutic response [3] [48] G) infection; may blunt therapeutic response (intranasal) [3] [48] H) intravenous use; may result in nearly all of the dose being lost in the urine; should be avoided [33] I) iron deficiency; may blunt therapeutic response (intranasal) [3] [48] J) Leber's disease, early (hereditary optic nerve atrophy); may increase risk of optic atrophy, potentially sudden and severe; use is not recommended [3] [48] [33] K) megaloblastic anemia, severe; when treated intensely with cyanocobalamin, may increase risk of hypokalemia, thrombocytosis, and sudden death [3] [48] [33] L) nasal pathology, significant; potential for erratic or blunted absorption (intranasal) [3] M) premature infants; contains benzyl alcohol; increased risk of fatal gasping syndrome (injection) [33] N) renal impairment; prolonged parenteral administration increases risk of aluminum toxicity, particularly in premature infants (injection) [33] O) uremia; may blunt therapeutic response (intranasal) [3] [48] P) vitamin B12 concentrations, declining or abnormally low with maximum dose; may produce irreversible neurological damage if inadequate treatment for longer than 3 months [3]

21 [48] [33] Adverse Reactions Cardiovascular Effects Congestive heart failure 1) Congestive heart failure has been reported early in treatment with parenteral administration of cyanocobalamin [33] Hypervolemia 1) Volume overload is a major risk if transfusion therapy is deemed necessary as an adjunct to cyanocobalamin in patients with severe megaloblastic anemia This complication can be minimized by exchange transfusion, with exchanges performed in 50 ml increments with a 3-way stopcock and 50 ml syringe Transfusions are rarely needed as the response to cyanocobalamin is rapid [49] Peripheral vascular disease 1) Peripheral vascular thrombosis has been reported with parenteral administration of cyanocobalamin [33] Pulmonary edema 1) Pulmonary edema has been reported early in treatment with parenteral administration of cyanocobalamin [33] Dermatologic Effects Injection site pain 1) Injection site pain has been infrequently reported with intramuscular or subcutaneous injections of cyanocobalamin [49] Pruritus 1) Incidence: rare [51] 2) Pruritus has been associated with cyanocobalamin injections; these reactions appear to be very rare [51] Pyoderma faciale 1) In one case report, a 17-year-old white woman developed numerous confluent nodules, papulopustules, and seborrhea on her cheeks, chin, and neck 2 weeks after she began taking a vitamin B supplement containing 80 milligrams (mg) of pyridoxine (4000% of the recommended dietary allowance), and 20 micrograms of vitamin B12 (2000% of the recommended dietary allowance) Fourteen days of treatment with minocycline 100 mg/day produced no change No pathogenic

22 Rash organisms were found in bacteriological and mycological cultures Endocrinological evaluation was normal The condition was diagnosed as rosacea fulminans, a rare variant of rosacea conglobata After discontinuation of the nutritional supplement, oral methylprednisolone 1 mg/kilogram (kg) body weight per day was given for 2 weeks, followed by isotretinoin 1 mg/kg, plus an antiandrogen type of contraceptive; the corticosteroid was tapered over the next 2 weeks Warm compresses and clobetasol propionate cream were applied topically twice daily for 2 weeks All skin changes resolved within 4 months, with no residual scarring [53] 1) Incidence: rare [51] 2) Skin rash has been associated with cyanocobalamin injections; these reactions appear to be very rare [51] Urticaria 1) Incidence: rare [51] 2) Urticaria has been associated with cyanocobalamin injections; these reactions appear to be very rare [51] 3) Chronic and severe urticaria was described in one patient during cyanocobalamin therapy This patient subsequently developed anaphylaxis to both parenteral and oral cyanocobalamin; urticaria persisted without anaphylaxis with subsequent hydroxocobalamin administration [52] Gastrointestinal Effects Diarrhea, Transient 1) Mild transient diarrhea has been reported with parenteral administration of cyanocobalamin [33] Nausea 1) In a short-term clinical trial of patients in hematologic remission being treated for vitamin B12 deficiency with either intranasal gel (n=24) or intramuscular injection (n=25), 1 patient in the intranasal group experienced 1 occurrence of nausea compared with 1 patient in the intramuscular group who experienced 1 occurrence of nausea The relationship of nausea to cyanocobalamin was judged as possible [48] Hematologic Effects Polycythemia vera

23 1) Cyanocobalamin therapy may unmask signs of polycythemia vera This condition can be suppressed in the presence of vitamin B12 deficiency [48] Polycythemia vera has been reported with parenteral use only [33] Immunologic Effects Anaphylaxis 1) Anaphylactic shock has been reported with parenteral administration of cyanocobalamin [33] 2) Anaphylactic reactions have been described rarely following both parenteral and oral cyanocobalamin administration [52] [54] [55] Cross-sensitivity of cyanocobalamin and hydroxocobalamin has been reported [52] [55] Angioedema 1) Angioedema and angioedema-like reactions have been reported during postmarketing use of parenteral cyanocobalamin only [3] Antibody titer - finding 1) Antibodies to the hydroxocobalamin-transcobalamin II complex have been reported in patients treated with hydroxocobalamin [56] [49] Common cold 1) In a short-term clinical trial of patients in hematologic remission being treated for vitamin B12 deficiency with either intranasal gel (n=24) or intramuscular injection (n=25), 3 patients in the intranasal group experienced 4 occurrences of common cold or sore throat compared with 3 patients in the intramuscular group who experienced 3 occurrences of common cold or sore throat [48] Musculoskeletal Effects Arthralgia 1) Incidence: 12% [3] 2) In an uncontrolled clinical trial (n=25), arthralgia was reported in 12% of patients who received cyanocobalamin 50 mcg intranasally once daily for 8 weeks [3] Neurologic Effects Asthenia

24 1) In a short-term clinical trial of patients in hematologic remission being treated for vitamin B12 deficiency with either intranasal gel (n=24) or intramuscular injection (n=25), 1 patient in the intranasal group experienced 1 occurrence of asthenia compared with 4 patients in the intramuscular group who experienced 4 occurrences of asthenia [48] Dizziness 1) Incidence: 12% [3] 2) In an uncontrolled clinical trial (n=25), dizziness was reported in 12% of patients who received cyanocobalamin 50 mcg intranasally once daily for 8 weeks [3] 3) In a short-term clinical trial of patients in hematologic remission being treated for vitamin B12 deficiency with either intranasal gel (n=24) or intramuscular injection (n=25), no patients in the intranasal group experienced any occurrence of dizziness compared with 3 patients in the intramuscular group who experienced 3 occurrences of dizziness [48] Headache 1) Incidence: 12% [3] 2) In an uncontrolled clinical trial (n=25), headache was reported in 12% of patients who received cyanocobalamin 50 mcg intranasally once daily for 8 weeks [3] 3) In a short-term clinical trial of patients in hematologic remission being treated for vitamin B12 deficiency with either intranasal gel (n=24) or intramuscular injection (n=25), 1 patient in the intranasal group experienced 2 occurrences of headache compared with 5 patients in the intramuscular group who experienced a total of 11 occurrences of headache The relationship of headache to cyanocobalamin was judged as possible [48] Incoordination 1) In a short-term clinical trial of patients in hematologic remission being treated for vitamin B12 deficiency with either intranasal gel (n=24) or intramuscular injection (n=25), no patients in the intranasal group experienced any occurrences of incoordination compared with 1 patient in the intramuscular group who experienced 2 occurrences of incoordination The relationship of incoordination to cyanocobalamin was judged as possible [48] Ophthalmic Effects Optic atrophy

25 1) Rapid progression of optic atrophy has been reported in some patients with early Leber's disease (hereditary optic atrophy) during cyanocobalamin administration [3] [48] [33] [50] Hydroxocobalamin is the preferred agent in these patients Psychiatric Effects Anxiety 1) In a short-term clinical trial of patients in hematologic remission being treated for vitamin B12 deficiency with either intranasal gel (n=24) or intramuscular injection (n=25), no patients in the intranasal group experienced any occurrences of anxiety compared with 1 patient in the intramuscular group who experienced 1 occurrence of anxiety The relationship of anxiety to cyanocobalamin was judged as possible [48] Feeling nervous 1) In a short-term clinical trial of patients in hematologic remission being treated for vitamin B12 deficiency with either intranasal gel (n=24) or intramuscular injection (n=25), no patients in the intranasal group experienced any occurrences of nervousness compared with 1 patient in the intramuscular group who experienced 3 occurrences of nervousness The relationship of nervousness to cyanocobalamin was judged as "possible" [48] Respiratory Effects Asthma 1) Incidence: 4% [3] 2) In an uncontrolled clinical trial (n=25), asthma was reported in 4% of patients who received cyanocobalamin 50 mcg intranasally once daily for 8 weeks [3] Bronchitis 1) Incidence: 8% [3] 2) In an uncontrolled clinical trial (n=25), bronchitis was reported in 8% of patients who received cyanocobalamin 50 mcg intranasally once daily for 8 weeks [3] Dyspnea 1) In a short-term clinical trial of patients in hematologic remission being treated for vitamin B12 deficiency with either intranasal gel (n=24) or intramuscular injection (n=25), no patients in the intranasal group experienced any occurrence of dyspnea compared with 1 patient in the intramuscular group who experienced 1 occurrence of dyspnea [48]

26 Nasopharyngitis 1) Incidence: 12% [3] 2) In an uncontrolled clinical trial (n=25), nasopharyngitis was reported in 12% of patients who received cyanocobalamin 50 mcg intranasally once daily for 8 weeks [3] Respiratory insufficiency syndrome of newborn 1) The benzyl alcohol preservative in some parenteral vitamin B12 formulations has been associated with fatal "gasping syndrome" in premature infants [49] Rhinitis 1) In a short-term clinical trial of patients in hematologic remission being treated for vitamin B12 deficiency with either intranasal gel (n=24) or intramuscular injection (n=25), 1 patient in the intranasal group experienced 1 occurrence of rhinitis compared with 2 patients in the intramuscular group who experienced 2 occurrences of rhinitis The relationship of rhinitis to cyanocobalamin was judged as possible [48] Sinusitis 1) Incidence: 4% [3] Other Death 2) In an uncontrolled clinical trial (n=25), sinusitis was reported in 4% of patients who received cyanocobalamin 50 mcg intranasally once daily for 8 weeks [3] 1) Death has been reported with parenteral administration of cyanocobalamin [33] Fever 1) Incidence: 4% [3] 2) In an uncontrolled clinical trial (n=25), pyrexia was reported in 4% of patients who received cyanocobalamin 50 mcg intranasally once daily for 8 weeks [3] Swelling 1) Feeling of swelling of entire body has been reported with parenteral administration of cyanocobalamin [33] Teratogenicity/Effects in Pregnancy/Breastfeeding

27 A) Teratogenicity/Effects in Pregnancy 1) US Food and Drug Administration's Pregnancy Category: Category C (All Trimesters) a) Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available Drugs should be given only if the potential benefit justifies the potential risk to the fetus See Drug Consult reference: PREGNANCY RISK CATEGORIES 2) Crosses Placenta: Yes 3) Clinical Management a) Although well-controlled studies in pregnant women have not been conducted, cyanocobalamin (vitamin B12) is an essential vitamin and requirements are increased during pregnancy According to the Food and Nutrition Board of the National Academy of Science- National Research Council, 4 mcg per day is recommended in pregnant women (Prod Info Cyanocobalamin Injection, 2003) Another source suggests that dietary vitamin B-12 requirements are increased during pregnancy to a recommended dietary reference intake of 26 micrograms daily, an amount 8% over nonreproducing adult women [69] 4) Literature Reports a) No studies examining the use of cyanocobalamin during pregnancy are available at this time B) Breastfeeding 1) Thomson Lactation Rating: Infant risk is minimal a) The weight of an adequate body of evidence and/or expert consensus suggests this drug poses minimal risk to the infant when used during breastfeeding 2) Clinical Management a) Cyanocobalamin is excreted in human milk Although well-controlled studies in lactating women have not been conducted, cyanocobalamin (vitamin B12) is an essential vitamin and requirements are likely increased during lactation According to the Food and Nutrition Board of the National Academy of Science-National Research Council, 4 mcg per day is recommended in lactating women (Prod Info Cyanocobalamin injection, 2003) 3) Literature Reports a) Megaloblastic anemia has been described in some infants breast-fed by vitamin B12- deficient mothers; many of the mothers were vegetarians [70] [71] [72] Supplementation of the diet with vitamin B12 should be considered during lactation in vegetarians [73]

28 Drug Interactions Drug-Drug Combinations Aminosalicylic Acid 1) Interaction Effect: reduced cyanocobalamin absorption 2) Summary: Long-term therapy with aminosalicylic acid may reduce the absorption of cyanocobalamin from the gastrointestinal tract, possibly resulting in cyanocobalamin deficiency [60] This may be related to an aminosalicylic acid-induced malabsorption syndrome [61] [62] Theoretically, higher doses of oral cyanocobalamin may be required in patients treated with aminosalicylic acid However, this interaction is of doubtful clinical relevance unless large doses of aminosalicylic acid are taken for prolonged periods 3) Severity: minor 4) Onset: delayed 5) Substantiation: theoretical 6) Clinical Management: Patients receiving aminosalicylic acid for more than one month may require supplemental cyanocobalamin 7) Probable Mechanism: unknown, possibly due to a malabsorption syndrome 8) Literature Reports a) Cyanocobalamin absorption has been reduced 55% by aminosalicylic acid 5 grams as a result of competition Clinically significant erythrocyte abnormalities developed after the depletion of cyanocobalamin [59] Ascorbic Acid 1) Interaction Effect: reduced amounts of cyanocobalamin available for serum and body stores 2) Summary: Ascorbic acid in doses as low as 250 mg may destroy up to 81% of the cyanocobalamin in a moderate vitamin B12-containing meal, and up to 25% in a high vitamin B12-containing meal [63] The degree of destruction appears to be dependent on the various other ingredients in the meal, such as iron in moderate amounts and nitrates, which may counteract ascorbic acid's effect on cyanocobalamin To diminish the possibility and magnitude of such destruction, it is suggested that ascorbic acid be taken two or more hours after meals While ascorbic acid may still destroy a substantial amount of the normally excreted vitamin B12 and possibly lower vitamin B12 in serum and body stores, frank megaloblastic anemia would require megadoses of ascorbic acid ingested over several years 3) Severity: minor 4) Onset: delayed 5) Substantiation: probable 6) Clinical Management: Ascorbic acid should be administered two or more hours after a meal or vitamin B12 supplements 7) Probable Mechanism: unknown Chloramphenicol

29 1) Interaction Effect: decreased hematologic response 2) Summary: The use chloramphenicol in vitamin B12-deficient patients treated with cyanocobolamin may result in a suboptimal clinical response to cyanocobolamin [57] [58] 3) Severity: minor 4) Onset: delayed 5) Substantiation: probable 6) Clinical Management: In the rare event that this interaction occurs, monitor for an adequate hematologic response with a periodic CBC 7) Probable Mechanism: antagonism Colchicine 1) Interaction Effect: decreased cyanocobalamin absorption 2) Summary: Colchicine therapy is associated with reduced cyanocobalamin absorption [66], with the greatest reductions observed with tubal administration directly into the ileum The effects were reversible with colchicine discontinuation [67] 3) Severity: minor 4) Onset: delayed 5) Substantiation: established 6) Clinical Management: Patients receiving colchicine therapy may require supplemental cyanocobalamin During therapy, monitor patient for signs/symptoms of cyanocobalamin deficiency, including paresthesia, diminution of the vibration sense and/or position sense, unsteadiness, and poor muscular coordination and ataxia In patients receiving long-term colchicine therapy, monitor serum levels of cyanocobalamin (vitamin B 12), especially elderly and those with chronic liver or renal failure [65] 7) Probable Mechanism: disruption of intestinal mucosal function 8) Literature Reports a) In a subgroup analysis of 11 obese patients given colchicine while maintaining a nutritionally-stable diet, consistent reductions in vitamin B12 absorption were noted in 3 patients administered colchicine (26 to 39 mg/day) plus 025 microcuries/day of cobalt 57-labeled vitamin B12 Schilling tests showed decreased vitamin B12 absorption during colchicine periods, with a decrease to subnormal levels (less than 7%) in 2 of the 3 patients Vitamin B12 excretion increased between the control and recovery periods for patient 1 (225% to 27%), patient 2 (222% to 295%), and patient 3 (24% to 40%) Levels returned to normal following colchicine withdrawal [66] b) Oral colchicine reduced cyanocobalamin absorption in 18 out of 19 patients studied, with the greatest reductions reported with direct delivery to the ileum Three male and 16 female patients (18 obese and 1 with hyperlipemia) were

30 given a constant diet and administered daily oral doses of 01 microcuries of cobalt 57-labeled vitamin B12 followed by 1 mg of intramuscular vitamin B12 two hours later Urine and feces were analyzed for cobalt 57 during control periods, with administration of colchicine (19 to 36 mg/day by mouth or tube over 4 to 8 days), and with cascara sagrada fluid extract (18 ml) given during control periods Overall, there were significant decreases in vitamin B12 absorption during colchicine periods (p less than 001), with all but one patient having higher vitamin B12 excretion after colchicine than before The greatest reductions in absorption (less than 5% excretion) were noted when colchicine was administered by tube directly into the ileum Three to five days after colchicine withdrawal, vitamin B12 levels returned to baseline in all but one patient [67] Omeprazole 1) Interaction Effect: decreased cyanocobalamin absorption 2) Summary: A prospective study involving 10 healthy volunteers demonstrated that omeprazole therapy for 2 weeks' duration resulted in a decrease of 90% (p=0031) in protein-bound cyanocobalamin absorption [64] It is not known to what degree absorption of an oral cyanocobalamin supplement would be affected if taken with a protein meal under similar conditions Cyanocobalamin by intramuscular or subcutaneous route would therefore be preferred in patients receiving long-term omeprazole therapy 3) Severity: minor 4) Onset: delayed 5) Substantiation: probable 6) Clinical Management: If possible, switch to another anti-ulcer medication (eg, ranitidine, famotidine, or sucralfate) and separate the doses by at least two hours However, if long term omeprazole therapy is required, cyanocobalamin by the intramuscular or subcutaneous route would be preferred 7) Probable Mechanism: altered gastric ph Intravenous Admixtures Drugs Ascorbic Acid 1) Conflicting Data a) Incompatible 1) Rubramin (incompatible with ascorbic acid; conditions not specified) [209] [210] b) Compatible 1) Ascorbic acid (1 g/l with cyanocobalamin 1000 mcg/l physically compatible in the solutions listed below; conditions not specified) [190] : Dextran 12%

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