cyanocobalamin

sye-an-oh-koe-BAL-a-min

Therapeutic Classification: antianemics, vitamins

Pharmacologic Classification: water soluble vitamins

REMS

Vitamin B₁₂ deficiency (parenteral products or nasal spray should be used when deficiency is due to malabsorption).
Pernicious anemia (parenteral products should be used for initial therapy; nasal or oral products are not indicated until patients have achieved hematologic remission following parenteral therapy and have no signs of CNS involvement).
Part of the Schilling test (vitamin B₁₂ absorption test) (diagnostic).

Necessary coenzyme for metabolic processes, including fat and carbohydrate metabolism and protein synthesis.
Required for cell reproduction and hematopoiesis.

Therapeutic effects:

Corrects manifestations of pernicious anemia (megaloblastic indices, GI lesions, and neurologic damage).
Corrects vitamin B₁₂ deficiency.
Schilling test confirms impaired vitamin B ₁₂ absorption.

Absorption: Oral absorption in GI tract requires intrinsic factor and calcium; well absorbed after IM, SUBQ and nasal administration.

Distribution: Stored in the liver and bone marrow.

Metabolism/Excretion: Primarily excreted unchanged in urine.

Half-Life: 6 days (400 days in liver).

(reticulocytosis)

ROUTE	ONSET	PEAK	DURATION
IM	unknown	3–10 days	unknown
SUBQ	unknown	3–10 days	unknown
Nasal	unknown	3–10 days	unknown

Contraindicated in:

Hypersensitivity;
Pedi: Avoid using preparations containing benzyl alcohol in premature infants (associated with fatal gasping syndrome).

Use Cautiously in:

Hereditary optic nerve atrophy (accelerates nerve damage);
Renal impairment (when using aluminum-containing products);
Uremia, folic acid deficiency, concurrent infection, iron deficiency (response to vitamin B₁₂ will be impaired).

CV: HF

Derm: itching, swelling of the body

F and E: hypokalemia

GI: diarrhea

Hemat: thrombocytosis

Local: pain at IM site

Neuro: headache

Resp: pulmonary edema

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

Drug-drug:

Chloramphenicol and antineoplastics may ↓ hematologic response.
Colchicine, aminosalicylic acid, or excessive intake of alcohol or vitamin C may ↓ absorption/effectiveness.

Oral products are usually not recommended due to poor absorption and should be used only if patient refuses the intramuscular, deep SUBQ, or intranasal route of administration.

Vitamin B12 Deficiency

PO (Adults and Children ): Amount depends on deficiency (up to 1000 mcg/day have been used).
IM SC (Adults ): 30 mcg/day for 5–10 days; then 100–200 mcg/mo.
IM SC (Children ): 0.2 mcg/kg for 2 days; then 1000 mcg/day for 2–7 days; then 100 mcg/wk for 1 mo.
(Adults ): 500 mcg (one spray) in one nostril once weekly.

Pernicious Anemia

IM SC (Adults ): 100 mcg/day for 6–7 days; if improvement, give same dose every other day for 7 doses; then every 3–4 days for 2–3 wk; once hematologic values return to normal (remission), can give maintenance dose of 100 mcg/mo (doses up to 1000 mcg have been used for maintenance) (could alternatively use oral or intranasal formulations below for maintenance at specified doses).
PO (Adults ): For hematologic remission only: 1000–2000 mcg/day.
(Adults ): For hematologic remission only: 500 mcg (one spray) in one nostril once weekly.
IM SC (Children ): 30–50 mcg/day for 2 or more wk (to a total dose of 1000–5000 mcg); then give maintenance dose of 100 mcg/mo (doses up to 1000 mcg have been used for maintenance).

Schilling Test

IM SC (Adults ): Flushing dose is 1000 mcg.

(Generic available)

Tablets: 100 mcgOTC; 250 mcgOTC; 500 mcgOTC; 1000 mcgOTC
Extended-release tablets: 1000 mcgOTC
Sublingual tablets: 2500 mcg OTC
Lozenges: 50 mcgOTC; 100 mcgOTC; 250 mcgOTC; 500 mcgOTC
Nasal spray: 500 mcg/0.1 mL actuation (8 sprays/bottle)
Solution for injection: 1000 mcg/mL

Assess patient for signs of vitamin B₁₂ deficiency (pallor; neuropathy; psychosis; red, inflamed tongue) and folate deficiency (fatigue, mouth sores, confusion, neuropathy) before and periodically during therapy.
Polycythemia vera can be masked by vitamin B ₁₂deficiency; assess for headaches, fatigue, dizziness, blurred vision, night sweats, pruritus.

Lab Test Considerations:

Obtain hematocrit; reticulocyte count; and vitamin B ₁₂, folate, and iron levels prior to therapy, 1 mo after the start of therapy, and then every 3–6 mo. Evaluate serum potassium level in patients receiving vitamin B₁₂ for pernicious anemia for hypokalemia during the first 48 hr of treatment. Serum potassium levels and platelet counts should be monitored routinely during the course of therapy.

Usually administered in combination with other vitamins; solitary vitamin B₁₂ deficiencies are rare.
- Administration of vitamin B₁₂ by the oral route is useful only for nutritional deficiencies. Patients with small-bowel disease, malabsorption syndrome, or gastric or ileal resections require parenteral administration.
IM: SC: Vials should be protected from light.
- If SUBQ route used, deep SUBQ administration is preferred.
PO: Administer with meals to increase absorption.
- May be mixed with fruit juices. Administer immediately after mixing; ascorbic acid alters stability.
- Do not give extended-release tablets within 2 hr of other medications.
Dose should not be administered within 1 hr of hot foods or liquids (these substances may result in the formation of nasal secretions, which may result in ↓ effectiveness of nasal spray).
- Nasal spray unit must be primed with 3 strokes on first use. Unit must be primed with 1 stroke before each remaining dose. Advise patient to clear nose; then place tip approximately 1 inch into nostril and press pump once, firmly and quickly. After dose, remove unit from nose and massage dosed nostril gently for a few seconds. Vial delivers 8 doses. Unit should be stored at room temperature and protected from light.

Teach patient reason for vitamin B ₁₂therapy and side effects. Explain that they should take oral forms with food for best absorption and avoid alcohol during therapy.
Encourage patient to comply with diet recommendations of health care professional. Explain that the best source of vitamins is a well-balanced diet. Foods high in vitamin B₁₂ include meats, seafood, egg yolk, and fermented cheeses.
Patients self-medicating with vitamin supplements should be cautioned not to exceed RDA. Effectiveness of megadoses for treatment of various medical conditions is unproven and may cause side effects.
Inform patients with pernicious anemia of the lifelong need for vitamin B₁₂ replacement.
Emphasize the importance of follow-up exams to evaluate progress.

Resolution of the symptoms of vitamin B₁₂ deficiency.
- Increase in reticulocyte count.
Improvement in manifestations of pernicious anemia.
Schilling test confirms impaired vitamin B ₁₂ absorption.

Dodex, ~~Nascobal~~

NDC Code

0143- West-Ward Pharmaceuticals Corp
- 0143-9619- Cyanocobalamin
  - 0143-9619-10- 10 VIAL, MULTI-DOSE in 1 BOX (0143-9619-10) > 30 mL in 1 VIAL, MULTI-DOSE (0143-9619-01)

0143- West-Ward Pharmaceuticals Corp
- 0143-9620- Cyanocobalamin
  - 0143-9620-10- 10 VIAL, MULTI-DOSE in 1 BOX (0143-9620-10) > 10 mL in 1 VIAL, MULTI-DOSE (0143-9620-01)

0143- West-Ward Pharmaceuticals Corp
- 0143-9621- Cyanocobalamin
  - 0143-9621-25- 25 VIAL in 1 BOX (0143-9621-25) > 1 mL in 1 VIAL (0143-9621-01)

0517- American Regent, Inc.
- 0517-0031- Cyanocobalamin
  - 0517-0031-25- 25 VIAL, SINGLE-USE in 1 TRAY (0517-0031-25) > 1 mL in 1 VIAL, SINGLE-USE (0517-0031-01)

0517- American Regent, Inc.
- 0517-0032- Cyanocobalamin
  - 0517-0032-25- 25 VIAL, MULTI-DOSE in 1 TRAY (0517-0032-25) > 10 mL in 1 VIAL, MULTI-DOSE (0517-0032-01)

0517- American Regent, Inc.
- 0517-0130- Cyanocobalamin
  - 0517-0130-01- 1 VIAL, MULTI-DOSE in 1 BOX (0517-0130-01) > 30 mL in 1 VIAL, MULTI-DOSE

49884- Par Pharmaceutical, Inc.
- 49884-270- Nascobal
  - 49884-270-82- 4 SPRAY in 1 CARTON (49884-270-82)

50090- A-S Medication Solutions
- 50090-2709- Cyanocobalamin
  - 50090-2709-0- 25 VIAL in 1 BOX (50090-2709-0) > 1 mL in 1 VIAL

51662- HF Acquisition Co LLC, DBA HealthFirst
- 51662-1394- CYANOCOBALAMIN
  - 51662-1394-1- 30 mL in 1 VIAL, MULTI-DOSE (51662-1394-1)

52584- General Injectables and Vaccines, Inc.
- 52584-080- CYANOCOBALAMIN
  - 52584-080-01- 1 VIAL, MULTI-DOSE in 1 BAG (52584-080-01) > 30 mL in 1 VIAL, MULTI-DOSE

52584- General Injectables and Vaccines, Inc.
- 52584-399- CYANOCOBALAMIN
  - 52584-399-10- 1 VIAL in 1 BAG (52584-399-10) > 10 mL in 1 VIAL

63323- Fresenius Kabi USA, LLC
- 63323-044- Cyanocobalamin
  - 63323-044-01- 25 VIAL, MULTI-DOSE in 1 TRAY (63323-044-01) > 1 mL in 1 VIAL, MULTI-DOSE (63323-044-00)

63323- Fresenius Kabi USA, LLC
- 63323-044- Cyanocobalamin
  - 63323-044-44- 25 VIAL, MULTI-DOSE in 1 TRAY (63323-044-44) > 1 mL in 1 VIAL, MULTI-DOSE (63323-044-41)

69680- Vitruvias Therapeutics
- 69680-112- Cyanocobalamin
  - 69680-112-10- 10 VIAL in 1 BOX (69680-112-10) > 1 mL in 1 VIAL

69680- Vitruvias Therapeutics
- 69680-112- Cyanocobalamin
  - 69680-112-25- 25 VIAL in 1 BOX (69680-112-25) > 1 mL in 1 VIAL

69680- Vitruvias Therapeutics
- 69680-113- Cyanocobalamin
  - 69680-113-99- 10 VIAL in 1 BOX (69680-113-99) > 10 mL in 1 VIAL

70069- Somerset Therapeutics, LLC
- 70069-005- cyanocobalamin
  - 70069-005-10- 25 VIAL in 1 CARTON (70069-005-10) > 1 mL in 1 VIAL (70069-005-01)

70069- Somerset Therapeutics, LLC
- 70069-171- CYANOCOBALAMIN
  - 70069-171-05- 5 VIAL in 1 CARTON (70069-171-05) > 30 mL in 1 VIAL (70069-171-01)

70069- Somerset Therapeutics, LLC
- 70069-171- CYANOCOBALAMIN
  - 70069-171-10- 10 VIAL in 1 CARTON (70069-171-10) > 30 mL in 1 VIAL (70069-171-01)

70069- Somerset Therapeutics, LLC
- 70069-172- cyanocobalamin
  - 70069-172-10- 10 VIAL in 1 CARTON (70069-172-10) > 10 mL in 1 VIAL (70069-172-01)

70069- Somerset Therapeutics, LLC
- 70069-172- cyanocobalamin
  - 70069-172-25- 25 VIAL in 1 CARTON (70069-172-25) > 10 mL in 1 VIAL (70069-172-01)

70529- IT3 Medical LLC
- 70529-290- Vitamin Deficiency Injectable System - B12
  - 70529-290-01- 1 KIT in 1 PACKAGE (70529-290-01) * 1 mL in 1 VIAL (0143-9621-01) * 1 mL in 1 PACKET (68599-5804-1)

70529- IT3 Medical LLC
- 70529-293- Vitamin Deficiency System
  - 70529-293-01- 1 VIAL, MULTI-DOSE in 1 PACKAGE (70529-293-01) > 30 mL in 1 VIAL, MULTI-DOSE

72843- UBI Pharma Inc.
- 72843-487- Cyanocobalamin
  - 72843-487-25- 25 VIAL in 1 BOX (72843-487-25) > 1 mL in 1 VIAL

72843- UBI Pharma Inc.
- 72843-497- Cyanocobalamin
  - 72843-497-99- 10 VIAL in 1 BOX (72843-497-99) > 10 mL in 1 VIAL

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