Vitamin B12

Cyanocobalamin

Approved 30 Jun 2023NasalSpray, metered

The FDA lists this product in 38 strengths and forms.

Indications

Cyanocobalamin Nasal Spray is indicated for: Vitamin B12 maintenance therapy in adult patients with pernicious anemia who are in remission following intramuscular vitamin B12 therapy and who have no nervous system involvement Treatment of adult patients with dietary, drug-induced, or malabsorption-related vitamin B12 deficiency not due to pernicious anemia Prevention of vitamin B12 deficiency in adult patients with vitamin B12 requirements in excess of normal Limitations of Use: Cyanocobalamin Nasal Spray should not be used for the vitamin B12 absorption test (Schilling test).

In patients with correctible or temporary causes of vitamin B12 deficiency, the benefit of continued long term use of Cyanocobalamin Nasal Spray following adequate correction of vitamin B12 deficiency and underlying disease has not been established. The effectiveness of Cyanocobalamin Nasal Spray in patients with active symptoms of nasal congestion, allergic rhinitis or upper respiratory infection has not been determined.

Treatment with Cyanocobalamin Nasal Spray should be deferred until symptoms have subsided. Cyanocobalamin Nasal Spray is a vitamin B12 indicated for: Vitamin B12 maintenance therapy in adult patients with pernicious anemia who are in remission following intramuscular vitamin B12 therapy and who have no nervous system involvement Treatment of adult patients with dietary, drug-induced, or malabsorption related vitamin B12 deficiency not due to pernicious anemia Prevention of vitamin B12 deficiency in adult patients with vitamin B12 requirements in excess of normal Limitations of Use: Should not be used for the vitamin B12 absorption test (Schilling test).

In patients with correctible or temporary causes of vitamin B12 deficiency the benefit of continued long-term use following correction of vitamin B12 deficiency and underlying disease has not been established. In patients with active symptoms of nasal congestion, allergic rhinitis or upper respiratory infection effectiveness has not been established.

Contraindications

Cyanocobalamin Nasal Spray is contraindicated in patients with hypersensitivity to cobalt and/or vitamin B12 or any of its excipients [ see Warnings and Precautions (5.2) ] . Anaphylactic shock and death have been reported after parenteral vitamin B12 administration in sensitive patients.

Indications

Warnings and precautions

Severe Optic Atrophy in Patients with Leber's Disease : Patients with early Leber's disease who were treated with vitamin B12 suffered severe and swift optic atrophy. Cyanocobalamin Nasal Spray is not recommended for use in these patients ( 5.1 ) Anaphylactic Reactions : Anaphylactic shock and death have been reported after parenteral vitamin B12 administration. If patients are to start Cyanocobalamin Nasal Spray before having tolerated cyanocobalamin parenterally, consider administering an intradermal test dose of parenteral vitamin B12 to patients suspected of cyanocobalamin hypersensitivity.

( 2.1 , 5.2 ) Masking of Folate Deficiency with Vitamin B12 Use : Doses of vitamin B12 exceeding 10 mcg daily may produce hematologic response in patients with folate deficient megaloblastic anemia and may therefore mask a previously unrecognized folate deficiency. Assess both vitamin B12 and folate levels prior to initiating therapy with Cyanocobalamin Nasal Spray or with folic acid. ( 5.3 ) Hypokalemia and Thrombocytosis Due to Intense Treatment of Megaloblastic Anemia : Hypokalemia and sudden death may occur in severe megaloblastic anemia that is treated intensely with vitamin B12.

Monitor serum potassium levels and platelet count during therapy. ( 5.4 ) Unmasking of Polycythemia Vera : Vitamin B12 deficiency may suppress the signs of polycythemia vera. Treatment with Cyanocobalamin Nasal Spray may unmask this condition. Patients exhibiting clinical or hematologic response consistent with polycythemia vera should be referred for further evaluation. ( 5.5 )

5.1Severe Optic Atrophy in Patients with Leber’s Disease Patients

with early Leber's disease (hereditary optic nerve atrophy) who were treated with vitamin B12 suffered severe and swift optic atrophy. Cyanocobalamin products, including Cyanocobalamin Nasal Spray, is not recommended for use in patients with Leber's optic atrophy. For patients with Leber's disease requiring vitamin B12, consider alternative therapy (e.g., hydroxocobalamin) for B12 supplementation.

5.2Anaphylactic Reactions

Anaphylactic shock and death have been reported after parenteral vitamin B12 administration. If patients are to start Cyanocobalamin Nasal Spray before having tolerated cyanocobalamin parenterally, consider administering an intradermal test dose of parenteral vitamin B12 to patients suspected of cyanocobalamin hypersensitivity [ see Dosage and Administration (2.1) ] .

5.3Masking of Folate Deficiency with Vitamin B12 Use Doses

of vitamin B12 exceeding 10 mcg daily may produce hematologic response in patients with folate deficient megaloblastic anemia and may therefore mask a previously unrecognized folate deficiency. Vitamin B12 is not a substitute for folic acid [ see Dosage and Administration (2.4) ] . Assess both vitamin B12 and folate levels prior to initiating therapy with vitamin B12, including Cyanocobalamin Nasal Spray, or with folic acid [ see Dosage and Administration (2.1) ] .

5.4Hypokalemia and Thrombocytosis Due to Intense Treatment of Megaloblastic Anemia Hypokalemia

and sudden death may occur in severe megaloblastic anemia that is treated intensely with vitamin B12. Hypokalemia and thrombocytosis can occur upon conversion of severe megaloblastic anemia to normal erythropoiesis with vitamin B12 therapy. Therefore, serum potassium levels and platelet count should be monitored carefully during therapy [ see Dosage and Administration (2.3) ] .

5.5Unmasking of Polycythemia Vera Vitamin

B12 deficiency may suppress the signs of polycythemia vera. Treatment with vitamin B12 may unmask this condition. Patients exhibiting clinical or hematologic response consistent with polycythemia vera should be referred for further evaluation.

Cyanocobalamin

Indications

Contraindications

Two medicines in one question?

Cyanocobalamin

Indications

Contraindications

Two medicines in one question?

Warnings and precautions

5.1Severe Optic Atrophy in Patients with Leber’s Disease Patients

5.2Anaphylactic Reactions

5.3Masking of Folate Deficiency with Vitamin B12 Use Doses

5.4Hypokalemia and Thrombocytosis Due to Intense Treatment of Megaloblastic Anemia Hypokalemia

5.5Unmasking of Polycythemia Vera Vitamin

Interactions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

Composition

Strengths and forms

Official product information

At a glance