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IMPORTANT SAFETY INFORMATION FOR NASCOBAL® NASAL SPRAY

NASCOBAL® is contraindicated in patients with sensitivity to cobalt, vitamin B12, or any component of the medication. Anaphylactic shock and death have been reported with parenteral forms of vitamin B12. Consider administering an intradermal test dose of parenteral vitamin B12 to patients suspected of cyanocobalamin hypersensitivity prior to starting NASCOBAL®.

Patients with Leber's disease who were treated with vitamin B12 suffered severe and swift optic atrophy. NASCOBAL® is not recommended for use in patients with Leber’s optic atrophy.

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. NASCOBAL® is not a substitute for folic acid. Assess both vitamin B12 and folate levels prior to initiating therapy with NASCOBAL®.

Hypokalemia, thrombocytosis and sudden death may occur in severe megaloblastic anemia which is treated intensely with vitamin B12. Serum potassium levels and platelet count should be monitored.

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

Hematocrit, reticulocyte count, vitamin B12, folate and iron levels should be obtained prior to treatment. Consider the potential for concomitant drugs to interfere with vitamin B12 and folate diagnostic blood assays. Vitamin B12 and peripheral blood counts must be monitored initially at one month after the start of treatment, and then at intervals of 3 to 6 months. If a patient is not properly maintained with NASCOBAL®, consider alternative therapy.

If NASCOBAL® is used concomitantly with chloramphenicol, monitor for reduced efficacy and, if needed, consider an alternative therapy.

The limited available data on NASCOBAL® in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes.

The most common adverse reactions (≥4%) were infection, headache, glossitis, paresthesia, asthenia, nausea and rhinitis.

INDICATIONS

  • 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

  • NASCOBAL® 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 NASCOBAL® following adequate correction of vitamin B12 deficiency and underlying disease has not been established.
  • The effectiveness of NASCOBAL® in patients with active symptoms of nasal congestion, allergic rhinitis or upper respiratory infection has not been determined. Treatment with NASCOBAL® should be deferred until symptoms have subsided.
Please see the full Prescribing Information.

IMPORTANT SAFETY INFORMATION FOR NASCOBAL® NASAL SPRAY

NASCOBAL® is contraindicated in patients with sensitivity to cobalt, vitamin B12, or any component of the medication. Anaphylactic shock and death have been reported with parenteral forms of vitamin B12. Consider administering an intradermal test dose of parenteral vitamin B12 to patients suspected of cyanocobalamin hypersensitivity prior to starting NASCOBAL®.

Patients with Leber's disease who were treated with vitamin B12 suffered severe and swift optic atrophy. NASCOBAL® is not recommended for use in patients with Leber’s optic atrophy.

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. NASCOBAL® is not a substitute for folic acid. Assess both vitamin B12 and folate levels prior to initiating therapy with NASCOBAL®.

Hypokalemia, thrombocytosis and sudden death may occur in severe megaloblastic anemia which is treated intensely with vitamin B12. Serum potassium levels and platelet count should be monitored.

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

Hematocrit, reticulocyte count, vitamin B12, folate and iron levels should be obtained prior to treatment. Consider the potential for concomitant drugs to interfere with vitamin B12 and folate diagnostic blood assays. Vitamin B12 and peripheral blood counts must be monitored initially at one month after the start of treatment, and then at intervals of 3 to 6 months. If a patient is not properly maintained with NASCOBAL®, consider alternative therapy.

If NASCOBAL® is used concomitantly with chloramphenicol, monitor for reduced efficacy and, if needed, consider an alternative therapy.

The limited available data on NASCOBAL® in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes.

The most common adverse reactions (≥4%) were infection, headache, glossitis, paresthesia, asthenia, nausea and rhinitis.

INDICATIONS

  • 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

  • NASCOBAL® 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 NASCOBAL® following adequate correction of vitamin B12 deficiency and underlying disease has not been established.
  • The effectiveness of NASCOBAL® in patients with active symptoms of nasal congestion, allergic rhinitis or upper respiratory infection has not been determined. Treatment with NASCOBAL® should be deferred until symptoms have subsided.
Please see the full Prescribing Information.