Nascobal

NASCOBAL- cyanocobalamin spray
Par Pharmaceutical, Inc.

1 INDICATIONS AND USAGE

NASCOBAL 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

  • 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.

2 DOSAGE AND ADMINISTRATION

2.1 Testing and Other Considerations Prior to Dosing

Prior to treatment, obtain hematocrit, reticulocyte count, vitamin B12 , folate, and iron levels [see Dosage and Administration (2.4)]. Consider the potential for concomitant drugs to interfere with vitamin B12 and folate diagnostic blood assays [see Drug Interactions (7)].

In patients with suspected cobalamin hypersensitivity, consider administering an intradermal test dose of parenteral vitamin B12 prior to use of NASCOBAL [see Warnings and Precautions (5.2)].

2.2 Recommended Dosage

The recommended initial dose of NASCOBAL is one spray (500 mcg) administered in ONE nostril once weekly. Administer NASCOBAL at least one hour before or one hour after ingestion of hot foods or liquids since hot foods may cause nasal secretions and a resulting loss of medication. Defer use of NASCOBAL in patients with nasal congestion, allergic rhinitis, or upper respiratory infections until after symptoms have subsided.

2.3 Monitoring, Dosage Modifications, and Treatment Duration

Monitoring for Response and Safety

Monitor serum B12 levels periodically during therapy to establish adequacy of therapy. Obtain a serum B12 level and peripheral blood count one month after treatment initiation, then subsequently at intervals of 3 to 6 months [see Warnings and Precautions (5.3)].

Dosage Modifications

If serum levels of B12 decline after one month of treatment with NASCOBAL, consider increasing the dose. Assess serum B12 level one month after each dose adjustment. If serum B12 levels are persistently low, consider alternative therapy (e.g., intramuscular or subcutaneous vitamin B12 therapy).

Treatment Duration

In patients whose underlying cause of vitamin B12 deficiency has been corrected and are deemed no longer at risk for vitamin B12 deficiency, discontinue NASCOBAL. The safety and effectiveness of continued long-term use in these individuals has not been established.

In patients with pernicious anemia, continue appropriate vitamin B12 treatment indefinitely.

2.4 Administration of NASCOBAL with Other Therapy

NASCOBAL should be administered with other therapy(ies) in:

  • Patients with concurrent folate and vitamin B12 deficiency:Administer folic acid in addition to NASCOBAL
  • Patients with concurrent iron and vitamin B12 deficiency:Administer iron in addition to NASCOBAL
  • Patients with correctible causes of vitamin B12 deficiency:Consider measures to treat the underlying condition associated with vitamin B12 deficiency in addition to treatment with NASCOBAL

3 DOSAGE FORMS AND STRENGTHS

Nasal spray: 500 mcg/0.1 mL (per actuation), packaged in a single-use device containing 0.125 mL of solution

4 CONTRAINDICATIONS

NASCOBAL 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.

5 WARNINGS AND PRECAUTIONS

5.1 Severe 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 NASCOBAL, 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.

5.2 Anaphylactic Reactions

Anaphylactic shock and death have been reported after parenteral vitamin B12 administration. If patients are to start NASCOBAL 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)].

5.3 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. 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 NASCOBAL, or with folic acid [see Dosage and Administration (2.1)].

5.4 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 . 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)].

5.5 Unmasking 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.

6 ADVERSE REACTIONS

The following serious adverse reactions are described elsewhere in the labeling:

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reactions described in Table 1 below are based on data from an eight week cross over trial in which vitamin B12 deficient patients in hematologic remission received one vitamin B12 intramuscular injection (N=25) and then received once weekly intranasal administration of another nasal cyanocobalamin formulation (N=24) for 4 weeks.

Table 1. Adverse Reactions Following Intranasal or Intramuscular Administration of Cyanocobalamin In Vitamin B12 Deficient Patients in Hematologic Remission
Adverse Reaction Number of Patients (%)
Another Cyanocobalamin Nasal Formulation, 500 mcg
(n=24)
Intramuscular Cyanocobalamin*, 100 mcg
(n=25)
Infection a 3 (13) 3 (12)
Headache 1 (4) 5 (20)
Asthenia 1 (4) 4 (16)
Nausea 1 (4) 1 (4)
Glossitis 1 (4) 0 (0)
Paresthesia 1 (4) 1 (4)
Rhinitis 1 (4) 2 (8)

a Sore throat, common cold
* The data are not an adequate basis for comparison of rates between the study drug and the active control


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