Cyanocobalamin (nasal)

FDA label, Par Health USA, LLC, nasal, effective 2024-03-01. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Vitamin B12

Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Preparation and administration

Administration of NASCOBAL with Other Therapy NASCOBAL should be administered with other therapy(ies) in: Patients with concurrent folate and vitamin B 12 deficiency:Administer folic acid in addition to NASCOBAL Patients with concurrent iron and vitamin B 12 deficiency:Administer iron in addition to NASCOBAL Patients with correctible causes of vitamin B 12 deficiency:Consider measures to treat the underlying condition associated with vitamin B 12 deficiency in addition to treatment with NASCOBAL

Drug interactions

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Label text (1 paragraph)

Chloramphenicol may decrease the efficacy of NASCOBAL when used for treatment of anemia. If NASCOBAL is used for the treatment of anemia concomitantly with chloramphenicol, monitor for reduced efficacy and if needed, consider an alternative therapy

Contraindications

4 CONTRAINDICATIONS NASCOBAL is contraindicated in patients with hypersensitivity to cobalt and/or vitamin B 12 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. • Hypersensitivity to cobalt, vitamin B 12 or any excipients (4)

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for cyanocobalamin (nasal). Check the label's hepatic warnings.

Pregnancy and lactation

Pregnancy

8.1 Pregnancy Risk Summary The limited available data on NASCOBAL in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. However, vitamin B12 is an essential vitamin and requirements are increased during pregnancy. Animal reproduction studies have not been conducted with vitamin B 12 . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

Supply and cost

Drug shortage status

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Recalls (last 24 months)

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Therapeutic equivalence (Orange Book)

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Price ladder

Not the price at the counter
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These are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.

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Recruiting clinical trials

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