Nascobal

Patients with early Leber's disease (hereditary optic nerve atrophy) who were treated with vitamin B12 suffered severe and swift optic atrophy.

Hypokalemia and sudden death may occur in severe megaloblastic anemia which is treated intensely with vitamin B12. Folic acid is not a substitute for vitamin B12 although it may improve vitamin B12-deficient megaloblastic anemia. Exclusive use of folic acid in treating vitamin B12-deficient megaloblastic anemia could result in progressive and irreversible neurologic damage.

Anaphylactic shock and death have been reported after parenteral vitamin B12 administration. No such reactions have been reported in clinical trials with Nascobal (cyanocobalamin) Nasal Spray or Nascobal (cyanocobalamin) Nasal Gel.

Blunted or impeded therapeutic response to vitamin B12 may be due to such conditions as infection, uremia, drugs having bone marrow suppressant properties such as chloramphenicol, and concurrent iron or folic acid deficiency.

• Celiac Disease
• Crohn's Disease

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of cyanocobalamin, there are no specific foods that you must exclude from your diet when receiving this medication.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to cyanocobalamin injection.

Unless your doctor tells you otherwise, continue your normal diet.

Vitamin B12 Deficiency

Treatment of pernicious anemia and other vitamin B12 deficiency states.a 102 105

Parenteral cyanocobalamin or hydroxocobalamin: Treatment of vitamin B12 deficiency due to inadequate intrinsic factor (IF) secretion; impaired intestinal absorption; or dietary deficiency associated with a vegetarian diet.a 102 105

Cyanocobalamin is considered the parenteral vitamin B12 preparation of choice; hydroxocobalamin may be preferred for initial treatment.a

Cyanocobalamin nasal spray: Used to maintain hematologic status in adults with pernicious anemia with no nervous system involvement who have responded to parenteral vitamin B 12 therapy.103 Also used as a supplement for vitamin B12 deficiency due to dietary deficiency, impaired absorption, inadequate secretion of IF, or certain other conditions.103

Dietary Requirements

Adequate intake needed to prevent vitamin B12 deficiency and neurologic complications associated with vitamin B12 deficiency.101

Adequate intake of vitamin B12 usually can be accomplished through consumption of foodstuffs; however, about 10–30% of geriatric individuals are unable to absorb naturally occurring vitamin B12 and should consume vitamin B12-fortified food or supplements.101 Inadequate intake can occur in vegetarians and their breast-fed infants.a Mixed foods whose main ingredient is meat, fish, or poultry; milk; and fortified ready-to-eat cereals are the main sources of vitamin B12 in the diet of US adults and children.101

Recommended Dietary Allowance (RDA) in adults based on amount needed to maintain hematologic status and normal serum vitamin B12 concentrations.101

Adequate intake (AI) established for infants ≤6 months of age based on observed mean vitamin B12 intake of infants fed principally human milk; AI for infants 7–12 months of age based on AI for younger infants and data in adults.101

RDA for children 1–18 years of age based on data in adults.101

Metabolic Disorders

Parenteral cyanocobalamin: Management of hereditary deficiency of transcobalamin II.a

Schilling Test

Parenteral cyanocobalamin and hydroxocobalamin: Used in conjunction with cyanocobalamin Co 57 in Schilling test to study vitamin B12 absorption. a

Cyanide Poisoning

Hydroxocobalamin (Cyanokit): Treatment of known or suspected cyanide poisoning.104 107 108 109 Used in conjunction with airway and cardiovascular support and management of seizure activity.104

• Advise patients with pernicious anemia that they must receive maintenance dosages of cyanocobalamin or hydroxocobalamin for the remainder of their lives to prevent irreversible neurologic damage.a

• Advise patient of necessity of follow-up tests to confirm adequacy of therapy.103

• Advise individuals who follow a vegetarian diet that contains no animal products to take oral vitamin B12 regularly.102 103

• Importance of informing patients using intranasal cyanocobalamin to administer the dose at least 1 hour before or after ingestion of hot foods or liquids.103

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.102 103

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.102 103 Importance of vitamin B12 supplements in pregnant and lactating women who follow a vegetarian diet.102 103 Advise women given hydroxocobalamin for cyanide poisoning to discuss timing of resumption of breast-feeding with their clinician.104

• Advise patients given hydroxocobalamin for cyanide poisoning that skin redness may last up to 2 weeks and urine coloration may last up to 5 weeks.104 Importance of avoiding direct sun exposure while skin is discolored.104

• Importance of informing patients of other important precautionary information.a (See Cautions.)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Normal daily requirements of vitamin B12 vary according to age.

Geriatric

No information is available on the relationship of age to the effects of cyanocobalamin nasal spray in geriatric patients.

Pregnancy

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergic rhinitis or
• Hay fever or
• Upper respiratory infection—Cyanocobalamin may not be effective when used in patients with these conditions.

• Allergy to cobalt—Should not be used in patients with this condition.

• Bone marrow problems or
• Folic acid deficiency or
• Iron deficiency or
• Leber's disease (genetic eye disease) or
• Uremia (high urea in the blood)—Use with caution. May make these conditions worse.

• Megaloblastic anemia—May increase risk for hypokalemia.

• Polycythemia vera (bone marrow disorder)—Using this medicine may mask or hide the signs of polycythemia vera.

• It is used to treat anemia.
• It is used to treat or prevent low vitamin B12.
• It may be given to you for other reasons. Talk with the doctor.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• To gain the most benefit, do not miss doses.
• Keep taking Nascobal as you have been told by your doctor or other health care provider, even if you feel well.
• Do not take this medicine by mouth. Use in your nose only. Keep out of your mouth and eyes (may burn).
• Blow your nose before use.
• Check your spray use with your doctor at each visit. Read and follow the facts on how to use the spray. Make sure you use the spray the right way.
• Use 1 hour before or after eating or drinking hot foods or liquids.
• Read the package insert for more details.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

• Store at room temperature. Do not freeze.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Store upright with the cap on.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Sensitivity to cobalt and/or vitamin B12 or any component of the medication is a contraindication.

Nascobal Nasal Spray, 500 mcg is supplied in boxes of 4 unit dose nasal spray devices and a package insert (NDC 49884-270-82). Each unit dose spray delivers 500 mcg of cyanocobalamin, USP.