Nascobal

Name: Nascobal

What should i discuss with my healthcare provider before using nasal cyanocobalamin (calomist, nascobal)?

You should not use this medication if you are allergic to cobalt, or if you have Leber's disease. Cyanocobalamin can lead to optic nerve damage (and possibly blindness) in people with Leber's disease.

Before using cyanocobalamin, tell your doctor if you have:

  • any type of infection;
  • iron or folic acid deficiency;
  • kidney or liver disease; or
  • if you are receiving any medication or treatment that affects bone marrow.

Tell your doctor if you develop nasal congestion, a cold, or allergies. Nasal cyanocobalamin may not work as well if your nose is congested.

FDA pregnancy category C. It is not known whether this medication can harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Cyanocobalamin passes into breast milk, but it is not known whether cyanocobalamin could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Manufacturer

  • Par Pharmaceutical , Inc

  • Par Pharmaceutical, Inc.

  • QOL Medical, LLC.

Nascobal Drug Class

Nascobal is part of the drug class:

  • Vitamin B12 cyanocobalamin and analogues

Nascobal Dosage

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

  • the condition being treated
  • other medical conditions you have
  • other medications you are taking
  • how you respond to this medication

The recommended dose of cyanocobalamin for the treatment of pernicious anemia is 100 mcg a day. A dose of 100 mcg daily for 6 or 7 days should be administered. If there is clinical improvement the same amount may be given on alternate days for seven doses, then every 3 to 4 days for another 2 to 3 weeks. The regimen will depend on you respond to cyanocobalamin.

This regimen should be followed by 100 mcg monthly for life.

Nascobal Dosage and Administration

Administration

Cyanocobalamin is administered orally, intranasally, or by IM or deep sub-Q injection.a 102 103

Hydroxocobalamin is administered by IM injection or IV infusion.104 105

Oral Administration

Oral therapy is inferior to parenteral therapy. a May be used for treatment of dietary vitamin B12 deficiency in patients with normal GI absorption.a

Parenteral Administration

Cyanocobalamin: Administer by IM or deep sub-Q injection.102 If administered sub-Q, avoid injection into the dermis or upper subcutaneous tissue.a Avoid administering IV; vitamin is rapidly excreted in urine when administered IV.102

Hydroxocobalamin: Administer by IM injection (vitamin deficiency)105 or by IV infusion (cyanide poisoning).104 Avoid administering IV for vitamin deficiency.105

For drug compatibility information, see Compatibility under Stability.

IV Administration for Cyanide Poisoning

Hydroxocobalamin: (Cyanokit); Administer by IV infusion.104

May require a dedicated IV line.104 Administration through the same IV line as blood products not recommended.104

Reconstitution

Reconstitute vial containing 2.5 g of hydroxocobalamin with 100 mL of 0.9% sodium chloride injection; invert or rock vial for at least 30 seconds.104 Do not shake vial.104 Lactated Ringer's injection or 5% dextrose injection can be used if 0.9% sodium chloride injection is not available.104 Reconstituted solution contains 25 mg/mL.104

Rate of Administration

Initial 5-g dose: 15 minutes.104

Second 5-g dose: 15 minutes (for patients in extremis) to 2 hours; rate depends on patient condition.104

Intranasal Administration

Administer intranasally using a metered-dose pump.103 Administer 1 hour before or 1 hour after ingestion of hot foods or liquids.103

Prior to intranasal administration, clear nasal passages.110 Insert the nasal adapter 1 cm into one nostril, point the tip of the adapter toward the back of the nose, hold the other nostril closed, and tilt head slightly forward, pump the drug into nostril, sniff gently during and immediately after dosing, return head to upright position, remove pump unit from nose.110 a

Efficacy has not been established in patients with nasal congestion, allergic rhinitis, or upper respiratory tract infection; defer use until these symptoms have subsided.103

Prime the pump before each use.103

Dosage

Vitamin B 12 deficiency: Duration of therapy depends on cause; long-term therapy not needed when other therapeutic measures correct the underlying cause of the deficiency.a

Cyanocobalamin metered-dose pump delivers 500 mcg of the drug (0.1 mL) per actuation.103

Pediatric Patients

Vitamin B 12 Deficiency IM

Hydroxocobalamin: Initially, single doses of 100 mcg to total dose of 1–5 mg given over ≥2 weeks.105

Hydroxocobalamin: Maintenance, 30–50 mcg every 4 weeks.105

Dietary and Replacement Requirements Oral

Infants born to vegan mothers: Supplement with AI from birth because these infants' vitamin B12 stores are low and their mother’s milk may supply very small amounts of the vitamin.101

Infants ≤6 months of age: Recommended AI is 0.4 mcg (0.06 mcg/kg) daily.101

Infants 7–12 months of age: Recommended AI is 0.5 mcg (0.06 mcg/kg) daily.101

Children 1–3 years of age: RDA is 0.9 mcg daily.101

Children 4–8 years of age: RDA is 1.2 mcg daily.101

Children 9–13 years of age: RDA is 1.8 mcg daily.101

Children 14-18 years of age: RDA is 2.4 mcg daily.101

The RDAs will not meet the needs of individuals with malabsorption syndrome.101

Cyanide Poisoning† IV

Hydroxocobalamin: 70 mg/kg has been used.104 107

Adults

Vitamin B 12 Deficiency IM or Sub-Q

Cyanocobalamin: Initially, 100 mcg daily for 6–7 days.102 If clinical manifestations improve and reticulocyte response observed, administer 100 mcg every other day for 7 doses and then 100 mcg every 3–4 days for 2–3 weeks.102

Cyanocobalamin: Maintenance, 100 mcg every month.102

IM

Hydroxocobalamin: Initially, 30 mcg daily for 5–10 days.105

Hydroxocobalamin: Maintenance, 100–200 mcg every month.105

Intranasal

Maintenance, 500 mcg (one actuation) once weekly.103 Increase dose in patients who experience a decline in serum vitamin B12 concentrations after 1 month of therapy.103

Dietary and Replacement Requirements Oral

Men and women ≥19 years of age: RDA is 2.4 mcg daily.101

Adults ≥51 years of age should obtain most of their vitamin B12 from fortified food or a vitamin B12 supplement.101

The RDAs will not meet the needs of individuals with malabsorption syndrome.101

Cyanide Poisoning IV

Hydroxocobalamin: Initially, 5 g (two 2.5-g vials).104 A second 5-g dose may be administered, based on the severity of the poisoning and clinical response.104

Schilling Test IM or Sub-Q

Cyanocobalamin: Flushing dose is 1000 mcg.102

IM

Hydroxocobalamin: Flushing dose is 1000 mcg. 105

Special Populations

Pregnant Women

RDA for pregnant women is 2.6 mcg daily.101

Lactating Women

RDA for lactating women is 2.8 mcg daily.101

Requirements increased in lactating women to ensure adequate concentration of the vitamin in milk.101

Commonly used brand name(s)

In the U.S.

  • CaloMist
  • Nascobal

Available Dosage Forms:

  • Gel/Jelly
  • Spray

Therapeutic Class: Nutritive Agent

Pharmacologic Class: Vitamin B (class)

What are some other side effects of Nascobal?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dizziness.
  • Headache.
  • Nervous and excitable.
  • Upset stomach or throwing up.
  • Loose stools (diarrhea).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Adverse Reactions

The incidence of adverse experiences described in the Table below are based on data from a short-term clinical trial in vitamin B12 deficient patients in hematologic remission receiving Nascobal (Cyanocobalamin, USP) Gel for Intranasal Administration (N=24) and intramuscular vitamin B12 (N=25). In the pharmacokinetic study comparing Nascobal Nasal Spray and Nascobal Nasal Gel, the incidence of adverse events was similar.

Table Adverse Experiences by Body System, Number of Patients and Number of Occurrences by Treatment Following Intramuscular and Intranasal Administration of Cyanocobalamin.
a Sore throat, Common cold
* There may be a possible relationship between these adverse experiences and the study drugs. These adverse experiences could have also been produced by the patient’s clinical state or other concomitant therapy.

 

 

Number of Patients (Occurrences)

Body System

Adverse Experience

Vitamin B12

Nasal Gel,

500mcg

N=24

Intramuscular

Vitamin B12,

100 mcg

N=25

Body as a Whole

Asthenia

1 (1)

4 (4)

Back Pain

0 (0)

1 (1)

Generalized Pain

0 (0)

2 (3)

Headache

1 (2)*

5 (11)

Infectiona

3 (4)

3 (3)

Cardiovascular System

Peripheral Vascular Disorder

0 (0)

1 (1)

Digestive System

Dyspepsia

0 (0)

1 (2)

Glossitis

1 (1)

0 (0)

Nausea

1 (1)*

1 (1)

Nausea & Vomiting

0 (0)

1 (1)

Vomiting

0 (0)

1 (1)

Musculoskeletal System

Arthritis

0 (0)

2 (2)

Myalgia

0 (0)

1 (1)

Nervous System

Abnormal Gait

0 (0)

1 (1)

Anxiety

0 (0)

1 (1)*

Dizziness

0 (0)

3 (3)

Hypoesthesia

0 (0)

1 (1)

Incoordination

0 (0)

1 (2)*

Nervousness

0 (0)

1 (3)*

Paresthesia

1 (1)

1 (1)

Respiratory System

Dyspnea

0 (0)

1 (1)

Rhinitis

1 (1)*

2 (2)

The intensity of the reported adverse experiences following the administration of Nascobal (Cyanocobalamin, USP) Gel for Intranasal Administration and intramuscular vitamin B12 were generally mild. One patient reported severe headache following intramuscular dosing. Similarly, a few adverse experiences of moderate intensity were reported following intramuscular dosing (two headaches and rhinitis; one dyspepsia, arthritis, and dizziness), and dosing with Nascobal (Cyanocobalamin, USP) Gel for Intranasal Administration (one headache, infection, and paresthesia).

The majority of the reported adverse experiences following dosing with Nascobal (Cyanocobalamin, USP) Gel for Intranasal Administration and intramuscular vitamin B12 were judged to be intercurrent events. For the other reported adverse experiences, the relationship to study drug was judged as "possible" or "remote". Of the adverse experiences judged to be of "possible" relationship to the study drug, anxiety, incoordination, and nervousness were reported following intramuscular vitamin B12 and headache, nausea, and rhinitis were reported following dosing with Nascobal (Cyanocobalamin, USP) Gel for Intranasal Administration.

The following adverse reactions have been reported with parenteral vitamin B12:

Generalized: Anaphylactic shock and death (See Warnings and Precautions).

Cardiovascular: Pulmonary edema and congestive heart failure early in treatment; peripheral vascular thrombosis.

Hematological: Polycythemia vera.

Gastrointestinal: Mild transient diarrhea.

Dermatological: Itching; transitory exanthema.

Miscellaneous: Feeling of swelling of the entire body.

Overdosage

No overdosage has been reported with Nascobal Nasal Spray, Nascobal (Cyanocobalamin, USP) Gel for Intranasal Administration or parenteral vitamin B12.

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