CaloMist Nasal Spray

Vitamin B12 Deficiency

CaloMist Nasal Spray is indicated for maintenance of vitamin B12 concentrations after normalization with intramuscular vitamin B12 therapy in patients with vitamin B12 deficiency who have no nervous system involvement.

Important Limitations of Use

CaloMist Nasal Spray has not been evaluated for the treatment of newly diagnosed vitamin B12 deficiency.

CaloMist Nasal Spray is not suitable for use in the vitamin B12 absorption test (Schilling Test).

The effectiveness of CaloMist Nasal Spray in patients with nasal pathology (e.g., nasal congestion, allergic rhinitis, upper respiratory infections) has not been determined. Treatment with CaloMist Nasal Spray should be deferred until nasal symptoms have subsided [see WARNINGS and PRECAUTIONS].

AND STORAGE AND HANDLING

CaloMist Nasal Spray is available as a metered dose spray in 30 mL plastic bottles containing 18 mL of solution. CaloMist Nasal Spray is available in a dosage strength of 25 mcg cyanocobalamin, USP, per actuation (0.1 mL/actuation). CaloMist Nasal Spray is provided in a carton containing one bottle of nasal spray solution affixed with a nasal spray pump, a package insert, and a patient instruction sheet. One bottle delivers thirty 50 mcg doses (60 sprays) (NDC 0256-0203-01).

Storage

Protect from light. Store upright at a controlled temperature of 15 to 30° C (59 to 86° F).

Protect from freezing.

Manufactured by: Fleming Pharmaceuticals., Fenton, MO 63026 USA
calomist@flemingcompany.com., 1-800-343-0164. FDA rev date: 7/27/2007

Included as part of the PRECAUTIONS section.

PATIENT COUNSELING INFORMATION

[See FDA-approved Patient Labeling]

Important Information for Patients

Patients with a chronic underlying cause of vitamin B12 deficiency will require indefinite administration of a vitamin B12 product, such as CaloMist Nasal Spray. Noncompliance or inadequate treatment with vitamin B12 therapy may result in recurrence of anemia and the development or worsening of irreversible neurological damage.

The dosing of CaloMist Nasal Spray and other intranasal medications should be separated by several hours.

Vitamin B12 concentrations should be monitored one month after CaloMist Nasal Spray initiation or dose change and every 3-6 months thereafter.

Careful instructions on the priming of the actuator and nasal administration of CaloMist Nasal Spray should be given to the patient, and the procedures for use should be demonstrated.

Patient Instruction Sheet

Instructions for Using CaloMist Nasal Spray. Read the following instructions carefully before using CaloMist Nasal Spray.

• Use CaloMist Nasal Spray as directed by your doctor.

NOTE: CaloMist Nasal Spray is prefilled to give 30 doses (60 sprays of medicine). One dose is one spray in each nostril once a day.

CaloMist Nasal Spray Pump Priming: Before you use the medicine for the first time the nasal spray pump unit must be readied (primed).

1. Hold the nasal spray bottle upright with your index finger on top of one of the two arms of the pump. Remove the clear protective cap from the top of the nozzle. (See Diagram 1)

2. Remove the safety clip from the nasal spray pump. (See Diagram 1)

3. While holding the nasal spray bottle upright with your index and middle fingers on the two side arms of the pump, and your thumb on the bottom of the bottle, press the arms down firmly and quickly. (See Diagram 2)

4. Repeat Step 3, 6 more times for a total of 7 priming sprays. You should see a full spray of medicine with the 7th priming spray. (See Diagram 2)

NOTE: You must prime CaloMist Nasal Spray with two re-priming sprays if you do not use for five days or more.

Your CaloMist Nasal Spray is now ready to use.

1. Blow your nose gently to clear both nostrils. (See Diagram 3)

2. Hold the nasal spray bottle upright with your first and second fingers on the two side arms of the pump, and your thumb on the bottom of the bottle. (See Diagram 4)

3. Gently insert the nasal spray pump to one nostril (about ½ inch), pointing the tip towards the back of the nose. (See Diagram 4)

4. With your other hand (the one not holding the bottle) use a finger to gently push close your other nostril (the one without a spray pump inserted). (See Diagram 4)

5. Tilt your head forward and press the arms of the nasal spray bottle down firmly and quickly.

6. Sniff in gently during and right after a spray and return your head to an upright position. Repeat these steps for the other nostril.

7. Wipe the nozzle of the nasal spray pump with a clean tissue after use. Replace the safety clip and clear cover on the nasal spray pump.

8. Store CaloMist Nasal Spray upright at room temperature, 59 to 86° F (15 to 30° C). Do not freeze.

Discard CaloMist Nasal Spray after 30 doses (60 sprays).

1. Unscrew the cap, rinse the bottle and pump assembly under a water faucet.
2. Dispose of all parts in a trashcan.

Keep CaloMist Nasal Spray and all medicines out of the reach of children.

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 data described below and in Table 1 reflect exposure in 25 subjects (age range 27-82 years; 17 women; 21 Caucasians) with vitamin B12 deficiency (12 with pernicious anemia, 4 secondary to gastrointestinal surgery, 9 with unknown cause) who received CaloMist Nasal Spray 50 mcg daily for 8 weeks in an uncontrolled clinical trial. Prior to enrollment, all subjects were required to have normal vitamin B12 levels with intramuscular vitamin BI2 injections. One patient who completed the study developed epistaxis on Day 12 of dosing and was noted to have irritation of the right nasal septum at study end. This patient had pre-existing allergic rhinitis and required a doubling of the CaloMist Nasal Spray dose during the last week of the study because of declining vitamin B12 concentrations.

Table 1. Potentially related adverse reactions reported during 8 weeks of treatment with CaloMist Nasal Spray in an uncontrolled clinical trial.

Experience with Parenteral Vitamin B12

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

Generalized: Anaphylactic shock and death

Cardiovascular: Pulmonary edema and congestive heart failure early in treatment Peripheral vascular thrombosis

Hematological : Polycythemia vera

Gastrointestinal: Mild transient diarrhea Dermatological: Itching; transitory exanthema

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of cyanocobalamin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Angioedema and angioedema-like reactions [See WARNINGS and PRECAUTIONS]

Read the entire FDA prescribing information for CaloMist Nasal Spray (Cyanocobalamin)