CaloMist

Cyanocobalamin is a prescription medication used to treat and prevent a lack of vitamin B12 that may be caused by any of the following:

• pernicious anemia (lack of a natural substance needed to absorb vitamin B12 from the intestine)
• folic acid deficiency
• certain diseases
• infections
• malignancy of pancreas or bowel
• medications that decrease the amount of vitamin B12 absorbed from food
• a vegan diet (strict vegetarian diet that does not allow any animal products, including dairy products and eggs)

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with cyanocobalamin. See the “Cyanocobalamin Precautions” section.

Common side effects of cyanocobalamin include the following:

• diarrhea
• feeling as if your entire body is swollen
• itching
• eruption of the skin
• diarrhea

This is not a complete list of cyanocobalamin side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• antibiotics such as chloramphenicol (Chloromycetin, Mychel-S)
• colchicine (Colcrys)
• folic acid
• methotrexate (Rheumatrex, Trexall)
• para-aminosalicylic acid (Paser)
• pyrimethamine (Daraprim)

Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

This is not a complete list of cyanocobalamin drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Cyanocobalamin falls into category C.There are no well-controlled studies that have been done in pregnant women. Cyanocobalamin should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

However, vitamin B12 is an essential vitamin and requirements are increased during pregnancy. Amounts of vitamin B12 that are recommended by the Food and Nutrition Board, National Academy of Science-National Research Council for pregnant women (4 mcg daily) should be consumed during pregnancy.

Take Cyanocobalamin exactly as prescribed.

This medication is available in an injectable form to be given directly into the muscle (IM) or under the skin by a healthcare professional.

Patients with pernicious anemia will require monthly injections of vitamin B12 for the remainder of their lives.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of cyanocobalamin at the same time.

This section provides information on the proper use of a number of products that contain cyanocobalamin. It may not be specific to CaloMist. Please read with care.

Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of side effects.

This medicine is only used in the nose. Do not get it in your eyes or on your skin. If it does get on these areas, rinse it off right away and call your doctor.

Some patients may need a test dose of vitamin B12 injection before using Nascobal® nasal spray. This is to check if you have an allergic reaction to cyanocobalamin.

Carefully follow your doctor's instructions about diet and oral vitamin supplements (pills).

If you are using this medicine to treat pernicious anemia, you will need to use the medicine for the rest of your life.

Do not drink hot liquid or eat a hot meal for at least 1 hour before or 1 hour after using this medicine.

To use the nasal spray:

• Before each use of this medicine, you must prime the pump. To prime the spray, hold the bottle with the nozzle between two fingers and your thumb on the bottom of the bottle. Pump the bottle until the spray or gel appears, and then pump 2 more times. Now the medicine is ready to use.
• Gently blow your nose to clear the nostrils before you use this medicine.
• After using the nasal spray, wipe the tip of the bottle with a clean tissue and put the cap back on.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For nasal dosage form (spray):
  • For pernicious anemia and vitamin B12 deficiency:
    • Adults—One spray into one nostril once a week. Each spray contains 500 micrograms (mcg).
    • Children—Dose must be determined by your doctor.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with CaloMist. Although vitamin B12 is an essential vitamin and requirements are increased during pregnancy, it is not known whether CaloMist can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CaloMist should be given to a pregnant woman only if clearly needed. Adequate and well-controlled studies have not been conducted in pregnant women.

Nursing Mothers

Although vitamin B12 is an essential vitamin and requirements are increased during lactation, it is not known whether CaloMist can cause harm to an infant when administered to a nursing woman. Vitamin B12 appears in the milk of nursing mothers in concentrations that approximate the mother's vitamin B12 blood level. Caution should be exercised when CaloMist is administered to a nursing woman.

Pediatric Use

Because CaloMist has not been studied in children, safety and effectiveness have not been established in pediatric patients.

Geriatric Use

Clinical studies of CaloMist did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Renal/Hepatic Impairment

Patients with vitamin B12 deficiency and concurrent renal or hepatic disease may require increased doses or more frequent administration of vitamin B12 therapy.

[See FDA-approved Patient Labeling (17.2)]

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. 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 and other intranasal medications should be separated by several hours.

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

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

Patient Instruction Sheet

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

• Use CaloMist as directed by your doctor.

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

CaloMist 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 7 th priming spray. (See Diagram 2)

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

Your CaloMist 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. Place your thumb on the bottom of the bottle. (See Diagram 4)

3.   Gently insert the nasal spray pump into 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. Firmly and quickly press down the arms of the nasal spray bottle.

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.   After use, wipe the nozzle of the nasal spray pump with a clean tissue. Replace the safety clip and clear cover on the nasal spray pump.

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

Discard CaloMist 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 and all medicines out of the reach of children.

Manufactured by:

Fleming Pharmaceuticals

St. Louis County, MO 63026 USA

Calomist@flemingpharma.com

1-800-343-0164

principal display panel - bottle

Do not drink hot liquid or eat hot food within 1 hour before or after you use CaloMist.

Avoid drinking large amounts of alcohol while you are being treated with CaloMist.