CaloMist nasal spray contains cyanocobalamin, a man-made form of vitamin B12. Vitamin B12 is important for growth, cell reproduction, blood formation, and protein and tissue synthesis.

CaloMist nasal spray is used to treat vitamin B12 deficiency in people with pernicious anemia and other conditions.

CaloMist nasal spray is usually given after treatment with an injection form of this medicine.

CaloMist may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to cobalt, or if you have Leber's disease.

To treat pernicious anemia, you will have to use CaloMist on a regular basis for the rest of your life. Not using the medication can lead to irreversible nerve damage in your spinal cord.

Pernicious anemia is also treated with folic acid to help maintain red blood cells. However, folic acid will not treat Vitamin B12 deficiency and will not prevent possible damage to the spinal cord. Use all of your medications as directed.

Tell your doctor if you develop nasal congestion, a cold, or allergies. The nasal spray may not work as well if you are congested.

CaloMist nasal spray is usually given once per week. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

This medicine comes with patient instructions for safe and effective use, and directions for priming the nasal spray. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

To use the nasal spray:

• Blow your nose gently. Keep your head upright and insert the tip of bottle into one nostril. Press your other nostril closed with your finger. Spray the medicine into your nose and gently sniff at the same time. Then use the spray in your other nostril.

• Do not blow your nose for at least a few minutes after using the nasal spray.

• Wait several hours after using CaloMist nasal spray before using any other nasal medicines your doctor has prescribed.

• Clean the tip of the spray with a clean tissue and recap.

Tell your doctor if you have a prolonged illness that causes sinus congestion. CaloMist nasal spray may not work as well if you have a stuffy nose.

Your dose needs may change if you become pregnant, if you breast-feed, or if you eat a vegetarian diet. Tell your doctor about any changes in your diet or medical condition.

While using CaloMist, you may need blood tests every 3 to 6 months. Based on the results of these tests, your doctor may occasionally change your dose or recommend a cyanocobalamin injection.

Use CaloMist nasal spray regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

To treat pernicious anemia, you may have to use cyanocobalamin for the rest of your life. Do not stop using the medicine unless your doctor tells you to. Untreated vitamin B12 deficiency can lead to a recurrence of anemia and irreversible nerve damage.

Pernicious anemia is also treated with folic acid to help maintain red blood cells. However, folic acid will not treat Vitamin B12 deficiency and will not prevent possible damage to the spinal cord. Use all of your medications as directed.

Store in an upright position at room temperature, away from moisture, heat, and light. Do not freeze.

You should not use CaloMist if you are allergic to cyanocobalamin or cobalt, or if you have Leber's disease (an inherited form of vision loss). Cyanocobalamin can lead to optic nerve damage (and possibly blindness) in people with Leber's disease.

To make sure CaloMist is safe for you, tell your doctor if you have:

• cold or allergy symptoms that affect your nose (sinus congestion, sneezing);

• kidney or liver disease;

• iron or folic acid deficiency;

• any type of infection; or

• if you are receiving any medication or treatment that affects bone marrow.

FDA pregnancy category C. It is not known whether CaloMist will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

Cyanocobalamin can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medication to anyone under 18 years old without medical advice.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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.

Get emergency medical help if you have any of these signs of an allergic reaction to CaloMist: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have signs of low potassium--confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling.

Common CaloMist side effects may include:

• runny nose, sneezing;

• stuffy nose, sinus pain, sore throat, cough with mucus;

• headache, dizziness;

• joint pain; or

• itching or rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with cyanocobalamin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.