Miacalcin (Nasal)

Calcitonin nasal spray is used along with calcium and vitamin D to treat bone loss in women with postmenopausal osteoporosis who have been postmenopause for at least 5 years.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress at regular visits to ensure that this medicine is working properly. Blood and urine tests may be needed to look for unwanted effects. Your doctor may also want to check your nose before and during treatment with this medicine.

Your doctor might perform an allergy skin test to see if you are allergic to calcitonin before using this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while using this medicine. If these side effects occur, get emergency help at once.

This medicine can lower your calcium levels in the blood (hypocalcemia). Check with your doctor right away if you experience abdominal or stomach cramps, confusion, convulsions, difficulty breathing, mood or mental changes, muscle cramps in your hands, arms, feet, legs, or face, or numbness and tingling around your mouth, fingertips, or feet.

This medicine may cause irritation in the nose that can be painful and serious. Check with your doctor right away if you have more than one of the following symptoms: sneezing, runny or stuffy nose, shortness of breath, troubled breathing, or heavy nosebleeds.

This medicine may increase your risk of having cancer. Talk to your doctor if you have concerns about this risk.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to weigh the risks against the benefits. For this medicine, consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also inform your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to see how age affects the use of calcitonin nasal spray in children. Safety and effectiveness have not been established.

Geriatric

Studies so far have not shown any specific problems in elderly patients that would limit the usefulness of calcitonin nasal spray. However, older adults may be more likely to experience unwanted side effects (for example, irritation or redness of the nose, stuffy or runny nose), which may require caution when using calcitonin nasal spray.

Breast Feeding

There are no adequate studies on the risks to infants when women use this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. If you are taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are significant but may not be a complete list.

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both medicines.

• Lithium

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or specific types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how you use this medicine. Be sure to inform your doctor if you have any other medical problems, especially:

• Paget's disease—Use with caution. Some medicines for this condition (for example, alendronate, etidronate, or risedronate) may prevent calcitonin nasal spray from working properly.

• Hypocalcemia (low calcium levels) or
• Vitamin D deficiency—Must be treated first before using this medicine.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects will happen, but if they do, you might need medical attention.

Check with your doctor right away if any of the following side effects happen:

More common

• Crusting, patches, or sores inside the nose
• Dryness, itching, redness, swelling, tenderness, or other signs of nasal irritation not present before using this medicine
• Severe or ongoing headaches
• Nosebleeds
• Runny nose
• Sneezing
• Stuffy nose

Less common

• Bloody or cloudy urine
• Chills
• Cough
• Painful, burning, or difficult urination
• Severe difficulty breathing or wheezing
• Dizziness
• Fever
• Frequent urge to urinate
• Congestion in the head
• Loss of sense of smell
• Sore throat
• Swollen glands

Rare

• Hair loss
• Hives, itching, or skin rash
• Increased thirst
• Shakiness in the legs, arms, hands, or feet
• Taste disturbances
• Trembling or shaking of the hands or feet

Incidence not known

• Abdominal or stomach cramps
• Bloating or swelling of the face, arms, hands, lower legs, or feet
• Blurred vision
• Confusion
• Diarrhea
• Difficulty swallowing
• Fainting
• Increased sweating
• Irregular heartbeats
• Muscle cramps in the hands, arms, feet, legs, or face
• Numbness and tingling around the mouth, fingertips, or feet
• Pain or tightness in the chest
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Rapid weight gain
• Seizures
• Unusual tiredness or weakness
• Unusual weight gain or loss

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also have ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Back pain
• Joint pain

Less common or rare

• Abdominal or stomach pain
• Body aches
• Burning, dry, or itching eyes
• Constipation
• Flushing
• Mental depression
• Muscle pain
• Nausea
• Unusual tearing of the eyes
• Upset stomach

Incidence not known

• Continuing ringing or buzzing or other unexplained noise in the ears
• Hearing loss
• Trouble hearing
• Trouble seeing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Fortical
• Miacalcin

In Canada

• Miacalcin Ns

Available Dosage Forms:

• Spray

Therapeutic Class: Calcium Regulator

Pharmacologic Class: Calcitonin

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine is for use only in the nose. Do not get any of it in your eyes or on your skin. If it does get on these areas, rinse it off with water right away.

Each spray bottle contains 30 doses of the medicine. Keep track of the doses you use and throw away any unused medicine after 30 doses, even if the bottle is not completely empty.

This medicine usually comes with patient instructions. Read the instructions carefully before using this medicine. If you have any questions about using the pump spray, ask your doctor.

To assemble the pump:

• If your medicine and its pump were not already assembled by the pharmacist, carefully follow the instructions provided with the container.
• Remove the bottle of solution from the refrigerator and let it slowly warm up to room temperature (less than 77 degrees F).
• Lift the plastic tab and pull the metal safety seal off the bottle.
• Hold the bottle upright and carefully pull the rubber stopper out of the bottle.
• Hold the spray pump unit and remove the plastic cap from the bottom of the unit.
• Hold the bottle upright and place the spray pump unit into the bottle.
• Turn the spray pump unit clockwise and tighten it until it is securely fastened.

To prepare this medicine:

• Before you use a new bottle of calcitonin spray, the spray pump will need to be primed (started). If your pharmacist assembled the unit for you, check to see if it has already been primed by pumping the unit once. If a full spray comes out, the unit has already been primed; if not, you must prime the pump.
• To prime a new bottle, hold the bottle upright and away from you, then pump it several times until you see a faint spray.
• Do not prime the pump again before each daily use.

To use the nose spray:

• Before using the spray, blow your nose gently to clear the nostrils.
• Keeping your head in an upright position, carefully place the nozzle into one nostril.
• Press the pump toward the bottle one time. Do not spray more than once.
• Do not inhale while spraying.
• To keep the nosepiece clean, wipe it with a clean tissue and replace the dust cap after use.

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 postmenopausal osteoporosis: Adults—200 International Units (IU) or 1 spray into one nostril per day. It is best to change which nostril you use each day. As an example, you should spray into the left side on the first day, then into the right side on the second day, and back to the left side on the third day. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

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.

Store the unopened bottle in the refrigerator. Do not freeze. You may store the opened bottle in an upright position at room temperature, away from heat and direct light. An opened bottle of Miacalcin® can be stored for up to 35 days, and an opened bottle of Fortical® can be stored for up to 30 days. Throw away any unused medicine after 30 or 35 days based on the brand you are using.