Pronunciation:

kal-si-TOE-nin

Uses of This Medicine:

Calcitonin is used to treat Paget's disease of bone. It also may be used to prevent continuing bone loss in women with postmenopausal osteoporosis and to treat hypercalcemia (too much calcium in the blood). This medicine may be used to treat other conditions as determined by your doctor.

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

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, calcitonin is used in certain patients with the following medical condition:

• Osteoporosis caused by hormone problems, certain drugs, and other causes

Before Using This Medicine:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children

Studies on this medicine have been done only in adult patients, and there is no specific information comparing the use of calcitonin in children with use in other age groups. Therefore, be sure to discuss with your doctor the use of this medicine in children.

Older adults

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing the use of calcitonin in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults. Calcitonin is often used in elderly patients.

Pregnancy

Calcitonin has not been studied in pregnant women. However, in animal studies, calcitonin has been shown to lower the birth weight of the baby when the mother was given a dose of calcitonin many times the human dose.

Breast-feeding

Calcitonin has not been reported to cause problems in nursing babies. However, studies in animals have shown that calcitonin may decrease the flow of breast milk.

Other medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of This Medicine:

Make certain your health care professional knows if your diet includes large amounts of calcium-containing foods and/or vitamin D-containing foods, such as milk or other dairy products. Calcium and vitamin D may cause the calcitonin to be less effective in treating a high blood calcium. Also let your health care professional know if you are on any special diet, such as low-sodium or low-sugar diet.

This medicine is for injection only. If you will be giving yourself the injections, make sure you understand exactly how to give them, including how to fill the syringe before injection. If you have any questions about this, check with your doctor.

Use the calcitonin only when the contents of the syringe are clear and colorless. Do not use it if it looks grainy or discolored.

Dosing

The dose medicines in this class 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 these medicines. 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 injection dosage form:
  • For Paget's disease of bone:
    • Adults To start, 500 micrograms (mcg) injected under the skin once a day. Your doctor may reduce your dose or increase the time between doses. Or, your doctor may give you a smaller dose to start and increase your dose over two weeks.
    • Children Dose must be determined by your doctor.

• For injection dosage form:
  • For Paget's disease of bone:
    • Adults To start, 100 Units injected into a muscle or under the skin once a day, once every other day, or three times a week. Your doctor may reduce your dose or increase the time between doses.
    • Children Dose must be determined by your doctor.
  • For hypercalcemia (too much calcium in the blood):
    • Adults To start, 4 Units per kilogram (kg) (1.8 Units per pound) of body weight injected into a muscle or under the skin every twelve hours. Your doctor may increase your dose or increase the time between doses.
    • Children Dose must be determined by your doctor.
  • For postmenopausal osteoporosis:
    • Adults 100 Units injected into a muscle or under the skin once a day, once every other day, or three times a week. Or, your doctor may give you a smaller dose to start and increase your dose over two weeks.
    • Children Dose must be determined by your doctor.

Missed dose

Call your doctor or pharmacist for instructions.

If you miss a dose of this medicine and your dosing schedule is:

• Two doses a day If you remember within 2 hours of the missed dose, give it right away. Then go back to your regular dosing schedule. But if you do not remember the missed dose until later, skip it and go back to your regular dosing schedule. Do not double doses.
• One dose a day Give the missed dose as soon as possible. Then go back to your regular dosing schedule. If you do not remember the missed dose until the next day, skip it and go back to your regular dosing schedule. Do not double doses.
• One dose every other day ;Give the missed dose as soon as possible if you remember it on the day it should be given. Then go back to your regular dosing schedule. If you do not remember the missed dose until the next day, give it at that time. Then skip a day and start your dosing schedule again.
• One dose three times a week Give the missed dose the next day. Then set each injection back a day for the rest of the week. Go back to your regular Monday-Wednesday-Friday schedule the following week. Do not double doses.

If you have any questions about this, check with your doctor.

Storage

Keep out of the reach of children.

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

Do not keep outdated medicine or medicine no longer needed.

Store calcitonin-human at a temperature below 77 °F. Do not refrigerate. Use prepared solution within 6 hours.

Store calcitonin-salmon in the refrigerator. However, keep it from freezing.

Precautions While Using This Medicine:

Your doctor should check your progress at regular visits to make sure that this medicine does not cause unwanted effects.

If you are using this medicine for hypercalcemia (too much calcium in the blood), your doctor may want you to follow a low-calcium diet. If you have any questions about this, check with your doctor.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

Skin rash or hives

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

More common

Diarrhea

flushing or redness of face, ears, hands, or feet

loss of appetite

nausea or vomiting

pain, redness, soreness, or swelling at place of injection

stomach pain

Less common

Increased frequency of urination

Rare

Chills

dizziness

headache

pressure in chest

stuffy nose

tenderness or tingling of hands or feet

trouble in breathing

weakness

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.