Pronunciation:

kal-si-TOE-nin (SA-man)

Brand Names:

• Miacalcin

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Calcium Regulator

Pharmacologic—

Calcitonin

Uses of This Medicine:

Calcitonin injection is used to treat Paget's disease of the bone. It may also be used to prevent bone loss in women with postmenopausal osteoporosis and to treat hypercalcemia (too much calcium in the blood).

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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—

Appropriate studies have not been performed on the relationship of age to the effects of calcitonin injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of calcitonin injection in the elderly. However, elderly patients are more likely to have kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving calcitonin injection.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

• Lithium

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.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Hypocalcemia (low calcium in the blood)—Use with caution. May make this condition worse.

• Vitamin D deficiency—Must be treated first before using this medicine.

Proper Use of This Medicine:

This medicine is given as a shot under your skin or into one of your muscles. Calcitonin injection may be given at home to patients who do not need to be in the hospital. If you are using this medicine at home, your doctor will teach you how to prepare and inject the medicine. Be sure you understand exactly how to use the medicine.

You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections.

Use a new needle and syringe each time you inject your medicine.

Carefully look at each vial (glass container) of medicine before you use it. Do not use the vial if it appears to be damaged or if the medicine has changed color or has specks (particles) in it.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

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 injection dosage form:
  • For Paget's disease of the bone:
    • Adults—100 International Units (IU) or 0.5 milliliter (mL) injected into a muscle or under the skin once a day. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.
  • For hypercalcemia:
    • Adults—Dose is based on body weight and must be determined by your doctor. The starting dose is 4 International Units (IU) per kilogram (kg) of body weight injected into a muscle or under the skin every 12 hours. Your doctor may adjust your dose as needed. However, the dose is usually not more than 8 IU per kg of body weight every 6 hours.
    • Children—Use and dose must be determined by your doctor.
  • For postmenopausal osteoporosis:
    • Adults—100 International Units (IU) or 0.5 milliliter (mL) injected into a muscle or under the skin every other 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—

Store in the refrigerator. Do not freeze.

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Your doctor might give you 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 you are using this medicine. If these side effects occur, get emergency help at once.

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.

If you are using this medicine for postmenopausal osteoporosis, your doctor may also want you to take calcium and vitamin D every day. If you have any questions about this, check with your doctor.

This medicine may increase your risk of having a cancer. Talk with your doctor about this risk.

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 immediately if any of the following side effects occur:

Incidence not known

Blurred vision

chills or fever

cough

difficulty with breathing

difficulty with swallowing

dizziness

frequent urination

headache

joint pain

muscle aches and pains

muscle cramps in the hands, arms, feet, legs, or face

nausea or vomiting

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

seizures

skin rash or itching

slow or fast heartbeat

sweating

swelling of the hands, ankles, feet, or lower legs

tightness in the chest

tingling of the hands or feet

trembling or shaking of the legs, arms, hands or feet

trouble sleeping

unusual tiredness or weakness

unusual weight gain or loss

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

Red streaks on the skin

swelling, tenderness, or pain at the injection site

Less common

Feeling of warmth

redness of the face, neck, arms, and occasionally, upper chest

Incidence not known

Abdominal or stomach pain

changes in vision

diarrhea

pain in the eyes

poor appetite

waking to urinate at night

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.