Miacalcin (Injection)

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.

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 cancer. Talk with your doctor about this risk.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare 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.

Pediatric

Appropriate studies have not been done on how age affects the effects of calcitonin injection in children. Safety and effectiveness have not been proven.

Geriatric

Studies done so far have not shown any specific problems in older adults that would limit the usefulness of calcitonin injection. However, older patients are more likely to have kidney, liver, or heart issues, which may require caution and a dose adjustment for those using calcitonin injection.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while 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 could occur. In these situations, your doctor may need to change the dose, or other precautions may be necessary. When taking this medicine, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential significance and are not necessarily all-inclusive.

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

• Lithium

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used at or around the time of eating food or certain types of food because interactions may happen. Using alcohol or tobacco with certain medicines may also cause interactions. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Hypocalcemia (low calcium in the blood)—Use with caution. This condition may worsen.

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

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

Check with your doctor right away 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. Your healthcare professional may also have ways to prevent or lessen some of these side effects. Check with your healthcare professional if any of the following side effects continue, 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 happen 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.

• Miacalcin

Available Dosage Forms:

• Solution

Therapeutic Class: Calcium Regulator

Pharmacologic Class: Calcitonin

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 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.