Miacalcin

Dosage Forms And Strengths

Miacalcin injection is available as a clear, colorless, sterile solution of synthetic calcitonin-salmon in individual 2 mL multi-dose vials containing 200 International Units per mL.

Miacalcin (calcitonin-salmon) injection, synthetic is available as a sterile solution in individual 2 mL multi-dose vials containing 200 International Units per mL .......................NDC 0078-0149-23

Storage and Handling

Store in refrigerator between 2°C–8°C (36°F–46°F).

Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936. Revised: Feb 2015

The following serious adverse reactions are discussed in greater detail in other sections of the label:

• Hypersensitivity Reactions, including anaphylaxis [see WARNINGS AND PRECAUTIONS]
• Hypocalcemia [see WARNINGS AND PRECAUTIONS]
• Malignancy [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of calcitonin-salmon injection was assessed in open-label trials several months to two years in duration. The most common adverse reactions are discussed below.

Nausea

Nausea with or without vomiting has been noted in about 10% of patients treated with calcitonin-salmon. It is most evident when treatment is first initiated and tends to decrease or disappear with continued administration.

Dermatologic Reactions

Local inflammatory reactions at the site of subcutaneous or intramuscular injection have been reported in about 10% of patients. Flushing of face or hands occurred in about 2%–5% of patients. Skin rashes and pruritus of the ear lobes have also been reported.

Other Adverse Reactions

Nocturia, feverish sensation, pain in the eyes, poor appetite, abdominal pain, pedal edema, and salty taste have been reported in patients treated with calcitonin-salmon injection.

A meta-analysis of 21 randomized, controlled clinical trials with calcitonin-salmon (nasal spray or investigational oral formulations) was conducted to assess the risk of malignancies in calcitonin-salmon-treated patients compared to placebo-treated patients. The trials in the meta-analysis ranged in duration from 6 months to 5 years and included a total of 10883 patients (6151 treated with calcitonin-salmon and 4732 treated with placebo). The overall incidence of malignancies reported in these 21 trials was higher among calcitonin-salmon-treated patients (254/6151 or 4.1%) compared with placebo-treated patients (137/4732 or 2.9%). Findings were similar when analyses were restricted to the 18 nasal spray only trials [calcitonin-salmon 122/2712 (4.5%); placebo 30/1309 (2.3%)].

The meta-analysis results suggest an increased risk of overall malignancies in calcitonin-salmon-treated patients compared to placebo-treated patients when all 21 trials are included and when the analysis is restricted to the 18 nasal spray only trials (see Table 1). It is not possible to exclude an increased risk when calcitonin-salmon is administered by the subcutaneous, intramuscular, or intravenous route because these routes of administration were not investigated in the meta-analysis. The increased malignancy risk seen with the meta-analysis was heavily influenced by a single large 5-year trial, which had an observed risk difference of 3.4% [95% CI (0.4%, 6.5%)]. Imbalances in risks were still observed when analyses excluded basal cell carcinoma (see Table 1); the data were not sufficient for further analyses by type of malignancy. A mechanism for these observations has not been identified. Although a definitive causal relationship between calcitonin-salmon use and malignancies cannot be established from this meta-analysis, the benefits for the individual patient should be carefully evaluated against all possible risks [see WARNINGS AND PRECAUTIONS].

Table 1: Risk Difference for Malignancies in Calcitonin-Salmon-Treated Patients Compared with Placebo-Treated Patients

Postmarketing Experience

Because postmarketing adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following adverse reactions have been reported during post-approval use of Miacalcin injection.

Allergic / Hypersensitivity Reactions: Serious hypersensitivity reactions have been reported in patients receiving calcitonin-salmon injection, e.g., bronchospasm, swelling of the tongue or throat, anaphylactic shock, and death due to anaphylaxis.

Skin and subcutaneous tissue disorders: Urticaria

Hypocalcemia: Hypocalcemia with tetany (i.e. muscle cramps, twitching) and seizure activity have been reported.

Body as a Whole: influenza-like symptoms, fatigue, edema (facial, peripheral, and generalized)

Musculoskeletal: arthralgia, musculoskeletal pain

Cardiovascular: hypertension

Gastrointestinal: abdominal pain, diarrhea

Urinary System: polyuria

Nervous System: dizziness, headache, paresthesia, tremor

Vision: visual disturbance

Immunogenicity

Consistent with the potentially immunogenic properties of medicinal products containing peptides, administration of Miacalcin may trigger the development of anti-calcitonin antibodies. Circulating antibodies to calcitonin-salmon after 218 months of treatment have been reported in about one-half of the patients with Paget's disease in whom antibody studies were done. In some cases, high antibody titers are found; these patients usually will have a loss of response to treatment [see WARNINGS AND PRECAUTIONS].

The incidence of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of a positive antibody test result may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of antibodies among different calcitonin-salmon products may be misleading.

Do not use this medication if you are allergic to salmon calcitonin.

To make sure you are not allergic to this medication, your doctor may perform an allergy skin test before your first dose of calcitonin injection.

Calcitonin injection is not a cure for Paget's disease and you may have a relapse, especially if your body forms antibodies and you become immune to calcitonin. Talk with your doctor at any time if you think the medication is not working as well as it did before.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Your urine may also need to be tested. Do not miss any scheduled appointments.

Calcitonin injection can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

It is important to use calcitonin injection regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using calcitonin injection.

Calcitonin injection can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Your pharmacist can provide more information about calcitonin injection.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Calcitonin is a prescription medication used for the treatment of osteoporosis in women more than 5 years after menopause (end of monthly menstrual periods) who cannot or do not want to take estrogen products. It is used along with calcium and vitamin D.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Calcitonin is not approved for premenopausal women, including women who are breastfeeding. It is not known if calcitonin is excreted in human breast milk or if it will harm your nursing baby.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Treatment of Paget’s Disease of Bone

Miacalcin injection is indicated for the treatment of symptomatic Paget’s disease of bone in patients with moderate to severe disease characterized by polyostotic involvement with elevated serum alkaline phosphatase and urinary hydroxyproline excretion. There is no evidence that the prophylactic use of calcitonin-salmon is beneficial in asymptomatic patients. Miacalcin injection should be used only in patients who do not respond to alternative treatments or for whom such treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies).

Treatment of Hypercalcemia

Miacalcin injection is indicated for the early treatment of hypercalcemic emergencies, along with other appropriate agents, when a rapid decrease in serum calcium is required, until more specific treatment of the underlying disease can be accomplished. It may also be added to existing therapeutic regimens for hypercalcemia such as intravenous fluids and furosemide, oral phosphate or corticosteroids, or other agents.

Treatment of Postmenopausal Osteoporosis

Miacalcin injection is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause. The evidence of efficacy for calcitonin-salmon injection is based on increases in total body calcium observed in clinical trials. Fracture reduction efficacy has not been demonstrated. Miacalcin injection should be reserved for patients for whom alternative treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies).

Important Limitations of Use

Due to the possible association between malignancy and calcitonin-salmon use, the need for continued therapy should be re-evaluated on a periodic basis [see Warnings and Precautions (5.3)].

Manufactured for:
Mylan Institutional LLC
Rockford, IL 61103 U.S.A.

Manufactured by:
Novartis Pharma Stein AG
Stein, Switzerland

MI:MIACIJ:R2

Use Miacalcin Nasal Spray exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

To make sure you are not allergic to calcitonin, your doctor may perform an allergy skin test before your first dose of this medicine.

Miacalcin comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Store unopened bottle of Miacalcin in the refrigerator but do not allow it to freeze.

Once you put the bottle and pump assembly together, you may keep the medicine at room temperature, away from light and heat. Store the bottle upright with the pump attached.

Before your first use of the assembled bottle and pump, you must prime the spray. Allow the medicine to reach room temperature before priming.

To prime Miacalcin, press the pump at least 5 times until a fine mist appears. Prime the spray only before your first use of the newly assembled bottle.

To use the nasal spray:

• Blow your nose gently. Keep your head upright and insert the tip of bottle into one nostril. Hold the nasal spray upright with your first and second fingers on each side of the pump and your thumb on the bottom of the bottle.

• Pump the spray unit firmly to spray the medicine into your nostril. You do not need to sniff or inhale deeply.

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

• If the spray gets in your eyes or mouth or on your skin, rinse with water.

Miacalcin is usually given as one spray per day into only one of your nostrils. Use the other nostril the next day and continue alternating back and forth for each daily dose.

Miacalcin spray delivers a fine mist into the nose. Even if you do not feel the spray while using it, the medication is still being absorbed by your nasal passages.

Each bottle contains 30 doses of Miacalcin. Throw away the medicine after 30 uses, even if there is still medicine left in the bottle.

To be sure this medication is not causing harmful side effects to the inside of your nose, your doctor may want to check your nasal passages often.

Your doctor may have you take extra vitamin D while you are using Miacalcin. Take only the amount of vitamin D that your doctor has prescribed.