Miacalcin

• Overview
• Consumer Information
• Professional Information

 

Miacalcin Side Effects Center

What Is Miacalcin?

Miacalcin (calcitonin-salmon) is a man-made form of a hormone that occurs naturally in the thyroid gland used to treat Paget's disease of bone, postmenopausal osteoporosis, or high levels of calcium in the blood (hypercalcemia).

What Are Side Effects of Miacalcin?

Common side effects of Miacalcin include:

• runny nose,
• nose bleeds,
• nasal irritation,
• dry nose with crusting,
• headache,
• dizziness,
• nausea,
• vomiting,
• loss of appetite,
• stomach pain,
• flushing of the face (warmth, redness, itching, or tingly feeling under your skin),
• skin rash or itching,
• increased urination (especially at night),
• eye pain,
• swelling in your feet,
• back pain, and
• swelling or irritation of the skin where the injection was given.

Tell your doctor if you have serious side effects of Miacalcin including:

• nasal sores,
• muscle cramps or spasms, or
• numbness or tingling of the arms or legs.

Dosage for Miacalcin

The recommended dose of Miacalcin Nasal Spray in postmenopausal osteoporotic females is one spray (200 I.U.) per day administered intranasally (in the nose), alternating nostrils daily.

What Drugs, Substances, or Supplements Interact with Miacalcin?

There may be other drugs that can affect Miacalcin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Miacalcin is used mainly in women after menopause.

Miacalcin During Pregnancy or Breastfeeding

It is unlikely to be used during pregnancy or breastfeeding. Consult your doctor if you have any questions about this product and pregnancy or breastfeeding.

Additional Information

Our Miacalcin (calcitonin-salmon) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Miacalcin Consumer Information

You may have increased bone pain during the first few months of treatment with calcitonin injection. This is not a sign that the medication isn't working properly.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out; or
• low calcium levels--muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes).

Common side effects may include:

• flushing (warmth, redness, or tingly feeling);
• nausea, vomiting; or
• swelling where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Miacalcin (Calcitonin-Salmon)

 

Miacalcin Professional Information

SIDE EFFECTS

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% to 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.

Malignancy

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

Patients	Malignancies	Risk Difference* (%)	95% Confidence Interval† (%)
All (nasal spray + oral)	All	1.0	(0.3, 1.6)
All (nasal spray + oral)	Excluding basal cell carcinoma	0.5	(-0.1, 1.2)
All (nasal spray only)	All	1.4	(0.3, 2.6)
All (nasal spray only)	Excluding basal cell carcinoma	0.8	(-0.2, 1.8)
* The overall adjusted risk difference is the difference between the percentage of patients who had any malignancy (or malignancy excluding basal cell carcinoma) in calcitonin salmon and placebo treatment groups, using the Mantel-Haenszel (MH) fixed-effect method. A risk difference of 0 is suggestive of no difference in malignancy risks between the treatment groups. † The corresponding 95% confidence interval for the overall adjusted risk difference also based on MH fixed-effect method.

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 2 to 18 months of treatment have been reported in about onehalf 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.

DRUG INTERACTIONS

No formal drug interaction studies have been performed with Miacalcin injection.

Concomitant use of calcitonin salmon and lithium may lead to a reduction in plasma lithium concentrations due to increased urinary clearance of lithium. The dose of lithium may require adjustment.

Read the entire FDA prescribing information for Miacalcin (Calcitonin-Salmon)

&Copy; Miacalcin Patient Information is supplied by Cerner Multum, Inc. and Miacalcin Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.