Calcitonin (nasal)

Calcitonin (nasal)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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Overview

Calcitonin (nasal) is an endocrine metabolic agent that is FDA approved for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause when alternative treatments are not suitable. Common adverse reactions include rhinitis, epistaxis, back pain, arthralgia, and headache..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Treatment of Postmenopausal Osteoporosis

• Fortical nasal spray is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause. Fracture reduction efficacy has not been demonstrated. Fortical nasal spray 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.

Calcitonin-salmon nasal spray has not been shown to increase spinal bone mineral density in early postmenopausal women.

Dosing

Basic Dosing Information

• The recommended dose of Fortical nasal spray is 1 spray (200 International Units) per day intranasally, alternating nostrils daily.

Priming (Activation) of Pump

• Unopened Fortical nasal spray should be stored in the refrigerator. Before using the first dose of Fortical nasal spray, the patient should wait until the bottle has reached room temperature. Remove the protective cap and clip from the bottle of Fortical nasal spray. To prime the pump before it is used for the first time, the bottle should be held upright and the two white side arms of the pump depressed toward the bottle at least 5 times until a full spray is produced. The pump is primed once the first full spray is emitted. To administer, the nozzle should be carefully placed into the nostril with the patient's head in the upright position, then the pump should be firmly depressed toward the bottle. The pump should not be primed before each daily use.

Recommendations for Calcium and Vitamin D Supplementation

• Patients who use Fortical nasal spray should receive adequate calcium (at least 1000 mg elemental calcium per day) and Vitamin D (at least 400 International Units per day).

DOSAGE FORMS AND STRENGTHS

• Fortical nasal spray consists of one glass bottle and one screw-on pump. The bottle contains 3.7 mL of calcitonin-salmon clear solution at a concentration of 2200 International Units per mL. A primed pump delivers 0.09 mL (200 International Units) calcitonin-salmon per actuation.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Calcitonin (nasal) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Calcitonin (nasal) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Calcitonin (nasal) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Calcitonin (nasal) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Calcitonin (nasal) in pediatric patients.

Contraindications

• Hypersensitivity to calcitonin-salmon or any of the excipients. Reactions have included anaphylactic shock, anaphylaxis, bronchospasm, and swelling of the tongue or throat.

Warnings

Hypersensitivity Reactions

• Serious hypersensitivity reactions have been reported in patients receiving calcitonin-salmon nasal spray, e.g., bronchospasm, swelling of the tongue or throat, anaphylaxis and anaphylactic shock. Reports of serious hypersensitivity reactions with injectable calcitonin-salmon have also been reported, including reports of death attributed to anaphylaxis. The usual provisions should be made for emergency treatment if such a reaction occurs. Hypersensitivity reactions should be differentiated from generalized flushing and hypotension.

• For patients with suspected hypersensitivity to calcitonin-salmon, skin testing should be considered prior to treatment utilizing a dilute, sterile solution of a calcitonin-salmon injectable product. Healthcare providers may wish to refer patients who require skin testing to an allergist. A detailed skin testing protocol is available from Upsher-Smith Laboratories, Inc. by calling toll-free at 1-888-650-3789.

Hypocalcemia

• Hypocalcemia associated with tetany (i.e. muscle cramps, twitching) and seizure activity has been reported with calcitonin therapy. Hypocalcemia must be corrected before initiating therapy with Fortical nasal spray. Other disorders affecting mineral metabolism (such as vitamin D deficiency) should also be effectively treated. In patients with these conditions, serum calcium and symptoms of hypocalcemia should be monitored during therapy with Fortical nasal spray. Use of Fortical nasal spray is recommended in conjunction with an adequate intake of calcium and vitamin D.

Nasal Adverse Reactions

• Adverse reactions related to the nose including rhinitis and epistaxis have been reported. Development of mucosal alterations may occur. Therefore, periodic nasal examinations with visualization of the nasal mucosa, turbinates, septum and mucosal blood vessels are recommended prior to start of treatment with Fortical nasal spray, periodically during the course of therapy, and at any time nasal symptoms occur.

• Fortical nasal spray should be discontinued if severe ulceration of the nasal mucosa occurs, as indicated by ulcers greater than 1.5 mm in diameter or penetrating below the mucosa, or those associated with heavy bleeding. Although smaller ulcers often heal without withdrawal of Fortical nasal spray, medication should be discontinued temporarily until healing occurs.

Malignancy

• In a meta-analysis of 21 randomized, controlled clinical trials with calcitonin-salmon (nasal spray or investigational oral formulations), the overall incidence of malignancies reported was higher among calcitonin-salmon-treated patients (4.1%) compared with placebo-treated patients (2.9%). This suggests an increased risk of malignancies in calcitonin-salmon-treated patients compared to placebo-treated patients. The benefits for the individual patient should be carefully considered against possible risks.

Antibody Formation

• Circulating antibodies to calcitonin-salmon have been reported with calcitonin-salmon nasal spray. The possibility of antibody formation should be considered in any patient with an initial response to Fortical nasal spray who later stops responding to treatment.

Urine Sediment Abnormalities

• Coarse granular casts and casts containing renal tubular epithelial cells were reported in young adult volunteers at bed rest who were given injectable calcitonin-salmon to study the effect of immobilization on osteoporosis. There was no other evidence of renal abnormality and the urine sediment normalized after calcitonin-salmon was stopped. Periodic examinations of urine sediment should be considered. Urine sediment abnormalities have not been reported in ambulatory volunteers treated with calcitonin-salmon nasal spray.

Adverse Reactions

Clinical Trials Experience

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

• Hypersensitivity Reactions, including anaphylaxis
• Hypocalcemia
• Nasal Adverse Reactions
• Malignancy

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 nasal spray in the treatment of postmenopausal osteoporosis was assessed in 5 randomized, double-blind, placebo controlled trials that enrolled postmenopausal women, aged 45-75 years. The duration of the trials ranged from 1 to 2 years. The incidence of adverse reactions reported in studies involving postmenopausal osteoporotic patients chronically exposed to calcitonin-salmon nasal spray (N=341) and to placebo nasal spray (N=131), and reported in greater than 3% of calcitonin-salmon treated patients are presented in the following table. Other than flushing, nausea, possible allergic reactions, and possible local irritative effects in the respiratory tract, a relationship to calcitonin-salmon nasal spray has not been established.

This image is provided by the National Library of Medicine.

Nasal Adverse Reactions: In all postmenopausal patients treated with calcitonin-salmon nasal spray, the most commonly reported nasal adverse reactions included rhinitis (12%), epistaxis (4%), and sinusitis (2%). Smoking did not have a contributory effect on the occurrence of nasal adverse reactions.

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 2). 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 2); 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 [se

• Adverse reactions reported in 1-3% of patients treated with calcitonin-salmon nasal spray include: influenza-like symptoms, erythematous rash, arthrosis, myalgia, sinusitis, upper respiratory tract infection, bronchospasm, abdominal pain, nausea, dizziness, paresthesia, abnormal lacrimation, conjunctivitis, lymphadenopathy, infection, and depression.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Calcitonin (nasal) in the drug label.

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Calcitonin (nasal) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Calcitonin (nasal) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Calcitonin (nasal) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Calcitonin (nasal) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Calcitonin (nasal) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Calcitonin (nasal) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Calcitonin (nasal) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Calcitonin (nasal) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Calcitonin (nasal) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Calcitonin (nasal) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Calcitonin (nasal) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Calcitonin (nasal) in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Calcitonin (nasal) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Calcitonin (nasal) in the drug label.

Pharmacology

There is limited information regarding Calcitonin (nasal) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Calcitonin (nasal)01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Calcitonin (nasal) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Calcitonin (nasal) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Calcitonin (nasal) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Calcitonin (nasal) in the drug label.

How Supplied

Storage

There is limited information regarding Calcitonin (nasal) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Calcitonin (nasal) in the drug label.

Precautions with Alcohol

• Alcohol-Calcitonin (nasal) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• FORTICAL ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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