Miacalcin Ns Side Effects

Please note - some side effects for Miacalcin Ns may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects by Body System - for Healthcare Professionals

Applies to: injectable solution; nasal spray

General

Side effects are often mild, but commonly occur in about 10% of patients and may occur in up to 30%. About one third of treated patients discontinue the drug due to side effects. Diminished adverse effects occur with the subcutaneous route versus the intramuscular route. After injection, side effects generally occur within an hour.

Calcitonin is a large, manufactured peptide. A certain percentage of what is produced during manufacturing may be "error peptides" which may increase or change the side effects.

Gastrointestinal

Nausea is the most common symptom and occurs in about 10% to 21% of patients. Vomiting, diarrhea, anorexia, and abdominal discomfort are also common effects of calcitonin. A metallic taste is reported.

A 71-year-old with Paget's disease was treated with 100 intl units of synthetic salmon calcitonin five times a week. After each injection she experienced nausea, vomiting, and severe shivering. Administration of the 5HT antagonist pizotifen eliminated the side effects.

Cardiovascular

Cardiovascular side effects including tingling of the hands and flushing of the palms, soles, face, or ears are common. A feeling of pressure in the chest may occur.

Nervous system

Within 90 minutes of a subcutaneous injection of 100 intl units of synthetic salmon calcitonin, a 35-year-old woman developed widespread fine tremor which lasted an hour. The reaction could be repeated with a different batch of the drug but not with placebo.

Central nervous system side effects of shivering, chills, paresthesias, dizziness, headache, vertigo, migraine, neuralgia, agitation and tremor have been reported. Tetany has been reported rarely.

Local

Local side effects including pain, wheals, and erythema at the injection site have been reported. Local reactions are less likely after injection of synthetic human calcitonin than with the synthetic salmon preparation.

Respiratory

Respiratory side effects of shortness of breath and nasal congestion occur infrequently. Rhinorrhea, mild nose bleeds, and nasal dryness may occur with nasal administration.

Immunologic

Antibodies may develop to extracted or synthetic calcitonin products after chronic use. The time to antibody development is variable and patient dependent. Antibodies have been reported with the salmon preparation, and rarely to the human product. Antibody development will render a patient resistant to therapy.

Metabolic

Hyperglycemia has been reported as a metabolic side effect in patients with Paget's disease. Impaired glucose tolerance may occur in healthy volunteers. Diabetics may lose control of blood sugar.

Metabolic acidosis and hypocalcemia may occur. Transient increases in water and sodium excretion may occur.

A study of 20 postmenopausal women on calcitonin for osteoporosis for 6 months showed that about seven hours after administration of 100 intl units (intramuscularly) of synthetic salmon calcitonin a mild metabolic acidosis developed.

Renal

Renal side effects including polyuria and urinary frequency may occur in 5% to 10% of patients. Abnormal urinary sediment (but not proteinuria or reduced creatinine clearance) is a rare side effect.

Dermatologic

A 66-year-old woman received a total of 5600 intl units of intranasal synthetic salmon calcitonin for treatment of osteoporosis. Within one month she developed disseminated granuloma annulare (DGA). The calcitonin was continued for one month after symptoms of DGA were recognized. Lesions did not disappear immediately but continued for 10 months. The relationship was temporal but could not be proved as causal.

Dermatologic side effects including various rashes, urticaria, and flushing and itching of the palmar and plantar surfaces have been reported. Flushing is a common effect. A single case of disseminated granuloma annulare was temporarily related to synthetic salmon calcitonin use. It is a rare effect.

Musculoskeletal

Musculoskeletal side effects including a bilateral deformation of the alar nasal cartilages have been rarely reported after intranasal use. Musculoskeletal weakness may occur.

A 58-year-old woman being treated for osteoporosis with 100 intl units of salmon calcitonin spray per nostril per day developed a progressive bilateral deformation of the alar nasal cartilages. Two depresses, symmetric areas appeared after 4 months. There was nasal septum deformation. The relationship was temporal but could not be proven as causal.

Hypersensitivity

Hypersensitivity side effects have included a few cases of serious allergic-type reactions (e.g., bronchospasm, swelling of the tongue or throat, anaphylactic shock), including very rare reports of death attributed to anaphylaxis.

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