MIACALCIC NASAL 200 200 IU/DOSE [SIN10214P]

Product Info

MIACALCIC NASAL 200 200 IU/DOSE

[SIN10214P]

INDICATIONS
Miacalcic Nasal Spray is indicated for the treatment of:
Bone pain associated with osteolysis and/or osteopenia
Paget’s disease of bone (osteitis deformans) only in patients who do not respond to alternative treatments or for whom such treatments are not suitable
Neurodystrophic disorders (synonymous with algodystrophy or Sudeck’s disease)
Neurodystrophic disorders caused by various etiological and predisposing factors such as post-traumatic painful osteoporosis, reflex dystrophy, shoulder-arm syndrome, causalgia, drug-induced neurotrophic disorders.

DOSAGE AND ADMINISTRATION

Dosage

Adults

All indications
It is recommended to administer Miacalcic Nasal Spray per actuation to alternating nostrils.
Due to the association between occurrence of malignancies and long term calcitonin use (see section WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information), the treatment duration in all indications should be limited to the shortest period of time possible and using the lowest effective dose.

Bone pain associated with osteolysis and/or osteopenia
In bone pain associated with osteolysis and/or osteopenia the recommended dose is 200–400 international units daily. Up to 200 international units may be administered as a single dose; in cases where a higher dosage is required, it should be given in divided doses.
Dosage should be adjusted to the individual patient’s needs.
It may take several days of treatment until the analgesic effect is fully developed. For continuing therapy, the initial daily dosage can usually be reduced and/or the interval between administrations prolonged.

Paget’s disease
In Paget’s disease the recommended dose is 200 international units daily in a single dose or in divided doses. In some cases 400 international units in divided doses may be necessary at the beginning of therapy.
Dosage should be adjusted to the individual patient’s needs. Treatment should be discontinued once the patient has responded and symptoms have resolved. Duration of treatment should not normally exceed 3 months due to the association of the increased risk of malignancies with long term calcitonin use. Under exceptional circumstances, e.g. in patients with impending pathologic fracture, treatment duration may be extended up to a recommended maximum of 6 months.
Treatment with Miacalcic markedly reduces serum alkaline phosphatase and urinary hydroxyproline excretion, often to normal levels. However, in rare cases, alkaline phosphatase and hydroxyproline excretion levels may rise after an initial fall; the physician must then judge from the clinical picture whether treatment should be discontinued and when it may be resumed.
Disorders of bone metabolism may recur one or several months after treatment has been discontinued, necessitating a new course of Miacalcic therapy.

Neurodystrophic disorders
Early diagnosis of neurodystrophic disorders is essential and treatment should start as soon as the diagnosis is confirmed.
The recommended dose is 200 international units daily in a single dose over a period of 2 to 4 weeks. Subsequently, 200 international units may be administered every second day for up to 6 weeks depending on clinical progress.

Development of antibodies
Antibodies to calcitonins may develop in patients under long-term therapy; however clinical efficacy is usually not affected. Escape phenomena, which occur in particular in patients with Paget’s disease receiving long-term therapy, may be due to saturation of the binding sites and are apparently not related to the development of antibodies. Following interruption of treatment, the therapeutic response to Miacalcic is restored.

Special populations

Renal impairment
There is no evidence of reduced tolerance or altered dosage requirements of Miacalcic Nasal Spray in patients with renal impairment; although no formal studies have been carried out in this specific patient population.

Hepatic impairment
There is no evidence of reduced tolerance or altered dosage requirements of Miacalcic Nasal Spray in patients with hepatic impairment; although no formal studies have been carried out in this specific patient population.
Paediatric patients (below 18 years of age)There is limited experience with the use of Miacalcic Nasal Spray in children, therefore no recommendations can be given for this patient population.

Geriatric patients (65 years of age and above)
Extensive experience with the use of Miacalcic Nasal Spray in the elderly has shown no evidence of reduced tolerance or altered dosage requirements.

CONTRAINDICATIONS
Known hypersensitivity to synthetic salmon calcitonin or to any of the excipients (see section WARNINGS AND PRECAUTIONS, ADVERSE DRUG REACTIONS and DESCRIPTION AND COMPOSITION -EXCIPIENTS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).