MIACALCIC INJECTION 100 IU/ML [SIN04735P]

Product Info

MIACALCIC INJECTION 100 IU/ML

[SIN04735P]

INDICATIONS
Miacalcic solution for injection or infusion 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

Hypercalcemia and hypercalcemic crisis due to

• tumoral osteolysis secondary to breast, lung or kidney carcinoma, myeloma and other malignancies,

• hyperparathyroidism, immobilization or vitamin D intoxication, for both the acute treatment of emergencies and the prolonged treatment of chronic hypercalcemia, until specific therapy of the underlying condition proves effective.

Neurodystrophic disorders (synonymous with algodystrophy or Sudeck’s disease)
Caused by various etiological and predisposing factors such as post-traumatic painful osteoporosis, reflex dystrophy, shoulder-arm syndrome, causalgia, drug-induced neutrophic disorders.

Adjuvant therapy of acute pancreatitis

DOSAGE AND ADMINISTRATION

Dosage

Adults

All indications
The solution in the multidose vials can be used for subcutaneous (s.c) or intramuscular (i.m), injection or for continuous intravenous (i.v) infusion, but is not suitable for i.v. bolus injection as it contains phenol (5 mg/mL) as a preservative.
Patients who will administer Miacalcic by themselves should first receive precise instruction in the self-administration of subcutaneous injections from the physician or the nurse.
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 100 to 200 international units daily by slow i.v. infusion in physiological saline, or by s.c. or i.m. injection in divided doses spread over the day, until a satisfactory response is achieved.
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 100 international units daily or every second day by s.c. or i.m. injection. 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 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.

Hypercalcemia

Emergency treatment of hypercalcemic crisis
Intravenous infusion is the most effective method of administration and should therefore be preferred in the treatment of emergencies or other severe conditions.
The recommended dose is 5 to 10 international units per kg body weight in 500 mL physiological saline daily by i.v. infusion over at least six hours, or by slow i.v. injection in 2 to 4 divided doses spread over the day.

Treatment of chronic hypercalcemic states
The recommended dosage in treatment of chronic hypercalcemic states is 5 to 10 international units per kg body weight daily by s.c. or i.m. injection as a single dose or in two divided doses. Treatment should be adjusted to the patient’s clinical and biochemical response. If the volume of Miacalcic to be injected exceeds 2 mL, i.m. administration is preferable and multiple sites of injection should be used.

Neurodystrophic disorders
Early diagnosis of neurodystrophic disorders is essential and treatment should start as soon as the diagnosis is confirmed.
The recommended dosage is 100 international units daily by s.c. or i.m. injection for 2 to 4 weeks. Subsequently, 100 international units may be given every second day for up to 6 weeks depending on clinical progress.

Acute pancreatitis
Miacalcic is a useful adjunct in conservative management of acute pancreatitis when administered at the recommended dosage of 300 international units by i.v. infusion in physiological saline over a 24 hours period for up to 6 consecutive days.

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 pagetic patients 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 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 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 parenteral Miacalcic in children, therefore no recommendations can be given for this patient group.

Geriatric patients (65 years of age and above)
Extensive experience with the use of parenteral Miacalcic 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 sections 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).