AREDIA ® - Pamidronic acid

AREDIA ® is a drug based on pamidronic acid sodium salt

THERAPEUTIC GROUP: Drugs affecting bone metabolism - Bisphosphonates

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications AREDIA ® - Pamidronic acid

AREDIA ® is used in the treatment of hypercalcaemia associated with neoplastic osteolysis, Paget's bone disease and tumor bone metastases.

Mechanism of action AREDIA ® - Pamidronic acid

Pamidronic acid is a drug belonging to the category of bisphosphonates, used in the medical field for the treatment of bone diseases.

More precisely, AREDIA ®, administered intravenously, reaches the bone tissue, depositing preferentially at the level of the hydroxyapatite crystals present in the resorption sites and thus inhibiting both the local differentiation process of the osteoclasts and their osteoriasorbent activity.

The aforementioned properties affect local bone mineral density as well as some important metabolic parameters such as serum calcium levels and alkaline phosphatase concentrations.

Different clinical trials have also shown how the use of AREDIA ® in the course of tumors with bone metastases, as well as improving the clinical picture and skeletal health has also proved important in reducing the painful manifestations of the disease.

Studies carried out and clinical efficacy

1. BIPOSPHONATE / INTERFERON COMBINED THERAPY

Treatment of osteoporosis secondary to mastocytosis with interferon and pamidronate proved to be particularly effective in significantly increasing bone mineral density.

The addition of pamidronic acid to the normal chemotherapeutic scheme has been shown to be effective in the treatment of osteosarcoma without compromising in any way the efficacy of chemotherapy.

3. ADMINISTRATION IN PAMIDRONATE BOLUS AND ACUTE INFLAMMATION

The risk of bolus administration of pamidronate is confirmed by this study which demonstrates the significant increase in inflammatory cytokine mRNA concentrations following the administration of this drug. The increase in C reactia protein, TNF-alpha and other inflammatory molecules underlines the risk of acute inflammation.

Method of use and dosage

AREDIA ®

Powder and solvent for solution for infusion of 15 mg, 30 mg, 60 mg and 90 mg of pamidronate disodium:

AREDIA ® is a drug used exclusively in the hospital setting, therefore the therapeutic scheme should be defined by the ward doctor, based on the patient's physical condition.

Pamidronic acid should never be administered as a bolus, but diluted in a calcium-free infusion solution and administered at the maximum rate of 60mg / hour.

Warnings AREDIA ® - Pamidronic acid

Given the specialized nature of the therapeutic indications, the administration of pamidronic acid must necessarily be carried out in hospital facilities and only after having carefully evaluated the patient's state of health and the possible presence of conditions incompatible with the aforementioned active ingredient.

In fact, patients suffering from renal and cardiac diseases subjected to AREDIA ® therapy could manifest a significant aggravation of their clinical picture which requires the urgent suspension of treatment.

In patients without hypercalcaemia, treatment with pamidronic acid could be combined with a correct supplementation of vitamin D and calcium, in order to preserve the blood concentrations of this element thus avoiding the appearance of symptomatic hypercalcemia.

The increased risk of osteonecrosis of the jaw in patients receiving AREDIA ® should be seriously considered before any dental treatment.

All patients receiving pamidronic acid therapy should be monitored for blood concentrations of trace elements.

PREGNANCY AND BREASTFEEDING

Experimental studies have shown that pamidronic acid can easily pass through both the placental and mammary filters, thus reaching both the fetus and the infant.

For this reason the intake of AREDIA ® is contraindicated both during pregnancy and in the subsequent period of breastfeeding.

Interactions

Administration of AREDIA ® has been shown to be safe in relation to the presence of clinically relevant drug interactions.

In fact, the simultaneous intake of pamidronic acid with antitumor drugs of various kinds has not caused any kind of side effect.

Contraindications AREDIA ® - Pamidronic acid

AREDIA ® is contraindicated in case of renal insufficiency and hypersensitivity to the active ingredient or to one of its excipients.

Undesirable effects - Side effects

Although different clinical trials have demonstrated the relative safety of pamidronic acid, when administered according to medical indications, taking AREDIA ® may be associated with the appearance of anemia, thrombocytopenia, lymphocytopenia, hypokalemia, hypomagnesemia, headache, insomnia, drowsiness, conjunctivitis, hypertension, skin rash and dermatological allergic manifestations, increased creatininemia, reduced renal function, fever and flu-like symptoms.

However, the most frequently observed adverse reaction is hypokalemia symptomatology usually accompanied by paresthesia and tetany.