Pamifos® [Disodium pamidronate]

The concentrate for the Pamifos infusion solution is indicated for the treatment of diseases accompanied by increased osteoclast activity:

• metastases of malignant tumors in the bones (mainly osteolytic in nature) and myeloma disease (multiple myeloma) stage III;
• hypercalcemia due to malignant tumors;
• Pagets disease.

Structure

The active substance is pamidronic acid (1 ml of the concentrate contains 3 mg of pamidronate disodium, which corresponds to 2.527 mg of pamidronic acid).

Excipients: sodium hydroxide, concentrated hydrochloric acid, water for injection.

Contraindications

Hypersensitivity to pamidronate disodium or other bisphosphonates or to any components of the drug.

Mode of application

The drug "Pamifos" can not be administered intravenously.

Before administration, the infusion concentrate should be further diluted with an infusion solution that does not contain calcium (for example, 0.9% sodium chloride solution or 5% glucose solution).

The concentration of the drug "Pamifos" in the infusion solution should not exceed 90 mg / 250 ml. The resulting solution of this drug is administered slowly by infusion.

The infusion rate of the drug should not exceed 60 mg / hour (1 mg / minute). As a rule, the dose of Pamifos, which is 90 mg in 250 ml of solution, is administered within 2 hours.

For patients with myeloma and hypercalcemia due to malignant tumors, it is not recommended to exceed the dose of this drug, which is 90 mg, and to inject it in 500 ml of the solution for more than 4 hours.

To minimize reactions at the site of drug infusion, the injection needle must be carefully installed in the vein lumen of a relatively large caliber.

Disodium pamidronate should be used under the supervision of a physician who has equipment to monitor the clinical and biochemical effects. Patients who are treated with Pamifos infusion solution concentrate 3 mg / ml should be given instructions for the use of the drug.

Use only freshly prepared and clean dilutions.

Bone cancer metastases (mainly osteolytic in nature) and myeloma (use in adults and elderly patients)

Pamifos should be used in a dose of 90 mg in the form of single infusions, which are carried out every 4 weeks. In patients with bone metastases of malignant tumors who receive chemotherapy at weekly intervals, Pamifos at a dose of 90 mg can be used at weekly intervals.

Hypercalcemia due to malignant tumors (use in adults and elderly patients)

Before starting to use this drug or during therapy, it is recommended to rehydrate the patient with a 0.9% sodium chloride solution. The total dose of Pamifos concentrate, which is used during the course of treatment, depends on the initial level of calcium in the patients blood serum. The total dose of this drug can be administered both during a single infusion, and with the help of several injections carried out over 2-4 consecutive days. The maximum course dose of the drug (for both the first and subsequent courses of treatment) is 90 mg. Increasing the dose does not enhance the therapeutic effect. A significant decrease in the concentration of calcium in serum is usually observed 24-48 hours after the administration of this drug, and the normalization of this indicator within 3-7 days. If normalization of the level of calcium in the blood within the specified time is not achieved, additional administration of the drug is possible. The duration of preservation of the effect obtained is different in certain groups of patients. When restoring hypercalcemia, repeat the courses of administration of this drug.Clinical experience gained by this time indicates that with an increase in the number of drug administration courses, the effectiveness of the Pamifos concentrate may decrease.

Pagets disease (use in adults and elderly patients)

The recommended course of treatment is a total dose of 180 to 210 mg, which is administered in unit doses or 30 mg once a week for 6 consecutive weeks, or 60 mg every two weeks for 6 weeks. Current experience shows that any mild and transient side effects usually occur after the first dose. For this reason, if you use standardized doses of 60 mg, it is recommended that treatment be started with an initial dose of 30 mg followed by 60 mg once every two weeks (that is, the total dose is 210 mg). Each dose of 30 mg or 60 mg should be diluted in 125 ml or 250 ml of a 0.9% sodium chloride solution, respectively, and the rate of administration should not exceed 60 mg / hour (1 mg / minute). This course or increased dosage levels in accordance with the severity of the disease, up to a maximum total dose of 360 mg (in divided doses of 60 mg), can be repeated every 6 months until disease remission is achieved, and if relapse occurs.

Application features

Pregnant women

The drug should not be used during pregnancy, with the exception of cases of hypercalcemia, which are life-threatening.

Women who are undergoing treatment with the Pamifos infusion solution concentrate should refuse to breast-feed during lactation.

Women of reproductive age should use highly effective contraceptives during the treatment period.

Children

The safety and effectiveness of the use of this drug in children is unknown, therefore, Pamifos should not be prescribed in this category of patients.

Drivers

Patients should be cautioned that after infusion with this drug, drowsiness and / or dizziness may occasionally develop. In such cases, it is recommended to abandon driving, other potentially dangerous mechanisms or from activities that may become dangerous due to a decrease in the patients reaction rate.

Overdose

It is necessary to carefully monitor the condition of patients who received a dose exceeding the recommended one. Clinical signs of hypocalcemia (paresthesia, tetany and arterial hypotension) can be eliminated by calcium gluconate infusion.

Side effects

Adverse reactions to the drug "Pamifos" are usually mild and passing. The adverse reactions that occur most often are asymptomatic hypocalcemia and fever (an increase in body temperature by 1-2 ° C), usually develop in the first 48 hours after drug infusion. Fever usually goes away on its own and does not require treatment.

Interaction

Do not mix Pamifos with other bisphosphonates, and also use preparations that contain calcium to prepare the solution.

Storage conditions

Keep out of the reach of children. The concentrate does not require special storage conditions.

Shelf life is 4 years.