Consumer medicine information

1. Why am I being treated with Pamisol?

Pamisol contains the active ingredient pamidronate disodium. Pamisol is used to treat bone cancer, high blood calcium levels or a bone disease where bone breaks down excessively and is incorrectly repaired by the body.
For more information, see Section 1. Why am I being treated with Pamisol? in the full CMI.

2. What should I know before treatment with Pamisol?

Pamisol should not be used if you have ever had an allergic reaction to pamidronate disodium, any of the ingredients listed at the end of the CMI, other similar types of medicine, or are pregnant or breastfeeding.
Talk to your doctor if you have any other medical conditions or take any other medicines.
For more information, see Section 2. What should I know before treatment with Pamisol? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Pamisol and affect how it works. Examples include other bisphosphonates, medicines to slow down or prevent bone loss; calcitonin, a medicine to reduce calcium in the blood; thalidomide, a medicine used to treat a number of cancers; medicines that may have side effects on your kidneys.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How is Pamisol given?

Your doctor will give you Pamisol as a slow drip into a vein and decide how much you will be given and for how long.
More instructions can be found in Section 4. How is Pamisol given? in the full CMI.

5. What should I know during treatment with Pamisol?

6. Are there any side effects?

Possible side-effects include: seizures; signs of an allergic reaction (shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of body, rash, itching, hives); light headedness, dizziness, faintness; a tingling/burning sensation, numbness/cramps, twitching/muscle spasms; difficulty urinating, blood in urine, vomiting, nausea; anaemia and/or other blood disorders, or infection, bleeding and bruising more easily; irregular or changes to heart rhythm; irritated, itchy, red or swollen eyes, sensitivity to light, blurred vision or pain in the eye; pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, loosening of a tooth, infection; ear pain, discharge or ear infection; thigh or groin pain; pain/pressure in the head with hearing or vision changes; breathlessness, swollen feet or lower legs. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Pamidronate disodium.

2 Qualitative and Quantitative Composition

Each mL of Pamisol 15 mg/5 mL and 30 mg/10 mL concentrated injection contains 3 mg pamidronate disodium.
Each mL of Pamisol 60 mg/10 mL concentrated injection contains 6 mg pamidronate disodium.
Each mL of Pamisol 90 mg/10 mL concentrated injection contains 9 mg pamidronate disodium.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Concentrated injection.
Pamisol is a clear, colourless, sterile solution. The pH of the solution is approximately 6.5.

4 Clinical Particulars

4.9 Overdose

Signs and symptoms. Overdosage with pamidronate disodium would be likely to result in symptoms of hypocalcaemia, such as paraesthesia, tetany and hypotension.
Treatment. Patients who have received doses of pamidronate disodium higher than those recommended should be carefully monitored. In the event of clinically significant hypocalcaemia with paraesthesia, tetany and hypotension, reversal may be achieved with an infusion of calcium gluconate. Acute hypocalcaemia is not expected to occur with pamidronate disodium since plasma calcium levels fall progressively for several days after treatment.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

The toxicity of pamidronate disodium is characterised by direct (cytotoxic) effects on organs with a copious blood supply, such as the stomach, lungs and kidneys. In animal studies with intravenous administration, renal tubular lesions were the prominent and consistent untoward effects of treatment.
Studies conducted in young rats have reported the disruption of dental dentine formation following single and multiple dose administration of bisphosphonates. The clinical significance of these findings is unknown.
Genotoxicity. Pamidronate disodium showed no genotoxic activity in a standard battery of assays for gene mutations and chromosomal damage.
Carcinogenicity. There is a lack of long-term toxicology data from animal studies with intravenous administration. In a 104 week carcinogenicity study of daily oral administration to rats, there was a positive dose response relationship for benign phaeochromocytoma in male animals.
Although this condition was also observed in female animals, the incidence was not statistically significant. When the dosage calculations were adjusted to account for the limited oral bioavailability of pamidronate disodium in rats, the lowest daily dose associated with adrenal phaeochromocytoma was similar to the intended clinical dose in humans. In a second rat carcinogenicity study, adrenal phaeochromocytomas were not reported at doses similar to the intended clinical dose in humans. Pamidronate disodium by daily oral administration was not carcinogenic in an 80 week or a 104 week study in mice.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Pamidronate disodium is a white crystalline powder that is soluble in water or 2 N sodium hydroxide, poorly soluble in 0.1 N hydrochloric acid and 0.1 N acetic acid and virtually insoluble in organic solvents. The pH of a 1% solution in water is approximately 8.2.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSDIPAMI.gif Chemical name: disodium-3-amino-1- hydroxypropylidene-1,1-biphosphonate.
Molecular formula: C₃H₉NO₇P₂Na₂.
Molecular weight: 279.03 (anhydrous).
CAS number. 57248-88-1.

7 Medicine Schedule (Poisons Standard)

S4, Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/PAMISOST.gif