Consumer Information for: PAMIDRONATE DISODIUM FOR INJECTION

Before Starting Treatment with Pamidronate Disodium for Injection
Be sure that you have discussed Pamidronate Disodium for Injection treatment with your doctor. You may only be given Pamidronate Disodium for Injection after a full medical examination. Your doctor may also request a dental examination with any necessary preventive dentistry carried out prior to treatment with Pamidronate Disodium for Injection. This may be required since some patients have experienced side effects following dental procedures (such as tooth extraction) while on treatment with Pamidronate Disodium for Injection; as well since patients with dental infections or periodontal disease (disease affecting surrounding tissues of a tooth) may be at increased risk of problems with their jaw bones following dental procedures (such as tooth extraction) while on treatment with Pamidronate Disodium for Injection (see SIDE EFFECTS AND WHAT TO DO ABOUT THEM).

BEFORE you use Pamidronate Disodium for Injection, talk to your doctor or pharmacist if you:

• have a heart, liver or kidney problem;
• suffer from calcium or vitamin D deficiency (for example owing to your diet or as a result of digestive problems);
• have any dental problems or any dental procedures planned in the future;
• had or have pain, swelling or numbness of the jaw or a “heavy jaw feeling” or loosening of a tooth;
• have an eye problem;
• have sores in the mouth. This can lead to osteonecrosis of the jaw. Your doctor may check if you::
  • smoke
  • have or have had teeth and/or gum disease
  • have dentures that do not fit well
  • have other relevant medical conditions at the same time such as a low red blood cell count (called anemia) or if your blood cannot form clots in the normal way.

Your doctor may tell you to stop taking Pamidronate Disodium for Injection until all sores in your mouth are healed.

During Treatment with Pamidronate Disodium for Injection:
Ensure sufficient intake of liquids prior to infusions as directed by your doctor as this will help to prevent dehydration.

Your treatment may need to be supplemented with calcium and vitamin D to prevent low calcium levels.

It is important that your doctor checks your progress at regular intervals. Since bisphosphonates (the class of drugs to which Pamidronate Disodium for Injection belongs) may cause damage to the kidneys (worsening of kidney function including kidney failure and death have been reported very rarely with the use of Pamidronate Disodium for Injection), he or she may want to take repeated blood tests, especially after starting your treatment with Pamidronate Disodium for Injection and before each additional dose.

Your doctor may also want to take other repeated blood tests if you have low level of white blood cells, red blood cells and/or platelets.

Tooth Extraction and Other Dental Procedures
If possible, you should not undergo tooth extraction or other dental procedures (excluding regular dental cleaning) while you are receiving treatment with Pamidronate Disodium for Injection. Please consult your doctor if a dental procedure (excluding regular dental cleaning) is required while you are receiving treatment with Pamidronate Disodium for Injection. It is important to maintain good dental hygiene; regularly scheduled dental examinations are recommended.

Pregnancy or Breast-Feeding
You should tell your doctor if you:

• are pregnant, or planning to become pregnant before you receive Pamidronate Disodium for Injection. It should not be given during pregnancy
• are breast-feeding, or intend to breast-feed. Mothers treated with Pamidronate Disodium for Injection should not breast-feed their babies.

Women of Child-bearing Potential
You must use highly effective contraception during treatment.

Use in Children, Adolescents and Elderly Patients
Pamidronate Disodium for Injection has not been adequately studied in children or adolescents. Until further experience is gained, Pamidronate Disodium for Injection is only recommended for use in adult patients.

Elderly patients at the age of 65 years or older may be safely treated with Pamidronate Disodium for Injection, provided that they do not have a serious heart, liver or kidney problem. Ask your doctor if you have any questions about this.

If You Drive A Vehicle or Use Machinery
Pamidronate Disodium for Injection may cause some patients to become sleepy or dizzy, especially immediately after the infusion. If this happens, you should not drive or use machinery or perform other tasks that need full attention.