Patient Medication Information: uses, side effects, how to take - Pamidronate Disodium for Injection (Fresenius Kabi Canada)
Serious Warnings and Precautions
Possible serious side effects with the use of pamidronate disodium include:
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What is Pamidronate Disodium for Injection used for:
Pamidronate Disodium for Injection is used to treat:
- High calcium levels in the blood due to cancer (tumor induced hypercalcemia);
- Bone tumors resulting from the spread of tumors at other sites and multiple myeloma;
- Paget’s disease of bone in patients with symptoms.
How does Pamidronate Disodium for Injection work?
Pamidronate Disodium for Injection is a bisphosphonate which strongly binds to the bone and slows down the rate of bone change. This helps to reduce the amount of calcium in the blood and bone loss.
What are the ingredients in Pamidronate Disodium for Injection
Medicinal Ingredients: Pamidronate Disodium
Non-medicinal ingredients: Mannitol, Phosphoric Acid, Sodium Hydroxide, and Water for Injection
Pamidronate Disodium for Injection comes in the following dosage forms:
Solution
Pamidronate Disodium for Injection is available as 3 mg / mL, 6 mg / mL, and 9 mg / mL strengths in 10 mL plastic single-dose vials packaged individually.
Vial stoppers do not contain any natural rubber latex.
Pamidronate Disodium for Injection is given as an infusion into a vein after appropriate dilution.
Do not use Pamidronate Disodium for Injection if:
- you are allergic to Pamidronate Disodium for Injection or other bisphosphonates;
you are pregnant;
- you are breast-feeding.
If this applies to you, tell your doctor before being given Pamidronate Disodium for Injection. If you think you may be allergic, ask your doctor for advice.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Pamidronate Disodium for Injection. Talk about any health conditions or problems you may have, including 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 an ear 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 can not 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.
Other warnings that you should know:
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).
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. Pamidronate Disodium for Injection 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.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Pamidronate Disodium for Injection:
Other bisphosphonates, calcitonin, thalidomide, or vitamin supplements.
How to take Pamidronate Disodium for Injection:
Pamidronate Disodium for Injection can be given only by slow infusion into a vein. The dose will be decided by your doctor.
Usual dose:
Tumor-induced hypercalcemia: 30-90 mg
Bone tumors or multiple myeloma: 90 mg every 3-4 weeks
Paget’s disease: 30-60 mg in one infusion
An infusion may last one or more hours, depending on the dose given and the condition of your kidney. You may receive additional saline solution for re-hydration.
Overdose:
| If you think you have taken too much Pamidronate Disodium for Injection, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
What are possible side effects from using Pamidronate Disodium for Injection?
These are not all the possible side effects you may feel when taking Pamidronate Disodium for Injection. If you experience any side effects not listed here, contact your healthcare professional.
Very common side effects:
These side effects may affect more than 1 in 10 patients.
- short-lasting fever and flu-like condition with chills, sometimes together with a feeling of tiredness and general discomfort;
- low level of calcium and phosphate in blood;
- tiredness, lack of energy.
If any of these affects you severely, tell your doctor.
Common side effects:
These side effects may affect between 1 and 10 in every 100 patients.
- Low level of red blood cells
- Low level of white blood cells
- Low level of platelets (cells in the blood that help stop bleeding)
- Headache
- Sleep disturbances
- Eye irritation
- High blood pressure
- Irregular heart rhythm (atrial fibrillation)
- Vomiting
- Loss of appetite
- Abdominal pain
- Diarrhea
- Constipation
- Stomach pain
- Sickness (nausea)
- Skin rash
- Generalised pain
- Low levels of potassium and magnesium in the blood
- Short-lasting muscle or joint pain
If any of these affects you severely, tell your doctor.
Uncommon side effects:
These side effects may affect between 1 and 10 in every 1 000 patients.
- Agitation
- Muscle cramps
- Low blood pressure
- Itching
- Abnormal liver function test
- Problems with jaw bones (osteonecrosis of the jaw)
If any of these affects you severely, tell your doctor.
The following side effects have been reported in some patients taking pamidronate disodium:
- Painful red eye and/or swollen eye, painful eyeball, photophobia, excessive tearing or decreased vision. You should report these to your doctor as they may indicate more serious complications.
- Problems with jaw bones (osteonecrosis of the jaw). Dental hygiene is an important element of your overall patient care and is important in possibly decreasing the chances of this type of problem occurring. Removable dentures should fit properly and should be removed at night. Please consult with your doctor if you experience pain in your mouth, teeth or jaw, or if your gums or mouth heals poorly. Any non-healing of a dental extraction site or chronic dental infection should be assessed. If you notice any other effects, tell your doctor immediately. In addition, if possible you should not undergo tooth extraction or other dental procedures (excluding regular dental cleaning) while on therapy 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 (seeOther warnings that you should know: Tooth Extraction and Other Dental Procedures).
Serious side effects and what to do about them
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If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
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Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Pamidronate Disodium for Injection should be stored between 15 °C ‒ 30 °C and protected from heat. Store in the original package.
Keep this medicine out of reach and sight of children and pets.
Pamidronate Disodium for Injection should not be used after the expiry date shown on the package label. Remember to take back any unused medicine to your pharmacist.
If you want more information about Pamidronate Disodium for Injection:
- Talk to your healthcare professional
- Find the full Prescribing Information that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); Fresenius Kabi Canada’s website (http://www.fresenius-kabi.com/en-ca/), or by calling 1-877-821-7724.
Fresenius Kabi Canada Ltd.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8