Pamidronate disodium for Injection by Sandoz

Brand Name

Pamidronate disodium for Injection by Sandoz

Common Name

pamidronate for injection

In this drug factsheet:

• How does this medication work? What will it do for me?
• How should I use this medication?
• What form(s) does this medication come in?
• Who should NOT take this medication?
• What side effects are possible with this medication?
• Are there any other precautions or warnings for this medication?
• What other drugs could interact with this medication?

How does this medication work? What will it do for me?

Pamidronate belongs to the family of medications known as bisphosphonates. It is used to treat hypercalcemia (high blood calcium) in people who have cancer. Pamidronate is also used to treat cancer that has spread to bones (bone metastases) due to different types of tumours and multiple myeloma (cancer of the bone marrow). Pamidronate is also used to treat the symptoms of Paget's disease of bone.

This medication works by reducing the breakdown of bone.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are being given this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.

How should I use this medication?

The dosage of this medication depends on the condition that is being treated.

For hypercalcemia due to cancer (high calcium levels in the blood), the recommended total dose of pamidronate per treatment course will depend on the starting levels of calcium in the blood. The recommended maximum dose per treatment course is 90 mg, which can be given as a single intravenous (into the vein) infusion of 90 mg or multiple infusions spread over 2 to 4 days.

For bone metastases and multiple myeloma, the recommended dose of pamidronate is 90 mg given as a single-dose intravenous infusion every 4 weeks. The dose should be given over a period of 2 to 4 hours. People who receive chemotherapy every 3 weeks may receive 90 mg of pamidronate every 3 weeks.

For Paget's disease of bone, the recommended dose of pamidronate ranges from 180 mg to 210 mg given as intravenous infusions. The initial dosing schedule may be either 6 doses of 30 mg once a week (total dose 180 mg), or 30 mg for the first dose and 3 doses of 60 mg every second week (total dose 210 mg). Once this dosing schedule is complete, it can be repeated after 6 months. For repeat dosing, pamidronate is usually given as 3 doses of 60 mg every second week (total dose 180 mg).

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications.

It is important that this medication be given exactly as recommended by your doctor. If you miss an appointment to receive pamidronate, contact your doctor as soon as possible to reschedule your appointment.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

3 mg/mL
Each 10 mL vial of clear, colourless solution contains 30 mg of pamidronate disodium. Nonmedicinal ingredients: mannitol, water for injection, and phosphoric acid. This preparation contains no preservatives.

6 mg/mL
Each 10 mL vial of clear, colourless solution contains 60 mg of pamidronate disodium. Nonmedicinal ingredients: mannitol, water for injection, and phosphoric acid. This preparation contains no preservatives.

9mg/mL
Each 10 mL vial of clear, colourless solution contains 90 mg of pamidronate disodium. Nonmedicinal ingredients: mannitol, water for injection, and phosphoric acid. This preparation contains no preservatives.

Who should NOT take this medication?

Do not use this medication if you:

• are allergic to pamidronate or to any ingredients of this medication
• are allergic to other bisphosphonates (e.g., alendronate, etidronate, risedronate)
• are pregnant
• are breast-feeding

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• constipation
• diarrhea
• difficulty sleeping
• dizziness
• flu-like symptoms (fever, chills, muscle pain)
• headache
• increased tear production
• loss of appetite
• nausea
• pain, redness, or swelling at the injection site
• short term muscle or joint pain
• stomach pain
• unusual tiredness or weakness
• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• agitation
• blood pressure changes (increase or decrease)
• confusion
• decreased vision
• eye pain or irritation
• flare up of cold sores, herpes lesions or shingles
• increased frequency of infection
• irregular heart beat
• itching
• jaw, mouth, or teeth pain
• muscle pain or cramps
• numbness or tingling in the hands, feet or lips
• sensitivity to light
• signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)

• signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)

• signs of heart failure (e.g., fast, irregular heartbeat or pulse, chest pain, sudden weight gain,  difficulty breathing, leg swelling)
• signs of kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine, change of urine colour)
• skin rash
• visual hallucinations (seeing things that aren't there)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• seizures
• symptoms of a severe allergic reaction (difficulty breathing, hives, swelling of the mouth or throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Atypical femur fracture: There is evidence that long term use of this class of medication may contribute to a type of rare fracture of the long bone in the thigh (femur).

If you experience new or unusual pain in the groin, hip, or thigh area, contact your doctor as soon as possible.

Bone, joint, and muscle problems: On rare occasions, people taking this medication experience severe bone, joint, or muscle pain. This is usually reversed when the medication is stopped.

Deterioration of the jawbone: People with cancer treated with pamidronate (or other bisphosphonates) may rarely develop osteonecrosis of the jaw (deterioration of the jaw bone). If you experience any pain, swelling, or infection of the jaw, report this to your doctor. Before starting treatment with pamidronate, your doctor may recommend that you see a dentist for an examination and any necessary dental treatment. While receiving pamidronate, people should avoid invasive dental procedures such as tooth extractions.

Drowsiness/reduced alertness: Pamidronate may cause drowsiness and dizziness. Avoid driving, operating potentially dangerous machinery, or participating in other activities that may be hazardous until you know how this medication affects you.

Heart disease: Treatment with pamidronate usually requires intravenous fluids to be given before the medication, to ensure that your kidneys will be able to effectively remove the medication from the body. This extra fluid may cause extra work for the heart to move the blood through the body, leading to symptoms of congestive heart failure. If you experience symptoms such as difficulty breathing, swelling in the ankles, legs, or hands, or chest pain while receiving the fluids or medication, let your doctor know immediately.

Some people experience an irregular heartbeat with the use of pamidronate. If you experience a rapid, pounding heart beat, dizziness or fainting, or difficulty breathing while receiving this medication, let your doctor know right away.

If you have any type of heart condition, including high blood pressure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney problems: Decreased kidney function and kidney disease may cause pamidronate to build up in the body, leading to side effects. If you have reduced kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. You doctor will monitor your kidney function during and after intravenous infusions of pamidronate.

Pamidronate may also cause decreased kidney function. If you experience symptoms of decreased kidney function, such as change of urine colour, decreased urine production, swelling, fatigue, or abdominal pain, contact your doctor as soon as possible.

Low calcium levels: Pamidronate may cause low calcium levels. You will need to have regular blood tests while taking pamidronate to monitor your calcium levels. Your doctor may recommend taking calcium and vitamin D supplements while you are being treated with pamidronate, to ensure there is enough calcium in your blood.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if pamidronate passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

What other drugs could interact with this medication?

There may be an interaction between pamidronate and any of the following:

• aminoglycosides (e.g., gentamicin, tobramycin)
• angiogenesis inhibitors;
• medications that prevent blood vessel growth in tumours (e.g., axitinib, bevacizumab, lenalidomide, pazopanib, regorafenib, sorafenib, sunitinib, thalidomide)
• other bisphosphonates (e.g., alendronate, risedronate, etidronate)
• deferasirox
• nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen, naproxen, ketoprofen)
• proton pump inhibitors (e.g., lansoprazole, omeprazole)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Pamidronate-disodium-for-Injection-by-Sandoz