Pamidronate 3mg/ml Inj, 10ml
It is used to treat high calcium levels.It is used to treat Paget's disease.It is used when treating some cancers.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Bone Resorption Inhibitor
Pharmacologic Class
Bisphosphonate
Pregnancy Category
Category D
FDA Approved
Oct 1991
DEA Schedule
Not Controlled
Overview
What is this medicine?
Pamidronate is a medicine given by injection into a vein to help strengthen bones and lower high calcium levels in the blood. It works by slowing down the breakdown of bone, which can be helpful for conditions like cancer that has spread to the bones, or a bone disease called Paget's disease.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and adhere to the dosage instructions.
This medication is administered as an intravenous infusion, which means it is given through a vein over a specified period of time. To help your body process the medication, drink plenty of non-caffeinated fluids, unless your doctor advises you to limit your fluid intake.
Storing and Disposing of Your Medication
If you need to store your medication at home, consult with your doctor, nurse, or pharmacist to determine the best storage method.
What to Do If You Miss a Dose
If you miss a dose, contact your doctor immediately to find out the best course of action. They will advise you on how to proceed and ensure your treatment plan stays on track.
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and adhere to the dosage instructions.
This medication is administered as an intravenous infusion, which means it is given through a vein over a specified period of time. To help your body process the medication, drink plenty of non-caffeinated fluids, unless your doctor advises you to limit your fluid intake.
Storing and Disposing of Your Medication
If you need to store your medication at home, consult with your doctor, nurse, or pharmacist to determine the best storage method.
What to Do If You Miss a Dose
If you miss a dose, contact your doctor immediately to find out the best course of action. They will advise you on how to proceed and ensure your treatment plan stays on track.
Lifestyle & Tips
- Maintain good oral hygiene and have regular dental check-ups, especially if you have cancer, to reduce the risk of jaw problems.
- Report any new or unusual pain in your thigh, hip, or groin immediately, as this could be a sign of a rare but serious bone fracture.
- Ensure adequate calcium and vitamin D intake as recommended by your doctor, especially if you are not hypercalcemic.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication
Condition-Specific Dosing:
Hypercalcemia of Malignancy (HCM):
60-90 mg IV infusion over 2-24 hours, single dose or divided over 2-4 days. May repeat after 7 days if needed.
Paget's Disease of Bone:
30 mg IV infusion over 4 hours daily for 3 consecutive days (total 90 mg per course). May repeat after 6 months.
Osteolytic Bone Metastases of Breast Cancer and Multiple Myeloma:
90 mg IV infusion over 2 hours every 3-4 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Limited data; used off-label for severe hypercalcemia or osteogenesis imperfecta. Dosing highly individualized (e.g., 0.5-1 mg/kg/dose IV over 2-4 hours, monthly or every 3 months).
Adolescent:
Limited data; used off-label for severe hypercalcemia or osteogenesis imperfecta. Dosing highly individualized.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment required (CrCl > 60 mL/min).
Moderate:
For osteolytic bone metastases, reduce infusion rate to 90 mg over 4 hours if CrCl 30-60 mL/min. For HCM, no specific adjustment but monitor renal function closely.
Severe:
Not recommended in patients with severe renal impairment (CrCl < 30 mL/min) for osteolytic bone metastases. For HCM, use with caution and only if benefits outweigh risks, monitor renal function closely.
Dialysis:
Not studied. Pamidronate is not significantly removed by hemodialysis. Avoid use if possible due to renal toxicity risk.
Hepatic Impairment:
Mild:
No specific dose adjustment information available.
Moderate:
No specific dose adjustment information available.
Severe:
No specific dose adjustment information available.
Pharmacology
Mechanism of Action
Pamidronate is a bisphosphonate that inhibits osteoclastic bone resorption. It binds to hydroxyapatite crystals in bone, particularly at sites of high bone turnover, and inhibits the formation and dissolution of these crystals. It also directly inhibits osteoclast activity and recruitment, leading to a decrease in bone resorption and a reduction in the release of calcium from bone.
Pharmacokinetics
Absorption:
Bioavailability:
100% (IV administration)
Tmax:
Not applicable (IV infusion)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 13-20 L (initial distribution phase); 22-30 L (steady-state)
ProteinBinding:
Approximately 54%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 21-35 hours (terminal elimination half-life from bone); 0.8-1.7 hours (plasma elimination half-life)
Clearance:
Approximately 107 mL/min (renal clearance)
ExcretionRoute:
Renal (primarily)
Unchanged:
Approximately 50-60% of the administered dose is excreted unchanged in urine within 120 hours.
Pharmacodynamics
OnsetOfAction:
Within 24-48 hours (for hypercalcemia)
PeakEffect:
Within 5-7 days (for hypercalcemia)
DurationOfAction:
Several weeks to months, depending on dose and indication (e.g., 2-4 weeks for hypercalcemia, up to 6 months for Paget's disease)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or significant weight gain.
Signs of electrolyte problems: mood changes, confusion, muscle pain, cramps, or spasms, weakness, shakiness, balance changes, abnormal heartbeat, seizures, loss of appetite, or severe nausea and vomiting.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Signs of a urinary tract infection (UTI): blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Signs of low thyroid levels: constipation, sensitivity to cold, memory problems, mood changes, or abnormal burning, numbness, or tingling sensations.
Vomiting blood or coffee ground-like material.
Black, tarry, or bloody stools.
Rapid or irregular heartbeat.
Fever.
Shortness of breath.
Swelling.
Important Warnings
This medication may increase the risk of fractures, particularly in the leg. Discuss this risk with your doctor. If you experience new or unusual pain in the groin, hip, or thigh, contact your doctor immediately.
Additionally, this medication may cause jawbone problems, especially with prolonged use, cancer, dental issues, ill-fitting dentures, anemia, blood clotting disorders, or infections. The risk may also be higher if you undergo dental procedures, chemotherapy, radiation, or take other medications that can cause jawbone problems. If you have concerns or questions, discuss them with your doctor. Seek medical attention immediately if you experience jaw swelling or pain.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although not everyone will experience them. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or persist:
Constipation, stomach pain, nausea, vomiting, or decreased appetite.
Back, bone, joint, or muscle pain.
Dizziness, drowsiness, fatigue, or weakness.
Headache.
Excessive sweating.
Sleep disturbances.
Cough.
Runny nose.
* Irritation at the injection site.
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or significant weight gain.
Signs of electrolyte problems: mood changes, confusion, muscle pain, cramps, or spasms, weakness, shakiness, balance changes, abnormal heartbeat, seizures, loss of appetite, or severe nausea and vomiting.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Signs of a urinary tract infection (UTI): blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Signs of low thyroid levels: constipation, sensitivity to cold, memory problems, mood changes, or abnormal burning, numbness, or tingling sensations.
Vomiting blood or coffee ground-like material.
Black, tarry, or bloody stools.
Rapid or irregular heartbeat.
Fever.
Shortness of breath.
Swelling.
Important Warnings
This medication may increase the risk of fractures, particularly in the leg. Discuss this risk with your doctor. If you experience new or unusual pain in the groin, hip, or thigh, contact your doctor immediately.
Additionally, this medication may cause jawbone problems, especially with prolonged use, cancer, dental issues, ill-fitting dentures, anemia, blood clotting disorders, or infections. The risk may also be higher if you undergo dental procedures, chemotherapy, radiation, or take other medications that can cause jawbone problems. If you have concerns or questions, discuss them with your doctor. Seek medical attention immediately if you experience jaw swelling or pain.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although not everyone will experience them. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or persist:
Constipation, stomach pain, nausea, vomiting, or decreased appetite.
Back, bone, joint, or muscle pain.
Dizziness, drowsiness, fatigue, or weakness.
Headache.
Excessive sweating.
Sleep disturbances.
Cough.
Runny nose.
* Irritation at the injection site.
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Jaw pain, swelling, numbness, or exposed bone in the mouth (signs of osteonecrosis of the jaw)
- New or unusual pain in your thigh, hip, or groin (signs of an atypical femur fracture)
- Muscle cramps, spasms, numbness or tingling around the mouth or in fingers/toes (signs of low calcium)
- Swelling in ankles or feet, decreased urination, unusual tiredness (signs of kidney problems)
- Fever, chills, bone pain, joint pain, muscle aches (flu-like symptoms, common with first dose)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have kidney disease, as this may affect your ability to take this medication.
This list is not exhaustive, and it is crucial to discuss all your medications, health conditions, and concerns with your doctor. This includes:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems you have
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Your doctor and pharmacist will work together to determine the best course of treatment for you.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have kidney disease, as this may affect your ability to take this medication.
This list is not exhaustive, and it is crucial to discuss all your medications, health conditions, and concerns with your doctor. This includes:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems you have
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Your doctor and pharmacist will work together to determine the best course of treatment for you.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Regular blood tests and dental exams should be performed as directed by your doctor to monitor your health. Practicing good oral hygiene and scheduling regular dental check-ups is crucial.
To support your overall health, take calcium and vitamin D supplements as advised by your doctor.
Be aware that this medication has been associated with kidney problems, including kidney failure, in some cases. If you have a history of kidney issues, notify your doctor promptly.
If you are pregnant or become pregnant while taking this medication, immediately contact your doctor, as it may pose a risk to the unborn baby.
Additionally, if you are breast-feeding, consult your doctor to discuss any potential risks to your baby and determine the best course of action.
Regular blood tests and dental exams should be performed as directed by your doctor to monitor your health. Practicing good oral hygiene and scheduling regular dental check-ups is crucial.
To support your overall health, take calcium and vitamin D supplements as advised by your doctor.
Be aware that this medication has been associated with kidney problems, including kidney failure, in some cases. If you have a history of kidney issues, notify your doctor promptly.
If you are pregnant or become pregnant while taking this medication, immediately contact your doctor, as it may pose a risk to the unborn baby.
Additionally, if you are breast-feeding, consult your doctor to discuss any potential risks to your baby and determine the best course of action.
Overdose Information
Overdose Symptoms:
- Significant hypocalcemia (e.g., tetany, seizures, cardiac arrhythmias)
- Renal impairment
- Hypophosphatemia
- Hypomagnesemia
What to Do:
Treatment is symptomatic and supportive. Correct hypocalcemia with intravenous calcium gluconate. Monitor electrolytes and renal function. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
- Other bisphosphonates (increased risk of adverse effects, especially renal toxicity and hypocalcemia)
- Thalidomide (increased risk of renal dysfunction in multiple myeloma patients)
Moderate Interactions
- Aminoglycosides (may potentiate hypocalcemia due to additive effects on serum calcium levels)
- Loop diuretics (may increase risk of hypocalcemia)
- Nephrotoxic drugs (e.g., NSAIDs, cisplatin, cyclosporine, amphotericin B) - increased risk of renal toxicity
Monitoring
Baseline Monitoring
Serum Calcium (corrected for albumin)
Rationale: To assess baseline hypercalcemia and guide dosing.
Timing: Prior to initiation of therapy.
Serum Phosphate, Magnesium, Potassium
Rationale: To assess baseline electrolyte status, as pamidronate can cause hypophosphatemia, hypomagnesemia, and hypokalemia.
Timing: Prior to initiation of therapy.
Renal Function (Serum Creatinine, BUN, CrCl)
Rationale: To assess baseline renal function and guide dosing/infusion rate, as pamidronate is renally eliminated and can cause renal toxicity.
Timing: Prior to initiation of therapy.
Dental Examination (for patients with cancer)
Rationale: To identify and address pre-existing dental disease before starting therapy, reducing risk of osteonecrosis of the jaw (ONJ).
Timing: Prior to initiation of therapy.
Routine Monitoring
Serum Calcium (corrected for albumin)
Frequency: Daily or every 2-3 days during initial treatment for hypercalcemia; prior to each dose for chronic therapy.
Target: 8.5-10.2 mg/dL (normal range)
Action Threshold: < 8.0 mg/dL (consider calcium supplementation); > 10.2 mg/dL (assess need for further treatment)
Serum Phosphate, Magnesium, Potassium
Frequency: Periodically during therapy, especially during initial treatment or if symptoms of electrolyte imbalance occur.
Target: Normal ranges
Action Threshold: Below normal limits (consider supplementation)
Renal Function (Serum Creatinine, BUN)
Frequency: Prior to each dose for chronic therapy; more frequently during initial treatment for hypercalcemia or if renal impairment is suspected.
Target: Stable or within normal limits
Action Threshold: Significant increase from baseline (consider dose adjustment, slower infusion, or discontinuation)
Symptom Monitoring
- Signs/symptoms of hypocalcemia (e.g., muscle cramps, spasms, paresthesias, tetany)
- Signs/symptoms of osteonecrosis of the jaw (ONJ) (e.g., jaw pain, swelling, numbness, loose teeth, exposed bone)
- Signs/symptoms of atypical femur fractures (e.g., new or unusual thigh, hip, or groin pain)
- Signs/symptoms of renal dysfunction (e.g., decreased urine output, swelling, fatigue)
- Flu-like symptoms (fever, chills, bone pain, arthralgia, myalgia) - common with first dose
Special Patient Groups
Pregnancy
Pamidronate is classified as Pregnancy Category D. It can cause fetal harm when administered to a pregnant woman. Bisphosphonates are incorporated into the bone matrix and are gradually released over weeks to years. The amount of bisphosphonate incorporated into adult bone and subsequently released is directly related to the total dose and duration of bisphosphonate use. There are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm, including skeletal abnormalities, based on animal studies and mechanism of action.
Second Trimester:
Potential for fetal harm, including skeletal abnormalities, based on animal studies and mechanism of action.
Third Trimester:
Potential for fetal harm, including skeletal abnormalities, based on animal studies and mechanism of action. May affect fetal bone mineralization.
Lactation
Pamidronate is classified as L3 (Moderately Safe) by some sources, but caution is advised. It is not known whether pamidronate is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from bisphosphonates, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Potential for adverse effects on infant bone metabolism or calcium levels. Risk is likely low due to poor oral absorption if ingested, but long-term effects are unknown.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Use is generally off-label for severe hypercalcemia or certain bone disorders (e.g., osteogenesis imperfecta) under specialist supervision, with careful monitoring of growth and bone development.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients are more likely to have decreased renal function, so careful monitoring of renal function is important.
Clinical Information
Clinical Pearls
- Always ensure adequate hydration before and during pamidronate infusion, especially for hypercalcemia of malignancy, to help prevent renal toxicity.
- Infusion rate is critical: rapid infusion can increase the risk of renal impairment. Adhere strictly to recommended infusion times (e.g., 90 mg over at least 2 hours, or 4 hours for renal impairment).
- Flu-like symptoms (fever, myalgia, arthralgia) are common after the first dose, usually transient and self-limiting. Pre-medication with acetaminophen may help.
- Patients should be advised to maintain good oral hygiene and report any jaw pain or dental issues promptly due to the risk of osteonecrosis of the jaw (ONJ).
- Monitor serum calcium, phosphate, magnesium, and potassium, as well as renal function, before and during therapy.
- For hypercalcemia, pamidronate's full effect may not be seen for several days, so repeat doses should not be given sooner than 7 days.
Alternative Therapies
- Other bisphosphonates (e.g., zoledronic acid, ibandronate, alendronate, risedronate)
- Calcitonin (for acute hypercalcemia)
- Denosumab (RANK ligand inhibitor, for bone metastases and hypercalcemia of malignancy)
- Glucocorticoids (for hypercalcemia associated with certain malignancies)
- Cinacalcet (calcimimetic, for primary hyperparathyroidism or secondary hyperparathyroidism in dialysis patients)
Cost & Coverage
Average Cost:
Varies widely, typically several hundred to over a thousand USD per dose per 90 mg vial
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Specialty drug, may require prior authorization)
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the quantity, and the time it was taken.