Pamidronatdinatrium Pfizer (Disodium Pamidronate) 3 mg/ml
Bisphosphonate concentrate for solution for infusion — intravenous therapy for cancer-related bone disease
Pamidronatdinatrium Pfizer contains disodium pamidronate at 3 mg/ml, a second-generation aminobisphosphonate that powerfully inhibits osteoclast-mediated bone resorption. It is administered as a slow intravenous infusion under medical supervision to treat high blood calcium caused by cancer (tumour-induced hypercalcaemia), to reduce skeletal complications from breast cancer bone metastases, and to manage bone lesions in advanced multiple myeloma. This medication is given exclusively in hospital or specialist clinic settings.
Quick Facts
Key Takeaways
- Pamidronatdinatrium Pfizer is a bisphosphonate given by slow intravenous drip to reduce high blood calcium and protect bones damaged by cancer.
- It is used for tumour-induced hypercalcaemia, osteolytic bone metastases from breast cancer, and bone lesions in advanced multiple myeloma (stage III).
- The most common side effects are transient flu-like symptoms and mild fever, which typically occur only with the first infusion and resolve within 24 hours.
- Renal function (serum creatinine) must be checked before every dose; treatment is paused if kidney function deteriorates beyond set thresholds.
- A dental examination is recommended before starting treatment because of the risk of osteonecrosis of the jaw (ONJ), particularly in patients receiving chemotherapy or corticosteroids.
What Is Pamidronatdinatrium Pfizer and What Is It Used For?
Pamidronatdinatrium Pfizer belongs to the bisphosphonate class of medicines (ATC code M05BA03), a group of drugs that act primarily on bone metabolism by inhibiting the activity of osteoclasts — the cells responsible for breaking down bone tissue. The active substance, disodium pamidronate, binds with high affinity to hydroxyapatite crystals in bone, where it interferes with osteoclast attachment and function. This slows the rate at which bone is resorbed and consequently reduces the release of calcium, phosphate, and bone-matrix proteins into the circulation.
The medicine is supplied as a concentrated sterile solution containing 3 mg of disodium pamidronate per millilitre. This concentrate must be diluted before use with a calcium-free infusion solution and is administered exclusively as a slow intravenous (IV) infusion. It is never taken orally, injected as a bolus, or given intramuscularly. All infusions are performed under the supervision of a physician experienced in managing cancer-related bone disease, in a hospital or specialised oncology clinic equipped with appropriate monitoring facilities.
As a second-generation aminobisphosphonate, pamidronate is significantly more potent than first-generation agents such as etidronate. Its clinical utility was established in two landmark randomised controlled trials published in the New England Journal of Medicine in 1996, which demonstrated substantial reductions in skeletal-related events for patients with breast cancer bone metastases and multiple myeloma. Today it remains on the World Health Organization (WHO) Model List of Essential Medicines and is listed in the British National Formulary (BNF) and the European Medicines Agency (EMA) Summary of Product Characteristics.
Approved Indications
Pamidronatdinatrium Pfizer is authorised for the following clinical indications:
- Tumour-induced hypercalcaemia (TIH): Many cancers — particularly of the lung, breast, kidney, head and neck, and blood (myeloma, lymphoma) — can release parathyroid hormone-related peptide (PTHrP) or directly destroy bone, producing dangerously elevated blood calcium. Left untreated, severe hypercalcaemia causes confusion, cardiac arrhythmias, renal failure, coma, and death. Pamidronate rapidly normalises serum calcium in most patients within 3–7 days.
- Osteolytic bone metastases from breast cancer: When breast cancer spreads to the skeleton, it activates osteoclasts and causes painful bone destruction, pathological fractures, spinal cord compression, and further calcium release. Regular pamidronate infusions every 3–4 weeks significantly reduce skeletal-related events and bone pain, and improve quality of life.
- Advanced multiple myeloma (stage III): This plasma-cell malignancy causes widespread osteolytic bone lesions through activation of osteoclasts by cytokines such as RANKL and IL-6. Pamidronate 90 mg every four weeks helps preserve bone integrity and reduces vertebral and non-vertebral fractures.
Disodium pamidronate may also be used for selected non-cancer indications in certain jurisdictions, including severe Paget’s disease of bone (for which it was historically approved) and, less commonly, severe osteogenesis imperfecta in specialist centres. Patients must always follow their treating physician’s instructions regarding off-label use. The EMA, the US Food and Drug Administration (FDA), and the WHO all recognise pamidronate as an established bisphosphonate for malignancy-related bone disease.
Pamidronatdinatrium Pfizer is intended for adult patients (18 years and older). Safety and efficacy in children and adolescents have not been established for cancer indications, and the medicine should only be given within a clinical trial or on named-patient basis in paediatrics. The drug is always administered in a healthcare facility with capacity to monitor clinical and biochemical effects.
What Should You Know Before Receiving Pamidronatdinatrium Pfizer?
Before the first infusion, the treating physician will conduct a thorough medical history and perform baseline laboratory tests including serum electrolytes (calcium, phosphate, magnesium, potassium), a full blood count, renal function (serum creatinine, estimated glomerular filtration rate), and liver enzymes. Adequate hydration must be confirmed or established before every infusion to protect renal function.
Contraindications
Pamidronatdinatrium Pfizer must not be used in the following situations:
- Hypersensitivity: Known allergy to disodium pamidronate, pamidronic acid, other bisphosphonates (such as zoledronic acid, alendronate, ibandronate, risedronate), or any of the excipients in the formulation (sodium hydroxide, hydrochloric acid, water for injections).
- Breastfeeding: Pamidronate may pass into breast milk and harm a nursing infant. Breastfeeding must be discontinued before treatment begins.
Warnings and Precautions
Before receiving Pamidronatdinatrium Pfizer, the following conditions and situations must be discussed with your treating physician:
- Kidney disease: Pamidronate is excreted unchanged by the kidneys and can itself impair renal function, particularly if infused rapidly or given with other nephrotoxic agents. Serum creatinine must be measured before every dose. The medicine should not be given to patients with severe renal impairment (creatinine clearance <30 ml/min) except in cases of life-threatening tumour-induced hypercalcaemia.
- Heart rhythm problems: Atrial fibrillation has been reported in patients receiving bisphosphonates, although a causal relationship has not been definitively established. Patients with known arrhythmias or cardiac disease should be assessed individually.
- Liver disease: No dose adjustment is required for mild to moderate hepatic impairment, but pamidronate has not been systematically studied in severe liver disease. Use cautiously and monitor closely.
- Low blood counts: Anaemia, thrombocytopenia (low platelets), leukopenia (low white blood cells), and lymphopenia have been reported. Blood counts should be monitored regularly during treatment.
- Thyroid or parathyroid surgery: Patients who have undergone thyroidectomy or parathyroidectomy may be more susceptible to symptomatic hypocalcaemia after infusion and should be monitored closely for tetany, numbness, and muscle cramps.
- Sodium-restricted diet: Each vial contains less than 1 mmol (23 mg) sodium and is therefore essentially “sodium-free”. Patients on strict sodium restriction should nonetheless be informed of the sodium content of the diluent used (e.g., 0.9% sodium chloride).
- Concurrent nephrotoxic drugs: Aminoglycoside antibiotics, NSAIDs, cisplatin, iodinated contrast agents, and other nephrotoxic medications should be used cautiously alongside pamidronate, with enhanced renal monitoring.
- Previous ear infection or hearing loss: Report any unusual ear pain, discharge, or hearing changes during treatment, as rare cases of external auditory canal osteonecrosis have been described.
Cases of osteonecrosis of the jaw have been reported in cancer patients treated with bisphosphonates including pamidronate, most commonly after dental extractions or other invasive dental procedures. Typical symptoms are persistent jaw pain, swelling, non-healing sores in the mouth, numbness, a feeling of heaviness in the jaw, or loose teeth. Risk factors include concurrent chemotherapy, radiotherapy, corticosteroid use, dental surgery, poor oral hygiene, pre-existing dental disease, tobacco use, and alcohol misuse. A dental examination with any necessary preventive dentistry is recommended before starting treatment. Invasive dental procedures should be avoided during treatment if at all possible. Report any oral symptoms immediately to your oncologist and dentist.
Pregnancy and Breastfeeding
Women who are pregnant, suspect they may be pregnant, or are planning a pregnancy must inform their doctor before receiving Pamidronatdinatrium Pfizer. Bisphosphonates are incorporated into the bone matrix and may be slowly released over weeks to years; the potential exposure to a developing fetus is therefore not limited to the period of active drug administration. Animal reproductive studies have shown adverse effects on ossification, foetal bone development, and viability. Pamidronate should be used during pregnancy only when the benefit clearly outweighs the potential risk to the foetus, and only after full discussion with the patient.
Breastfeeding is contraindicated during treatment. It is not known whether pamidronate is excreted in human breast milk, but given the potential for serious adverse reactions in nursing infants and the prolonged skeletal retention of the drug, breastfeeding must be discontinued before treatment begins and not resumed during the treatment period.
Women of childbearing potential are advised to use reliable contraception during and for a period after treatment, as determined by the treating oncologist.
Driving and Operating Machinery
Patients should not drive or operate machinery if they experience drowsiness, dizziness, visual disturbances, or severe fatigue after an infusion of Pamidronatdinatrium Pfizer. Flu-like symptoms with the first dose may also impair concentration. Each individual is responsible for assessing their own fitness to drive, and should discuss any concerns with their healthcare provider. For initial infusions, it is advisable to have someone available to drive the patient home.
How Does Pamidronatdinatrium Pfizer Interact with Other Drugs?
Drug interactions with pamidronate can be clinically significant and may affect both the efficacy and safety of treatment. Because Pamidronatdinatrium Pfizer is administered intravenously in a clinical setting, potential interactions are generally managed by the treating physician, but patients must provide a complete and up-to-date list of all their current medications and supplements.
Major Interactions
The following drug categories require particular caution when co-administered with Pamidronatdinatrium Pfizer:
| Drug / Class | Mechanism / Interaction | Clinical Management |
|---|---|---|
| Calcitonin | Additive calcium-lowering effect; risk of severe symptomatic hypocalcaemia | Monitor serum calcium closely; rarely combined outside severe hypercalcaemia |
| Other bisphosphonates (zoledronic acid, ibandronate, alendronate) | Additive effect on bone resorption inhibition and renal toxicity | Avoid concurrent use; separate therapies in time |
| Nephrotoxic drugs (aminoglycosides, NSAIDs, cisplatin, iodinated contrast agents) | Additive renal tubular injury; increased risk of acute kidney injury | Monitor creatinine frequently; avoid high-risk combinations where possible |
| Thalidomide | Increased risk of renal impairment, particularly in multiple myeloma patients | Enhanced renal monitoring; dose adjustments may be needed |
| Aminoglycoside antibiotics (gentamicin, tobramycin) | Additive hypocalcaemia (aminoglycosides lower serum calcium) and renal toxicity | Monitor calcium and creatinine closely; avoid combination where alternatives exist |
| Loop diuretics (furosemide) | Potentiate calcium excretion; may deepen hypocalcaemia | Monitor electrolytes; useful in hypercalcaemia treatment under supervision |
Minor Interactions and Incompatibilities
Pamidronatdinatrium Pfizer must not be mixed with calcium-containing intravenous solutions such as Ringer’s lactate, as pamidronate readily forms insoluble complexes with divalent cations (Ca2+, Mg2+). The drug is also incompatible with lipid-based parenteral nutrition formulations (e.g., soybean oil emulsions). It should only be diluted with calcium-free infusion fluids: 0.9% sodium chloride (saline) or 5% glucose (dextrose).
Because bisphosphonates can alter the appearance of bone scintigraphy (bone scans) by reducing tracer uptake in regions of increased turnover, patients scheduled for bone scanning should inform their radiologist and nuclear medicine physician that they are receiving bisphosphonate therapy. Similarly, certain laboratory markers of bone turnover (serum CTX, urinary NTX, alkaline phosphatase) will be suppressed during active treatment and should be interpreted in this context.
Over-the-counter calcium and vitamin D supplements are generally compatible and may even be recommended by the physician to prevent post-infusion hypocalcaemia. However, oral supplements should not be taken at the exact time of the IV infusion to avoid any local incompatibility in the gastrointestinal tract.
Always inform your treating physician, infusion nurse, and pharmacist about all medications you are currently taking, have recently taken, or plan to take. This includes prescription medicines, over-the-counter products, vitamins, dietary supplements, herbal remedies, and recreational substances. Many interactions can be safely managed with monitoring or timing adjustments.
What Is the Correct Dosage of Pamidronatdinatrium Pfizer?
Pamidronatdinatrium Pfizer is always administered under medical supervision as a slow intravenous infusion. The 3 mg/ml concentrate must be diluted with a calcium-free infusion solution (0.9% sodium chloride or 5% glucose) before use. The final concentration of pamidronate in the infusion solution should not exceed 90 mg per 250 ml. Only freshly prepared, clear, and particle-free solutions may be used.
Adults — General Principles
Before every infusion, serum calcium, phosphate, magnesium, electrolytes, creatinine, and a full blood count are assessed. Patients are adequately hydrated with 0.9% sodium chloride, particularly before treatment of hypercalcaemia. The infusion is administered via a dedicated peripheral or central venous line, and the rate is carefully controlled using an infusion pump. Vital signs and the infusion site are monitored throughout. After the infusion, patients are observed for hypocalcaemia symptoms and other acute reactions for at least 30–60 minutes.
Tumour-Induced Hypercalcaemia
Patients must be adequately rehydrated with 0.9% sodium chloride before and during administration. The total dose per treatment cycle depends on the initial (corrected) serum calcium level:
| Initial Serum Calcium | Recommended Total Dose | Infusion Concentration | Max Infusion Rate |
|---|---|---|---|
| <3.0 mmol/L (<12.0 mg/dl) | 15–30 mg | 30 mg / 125 ml | 22.5 mg/h |
| 3.0–3.5 mmol/L (12.0–14.0 mg/dl) | 30–60 mg | 30 mg / 125 ml or 60 mg / 250 ml | 22.5 mg/h |
| 3.5–4.0 mmol/L (14.0–16.0 mg/dl) | 60–90 mg | 60 mg / 250 ml or 90 mg / 500 ml | 22.5 mg/h |
| >4.0 mmol/L (>16.0 mg/dl) | 90 mg | 90 mg / 500 ml | 22.5 mg/h |
The total dose may be given in a single infusion or divided over 2–4 consecutive days. The maximum dose per cycle is 90 mg, which has been used in both initial and repeat treatment. A significant decrease in serum calcium is generally observed within 24–48 hours, with normalisation typically achieved within 3–7 days. If normocalcaemia is not reached, an additional dose may be considered. Treatment can be repeated whenever hypercalcaemia recurs, although clinical experience suggests that pamidronate may become less effective with repeated cycles, in which case zoledronic acid is often considered as an alternative.
Bone Metastases from Breast Cancer and Multiple Myeloma
| Indication | Dose / Schedule | Infusion Solution | Infusion Duration |
|---|---|---|---|
| Breast cancer skeletal metastases | 90 mg every 3–4 weeks | 90 mg / 250 ml (saline or 5% glucose) | 2 hours (max rate 45 mg/h) |
| Advanced multiple myeloma | 90 mg every 4 weeks | 90 mg / 500 ml (saline or 5% glucose) | 4 hours (max rate 22.5 mg/h) |
For breast cancer skeletal metastases, the 3-weekly schedule may be preferred to align with chemotherapy cycles, while the 4-weekly schedule is often chosen for endocrine therapy. For multiple myeloma, the slower 4-hour infusion is preferred because these patients typically have more compromised renal function. Treatment continues until there is clear evidence of substantial deterioration in the patient’s general condition or a decision to discontinue is made by the treating oncologist. During long-term therapy, patients undergo regular blood tests, monitoring of renal function, and periodic dental assessments.
Elderly Patients
No specific dose adjustment is required based on chronological age alone. However, elderly patients are more likely to have impaired renal function and comorbidities, and are therefore at higher risk of acute kidney injury, electrolyte disturbances, and cumulative toxicity. Baseline and ongoing assessment of creatinine clearance is essential. Attention should also be paid to hydration status, concurrent medications (especially NSAIDs and diuretics), and dental health.
Children and Adolescents
The safety and efficacy of Pamidronatdinatrium Pfizer have not been established in children and adolescents for the treatment of tumour-induced hypercalcaemia, bone metastases, or multiple myeloma. Use in paediatric populations should be restricted to specialist centres and, where appropriate, to clinical trial or named-patient pathways. Paediatric indications such as severe osteogenesis imperfecta are managed by specialists in paediatric metabolic bone disease using protocols outside the scope of this cancer-focused medication guide.
Renal Impairment
Pamidronatdinatrium Pfizer should not be administered to patients with severe renal impairment (creatinine clearance <30 ml/min), except in cases of life-threatening tumour-induced hypercalcaemia where the potential benefits clearly outweigh the risks. For patients with mild (CrCl 61–90 ml/min) to moderate (CrCl 30–60 ml/min) renal impairment, no dose adjustment is required, but the infusion rate should not exceed 90 mg over 4 hours (approximately 22 mg/hour).
If renal function deteriorates during treatment — defined as an increase in serum creatinine of 0.5 mg/dl (44 µmol/L) in patients with normal baseline values, or 1.0 mg/dl (88 µmol/L) in patients with abnormal baseline values — the next dose should be withheld until creatinine returns to within 10% of baseline.
Missed Dose
Because Pamidronatdinatrium Pfizer is administered exclusively in a clinical setting according to a schedule, missed doses are managed by the treating team. If a scheduled infusion cannot be given (for example, because of infection, hospitalisation, or a rise in creatinine), the dose is typically deferred until the underlying issue is resolved rather than doubled or combined with the next dose. Patients are encouraged to contact their oncology unit promptly if they need to reschedule an infusion.
Overdose
Because Pamidronatdinatrium Pfizer is administered in a hospital setting with strict rate controls, overdose is unlikely. However, if higher-than-intended doses are inadvertently given, symptoms may include paraesthesia (tingling or numbness), tetany (muscle cramps, particularly in the jaw, face, arms, or legs), positive Chvostek’s or Trousseau’s signs, hypotension (low blood pressure, causing dizziness), and cardiac arrhythmias from electrolyte disturbance. Treatment involves intravenous infusion of calcium gluconate to correct hypocalcaemia and supportive management of any renal or haemodynamic complications. Patients who have received higher-than-recommended doses are monitored closely by their physician in hospital.
What Are the Side Effects of Pamidronatdinatrium Pfizer?
Like all medicines, Pamidronatdinatrium Pfizer can cause side effects, although not everyone will experience them. Many listed side effects can also be caused by the underlying cancer or its concurrent treatments (chemotherapy, radiotherapy, corticosteroids), so careful clinical evaluation is needed. The most characteristic reaction to pamidronate is an acute “flu-like” syndrome with mild fever (1–2°C increase in body temperature) occurring within 24–48 hours of the first infusion. This reaction typically resolves within 24 hours and is considerably less likely with subsequent infusions.
Very Common
May affect more than 1 in 10 patients
- Low blood calcium (hypocalcaemia) and low blood phosphate (hypophosphataemia)
- Fever and flu-like symptoms, often with fatigue, chills, generalised malaise, and flushing
Common
May affect up to 1 in 10 patients
- Anaemia (low red blood cells), thrombocytopenia (low platelets), lymphopenia (low lymphocytes)
- Low blood potassium (hypokalaemia), low blood magnesium (hypomagnesaemia)
- Symptoms from low calcium: numbness or tingling around the mouth and in extremities, muscle cramps or spasms (tetany)
- Headache, insomnia, daytime drowsiness (somnolence)
- Conjunctivitis (red, irritated eyes)
- High blood pressure (hypertension)
- Nausea, vomiting, loss of appetite, abdominal pain, diarrhoea, constipation, gastritis
- Skin rash
- Bone, joint, or muscle pain (often transient, resolving within days)
- Injection-site reactions: pain, rash, swelling, induration, or phlebitis of the infused vein
- Transient elevations in serum creatinine
Uncommon
May affect up to 1 in 100 patients
- Hypersensitivity reactions: wheezing (bronchospasm), difficulty breathing (dyspnoea), swelling of eyelids, lips, or tongue (angioneurotic oedema)
- Seizures, agitation, dizziness, lethargy
- Uveitis (inflammation of the uvea in the eye)
- Low blood pressure (hypotension)
- Indigestion, generalised pruritus (itching), muscle cramps
- Osteonecrosis (typically of the jaw)
- Decreased urine output and acute renal impairment
- Abnormal liver and renal function tests
Rare
May affect up to 1 in 1,000 patients
- Atypical femoral fractures, particularly in patients on prolonged bisphosphonate therapy
- Focal segmental glomerulosclerosis (a kidney condition with proteinuria, oedema, and fatigue)
- Nephrotic syndrome (heavy protein loss in urine with swelling of legs, ankles, and abdomen)
- Atrial fibrillation (irregular heartbeat)
Very Rare
May affect up to 1 in 10,000 patients
- Reactivation of herpes simplex or herpes zoster (shingles)
- Leukopenia (low white blood cell count)
- Anaphylactic shock (life-threatening allergic reaction)
- Elevated blood potassium (hyperkalaemia), elevated blood sodium (hypernatraemia)
- Confusion, disorientation, visual hallucinations
- Episcleritis, scleritis (painful, red inflammation of the eye wall)
- Xanthopsia (yellow-tinted vision)
- Worsening of pre-existing heart failure with shortness of breath and oedema
- Acute respiratory distress syndrome (ARDS), interstitial lung disease
- Worsening of pre-existing kidney disease, haematuria (blood in urine), tubulo-interstitial nephritis
- Osteonecrosis of the external auditory canal of the ear
Sudden skin rash with itching; swelling of hands, feet, ankles, face, lips, mouth, or throat; difficulty swallowing or breathing (signs of a severe allergic reaction); chest tightness or wheezing; symptoms of osteonecrosis of the jaw such as persistent jaw pain, non-healing mouth sores, numbness or heaviness in the jaw, or loose teeth; thigh, hip, or groin pain that may signal an atypical femoral fracture; or severe generalised tetany, muscle spasms, or cardiac arrhythmia.
Irregular heartbeat (atrial fibrillation) has been observed in patients treated with pamidronate and other bisphosphonates. It is currently unclear whether pamidronate directly causes this; patients should nonetheless report any palpitations, sensation of irregular heartbeat, dizziness, or fainting to their doctor.
Thigh, hip, or groin pain may represent an early sign of an atypical femoral fracture (AFF), a rare but recognised complication of long-term bisphosphonate therapy. Pain can begin weeks or months before an overt fracture occurs. Report such pain to your oncologist, who may arrange targeted imaging of both femurs. If an atypical fracture is confirmed, the physician will consider discontinuing bisphosphonate therapy and assessing the contralateral femur.
Report any ear pain, discharge, or new-onset hearing impairment during treatment, as these may indicate bone damage in the external auditory canal (osteonecrosis of the ear canal).
How Should Pamidronatdinatrium Pfizer Be Stored?
Pamidronatdinatrium Pfizer should be stored out of the sight and reach of children. Do not use the medicine after the expiry date printed on the vial label and outer carton after “EXP”. The expiry date refers to the last day of the stated month.
The concentrated solution in its original unopened vial is stable at standard pharmacy storage conditions and does not require refrigeration. Store in the original carton to protect the vials from light. The product must not be frozen.
After dilution in 0.9% sodium chloride or 5% glucose solution, the chemical and physical stability of the diluted infusion has been demonstrated for up to 96 hours at 25°C. However, from a microbiological perspective, the diluted solution should be used immediately after preparation. If not used immediately, in-use storage times and conditions are the responsibility of the user and should normally not exceed 24 hours at 2–8°C, unless dilution was performed under controlled and validated aseptic conditions (for example, in a hospital pharmacy clean room).
Only freshly prepared, clear, colourless, and particle-free solutions should be used for infusion. Inspect each prepared bag visually before administration. Any remaining solution after use or any vial of concentrate that has been partly used should be discarded in accordance with local regulations on cytotoxic or pharmaceutical waste. Pamidronatdinatrium Pfizer concentrate is intended for single use only.
Do not dispose of medicines in household wastewater or household waste. Ask your pharmacist or hospital how to dispose of medicines you no longer use. These measures help to protect the environment.
What Does Pamidronatdinatrium Pfizer Contain?
Active Ingredient
The active substance is disodium pamidronate (disodium pamidronate pentahydrate in some formulations), which belongs to the bisphosphonate group of medicines (ATC code M05BA03). Each millilitre of concentrate contains 3 mg of disodium pamidronate, equivalent to 2.527 mg of pamidronic acid, the biologically active moiety.
Excipients
The other ingredients in Pamidronatdinatrium Pfizer are:
- Sodium hydroxide — for pH adjustment
- Hydrochloric acid — for pH adjustment
- Water for injections — as solvent
The product contains less than 1 mmol sodium (23 mg) per vial and is therefore considered essentially “sodium-free”. It does not contain lactose, gluten, ethanol, benzyl alcohol, or preservatives.
Available Pack Sizes
Pamidronatdinatrium Pfizer is supplied in clear colourless glass vials closed with rubber stoppers and aluminium flip-off caps, in the following presentations:
- 5 ml vial — contains 15 mg of disodium pamidronate (concentration 3 mg/ml)
- 10 ml vial — contains 30 mg of disodium pamidronate
- 20 ml vial — contains 60 mg of disodium pamidronate
- 30 ml vial — contains 90 mg of disodium pamidronate
Packs typically contain 1, 4, or 10 vials. Multi-packs containing multiple individual cartons may also be supplied. Not all pack sizes may be marketed in every country.
Appearance
The concentrate for solution for infusion is a clear, colourless, particle-free liquid. It should be visually inspected before use; any vial showing discolouration, turbidity, or particulate matter must be discarded.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder and manufacturer of Pamidronatdinatrium Pfizer is Pfizer. The product is authorised in multiple European markets and manufactured at Pfizer facilities licensed by the competent regulatory authorities. For country-specific information on the local marketing authorisation holder, contact details, batch numbers, or local trade names, refer to the package leaflet supplied with the product or the relevant national regulatory authority’s medicine information database.
Frequently Asked Questions About Pamidronatdinatrium Pfizer
Pamidronatdinatrium Pfizer (disodium pamidronate 3 mg/ml) is a bisphosphonate used for three main indications: treating dangerously high blood calcium caused by cancer (tumour-induced hypercalcaemia), reducing bone destruction in breast cancer patients whose disease has spread to the skeleton, and managing osteolytic bone lesions in advanced (stage III) multiple myeloma. It works by inhibiting osteoclasts — the cells that break down bone — thereby reducing calcium release into the bloodstream and protecting skeletal integrity.
Pamidronatdinatrium Pfizer is given exclusively as a slow intravenous infusion (drip) in a hospital or specialist clinic setting. The 3 mg/ml concentrate is first diluted with a calcium-free infusion fluid (0.9% sodium chloride or 5% glucose). The infusion usually lasts 2–4 hours depending on dose and indication. The maximum rate is 60 mg per hour (1 mg/min). It is never given as a rapid injection, taken by mouth, or injected into muscle. Treatment ranges from a single infusion for acute hypercalcaemia to regular infusions every 3–4 weeks for bone metastases or myeloma.
The principal risks are osteonecrosis of the jaw (particularly following dental surgery), renal impairment (which is why kidney function is checked before every dose), low blood calcium (which may cause numbness or muscle cramps), and severe allergic reactions. Atypical femoral fractures have been reported rarely with long-term bisphosphonate use. Most patients tolerate the treatment well, with the most common experience being a transient flu-like reaction after the first infusion that resolves within 24 hours.
Yes. Pamidronate is eliminated through the kidneys and can itself impair renal function, especially when infused quickly or combined with other nephrotoxic drugs such as NSAIDs, aminoglycoside antibiotics, or cisplatin. Serum creatinine is therefore measured before every infusion. Risk is reduced by adhering to the recommended infusion rate (never exceeding 60 mg/hour) and ensuring adequate hydration with intravenous saline. Treatment is paused if creatinine rises significantly, and the medicine should not be given to patients with severe kidney impairment (creatinine clearance below 30 ml/min) except in life-threatening hypercalcaemia.
Yes. A dental examination with any necessary preventive dental treatment is strongly recommended before starting Pamidronatdinatrium Pfizer, due to the risk of osteonecrosis of the jaw (ONJ). During treatment, maintain excellent oral hygiene, attend regular dental check-ups, and avoid invasive dental procedures such as tooth extractions or dental implants where possible. If dental surgery is unavoidable, inform both your oncologist and dentist in advance so that timing and preventive measures can be optimised. Report any jaw pain, non-healing mouth sores, loose teeth, or numbness in the jaw to your doctor immediately.
The duration of therapy depends on the indication. For tumour-induced hypercalcaemia, treatment may involve a single infusion or a short series over a few days, repeated as needed when calcium levels rise again. For bone metastases from breast cancer and for multiple myeloma, infusions are typically given every 3–4 weeks and continued as long as the patient is benefiting and their general condition remains adequate. Your oncologist will determine the optimal treatment duration based on your individual response, bone-turnover markers, imaging, and overall health. After prolonged therapy, physicians may consider a “drug holiday” to balance benefits against the risks of atypical fracture and ONJ.
Yes — Pamidronatdinatrium Pfizer, Pamifos, and other branded or generic pamidronate products all contain the same active ingredient, disodium pamidronate 3 mg/ml concentrate for solution for infusion. They are considered therapeutically equivalent when used at equivalent doses. Differences between brands may lie in the manufacturer, pack size, auxiliary excipients, regulatory status in a given country, and occasionally price. Always use the product prescribed for you by your oncology team and follow their infusion protocol.
References
- European Medicines Agency (EMA). Pamidronate disodium — Summary of Product Characteristics. Available at: www.ema.europa.eu.
- U.S. Food and Drug Administration (FDA). Aredia (pamidronate disodium for injection) prescribing information. FDA Drug Database. Available at: www.fda.gov.
- British National Formulary (BNF). Pamidronate disodium. National Institute for Health and Care Excellence (NICE); 2025.
- Berenson JR, Lichtenstein A, Porter L, et al. Efficacy of pamidronate in reducing skeletal events in patients with advanced multiple myeloma. New England Journal of Medicine. 1996;334(8):488–493. doi:10.1056/NEJM199602223340802.
- Hortobagyi GN, Theriault RL, Porter L, et al. Efficacy of pamidronate in reducing skeletal complications in patients with breast cancer and lytic bone metastases. New England Journal of Medicine. 1996;335(24):1785–1791. doi:10.1056/NEJM199612123352401.
- Major P, Lortholary A, Hon J, et al. Zoledronic acid is superior to pamidronate in the treatment of hypercalcemia of malignancy: a pooled analysis of two randomized, controlled clinical trials. Journal of Clinical Oncology. 2001;19(2):558–567.
- Ruggiero SL, Dodson TB, Aghaloo T, et al. American Association of Oral and Maxillofacial Surgeons position paper on medication-related osteonecrosis of the jaw — 2022 update. Journal of Oral and Maxillofacial Surgery. 2022;80(5):920–943.
- Khan AA, Morrison A, Hanley DA, et al. Diagnosis and management of osteonecrosis of the jaw: a systematic review and international consensus. Journal of Bone and Mineral Research. 2015;30(1):3–23.
- Shane E, Burr D, Abrahamsen B, et al. Atypical subtrochanteric and diaphyseal femoral fractures: second report of a task force of the American Society for Bone and Mineral Research. Journal of Bone and Mineral Research. 2014;29(1):1–23.
- World Health Organization (WHO). WHO Model List of Essential Medicines — 23rd List. Geneva: WHO; 2023.
- Coleman R, Hadji P, Body JJ, et al. Bone health in cancer: ESMO Clinical Practice Guidelines. Annals of Oncology. 2020;31(12):1650–1663.
- Van Poznak C, Somerfield MR, Barlow WE, et al. Role of bone-modifying agents in metastatic breast cancer: an American Society of Clinical Oncology–Cancer Care Ontario focused guideline update. Journal of Clinical Oncology. 2017;35(35):3978–3986.
Medical Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, comprising licensed physicians specialising in oncology, clinical pharmacology, and internal medicine. All content is based on current evidence-based guidelines from the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), the British National Formulary (BNF), the World Health Organization (WHO), the European Society for Medical Oncology (ESMO), and peer-reviewed medical literature.
iMedic Medical Editorial Team — Specialists in Oncology and Clinical Pharmacology
iMedic Medical Review Board — Independent expert panel following the GRADE evidence framework
Evidence standard: Level 1A — Based on systematic reviews and meta-analyses of randomised controlled trials, international regulatory Summaries of Product Characteristics, and consensus guidelines. All medical claims adhere to the GRADE evidence framework.
Conflict of interest: The iMedic Medical Editorial Team has no financial ties to pharmaceutical companies. This content is entirely independent and receives no commercial funding or advertising.