Loading…
PAMIDRONATE DISODIUM is a brand name for Pamidronate (also known as Pamidronic Acid). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: The treatment of tumour-induced hypercalcaemia The prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, hypercalcaemia and bone pain) in patients with breast cancer with bone metastases, or multiple myeloma with bone lesions, in addition to specific treatment…
Verbatim from this product's MHRA label. Tap a section to expand.
Patients treated with pamidronate disodium should be given the package leaflet and the patient reminder card. Posology Until further experience is gained, pamidronate disodium is only recommended for use in adult patients. Paediatric population There is no clinical experience in the paediatric and adolescent (<18 years old) population.
9% w/v sodium chloride solution before and during treatment. The total dose of pamidronate disodium to be used for a treatment course depends on the patient’s initial serum calcium levels. The following guidelines are derived from clinical data on uncorrected calcium values.
However, doses within the ranges given are also applicable for calcium values corrected for serum protein or albumin in rehydrated patients. 0 90 The total dose of pamidronate disodium may be administered either in a single infusion or in multiple infusions over 2-4 consecutive days.
The maximum dose per treatment course is 90 mg for both initial and repeat courses. A significant decrease in serum calcium is generally observed 24-48 hours after administration of pamidronate disodium, and normalisation is usually achieved within 3 to 7 days.
If normocalcaemia is not achieved within this time, a further dose may be given. The duration of the response may vary from patient to patient, and treatment can be repeated whenever hypercalcaemia recurs. Clinical experience to date suggests that pamidronate disodium may become less effective as the number of treatments increases.
Osteolytic lesions and bone pain in multiple myeloma:
The recommended dose is 90 mg administered as a single infusion every 4 weeks.
Osteolytic lesions and bone pain in bone metastases associated with breast cancer:
The recommended dose is 90 mg administered as a single infusion every 4 weeks. This dose may also be administered at 3 weekly intervals to coincide with chemotherapy if desired.
Paget’s disease of bone:
The recommended total dose of pamidronate disodium for a treatment course is 180 to 210 mg. This can be administered either in 6 unit doses of 30 mg once a week (total dose 180 mg) or in 3 doses of 60 mg every other week. Experience to date suggests that any mild and transient unwanted effects (see “Undesirable Effects”) tend to occur after the first dose.
Adverse reactions to pamidronate disodium are usually mild and transient. The most common adverse reactions are asymptomatic hypocalcaemia, with influenza- like symptoms and mild fever (an increase in body temperature of >1°C which may last up to 48 hours).
Fever usually resolves spontaneously and does not require treatment. Acute “influenza-like” reactions usually occur only with the first pamidronate infusion. Symptomatic hypocalcaemia is uncommon. Local soft tissue inflammation at the infusion site also occurs, especially at the highest dose.
5%). 6%). The mechanism behind the increased incidence of atrial fibrillation in association with zoledronate and pamidronate treatment is unknown.
Frequency estimate:
Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000 <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000 including isolated reports); not known (cannot be estimated from the available data). The following adverse drug reactions were reported from clinical studies and from post-marketing experience with pamidronate.
Adverse Reactions Table Infections and Infestations:
Common Conjunctivitis Very rare Herpes simplex, herpes zoster Blood and Lymphatic System Disorders: Common Anaemia, thrombocytopenia, lymphocytopenia Very rare Leukopenia Immune System Disorders: Uncommon Hypersensitivity, anaphylactic reaction, angioedema Very rare Anaphylactic shock Metabolism and Nutrition Disorders: Very common Hypocalcaemia, hypophosphataemia Common Hypokalaemia, hypomagnesaemia, anorexia, tetany Very rare Hyperkalaemia, hypernatraemia Psychiatric disorders Common Insomnia Uncommon Agitation Very rare Confusional state, hallucinations visual Nervous System Disorders: Common Paraesthesia, headache, somnolence Uncommon Seizures, dizziness, lethargy Eye Disorders: Uncommon Uveitisa Very rare Scleritis, episcleritis, xanthopsia Not known Parophthalmia inflammation Ear and labyrinth disorders Very rare Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) Cardiac Disorders: Very rare Left ventricular failureb, congestive heart failurec Not known Atrial fibrillation Vascular Disorders: Common Hypertension Uncommon Hypotension Respiratory, Thoracic and Mediastinal Disorders: Uncommon Bronchospasm, dyspnoea Very rare Acute respiratory distress syndrome, interstitial lung disease Gastrointestinal Disorders: Common Nausea, vomiting, abdominal pain, diarrhoea, constipation, gastritis Uncommon Dyspepsia Skin and Subcutaneous Tissue Disorders: Common Rash Uncommon Pruritus Musculoskeletal, Connective Tissue and Bone Disorders: Common Transient bone pain, arthralgia, myalgia Uncommon Muscle cramps, osteonecrosis Not known Osteonecrosis of the jaw Renal and Urinary Disorders: Uncommon Acute renal failure Rare Deterioration of renal functiond, focal segmental glomerulosclerosisd, nephrotic syndromed Very rare Haematuria, deterioration of pre-existing renal disease, renal tubular disorder, tubulointerstitial nephritis, glomerulonephropathy General Disorders and Administration Site Conditions: Very common Fever, influenza-like symptomse Common Pain, infusion site reactionf Investigations: Common Blood creatinine increased Uncommon Abnormal liver function tests, blood urea increased Injury, Poisoning and Procedural Complications Very rare Atypical femur fractureg a Includes uveitis iritis and iridocyclitis b Manifestations include dyspnoea and pulmonary oedema c Includes oedema due to fluid overload d Reports of these events are generally associated with high dosage (exceeding the recommended dosage or reduced dosing intervals) and/or long-term use.
General Pamidronate should never be given as a bolus injection since severe local reactions and thrombophlebitis may occur. 2). Do not co-administer pamidronate with other bisphosphonates. If other calcium lowering agents are used in conjunction with pamidronate, significant hypocalcaemia may result.
2). Pamidronate is not recommended during pregnancy. Patients must be assessed prior to administration of pamidronate to assure that they are appropriately hydrated to maintain urine output. This is especially important for patients receiving diuretic therapy.
Standard hypercalcaemia-related metabolic parameters including serum calcium and phosphate should be monitored following initiation of therapy with pamidronate. Patients who have undergone thyroid surgery may be particularly susceptible to develop hypocalcaemia due to relative hypoparathyroidism.
The safety and efficacy of pamidronate in the treatment of hyperparathyroidism has not been established. In patients with cardiac disease, especially in the elderly, additional saline overload may precipitate cardiac failure (left ventricular failure or congestive heart failure).
Fever (influenza-like symptoms) may also contribute to this deterioration. Patients with anaemia, leukopenia or thrombocytopenia should have regular haematology assessments. The safety and efficacy of pamidronate in children has not been established.
Until further experience is gained, pamidronate is only recommended for use in adult patients. Patients with tumor-induced hypercalcaemia Convulsions have been precipitated in some patients with tumour-induced hypercalcaemia due to the electrolyte changes associated with this condition and its effective treatment.
It is essential in the initial treatment of tumour induced hypercalcaemia that intravenous rehydration be instituted to maintain urine output. Patients should be hydrated adequately throughout treatment but overhydration must be avoided.
1, or to other bisphosphonates.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Pamidronate in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
e. total dose 210 mg). 9 % w/v Sodium Chloride Intravenous Infusion BP respectively, and the infusion rate should not exceed 60 mg/hour (1 mg/min). This regimen, or increased dose levels according to disease severity up to a maximum total dose of 360mg (in divided doses of 60mg), can be repeated every 6 months until remission of disease is achieved, and if relapse occurs.
2). In such patients, the infusion rate should not exceed 90 mg/4 h (approximately 22 mg/h). Pamidronate disodium should not be administered to patients with severe renal impairment (creatinine clearance < 30 ml/min) unless in case of life-threatening tumour-induced hypercalcaemia where the benefit outweighs the potential risk.
4). v. bisphosphonates, renal monitoring is recommended, for instance, measurement of serum creatinine prior to each dose of pamidronate disodium. In patients receiving pamidronate disodium for bone metastases or multiple myeloma who show evidence of deterioration in renal function, pamidronate disodium treatment should be withheld until renal function returns to within 10% of the baseline value.
5 mg/dL. 0 mg/dL.
Hepatic impairment:
Although patients with hepatic impairment exhibited higher mean AUC and Cmax values compared to patients with normal hepatic function, this is not perceived as being clinically relevant. As pamidronate is still rapidly cleared from the plasma almost entirely into the bone and as it is administered on a monthly basis for chronic treatment, drug accumulation is not expected.
Therefore no dose adjustment is necessary in patients with mild to moderate abnormal hepatic function. 4). Method of administration For intravenous use as infusion only. 4). The solution must be diluted before use (see below) and must be infused slowly.
2. The infusion rate should never exceed 60 mg/hour (1 mg/min), and the concentration of pamidronate disodium in the infusion solution should not exceed 90 mg/250 ml. g. those with tumour- induced hypercalcaemia or multiple myeloma) it is recommended that the infusion rate does not exceed 22 mg/hour (see also “Renal Impairment”).
In order to minimise local reactions at the infusion site, the cannula should be inserted carefully […]
4). Many of these patients were also receiving chemotherapy and corticosteroids and had signs of local infection including osteomyelitis. The majority of the reports refer to cancer patients following tooth extractions or other dental surgeries.
Many of these undesirable effects may have been related to the underlying disease. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Renal impairment Bisphosphonates, including pamidronate disodium have been associated with renal toxicity manifested as deterioration of renal function and potential renal failure. Renal deterioration, progression to renal failure and dialysis have been reported in patients after the initial dose or a single dose of pamidronate disodium.
Deterioration of renal function (including renal failure) has been reported following long-term treatment with pamidronate in patients with multiple myeloma; however, underlying disease progression and/or concomitant complications were also present and therefore a causal relationship with pamidronate is unproven.
If there is deterioration of renal function during pamidronate therapy, the infusion must be stopped. 2). 2), thus the risk of renal adverse reactions may be greater in patients with impaired renal function. g. patients with multiple myeloma and/or tumour-induced hypercalcaemia).
Fluid balance (urine output, daily weights) should also be followed carefully. Experience with pamidronate in patients with severe renal impairment (serum creatinine: >440 micromol/litre, or 5 mg/dl in TIH patients; 180 micromol/litre, or 2 mg/dl in multiple myeloma patients) is limited.
If clinical judgement determines that the potential benefits outweigh the risk in such cases, pamidronate should be used cautiously and renal function carefully monitored. There is very little experience of the use of pamidronate disodium in patients receiving haemodialysis.
2). Pamidronate should not be given with other bisphosphonates because their combined effects have not been investigated. 2). g. through malabsorption or lack of exposure to sunlight), and patients with Paget's disease of the bone, should be given oral calcium and vitamin D supplementation, in order to minimise the potential risk of hypocalcaemia.
Osteonecrosis of the jaw Osteonecrosis of the jaw (ONJ) has been reported in clinical trials and in the post- marketing setting in patients receiving pamidronate. The start of treatment or of a new course of treatment should be delayed in patients with unhealed open soft tissue lesions in the mouth except in medical emergency situations.
A dental examination with appropriate preventive dentistry and an individual benefit- risk assessment is recommended prior to treatment with bisphosphonates in patients with concomitant risk factors. The following risk factors should be considered when evaluating an individual’s risk of developing ONJ: • Potency of the bisphosphonate (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative […]