Pamidronic Acid

Registered South African indications:

• Conditions associated with increased osteoclast activity 

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to other bisphosphonates
• Pregnancy 
• Breastfeeding 

Cautions

• Renal impairment 
• Severe hepatic impairment 
• Thyroid surgery 
• Long-term treatment 
• Bolus injection 
• Dehydration 
• Overhydration 
• Cardiac disease
• Infection 
• Fever 
• Unhealed, open soft tissue lesions in the mouth 
• Invasive dental procedures 
• Poor oral hygiene 
• Periodontal disease 
• Poorly fitting dentures
• Local infection or trauma of the external auditory canal 
• Advanced tumour
• Highly potent bisphosphonates 
• Cumulative doses
• Coagulopathies 
• Smoking 
• Haemodialysis 
• Anaemia 
• Leukopaenia 
• Thrombocytopaenia 
• Risk for hypocalcaemia 
• Risk for vitamin D deficiency 

Forms avail. in SA and covered in this monograph: inj 

Tumour induced hypercalcaemia

• IV: The total dose to be used for a treatment course depends on the patient's initial serum calcium levels. See table

Initial serum calcium		Recommended total
(mmol/l	(mg %)	dose (mg)
Up to 3.0	Up to 12	15-30
3.0-3.5	12.0-14.0	30-60
3.5-4.0	14.0-16.0	60-90
> 4.0	> 16.0	90

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Doses within the ranges given are also applicable for corrected calcium values

The total dose may be administered either in a single infusion or in multiple infusions over 2-4 consecutive days

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Patients to be rehydrated with 0.9% sodium chloride before or during treatment

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A significant decrease in serum calcium is generally observed 24-48 hours after administration

If normacalcaemia is not achieved within 3-7 days, a repeat infusion may be given according to the initial guidelines

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See additional prescribing points 

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Lytic bone metastasis
Bone pain in patients with breast cancer or multiple myeloma

• IV: 90mg, as a single infusion, 4 weekly

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Can be administered at 3 weekly intervals to coincide with chemotherapy

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See additional prescribing points 

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Paget’s disease

• IV: 30mg, weekly; Treatment duration: 6 weeks; Max: 180mg
  OR
• IV: Initial: 30mg; Then: 60mg, every other week; Max: 210mg

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See additional prescribing points 

Not established for use in children

Pregnancy

• Caution; not recommended
• The drug should not be given to pregnant women at any stage unless life-threatening hypercalcaemia cannot be controlled by any other means
• In animal experiments, pamidronate showed no teratogenic potential and did not affect general reproductive performance or fertility. Pamidronate may pose a risk to the foetus/newborn child through its pharmacological action on calcium homeostasis
• When administered during the entire period of gestation in animals, pamidronate can cause bone mineralisation defects, especially in long bones, resulting in angular distortion
• The potential risk for humans is unknown, and there is an insufficient clinical experience to support the use of pamidronate in pregnant women. It is not known if pamidronate crosses the human placenta

Breastfeeding

• Contraindicated  

Renal Impairment 

• Mild to moderate: Caution; no dose adjustment recommended 
• Severe: Caution; dose adjustment recommended 

Hepatic Impairment

• Severe: Caution; no information available

Elderly 

• No dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Central Nervous System Disorders

• Paraesthesia
• Headache
• Insomnia
• Somnolence
• Seizures
• Agitation
• Fatigue 
• Dizziness
• Lethargy
• Confusion
• Visual hallucinations

Cardiovascular Disorders

• Left ventricular failure 
• Congestive cardiac failure
• Atrial fibrillation
• Hypertension
• Hypotension
• Flushing 

Respiratory Disorders

• Acute respiratory distress syndrome
• Interstitial lung disease
• Pulmonary oedema
• Bronchospasm 
• Dyspnoea 

Gastrointestinal disorders

• Nausea and vomiting
• Anorexia
• Abdominal pain
• Diarrhoea
• Constipation
• Gastritis
• Dyspepsia

Hepatobiliary Disorders

• Abnormal hepatic function tests  

Genitourinary Disorders

• Acute renal failure
• Focal segmental glomerulosclerosis
• Nephrotic syndrome
• Deterioration of pre-existing renal disease
• Haematuria
• Renal tubular disorder
• Tubulointerstitial nephritis
• Glomeruloephropathy

Endocrine and Metabolic Disorders

• Hypocalcaemia
• Hypophosphataemia
• Hypokalaemia
• Hypomagnesaemia
• Hyperkalaemia
• Hypernatraemia

Musculoskeletal Disorders

• Transient bone pain
• Arthralgia
• Myalgia
• Generalised pain
• Tetany 
• Muscle cramps
• Osteonecrosis of the external auditory canal
• Osteonecrosis of the jaw

Skin and Subcutaneous Tissue Disorders

• Rash
• Pruritus
• Infusion site reactions 

Immune, Blood and Lymphatic System disorders

• Allergic reactions 
• Anaphylactoid reactions
• Angioneurotic oedema
• Reactivation of Herpes simplex
• Reactivation of Herpes zoster
• Anaphylactic shock
• Anaemia
• Thrombocytopenia
• Lymphocytopenia
• Leukopenia
• Fever
• Influenza-like symptoms
• Rigors 

Sensory Disorders

• Conjunctivitis
• Iritis
• Iridocyclitis
• Uveitis 
• Scleritis
• Episcleritis
• Xanthopsia
• Orbital inflammation

• Antiangiogenic agents 
• Calcitonin 
• Nephrotoxic agents 
• Thalidomide 
• Aminoglycosides 
• Radiotherapy 
• Chemotherapy
• Corticosteroids 
• Bone scintigraphy

• Electrolytes 
• Renal function 
• Full blood count

Specific cases may require

• Dental examination
• Urine albumin

Administration directions

• Dilute in 250ml normal saline prior to infusion 
• The infusion rate should never exceed 60mg/hour (1mg/min)
• Single doses should not exceed 90mg
• The concentration of pamidronic acid in the infusion solution should not exceed 90mg/250mL

Pamidronic acid is a nitrogen-containing bisphosphonate. It inhibits bone resorption and decreases mineralization by disrupting osteoclast activity.

Injection (per vial) 15mg

• Aredia (Novartis) originator