RECLAST (zoledronic acid in mannitol and water for injection)

There are 9 contraindications. Absolute contraindication.

Contraindication List
Acute renal failure
Anuria
Capillary fragility
Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
Chronic kidney disease stage 5 (failure) GFr<15 ml/min
Lactation
Pulmonary congestion
Severe chronic heart failure
Severe dehydration

There are 12 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Aseptic necrosis of jaw bone
Atypical femoral fracture
Dehydration
Hypernatremia
Hypocalcemia
Hypomagnesemia
Hypophosphatemia
Intracranial bleeding
Invasive dental procedure
Kidney disease with reduction in glomerular filtration rate (GFr)
Periodontitis
Pregnancy

There are 6 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Arthralgia
Hyperkalemia
Hyponatremia
Hypovolemia
Kidney disease with likely reduction in glomerular filtration rate (GFr)
Myalgia

There are 39 severe adverse reactions.

More Frequent	Less Frequent
Bone pain Dyspnea General weakness Hypertension Hypokalemia Hypomagnesemia Hypophosphatemia	Anemia Atrial fibrillation Granulocytopenic disorder Hypotension Infection Thrombocytopenic disorder

Rare/Very Rare

Acute renal failure Anaphylaxis Angioedema Aseptic necrosis of bone in orofacial region Aseptic necrosis of jaw bone Asthma exacerbation Atypical femoral fracture Avascular necrosis of bone Blurred vision Bradycardia Bronchospastic pulmonary disease Fanconi syndrome Hypernatremia Hypersensitivity drug reaction Hypocalcemia Injection site sequelae Interstitial lung disease Iritis Kidney disease with reduction in glomerular filtration rate (GFr) Pancytopenia Scleritis Seizure disorder Stevens-johnson syndrome Toxic epidermal necrolysis Urticaria Uveitis

There are 46 less severe adverse reactions.

More Frequent	Less Frequent
Acute abdominal pain Allergic dermatitis Arthralgia Back pain Chills Constipation Cough Diarrhea Dizziness Fatigue Fever Flu-like symptoms Headache disorder Insomnia Myalgia Nausea Ocular inflammation Peripheral edema Urinary tract infection Vomiting	Acute cognitive impairment Agitation Anorexia Cramps Dysgeusia Dyspepsia Dysphagia Hyperhidrosis Paresthesia Stomatitis Upper abdominal pain

Rare/Very Rare
Arthritis Chest pain Conjunctivitis Cramps in legs Dehydration Hematuria Hyperesthesia Hypoesthesia Malaise Proteinuria Pruritus of skin Skin rash Symptoms of anxiety Tremor Xerostomia

Category D. (See Users Guide and see Fetal/Neonatal Morbidity and Mortality under Cautions: Warnings/Precautions.)

It is not known whether zoledronic acid is distributed into milk; because of the potential for serious adverse effects in nursing infants from zoledronic acid, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman. It is also important to consider that zoledronic acid is retained by bone for prolonged periods and may be released over weeks to years, possibly affecting nursing infants.

No overall differences in safety and efficacy of zoledronic acid relative to younger adults; however, the incidence of acute-phase inflammatory reactions was less in geriatric patients with osteoporosis or Paget disease of bone than in younger adults. Because of the greater frequency of impaired renal function in geriatric patients, the manufacturer states that renal function should be monitored with particular care in this age group.