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ZOLEDRONIC ACID INJECTION - FOR INTRAVENOUS INFUSION (zoledronic acid for injection - FOR INTRAVENOUS INFUSION) Adverse Reactions

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Paget's Disease of Bone

In the Paget's disease trials, two 6-month, double-blind, comparative, multinational studies of 349 men and women aged greater than 30 years with moderate to severe disease and with confirmed Paget's disease of bone, 177 patients were exposed to zoledronic acid and 172 patients exposed to risedronate. Zoledronic acid was administered once as a single 5 mg dose in 100 mL solution infused over at least 15 minutes. Risedronate was given as an oral daily dose of 30 mg for 2 months.

The incidence of serious adverse events was 5.1% in the zoledronic acid group and 6.4% in the risedronate group. The percentage of patients who withdrew from the study due to adverse events was 1.7% and 1.2% for the zoledronic acid and risedronate groups, respectively.

Adverse reactions occurring in at least 2% of the Paget's patients receiving zoledronic acid (single 5 mg intravenous infusion) or risedronate (30 mg oral daily dose for 2 months) over a 6-month study period are listed by system organ class in Table 1.

Table 1: Adverse Reactions Reported in at Least 2% of Paget's Patients Receiving Zoledronic Acid (Single 5 mg Intravenous Infusion) or Risedronate (Oral 30 mg Daily for 2 Months) Over a 6-Month Follow-up Period

System Organ Class

5 mg IV Zoledronic Acid

%

(N = 177)

30 mg/day × 2 Months

Risedronate

%

(N = 172)

Infections and Infestations

                 Influenza

 

7

 

5

Metabolism and Nutrition Disorders

                 Hypocalcemia

                 Anorexia

 

3

2

 

1

2

Nervous System Disorders

                 Headache

                 Dizziness

                 Lethargy

                 Paresthesia

 

11

9

5

2

 

10

4

1

0

Respiratory, Thoracic and Mediastinal Disorders

                 Dyspnea

 

5

 

1

Gastrointestinal Disorders

                 Nausea

                 Diarrhea

                 Constipation

                 Dyspepsia

                 Abdominal Distension

                 Abdominal Pain

                 Vomiting

                 Abdominal Pain Upper

 
9

6

6

5

2

2

2

1

 
6

6

5

4

1

2

2

2

Skin and Subcutaneous Tissue Disorders

                 Rash

 

3

 

2

Musculoskeletal, Connective Tissue and Bone Disorders

 

 

                 Arthralgia

                 Bone Pain

                 Myalgia

                 Back Pain

                 Musculoskeletal Stiffness

9

9

7

4

2

11

5

4

7

1

General Disorders and Administrative Site Conditions

 

 

                 Influenza-like Illness

                 Pyrexia

                 Fatigue

                 Rigors

                 Pain

                 Peripheral Edema

                 Asthenia

11

9

8

8

5

3

2

6

2

4

1

4

1

1

Laboratory Findings

In the Paget's disease trials, early, transient decreases in serum calcium and phosphate levels were observed. Approximately 21% of patients had serum calcium levels less than 8.4 mg/dL 9 to 11 days following zoledronic acid administration.

Renal Impairment

In clinical trials in Paget's disease there were no cases of renal deterioration following a single 5 mg 15-minute infusion [see Warnings and Precautions (5.3)].

Acute Phase Reaction

The signs and symptoms of acute phase reaction (influenza-like illness, pyrexia, myalgia, arthralgia, and bone pain) were reported in 25% of patients in the zoledronic acid-treated group compared to 8% in the risedronate-treated group. Symptoms usually occur within the first 3 days following zoledronic acid administration. The majority of these symptoms resolved within 4 days of onset.

Osteonecrosis of the Jaw

Osteonecrosis of the jaw has been reported with zoledronic acid [see Warnings and Precautions (5.4)].

6.2 Post-Marketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following adverse reactions have been identified during post approval use of zoledronic acid:

Acute Phase Reactions

Fever, headache, flu-like symptoms, nausea, vomiting, diarrhea, arthralgia, and myalgia. Symptoms may be significant and lead to dehydration.

Acute Renal Failure

Acute renal failure requiring hospitalization and/or dialysis or with a fatal outcome have been rarely reported. Increased serum creatinine was reported in patients with 1) underlying renal disease, 2) dehydration secondary to fever, sepsis, gastrointestinal losses, or diuretic therapy, or 3) other risk factors such as advanced age, or concomitant nephrotoxic drugs in the post-infusion period. Transient rise in serum creatinine can be correctable with intravenous fluids.

Allergic Reactions

Allergic reactions with intravenous zoledronic acid including anaphylactic reaction/shock, urticaria, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis, and bronchoconstriction have been reported.

Asthma Exacerbations

Asthma exacerbations have been reported.

Hypocalcemia

Hypocalcemia has been reported.

Hypophosphatemia

Hypophosphatemia has been reported.

Osteonecrosis of the Jaw

Osteonecrosis of the jaw has been reported.

Osteonecrosis of other bones

Cases of osteonecrosis of other bones (including femur, hip, knee, ankle, wrist and humerus) have been reported; causality has not been determined in the population treated with zoledronic acid injection.

Ocular Adverse Events

Cases of the following events have been reported: conjunctivitis, iritis, iridocyclitis, uveitis, episcleritis, scleritis and orbital inflammation/edema.

Other

Hypotension in patients with underlying risk factors has been reported.

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