ZOMETA? - Novartis Pharmaceuticals Corporation

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Outpatient Infusion With ZOMETA? (zoledronic acid) Injection
The instructions below are also available in a convenient wallchart for your office. To order a complimentary copy of the wallchart, use our Order Form. In addition, we have an Infusion Log available in pdf format for recording patient information. This document requires Adobe Reader? to open and print. If you do not already have this program on your computer, you can download it free.
Step 1 - Evaluate Patient
BEFORE INFUSION
Check for clinical signs of dehydration: skin turgor, thirst, dry mouth, low urine output
Serum creatinine should be measured before each ZOMETA? dose and treatment should be withheld for renal deterioration. In the clinical studies, renal deterioration was defined as follows:
For patients with normal baseline creatinine an increase of 0.5 mg/dL; for patients with abnormal baseline creatinine, an increase of 1.0 mg/dL
In the clinical studies, ZOMETA? treatment was resumed only when the creatinine returned to within 10% of the baseline value
Check and record baseline vital signs.
COMPLETE PREPARATION
Assemble all supplies.
Explain to your patient what you are about to do.
START IV
Patient should be positioned in a sitting or reclined position, with the elbow supported.
Insert IV catheter.
Step 2 - Reconstitute ZOMETA?
Add 5 mL of Sterile Water for Injection, USP, to ZOMETA? vial.
Direct diluent to side of vial.
Gently swirl vial 360? to dilute lyophilized cake.
Inspect the vial to ensure drug is completely dissolved before the solution is withdrawn.
Further dilute in 100 mL sterile 0.9% sodium chloride or 5% dextrose injection.
Prime the tubing.
Fill in IV label and place on bag.
Step 3 - Administer ZOMETA?
DURING INFUSION
ZOMETA? 4 mg/5 mL diluted in 100 mL of solution should be administered as an IV infusion over no less than 15 minutes.*
Observe IV drip rate:
TheZOMETA? drip rate is 133 drops/minute or 33 drops/15 seconds - calculation based on a tubing drip factor of 20 drops/mL.
Count the drops for at least 15 seconds to ensure accurate drip rate.
Monitor your patient:
Check IV site for redness, tenderness, swelling, leakage or temperature elevations.
Encourage patient feedback.
AFTER INFUSION
Discontinue patient IV and properly dispose of materials.
Check IV site and patient's vital signs.
Discuss with patient the potential side effects: flu-like symptoms, muscle pain and tenderness at the site.
Schedule serum creatinine test and date for next infusion before patient leaves.
Complete documentation in patient chart.
Facilities Needed
Any physician's office should be able to accommodate infusion therapy with ease. To provide for your patients' needs and yours, you will need the following:
A room with a comfortable armchair
An IV pole with wheels for flexibility
Adequate counter space for supplies and reconstitution
A sink nearby, if possible
If you need a trained, qualified nurse, contact the Visiting Nurse Association.
Dosage for the Treatment of Bone Metastases
Recommended dose of ZOMETA? is 4 mg/5 ml diluted in 100 mL of solution, administered as an IV infusion over no less than 15 minutes every 3 to 4 weeks.
The recommended dose of ZOMETA? in patients with multiple myeloma and metastatic bone lesions from solid tumors is 4 mg infused over 15 minutes every three or four weeks. The optimal duration of therapy is not known. Clinical study data was analyzed at 15 months for prostate cancer, 12 months for breast cancer and multiple myeloma, and 9 months for other solid tumors. Patients should also be administered an oral calcium supplement of 500 mg and a multiple vitamin containing 400 IU of Vitamin D daily.
Serum creatinine should be measured before each ZOMETA? dose and treatment should be withheld for renal deterioration. In the clinical studies, renal deterioration was defined as follows:
For patients with normal baseline creatinine, increase of 0.5 mg/dL
For patients with abnormal baseline creatinine, increase of 1.0 mg/dL
In the clinical studies, ZOMETA? treatment was resumed only when the creatinine returned to within 10% of the baseline value.
ZOMETA? Infusion Pack (ZIP)
The ZIP contains all the supplies you need, except for gloves and the ZOMETA? medication.
Sodium Chloride 0.9% 100 mL IV Bag (1)
IV Administration Set (1)
IV Catheter 22 g x 1" (1)
Sterile Water for Injection, USP for Reconstituting Drug 10 mL (1)
Sodium Chloride 0.9% 10 mL Vial (1)
Syringe 10 cc with 21 g x 1" Needle (2)
Needle 21 g x 1" (1)
PRN Adapter (Leur Lock Injection Cap [1])
Alcohol Pad Medium (5)
Gauze Sponge 2" x 2" 12-ply Sterile (1)
Band-Aid? (2)
Tape Transpore 1" Single Use (1)
Tourniquet (1)
ZOMETA? IV Label (1)