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ZOLEDRONIC ACID INJECTION - FOR INTRAVENOUS INFUSION (zoledronic acid for injection - FOR INTRAVENOUS INFUSION) Patient Counseling Information

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Information for Patients

Patients should be made aware that Zoledronic Acid Injection contains the same active ingredient (zoledronic acid) found in Zometa®, and that patients being treated with Zometa should not be treated with Zoledronic Acid Injection.

Zoledronic Acid Injection is contraindicated in patients with creatinine clearance less than 35 mL/min [see Contraindications (4)].

Before being given zoledronic acid, patients should tell their doctor if they have kidney problems and what medications they are taking.

Zoledronic acid should not be given if the patient is pregnant or plans to become pregnant, or if she is breast-feeding [see Warnings and Precautions (5.6)].

There have been reports of bronchoconstriction in aspirin-sensitive patients receiving bisphosphonates, including zoledronic acid. Before being given zoledronic acid, patients should tell their doctor if they are aspirin-sensitive.

If the patient had surgery to remove some or all of the parathyroid glands in their neck, or had sections of their intestine removed, or are unable to take calcium supplements they should tell their doctor.

Zoledronic acid is given as an infusion into a vein by a nurse or a doctor, and the infusion time must not be less than 15 minutes.

On the day of treatment the patient should eat and drink normally, which includes drinking at least 2 glasses of fluid such as water within a few hours prior to the infusion, as directed by their doctor, before receiving zoledronic acid.

After getting zoledronic acid it is strongly recommended patients with Paget's disease take calcium in divided doses (for example, 2 to 4 times a day) for a total of 1,500 mg calcium a day to prevent low blood calcium levels. This is especially important for the two weeks after getting zoledronic acid [see Warnings and Precautions (5.2)].

Patients should be aware of the most commonly associated side effects of therapy. Patients may experience one or more side effects that could include: fever, flu-like symptoms, myalgia, arthralgia, and headache. Most of these side effects occur within the first 3 days following the dose of zoledronic acid. They usually resolve within 3 days of onset but may last for up to 7 to 14 days. Patients should consult their physician if they have questions or if these symptoms persist. The incidence of these symptoms decreased markedly with subsequent doses of zoledronic acid.

Administration of acetaminophen following zoledronic acid administration may reduce the incidence of these symptoms.

Physicians should inform their patients that there have been reports of persistent pain and/or a non-healing sore of the mouth or jaw, primarily in patients treated with bisphosphonates for other illnesses. During treatment with zoledronic acid, patients should be instructed to maintain good oral hygiene and undergo routine dental check-ups. If they experience any oral symptoms, they should immediately report them to their physician or dentist.

Severe and occasionally incapacitating bone, joint, and/or muscle pain have been infrequently reported in patients taking bisphosphonates, including zoledronic acid. Consider withholding future zoledronic acid treatment if severe symptoms develop.

Atypical femur fractures in patients on bisphosphonate therapy have been reported; patients with thigh or groin pain should be evaluated to rule out a femoral fracture.

Zometa® is a registered trademark of Novartis Pharmaceutical Corporation.

Manufactured by:
Laboratorios Grifols, SA
Barcelona, Spain

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

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LAB-0929-4.0

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