Zoledronic acid-injection

Name: Zoledronic acid-injection

Notes

Laboratory and/or medical tests (such as calcium and other blood mineral levels, kidney function tests) will be performed before you start treatment, periodically to monitor your progress, or to check for side effects. Consult your doctor for more details.

Indications and Usage for Zoledronic Acid Injection

Hypercalcemia of Malignancy

Zoledronic Acid Injection is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-corrected calcium (cCa) of greater than or equal to 12 mg/dL [3.0 mmol/L] using the formula: cCa in mg/dL = Ca in mg/dL + 0.8 (4.0 g/dL - patient albumin (g/dL)).

Multiple Myeloma and Bone Metastases of Solid Tumors

Zoledronic Acid Injection is indicated for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy.

Important Limitation of Use

The safety and efficacy of zoledronic acid in the treatment of hypercalcemia associated with hyperparathyroidism or with other nontumor-related conditions have not been established.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Standard lifetime carcinogenicity bioassays were conducted in mice and rats. Mice were given oral doses of zoledronic acid of 0.1, 0.5, or 2.0 mg/kg/day. There was an increased incidence of Harderian gland adenomas in males and females in all treatment groups (at doses ≥0.002 times a human intravenous dose of 4 mg, based on a comparison of relative body surface areas). Rats were given oral doses of zoledronic acid of 0.1, 0.5, or 2.0 mg/kg/day. No increased incidence of tumors was observed (at doses ≤0.2 times the human intravenous dose of 4 mg, based on a comparison of relative body surface areas).

Zoledronic acid was not genotoxic in the Ames bacterial mutagenicity assay, in the Chinese hamster ovary cell assay, or in the Chinese hamster gene mutation assay, with or without metabolic activation. Zoledronic acid was not genotoxic in the in-vivo rat micronucleus assay.

Female rats were given subcutaneous doses of zoledronic acid of 0.01, 0.03, or 0.1 mg/kg/day beginning 15 days before mating and continuing through gestation. Effects observed in the high-dose group (with systemic exposure of 1.2 times the human systemic exposure following an intravenous dose of 4 mg, based on AUC comparison) included inhibition of ovulation and a decrease in the number of pregnant rats. Effects observed in both the mid-dose group (with systemic exposure of 0.2 times the human systemic exposure following an intravenous dose of 4 mg, based on an AUC comparison) and high-dose group included an increase in preimplantation losses and a decrease in the number of implantations and live fetuses.

How Supplied/Storage and Handling

4 mg/100 mL single-dose premixed bag

Carton of 1 bag                                    NDC 0409-4229-01

Store at temperatures not exceeding 30°C (86°F). Do not freeze.

Single Dose Only – Discard Unused Portion.

Patient Counseling Information

• Patients should be instructed to tell their doctor if they have kidney problems before being given Zoledronic Acid Injection. • Patients should be informed of the importance of getting their blood tests (serum creatinine) during the course of their Zoledronic Acid Injection therapy. • Zoledronic Acid Injection should not be given if the patient is pregnant or plans to become pregnant, or if she is breastfeeding. • Patients should be advised to have a dental examination prior to treatment with Zoledronic Acid Injection and should avoid invasive dental procedures during treatment. • Patients should be informed of the importance of good dental hygiene and routine dental care. • Patients with multiple myeloma and bone metastasis of solid tumors should be advised to take an oral calcium supplement of 500 mg and a multiple vitamin containing 400 international units of vitamin D daily. • Patients should be advised to report any thigh, hip, or groin pain. It is unknown whether the risk of atypical femur fracture continues after stopping therapy. • Patients should be aware of the most common side effects including: anemia, nausea, vomiting, constipation, diarrhea, fatigue, fever, weakness, lower limb edema, anorexia, decreased weight, bone pain, myalgia, arthralgia, back pain, malignant neoplasm aggravated, headache, dizziness, insomnia, paresthesia, dyspnea, cough, and abdominal pain. • 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.

 

3044318

Manufactured by:

Laboratorios Grifols, SA

Barcelona, Spain

                                                                                       EN-4157

Manufactured for:
Hospira, Inc., Lake Forest, IL 60045 USA                                                                                         

Product of Spain

Ca- 4276

ZOLEDRONIC ACID 
Zoledronic Acid Injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0409-4229
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZOLEDRONIC ACID (ZOLEDRONIC ACID ANHYDROUS) ZOLEDRONIC ACID ANHYDROUS 4 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 900 mg  in 100 mL
MANNITOL 220 mg  in 100 mL
SODIUM CITRATE, UNSPECIFIED FORM 24 mg  in 100 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:0409-4229-01 1 BAG in 1 CARTON
1 100 mL in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204016 08/07/2017
Labeler - Hospira, Inc. (141588017)
Establishment
Name Address ID/FEI Operations
Laboratorios Grifols, S.A. 463719725 MANUFACTURE(0409-4229), PACK(0409-4229)
Establishment
Name Address ID/FEI Operations
Hospira, Inc. 093132819 ANALYSIS(0409-4229)
Establishment
Name Address ID/FEI Operations
Hospira Boulder, Inc. 141565163 ANALYSIS(0409-4229), API MANUFACTURE(0409-4229)
Establishment
Name Address ID/FEI Operations
Laboratorios Grifols, S.A. 461842294 ANALYSIS(0409-4229)
Revised: 08/2017   Hospira, Inc.
(web3)