Zometa (Page 8 of 8)

16 HOW SUPPLIED/STORAGE AND HANDLING

4 mg/100 mL (0.04 mg/mL) single-dose ready-to-use bottle

Carton of 1 bottle………………………………………………………………………………NDC 0078-0590-61

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F-86°F) [see USP Controlled Room Temperature]. Discard unused portion.

4 mg/5 mL (0.8 mg/mL) single-dose vial for dilution prior to intravenous infusion

Carton of 1 vial……………………………………………………………………………..NDC 0078-0387-25

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F-86°F) [see USP Controlled Room Temperature]. Discard unused portion.

17 PATIENT COUNSELING INFORMATION

Drugs With Same Active Ingredient or in the Same Drug Class

Inform patients not to take Reclast or other bisphosphonates during the course of their Zometa therapy [see Warnings and Precautions (5.1)].

Renal Impairment

  • Instruct patients to tell their doctor if they have kidney problems before being given Zometa.
  • Inform patients of the importance of getting their blood tests (serum creatinine) during the course of their Zometa therapy [see Warnings and Precautions (5.3)].

Osteonecrosis of the Jaw (ONJ)

  • Advise patients to have a dental examination prior to treatment with Zometa and to avoid invasive dental procedures during treatment.
  • Inform patients of the importance of good dental hygiene, routine dental care, and regular dental check-ups.
  • Advise patients to immediately tell their doctor about any oral symptoms such as loosening of a tooth, pain, swelling, or non-healing of sores or discharge during treatment with Zometa [see Warnings and Precautions (5.4)].

Musculoskeletal Pain

Advise patients to immediately tell their doctor about any severe bone, joint, and/or muscle pain [see Warnings and Precautions (5.5)].

Atypical Subtrochanteric and Diaphyseal Femoral Fracture

Advise patients to report any thigh, hip, or groin pain. It is unknown whether the risk of atypical femur fracture continues after stopping therapy [see Warnings and Precautions (5.6)].

Patients With Asthma

There have been reports of bronchoconstriction in aspirin-sensitive patients receiving bisphosphonates, including zoledronic acid. Before being given zoledronic acid, instruct patients to tell their doctor if they are aspirin-sensitive [see Warnings and Precautions (5.7)].

Hypocalcemia

Advise patients with multiple myeloma and bone metastasis of solid tumors to take an oral calcium supplement of 500 mg and a multiple vitamin containing 400 international units of vitamin D daily [see Warnings and Precautions (5.9)].

Embryo-Fetal Toxicity

  • Zometa should not be given if the patient is pregnant or plans to become pregnant. Inform female patients of the risk to a fetus and potential loss of the pregnancy [see Warnings and Precautions (5.10)].
  • Advise females of reproductive potential to use effective contraception during and after treatment with Zometa [see Warnings and Precautions (5.10), Use in Specific Populations (8.1, 8.3)].

Lactation

Advise lactating women not to breastfeed during and after treatment with Zometa [see Use in Specific Populations (8.2)].

Common Adverse Reactions

Advise patients that the most common side effects of ZOMETA are nausea, fatigue, anemia, bone pain, constipation, fever, vomiting, and dyspnea.

Distributed by:
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936

© Novartis

T2018-137
December 2018

PRINCIPAL DISPLAY PANEL

NDC 0078-0387-25

Zometa®

(zoledronic acid)

Injection

4 mg / 5 mL(0.8 mg / mL)

For Intravenous Infusion after Dilution

Single-dose

Discard unsed portion.

One 5 mL vial

Sterile

Not for direct injection. Dose must be diluted.

See package insert for Preparation of Solution.

Do not mix with calcium-containing infusion solutions.

Rx only

NOVARTIS

NDC 0078-0387-25
									Zometa®
									Injection
									4 mg / 5 mL (0.8 mg / mL)
(click image for full-size original)

ZOMETA zoledronic acid injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0387
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 5 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL 220 mg in 5 mL
SODIUM CITRATE 24 mg in 5 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0387-25 1 VIAL in 1 CARTON contains a VIAL
1 5 mL in 1 VIAL This package is contained within the CARTON (0078-0387-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021223 08/20/2001 11/30/2020
Labeler — Novartis Pharmaceuticals Corporation (002147023)

Revised: 06/2020 Novartis Pharmaceuticals Corporation

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