zoledronic acid for injection 4 MG VIAL Patient Counseling Information

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 zoledronic acid injection therapy [see Warnings and Precautions (5.1)].

Renal Impairment

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

Osteonecrosis of the Jaw (ONJ)

  • Advise patients to have a dental examination prior to treatment with zoledronic acid injection 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 zoledronic acid injection [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

Lactation

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

Common Adverse Reactions

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

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Patient Counseling Information

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 zoledronic acid injection therapy [see Warnings and Precautions (5.1)].

Renal Impairment

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

Osteonecrosis of the Jaw (ONJ)

  • Advise patients to have a dental examination prior to treatment with zoledronic acid injection 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 zoledronic acid injection [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

Lactation

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

Common Adverse Reactions

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

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