bortezomib injection 1 MG and 2.5 MG VIAL Patient Counseling Information

(bortezomib for injection)

17 PATIENT COUNSELING INFORMATION

Discuss the following with patients prior to treatment with Bortezomib for Injection:

Peripheral Neuropathy

Advise patients to report the development or worsening of sensory and motor peripheral neuropathy to their healthcare provider [see Warnings and Precautions (5.1)].

Hypotension

Advise patients to drink adequate fluids to avoid dehydration and to report symptoms of hypotension to their healthcare provider [see Warnings and Precautions (5.2)].

Instruct patients to seek medical advice if they experience symptoms of dizziness, light headedness or fainting spells, or muscle cramps.

Cardiac Toxicity

Advise patients to report signs or symptoms of heart failure to their healthcare provider [see Warnings and Precautions (5.3)].

Pulmonary Toxicity

Advise patients to report symptoms of ARDS, pulmonary hypertension, pneumonitis, and pneumonia immediately to their healthcare provider [see Warnings and Precautions (5.4)].

Posterior Reversible Encephalopathy Syndrome (PRES)

Advise patients to seek immediate medical attention for signs or symptoms of PRES [see Warnings and Precautions (5.5)].

Gastrointestinal Toxicity

Advise patients to report symptoms of gastrointestinal toxicity to their healthcare provider and to drink adequate fluids to avoid dehydration. Instruct patients to seek medical advice if they experience symptoms of dizziness, light headedness or fainting spells, or muscle cramps [see Warnings and Precautions (5.6)].

Thrombocytopenia/Neutropenia

Advise patients to report signs or symptoms of bleeding or infection immediately to their healthcare provider [see Warnings and Precautions (5.7)].

Tumor Lysis Syndrome

Advise patients of the risk of tumor lysis syndrome and to drink adequate fluids to avoid dehydration [see Warnings and Precautions (5.8)].

Hepatic Toxicity

Advise patients to report signs or symptoms of hepatic toxicity to their healthcare provider [see Warnings and Precautions (5.9)].

Thrombotic Microangiopathy

Advise patients to seek immediate medical attention if any signs or symptoms of thrombotic microangiopathy occur [see Warnings and Precautions (5.10)].

Ability to Drive or Operate Machinery or Impairment of Mental Ability

Bortezomib for Injection may cause fatigue, dizziness, syncope, orthostatic/postural hypotension. Advise patients not to drive or operate machinery if they experience any of these symptoms [see Warnings and Precautions (5.2, 5.5)].

Embryo-Fetal Toxicity

Advise females of the potential risk to the fetus and to use effective contraception during treatment with Bortezomib for Injection and for seven months following the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with Bortezomib for Injection and for four months following the last dose. Instruct patients to report pregnancy to their physicians immediately if they or their female partner becomes pregnant during treatment or within seven months following last dose [see Warnings and Precautions (5.11)].

Lactation

Advise women not to breastfeed while receiving Bortezomib for Injection and for two months after last dose [see Use in Specific Populations (8.2)].

Concomitant Medications

Advise patients to speak with their physicians about any other medication they are currently taking.

Diabetic Patients

Advise patients to check their blood sugar frequently if using an oral antidiabetic medication and to notify their physicians of any changes in blood sugar level.

Dermal

Advise patients to contact their physicians if they experience rash, severe injection site reactions [see Dosage and Administration (2.9)], or skin pain. Discuss with patients the option for antiviral prophylaxis for herpes virus infection [see Adverse Reactions (6.1)].

Other

Instruct patients to contact their physicians if they develop an increase in blood pressure, bleeding, fever, constipation, or decreased appetite.

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Patient Counseling Information

17 PATIENT COUNSELING INFORMATION

Discuss the following with patients prior to treatment with Bortezomib for Injection:

Peripheral Neuropathy

Advise patients to report the development or worsening of sensory and motor peripheral neuropathy to their healthcare provider [see Warnings and Precautions (5.1)].

Hypotension

Advise patients to drink adequate fluids to avoid dehydration and to report symptoms of hypotension to their healthcare provider [see Warnings and Precautions (5.2)].

Instruct patients to seek medical advice if they experience symptoms of dizziness, light headedness or fainting spells, or muscle cramps.

Cardiac Toxicity

Advise patients to report signs or symptoms of heart failure to their healthcare provider [see Warnings and Precautions (5.3)].

Pulmonary Toxicity

Advise patients to report symptoms of ARDS, pulmonary hypertension, pneumonitis, and pneumonia immediately to their healthcare provider [see Warnings and Precautions (5.4)].

Posterior Reversible Encephalopathy Syndrome (PRES)

Advise patients to seek immediate medical attention for signs or symptoms of PRES [see Warnings and Precautions (5.5)].

Gastrointestinal Toxicity

Advise patients to report symptoms of gastrointestinal toxicity to their healthcare provider and to drink adequate fluids to avoid dehydration. Instruct patients to seek medical advice if they experience symptoms of dizziness, light headedness or fainting spells, or muscle cramps [see Warnings and Precautions (5.6)].

Thrombocytopenia/Neutropenia

Advise patients to report signs or symptoms of bleeding or infection immediately to their healthcare provider [see Warnings and Precautions (5.7)].

Tumor Lysis Syndrome

Advise patients of the risk of tumor lysis syndrome and to drink adequate fluids to avoid dehydration [see Warnings and Precautions (5.8)].

Hepatic Toxicity

Advise patients to report signs or symptoms of hepatic toxicity to their healthcare provider [see Warnings and Precautions (5.9)].

Thrombotic Microangiopathy

Advise patients to seek immediate medical attention if any signs or symptoms of thrombotic microangiopathy occur [see Warnings and Precautions (5.10)].

Ability to Drive or Operate Machinery or Impairment of Mental Ability

Bortezomib for Injection may cause fatigue, dizziness, syncope, orthostatic/postural hypotension. Advise patients not to drive or operate machinery if they experience any of these symptoms [see Warnings and Precautions (5.2, 5.5)].

Embryo-Fetal Toxicity

Advise females of the potential risk to the fetus and to use effective contraception during treatment with Bortezomib for Injection and for seven months following the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with Bortezomib for Injection and for four months following the last dose. Instruct patients to report pregnancy to their physicians immediately if they or their female partner becomes pregnant during treatment or within seven months following last dose [see Warnings and Precautions (5.11)].

Lactation

Advise women not to breastfeed while receiving Bortezomib for Injection and for two months after last dose [see Use in Specific Populations (8.2)].

Concomitant Medications

Advise patients to speak with their physicians about any other medication they are currently taking.

Diabetic Patients

Advise patients to check their blood sugar frequently if using an oral antidiabetic medication and to notify their physicians of any changes in blood sugar level.

Dermal

Advise patients to contact their physicians if they experience rash, severe injection site reactions [see Dosage and Administration (2.9)], or skin pain. Discuss with patients the option for antiviral prophylaxis for herpes virus infection [see Adverse Reactions (6.1)].

Other

Instruct patients to contact their physicians if they develop an increase in blood pressure, bleeding, fever, constipation, or decreased appetite.

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