BORTEZOMIB

5 mg/mL) Because each route of administration has a different concentration, caution should be used when calculating the volume to be administered for intravenous injection to avoid the risk of overdose. For subcutaneous administration, the solution is injected into the thighs (right or left) or abdomen (right or left).

Injection sites should be rotated for successive injections. 5 cm from an old site and never into areas where the site is tender, bruised, erythematous, or indurated. 4 Administration and follow dilution instructions for 1 mg/mL). 4 Administration).

In clinical trials, local skin irritation was reported in 5% of patients, but extravasation of bortezomib was not associated with tissue damage. In a clinical trial of subcutaneous Bortezomib Injection, a local reaction was reported in 6% of patients as an adverse event, mostly redness.

Treatment must be administered under the supervision of a physician qualified and experienced in the use of antineoplastic agents. Bortezomib has not been formally studied in patients with impaired renal function. Patients with compromised renal function should be monitored carefully, especially if creatinine clearance is  30 mL/minute (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS).

Bortezomib has been studied in patients with impaired hepatic function. Patients with mild hepatic impairment do not require a starting dose adjustment and should be treated as per the recommended Bortezomib Injection dose. Patients with moderate or severe hepatic impairment should be started on a reduced dose.

See Dose Modification in Patients with Hepatic Impairment and 7 WARNINGS AND PRECAUTIONS. There is no evidence to suggest that dose adjustments are necessary in elderly patients (see 8 ADVERSE REACTIONS). 4 mL Page 6 of 77 established.

3 mg/m2 body surface area to be administered intravenously twice weekly on days 1, 4, 8, and 11, followed by a rest period of up to 20 days, which is considered a treatment cycle. Three to six cycles should be administered. At least 72 hours should elapse between consecutive doses of Bortezomib Injection.

For Bortezomib Injection dosage adjustments for transplant eligible patients follow dose modification guidelines described under Dosage in Relapsed Multiple Myeloma and Relapsed/RefractoryMantle Cell Lymphoma and Dose Modification in Patients with Hepatic Impairment.

, 10 CLINICAL PHARMACOLOGY and 14 CLINICAL TRIALS). 2 CONTRAINDICATIONS • Bortezomib Injection is contraindicated in patients with hypersensitivity to bortezomib, boronic or any of the excipients. • Bortezomib Injection is contraindicated for intrathecal administration.

Fatal events have occurred with intrathecal administration of bortezomib. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • Bortezomib Injection must be administered under the supervision of a physician qualified in the use of antineoplastic agents.

5 mg/mL) Because each route of administration has a different concentration, caution should be used when calculating the volume to be administered for intravenous injection to avoid the risk of overdose. For subcutaneous administration, the solution is injected into the thighs (right or left) or abdomen (right or left).

Injection sites should be rotated for successive injections. 5 cm from an old site and never into areas where the site is tender, bruised, erythematous, or indurated. 4 Administration and follow dilution instructions for 1 mg/mL). 4 Administration).

In clinical trials, local skin irritation was reported in 5% of patients, but extravasation of bortezomib was not associated with tissue damage. In a clinical trial of subcutaneous Bortezomib Injection, a local reaction was reported in 6% of patients as an adverse event, mostly redness.

Treatment must be administered under the supervision of a physician qualified and experienced in the use of antineoplastic agents. Bortezomib has not been formally studied in patients with impaired renal function. Patients with compromised renal function should be monitored carefully, especially if creatinine clearance is  30 mL/minute (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS).

Bortezomib has been studied in patients with impaired hepatic function. Patients with mild hepatic impairment do not require a starting dose adjustment and should be treated as per the recommended Bortezomib Injection dose. Patients with moderate or severe hepatic impairment should be started on a reduced dose.

5 mg/mL) Because each route of administration has a different concentration, caution should be used when calculating the volume to be administered for intravenous injection to avoid the risk of overdose. For subcutaneous administration, the solution is injected into the thighs (right or left) or abdomen (right or left).

Injection sites should be rotated for successive injections. 5 cm from an old site and never into areas where the site is tender, bruised, erythematous, or indurated. 4 Administration and follow dilution instructions for 1 mg/mL). 4 Administration).

In clinical trials, local skin irritation was reported in 5% of patients, but extravasation of bortezomib was not associated with tissue damage. In a clinical trial of subcutaneous Bortezomib Injection, a local reaction was reported in 6% of patients as an adverse event, mostly redness.

Treatment must be administered under the supervision of a physician qualified and experienced in the use of antineoplastic agents. Bortezomib has not been formally studied in patients with impaired renal function. Patients with compromised renal function should be monitored carefully, especially if creatinine clearance is  30 mL/minute (see 7 WARNINGS AND PRECAUTIONS and

• Bortezomib Injection is contraindicated in patients with hypersensitivity to bortezomib, boronic or any of the excipients. • Bortezomib Injection is contraindicated for intrathecal administration. Fatal events have occurred with intrathecal administration of bortezomib.