HOW TO USE Zomiba

How to use Zomiba:

Administration Precautions:

The drug quantity contained in one vial (3.5 mg) may exceed the usual dose required. Caution should be used in calculating the dose to prevent overdose. When administered subcutaneously, sites for each injection (thigh or abdomen) should be rotated. New injections should be given at least one inch from an old site and never into areas where the site is tender, bruised, erythematous, or indurated.

If local injection site reactions occur following ZOMIBA administration subcutaneously, a less concentrated ZOMIBA solution (1 mg/mL instead of 2.5 mg/mL) may be administered subcutaneously. Alternatively, consider use of the intravenous route of administration.

ZOMIBA is a cytotoxic drug. Follow applicable special handling and disposal procedures.

Reconstitution/Preparation for Intravenous and Subcutaneous Administration:

Use proper aseptic technique. Reconstitute only with 0.9% sodium chloride. The reconstituted product should be a clear and colorless solution.

Different volumes of 0.9% sodium chloride are used to reconstitute the product for the different routes of administration. The reconstituted concentration of Bortezomib for subcutaneous administration (2.5 mg/mL) is greater than the reconstituted concentration of Bortezomib for intravenous administration (1 mg/mL). Because each route of administration has a different reconstituted concentration, use caution when calculating the volume to be administered.

For each 3.5 mg single-dose vial of ZOMIBA reconstitute with the following volume of 0.9% sodium chloride based on route of administration.

Dose must be individualized to prevent overdosage. After determining patient body surface area (BSA) in square meters, use the following equations to calculate the total volume (mL) of reconstituted ZOMIBA to be administered:

  • Intravenous Administration [1 mg/mL concentration]:
  • Subcutaneous Administration [2.5 mg/mL concentration]

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. If any discoloration or particulate matter is observed, the reconstituted product should not be used.