How to take Zomiba?
Your doctor will work out your dose of Zomiba according to your height and weight (body surface area).
The usual starting dose of Zomiba is 1.3 mg/m2 body surface area twice a week.Your doctor may change the dose and total number of treatment cycles, depending on your response to the treatment on the occurrence of certain side effects and on your underlying conditions (e.g. liver problems).
Progressive multiple myeloma:
When Zomiba is given alone, you will receive 4 doses of Zomiba intravenously or subcutaneously on days 1, 4, 8 and 11, followed by a 10-day ‘rest period’ without treatment. This 21-day period (3 weeks) corresponds to one treatment cycle. You might receive up to 8 cycles (24 weeks).
You may also be given Zomiba together with the medicines pegylated liposomal doxorubicin or dexamethasone.
When Zomiba is given together with pegylated liposomal doxorubicin, you will receive Bortezomib intravenously or subcutaneously as a 21-day treatment cycle and pegylated liposomal doxorubicin 30 mg/m2 is given on day 4 of the Zomiba 21-day treatment cycle as an intravenous infusion after the Zomiba injection.You might receive up to 8 cycles (24 weeks).
When Zomiba is given together with dexamethasone, you will receive Zomiba intravenously or subcutaneously as a 21-day treatment cycle and dexamethasone 20 mg is given orally on days 1, 2, 4, 5, 8, 9, 11, and 12, of the Bortezomib, 21-day treatment cycle.
You might receive up to 8 cycles (24 weeks).
Previously untreated multiple myeloma:
If you have not been treated before for multiple myeloma, and you are not suitable for blood stem cell transplantation you will receive Zomiba together with two other medicines; melphalan and prednisone.
In this case, the duration of a treatment cycle is 42 days (6 weeks). You will receive 9 cycles (54 weeks).
In cycles 1 to 4, Zomiba is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29 and 32.
In cycles 5 to 9, Zomiba is administered once weekly on days 1, 8, 22 and 29.
Melphalan (9 mg/m2) and prednisone (60 mg/m2) are both given orally on days 1, 2, 3 and 4 of the first week of each cycle.
If you have not been treated before for multiple myeloma, and you are suitable for blood stem cell transplantation you will receive Zomiba intravenously or subcutaneously together with the medicines dexamethasone, or dexamethasone and thalidomide, as induction treatment.
When Zomiba is given together with dexamethasone, you will receive Zomiba intravenously or subcutaneously as a 21-day treatment cycle and dexamethasone 40 mg is given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of the Zomiba 21-day treatment cycle.
You will receive 4 cycles (12 weeks).
When Zomiba is given together with thalidomide and dexamethasone, the duration of a treatment cycle is 28 days (4 weeks).
Dexamethasone 40 mg is given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of the Zomiba 28-day treatment cycle and thalidomide is given orally daily at 50 mg up to day 14 of the first cycle, and if tolerated the thalidomide dose is increased to 100 mg on days 15-28 and may be further increased to 200 mg daily from the second cycle onwards.
You might receive up to 6 cycles (24 weeks).
Previously untreated mantle cell lymphoma:
If you have not been treated before for mantle cell lymphoma you will receive Zomiba intravenously or subcutaneously together with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone.
Zomiba is given intravenously or subcutaneously on days 1, 4, 8 and 11, followed by a ‘rest period’ without treatment. The duration of a treatment cycle is 21 days (3 weeks). You might receive up to 8 cycles (24 weeks).
The following medicinal products are given on day 1 of each Zomiba 21-day treatment cycle as intravenous infusions:
Rituximab at 375 mg/m2, cyclophosphamide at 750 mg/m2 and doxorubicin at 50 mg/m2. Prednisone is given orally at 100 mg/m2 on days 1, 2, 3, 4 and 5 of the Zomiba treatment cycle.
This medicine is for intravenous or subcutaneous use.
Zomiba will be administered by a health care professional experienced in the use of cytotoxic medicines.
Reconstitution for intravenous injection: add 3.5 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib powder. Dissolution of the lyophilized powder is completed in less than 2 minutes. The concentration of the resulting solution will be 1 mg/ml. The solution will be clear and colorless.
Reconstitution for subcutaneous injection: add 1.4 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib powder.
Dissolution of the lyophilized powder is completed in less than 2 minutes.
The concentration of the resulting solution will be 2.5 mg/ml.
The solution will be clear and colorless.
Before administration, visually inspect the solution for particulate matter and discoloration. If any discoloration or particulate matter is observed, the solution should be discarded.
The resulting solution is then either injected into a vein or under the skin. Injection into a vein is rapid, taking 3 to 5 seconds. Injection under the skin is in either the thighs or the abdomen.
