Bortezomib

Lyophilized powder for injection Bortezomib is indicated for:

• Treatment of multiple myeloma in patients who have not previously received treatment and who cannot be given high-dose chemotherapy with hematopoietic stem cell transplantation as part of combination therapy with melphalan and prednisone (first-line therapy).
• Treatment of progressive multiple myeloma in patients who have received at least one line of therapy and who underwent hematopoietic stem cell transplantation or who are not candidates for transplantation - as monotherapy or as part of combination therapy with pegylated liposomal doxorubicin or dexamethasone (second-line therapy).
• Treatment of multiple myeloma in patients who have not previously received treatment and are candidates for high-dose chemotherapy with hematopoietic stem cell transplantation - as part of a combination therapy with dexamethasone or dexamethasone and thalidomide (induction therapy).
• Treatment of mantle clintin lymphoma in patients who have not previously received treatment and who are not candidates for hematopoietic stem cell transplantation - as part of combination therapy with rituximab, cyclophosphamide, doxorubicin and prednisone.

Structure

Active substance: bortezomib;

1 bottle contains bortezomib - 3.5 mg;

Excipients: mannitol (E421) nitrogen.

Contraindications

Hypersensitivity to bortezomib, boron or any of the excipients of the drug.

Acute diffuse infiltrative pulmonary and pericardial diseases.

In the case of the use of bortezomib in combination with other drugs, see also the instructions for the use of these drugs for additional contraindications.

Mode of application

Treatment should begin under the supervision of a qualified physician with experience in the use of antitumor agents. The preparation of the solution should be carried out only by qualified medical personnel.

Bortezomib is used as an intravenous or subcutaneous injection. Accidental intrathecal administration of the drug was fatal.

Application features

Pregnant women

Contraindicated.

Children

Not applicable.

Drivers

Carefully.

Overdose

Exceeding the recommended dose by more than twice was accompanied in patients with an acute decrease in blood pressure and fatal thrombocytopenia.

The specific antidote to bortezomib is unknown. In case of an overdose, it is recommended to carefully monitor hemodynamic parameters (infusion therapy, vasopressor drugs and / or inotropic drugs) and body temperature.

Side effects

Among severe adverse reactions during treatment with bortezomib, cardiac arrest, tumor lysis syndrome, pulmonary hypertension, reverse posterior encephalopathy syndrome (Sosa), acute diffuse infiltrative pulmonary disorders, and rarely vegetative neuropathy have been reported infrequently. The most common adverse reactions during treatment with bortezomib are nausea, diarrhea, constipation, vomiting, weakness, pyrexia, thrombocytopenia, anemia, neutropenia, peripheral neuropathy (including sensory), headache, paresthesia, loss of appetite, shortness of breath, rash, shingles and shingles .

Interaction

In studies of the effects of rifampicin, a potent inducer of CYRZA4, an average decrease in AUC of bortezomib (after intravenous use) by 45% was detected. Therefore, the simultaneous use of bortezomib with powerful CYPZA4 inducers (such as rifampicin, carbamazepine, phenytoin, phenobarbital and St. Johns wort extract) is not recommended, since the effectiveness of bortezomib can be reduced.

In patients with diabetes who received oral hypoglycemic agents, registered cases of hypo- and hyperglycemia.Patients taking oral antidiabetic drugs in the treatment of bortezomib should monitor blood glucose levels and adjust the dose of antidiabetic agents.

Storage conditions

Store the bottle in an outer packaging, in a dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life is 36 months.