Pricing
Prices are indicative MRP and may vary by pharmacy. Trend compares against the last recorded price.
All price changes →More from Bortez
Other strengths and forms by Beacon Pharmaceuticals PLC
Indications & Uses
Bortez is indicated for:
Pharmacology
Bortezomib for Injection is an antineoplastic medicine given as an intravenous (IV) or subcutaneous injection. It reversibly blocks the chymotrypsin-like activity of the 26S proteasome in mammalian cells. This proteasome is a large protein complex that breaks down ubiquitinated proteins. The ubiquitin-proteasome pathway has an essential role in regulating the intracellular concentration of specific proteins, and that keeps the cell in balance (homeostasis). When Bortezomib inhibits the 26S proteasome, this targeted breakdown of proteins is stopped, which can affect multiple signaling cascades within the cell. Normal homeostatic mechanisms are disrupted, and this can lead to cell death. Experiments have shown that Bortezomib is cytotoxic to many types of cancer cells in vitro. In nonclinical tumor models, including multiple myeloma, it delays tumor growth in vivo.
Distribution:
In patients with multiple myeloma, the distribution volume of Bortezomib as a single agent was not assessed at the recommended dose. Binding to human plasma proteins averaged 83% over the concentration range of 100 to 1000 ng/mL.
Metabolism:
Bortezomib is mainly metabolised by oxidation through cytochrome P450 enzymes 3A4, 2C19 and 1A2. CYP 2D6 and 2C9 enzymes play only a minor part. The major pathway is deboronation, which forms 2 deboronated metabolites, and these then undergo hydroxylation to several metabolites. Deboronated Bortezomib metabolites are inactive as 26S proteasome inhibitors.
Elimination:
In patients with advanced malignancies, the mean elimination half-life of Bortezomib after the first dose ranged from 9 to 15 hours at doses from 1.45 to 2.00 mg/m2. How Bortezomib leaves the body has not been characterized in humans.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
The recommended dose of Bortezomib is 1.3 mg/m2/dose, given as a 3 to 5 second bolus injection, either into a vein or under the skin. It is given twice weekly for 2 weeks (Days 1, 4, 8, and 11), followed by a 10-day rest period (Days 12 to 21). If treatment goes beyond 8 cycles, Bortezomib can be given on the standard schedule or on a maintenance schedule, which is once weekly for 4 weeks (Days 1, 8, 15, and 22) followed by a 13-day rest period (Days 23 to 35).
Retreatment with Bortezomib may be considered for patients with multiple myeloma who responded to Bortezomib before and who relapsed at least 6 months after finishing that earlier course. In that case, treatment may be started at the last tolerated dose. Bortezomib is for intravenous or subcutaneous use only, and it should not be given by any other route.
Side Effects
Treatment with Bortezomib Ever Pharma can cause these side effects: peripheral neuropathy, hypotension, cardiac toxicity, pulmonary toxicity, Posterior Reversible Encephalopathy Syndrome (PRES), gastrointestinal toxicity, thrombocytopenia or neutropenia, Tumor Lysis Syndrome and hepatic toxicity.
Cautions & Contraindications
Warnings & Precautions
Bortezomib Ever Pharma should be given under the supervision of a physician experienced in antineoplastic therapy. Peripheral neuropathy: treatment causes a peripheral neuropathy that is mostly sensory, though cases of motor neuropathy have also been reported. Patients who already have symptoms (numbness, pain or a burning feeling in the feet or hands) and/or signs of peripheral neuropathy may find it gets worse, including to greater than Grade 3, during treatment. Patients should be monitored for symptoms such as a burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort or neuropathic pain. If neuropathy is new or getting worse, the dose and schedule may need to change. For patients who already have peripheral neuropathy or are at high risk of it, starting the medicine subcutaneously may be considered. The long-term outcome of peripheral neuropathy has not been studied in mantle cell lymphoma. Hypotension: take care when treating patients with a history of syncope, patients on medicines known to be linked with hypotension, and patients who are dehydrated. Orthostatic/postural hypotension may be managed by adjusting antihypertensive medicines, giving fluids, and giving mineralocorticoids and/or sympathomimetics. Cardiac disorders: congestive heart failure has appeared suddenly or got worse in patients with risk factors for heart disease or with existing heart disease. These patients should be watched closely. In clinical studies, isolated cases of QT-interval prolongation were seen. A cause has not been established. Gastrointestinal adverse events: Bortezomib Ever Pharma can cause nausea, diarrhea, constipation and vomiting, and sometimes antiemetic and antidiarrheal medicines are needed. Fluid and electrolyte replacement should be given to prevent dehydration. Pulmonary toxicity: Acute Respiratory Distress Syndrome (ARDS) and acute diffuse infiltrative pulmonary disease of unknown cause, such as pneumonitis, interstitial pneumonia and lung infiltration, have occurred in patients receiving the medicine. Some of these events have been fatal. Pulmonary hypertension has also been reported, in patients without left heart failure or significant pulmonary disease. If cardiopulmonary symptoms are new or getting worse, consider interrupting treatment until a prompt and full diagnostic evaluation has been done. Thrombocytopenia: the medicine is associated with thrombocytopenia and neutropenia that follow a cyclical pattern. The lowest counts come after the last dose of each cycle, and they typically recover before the next cycle begins. This pattern of falling and recovering platelet and neutrophil counts stayed consistent in the studies of multiple myeloma and mantle cell lymphoma, with no sign of cumulative thrombocytopenia or neutropenia in the treatment regimens studied. Complete blood counts (CBC) should be checked often during treatment, and platelet counts measured before each dose. The dose and schedule should be adjusted for thrombocytopenia. Gastrointestinal and intracerebral hemorrhage have been reported with Bortezomib Ever Pharma. Transfusions may be considered. Tumor lysis syndrome: this has been reported with the therapy. Patients at risk are those with a high tumor burden before treatment. Monitor them closely and take appropriate precautions. Hepatic toxicity: acute liver failure has been reported in patients taking multiple other medicines and in those with serious underlying medical conditions. Other liver reactions reported include hepatitis, raised liver enzymes and hyperbilirubinemia. Interrupt the therapy to assess whether the problem is reversible. There is limited re-challenge information in these patients.
Contraindications
Bortezomib must not be given to anyone who is hypersensitive to Bortezomib, boron or mannitol. Reactions in these patients have included anaphylaxis. It must also never be given intrathecally (into the spinal fluid space), because deaths have occurred when Bortezomib was given by this route.
Pregnancy & Breastfeeding
Bortezomib is Pregnancy Category D. Women who could become pregnant should avoid pregnancy while they are being treated with it. No studies have looked at whether Bortezomib crosses the placenta, and there are no adequate, well-controlled studies in pregnant women. If Bortezomib is used during pregnancy, or if a patient becomes pregnant while receiving it, she should be told about the possible hazard to the fetus.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Renal Impairment: The pharmacokinetics of Bortez don't change with the degree of renal impairment, so patients with renal insufficiency don't need a dose adjustment. Dialysis may lower Bortez concentrations, so Bortez should be given after the dialysis procedure.
Pediatric: The safety and effectiveness of Bortez in children have not been established.
Patients with Diabetes: Patients taking oral anti-diabetic agents while on Bortez treatment may need close monitoring of their blood glucose levels, and the dose of their anti-diabetic medicine may need adjusting.
Overdose
Taking more than twice the recommended dose of Bortezomib can bring on symptomatic hypotension and thrombocytopenia quite suddenly, and these have led to deaths. There is no known specific antidote for Bortez overdosage. If an overdose happens, the patient's vital signs should be monitored. Appropriate supportive care should be given to maintain blood pressure (such as fluids, pressors and/or inotropic agents) and body temperature.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Store unopened bortezomib vials at no more than 25°C, and keep each vial in its outer box to protect it from light. For the reconstituted solution, don't store it above 2°C to 8°C, and use it within 8 hours of reconstitution. Don't use the solution if you see any particles in it or if it has become discoloured.
Drug Interactions
Common questions about Bortez 1 mg
What is Bortez 1 mg IV/SC Injection?
Bortez 1 mg IV/SC Injection is a medicine that contains Bortezomib. It is made by Beacon Pharmaceuticals PLC. It belongs to the Targeted Cancer Therapy group of medicines.
What is Bortez used for?
Bortez is used for: Cancer.
What are the side effects of Bortez?
Treatment with Bortezomib Ever Pharma can cause these side effects: peripheral neuropathy, hypotension, cardiac toxicity, pulmonary toxicity, Posterior Reversible Encephalopathy Syndrome (PRES), gastrointestinal toxicity, thrombocytopenia or neutropenia, Tumor Lysis Syndrome and hepatic toxicity.
Can I take Bortez during pregnancy or while breastfeeding?
Bortezomib is Pregnancy Category D. Women who could become pregnant should avoid pregnancy while they are being treated with it. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Bortez?
Taking more than twice the recommended dose of Bortezomib can bring on symptomatic hypotension and thrombocytopenia quite suddenly, and these have led to deaths. There is no known specific antidote for Bortez overdosage. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Bortez?
Store unopened bortezomib vials at no more than 25°C, and keep each vial in its outer box to protect it from light. For the reconstituted solution, don't store it above 2°C to 8°C, and use it within 8 hours of reconstitution.
Can I take other medicines with Bortez?
Some medicines can interact with Bortezomib, for example: Thalidomide. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Bortez?
Bortez is a prescription (Rx) medicine. Take it as your doctor advises.