BORTENAT

Velcade (bortezomib) instructions
Common name: Velcade
Trade name: VELCADE
Full names: Velcade, bortezomib, VELCADE, Bortezomib for Injection, BORTENAT

Indications:
For the treatment of certain types of cancer (e.g., multiple myeloma, mantle cell lymphoma). It works by slowing or stopping the growth of cancer cells.

Usage and dosage:
The recommended dose for adult monotherapy is a single injection of 1.3 mg/m2, twice a week, for 2 consecutive weeks (i.e., injections on days 1, 4, 8, and 11) and then discontinued for 10 days (i.e., from days 12 to 21). A course of treatment is 3 weeks, and the interval between two doses is at least 72 hours. For maintenance treatment of more than 8 courses, it can be administered according to the standard regimen, or it can be administered once a week for 4 consecutive weeks (days 1, 8, 15 and 22), followed by a 12-day rest period (days 22 to 25).

Adverse reactions:
Abdominal pain
Anxiety
Blurred vision
Taste changes
Constipation
Decrease or loss of appetite
Diarrhea
Trouble breathing
Headache
Heartburn
Joint pain or stiffness
Muscle pain, cramping, or stiffness
Nausea Heart
numbness, burning, or tingling sensation in hands or feet
subcutaneous injection rash, itching, hives, redness, pain at the injection site
shivers
swelling of hands, feet, toes, or lower legs
trouble sleeping
unusual tiredness or weakness
vomiting
weight loss
blood pressure changes
cough
dizziness, Dizziness or fainting
Inability to urinate
Low blood pressure (such as dizziness or fainting)
Short breathing
Skin rash
Signs of anemia (low red blood cells; such as dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
Signs of bleeding (such as bloody nose, urine, coughing of blood, bleeding gums, cuts that don't stop bleeding) )
Concentration of breathing problems (e.g., shortness of breath, difficulty breathing, wheezing or tightness in the chest, fast or irregular breathing)
Episodes of depression (e.g., trouble concentrating, weight changes, changes in sleep, decreased interest in activities, suicidal thoughts)
Illness with heart problems (e.g., fast, irregular heartbeat or pulse, chest pain, trouble breathing) Difficult)
Signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
Symptoms of dehydration (thirst, weakness, decreased urine output, dark urine)
Symptoms of liver damage (yellowing of skin or eyes, abdominal pain, nausea, dark urine, pale stools, itching) Itching or fluid accumulation in the abdomen)
Symptoms of shingles (e.g., headache; sensitivity to light; joint pain, followed by an itching, stinging, or painful rash)
Chest pain
Irregular or rapid heartbeat
Seizures
Severe abdominal pain
Signs of a severe skin reaction, such as blistering, peeling, rash covering a large area, skin A rash that spreads quickly or is accompanied by fever or discomfort
Symptoms of a serious allergic reaction (such as hives; difficulty breathing; swelling of the face, mouth, tongue, or throat)
Symptoms of a stroke (sudden numbness or weakness, especially on one side of the body; sudden confusion, difficulty speaking or understanding speech; sudden problems with coordination or balance; one or both eyes Sudden vision problems; sudden severe headache without other cause)
Symptoms of gastrointestinal (stomach or intestine) bleeding (such as blood in the stool; black, tarry stools; coughing or vomiting of blood or material that looks like coffee grounds; abdominal pain; shortness of breath; weakness or tiredness)
Some people may experience other side effects than those listed. If you notice any symptoms that worry you while taking the medicine, please contact your doctor in time

Contraindications:
Contraindicated in patients allergic to bortezomib, boron or mannitol.

Precautions:
Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (e.g., boron, mannitol) that may cause allergic reactions or other problems.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: nerve problems (such as peripheral neuropathy), liver disease, kidney disease, too much water in the body (dehydration), heart disease (such as heart failure), bleeding/blood disease, current/recent infection, diabetes.
This medicine may make you dizzy. Alcohol or marijuana (cannabis) can make you dizzy. Do not drive, use machinery, or do anything that requires caution until you can do so safely. Limit alcoholic beverages.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Bortezomib can make you more susceptible to infections or may worsen a current infection. Avoid contact with infected people (e.g., chickenpox, measles, influenza) that may be spread to others. Please consult your doctor if you have been infected or for more details.
No immunization/vaccination without doctor's consent. Avoid contact with people who have recently received live vaccines (such as flu shots inhaled through the nose).
To reduce the possibility of cuts, scrapes, or injuries, use caution with sharp objects such as razors and nail clippers, and avoid activities such as contact sports.
Tell your doctor if you are pregnant or plan to become pregnant. You should take a pregnancy test before starting this medication. You should not become pregnant while using bortezomib. Bortezomib may harm your unborn baby. Women should ask about reliable forms of birth control while using this medication and for 7 months after stopping treatment. Men should ask about reliable forms of birth control while using this medication and for 4 months after stopping treatment. If you or your partner become pregnant, talk to your doctor right away about the risks and benefits of this medication.
It is not known whether this drug passes into breast milk. Due to the possible danger to the baby, breastfeeding is not recommended while using this drug and for two months after stopping use of this drug. Consult your doctor before breastfeeding.

Storage:
Unopened vials may be stored at controlled room temperature of 25°C (77°F); allowed excursion range is 15 to 30°C (59 to 86°F)

Mechanism of Action:
Bortezomib is a reversible inhibitor of the chymotrypsin-like activity of the 26S proteasome in mammalian cells. The 26S proteasome is a large protein complex that degrades ubiquitinated proteins. The ubiquitin-proteasome channel plays an important role in regulating the concentration of specific proteins in cells to maintain the stability of the intracellular environment. Proteolysis affects multi-level signaling cascades within cells, and this disruption of the normal intracellular environment can lead to cell death. Inhibition of the 26S proteasome prevents the hydrolysis of specific proteins. In vitro experiments have demonstrated that bortezomib is cytotoxic to many types of cancer cells. In vivo trials in preclinical tumor models have demonstrated the ability of bortezomib to delay tumor growth, including multiple myeloma.

Efficacy and Safety:
Two open-label Phase II clinical trials (SUMMIT and CREST) ​​determined the efficacy of Velcade 1.3 mg/m2 (with or without dexamethasone) given as an intravenous bolus on days 1, 4, 8, and 11 of a 21-day cycle in heavily pretreated patients with relapsed/refractory multiple myeloma for up to 8 cycles. The phase III APEX trial demonstrated that bortezomib 1.3 mg/m2 was superior to the high-dose dexamethasone regimen (eg, median TTP 6.2 vs 3.5 months, 1-year survival rate 80% vs 66%). Experimental Use: Velcade has been trialled in systemic lupus erythematosus (SLE) and appeared to reduce disease activity and plasma cell counts, but seven of 12 patients dropped out due to side effects, some of which were serious.
Velcade/bortezomib has been studied for the treatment of antibody-mediated renal allograft rejection. One study found that the use of high-dose intravenous immunoglobulin and a bortezomib-based regimen appeared to be useful, particularly when compared with a historical group of patients treated with low-dose intravenous immunoglobulin, plasmapheresis, and rituximab. Reminder: Peripheral neuropathy occurs in 30% of patients with bortezomib; this can occasionally be painful. This can be worse in patients with pre-existing neuropathy. Additionally, myelosuppression leading to neutropenia and thrombocytopenia may occur.