Velcade is an anti-tumor drug that is used to treat malignant tumors.
Release form and composition
Velcade is produced in the form of a lyophilisate, from which a solution is prepared for intravenous or subcutaneous administration. It is a white or almost white powder / lyophilized mass.
One vial contains 3.5 mg of bortezomib (PS-341). Auxiliary components: nitrogen and mannitol.
Pharmacies drug comes in 10 ml.
Indications for use
As an agent of the 1st line of therapy, Velcade is prescribed as part of the complex treatment of multiple myeloma (cancer, a type of plasma cell leukocyte in the bone marrow).
The use of Velcade as a means of 2 line therapy is appropriate for multiple myeloma and mantle cell lymphoma (high-grade B-cell neoplasm) in patients who have previously undergone at least 1 line of therapy.
According to the annotation to the drug, Velcade should not be prescribed for:
- Hypersensitivity to mannitol, bortezomib and / or boron;
- Acute interstitial lung disease;
- Pericardial lesions;
- Pregnancy and breastfeeding period.
There is no experience with Velcade in pediatrics, and therefore it is forbidden to prescribe the drug to children and adolescents under 18 years of age.
With caution, the drug is prescribed for:
- Moderately severe and severe violations of the liver;
- Severe renal dysfunction;
- Dehydration on the background of diarrhea or vomiting;
- Simultaneous use of antihypertensive drugs, inhibitors or substrates of CYP3A4 and CYP2C9 isoenzymes, oral hypoglycemic agents;
- Increased risk of developing chronic heart failure.
In addition, the instructions to Velcade indicate the need for careful use of the drug in patients with a history of indications of convulsive states, epilepsy or diabetic neuropathy.
Dosing and Administration
Velcade is intended only for subcutaneous and intravenous administration.
With intrathecal (directly into the cerebrospinal fluid system) administration, in some cases a lethal outcome was recorded!
The optimal concentration of the solution with the on / in the introduction - 1 mg / ml, with subcutaneous - 2.5 mg / ml.
Due to the fact that the concentration of the solution with different methods of administration of Velcade is significantly different, the issues of calculating the dosage should be approached with special care.
As a monotherapeutic agent, Velcade is recommended to be injected into the subcutaneous tissue or injected into the vein for 3-5 seconds.
The starting dose of the drug is 1.3 mg per square meter of patient surface area. This dosage is calculated on a 2-week course with a multiplicity of applications 2 times a week - in 1, 4, 8 and 11 days. At the end of one course stand a 10-day break (from 12 to 21 days). It should be remembered that between injections of successive doses of the drug should take at least 72 hours.
Assessment of the degree of therapeutic response is carried out after the passage of patients 3 and 5 cycles of treatment with the use of Velcade.
As soon as the full clinical response is reached, an additional 2 cycles of therapy are performed.
If the duration of treatment exceeds 8 cycles, Velcade is allowed to use both the standard scheme and the scheme of maintenance therapy, which involves the introduction of a weekly solution for 4 weeks - 1, 8, 15 and 22 days. At the end of the course from 23 to 35 days maintain a 13-day interval.
In the absence of a clinical response to therapy (i.e., if the disease continues to progress or stabilizes only after 2 or 4 cycles of treatment, respectively), according to the instructions to Velcade, the administration of the drug is permitted in combination with high doses of dexamethasone.
2. Combination Therapy
In this case, Velcade is injected into the subcutaneous tissue or jet into the vein for 3-5 seconds. Melphalan and prednisone are taken orally.
Treatment involves 9 6-week cycles. From the first to the fourth cycle, this drug is used twice a week (in 1, 4, 8, 11, 22, 25, 29 and 32 days), and from the fifth to the ninth cycle - once a week (in 1, 8, 22 and 29 days).
Dose adjustment and the method of administration of Velcade are carried out depending on the characteristics of the patient’s body and its response to drug treatment, the stage of development of the tumor process and the overall clinical situation.
The safety profiles of Velcade when used in monotherapy and in combination with other drugs (melphalan and prednisone) are similar.
The most common side effects are:
- Thrombocytopenia, neutropenia, anemia;
- Cardiogenic shock, cardiac arrest, angina pectoris, myocardial infarction, development / exacerbation of heart failure, pulmonary edema, complete atrioventricular block, ventricular hypokinesia, stopping of the sinus node, atrial fibrillation;
- Nausea, diarrhea, sore throat and pharynx, constipation, vomiting;
- Headache, dry mouth, peripheral neuropathy, paresthesia, depression, confusion, insomnia, vertigo, eye pain, blurred vision;
- Dehydration, hyper- or hypokalemia, rash on the skin, peri-lary edema, myalgia, increased fatigue, hyperthermia.
Treatment with Velcade should be carried out only under the supervision of a specialist who has sufficient experience in the use of anticancer chemotherapeutic agents.
Analogs of Velcade are the drugs Amilan FS, Milanfor, Boramlan FS, L-asparaginase, Arglabin, Hexalen, Hydrea, Irinotecan, Campto, Estracyt, Zolinza, Thromboreduktin, Zaltrap, Prospidin, Halaven, Erivedzh.
Terms and conditions of storage
Store Velcade should be in a dry, dark place. The optimum temperature is up to 25 ° C. The shelf life of the lyophilisate is 36 months, the solution prepared from it is 8 hours.