Multiple myeloma is a type of bone marrow cancer that is not so common (on average 150 thousand cases per year in Brazil), affecting mainly elderly people.
Some of the symptoms of the disease include: bone damage, muscle weakness, kidney failure, reduced blood cell production (red and white blood cells, platelets).
Among the treatments performed for this disease, there is the use of medications that rely on the active ingredient Bortezomibe. Check out more information about this substance below:
- 1 What is Bortezomibe?
- 2 What is Bortezomibe for?
- 3 What is the mechanism of action of the active ingredient Bortezomibe?
- 4 Is it chemotherapy?
- 5 How does the package insert indicate using Bortezomib?
- 6 What are the side effects of Bortezomibe?
- 7 What is the reference medicine? Are you generic?
- 8 What is the value of Bortezomibe?
- 9 Are you in SUS?
- 10 Is it approved by ANVISA?
- 11 How to budget Bortezomibe?
What is Bortezomibe?
Bortezomib is the active ingredient in some medications used to treat some cases of multiple myeloma (a type of bone marrow cancer).
But there are some pre-established conditions for the patient to qualify for treatment with Bortezomibe – such as not having responded to previous treatments, for example.
It is a powder that must be diluted to be applied intravenously (directly into the vein) or subcutaneously (under the skin).
The substance belongs to a group classified as cytotoxic – which includes drugs used to kill cancer cells. Some studies indicate that patients with multiple myeloma have a response within 1.5 months undergoing treatment with Bortezomib.
What is Bortezomibe for?
Bortezomibe may be indicated for the treatment of adults with multiple myeloma (bone marrow cancer), who meet certain criteria. The conditions for use are: not having been treated with a high dose of chemotherapy or not being able to do it, not being able to have a bone marrow transplant and having already had at least one previous treatment.
In addition, in some cases, Bortezomib can be used in conjunction with medications such as melphalan, prednisone, dexamethasone and / or thalidomide. Guidance that will be given by the responsible medical team.
Other conditions for the patient to receive treatment are: not having undergone previous treatment, being eligible to receive induction with a high dose of chemotherapy with hematopoietic stem cell transplantation.
Among other functions, hematopoietic cells are responsible for the production of blood cells.
What is the mechanism of action of the active ingredient Bortezomibe?
The active ingredient Bortezomibe is characterized as a reversible inhibitor of the activity of the proteasome – protein complex produced by the body, which can degrade ubiquitinated proteins , a type of protein that “marks” unwanted or defective proteins so that they can be destroyed.
Being a reversible inhibitor means that it reduces the activity of proteins, but for a certain period, not establishing a stable relationship.
The joint work of proteasomes and ubiquitinated proteins is essential to regulate the intracellular concentration of certain proteins. Only in this way is it possible to maintain cellular homeostasis (the ability to maintain the internal environment in stability).
That’s where Bortezomibe’s mechanism of action is. It breaks with this natural cycle by inhibiting the function of the proteasome and thus destroys intracellular stability. This interruption is what can lead to cell death (a process necessary in the treatment of cancer).
With that, studies prove that Bortezomibe causes a delay in tumor growth and cancer cell death.
Is it chemotherapy?
-Yeah . According to the Oncoguia Institute, the active ingredient Bortezomibe is a drug used in chemotherapy treatments. In this case, it is characterized as a proteasome inhibitor.
It is an energy-dependent enzyme (protein) (ATP) used to destroy damaged or synthesized proteins.
How does the package insert indicate using Bortezomib?
The substance Bortezomib can be administered intravenously (into the vein) or subcutaneously (injection under the skin).
However, considering that the drug can be used in conjunction with other substances, the package insert indicates that subcutaneous administration is only for when Bortezomibe is used alone.
In addition, there are indications that the volume of sodium chloride solution varies according to the different routes of administration.
According to the package insert, the recommended dose is 2 applications per week for two weeks (days 1, 4, 8 and 11). After that, you must take a 10-day break – thus characterizing a treatment cycle.
It is recommended that, if they present a satisfactory response to Bortezomibe, patients undergo up to 8 cycles of treatment.
It is worth mentioning that the preparation and application of the substance must be carried out by a health professional.
What are the side effects of Bortezomibe?
All medications and substances can cause side effects, but this varies between patients – it is possible to have no symptoms or even more than one. The drug (active ingredient) Bortezomibe can cause everything from “simple” reactions such as weakness and vomiting to serious complications such as pneumonia and kidney failure.
Check the details of some side effects according to the package leaflet:
Very common adverse reactions are those that occur in more than 10% of people who use them:
- Blood and lymphatic system disorders;
- Ophthalmological disorders: blurred vision;
- Gastrointestinal disorders: constipation , diarrhea , nausea, vomiting, gastrointestinal and abdominal pain, dyspepsia (discomfort in the stomach area);
- Asthenia (muscle weakness), weakness, fatigue, fever;
- Infection of the upper, lower respiratory tract and lungs, nasopharyngitis;
- Reduced appetite and anorexia, dehydration;
- Limb pain, myalgia (muscle pain), arthralgia (joint pain);
- Disorders of the nervous system: peripheral neuropathy (pain and / or tingling in the extremities), paresthesia and dysesthesia (weakening or alteration in the sensitivity of the senses), dizziness (excluding vertigo), headache, dysgeusia (distortion or decreased taste);
- Anxiety , insomnia;
- Cough, dyspnoea (shortness of breath);
- Low blood pressure.
We can also list the common reactions , which occur between 1% and 10% of people:
- Disorders of the blood and lymphatic system: leukopenia (decrease in leukocytes), lymphopenia (decrease in the number of lymphocytes), pancytopenia (decrease in all blood cells);
- Tachycardia (accelerated heartbeat), atrial fibrillation (altered heart rhythm), palpitations, pulmonary edema;
- Infection and conjunctiva irritation;
- Gastrointestinal reflux , abdominal distention, stomatitis and ulceration in the mouth, dysphagia (difficulty in swallowing), gastrointestinal hemorrhage (upper and lower tract) and rectal;
- Drowsiness, malaise, neuralgia (nerve pain without stimulation), chest pain ;
- Pneumonia , herpes simplex , bronchitis , sinusitis , pharyngitis, oral candidiasis , urinary tract infection;
- Hyperglycemia (increase in blood sugar), hypoglycemia (decrease in blood sugar), hyponatremia (decrease in blood sodium);
- Fainting ;
- Renal failure or failure, hematuria (presence of blood in the urine);
- Epistaxis (nosebleed), dyspnea on exercise, pleural effusion (accumulation of fluid around the lung), rhinorrhea (nasal discharge);
- Hives (itching with redness);
- Postural hypotension (drop in blood pressure when changing from sitting or lying to standing position), petechiae (red spot on the body caused by small hemorrhage).
To check for rare or very rare reactions, the ideal is to seek medical advice and consult the package insert for the substance .
What is the reference medicine? Are you generic?
A reference medicine is the originator of the medicine’s formula – which will later be made available to other laboratories to manufacture other versions.
When a drug is created, those who develop it gain exclusive time (patent) for marketing. This is provided due to the investments made during the period of preparation of the medicine.
After that time, other laboratories have access to the formula and can create generic or similar versions.
In the case of the active ingredient Bortezomibe, the reference medicine is Velcade . For this drug, there are already other versions available, both generic and similar. Check out:
- Bortezomibe Accord Farma (genérico);
- Bortezomibe Doctor Reddy’s (genérico);
- Bortezomibe Bergamo / Amgen (generic);
- Bozored (similar interchangeable);
- Myelocade (similar interchangeable);
- Bortyz (similar interchangeable);
- Tovar (similar interchangeable);
- Verazo (similar).
Similar interchangeable means that the medicine was approved by ANVISA as a medicine that can replace the reference one safely and effectively – which should always be done with medical guidance.
The difference between the similar and the interchangeable similar is that for a drug to be considered “interchangeable” (that is, possible for equivalent exchange) it is necessary to pass specific tests.
To be in this classification, you need to pass a bioequivalence and bioavailability test compared to the reference.
The tests prove the effectiveness of the drug and check its time of action / absorption. Thus, when it is classified as interchangeable, it is understood that the remedy acts the same as the reference.
It is worth remembering that the exchange of one medication for another should only be done with medical guidance.
What is the value of Bortezomibe?
The Bortezomib is the active ingredient of some medicines of different brands and manufacturers, among them there is the reference version and also generic and similar.
Consequently, there is a price variation *. Check now some of the responsible laboratories, their available medications and approximate values:
* Prices consulted in February 2020. Prices may change.
The Janssen-Cilag laboratory is responsible for the reference drug Velcade , that is, the originator of the formula that contains Bortezomib as an active ingredient.
Prices vary according to the region and availability of the drug. But, in general, the value of Velcade 3.5mg – box with 1 vial with powder for solution for intravenous use (hospital packaging) is close to R $ 5,000.
The Dr. Reddys laboratory produces two drugs whose active ingredient is Bortezomibe, it is a generic version and a similar one. Check prices:
- Bozored 3.5mg (similar interchangeable) – in general, the price of the box with 1 ampoule is around R $ 3,000;
- Bortezomibe Doctor Reddy’s 3.5mg (generic) – usually the price of the box with 1 ampoule varies between R $ 1,290 and R $ 2,089.
In this case, the Sandoz laboratory is responsible for marketing the medicine imported by Accord Farmacêutica.
It is a generic medicine, Bortezomibe Accord Farma 3.5mg – the price of the box with 1 ampoule is usually between R $ 2,000 and R $ 3,000.
Bergamo / Amgen
In partnership, the Bergamo and Amgen laboratories are responsible for a generic version that contains Bortezomibe as an active ingredient.
The drug is Bortezomibe Bergamo / Amgen 3.5mg and the box with 1 ampoule has a price of around R $ 1,000.
Are you in SUS?
No . Bortezomibe (as well as the drugs that contain it as an active ingredient) is not present in the National List of Essential Medicines (RENAME) of 2020. Therefore, it is currently not available through the Unified Health System (SUS).
In addition, medicines based on Bortezomibe are not considered to be exceptionally dispensable.
Is it approved by ANVISA?
-Yeah . The active ingredient Bortezomibe is approved by ANVISA (National Health Surveillance Agency) and classified as a cytotoxic antineoplastic agent.
It is worth noting that approval for the drug does not mean that laboratories do not need to request individual records for drugs derived from this substance. Therefore, it is necessary to carry out an individual consultation – which can be done on the ANVISA website itself.
How to budget Bortezomibe?
When the drug (active ingredient) and derived drugs are not available via SUS, patients with medical reports can make a judicial request to try to receive the treatment paid for by the government or even through the Health Plan – if applicable.
So, it is necessary to open a process according to the stipulated requests. Among them is the delivery of documents that include: medical report, exams, standard requirement and budget from 3 pharmacies .
To facilitate the procedure, it is possible to count on the help of the advisory in judicial quotations for the purchase of medicines, which provides a personalized quote in an easy way.
When accessing the link , it is necessary to perform your registration, stating some personal data and the medication in question. Finally, click on “request quotes” and wait for the return.
High-cost medications, such as those containing Bortezomib, are used to treat a variety of conditions – especially the rarest ones. Therefore, having reliable information about these medications is very important.
You can learn more about other remedies and substances by accessing the Remedies tab here at Minute Healthy. Keep following us for more texts on health, well-being, food and more!