Dalinvi: how does it work and what are the most common side effects?

The diagnosis of cancer is always a difficult process, due to the complexity of the disease. However, more and more, patients and close people have therapeutic resources to control the disease and have a better quality of life.

Although many of them require high-cost treatments, there are ways to access medications as soon as cancer patients have rights and benefits supported by legislation.

Access to the treatment indicated by the medical team, for example, is one of these rights. A few years ago, Dalinvi was approved by Anvisa for some cases of multiple myeloma. Medication brings new perspectives to treatment and favors the improvement of people’s well-being. Find out more about it:


What is Dalinvi?

Dalinvi is an injectable drug, administered via intravenous infusion, for the treatment of some situations of multiple myeloma (type of bone marrow cancer) in adults.

That is, the solution is applied as a serum that can take a few hours to be fully administered, depending on each case. That’s because the process needs to be slow to reduce the chances of reactions and side effects.

The medication has the active substance daratumumab, which acts by binding to cancer cells in the body, allowing them to be destroyed.

Treatment can be done in conjunction with other remedies, such as bortezomib and dexamethasone, or in isolation, according to the diagnosed condition, always according to medical guidelines.

Studies show that the use of it prevents the progression of the disease and considerably reduces the risk of death. Based on this, ANVISA approved the medication for the treatment of multiple myeloma, in Brazil, in January 2017, allowing for easier treatment of the disease.

Instructions for use: what is Dalinvi for?

Dalinvi is indicated for the treatment of multiple myeloma in some conditions.

Adult people who have received at least one previous treatment for multiple myeloma. In this case, they must use the medication associated with lenalidomide + dexamethasone or bortezomib + dexamethasone (other antineoplastic medications).

In this case, they must use the drug associated with bortezomib and dexamethasone (other antineoplastic medications).

In isolation, Dalinvi should be used on people who:

  • They have already been treated with at least three medications for multiple myeloma, including a proteasome inhibitor (IP) and an immunomodulatory agent;
  • Who did not respond to treatment with a proteasome inhibitor or an immunomodulatory agent.

More recently, Anvisa approved the drug (together with other substances) as a first line of therapy in people who are not indicated for autologous bone marrow transplantation (a process in which a part of the person’s bone marrow is collected, receiving drugs that destroy diseased cells and is reintroduced into the person).

That is, as soon as someone is diagnosed with multiple myeloma and, due to the adverse effects or risks of the transplant, has no indication for therapy, the active ingredient Daratumumab can be used.

What is multiple myeloma?

Multiple myeloma is a type of cancer that begins in the bone marrow (internal bone tissue), caused by a problem in the cells. The marrow is responsible for the production of blood cells, such as red and white blood cells.

In the process of producing a specific type of cell, plasmocytes (which will produce antibodies), an error occurs in one of its genes. This results in abnormal plasma cells, also called malignant cells.

Gradually, they accumulate in the bone marrow and make up a malignant tumor, which ends up also impairing the action of other healthy cells. This all results in an increased risk of anemia and infections (due to low immunity).

Among the treatments currently available, there are:

  • Chemotherapy (acts by fighting, controlling or inhibiting the growth of diseased cells);
  • Immunomodulators (act directly on the immune system, improving the body’s responses);
  • Proteasome inhibitors (act to attack sick cells), bone marrow transplantation;
  • Monoclonal antibodies (antibodies produced in the laboratory that act on the immune system).

Dalinvi is part of the latter group of monoclonal antibodies , also called immunotherapy. In this type of approach, the medication makes the body itself recognize the diseased cells and attack them.

How does the active substance Daratumumab act?

Daratumumab is a human monoclonal antibody, that is, an agent produced to attack specific cells.

After administration, the substance binds to the CD38 protein, which is found in large quantities on the surface of myeloma cells and in different hematological malignancies.

This connection allows the destruction of cancer cells and makes the immune system able to attack them as well.

What are the most common side effects?

According to the package insert, the most frequent adverse reactions associated with the use of Dalinvi are related to the infusion process. Wheezing may occur, difficulty breathing, swelling in the throat or swelling of the lungs, decreased oxygen concentrations in the blood, increased blood pressure and nasal congestion.

These reactions tend to be more common in the first infusion and, gradually, the occurrence rates decrease with each new application. Also remembering that not all people will necessarily experience an adverse symptom.

In addition, the label lists the most common reactions associated with the use of the drug, which are pneumonia , upper respiratory tract infection, decreased white blood cell count, lymphocytes and platelets, anemia, headache , cough , shortness of breath, diarrhea , nausea, vomiting, fatigue , fever and swelling in the extremities.

Contraindications: when not to use Dalinvi?

According to the package insert, Dalinvi should not be used by people with previous knowledge of allergy or severe hypersensitivity to the active substance Daratumumab.

What is the dosage indicated on the package leaflet?

The Dalinvi package leaflet states that the dose of Daratumumab (active substance) is 16mg / kg of body weight, administered by intravenous infusion, according to the weekly schedule duly guided by the medical team responsible for the treatment.

It is worth mentioning that the dosage, the days of application, the treatment time and any other information related to the administration must be guided by specialist professionals. In addition, the application of the drug should be done only in appropriate environments and by trained people.

Price and where to buy?

The Dalinvi is a counter medicine allowed only for hospitals, and the average price is from R $ 2500 *, varying according to how many mL have in each vial and also miligramagem.

It is worth remembering that patients diagnosed with cancer have some benefits, ensured by the Brazilian Legislation, so that treatment and well-being are ensured.

Therefore, it is possible to obtain drugs (even those at high cost) through SUS or through a special request through the courts.

People who have a medical indication for the use of the medication and are making the judicial request can count on the high cost medication quotation advice , by Consulta Remedies.

In a simple and personalized way, for this and several other treatments, it is possible to obtain the 3 quotes from different pharmacies necessary for the progress of the lawsuit.

* Average price consulted in December 2019. Prices may change.

Is Dalinvi approved by ANVISA?

Yea! On January 30, 2017, Dalinvi was approved by Anvisa for the treatment of multiple myeloma, under two specific therapeutic conditions.

In 2018, Janssen Brasil, the pharmaceutical industry, announced that Anvisa also approved, in advance, Dalinvi for the treatment of newly diagnosed people with multiple myeloma ineligible for autologous bone marrow transplantation. Thus, Brazil was the first country in the world to approve the use in this case.

Multiple myeloma is a condition that, although it can be asymptomatic, can cause symptoms that greatly compromise the life and well-being of patients. Regardless of symptomatic manifestations, after being diagnosed, the disease must be treated and monitored by onco-hematologists.

Increasingly, there are therapies that provide better results to people. Although there is no cure, the disease can be controlled with multiple treatment and care, including dietary changes and medication use.

Dalinvi is among the most recent treatments, indicated for specific cases of the disease. To learn more about multiple myeloma and other conditions, follow the Healthy Minute!