Imbruvica: what are the indications on the package leaflet and side effects?

Many serious illnesses require expensive drugs for treatment. High-Cost Medicines have high values ​​and, often, the cost is even greater because they are of prolonged use. In addition, many medications are difficult to access.

An example of these drugs is Imbruvica, indicated for the treatment against some types of cancer in the blood.

What is Imbruvica?

Imbruvica is a chemotherapeutic drug, in the form of a hard gelatinous capsule, used to treat cancer. It is a relatively new therapeutic substance in Brazil.

It contains the active substance ibrutinib, approved by the Food and Drug Administration (United States) and the National Health Surveillance Agency (Brazil).

Its action inhibits Bruton’s tyrosine kinase (BKT), a protein that maximizes the development of cancer cells. With this, Imbruvica can reduce and even eliminate these cells, delaying the spread of cancer.

According to the National Cancer Institute (INCA), the drugs used in chemotherapy have the function of destroying sick cells. Thus, they prevent them from spreading, being mixed with blood and carried to all parts of the body.

According to the Brazilian Oncology Manual, the active substance Ibrutinib has been shown to be highly effective in low-grade lymphomas, including mantle cell lymphoma and chronic lymphocytic leukemia.

What is Imbruvica for?

Imbruvica serves to block the enzyme that allows cancer cells to grow and multiply. It is used to treat the following types of blood cancer in adults:

Mantle Cell Lymphoma (LCM)

It is a type of cancer that affects the lymph nodes, which are responsible for the defense of the organism and the production of antibodies. Imbruvica can be indicated for patients who have received at least one previous treatment containing the rituximab antibody and who have not had good results.

Chronic Lymphocytic Leukemia (CLL) and Small Cell Lymphocytic Lymphoma (LLPC)

It is a type of cancer caused by white cells called lymphocytes, which multiply in an disordered way in the blood or in the lymph nodes. It is a rare disease in the blood and bone marrow that usually gets worse over time.

Macroglobulinemia de Waldenström

It is a type of cancer that affects white blood cells (lymphocytes). Imbruvica can be considered for patients who have received at least one previous treatment against the disease and there have been no results.

Marginal Zone Linkage (LZM)

It is a type of cancer that affects white blood cells (lymphocytes). In these cases, Imbruvica is indicated for patients who have already received a previous treatment containing rituximab and have not shown improvement.

Graft versus host chronic disease (GVHDc)

It is a condition in which transplanted cells from another donor person attack the recipient body and cause organ damage.

Is it released by Anvisa?

Imbruvica, from the manufacturer Janssen-Cilag Farmacêutica LTDA, was approved and registered by the National Health Surveillance Agency (ANVISA) in 2015, becoming a nationally released drug.

What are the side effects of Imbruvica?

According to the World Health Organization (WHO), the side effects of a medication are undesirable and unintended reactions of the organism in response to the use of some pharmacological substance.

Like all medicines, Imbruvica can cause some side effects, depending on the patient’s disease and body. Check out what these effects are:

Bleeding (bleeding)

During treatment with Imbruvica, reactions such as ecchymosis (red-purple spots on the skin) or nosebleeds may appear.

In rare cases, severe internal bleeding may occur in the stomach, intestine or brain, which may lead to the death of the patient.

In cases where the person uses other medications or supplements that increase the risk of bleeding, it is necessary to seek medical advice and inform the use of such substances.

Leucostase

Leukostasis is the difficulty in blood circulation due to the increase in the number of white cells in the blood.

In rare cases, this increase can be severe and hinder the flow of blood in the blood vessels. It is necessary to monitor the blood count.

Infections

Viral, bacterial or fungal infections may arise during treatment with Imbruvica.

If symptoms such as fever , chills, weakness, confusion, body aches, cold or symptoms of cold , tiredness and shortness of breath are present, seek medical advice, as these may be signs of an infection.

Reduced blood cell count

The use of Imbruvica can decrease the number of red blood cells, as well as white cells (neutrophils) and platelets (cells that help the blood to clot).

It is recommended that cell counts be performed regularly for verification and monitoring.

Non-heart rhythm problems

Problems in the heart rhythm can appear as acceleration and irregularity of the beats, vertigo, dizziness , shortness of breath and chest discomfort. In the presence of any symptom, the patient should seek medical advice.

Lung Disease, Interstitial

DPI, or interstitial lung disease, is actually a group of different respiratory diseases, leading to damage to breathing. The term interstitial refers to the space between the membranes of the endothelium and epithelium.

In general, inflammatory processes occur in the lungs, triggering progressive scarring, called fibrosis. This leads to respiratory impairment.

Tumor lysis syndrome

This syndrome can happen during treatment with Imbruvica and is characterized by the mass destruction of malignant cells, thus releasing the content of these cells in the extracellular space.

Despite the possibility of occurring spontaneously, the tumor lysis syndrome usually appears soon after the beginning of chemotherapy treatment against cancer.

This can cause changes in kidney function, abnormal heartbeat or seizures . To check for tumor lysis syndrome, blood tests may be performed regularly.

Non-melanoma skin cancer

Non- melanoma skin cancer can present tumors of the epidermis layer of different types.

The most frequent are basal cell carcinoma (a slow-growing lesion originating in the basal layers of the epidermis) and squamous cell carcinoma (tumor that appears in the most superficial layer of the skin, especially in the regions of the body most exposed to solar radiation).

Arterial hypertension

Treatment with Imbruvica can cause a sudden increase in blood pressure and, in people who already have hypertension, worsening may occur.

In such cases, antihypertensive medications or changes in the medication consumed by the patient may be indicated, by medical guidance, in order to control blood pressure.

Allergic reactions

Signs of an allergic reaction such as swelling of the face, lips, mouth, tongue or throat, difficulty swallowing or breathing, itchy rashes (hives) and redness of the skin may appear.

In the presence of any of these signs, the indication is to suspend the use of the medication and seek medical attention.

Other adverse reactions

Several other adverse reactions have been identified through clinical studies or reported during the post-marketing period of the drug. Check below, in occurrence levels, what these reactions are:

Very common reactions

They occur in more than 10% of patients who use this medication:

  • Pneumonia;
  • Infection of the upper respiratory tract (nose, sinuses or throat);
  • Skin infection;
  • Neutropenia (reduced neutrophil count in the blood);
  • Thrombocytopenia (low platelet count in the blood);
  • Headache (headache);
  • Hematomas;
  • Joint pain;
  • Muscle spasms (involuntary contraction of the muscles);
  • Musculoskeletal pain (pain in bones, muscles, tendons, ligaments and joints);
  • Fever;
  • Peripheral edema (swelling in the lower limbs);
  • Bronchitis;
  • Diarrhea;
  • Nausea;
  • Stomatitis (thrush in the mouth and / or throat);
  • Abdominal pain;
  • Constipation (constipation);
  • Rash;
  • Musculoskeletal pain.

Common reactions

Between 1% and 10% of patients using this medication occur:

  • Sepsis (generalized infection);
  • Sinusitis;
  • Urinary tract infection;
  • Non-melanoma skin cancer (skin tumor);
  • Basal cell carcinoma (type of skin cancer that begins in the basal cells);
  • Squamous cell carcinoma (Cancer caused by an uncontrolled growth of abnormal squamous cells);
  • Febrile neutropenia (decrease in neutrophils in the blood with fever);
  • Leukocytosis (increase in the number of white blood cells);
  • Lymphocytosis (increase in the number of a type of white blood cells, lymphocytes);
  • Interstitial lung disease (chronic respiratory disorder);
  • Sinusitis (sinus infection);
  • Hyperuricemia (elevated uric acid levels in the blood);
  • Peripheral neuropathy (change in sensitivity, weakness or pain, especially in the hands and feet);
  • Dizziness;
  • Blurred vision;
  • Petechia (red spot on the skin or mucous membranes, caused by a small hemorrhage from blood vessels);
  • Hives (skin irritation);
  • Erythema (redness of the skin);
  • Onycholysis (detachment of nails).

Unusual reactions

Occurs between 0.1% and 1% of patients using this medication:

  • Reactivation of Hepatitis B;
  • Subdural hematoma (accumulation of blood between the brain and the skull);
  • Angiodema (swelling of the skin);
  • Panniculitis (inflammation of the adipose tissue under the skin);
  • Ventricular tachyarrhythmia (change in heart rhythm).

It is important to note that not every patient will experience such side effects. Therefore, medical monitoring and attention to any symptoms presented, is essential during treatment with Imbruvica.

According to the package insert, the drug has a relatively new therapeutic indication in the country. Although research has indicated acceptable efficacy and safety and the use is done correctly, unpredictable and unknown adverse events can occur.

Fat?

There are no reports that the drug Imbruvica is fattening. What appears in the side effects of the medication is the swelling, which can give the impression that the patient has gained weight.

The side effects of cancer treatment are often contradictory. Some people may lose weight due to lack of appetite , nausea and diarrhea , caused by medication.

On the other hand, they may gain weight due to indisposition for physical activities, compensation for food due to anxiety or decrease in metabolism due to chemotherapy medication.

Therefore, the medicine Imbruvica does not make you fat, but the disease in general can cause changes in weight.

What is the value and where to buy?

The value of Imbruvica varies between R $ 41,550 and R $ 43,900, the box with 90 hard capsules, and about R $ 52,900 to R $ 65,180 box with 120 capsules *.

It can be purchased at physical pharmacies and online, such as Consulta Remédios , in which it is possible to make a quote and compare prices.

* Values ​​consulted in November 2019 at Consulta Remédios. Values ​​may change without notice.

Does SUS provide Imbruvica?

According to the Health Department of Paraná, SUS does not directly provide cancer drugs.

According to the National Commission for the Incorporation of Technologies in SUS (CONITEC), those who supply this medication are hospitals accredited by SUS and qualified in oncology, which are reimbursed by the Ministry of Health.

Currently, the Oncology Care Network is formed by health establishments qualified as a Unit of High Complexity Assistance in Oncology (UNACON) or as a Center of Assistance of High Complexity in Oncology (CACON).

In order to order the medication, it is necessary to resort to judicial means, opening a process of judicialization of medications. The process will be analyzed by competent bodies and, if the cost of treatment is granted, patients have the right to withdraw them free of charge by SUS.

In addition, it is necessary to submit a drug quote. To facilitate this process, it is possible to access the Advice on judicial quotations for obtaining high-cost medications. Simply and quickly, you receive a quote for Imbruvica.

Can I get it for health insurance?

According to the National Cancer Institute (INCA), health plans must provide the medication Imbruvica (registered by Anvisa), for patients undergoing cancer treatment.

The resolution was published by the National Supplementary Health Agency (ANS) in the Federal Official Gazette, in January 2018. Therefore, it is possible to request Imbruvica whenever there is a medical prescription.

Are there Imbruvica donation centers?

No. The donation of high-cost drugs from SUS is prohibited by the Ministry of Health due to the risks of using the substances.

This practice causes loss of control over the validity, storage and handling of medication. In addition, there is the possibility for people to obtain the medication and use it without a proper medical prescription.

Donation is not prohibited, but it is not recommended. The guidance of specialists is that if the patient is unable to acquire Imbruvica, request it through the Health Department or health plan by means of an application, to make the treatment safely.


High-cost medications are a way of mitigating symptoms caused by serious illnesses and increasing the chances of patients’ survival.

To learn more about health and medicines, keep following the Healthy Minute!

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