Adcetris: is it provided by SUS? What are the indications?

With the advancement of medicine, more and more patients with serious diseases are gaining more chances of cure and quality of life.

An example of this is the drug Adcetris manipulated by the pharmaceutical company Takeda. Do you want to know more about this remedy? Check the text below.

What is Adcetris?

Adcetris is a biological medicine, applied intravenously (directly into the vein).

The application should only be done in a hospital environment and with the help of health professionals.

It is indicated for the treatment of patients who have not responded to treatment against Hodgkin’s Lymphoma or against large-cell anaplastic lymphoma under specific conditions.

What is it for?

Adcetris is indicated to treat the following conditions:

  • When the patient has Hodgkin’s Lymphoma who has returned or has not responded to other forms of treatment after receiving an autologous stem cell transplant (when the person receives an infusion of their own stem cells);
  • When the patient has Hodgkin’s Lymphoma who has returned or has never responded to at least two previous treatments;
  • If the patient has Hodgkin’s lymphoma and can not receive chemotherapy drugs or stem cell transplantation.

In conjunction with other medications, Adcetris is used when the person has anaplastic large cell lymphoma and has not responded to other forms of treatment.

But, after all, what are these diseases? Learn more about them:

Hodgkin’s lymphoma

Quite simply, it can be said that this complication is a type of cancer that begins in the lymphatic system (set of organs, lymphatic vessels and lymph, responsible for the production of immunity cells and cover the veins).

When one of these cells becomes malignant and reproduces, it forms a tumor that, if not treated properly, can spread to other parts of the body.

In most cases, this change is in the type B lymphocyte, characterizing Hodgkin’s Lymphoma, which manifests itself in regions such as the neck and chest.

Thus, it is this lymphocyte that characterizes the disease, differentiating it from other diseases of the immune system.

People with weak immune systems (such as those with HIV ), the elderly (over 70 years old) and young people (between 20 and 30 years old) are the groups most likely to develop the disease.

The main symptoms include itching, tiredness , involuntary weight loss, fevers and the presence of lumps.

Anaplastic lymphoma

The anaplastic lymphoma tumor begins in the lymph nodes (which produce antibodies) and can spread to other parts of the body, commonly the skin.

This type of tumor is divided into 2 types:

  • Positive anaplastic large cell lymphoma: which usually affects younger people and has great chances of cure;   
  • Large-cell anaplastic lymphoma negative: in most cases, it manifests in elderly people (over 60 years) and has good chances of cure with the help of chemotherapy and radiotherapy. 

How to use Adcetris Takeda?

Adcetris is a drug for intravenous application, that is, it is applied with the aid of an access that will be placed in the patient’s vein.

Each application lasts about 30 minutes and the person must always have medical monitoring.

The recommended dose for each case varies depending on the weight of the person being treated. Generally, 1.8 mg is calculated for each patient’s body weight. However, if there are problems with the liver or kidney, or when it is used in conjunction with other medications, it is possible that medical advice is an initial dose of 1.2 mg per kilo.

The application of the dose recommended by the doctor must happen, in general, every 3 weeks, for a maximum of 16 times (which is equivalent to more or less 1 year of treatment).

Does the package insert have contraindications for treatment?

According to the Adcentris package insert, it cannot be administered to people who are undergoing treatment for cancer with drugs based on Bleomycin.

Patients with allergies to Brentuximab Vedotine or other components present in the formula should also not receive any doses.

What are the side effects?

First of all, it is worth mentioning that not all people have side effects with Adcetris.

Although its safety is recognized in the laboratory, this medicine can cause other adverse reactions that were not prescribed in the package insert.

If this happens, the ideal is to talk to the medical team and notify the Takeda laboratory by the Customer Service Department (SAC).

Side effects are divided according to their frequency:

Very common

The very common reactions happen in more than 10% of the cases and are:

  • Cough;
  • Shortness of breathe;
  • Respiratory infections;
  • Constipation;
  • Motion sickness;
  • Vomiting;
  • Diarrhea;
  • Loss of hair or hair;
  • Pains (muscular, bone, abdominal and in the joints);
  • Decrease in the number of white blood cells in the blood;
  • Weight loss;
  • Itch;
  • Fever;
  • Peripheral motor neuropathy (hindering the movement of arms and legs).

Ordinary

Side effects classified as common affect 1 in 10 patients. Are they:

  • Blood infections (sepsis);
  • Pneumonia;
  • Herpes zoster;
  • Anemia;
  • Dizziness;
  • Back pain;
  • Increased blood sugar (hyperglycemia);
  • Blisters on the skin;
  • Increased enzymes in the liver;
  • Reduction in the number of blood platelets;
  • Septic shock (a type of blood infection that can lead to death).

Unusual

The unusual symptoms are those that happen with a frequency that varies between 0.1% and 1% of the patients who use the medication. Among them are:

  • Thrush in the mouth (oral candidiasis);
  • Pneumonia;
  • Presence of bacteria in the bloodstream (bacteremia);
  • Pancreatitis;
  • Metabolic complications that can cause nausea, dizziness, changes in heart rate and shortness of breath (tumor lysis syndrome).

Rare

The frequency at which rare side effects occur varies between 0.01% and 0.1%. The only reaction cataloged on the Adcetris package insert is Stevens Jonhson Syndrome.

It is a rare type of toxic epidermal necrolysis that consists of blisters on the skin, which eventually peel off.

During this process, the person may experience pain, fever , itching, redness in the dermis and purplish bruising.

Unknown

Unknown side effects, on the other hand, are those that cannot have an estimated frequency with the results of laboratory tests.

In the case of using Adcetris, they are:

  • Febrile neutropenia (fever above 38.3 ° C for more than 1 hour);
  • Allergic reaction;
  • Progressive multifocal leukoencephalopathy (a rare disease caused by a virus that affects the central nervous system).

Does Adcetris have reactions to the infusion?

Monoclonal antibody remedies (such as Adcetris) can cause reactions during their application, called infusion reactions .

But what is this? They are side effects caused by the form of administration of the medicine and not by the substance.

In general, the reaction to the infusion takes place during or even a few hours after the drug is administered.

The main effects that can appear are nausea, vomiting, diarrhea , shortness of breath, fever, redness of the skin, pain in the limb of the application, cough , chills and headaches. 

These symptoms are very common. It is estimated that for every 10 patients, more than 1 is affected during or shortly after the application of Adcetris.

Reactions such as bleeding, skin blisters, severe stomach pain and dizziness can also manifest themselves in more rare situations (1 in 100 patients).

If any of these symptoms is very strong, the patient may receive other medications such as pain relievers and anti-inflammatory drugs, depending on each case.

What are the precautions when using Adcetris?

According to the package insert, Adcetris should not be used during all stages of pregnancy or while the woman is breastfeeding, as the medicine can be passed on to the baby through breastfeeding.

This medication can still affect the ability to drive vehicles and operate machinery. Therefore, it is advisable that the patient avoid these activities during treatment.

Regarding reproduction, men who wish to have children are recommended to take a sample of the sperm before using the drug. That’s because the medicine can compromise male fertility.

Women may also receive an indication to take contraceptive treatment while using Adcetris and for up to 6 months after administration of the doses, as the drug can cause fetal death.

Both sexes must use a condom if they have sex while on Brentuximab Vedotina treatment.

Does ANVISA approve Adcetris?

Yes. The National Health Surveillance Agency (ANVISA) approved Adcetris in September 2014.

The registration of the pharmaceutical company Takeda to commercialize this reference drug is valid in Brazil until September 2029.

This remedy is of the therapeutic class of antineoplastics, used to destroy malignant cells and prevent the spread of tumors.

Price

The box with 1 powder vial with 50mg of Adcetris can be purchased for values ​​close to R $ 23,000 *.

Is Adcetris provided by SUS?

Adcetris was included in the list of medications provided by the Unified Health System in March 2019, provided that it is for patients with refractory or relapsed Hodgkin’s lymphoma after stem cell transplantation.

To obtain the right to use this medication free of charge, the patient must follow a few steps:

  • Gather the necessary documents (among them are a medical report that proves the need for the substances and the SUS card);
  • Go to a basic health unit;
  • Present yourself for a medical examination at the health unit itself.

Even if correctly complying with the protocol indicated in the legislation, some conditions can result in the SUS being unable to pass the medication on to patients, such as lack of funds.

In such cases, the person must resort to a legal process with legal assistance.

To carry out these legal procedures, you will need other documents such as a budget with at least 3 drugstores that market the medicine.

How to make an Adcetris budget?

To make a budget for Adcetris, you can count on the Consultancy of Consultations Remedies.

Just access this link and fill in the fields with your data. Ready! In a few hours our team will email you a quote specially customized for your case.


Adcetris is an intravenous drug that helps cancer patients in the lymphatic system under certain conditions.

Although the price is high, this medicine is provided by SUS free of charge, in some cases.

In case of doubt, seek guidance from a medical professional.

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