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Brentuximab - Usage, Dosage, Side Effects, Drug Warnings, and Precautions

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Brentuximab is a medication that targets the CD30 protein and works as an anti-cancer drug. The following article discusses the drug in detail.

Written by

Dr. Shikha

Medically reviewed by

Dr. Kaushal Bhavsar

Published At August 12, 2022
Reviewed AtFebruary 2, 2023


An antibody-drug combination called Brentuximab Vedotin, commonly known as Adcetris, combines an anti-CD30 antibody with the medication Monomethyl Auristatin E (MMAE) and is used in the treatment of Hodgkin's lymphoma and anaplastic large cell lymphoma. Although moderate and temporary increases in blood enzymes have been connected to the drug Brentuximab Vedotin while it is being used, incidences of clinically obvious acute liver injury have not been attributed to it. It acts as an antineoplastic substance in the treatment of Hodgkin's lymphoma and systemic anaplastic large cell lymphoma. The first approval of Brentuximab Vedotin occurred in 2011.

A warning of progressive multifocal leukoencephalopathy (PML) and mortality from opportunistic JC (John Cunningham) virus infection following treatment was added to the medication label box in January 2012. Brentuximab Vedotin was approved by the American Food and Drug Administration in March 2018 to treat grown-up patients with stage III or IV classical Hodgkin's lymphoma who had not previously received chemotherapy. Additionally, Brentuximab Vedotin had previously received FDA (The United States Food and Drug Administration) approval for the treatment of Hodgkin's lymphoma following relapse, Hodgkin's lymphoma following stem cell transplantation when a patient faces a high risk of relapse or progression.

It also received approval for systemic anaplastic large cell lymphoma (ALCL) following the failure of other treatment plans, and primary cutaneous anaplastic large cell lymphoma following the failure of other treatment plans. Our lymphatic system, which aids in the fight against sickness and infection, is where lymphoma cancer first develops. Anywhere in our body, a lymphoma can develop, which can then spread to neighboring lymph nodes. Hodgkin's lymphoma, commonly known as Hodgkin's disease, and non-Hodgkin's lymphoma are the two main kinds of lymphomas.

The classical type of Hodgkin's lymphoma is present in the majority of cases. Reed-Sternberg cells, which are big, aberrant lymphocytes (a kind of white blood cell), are seen in the lymph nodes in this type of lymphoma. Patients with Hodgkin's lymphoma typically enjoy long-term remission with early detection and treatment. When compared to the prior standard of care, the research results showed that the medication in combination with a chemotherapy regimen was more effective. Importantly, the highly hazardous medication Bleomycin was fully eliminated from the regimen. This represents appreciable development in the care of individuals with this condition.

How Does Brentuximab Vedotin Work?

The development of targeted therapy follows roughly a century of studies into the distinctions between cancer cells and healthy cells. Since destroying quickly dividing cells which is one of the characteristics of cancer cells, this is the main focus of cancer treatment to date. Unfortunately, some of our healthy cells also divide quickly, which has a number of negative implications.

Finding additional characteristics of cancer cells is the goal of targeted therapy. Researchers are interested in unique variations between normal and malignant cells. Using this knowledge, a targeted medicine is developed to target cancer cells while sparing healthy ones, resulting in fewer adverse effects. All forms of targeted therapy interfere with the cancer cell's capacity to grow, divide, repair, and communicate with neighboring cells in slightly different ways.

Targeted therapies come in a variety of forms, broadly categorized into three groups. Some targeted treatments concentrate on the structure and operation of the cancer cell from the inside out. Small molecules are used in targeted therapies, which can enter cells and prevent them from functioning normally, ultimately leading to cell death. Numerous forms of targeted therapy concentrate on the interior of cells. Other targeted treatments go for receptors present outside of the cell. Monoclonal antibodies are another name for treatments that target receptors. Anti-angiogenesis inhibitors specifically target the blood arteries that carry oxygen to the cells, which eventually starves them.

Targeted therapy with an antibody component is what is present in Brentuximab Vedotin. The immune system of the body depends on antibodies. Antibodies are typically produced by the body in reaction to an antigen (such as a protein or a germ) that has been ingested. The antibodies bind to the antigen to identify it for immune system eradication. In the laboratory, researchers examine particular antigens on the surface of cancer cells to produce anti-cancer antibodies.

Then, they develop a particular antibody that will connect to the target antigen on the cancer cells utilizing both human and animal proteins. When administered to a patient, these antibodies will bind to compatible antigens, similar to how a key binds to a lock. Antibodies may be less damaging to healthy cells since they selectively target particular cells. Only malignancies that have known antigens and corresponding antibodies are typically treated using monoclonal antibodies.

As a CD30-directed antibody-drug conjugate (ADC), Brentuximab Vedotin combines a monoclonal antibody for targeted therapy with a chemotherapeutic drug to treat cancer. Together, this helps eliminate cancer cells. A monoclonal antibody called Brentuximab, which is present in the medication, targets the CD30 antigen found on the surface of cancer cells. It permits the antibody-drug conjugate to penetrate the cells and damage the microtubule network, which is a component of the structural network of the cell or its skeleton, when it attaches. This interference prevents the cell from duplicating and dividing.

The result of this disturbance is cell death. Research is still being conducted to determine which tumors may respond best to targeted therapy as well as to find new targets for additional cancer types.

What Are the Indications for the Usage of Brentuximab Vedotin:

Brentuximab Vedotin or Adcetris is a medication available only by prescription that targets the CD30 protein.

The following adult patients are treated with it:

  1. Patients who have recently been detected with stage III or stage IV of classical Hodgkin's lymphoma and in addition to other chemotherapy drugs to treat Hodgkin's lymphoma they are given Brentuximab Vedotin.

  2. Patients at risk for their classical Hodgkin's lymphoma to worsen or return after a stem cell transplant fails or have had at least two rounds of unsuccessful chemotherapy and no other treatment options are available.

  3. Patients who are being treated for newly discovered systemic anaplastic large cell lymphoma or other CD30 expressing peripheral T-cell lymphomas, such as angioimmunoblastic T-cell lymphoma and peripheral T-cell lymphomas that are not otherwise characterized.

  4. Patients who had a failure of at least one combination chemotherapy treatment for systemic anaplastic large cell lymphoma.

  5. Patients who received primary systemic treatment for anaplastic large cell lymphoma of the skin or CD30-expressing mycosis fungoides.

Dosage of Brentuximab Vedotin:

A medical expert injects this medicine over 30 minutes into a vein. It is administered as the doctor instructs, typically once every three weeks. The dosage is determined by the patient's weight, medical history, and treatment response. Throughout the infusion, the healthcare provider will keep an eye on the patient in case they experience a reaction to the drug.

If a severe but rare allergic response manifests, one should never retake Brentuximab. If a less severe reaction happens, the infusion will be stopped, the reaction will be treated, and then the infusion will resume. The doctor can advise the patient to take specific medications such as Acetaminophen, corticosteroids, and antihistamines before each subsequent infusion of Brentuximab if they experience a less severe infusion reaction in order to reduce the likelihood of symptoms. If someone gets symptoms within twenty-four hours of receiving the drug infusion, such as a fever, rashes, chills, cough, itching, or difficulty breathing, seek medical attention straight away.

Warnings and Precautions:

A. Reactions to Infusion and Anaphylaxis

Brentuximab Vedotin has been linked to infusion-related events, including anaphylaxis. Patients should be watched during infusion. If anaphylaxis strikes, stop giving the drug right away permanently and start with the proper medical treatment. Infusions should be stopped, and proper medical therapy should be implemented if an infusion-related response occurs. Patients who had an adverse reaction to an infusion in the past need to be pre-medicated for subsequent infusions. Acetaminophen, corticosteroids, and antihistamine are examples of possible premedications.

B. Peripheral Neuropathy

Treatment with Brentuximab Vedotin results in a sensory-predominant peripheral neuropathy. Peripheral motor neuropathy cases have also been documented. Peripheral neuropathy brought on by Brentuximab Vedotin is cumulative. Fifty-four percent of individuals in the Hodgkin's lymphoma and systemic anaplastic large cell lymphoma clinical trials had some degree of neuropathy. Of these patients, 31 percent experienced partial improvement, 49 percent experienced total resolution, and 20 percent showed no change. Watch for neuropathy symptoms in patients, such as weakness or neuropathic pain, paresthesia, hypoesthesia, hyperesthesia, discomfort, or a burning feeling. Patients who have worsening or new peripheral neuropathy may need to postpone taking the drug, adjust their dose, or stop taking it altogether.

C. Progressive Multifocal Leukoencephalopathy

Infection with the John Cunningham virus causing progressive multifocal leukoencephalopathy (PML) and mortality has been documented in individuals using Brentuximab Vedotin. Other potential contributing factors outside Brentuximab Vedotin medication include prior treatments and underlying illnesses that can result in immunosuppression. Any patient exhibiting newly developed symptoms and signs of central nervous system abnormalities should be diagnosed with progressive multifocal leukoencephalopathy. If progressive multifocal leukoencephalopathy is suspected, hold off on administering Brentuximab Vedotin and stop administering Brentuximab Vedotin if PML is determined after diagnosis.

D. Hematologic Toxicity

Grade III or Grade IV thrombocytopenia, anemia, or severe neutropenia, which are prolonged and last for more than one week, can occur with Brentuximab Vedotin. Treatment with Brentuximab Vedotin has been linked to reports of febrile neutropenia. Complete blood counts (CBC) should be checked prior to each dose of Brentuximab Vedotin, and for patients with neutropenia of Grade III or IV, further frequent monitoring should be taken into account. Check for fever in patients and consider dosage delays or G-CSF (granulocyte colony-stimulating factor) prophylaxis with successive doses of Brentuximab Vedotin.

E. Tumor Lysis Syndrome

Patients who have a quickly growing tumor and a significant tumor burden may be more susceptible to tumor lysis syndrome. A watchful eye should be kept on everything, and necessary action should be taken.

F. Increased Toxicity When Severe Renal Impairment Is Present

In patients with significant renal impairment compared to individuals with normal renal function, the prevalence of Grade 3 adverse events and mortality was higher. Individuals with significant renal impairment may experience Grade 3 adverse events more frequently than patients with normal renal function as a result of greater MMAE (monomethyl auristatin E) exposure. Brentuximab Vedotin should not be used in those with severe renal impairment.

G. Opportunistic Infections and Serious Infections

Patients receiving Brentuximab Vedotin have reported experiencing serious and opportunistic infections such as pneumonia, bacteremia, sepsis, or septic shock, including fatal consequences. During treatment, patients should be cautiously watched for the development of any potential bacterial, viral or fungal infections.

H. Toxicity to Embryos

Brentuximab Vedotin has not been adequately studied in pregnant women under controlled conditions. However, when given to a pregnant woman, the drug has the potential to harm the fetus based on its mode of action and animal studies.

Animals exposed to the drug at maternal exposures comparable to human exposures at the levels advised for patients with Hodgkin's lymphoma and systemic anaplastic large cell lymphoma experienced embryo-fetal toxicities, such as dramatically reduced embryo viability and fetal abnormalities. Patients should be informed priorly of the potential risk to the fetus if this medication is taken during pregnancy or if they become pregnant while taking it.

I. Hepatotoxicity

Patients who were receiving Brentuximab Vedotin have experienced severe incidences of hepatotoxicity, including fatal consequences. The cases fit the description of hepatocellular damage, as evidenced by elevated transaminases and/or bilirubin. Cases were reported after the initial dosage of the drug or after the Brentuximab Vedotin rechallenge. The risk may also be raised by pre-existing liver illness, increased baseline liver enzymes, and concurrent medicines. Observe bilirubin levels and liver enzymes. Patients who experience new, severe, or recurrent hepatotoxicity may need to postpone taking the drug, adjust their dose, or stop taking it altogether.

J. Toxicity Increment in Moderate or Severe Hepatic Impairment

Individuals with moderate and severe hepatic impairment experienced more Grade III adverse events and fatalities than patients with normal hepatic function did. Patients with moderate or severe hepatic impairment should not take Brentuximab Vedotin.

K. Critical Reactions in Dermatology

Brentuximab Vedotin has been linked to toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome, both of which can be deadly. Discontinue the drug and start the proper medical treatment if the above-mentioned conditions manifest.

For Patients:

What Is Hodgkin’s Lymphoma?

Cancer which affects the lymphatic system, a component of the body's immune system that fights infection, is called Hodgkin's lymphoma. White blood cells known as lymphocytes overgrow in Hodgkin's lymphoma, resulting in enlarged lymph nodes and growths all over the body. One of the two primary types of lymphoma is Hodgkin's lymphoma, formerly known as Hodgkin's disease. Non-lymphoma Hodgkin's is the other one.

What Causes Hodgkin’s Lymphoma?

The exact cause of Hodgkin lymphoma is unknown. Doctors are aware that it starts when DNA modifications take place in the infection-fighting white blood cells called lymphocytes. The instructions that inform a cell what to do are encoded in its DNA. When other cells would normally die, the DNA modifications instruct the cells to reproduce quickly and to stay alive.

Several healthy immune system cells are drawn to the lymphoma cells, protecting and promoting their growth. Hodgkin's lymphoma signs and symptoms such as swelling are brought on by the excess cells cramming into the lymph nodes. Hodgkin's lymphoma comes in a variety of forms. The type is determined by the traits of the disease-causing cells and how they behave. The treatment options are partially determined by the type of lymphoma one has. The more prevalent form of this condition is classical Hodgkin's lymphoma. The lymph nodes of people with this kind of lymphoma include giant lymphoma cells known as Reed-Sternberg cells.

Although the precise causation of Hodgkin lymphoma is unknown, the following risk factors are linked to it:

  • Viruses: Hodgkin's lymphoma has been linked to the Epstein-Barr virus, which also causes infectious mononucleosis (mono). Most Hodgkin lymphoma tumors contain this virus' genome.

  • Environment: Hodgkin lymphoma is more likely to develop in people with fewer siblings, early birth orders, single-family homes, and fewer playmates. This association may be caused by a lack of early exposure to bacterial and viral diseases.

  • Hereditary: Identical twins and siblings of an individual with Hodgkin lymphoma are at very high risk of contracting the illness. Children with a parent with Hodgkin's disease are likewise more at risk.

What Happens in Hodgkin’s Lymphoma?

The enlargement of the lymph nodes, which can result in a lump forming under the skin, is the most typical sign of Hodgkin's lymphoma. Typically, this bump does not hurt.

It frequently manifests in one of the following regions:

  • Around the groin.

  • Under the armpit.

  • On the side of the neck.

These are some other signs of Hodgkin's lymphoma:

  • Morning sweats.

  • Irritable bowel syndrome.

  • Fatigue.

  • Unexpected weight loss.

  • Ongoing cough.

  • Difficulty in breathing.

  • Chest pain.

  • Pain in the lymph nodes occurs following alcohol consumption.

  • Spleen enlargement.

More About the Drug:

Brentuximab Vedotin, sold under the brand name Adcetris, is used to treat classic Hodgkin's lymphoma. Additionally, systemic or localized anaplastic large cell lymphomas that solely affect the skin are both treated with Brentuximab Vedotin. Sometimes, after other therapies have failed, patients are given Brentuximab Vedotin.

When Is the Drug Contraindicated?

If patients are also receiving the cancer drug Bleomycin, they should not take Brentuximab Vedotin. A dangerous brain infection that may result in disability or death can be brought on by the drug. If someone experiences issues with speech, cognition, vision, or muscular movement, call your doctor straight away.

Before taking Brentuximab Vedotin:

If a patient has an allergy to Brentuximab Vedotin, they should avoid the drug. If they are also being treated for cancer with Bleomycin, the drug should be avoided.

Make your healthcare professional aware of the following conditions if you have ever suffered them:

When taking this medication, both women and men should use reliable birth control to avoid pregnancy. If either the mother or the father takes this medication, the unborn child could suffer injury or develop birth abnormalities. For at least six months following the final dosage of Brentuximab Vedotin, continue using birth control. If either of the parents is taking Brentuximab Vedotin when a pregnancy arises, notify your doctor immediately. While on Brentuximab Vedotin, one should not breastfeed.

How Is Brentuximab Vedotin Administered?

An intravenous injection of Brentuximab Vedotin is received from a healthcare professional. Usually, one dose of Brentuximab Vedotin is administered every two to three weeks. To assist avoid major side effects or an allergic response, patients might be prescribed additional drugs. The blood cell counts may decrease with the usage of Brentuximab Vedotin. There will be frequent blood tests required. Depending on the findings, the cancer treatments can be postponed. Doses of Brentuximab Vedotin are determined by weight. If patients put on or lose weight, the dosage requirements can alter. Inform the surgeon if someone is currently taking Brentuximab Vedotin and they require surgery.

What Happens if a Dose of the Drug Is Missed?

If patients could not show up for their Brentuximab Vedotin injection, they should call their doctor.

What if an Overdose of the Drug Happens?

Get immediate medical help.

What Must a Patient Stay Away From While Taking Brentuximab Vedotin?

Observe any dietary, beverage, or exercise limitations that the doctor prescribes.

What Are the Possible Side Effects Observed With Brentuximab Vedotin?

If someone has symptoms of an allergic reaction, such as hives, difficulty breathing, swelling in the neck or face, or a severe skin reaction, get emergency medical attention. There could be some negative effects during the injection or for up to 24 hours after the drug administration. If an individual experiences symptoms such as drowsiness, nausea, chills, fever, itching, or difficulty breathing, inform your doctor right away. A dangerous brain infection that may result in disability or death can be brought on by the drug Brentuximab Vedotin. If anyone experiences issues with speech, cognition, vision, or muscular movement, call your doctor straight away. These symptoms could develop gradually before rapidly worsening.

Call a doctor if someone experiences any of the following additional severe side effects, even if they start a few months after receiving Brentuximab Vedotin:

  • Arm or leg numbness, weakness, scorching pain, tingling, or lack of sensation.

  • Abrupt discomfort or soreness in the chest, wheezing, a dry cough, or feeling out of breath.

  • Increased thirst, increased urine, dry mouth, and fruity breath which can all be symptoms of high blood sugar.

  • Discomfort or burning during urination.

  • Low blood cell counts—fever, chills, fatigue, mouth or skin sores, quick bruising, abnormal bleeding, pale complexion, numbness, or shortness of breath.

  • Ketoacidosis, which is the presence of too much acid in the blood, can display symptoms like nausea, stomach pain, vomiting, confusion, unusual drowsiness, or difficulty breathing.

  • Confusion, weakness, cramping in the muscles, nausea, vomiting, a fast or slow heartbeat, decreased urination, and tingling in the hands, feet, or mouth are symptoms of tumor cell disintegration.

  • Pancreatitis can show symptoms like strong upper stomach pain radiating to the back, nausea, and vomiting.

  • Stomach issues such as serious constipation, new or escalating stomach discomfort, bloody or tarry stools, bloody cough, or vomit that resembles grounded coffee.

  • Liver issues include lack of appetite, upper right side stomach pain, fatigue, dark urine, and jaundice.

The following are examples of Brentuximab Vedotin's adverse effects:

  • Feeling numb or tingling sensation.

  • Fever.

  • Low levels of blood cells.

  • Diarrhea, constipation, and vomiting.

  • Fatigue.

Which Medications Can Have an Impact on Brentuximab Vedotin?

It is occasionally dangerous to take particular medications at the very same time. Other medications patients take may have their blood levels affected which could enhance a drug's negative effects or reduce their efficacy. Other medications, including prescription and over-the-counter drugs, vitamins, and herbal supplements, could have an impact on Brentuximab Vedotin. Patients should inform their doctor about all of the existing medications as well as any new or discontinued ones they take.

For Medical Professionals:

Chemical Taxonomy:


Mechanism of Action of the Drug:

Brentuximab Vedotin is an antibody-drug conjugate (ADC). Chimeric IgG1 antibody is used against CD30. The tiny molecule, MMAE (monomethyl auristatin E), is a microtubule disruptor. Through a linker, MMAE is covalently joined to the antibody. According to non-clinical evidence, the drug's anti-cancer effect is caused by the ADC binding to CD30-expressing cells, internalization of the ADC-CD30 complex, and proteolytic cleavage that releases MMAE. When MMAE binds to tubulin, the microtubule network inside the cell is disrupted, which causes cell cycle arrest and apoptotic cell death.


46 evaluable patients with CD30-expressing hematologic malignancies participated in an open-label, single-arm research to assess the impact of Brentuximab Vedotin on the QTc interval. The mean QTc interval was not prolonged by Brentuximab Vedotin administration by more than 10ms from the initial value. Since a placebo arm and a positive control arm were not included in this trial, small increases in the mean QTc interval (10ms) cannot be ruled out.


Phase 1 trials and a population pharmacokinetic study using data from 314 patients were used to assess the pharmacokinetics of the drug. The ADC and total antibodies displayed similar PK profiles, and the total antibody had the highest exposure.

Absorption of the Drug:

Antibody-drug conjugate concentrations reach their highest point, usually just before the infusion. ADC serum concentrations showed a multiexponential fall, with a terminal half-life of roughly four to six days. Exposures ranged from 1.2 to 2.7 mg/kg and were roughly dose proportionately. Every three-week dose of the drug resulted in the ADC reaching a steady state after 21 days, which is consistent with the terminal half-life prediction. Multiple doses administered on an every three-week frequency resulted in little to no ADC build-up. For MMAE, the time to reach maximum concentration varied between one and three days. Similar to the ADC, MMAE reached a steady state after 21 days of drug dosage every three weeks. With repeated administration of the drug, MMAE exposures were reduced, with the following doses of the drug showing between 50% and 80% of the initial dose's exposure.

Distribution of the Drug:

Between 68 and 82 percent of MMAE's binding to human plasma proteins occurred in vitro. Highly protein-bound medicines are unlikely to displace or be replaced by MMAE. In a test tube, MMAE was a P-gp (P-glycoprotein) substrate but not a strong P-gp inhibitor. For ADC, the average steady-state volume of distribution in people ranged between 6 and 10 L.

Metabolism of the Drug:

Only a small portion of the MMAE generated by Brentuximab Vedotin appears to be digested, according to in vivo evidence in both animals and people. Data from in vitro experiments show that CYP3A4/5 oxidation is the main mechanism by which MMAE is metabolized. Human liver microsome-based in vitro investigations show that MMAE inhibits CYP3A4/5 but not other CYP isoforms. No significant CYP450 enzymes were induced by MMAE in primary cultures of human hepatocyte cells.

Elimination of the Drug:

The clearance of this drug seems to follow metabolite kinetics, with the rate of release from the ADC (antibody-drug conjugate) appearing to be a limiting factor. Patients receiving the drug dosage of 1.8 mg/kg underwent an excretion study. Over a seven-day period, approximately 24% of the total MMAE consumed as part of the ADC during the drug infusion was retrieved in both urine and feces. The majority of the voided MMAE was excreted as an unmodified medication, with roughly 72% of the recovered MMAE being discovered in the feces.

Non-clinical Mutagenesis, Carcinogenesis, and Fertility Impairment Seen With the Drug:

There has not been any research conducted on the small molecule (MMAE) or Brentuximab Vedotin's ability to cause cancer. In studies conducted on animals, MMAE was genotoxic via an aneugenic mechanism. This result is in line with MMAE's pharmacological ability to break microtubules. There has not been any research conducted on the effects of MMAE or Brentuximab Vedotin on fertility. However, the results of research on the toxicity of repeated doses in rats suggest that brentuximab vedotin may reduce male fertility and reproductive function. Seminiferous tubule degeneration, Sertoli cell vacuolation, decreased spermatogenesis, and aspermia was noted in a 4-week repeat-dose toxicity trial in rats. These dosages are roughly three and six times of the human recommended dose, depending on body weight.

Clinical Trial Results:

Because adverse reaction rates in clinical trials of one treatment cannot be easily compared to adverse reaction rates in the clinical trials of another drug and may not accurately represent rates seen in practice, clinical trials are done under a wide range of situations. In two phase 2 trials including 160 patients, Brentuximab Vedotin was investigated as a monotherapy. Regardless of the cause, fatigue, nausea, upper respiratory tract infection, anemia, diarrhea, rash, pyrexia, thrombocytopenia, coughing, and vomiting were the mostly the adverse events seen throughout both studies.

  • Hodgkin’s Lymphoma Experience: Neutropenia, peripheral sensory neuropathy, tiredness, upper respiratory tract infection, diarrhea, anemia, nausea, pyrexia, rash, thrombocytopenia, stomach discomfort, coughing, and vomiting were the most frequent side effects regardless of etiology. Respiratory toxicity was also seen with the level of non-pulmonary toxicity in another clinical trial in patients with Hodgkin's lymphoma that examined Brentuximab Vedotin with Bleomycin as part of a combination regimen was higher. Most often, patients complained of coughing and dyspnea. On computed tomography (CT) and radiography of the chest, interstitial infiltration and inflammation were seen. Corticosteroids were effective for most patients.

  • Systemic Anaplastic Large Cell Lymphoma Experience: In a single-arm clinical trial involving 58 patients with systemic anaplastic large cell lymphoma, the effects of Brentuximab vedotin were examined. Regardless of the cause, peripheral sensory neuropathy, neutropenia, anemia, fatigue, nausea, rash, pyrexia, diarrhea, and pain were the most frequent side effects.

Drug Interaction:

Monomethyl auristatin E (MMAE), according to in vitro evidence, is both a substrate and an inhibitor of CYP3A4/5. MMAE (Monomethyl auristatin E) is a substrate of the efflux transporter P-glycoprotein, according to in vitro research.

  1. The Impact of Other Medications on Brentuximab Vedotin: Co-administration of Brentuximab Vedotin with the powerful CYP3A4 inhibitor ketoconazole led to a 34 percent increase in MMAE exposure. Strong CYP3A4 inhibitors should not be given concurrently with Brentuximab Vedotin in patients who are receiving these medications. Brentuximab Vedotin combined with P-gp inhibitors may result in increased exposure to MMAE. Patients using the drug and P-gp inhibitors simultaneously should be watched for reactions.

  2. Brentuximab Vedotin’s Impact on Other Drugs: Midazolam exposure was unaffected by co-administration of Brentuximab Vedotin. At relevant clinical doses, MMAE does not inhibit other CYP enzymes. The exposure to medications that are processed by CYP3A4 enzymes is not anticipated to be affected by Brentuximab vedotin.

Usage of the Drug in a Specific Population

  • Patients With Liver Impairment

Patients with mild to severe hepatic impairment should not use Brentuximab Vedotin. For MMAE, the liver serves as a clearing pathway. Pharmacokinetics and safety of MMAE and Brentuximab Vedotin were assessed. The rate of Grade 3 adverse responses in individuals with moderate - to - severe hepatic impairment was observed as opposed to patients with normal hepatic function.

  • Patients With Renal Dysfunction

Patients with severe renal impairment should not use Brentuximab vedotin.

Monomethyl auristatin E is excreted by the kidney (MMAE). The pharmacokinetics and safety of Brentuximab Vedotin and MMAE were assessed. The rate of adverse effects of grade III or worse was seen in individuals with severe renal impairment as opposed to in patients with normal renal function. Additionally, patients with significant renal impairment had an AUC of MMAE (a component of the drug) that was around two times higher than patients with normal kidney function.

  • Pregnant Patients

Pregnant women have not been the subject of any adequate or carefully monitored research using Brentuximab Vedotin. However, the drug, when given to a pregnant woman, can harm the fetus according to its mode of action and result in animals. Patients should be informed with priority of the potential risk to the fetus if this medication is used during pregnancy or if they become pregnant while taking it.

  • Nursing Patients

Whether Brentuximab Vedotin is excreted in human milk is unknown. Given that many medications are excreted and that Brentuximab Vedotin may cause major side effects in nursing infants, a choice should be taken regarding whether to stop breastfeeding or to stop the medication, taking into account the significance of the medication to the mother.

  • Pediatric Patients

Brentuximab Vedotin's effectiveness and safety in pediatric patients have not been proven. Only nine juvenile patients were enrolled in the clinical trials, which is insufficient to evaluate whether their responses differ from those of adult patients.

  • Geriatric Patients

Insufficient elderly people were enrolled in the drug's clinical trials to ascertain whether their responses differed from those of younger patients. There is no evidence of either safety or effectiveness.

Dr. Kaushal Bhavsar
Dr. Kaushal Bhavsar

Pulmonology (Asthma Doctors)


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