brentuximab (Intravenous route)

bren-TUX-i-mab ve-DOE-tin

Intravenous route(Powder for Solution)

Progressive multifocal leukoencephalopathy and/or death may occur, as a result of JC virus infection, in patients receiving brentuximab therapy .

Commonly used brand name(s)

In the U.S.

  • Adcetris

Available Dosage Forms:

  • Powder for Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Antibody Drug Conjugate

Uses For brentuximab

Brentuximab injection is used to treat a type of cancer called Hodgkin's lymphoma (HL). It is given to patients who have received an autologous stem cell transplant (ASCT) or other cancer treatments that did not work well.

Brentuximab injection is also used to treat patients with systemic anaplastic large cell lymphoma (sALCL). It is used after at least one other cancer medicine was given and did not work well.

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Brentuximab interferes with the growth of cancer cells, which are then destroyed by the body. Since the growth of normal body cells may also be affected by brentuximab, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, such as a skin rash, may not be serious but may cause concern. Some effects do not occur until months or years after the medicine is used.

brentuximab is to be administered only by or under the immediate supervision of your doctor.

Before Using brentuximab

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For brentuximab, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to brentuximab or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of brentuximab injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies have not been performed on the relationship of age to the effects of brentuximab injection in the geriatric population. Safety and efficacy have not been established.

Pregnancy

Pregnancy Category Explanation
All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving brentuximab, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using brentuximab with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Bleomycin

Using brentuximab with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Aprepitant
  • Atazanavir
  • Carbamazepine
  • Ceritinib
  • Clarithromycin
  • Cobicistat
  • Crizotinib
  • Dabrafenib
  • Eslicarbazepine Acetate
  • Fosaprepitant
  • Indinavir
  • Itraconazole
  • Ketoconazole
  • Mitotane
  • Nefazodone
  • Nelfinavir
  • Piperaquine
  • Primidone
  • Ritonavir
  • Saquinavir
  • Siltuximab
  • Telithromycin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of brentuximab. Make sure you tell your doctor if you have any other medical problems, especially:

  • Blood or bone marrow problems (e.g., neutropenia) or
  • Peripheral neuropathy (nerve problem)—Use with caution. May make these conditions worse.
  • Infection—May decrease your body's ability to fight infection.

Proper Use of brentuximab

Before receiving brentuximab, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

You will receive brentuximab while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you brentuximab. brentuximab is given through a needle placed in one of your veins.

brentuximab must be given slowly, so the needle will remain in place for 30 minutes. It is usually given every 3 weeks until your condition improves. You may also receive medicines (e.g., acetaminophen, steroid medicines) to help prevent possible allergic reactions to the injection.

Precautions While Using brentuximab

It is very important that your doctor check your progress at regular visits to make sure that brentuximab is working properly. Blood tests may be needed to check for unwanted effects.

Using brentuximab while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using brentuximab, tell your doctor right away.

Do not take brentuximab together with bleomycin (Blenoxane®). Using these medicines together may cause serious side effects, such as cough, shortness of breath, troubled breathing, or wheezing

Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

brentuximab may cause a serious side effect called an infusion reaction. This can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have a fever, chills, trouble with breathing, lightheadedness, fainting, or chest pain within a few hours after you receive it.

brentuximab may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are receiving brentuximab.

Check with your doctor if you notice any signs of fever, chills, sore throat, or painful urination. These could be symptoms of an infection resulting from low white blood cell counts.

brentuximab may cause a serious type of reaction called tumor lysis syndrome (TLS). Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount; joint pain, stiffness, or swelling; lower back, side, or stomach pain; a rapid weight gain; swelling of the feet or lower legs; or unusual tiredness or weakness.

Serious skin reactions can occur during treatment with brentuximab. Stop using brentuximab and check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using brentuximab.

brentuximab may cause a rare and serious brain infection called progressive multifocal leukoencephalopathy (PML). Talk to your doctor about the benefits of using brentuximab and the risk of this infection. Check with your doctor right away if you are having more than one of these symptoms: vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and weakness in the legs.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

brentuximab Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common
  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • body aches or pain
  • burning, numbness, tingling, or painful sensations
  • chills
  • cough
  • difficult or labored breathing
  • difficulty with breathing
  • ear congestion
  • fever
  • headache
  • loss of voice
  • lower back or side pain
  • pain
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • shortness of breath
  • sneezing
  • sore throat
  • stuffy or runny nose
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • tightness in the chest
  • troubled breathing with exertion
  • ulcers, sores, or white spots in the mouth
  • unsteadiness or awkwardness
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • weakness in the arms, hands, legs, or feet
  • wheezing
Less common
  • Anxiety
  • back pain
  • bladder pain
  • blistering, peeling, or loosening of the skin
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blurred vision
  • chest pain
  • cloudy urine
  • confusion
  • convulsions
  • diarrhea
  • dizziness or lightheadedness
  • drowsiness
  • fainting
  • fast heartbeat
  • frequent urge to urinate
  • general feeling of discomfort or illness
  • irregular heartbeat
  • itching
  • joint pain, stiffness, or swelling
  • muscle pain
  • rapid weight gain
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • severe pain in the chest
  • stomach pain
  • sudden onset of severe breathing difficulty
  • sudden shortness of breath or troubled breathing
  • thickening of bronchial secretions
  • troubled breathing
  • unusual weight gain or loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Decreased appetite or weight
  • difficulty having a bowel movement (stool)
  • difficulty with moving
  • hair loss or thinning of the hair
  • muscle spasms
  • muscle stiffness
  • nausea
  • night sweats
  • pain in the arms or legs
  • rash
  • sleeplessness
  • trouble with sleeping
  • unable to sleep
  • vomiting
Less common
  • Dry skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

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