Pronunciation:

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

Brand Names:

• Adcetris

Dosage Forms:

• Powder for Solution

Warnings:

John Cunningham (JC) virus infection resulting in progressive multifocal leukoencephalopathy (PML) and death can occur in patients receiving brentuximab vedotin .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Mitotic Inhibitor

Uses of This Medicine:

Brentuximab injection is used to treat Hodgkin lymphoma, systemic anaplastic large cell lymphoma (sALCL), and primary cutaneous anaplastic large cell lymphoma (pcALCL), which are blood cancers. It is given to patients who have received a bone marrow (autologous stem cell) transplant or other cancer treatments that did not work well.

Brentuximab injection is also used together with other cancer medicines (eg, doxorubicin, vinblastine, vincristine, dacarbazine, etoposide, prednisone, and cyclophosphamide) to treat a previously untreated high risk or stage III or IV classical Hodgkin lymphoma.

Brentuximab injection is also used together with other medicines (eg, cyclophosphamide, doxorubicin, prednisone) to treat patients with previously untreated sALCL or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL.

Brentuximab interferes with the growth of cancer cells, which are then destroyed by the body.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of brentuximab injection for the treatment of previously untreated high risk classical Hodgkin lymphoma (cHL) in children younger than 2 years of age and for the treatment of other conditions in children. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of brentuximab injection in the elderly.

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.

Other 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 this medicine, 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 this medicine 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 this medicine 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.

• Atazanavir
• Boceprevir
• Ceritinib
• Delavirdine
• Indinavir
• Itraconazole
• Nefazodone
• Nelfinavir
• Posaconazole
• Saquinavir
• Telithromycin
• Tipranavir
• Voriconazole

Other interactions—

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other medical problems—

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

• Diabetes or
• Hyperglycemia (high sugar in the blood) or
• Lung or breathing problems or
• Neutropenia (low white blood cells) or
• Peripheral neuropathy (nerve problem) or
• Pneumonitis (inflammation of the lung) or
• Stomach or bowel problems (eg, bleeding, ulcer) or
• Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.

• Infection—May decrease your body's ability to fight an infection.

• Kidney disease, mild to moderate or
• Liver disease, mild—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Kidney disease, severe or
• Liver disease, moderate to severe—Should not be used in patients with these conditions.

Proper Use of This Medicine:

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

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. It must be given slowly, so the needle will have to stay in place for at least 30 minutes every 2 or 3 weeks.

You may also receive other medicines (eg, fever medicine, allergy medicine, steroids, G-CSF) to help prevent possible allergic reactions to the injection.

Precautions While Using This Medicine:

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

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before receiving this medicine. Women should use an effective form of birth control to avoid pregnancy during treatment and for at least 2 months after the last dose. Men should use an effective form of birth control to avoid pregnancy in sexual partners during treatment and for at least 4 months after the last dose. If you think a pregnancy has occurred with the medicine, tell your doctor right away.

Talk with your doctor if you plan to have children after receiving this medicine. Some men may become infertile (unable to have children).

Do not receive this medicine together with bleomycin (Blenoxane®). Using these medicines together may cause serious side effects (eg, cough or troubled breathing).

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

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

This medicine may cause a serious allergic reaction, including anaphylaxis, which 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 this medicine.

Check with your doctor if you have a fever, chills, sore throat, or painful urination. These could be symptoms of an infection.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause a serious type of reaction called tumor lysis syndrome. 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, rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.

Serious skin reactions (eg, Stevens-Johnson syndrome and toxic epidermal necrolysis) can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.

This medicine may cause a rare and serious brain infection called progressive multifocal leukoencephalopathy (PML). Check with your doctor right away if you have vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, or muscle weakness in the legs.

This medicine may cause new or worsening lung problems. Tell your doctor right away if you have a cough or trouble with breathing after receiving this medicine.

Stomach or bowel problems may occur with this medicine. Tell your doctor right away if you have severe stomach pain, heartburn, or indigestion, bloody or black stools, trouble breathing, or if you vomit material that looks like coffee grounds.

This medicine may raise your blood sugar levels. Check with your doctor if you have these problems or if you notice a change in the results of your blood or urine sugar tests.

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.

Side Effects of This Medicine:

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

Back pain

black, tarry stools

bleeding gums

blood in the urine or stools

blurred vision

body aches or pain

bone pain

burning, numbness, tingling, or painful sensations

chest tightness

chills

cough

difficult or labored breathing

dry mouth

ear congestion

fever

flushed, dry skin

fruit-like breath odor

headache

increased hunger

increased thirst

increased urination

loss of voice

lower back or side pain

nausea

pain

painful or difficult urination

pale skin

pinpoint red spots on the skin

sneezing

sore throat

stomach pain

stuffy or runny nose

sweating

swollen, painful, or tender lymph glands in the neck, armpit, or groin

trouble breathing with exertion

unexplained weight loss

ulcers, sores, or white spots in the mouth

unsteadiness or awkwardness

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

weakness in the arms, hands, legs, or feet

Less common

Anxiety

bladder pain

blistering, peeling, or loosening of the skin

bloating or swelling of the face, arms, hands, lower legs, or feet

chest pain

cloudy urine

confusion

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

seizures

severe pain in the chest

sudden onset of severe breathing difficulty

thickening of bronchial secretions

unusual weight gain or loss

Incidence not known

Clay-colored stools

dark urine

heartburn

indigestion

severe abdominal pain, cramping, or burning

severe constipation

severe vomiting

vomiting of material that looks like coffee grounds

yellow eyes or skin

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

difficulty with moving

hair loss or thinning of the hair

muscle spasm or stiffness

night sweats

pain in the arms or legs

rash

trouble sleeping

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.