What is Brentuximab Vedotin?

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

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, dacarbazine) to treat a previously untreated 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 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.

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:

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.

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.

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

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.

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
• Nefazodone
• Nelfinavir
• Posaconazole
• Saquinavir
• Telithromycin
• Tipranavir
• Tofacitinib
• Voriconazole

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

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.

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. Women should use an effective form of birth control to avoid pregnancy during treatment and for at least 6 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 6 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 type of allergic reaction called 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 can occur with this medicine. 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.

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.