Brentuximab Vedotin

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Generic Name: Brentuximab Vedotin Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: N

Uses

What is Brentuximab Vedotin used for?

Brentuximab Vedotin is used to treat certain types of cancers (Hodgkin’s lymphoma, systemic anaplastic large cell lymphoma, primary cutaneous anaplastic large cell lymphoma or CD30-expressing mycosis fungoides). It works by slowing or stopping the growth of cancer cells.

How should I take Brentuximab Vedotin?

This medication is given by injection into a vein over 30 minutes by a health care professional. It is given as directed by your doctor, usually once every 3 weeks.

The dosage is based on your medical condition, weight, and response to treatment.

Your health care professional will monitor you during the infusion in case you develop a reaction to brentuximab. If a rare but severe allergic reaction occurs, the infusion will be stopped and you should never receive brentuximab again. If a less serious reaction occurs, the infusion will be interrupted, you will be treated for the reaction, and the infusion will be continued. If you develop a less serious infusion reaction, you will be directed by your doctor to take certain medications (such as acetaminophen, antihistamines, corticosteroids) before each future brentuximab infusion to lessen the chance of symptoms. Consult your doctor for more details. Get medical help right away if you have symptoms such as fever, chills, rash, itching, cough, or trouble breathing within 24 hours of the infusion.

How do I store Brentuximab Vedotin?

Brentuximab Vedotin is best stored in the refrigerator. To prevent drug damage, do not freeze. There may be different brands of Brentuximab Vedotin that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Brentuximab Vedotin down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Brentuximab Vedotin?

Before using brentuximab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease.

Brentuximab can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are using brentuximab. Brentuximab may harm an unborn baby. Men and women should ask about reliable forms of birth control while using this medication and for 6 months after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Because of the possible risk to a nursing infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Brentuximab Vedotin during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Brentuximab Vedotin. Brentuximab Vedotin is pregnancy risk category N according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Brentuximab Vedotin?

Nausea, vomiting, diarrhea, dizziness, headache, or unusual tiredness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Tell your doctor right away if you have any serious side effects, including: numbness/tingling/weakness/pain of the hands/feet/arms/legs, muscle weakness, signs of infection (such as fever, chills, cough, persistent sore throat), shortness of breath, easy bruising/bleeding, signs of liver disease (such as persistent nausea/vomiting, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine), severe diarrhea, severe constipation, black stools, vomit that looks like coffee grounds.

Brentuximab sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Brentuximab Vedotin?

Some products that may interact with this drug include: bleomycin, other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab).

Other medications can affect the removal of brentuximab from your body, which may affect how brentuximab works. One example is rifampin, among others.

Brentuximab Vedotin may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Brentuximab Vedotin?

Brentuximab Vedotin may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

What health conditions may interact with Brentuximab Vedotin?

Brentuximab Vedotin may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Brentuximab Vedotin.

What is the dose of Brentuximab Vedotin for an adult?

Usual Adult Dose for Hodgkin’s Disease

Previously Untreated State III or IV Classical Hodgkin Lymphoma: 1.2 mg/kg (maximum 120 mg) IV over 30 minutes in combination with chemotherapy; administer every 2 weeks until a maximum of 12 doses, disease progression, or unacceptable toxicity

Classical Hodgkin Lymphoma Consolidation: 1.8 mg/kg (maximum 180 mg) IV over 30 minutes; initiate therapy within 4 to 6 weeks post-auto-HSCT or upon recovery from auto-HSCT; administer every 3 weeks until a maximum of 16 cycles, disease progression, or unacceptable toxicity

Relapsed Classical Hodgkin Lymphoma: 1.8 mg/kg (maximum 180 mg) IV over 30 minutes; administer every 3 weeks until disease progression or unacceptable toxicity

Relapsed Primary Cutaneous Anaplastic Large Cell Lymphoma or DC30-Expressing Mycosis Fungoides (MF): 1.8 mg/kg (maximum 180 mg) IV over 30 minutes; administer every 3 weeks until a maximum of 16 cycles, disease progression, or unacceptable toxicity

Relapsed Systemic Anaplastic Large Cell Lymphoma: 1.8 mg/kg (maximum 180 mg) IV over 30 minutes; administer every 3 weeks until disease progression or unacceptable toxicity

Usual Adult Dose for Mycosis Fungoides

Previously Untreated State III or IV Classical Hodgkin Lymphoma: 1.2 mg/kg (maximum 120 mg) IV over 30 minutes in combination with chemotherapy; administer every 2 weeks until a maximum of 12 doses, disease progression, or unacceptable toxicity

Classical Hodgkin Lymphoma Consolidation: 1.8 mg/kg (maximum 180 mg) IV over 30 minutes; initiate therapy within 4 to 6 weeks post-auto-HSCT or upon recovery from auto-HSCT; administer every 3 weeks until a maximum of 16 cycles, disease progression, or unacceptable toxicity

Relapsed Classical Hodgkin Lymphoma: 1.8 mg/kg (maximum 180 mg) IV over 30 minutes; administer every 3 weeks until disease progression or unacceptable toxicity

Relapsed Primary Cutaneous Anaplastic Large Cell Lymphoma or DC30-Expressing Mycosis Fungoides (MF): 1.8 mg/kg (maximum 180 mg) IV over 30 minutes; administer every 3 weeks until a maximum of 16 cycles, disease progression, or unacceptable toxicity

Relapsed Systemic Anaplastic Large Cell Lymphoma: 1.8 mg/kg (maximum 180 mg) IV over 30 minutes; administer every 3 weeks until disease progression or unacceptable toxicity

Usual Adult Dose for Lymphoma

Previously Untreated State III or IV Classical Hodgkin Lymphoma: 1.2 mg/kg (maximum 120 mg) IV over 30 minutes in combination with chemotherapy; administer every 2 weeks until a maximum of 12 doses, disease progression, or unacceptable toxicity

Classical Hodgkin Lymphoma Consolidation: 1.8 mg/kg (maximum 180 mg) IV over 30 minutes; initiate therapy within 4 to 6 weeks post-auto-HSCT or upon recovery from auto-HSCT; administer every 3 weeks until a maximum of 16 cycles, disease progression, or unacceptable toxicity

Relapsed Classical Hodgkin Lymphoma: 1.8 mg/kg (maximum 180 mg) IV over 30 minutes; administer every 3 weeks until disease progression or unacceptable toxicity

Relapsed Primary Cutaneous Anaplastic Large Cell Lymphoma or DC30-Expressing Mycosis Fungoides (MF): 1.8 mg/kg (maximum 180 mg) IV over 30 minutes; administer every 3 weeks until a maximum of 16 cycles, disease progression, or unacceptable toxicity

Relapsed Systemic Anaplastic Large Cell Lymphoma: 1.8 mg/kg (maximum 180 mg) IV over 30 minutes; administer every 3 weeks until disease progression or unacceptable toxicity

Renal Dose Adjustments

CrCl 30 mL/min or greater: Initial: No adjustment recommended.

CrCl less than 30 mL/min: Not recommended.

Liver Dose Adjustments

Mild hepatic impairment (Child-Pugh A):

-If the recommended dose is 1.2 mg/kg (maximum 120 mg) IV over 30 minutes every 2 weeks, reduce the dose to 0.9 mg/kg (maximum 90 mg) IV over 30 minutes every 2 weeks; the dose for patients weighing greater than 100 kg should be calculated based on a weight of 100 kg

-If the recommended dose is 1.8 mg/kg (maximum 180 mg) IV over 30 minutes every 3 weeks, reduce the dose to 1.2 mg/kg (maximum 120 mg) IV over 30 minutes every 3 weeks; the dose for patients weighing greater than 100 kg should be calculated based on a weight of 100 kg

Moderate (Child-Pugh B) to severe (Child-Pugh C) hepatic impairment: Not recommended.

What is the dose of Brentuximab Vedotin for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Brentuximab Vedotin available?

Brentuximab Vedotin is available in the following dosage forms and strengths:

  • Intravenous powder for injection.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Brentuximab Vedotin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: November 13, 2018 | Last Modified: November 13, 2018

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