This section is intended for patients prescribed ADCETRIS. If you are a member of the public click here. If you are a UK healthcare professional click here.

Safety1,2

Like all anti-cancer drugs, brentuximab vedotin can cause side effects, but not everybody gets them, and each person will experience them differently and some are more likely to occur than others. It is important to tell your treating doctor or nurse about any side effects so they can be monitored and, where possible, treated.

What should I look out for during treatment that I should tell by doctor about?

If you experience any side effects, including those not listed, or if you are concerned about any other symptoms, talk to your treating doctor or nurse.

There are some side effects that are really important to look out for. Tell your doctor straight away if you notice any of the following side effects:


Symptoms of inflammation of the pancreas (pancreatitis) such as server and persistent stomach pain, with or without nausea and vomiting

Feeling tired, frequently needing to urinate, increased thirst, increased appetite with unintended weight loss and irritability, which may be signs of hyperglycaemia (high blood sugar)

Unusual bleeding or bruising under the skin, longer than usual bleeding after your blood has been drawn or bleeding from your gums, which may be signs of thrombocytopenia (low platelets)

Dizziness, reduced need to urinate, confusion, vomiting, nausea, swelling, shortness of breath or heart rhythm disturbances, which may be signs of tumour lysis syndrome

Headaches, dizziness or pale complexion, which may be signs of anaemia

Flu like symptoms followed by painful red or purplish blistering rash that spreads

Constipation

Shortness of breath or cough

Vomiting

Symptoms of progressive multifocal leukoencephalopathy

Chills or shivering

Feeling of weakness

Diarrhoea

Progressive multifocal leukoencephalopathy (PML)

You should be aware of the signs and symptoms of a condition called progressive multifocal leukoencephalopathy (PML). PML is a rare but serious and potentially fatal brain condition that has been reported in a small number of patients who received brentuximab vedotin after previously receiving multiple rounds of cancer treatment.

PML symptoms include:

  • confusion
  • memory loss
  • blurred or loss of vision
  • decreased strength
  • decreased control or sensation in one or more arm or leg
  • a change in the way of walking or loss of balance

If you have these symptoms prior to treatment with brentuximab vedotin, tell your doctor immediately about any changes in these symptoms. You should also inform your partner or caregivers about your treatment, since they may notice symptoms that you are not aware of.

Bleomycin

You should not take brentuximab vedotin if you are allergic to it or any of the other ingredients of this medicine or if you are currently receiving another chemotherapy drug called bleomycin.

Driving or using machinery

Your treatment may influence your ability to drive or operate machinery, so if you feel unwell during treatment, do not drive or operate machinery.

Male fertility

Brentuximab vedotin may affect male fertility, so men being treated with brentuximab vedotin are advised to have sperm samples frozen and stored before treatment.

Brentuximab vedotin may affect cell division so you are advised not to father a child during treatment and for up to 6 months following the last dose. You and your partner should use two methods of effective contraception during your treatment with brentuximab vedotin.

This could be a barrier method, such as the male condom or the diaphragm, and a method which has a low failure rate when used correctly, such as contraceptive injections, implants, intra-uterine devices with copper or hormone or combined contraceptive pills or patches.

Pregnancy or breastfeeding

You should not use brentuximab vedotin if you are pregnant unless you and your doctor decide that the benefit to you outweighs the potential risk to the unborn baby.

You and your partner should use two methods of effective contraception during your treatment with brentuximab vedotin. Women being treated with brentuximab vedotin must continue using contraception for 6 months following the last dose.

It is important to tell your doctor before and during treatment if you are pregnant, think you may be pregnant, or are planning to get pregnant. If you are breast feeding, you should discuss with your doctor whether you should receive this medicine.

Below is a list of the very common and common side effects which may be experienced following brentuximab vedotin.

Affect more than 1 in 10 people (very common)

  • Changes in feeling or sensitivity e.g. numbness or tingling in the hands or feet (these are symptoms of a condition known as peripheral neuropathy
  • Decreased level of cells in your blood that help you fight infections (white blood cells)
  • Infection
  • Diarrhoea, nausea, vomiting
  • Itching
  • Muscle pain
  • Fatigue, fever, infusion-related reactions
  • Shortness of breath or cough
  • Upper respiratory tract infection
  • Feeling of weakness
  • Constipation
  • Abdominal pain
  • Joint pain or painful, swollen joints
  • Weight loss

Affect more than 1 in 100, but less than 1 in 10 people (common)

  • Pneumonina
  • Decreased level of blood cell fragments that help clot your blood (platelets)
  • Dizziness
  • Blisters which may crust or scab
  • Increased level of blood sugar
  • Increased liver enzyme levels
  • Chills or shivering
  • Unusual hair loss or thinning
  • Sore, creamy yellow, raised patches in the mouth (thrush)

Will I react to the infusion?

Medicines of this type (monoclonal antibodies) can cause infusion reactions such as:

  • Chills
  • Cough
  • Headache
  • Feeling or being sick
  • A rash
  • Shortness of breath
  • Difficulty breathing
  • A tight chest
  • Fever
  • Back pain

Infusion reactions to this medicine affect more than 1 in 10 people. In general, these types of reactions may occur within minutes to several hours following completion of the infusion. They may develop more than several hours after completion of the infusion but this is uncommon. It is important to tell your doctor if you experience infusion reactions as they can be serious, or even fatal. If you think you have had a similar reaction before, tell your doctor before you are given brentuximab vedotin.

If you develop infusion reactions, your doctor may stop treatment with brentuximab vedotin and start support treatment. If your infusion is restarted, your doctor may increase the time over which your infusion is given so that you may be able to tolerate it better. You may also be given other medicines such as anti-histamines, corticosteroids or paracetamol to help reduce these reactions.

What is peripheral neuropathy?

Some cancer treatments can affect the nerves in the body, causing a condition known as peripheral neuropathy (PN). If you are being treated with anticancer drugs, your healthcare professional (HCP) will monitor you for signs and symptoms of PN before each of your treatment cycles.

How long does peripheral neuropathy last?

Peripheral neuropathy is often temporary and improves once treatment stops. How long it takes to improve varies, it can feel very slow, and may take many months or even years. Unfortunately, some people don’t fully recover and have permanent effects.

It is very important that you tell your nurse or doctor about any new symptoms as early as possible. You might be worried that your treatment will be stopped if you develop peripheral neuropathy, but rest assured there are other ways of dealing with it. Your doctor or nurse will develop a plan that could involve adding supportive treatment, reducing the dose, or a temporary break in your anticancer treatment to help you manage the symptoms.

Know It

Understand the signs of peripheral neuropathy

Difficulty with any of the following activities are signs that you may be suffering from peripheral neuropathy:


Holding and using
everyday objects such as:

Mobile phone

Pen

Small objects

Using
buttons or zips

Tying
your shoelaces

Feel It

Understand what ‘changes in feeling or sensitivity’ might be

The following symptoms of peripheral neuropathy typically occur in the toes, feet, calves, fingers and/or hands:


Tingling

Numbness

Burning

Weakness

Loss of feeling

Manage It

Understand what you can do to cope with symptoms

There are some things you can do to help alleviate the symptoms of peripheral neuropathy and reduce the chance of doing yourself harm:


Keep your hands and feet warm

Keep your skin moisturised and soft

Take gentle exercise when possible

Take care when cutting your nails

Wear well fitting, protective shoes

Take care when using stairs

Take care when using hot water – you may not be able to feel how hot the water is, and could burn yourself

Use oven gloves when cooking and protective gloves when gardening

If you do develop peripheral neuropathy when receiving your anticancer treatment, your doctor or nurse may give you a tracker to help you monitor your signs and symptoms.

Remember: Tell your nurse or doctor about any new symptoms or other side effects as early as possible. This includes any possible side effects not listed in the package leaflet that comes with your medicine(s).

UK: You can also report side effects directly via the Yellow Card Scheme at https:// yellowcard.mhra.gov.uk/.

Ireland: You can report side effects to the Pharmacovigilance Unit at the Health Products Regulatory Authority (medsafety@hpra.ie). Information about Adverse Event reporting can be found on the HPRA website (www.hpra.ie)

Information and support

Adcetris Patients Guide

ADCETRIS – Your treatment booklet

Takeda Oncology has developed this booklet providing information for patients who have been prescribed ADCETRIS.

Adcetris Management Tracker

Peripheral Neuropathy Tracker

Takeda Oncology has developed a peripheral neuropathy tracker for patients to help them record any symptoms and feelings of neuropathy.

ADCETRIS (brentuximab vedotin) is subject to additional monitoring. This will allow quick identification of new safety information.
You can help by reporting any side effects you may get. If you get any side effects whilst taking ADCETRIS, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed on this website or in the patient information leaflet. You can also report side effects directly via the Yellow Card Scheme at https://yellowcard.mhra.gov.uk/. By reporting side effects you can help provide more information on the safety of this medicine.