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

Safety1,2

Like all anti-cancer drugs, ADCETRIS (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 my 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:



A change in feeling or sensitivity, especially in the skin, numbness, tingling, discomfort, a burning sensation, weakness or pain in the hands or feet. These are symptoms of a condition known as Peripheral Neuropathy (very common)

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

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; common)

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; common)

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

Headaches, dizziness or pale complexion, which may be signs of anaemia (very common)

Flu like symptoms followed by painful red or purplish blistering rash that spreads and blisters including extensive detachment of the skin (uncommon)

Constipation (very common)

New or worsening shortness of breath or cough (very common)

Vomiting (very common)

Chills or shivering. You should take your temperature as you may have a fever or feel warm, which in combination with a low white blood cell count, may be a sign of a serious infection (common)

Feeling of weakness (very common)

Diarrhoea (very common)

Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome) (frequency cannot be estimated from the available data)

Very common symptoms are those that may affect more than 1 in 10 people.

Common symptoms are those that may affect up to 1 in 10 people.

Uncommon symptoms are those that may affect up to 1 in 100 people.

Rare symptoms are those that may affect less than 1 in 100 people.


Progressive multifocal leukoencephalopathy (PML)

You should be aware of the signs and symptoms of a condition called PML. PML is a rare (affects less than 1 in 100 people) 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, trouble with thinking, memory loss, blurred or loss of vision, decreased strength, decreased control or feeling in arms or legs, a change in the way of walking or loss of balance.



If you have experienced any of these symptoms before your treatment with brentuximab vedotin, tell your doctor immediately about any changes in these symptoms.

You should tell your partner or caregivers about your treatment, since they may notice symptoms that you are not aware of.

Other medicines

Tell your doctor if you are taking any other medicines, if you have taken any recently, or if you start taking new ones. This includes herbal medicines and other medicines you can obtain without a prescription.

You should not be given brentuximab vedotin if you are currently receiving another chemotherapy drug called bleomycin.

Pregnancy, breast-feeding, male and female fertility

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.

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.

You and your partner should use two methods of effective contraception during your treatment with brentuximab vedotin.

Women must continue using contraception for 6 months after the last dose of brentuximab vedotin.

Men are advised to have sperm samples frozen and stored before treatment and to not father a child during treatment and for up to 6 months after the last dose.

Driving or using machinery

Your treatment may affect your ability to drive or operate machines. If you feel unwell during treatment then do not drive or operate machines.

Possible side effects when brentuximab vedotin is given alone:

In addition to the side effects mentioned in the Tell your doctor section on this part of the website, the most common side effects people experience from brentuximab vedotin given alone include:

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
  • Nausea
  • Itching
  • Rash
  • Muscle pain
  • Fatigue
  • Fever
  • Infusion-related reactions
  • Upper respiratory tract infection
  • Stomach pain
  • Joint pain or painful, swollen joints
  • Weight loss

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

  • Pneumonia
  • 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
  • Unusual hair loss or thinning
  • Sore, creamy yellow, raised patches in the mouth (thrush)
  • Back pain
Possible side effects when brentuximab vedotin is given with other chemotherapy medicines:

In addition to the side effects mentioned in the Tell your doctor section on this part of the website, the most common side effects people experience from brentuximab vedotin given with other chemotherapy medicines include:

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)
  • Decreased level of white blood cells with a fever
  • Upper respiratory tract infection
  • Weight loss
  • Infection
  • Nausea
  • Stomach pain
  • Unusual hair loss or thinning
  • Muscle pain
  • Joint pain or painful, swollen joints
  • Dizziness
  • Decreased appetite
  • Not being able to sleep
  • Bone pain
  • Blisters which may crust or scab
  • Sore or inflammation in the mouth
  • Fever
  • Rash
  • Back pain
  • Infusion-related reactions
  • Fatigue

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

  • Infection in the blood (sepsis) and/or septic shock (a life-threatening form of sepsis)
  • Pneumonia
  • Decreased level of blood cell fragments that help clot your blood (platelets)
  • Sore, creamy-yellow, raised patches in the mouth (thrush)
  • Itching
  • Increased level of blood sugar
  • Increased liver enzyme levels

Please refer to the patient information leaflet for brentuximab vedotin for full information on possible side effects. In the UK it can be found at www.medicines.org.uk/emc/product/2859/pil.

In the UK, the patient information leaflets for medicines given in combination with brentuximab vedotin can be found at www.medicines.org.uk/emc.

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 occur within minutes to several hours after the end of the infusion. However, 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.

You should also let your doctor or nurse know if you experience a burning sensation, feel pain or tenderness at or surrounding the infusion site during the infusion, as this could indicate that brentuximab vedotin has leaked outside the blood vessel. If brentuximab vedotin has leaked outside the blood vessel, skin redness, pain, discolouration, swelling, blistering, peeling, or infection of deeper layers of your skin (cellulitis) at or surrounding the infusion site can occur within days or weeks after the infusion.

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 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).

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

C-ANPROM/GB/ADCE/0046 - January 2022

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 www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.