Adcetris 50 mg Solution

ADCETRIS contains the active substance brentuximab vedotin, an anti-cancer medicine, which is made up of a monoclonal antibody linked to a substance intended to kill cancer cells. Classical Hodgkin lymphoma expresses specific proteins on the cell surface that are different from non-classical Hodgkin lymphoma. ADCETRIS is used with other chemotherapy medicines to treat patients with classical Hodgkin lymphoma who have not had treatment before. ADCETRIS is used alone to treat classical Hodgkin lymphoma that has:

• come back after or not responded to an infusion of your own healthy stem cells into your body (autologous stem cell transplant), or
• come back after or never responded to at least two previous therapies, and where you cannot receive additional combination anti-cancer treatments or have an autologous stem cell transplant.

ADCETRIS is also used to lower the likelihood of classical Hodgkin Lymphoma coming back after an autologous stem cell transplant in patients with certain risk factors. ADCETRIS is used to treat systemic anaplastic large cell lymphoma which is found in your lymph nodes and/or throughout other parts of your body that has:

• not responded to other types of anti-cancer treatments, or
• come back after previous anti-cancer treatment.

Hodgkin lymphoma and systemic anaplastic large cell lymphoma are both types of cancer of the white blood cells. ADCETRIS is used to treat cutaneous T-cell lymphoma (CTCL) in patients who have previously received at least one medicine that travels through the bloodstream. CTCL is a cancer of a certain type of white blood cell called a ‘T-cell’ that mainly affects the skin. ADCETRIS is used to treat CTCL where a specific type of protein is present on the cells’ surface.

Do not use ADCETRIS if you:

• are allergic to brentuximab vedotin or any of the other ingredients of this medicine
• are currently using bleomycin, an anti-cancer medicine

Warnings and precautions

When you first receive ADCETRIS and during the course of treatment, tell your doctor if you:

• have confusion, trouble thinking, memory loss, blurred or loss of vision, decreased strength, decreased control or sensation in one arm or leg, a change in the way of walking, or loss of balance, as these may be symptoms of a serious and potentially fatal brain condition known as progressive multifocal leukoencephalopathy (PML). If you have these symptoms prior to treatment with this medicine, 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.
• have severe and persistent stomach pain, with or without nausea and vomiting, as these may be symptoms of a serious and potentially fatal condition known as pancreatitis (inflammation of the pancreas).
• have new or worsening shortness of breath or cough as these may be symptoms of a serious and potentially fatal lung complication (pulmonary toxicity)
• are taking, or have previously taken, medicines which may affect your immune system, such as chemotherapy or immunosuppressive medicines.
• have, or think you have, an infection. Some infections may be serious and can be due to viruses, bacteria, or other causes that may be life-threatening.
• experience a whistling sound during breathing (wheezing) /difficulty breathing, hives, itching, or swelling (signs of an infusion reaction).
• have any problems with a change in the sensitivity of the skin, especially in the hands or feet, such as numbness, tingling, a burning sensation, pain, discomfort or weakness (neuropathy).
• have headaches, feel tired, experience dizziness, look pale (anaemia), or have unusual bleeding or bruising under the skin, longer than usual bleeding after your blood has been drawn, or bleeding from your gums (thrombocytopenia).
• develop chills or shivering, or feel warm; you should take your temperature as you may have a fever. A fever with a low white blood cell count may be a sign of serious infection.
• experience dizziness, decreased urination, confusion, vomiting, nausea, swelling, shortness of breath, or heart rhythm disturbances (this may be a potentially life-threatening complication known as tumour lysis syndrome).
• experience flu-like symptoms followed by a painful red or purplish rash that spreads and blisters including extensive detachment of the skin that may be life-threatening (this may be a serious skin reaction known as Stevens-Johnson syndrome and toxic epidermal necrolysis).
• have new or worsening stomach pain, nausea, vomiting, constipation as these may be symptoms of a serious and potentially fatal stomach or intestinal complication (gastrointestinal complications).
• have abnormal liver test results as this may be related to a serious and potentially fatal liver injury (hepatotoxicity). Liver disease and other medical conditions that may have been present before you start taking ADCETRIS and some medications that you are currently taking might increase the risk of liver injury.
• feel tired, have frequent urination, increased thirst, increased appetite with unintended weight loss, or irritability (hyperglycaemia).
• have kidney or liver problems. Your doctor will perform regular blood tests to make sure that it is safe for you to receive ADCETRIS.

Other medicines and ADCETRIS

If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of ADCETRIS with these medicines may cause undesirable interactions. Please consult your doctor, pharmacist or other healthcare professional for advice.

Pregnancy, breast-feeding and fertility

You and your partner must use two methods of effective contraception during your treatment with ADCETRIS. Women must continue using contraception for 6 months following the last dose of ADCETRIS. You should not use ADCETRIS if you are pregnant. 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. You must not breastfeed your baby while you are receiving ADCETRIS. Men being treated with ADCETRIS are advised to have sperm samples frozen and stored before treatment. Men are advised not to father a child during treatment with ADCETRIS and for up to 6 months following the last dose of ADCETRIS.

Driving and using machinery

Your treatment may influence your ability to drive or operate machines. If you feel unwell during treatment then do not drive or operate machines. ADCETRIS contains sodium. ADCETRIS contains 13,2 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 0,7 % of the recommended maximum daily dietary intake of sodium for an adult.

If you have any questions on the use of ADCETRIS, ask the doctor or nurse who is giving you the infusion.

Dose and frequency

The dose of this medicine depends on your body weight. The recommended dose of ADCETRIS given in combination with other chemotherapy medicines is 1,2 mg/kg given every 2 weeks for 6 months. The other chemotherapy medicines are doxorubicin, vinblastine and dacarbazine. See the package leaflets for these medicines for additional information on their use and effects. After the first dose of ADCETRIS in combination with chemotherapy, your doctor may also give you a medicine that will help prevent development or reduce the severity of neutropenia (decrease of white blood cell count) which can increase the risk of infection. The recommended dose of ADCETRIS given alone is 1,8 mg/kg, given once every 3 weeks for no more than one year. Your doctor may lower your starting dose to 1,2 mg/kg if you have kidney or liver problems. ADCETRIS is to be given to adults only. It is not for use in children.

How ADCETRIS is given

ADCETRIS is given to you into a vein (intravenously) as an infusion. It is given by your doctor or nurse over 30 minutes. Your doctor or nurse will also monitor you during and after the infusion. If you have any other questions on the use of ADCETRIS, ask your doctor. Since a healthcare professional will administer ADCETRIS, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

ADCETRIS may cause side effects. Not all side effects reported for ADCETRIS are included in this leaflet. Should your general health worsen while taking ADCETRIS, please tell your doctor, pharmacist or other healthcare professional.

Infusion reactions such as:

• a rash
• shortness of breath
• difficulty breathing
• cough
• a tight chest
• fever
• back pain
• chills
• feeling sick (nausea) or being sick (vomiting)

Infusion reactions to ADCETRIS are frequent. In general, these types of reactions occur within minutes to several hours following completion of the infusion. However, they may develop more than several hours after completion of the infusion. These infusion reactions can be serious or even fatal (known as an anaphylactic reaction). You may be given other medicines such as anti-histamines, corticosteroids or paracetamol to help reduce any of the reactions above if you have already experienced these when receiving this type of medicine. If you think you have previously had a similar reaction, tell your doctor BEFORE you are given ADCETRIS. Tell your doctor immediately if you notice any of the following symptoms because some of them may be signs of a serious or possibly fatal condition:

• Progressive multifocal leukoencephalopathy (PML) symptoms such as confusion, trouble thinking, memory loss, blurred or loss of vision, decreased strength, decreased control or sensation in one arm or leg, a change in the way of walking, or loss of balance.
• shortness of breath or cough
• flu-like symptoms followed by a painful red or purplish rash that spreads and blisters including extensive detachment of the skin
• a change in feeling or sensitivity, especially in the skin, numbness, tingling, discomfort, a burning sensation, weakness, or pain in the hands or feet (neuropathy)
• a feeling of weakness
• constipation
• diarrhoea, vomiting
• chills or shivering
• feeling tired, frequent urination, increased thirst, increased appetite with unintended weight loss, and irritability (these may be signs of hyperglycaemia)
• unusual bleeding or bruising under the skin, longer than usual bleeding after your blood has been drawn, or bleeding from your gums (these may be signs of thrombocytopenia)
• headaches, experience dizziness, look pale (these may be signs of anaemia).

You may experience the following frequent side effects: The following side effects have been reported with ADCETRIS alone.

• decreased level of white blood cells
• infection
• nausea
• itching
• unusual hair loss or thinning
• muscle pain
• cough; upper respiratory tract infection; pneumonia
• decreased level of blood platelets
• dizziness
• joint pain or painful, swollen joints
• blisters which may crust or scab
• increased level of blood sugar

Less frequent side effects:

• Tumour lysis syndrome – a potentially-life threatening condition in which you may experience dizziness, decreased urination, confusion, vomiting, nausea, swelling, shortness of breath, or heart rhythm disturbances.
• Stevens-Johnson syndrome – a rare, serious disorder in which you may experience flu-like symptoms followed by a painful red or purplish rash that spreads and blisters
• sore, creamy-yellow, raised patches in the mouth (thrush)

The following side effects have been reported with ADCETRIS in combination with chemotherapy medicines:

Frequent side effects

• decreased level of white blood cells
• decreased level of blood platelets
• decreased level of white blood cells with a fever
• upper respiratory tract infection
• decrease in weight
• infection
• nausea
• abdominal pain
• unusual hair loss or thinning
• muscle pain
• joint pain or painful, swollen joints
• dizziness
• increased liver enzyme levels
• decreased appetite
• not being able to sleep
• bone pain
• sore or inflammation in the mouth
• an infection in the blood (sepsis) and/or septic shock (a life-threatening form of sepsis); pneumonia
• blisters which may crust or scab
• sore, creamy-yellow, raised patches in the mouth (thrush)
• itching
• increased level of blood sugar

Less frequent side effects

• Tumour lysis syndrome – a potentially-life threatening condition in which you may experience dizziness, decreased urination, confusion, vomiting, nausea, swelling, shortness of breath, or heart rhythm disturbances.
• Stevens-Johnson syndrome – a rare, serious disorder in which you may experience flu-like symptoms followed by a painful red or purplish rash that spreads and blisters including extensive detachment of the skin
• new or recurring cytomegalovirus (CMV) infection

If you notice any side effects not mentioned in this leaflet, please inform your doctor.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects you can help provide more information on the safety of this medicine.

Keep all medicines out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the vial label and the carton after EXP. The expiry date refers to the last day of that month.

Unopened vial: Store in a refrigerator (2 °C - 8 °C). Do not freeze. Keep the vial in the original carton in order to protect from light.

Reconstituted/diluted solution: Use immediately or store in a refrigerator (2 °C - 8 °C) and use within 24 hours. Do not use this medicine if you notice any particulate matter or discoloration prior to administration. Do not throw away any medicines via wastewater or household waste. The doctor or nurse will dispose of this medicine. These measures will help protect the environment.