Bonspri ® 20 mg/0,4 ml/50 mg Solution

What BONSPRI is

BONSPRI contains the active substance ofatumumab. Ofatumumab belongs to a group of medicines called monoclonal antibodies.

What BONSPRI is used for

BONSPRI is used to treat adults with relapsing forms of multiple sclerosis (MS).

How BONSPRI works

BONSPRI works by attaching to a target called CD20 on the surface of B cells. B cells are a type of white blood cell which are part of the immune system and which play a role in multiple sclerosis. BONSPRI targets and removes the B cells and thereby reduces the chance of having a relapse, relieves symptoms and slows down the progression of the disease.

Do not use BONSPRI

• if you are allergic to ofatumumab or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting BONSPRI

• Your doctor will check if you are at risk of hepatitis B infection by performing a blood test. If this shows that you have had hepatitis B or are a carrier of the hepatitis B virus, your doctor will refer you to a specialist. BONSPRI may cause the hepatitis B virus to become active again.
• Your doctor may check your immune system.
• If you have an infection, your doctor may decide that you cannot be given BONSPRI or may delay your treatment with BONSPRI until the infection is resolved.
• Your doctor will check if you need any vaccinations before you start your treatment with BONSPRI. If you need a type of vaccine called a live or live-attenuated vaccine, this should be given at least 4 weeks before you start BONSPRI treatment. Other types of vaccine should be given at least 2 weeks before you start BONSPRI treatment.

While using BONSPRI

Tell your doctor:

• if you have a general injection-related reaction or a local injection-site reaction. These are the most common side effects of BONSPRI treatment and are described in section 4. They usually occur in the 24 hours following injection of BONSPRI, in particular after the first injection, and the first injection should therefore be administered under the guidance of a healthcare professional.
• if you have an infection. You may get infections more easily or an infection you already have may get worse. This is because the immune cells that BONSPRI targets also help to fight infection. Infections could be serious and sometimes even life-threatening.
• if you plan to have any vaccinations. Your doctor will advise you on whether the vaccination you need is a live vaccine, a live-attenuated vaccine, or another type of vaccine. You should not be given live or live-attenuated vaccines during treatment with BONSPRI as this may result in infection. Other types of vaccine can be less effective if administered during treatment with BONSPRI.

Tell your doctor straight away if you get any of the following during your treatment with BONSPRI, because it could be serious:

• if you believe your multiple sclerosis is getting worse (e.g. weakness or visual changes) or if you notice any new or unusual symptoms. This may indicate a rare brain disorder caused by infection called progressive multifocal leukoencephalopathy (PML).

Children and adolescents

Do not give this medicine to children and adolescents below 18 years of age because BONSPRI has not yet been studied in this age group.

Other medicines and BONSPRI

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) In particular, tell your doctor or pharmacist:

• if you are taking, have recently taken or might take medicines that suppress or modulate the immune system, including other medicines used to treat MS such as ocrelizumab, cladribine, fingolimod, natalizumab, teriflunomide, mitoxantrone or dimethyl fumarate. This is because these may have an added effect on the immune system.
• if you plan to have any vaccinations (see “Warnings and precautions” above).

Do not share medicines prescribed for you with any other person.

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

How much BONSPRI to use and how often to use it

Do not exceed the dose prescribed by your doctor.

• The initial dose is 20 mg BONSPRI administered by subcutaneous injection at weeks 0, 1 and 2. There is no injection at week 3.
• Starting at week 4 and then every month, the recommended dose is 20 mg BONSPRI administered by subcutaneous injection.

Dosage regimen with subcutaneous injection of BONSPRI

If you get the impression that the effect of BONSPRI is too strong or too weak, tell your doctor or pharmacist.

What time of day to use BONSPRI

You can use BONSPRI at any time of day (morning, afternoon or evening).

How to use BONSPRI

BONSPRI is given by subcutaneous injection (injection under your skin). The first injection should be administered under the guidance of a healthcare professional.

BONSPRI pre-filled syringes are for single use only.

Instructions for use of BONSPRI pre-filled syringe

It is important that you read, understand, and follow these instructions for use before injecting BONSPRI. Talk to your doctor, pharmacist or nurse if you have any questions before you use BONSPRI for the first time.

Remember:

• Do not use the BONSPRI pre-filled syringe if either the seal on the outer carton or the seal of the blister is broken. Keep the BONSPRI pre-filled syringe in the sealed carton until you are ready to use it.
• Do not shake the BONSPRI pre-filled syringe.
• The pre-filled syringe has a needle guard that will be activated to cover the needle after the injection is finished. The needle guard will help to prevent needlestick injuries to anyone who handles the pre-filled syringe after injection.
• Do not remove the needle cap until just before you give the injection.
• Avoid touching the syringe guard wings before use. Touching them may cause the needle guard to be activated too early.
• Dispose of the used BONSPRI pre-filled syringe immediately after use. Do not re-use a BONSPRI pre-filled syringe.

BONSPRI can have side effects. Not all side effects reported for BONSPRI are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking BONSPRI, please consult your health care provider for advice.

The side effects of BONSPRI are listed below. Most are mild to moderate and will generally disappear after a few days to a few weeks of treatment. If any of these side effects becomes severe, tell your doctor, pharmacist or nurse.

Very frequent side effects

• upper respiratory tract infection, with symptoms such as sore throat and runny nose
• injection-site reactions, such as redness, pain, itching and swelling at the injection site
• injection-related reactions, such as fever, headache, muscle pain, chills and tiredness
• decrease in the blood level of a specific protein called immunoglobulin M, which helps protect against infection

Frequent side effects

• Decrease in a specific protein in the blood (immunoglobulins M) which help protect against infection

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. 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 BONSPRI.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.

Keep the syringe(s) in the outer carton in order to protect from light. Store in a refrigerator (2 °C – 8 °C). Do not freeze.

If necessary, BONSPRI may be stored unrefrigerated for a single period of up to 7 days at room temperature (not above 30°C). If not used during this period, BONSPRI can then be returned to the refrigerator for a maximum of 7 days.

Do not use this medicine if you notice that the solution contains visible particles or is cloudy.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.