Xacrel®

What is it?

The active substance is ocrelizumab. Ocrelizumab is a humanized monoclonal antibody that targets and removes CD20 positive B lymphocytes (a type of white blood cell) which contribute to nerve damage in MS. When targeted B cells are removed by ocrelizumab, inflammation is reduced and the chance of other nerve cells being affected is lessened.

Indications

Xacrel^® is used to treat adults with:

• Relapsing forms of multiple sclerosis (RMS)
• Primary progressive multiple sclerosis (PPMS)

You must not be given Xacrel^® if you:

• Are allergic to ocrelizumab or any of the other ingredients of this medicine.

• Currently have an infection
• Have been told that you have severe problems with your immune system
• Have cancer

What should I know BEFORE treatment?

What you need to know before you are given Xacrel^®:

Talk to your doctor before you are given Xacrel^® if you:

• Have an infection.
• Have ever had hepatitis B or are a carrier of the hepatitis B virus.
• Have cancer or if you have had cancer in the past.
• Have an autoimmune disease.
• Take medicines that affect the immune system.
• Take medicines for high blood pressure.

What should I know DURING treatment?

What you need to know when you are taking Xacrel^®:

Tell your doctor or nurse straight away if:

• You have any of these signs of infection during or after Xacrel^® treatment:
  • Fever or chills
  • Cough that does not go away
  • Herpes (such as cold sore, shingles or genital sores).

• You think your MS is getting worse or you notice any new symptoms.
• Signs like memory lapses, trouble thinking, difficulty walking, sight loss, or changes in the way of talking, occur.

Pregnancy and breast-feeding

• Tell your doctor before being given ocrelizumab if you are pregnant, think that you might be pregnant, are planning to have a baby or are breastfeeding.

How to Use?

How Xacrel^® is given

Xacrel^® will be given to you by an experienced doctor or nurse as a drip (intra-venous infusion). They will watch you closely for any side effects while you are being given this medicine and for one hour after it is finished.

Side Effects

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

• Infusion-related reactions are the most common side effect of ocrelizumab treatment. Symptoms may include: itchy skin, rash, hives, redness of the skin, throat irritation or pain, shortness of breath, swelling of the throat, flushing, low blood, pressure, fever, feeling tired, headache, feeling dizzy, feeling sick (nausea), fast heartbeat.
• You might get infections more easily with Xacrel^®. Including: upper and lower respiratory tract infections, viral infections like Herpes (cold sore or shingles), infection of the stomach and bowel (gastroenteritis) and skin infection (cellulitis)
• Tell your doctor or nurse straight away if you notice any sign of infection like fever or chills, cough which does not go away, herpes (such as cold sore, shingles and genital sores).

Storage

How to store Xacrel^®

• This medicine is to be stored in a refrigerator (2ºC - 8ºC). It is not to be frozen.
• The vials are to be kept in the outer carton to protect them from light.
• Xacrel^® must be diluted before it is given to you. It is recommended that the product is used immediately after dilution. If not used immediately, in-use storage times and conditions would normally not be longer than 24 hours at 2°C - 8°C and subsequently 8 hours at room temperature.
• This medicine is not to be used after the expiry date.
• This medicine is to be kept out of the sight and reach of children.