300 mg concentrate for solution for infusion
ocrelizumab
What Ocrevus is and what it is used for
What Ocrevus is
Ocrevus contains the active substance ocrelizumab. It is a type of protein called a “monoclonal antibody”. Antibodies work by attaching to specific targets in your body.
What Ocrevus is used for
Ocrevus is used to treat adults with:
- Forest Multiple Sclerosis (RMS)
- Early Primary Progressive Multiple Sclerosis (PPMS)
What is multiple sclerosis
Multiple sclerosis (MS) affects the central nervous system, especially the nerves in the brain and spinal cord. In MS, the immune system (the body’s defense system) malfunctions and attacks the protective layer (called the myelin sheath) around the nerve cells, and causes inflammation. Degradation of the myelin sheath prevents the nerves from functioning properly.
The symptoms of MS depend on which part of the central nervous system is affected and may include problems with walking and balance, weakness, numbness, double vision, blurred vision, coordination difficulties, and problems with the bladder.
- In relapsing-remitting MS , the patient has repeated attacks with symptoms ( relapses ). The symptoms may appear suddenly, within a few hours or slowly over several days. The symptoms disappear or improve between relapses , but injuries can build up and lead to permanent disability.
- In primary progressive MS , the symptoms usually worsen continuously after the onset of the disease.
How does Ocrevus work?
Ocrevus attaches to specific B cells, which are a type of white blood cell that is part of the immune system and is important in MS. Ocrevus seeks out and removes these specific B cells. This reduces inflammation and attacks on the myelin sheath, reduces the risk of having a relapse, and delays the development of your disease.
- In relapsing- remitting MS (RMS) , Ocrevus helps to significantly reduce the number of attacks ( relapses ) and significantly delays the rate of development of the disease. Ocrevus also significantly increases the possibility that a patient has no signs of disease activity (changes in the brain, relapses and worsening of disability).
- In primary progressive MS (PPMS) , Ocrevus helps to slow the rate of disease progression and reduce the deterioration of walking speed.
What you need to know before you get Ocrevus
You must not be given Ocrevus:
- if you are allergic to ocrelizumab or any of the other ingredients of this medicine (listed in section 6).
- if you have an ongoing infection
- if you have been told that you have severe problems with your immune system
- if you have cancer
If you are not sure, talk to your doctor before taking Ocrevus.
Warnings and cautions
Talk to your doctor before receiving Ocrevus if any of the following apply to you. Your doctor may decide to postpone treatment with Ocrevus or you may not be able to get Ocrevus if:
- you have an infection . Your doctor will wait until infection one has passed before receiving Ocrevus.
- you have ever had hepatitis B or are a carrier of the hepatitis B virus . This is because medicines like Ocrevus can cause the hepatitis B virus to become active again. Before starting treatment with Ocrevus, your doctor will check if you are at risk of getting hepatitis B infection . Patients who have had a hepatitis B‑ infection or are carriers of the hepatitis B‑ virus will be given a blood test and the doctor will monitor for signs of a hepatitis B‑ infection .
- you have cancer or have had cancer before. Your doctor may decide to postpone treatment with Ocrevus.
Effect on the immune system:
- Diseases that affect your immune system : if you have another disease that affects the immune system. Then maybe you can not get Ocrevus.
- Medicines that affect your immune system : if you have ever taken, are taking or plan to take medicines that affect the immune system, such as cytotoxic drugs, medicines that weaken the immune system or other medicines used to treat MS. Your doctor may decide to postpone treatment with Ocrevus or to ask you to stop taking such medicines before starting treatment with Ocrevus. For further information, see below under the heading “Other medicines and Ocrevus”.
Reactions associated with infusion one
- Reactions associated with infusion are the most common side effect of treatment with Ocrevus.
- Tell your doctor or nurse immediately if you get any reaction in connection with infusion one (see section 4 for a list of reactions associated with infusion ). Reactions associated with infusion one may occur during infusion one or up to 24 hours after infusion one.
- To reduce the risk of reactions associated with infusion one, your doctor will give you other medicines before each infusion of Ocrevus (see section 3) and you will be closely monitored during infusion one and for at least one hour after the end of the infusion .
Infection is
- Tell your doctor before taking Ocrevus if you think you may have an infection . Your doctor will wait until infection has receded before receiving Ocrevus.
- You can more easily get your infection when you are treated with Ocrevus. This is because the immune cells that Ocrevus attacks also help fight infection .
- Before starting treatment with Ocrevus and before giving you a subsequent infusion , your doctor may ask you to take a blood test to check your immune system as your infection is more common in severe problems with your immune system.
- If you are being treated with Ocrevus for primary progressive multiple sclerosis and you have difficulty swallowing, Ocrevus may increase the risk of severe pneumonia .
- Tell your doctor or nurse immediately if you experience any of these signs of infection during or after treatment with Ocrevus:
- fever or chills
- cough that does not go away
- herpes (such as cold sores, shingles or genital herpes).
- Tell your doctor or nurse immediately if you think your MS is getting worse or if you are experiencing new symptoms . The reason for this is a very rare and life-threatening infection in the brain, so-called progressive multifocal leukoencephalopathy (PML) which can cause symptoms similar to those in MS. PML can occur in patients taking medicines similar to Ocrevus and other medicines used to treat MS.
- Tell your partner or caregiver about your treatment with Ocrevus. They may notice symptoms of PML that you do not, e.g. memory gaps, difficulty thinking, difficulty walking, vision loss, changes in the way you speak, which your doctor may need to examine.
Vaccinations
- Tell your doctor if you have recently received a vaccine or are likely to receive a vaccine in the near future.
- During treatment with Ocrevus, you should not receive live or live attenuated vaccines (eg BCG tu vaccine against tuberculosis or vaccine against yellow fever).
- Your doctor may recommend that you be vaccinated against seasonal flu.
- Your doctor will check if you need any vaccinations before starting treatment with Ocrevus. All vaccinations should be given at least 6 weeks before starting treatment with Ocrevus.
Children and young people
Ocrevus is not intended for use in children and adolescents under 18 years of age. This is because the drug has not been studied in this age group.
Other medicines and Ocrevus
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You must tell your doctor about:
- you have ever taken, are taking or plan to take medicines that affect the immune system such as cytotoxic drugs, medicines that weaken the immune system or other medicines that are used to treat MS. The effect on the immune system of these medicines together with Ocrevus may be too strong. Your doctor may decide to postpone treatment with Ocrevus or to ask you to stop taking such medicines before starting treatment with Ocrevus.
- you are taking medicines for high blood pressure . This is because Ocrevus can lower blood pressure . Your doctor may ask you to stop taking your blood pressure medication 12 hours before each Ocrevus infusion .
If any of the above apply to you (or you are not sure), talk to your doctor before taking Ocrevus.
Pregnancy
- Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby, before you are given Ocrevus. This is because Ocrevus can pass the placenta and affect your baby.
- Do not use Ocrevus if you are pregnant unless you have discussed this with your doctor. Your doctor will weigh the benefits of the treatment against the risks to your child.
- Talk to your doctor before vaccinating your baby.
Contraceptives for women
If you are pregnant (may become pregnant) you must use contraception:
- during treatment with Ocrevus and
- for 12 months after the last infusion one with Ocrevus.
Breast-feeding
Do not breastfeed while you are being treated with Ocrevus. The reason is that Ocrevus can pass into breast milk.
Driving and using machines
It is not known whether Ocrevus affects the ability to drive and use tools and machines. Your doctor will tell you if your MS affects your ability to drive and use tools and machines safely.
Ocrevus contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’. it is next to “sodium-free”.
How Ocrevus is given
Ocrevus will be given to you by a doctor or nurse who has experience using this treatment. They will monitor you closely while you are receiving this medicine. This is done in case you get any side effects. You will always receive Ocrevus as a drip ( intravenous infusion ).
Medicines that you will be given before you receive Ocrevus
Before you are given Ocrevus, you will be given other medicines to prevent or reduce possible side effects such as reactions associated with infusion one (see sections 2 and 4 for information on reactions associated with infusion one).
You will be given a corticosteroid and an antihistamine before each infusion and you may also be given antipyretic medicines.
How Ocrevus is given
- Ocrevus will be given to you by a doctor or nurse. It is given as an infusion into a vein ( intravenous infusion or iv infusion ).
- You will be what
- closely monitored while receiving Ocrevus and for at least 1 hour after the end of the infusion . This is if you get any side effects such as reactions associated with infusion one. Infusion one can be given more slowly, temporarily or interrupted completely if you get a reaction in connection with infusion one, depending on how severe it is (see sections 2 and 4 for information on reactions in connection with infusion ).
How much and how often will you get Ocrevus
You will receive a total dose of 600 mg Ocrevus every 6 months.
- The first dose of 600 mg Ocrevus will be given as 2 separate infusions (300 mg each) at 2 week intervals. Each infusion will take approximately 2 hours and 30 minutes.
- The next doses of 600 mg Ocrevus will be given as a single infusion. Depending on the rate of subsequent infusion, each infusion will take either approximately 3 hours and 30 minutes or 2 hours.
If you miss an infusion of Ocrevus
- If you miss an infusion of Ocrevus, talk to your doctor to make sure you get it as soon as possible. Do not wait until the next scheduled infusion .
- To get the most out of Ocrevus, it is important that you receive each infusion when it is scheduled.
If you stop taking Ocrevus
- It is important that you continue your treatment as long as you and your doctor decide that it is beneficial for you.
- Some side effects may be related to too low B cells . After stopping treatment with Ocrevus, you may still experience side effects until your B cells return to normal. Your B cells in the blood will gradually increase to normal levels. This can take from 6 months to two and a half years, or up to several years in rare cases.
- Before you start taking any other medicines, tell your doctor when you received your last infusion of Ocrevus.
If you have any further questions on the use of this product, ask your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported with Ocrevus:
Reactions associated with infusion one
- Infusion – related reactions are the most common side effect with treatment with Ocrevus (very common: may affect more than 1 user in 10). In most cases, the reactions are mild but severe reactions can occur.
- Tell your doctor or nurse immediately if you experience any signs or symptoms of an infusion reaction during infusion one or up to 24 hours after infusion one.Symptoms may include, but are not limited to:
- itchy skin
- rash
- hives
- reddening of the skin
- irritation or sore throat
- respiratory distress
- swelling in the throat
- redness
- low blood pressure
- fever
- fatigue
- headache
- dizziness
- nausea
- fast heartbeat
- If you get a reaction in connection with infusion one, you will be given medicine to treat it and infusion one may need to be given more slowly or discontinued. Once the reaction has disappeared, the infusion may continue. If the infusion reaction is life-threatening, your doctor will stop your treatment with Ocrevus forever.
Infection is
- You can more easily get your infection when you are treated with Ocrevus. The following infections have been observed in patients treated with Ocrevus for MS:
- Very common : may affect more than 1 user in 10
- upper respiratory tract infection
- influenza
- Common: may affect up to 1 in 10 users
- sinusitis
- bronchitis ( inflammation of the trachea)
- herpes infection (cold sores or shingles )
- gastrointestinal infection ( gastroenteritis )
- respiratory tract infection
- virus infection
- skin infection ( cellulite )
- Very common : may affect more than 1 user in 10
Some of them can be serious.
- If you experience any of these signs of infection, tell your doctor or nurse immediately:
- fever or chills
- cough that does not go away
- herpes (such as cold sores, shingles and genital herpes).
Other side effects ar
Very common: may affect more than 1 user in 10
- reduction of specific proteins in the blood ( immunoglobulins ) that help protect against infection
Common: may affect up to 1 in 10 users
- cough
- accumulation of thick mucus in the nose, throat or chest
- low levels of a type of white blood cell ( neutropenia )
Unknown frequency: it is not known how often these side effects occur
- a decrease in white blood cells that may occur later
How to store Ocrevus
Ocrevus will be stored by healthcare professionals at the hospital or clinic under these conditions:
- 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 outer carton after the date of expiry and the label on the vial after “EXP”. The expiration date is the last day of the specified month.
- Store in a refrigerator (2 ° C-8 ° C). Do not freeze. Keep the vial in the outer carton. Sensitive to light.
Ocrevus must be diluted before it is given to you. The dilution is done by healthcare professionals. It is recommended that the product be used immediately after dilution. If the medicine is not used immediately, the healthcare professional is responsible for the storage time and conditions before use and storage should not normally exceed 24 hours at 2 ° C-8 ° C and then 8 hours at room temperature.
Medicines should not be disposed of via wastewater. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is ocrelizumab. Each vial contains 300 mg ocrelizumab in 10 ml at a concentration of 30 mg / ml.
- The other ingredients are sodium acetate trihydrate, concentrated acetic acid, trehalose dihydrate, polysorbate and water for injections.
What the medicine looks like and contents of the pack
- Ocrevus is a clear to slightly opalescent, colorless to slightly brown solution.
- It is provided as a concentrate for solution for infusion .
- This medicine is available in pack sizes of 1 or 2 vials (10 ml vials of concentrate). Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Manufacturer
Roche Pharma AG
Emil-Barell-Strasse 1
D-79639 Grenzach-Wyhlen
Germany
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Finland / FinlandRoche Oy Puh / Tel: +358 (0) 10 554 500 |
| SwedenRoche ABTel: +46 (0) 8 726 1200 |