Actemra 400Mg/20Ml Injection Infusion ( Refrigerator )

Product Description:

• Actemra contains the active substance tocilizumab, which is a protein made from specific immune cells (a monoclonal antibody),
• Which blocks the action of a specific protein (cytokine) called interleukin-6. 
• This protein is involved in the body's inflammatory processes, and by blocking it, the inflammation in the body can be reduced. 
• Actemra reduces symptoms such as pain and swelling in the joints, and may also improve your ability to carry out daily activities. 
• Actemra has been shown to delay the destruction of cartilage and bone in the joints caused by the disease, as well as improve your ability to carry out normal, daily activities.

Actemra is used to treat adults:

• With moderately to severely active rheumatoid arthritis (RA), an autoimmune disease, where previous treatment has been ineffective.
• Actemra is usually given together with methotrexate. 
• Actemra can also be given alone if the doctor decides that methotrexate is not suitable.
• Actemra can also be used to treat severe, active, and progressive rheumatoid arthritis where you have not previously been treated with methotrexate.

Actemra is used to treat children with sJIA:

• Actemra is used in children aged 2 years and older who have active systemic juvenile idiopathic arthritis (sjia) an inflammatory disease that causes pain and swelling in one or more joints, as well as fever and rash. 
• Actemra is used to improve the symptoms of sjia and can be given together with methotrexate or alone.

Actemra is used to treat children with pJIA:

• Actemra is used in children aged 2 years and older who have active polyarticular juvenile idiopathic arthritis (pjia), an inflammatory disease that causes pain and swelling in one or more joints. 
• Actemra is used to improve the symptoms of pjia and can be given together with methotrexate or alone.

Actemra is used to treat adults and children aged 2 years and older with severe or life-threatening cytokine release syndrome ( CRS ):

• A side effect in patients treated with chimeric antigen receptor (CAR) T-cell therapy, which is used in the treatment of certain types of cancer.

Actemra is used to treat adults with coronavirus disease 2019 (covid-19):

• who is receiving systemic corticosteroids and requires supplemental oxygen or mechanical ventilation?

How To Use:

• This medicine is subject to limited prescription by your doctor.
• Actemra will be given to you by a doctor or nurse as a drip into a vein (a vein). 
• They will dilute the solution, set up the intravenous solution, and monitor you during and after treatment.

Adult RA patients:

• The usual dosage for Actemra is 8 mg per kg of body weight. 
• Depending on the response, the doctor may reduce the dose to 4 mg/kg and increase it back to 8 mg/kg if necessary.
• Adults will receive Actemra once every 4 weeks as a drip into a vein ( intravenous infusion into a vein) over one hour.

Children with sJIA (2 years and above):

The usual dose of Actemra depends on your weight:

• If you weigh less than 30 kg, the dose is 12 mg for each kilogram of body weight.
• If you weigh 30 kg or more, the dose is 8 mg for each kilogram of body weight.
• The dose is calculated based on your body weight each time you need Actemra.
• Children with sjia will receive Actemra once every 2 weeks as a drip into a vein ( intravenous infusion into a vein) over 1 hour.

Children with pJIA (2 years and above):

The usual dose of Actemra depends on your weight:

• If you weigh less than 30 kg, the dose is 10 mg for each kilogram of body weight
• If you weigh 30 kg or more, the dose is 8 mg for each kilogram of body weight
• The dose is calculated based on your body weight each time you need Actemra.
• Children with pJIA will receive Actemra once every 4 weeks as a drip into a vein ( intravenous infusion) over one hour.

Patients with CRS:

• The usual dose of Actemra is 8 mg for every kg of body weight if you weigh 30 kg or more.
  The dose is 12 mg for each kg of body weight if you weigh less than 30 kg.
  Actemra can be given alone or in combination with corticosteroids.

Patients with covid-19:

• The usual dose of Actemra is 8 mg for each kg of body weight.
• A second dose may be needed.

If you are given too much Actemra:

• As Actemra is given by a doctor or nurse, it is unlikely that you will get too much. 
• Talk to your doctor if you are still concerned.

If you miss a dose of Actemra:

• Since Actemra is given by a doctor or nurses, it is unlikely that you will miss a dose.
• Talk to your doctor or nurse if you are still concerned.

If you stop treatment with Actemra:

• You should not stop treatment with Actemra without discussing this with your doctor first.
• Ask your doctor or nurse if you have any questions about the use of this medicine.

How To Store:

• Keep out of reach of children.
• Do not use this medicine after the expiry date which is stated on the carton.
• Store in a refrigerator (2-8ºc). Do not freeze.
• Keep the vials in the outer carton in order to protect them from light.

Warnings And Precautions:

You should not be given Actemra:

• If you are allergic to tocilizumab or any of the other ingredients of this medicine.
• If you have an active, severe infection.
• If any of this applies to you, you must inform the doctor or nurse who will give you the infusion.
• Talk to your doctor or nurse before you are given actemra.
• Tell your doctor immediately if you experience an allergic reaction such as tightness in the chest, wheezing, severe dizziness or light-headedness, swollen lips, or a rash during or after the infusion.
• If you have an infection, short or long-term, or if you often get infections.
• Inform your doctor immediately if you feel unwell. 
• Actemra can reduce the body's ability to respond to infections and can worsen an existing infection or increase the risk of getting new infections.
• Inform your doctor if you have had tuberculosis. 
• Your doctor will examine you for signs and symptoms of tuberculosis before you start treatment with Actemra. 
• In the event of symptoms of tuberculosis (persistent cough, weight loss, weakness, mild fever ), or if another infection occurs during or after treatment, you must tell your doctor immediately.
• Inform your doctor if you have had stomach ulcers or diverticulitis.
• Symptoms can be abdominal pain and unexplained changes in stool patterns with fever.
• Inform your doctor if you have liver disease.
• Before using Actemra, your doctor may choose to do a blood test to measure your liver function.
• Inform the patient's doctor if the patient to be treated (both children and adults) has recently received a vaccine, or is planning to be vaccinated. 
• It is recommended that all patients, especially children, are up to date with all vaccinations before starting treatment with Actemra unless an urgent start of treatment is necessary. Some types of vaccines should not be given during treatment with Actemra.
• Inform your doctor if you have cancer.
• The doctor will decide whether you can still receive Actemra.
• Inform your doctor if you have cardiovascular risk factors such as increased blood pressure and increased cholesterol. 
• These factors must be monitored while you are receiving Actemra.
• The doctor will monitor you closely if you have moderate to severe problems with your kidney function.

If you have persistent headaches:

• Your doctor will take blood tests before you receive Actemra and during treatment to check if you have low white blood cell counts, low platelet counts, or high levels of liver enzymes.

Children and youth:

• It is not recommended to use Actemra in patients under 2 years of age.
• Inform the child's doctor if the child has previously had macrophage activation syndrome ( activation and uncontrolled division of specific blood cells). 
• The doctor will decide whether the child can still be given Actemra.

Other medicines and Actemra:

• Talk to a doctor if you (or your child, if he/she is the patient) use, have recently used, or plan to use other medicines. 
• This also applies to other medicines without a prescription.
• Actemra can affect the effectiveness of some medicines, and it may be necessary to adjust the dosage of these. 

You must inform your doctor if you use medicines that contain any of the following active substances:

• Methylprednisolone, dexamethasone, used to reduce inflammation (inflammation)
• Simvastatin or atorvastatin used to lower cholesterol levels
• Calcium channel blockers (e.g. Amlodipine), used in the treatment of high blood pressure
• Theophylline, used in the treatment of asthma
• Warfarin or phenprocoumon, are used as blood thinners
• Phenytoin, used in the treatment of seizures
• Ciclosporin used to suppress the immune system in organ transplants
• Benzodiazepines (eg temazepam), are used to relieve anxiety.
• Due to a lack of clinical experience, it is not recommended to use Actemra with other biologics for the treatment of RA, sJIA, or pJIA.

Pregnancy, breastfeeding, and fertility:

• Actemra should not be used during pregnancy, unless strictly necessary.
• Talk to your doctor before taking this medicine if you are pregnant, think you may be pregnant, or are planning to become pregnant.
• Fertile women (fertile women) must use effective contraception during and up to 3 months after treatment.
• Stop breastfeeding if you are to receive Actemra and talk to your doctor. 
• Before you start breastfeeding, you should have received your last dose of Actemra at least 3 months ago.
• It is unknown whether Actemra is excreted in human milk.
• Data so far available suggest no effect on fertility with this treatment.

Driving and using machines:

• This medicine may cause dizziness.
• If you experience dizziness, do not drive or use machines.

Ingredients:

The active substance is tocilizumab:

• Each 4 ml vial contains 80 mg of tocilizumab (20 mg/ml).
• Each 10 ml vial contains 200 mg of tocilizumab (20 mg/ml).
• Each 20 ml vial contains 400 mg of tocilizumab (20 mg/ml).

What Actemra looks like and the contents of the pack:

• Actemra is a concentrate solution for infusion.
• The concentrate is clear to opalescent, colorless to pale yellow solution.
• Actemra is supplied in vials containing 4 ml, 10 ml or 20 ml of concentrate for infusion.