Things you should do
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Tell your doctor immediately or go to accident and emergency if you develop symptoms
of an allergic reaction.
Tell your doctor immediately if you develop an infection or have symptoms of an infection
while you are using Actemra.
Tell your doctor if you become pregnant or if you are breast-feeding while taking
Actemra.
If you are a woman of childbearing potential, you should use adequate contraception
during and for several months after treatment with Actemra.
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Driving or using machines
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Be careful driving or operating machinery until you know how Actemra affects you.
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Looking after your medicine
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Store in a refrigerator (2°C to 8°C). Do not freeze.
The pre-filled syringe must always be kept in the carton to protect from light and
keep dry.
Once removed from the refrigerator, the pre-filled syringe can be stored up to 2 weeks
(14 days) at or below 30°C.
|
(pronounced Act-tem-ra)
Do not use Actemra if:
1. you are allergic to:
2. you have an active, severe infection
Check with your doctor if:
Pregnancy and breastfeeding
Use in Children
How much to inject
Children and adolescents with pJIA (aged 1 and over)
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If the patient weighs less than 30 kg
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The dose is 162 mg (the content of 1 pre-filled syringe) once every 3 weeks
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If the patient weighs 30 kg or more
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The dose is 162 mg (the content of 1 pre-filled syringe) once every 2 weeks
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Children and adolescents with sJIA (aged 1 and over)
|
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If the patient weighs less than 30 kg
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The dose is 162 mg (the content of 1 pre-filled syringe) once every 2 weeks
|
If the patient weighs 30 kg or more
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The dose is 162 mg (the content of 1 pre-filled syringe) once every week
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How to inject Actemra
How to inject using the syringe
Included in the pack
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Pre-filled syringe
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Not included in the pack
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Alcohol pad
Sterile cotton ball or gauze
Puncture-resistant container (also called a "sharps" container) for safe disposal
of the needle cap and used syringe.
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When to use Actemra
If an adult with RA/GCA or a child or adolescent with pJIA or sJIA forgets to use Actemra
For once a week Actemra dosing
|
If you missed your once a week Actemra dose and you remember within 7 days, you should
skip the missed dose. Make sure you inject your next dose normally on the next scheduled
day.
For example, if you forget your scheduled dose on Monday but you remember on Wednesday,
you should skip your missed dose and inject the next dose as you would normally on
the following Monday.
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For fortnightly or every three week Actemra dosing
|
If you missed your fortnightly or every three week Actemra dose and you have remembered
within 7 days of the dose you missed, you should inject the missed dose as soon as
possible Inject the next dose as you would on the next scheduled day.
|
If you are given too much Actemra
(by calling 13 11 26), or
Things you must do
1. You develop an infection or have symptoms of an infection while you are using Actemra. Signs of an infection, with or without fever include:
2. you develop severe blisters and bleeding in the lips, eyes, mouth, nose and genitals while you are using Actemra.
Driving or using machines
Looking after your medicine
Getting rid of any unwanted medicine
Less serious side effects
Less serious side effects
|
What to do
|
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Blood pressure related:
high blood pressure or hypertension (symptoms may include headache, dizziness, ringing
in the ears)
Injection site reaction related:
skin redness
itchy skin
pain in the injection site
Stomach related:
constipation
General:
anxiety
difficulty sleeping
low potassium levels shown by blood tests
mouth ulcers
|
Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
Serious side effects
|
What to do
|
---|---|
Allergic reaction related:
chest tightness, wheezing or difficulty breathing,
severe dizziness or light-headedness
swelling of the face, lips, tongue, throat or other parts of your body with difficulty
breathing
skin rash, itching or (raised red
patches of skin that are often very itchy).
Infections:
signs of an infection, with or without fever: sweating or chills, feeling very tired,
cough, shortness of breath, muscle aches, weight loss, warm, red, or painful skin
or sores on your body, blood in phlegm, diarrhoea or stomach ache, persistent headaches,
burning when you urinate or urinating more often than normal.
Severe blisters and bleeding in lips, eyes, mouth, nose and genitals.
Stomach and gut:
signs of tears (perforation) of the stomach or intestines such as fever and pain in
the stomach area that does not go away, vomiting blood or material that looks like
coffee grounds, bleeding from your rectum, and a change in your bowel habits
signs of inflamed pancreas (pancreatitis) including: upper stomach pain, abdominal
pain that may spread to the back, generally feeling unwell/sick
Liver:
signs of liver disease, hepatitis and/or jaundice including: nausea, vomiting, loss
of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes,
light coloured bowel motions, dark coloured urine.
Laboratory tests:
low white blood cell and platelet counts.
increase in certain liver function tests.
raised blood fat (cholesterol) levels.
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
Call your doctor straight away if you notice any of these serious side effects.
Call your doctor straight away if you notice any of these serious side effects.
Call your doctor straight away if you notice any of these serious side effects.
Make sure you get all your follow-up blood tests done as ordered by your doctor.
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Reporting side effects
What Actemra contains
Active ingredient
(main ingredient)
|
tocilizumab (rch)
|
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Other ingredients (inactive ingredients)
|
Actemra
®
(AUST R 234034)
polysorbate 80
histidine
histidine hydrochloride monohydrate
arginine
arginine hydrochloride
methionine
water for injections
Actemra
®
SC (AUST R 370315)
polysorbate 80
histidine
histidine hydrochloride monohydrate
arginine hydrochloride
methionine
water for injections
|
What Actemra looks like
Who distributes Actemra
ABN 70 000 132 865
Level 8, 30-34 Hickson Road