ACTEMRA VIAL 400MG/20ML 1

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Authority Scripts

A valid prescription must be provided before we can send this product out via mail or courier. This medicine requires an Authority prescription for it to be subsidised under the PBS. Approval can be obtained by the prescriber simply by entering a special streamlined authorisation code to indicate that you meet the eligibility requirements, alternatively approval is obtained by telephone or by sending in an authority prescription for PBS authorisation. If you do not meet the authority prescription eligibility requirements, your doctor can only prescribe the medicine for you on a private prescription. This means that you will pay the full price for the medicine with no PBS subsidy. If you are unsure if your script meets the requirements please send an email and attach a picture of the script to pharmacist@superpharmacy.com.au


Product info

ACTEMRA®

pronounced (Act-tem-ra)

contains the active ingredient tocilizumab (rch)


Consumer Medicine Information


What is in this leaflet



This leaflet answers some common questions about ACTEMRA infusion.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking ACTEMRA against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.


What ACTEMRA is used for



ACTEMRA contains the active ingredient tocilizumab.
ACTEMRA belongs to a group of medicines called anti-rheumatic agents. There are many different classes of anti-rheumatic agents. ACTEMRA belongs to a class called monoclonal antibodies.
Monoclonal antibodies are proteins which specifically recognise and bind to other unique proteins in the body.
ACTEMRA is used to treat active moderate to severe rheumatoid arthritis (RA).
ACTEMRA is also used to treat active systemic juvenile idiopathic arthritis (sJIA) and active moderate
to severe polyarticular juvenile idiopathic arthritis (pJIA) in children over 2 years of age.
For RA ACTEMRA can also prevent damage occurring to your joints.
Some of the signs and symptoms of RA, pJIA and sJIA are caused by the actions of a protein called
interleukin-6 receptor (IL-6R).
ACTEMRA works by binding and blocking IL-6R thereby helping to relieve some of the signs and symptoms of RA, pJIA or sJIA.
There are many different types of medicines used to treat RA, pJIA and sJIA. Your doctor, however, may have prescribed ACTEMRA for another purpose.

Ask your doctor if you have any questions about why ACTEMRA has been prescribed for you.

ACTEMRA is not addictive.
This medicine is available only with a doctor's prescription. For pJIA and sJIA ACTEMRA should be prescribed by a doctor experienced in the management of these conditions.


Before you are given

ACTEMRA


When you must not be given

ACTEMRA

Do not use ACTEMRA if:

1. you have had an allergic reaction to ACTEMRA or any ingredients listed at the end of this leaflet

Some of the symptoms of an allergic reaction may include:
• shortness of breath
• wheezing or difficulty breathing
• swelling of the face, lips, tongue or other parts of the body
• rash, itching or hives on the skin

2. you have had an allergic reaction to any other recombinant human or humanised antibodies or proteins that are of hamster origin

3. you have an active, severe infection

4. the package is torn or shows signs of tampering

5. the expiry date (EXP) printed on the pack has passed.

If you take this medicine after the expiry date has passed, it may not work as well.

If you are not sure if you should be given ACTEMRA, talk to your doctor.

Before you are given

ACTEMRA

Tell your doctor if:

1. you have or develop any kind of infection

ACTEMRA can reduce your body's ability to respond to infections and may make an existing infection worse or increase the chance of getting a new infection. This may be important if you have diabetes or diverticulitis (which increase your risk of infection).
Your doctor will perform blood tests before you are given ACTEMRA to determine if you


ACTEMRA 141007 1

have low white blood cell or platelet counts, or high liver enzymes.

2. you have any other health problems, especially the following:

• liver disease such as viral hepatitis
• HIV or AIDs
• tuberculosis
• diverticulitis or intestinal ulcers
• a low white blood cell count or a low platelet count
• diabetes
• cancer
• raised blood pressure
• high cholesterol or triglycerides
• kidney disease
• nerve disease such as neuropathy

3. you have a history of macrophage activation syndrome (MAS)

MAS is a complication of sJIA. If you have a history of MAS your doctor will decide if you can still be given ACTEMRA.

4. you are planning to have a vaccination or have recently had a vaccination

Certain types of vaccines should not be given while receiving ACTEMRA. It is particularly recommended that sJIA patients receive all necessary vaccinations prior to receiving ACTEMRA.

5. you are pregnant or plan to become pregnant

Tell your doctor if you are pregnant or plan to become pregnant. Women of childbearing potential should be advised to use adequate contraception during
and for several months after treatment with ACTEMRA. ACTEMRA should not be used during pregnancy. However if there is a need to take ACTEMRA when you are pregnant your doctor will discuss the risks and benefits to you and the unborn baby.

6. you are breast-feeding or plan to breast-feed

It is not known whether ACTEMRA passes into breast milk. It is recommended that you discontinue breast-feeding while you are treated with ACTEMRA.

7. you are on a controlled sodium diet

ACTEMRA contains a small amount of sodium.

8. you are allergic to any other medicines, foods, dyes or preservatives

If you have not told your doctor about any of the above, tell him or her before you start taking ACTEMRA.

Use in Children

The safety and efficacy of ACTEMRA in patients below 18 years of age with conditions other than pJIA or sJIA have not been established. There is only limited data available for ACTEMRA use in children with pJIA who are under 4 years of age. The use of ACTEMRA
in children under the age of 2 has not been studied.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you have bought from a pharmacy, supermarket or health food shop.

Do not use ACTEMRA with other biological medicines including infliximab, adalimumab, etanercept, anakinra, abatacept, rituximab, certolizumab pegol and golimumab. It is unknown how ACTEMRA interacts with these medicines.
ACTEMRA may interfere with some medicines. These include:
• warfarin, a medicine used to prevent blood clots
• cyclosporin, a medicine used after organ transplants
• atorvastatin and simvastatin, medicines used to reduce cholesterol levels
• calcium channel blockers, such as amlodipine, which are used to treat raised blood pressure
• theophylline, a medicine used to treat asthma
• phenytoin, a medicine used to treat convulsions
• benzodiazepines, such as diazepam, which are used to treat anxiety
These medicines may be affected by ACTEMRA, or may affect how well the medicine works. You may need to use different amounts of your medicine, or you may need to take
different medicines. Your doctor will advise you.
Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking ACTEMRA.

Ask your doctor or pharmacist if you are not sure about this list of medicines.


How ACTEMRA is given


How ACTEMRA is given

ACTEMRA is given by infusion into a vein (intravenous infusion) by a health care professional.
The infusion usually takes one hour. For pJIA and sJIA ACTEMRA should be given in a hospital setting.
For RA and pJIA ACTEMRA is usually given in combination with methotrexate (MTX). However you may receive ACTEMRA on its own if your doctor determines that initial treatment with MTX is inappropriate or unsuccessful.
For sJIA ACTEMRA can be given on its own or in combination with MTX.

How much is given

For RA the normal dose of ACTEMRA is 8 mg per kilogram (kg) of your body weight. Your


ACTEMRA 141007 2

doctor will prescribe an amount of
ACTEMRA that is right for you.
For pJIA the normal dose of ACTEMRA is 8 mg per kg of your body weight if you weigh 30 kg or more, or 10 mg per kg of your body weight if you weigh less than 30 kg. Your doctor will prescribe amount of ACTEMRA that is right for you.
For sJIA the normal dose of ACTEMRA is 8 mg per kg of your body weight if you weigh 30 kg or more, or 12 mg per kg of your body weight if you weigh less than 30 kg. Your doctor will prescribe an amount of ACTEMRA that is right for you.

How long is ACTEMRA

given


While you are receiving ACTEMRA


Things you must do

Tell your doctor immediately if you experience allergic reactions such as chest tightness, wheezing, severe dizziness or light- headedness, swelling of the lips or skin rash during or after receiving ACTEMRA.

Tell your doctor immediately if you develop an infection while you are being treated with ACTEMRA. Signs of serious infection include fever and chills, stomach ache or persistent headaches.

Tell your doctor immediately if

Do not take any other medicines whether they require a prescription or not without first telling your doctor or consulting a pharmacist.

Things to be careful of

Be careful driving or operating machinery until you know how ACTEMRA affects you.

ACTEMRA has not been shown to impair the ability to drive or operate machinery. However if you experience dizziness, a reported side effect, then you should not drive or operate machinery until it has resolved.
For RA and pJIA you will be treated

you develop severe blisters and

with ACTEMRA once every 4 weeks. For sJIA you will be treated with ACTEMRA once every 2 weeks.
The number of infusions you will receive depends on how you are responding to treatment. Your doctor will discuss this with you.

Continue receiving ACTEMRA

until your doctor tells you to stop.

If you miss a dose

As ACTEMRA is given to you under the supervision of your doctor, you are unlikely to miss a dose. However, if you do then your doctor will
decide when you should be given your next dose of ACTEMRA.

Overdose

As ACTEMRA is given to you under the supervision of your doctor it is unlikely that you will be given too much. However, if you experience any side effects after being given ACTEMRA, tell your doctor immediately.

bleeding in the lips, eyes, mouth,

nose and genitals while you are being treated with ACTEMRA.

Tell all doctors, dentists and pharmacists who are treating you that you are receiving ACTEMRA.

Tell your doctor if you become pregnant while taking ACTEMRA.

Tell your doctor if you are breast- feeding while being treated with ACTEMRA.

Tell your doctor if you feel ACTEMRA is not helping your condition.

Be sure to keep all of your appointments with your doctor so that your progress can be checked.

Your doctor will perform blood tests at regular intervals during your treatment to determine if you have low white blood cell or platelet counts, or high liver enzymes or cholesterol.
For pJIA your doctor will check your cholesterol at 3 monthly intervals.

Things you must not do

You should not breast-feed your infant during treatment with ACTEMRA.

It is not known whether ACTEMRA
crosses into human milk.

Side effects


Tell your doctor or pharmacist as soon as possible if you do not feel well while you are receiving ACTEMRA.

ACTEMRA helps many patients with RA, pJIA or sJIA but it may have unwanted side effects.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

• high blood pressure (symptoms may include headache, dizziness, ringing in the ears)
• rashes or itching
• headache
• cough
• blocked or runny nose
• sore throat
• dizziness
• nausea or indigestion
• stomach pain
• constipation


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• diarrhoea
• cold sores
• mouth or skin blisters
• mouth ulcers
• skin infection (redness, pain and/
or swelling)
• low white blood cell and platelet counts shown by blood tests
• raised blood fat (cholesterol)
levels
These are the more common side effects of ACTEMRA. Mostly these are mild.

Tell your doctor immediately or go to Accident and Emergency at

your nearest hospital if you notice any of the following:

• difficulty breathing, chest tightness or wheezing
• severe light-headedness
• severe skin rash, itching, hives
• swelling of the face, lips, mouth
• signs of serious infection such as fever and chills, stomach ache or persistent headaches
• bleeding from the stomach or intestines. Signs and symptoms may include severe stomach pain, vomiting blood or material that looks like coffee grounds, bleeding from your rectum, black sticky motions, bloody diarrhoea
• severe blisters and bleeding in the lips, eyes, mouth, nose and genitals.
These are serious side effects. You may need urgent medical attention. Serious side effects are rare.
This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.

Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.

Ask your doctor or pharmacist if you don't understand anything in this list.

Do not be alarmed by this list of possible side effects. You may not experience any of them.


After receiving

ACTEMRA


Storage

ACTEMRA should be stored in the pharmacy or on the hospital ward.
The concentrated solution for infusion should be kept in a refrigerator at 2°C - 8°C. It should not be frozen.
ACTEMRA should be stored away from light.


Product Description


Availability

ACTEMRA is available as 80 mg/4 mL, 200 mg/10 mL and 400 mg/20 mL single dose vials
ACTEMRA comes in packs of 1 vial for each of the 80 mg, 200 mg or 400 mg presentations.

What ACTEMRA looks like

ACTEMRA is a clear to opalescent, colourless to pale yellow liquid for intravenous infusion.

Ingredients

Active ingredient - tocilizumab

(rch)

Inactive ingredients

• polysorbate 80
• sucrose
• dibasic sodium phosphate dodecahydrate
• monobasic sodium phosphate dihydrate
• water for injections


Distributor



ACTEMRA is distributed in
Australia by:
Roche Products Pty Limited
ABN 70 000 132 865
4 -10 Inman Road
Dee Why NSW 2099
AUSTRALIA
Medical enquiries: 1 800 233 950
Distributed in New Zealand by: Roche Products (New Zealand)
Limited
PO Box 109113 Newmarket
Auckland 1149
New Zealand
Medical enquiries: 0800 656 464
Please check with your pharmacist for the latest Consumer Medicine Information.
Australian Registration Numbers
• 80 mg/4 mL AUST R 149403
• 200 mg/10 mL AUST R 149404
• 400 mg/20 mL AUST R 149402
This leaflet was prepared on 7
October 2014.

ACTEMRA 141007 4

Delivery info

SUPERPHARMACY Orders will be packaged in plain impervious packaging that is unmarked for security and privacy reasons. Orders will be dispatched as soon as possible once payment is received.  For Orders containing prescription items please see the prescription processing procedure. Orders for both prescription and non-prescription items will most likely be delivered separately, unless otherwise directed, where we do not hold the prescription paperwork at the time of placing the order.

PRESCRIPTION PROCESSING PROCEDURE

Orders for prescription items can only be processed once we physically receive your prescription paperwork. Prescription product orders will be dispensed and dispatched on the business day the prescription or valid repeat authorisation is received at the SUPERPHARMACY registered premises.Please send your prescription paperwork to the appropriate store

NSW, NT and TAS:  SUPERPHARMACY PO Box 1877 Hornsby Westfield 1635

QLD: Superpharmacy 187 Days Road Grange Qld 4051

SA: Superpharmacy 41 Hindley street Adelaide, SA 5000

VIC: Superpharmacy 92 Lygon Street East Brunswick NSW 3057

WA: Superpharmacy 259 Walcott St, North Perth WA 6006

Ensure to allow sufficient time for the delivery of your prescription or repeat authorisation paperwork to us and the subsequent order delivery via our specialised delivery network. We recommend considering a total of up to 7 days for metro areas or 10 days in remote areas. If we do not already hold your prescription paperwork, it will be necessary for you to send the prescription paperwork to us before we can dispatch your order. Please also allow appropriate time for the prescription to reach us and for the order to be sent back so as to avoid running out of your ongoing prescription medicine.

SUPERPHARMACY uses various means of delivery to minimise delivery wait times, the services of: Star Track Couriers, localised contract Courier services and Australia Post are contracted for all deliveries. All Orders will be delivered to the stated address and will require a recipient photo identification and a signature confirming receipt. Due to security procedures and legal requirements all Order goods will not be left unattended. Where no one is present at the delivery address to sign for the parcel, a card will be left detailing how the Order will be subsequently delivered, details of the delivery process and conditions are included in the SUPERPHARMACY Terms and Conditions found on the Site.

SUPERPHARMACY will dispatch most orders within ONE business day on Monday to Friday assuming all items are in stock. All other orders will be dispatched as quickly as possible thereafter. It may be necessary for some orders to be shipped in more than one box from different distribution sites and therefore you may obtain these parcels at different times. We will notify you via email if there is a delay in the delivery of an item in your Order and what action we have taken. Please contact our Customer Service on 1300 4MEDICINE if you would like an alternative product or an alternative arrangement. Order processing and delivery times may vary in peak times with special arrangements during peak volume times such as Christmas, Mother's Day and SUPERPHARMACY promotions. Contact our Customer Service on 1300 4MEDICINE or more information.

Australia Wide shipment details

Standard Australia Post shipping within Australia

Please allow between 1-8 working days from the date we ship your order (by location in Australia).

FLAT RATE SHIPPING - Australian Orders

Less than $75.00:  $8.95

ORDER VALUE of $75.00 or greater, FREE Delivery (Delivery Waiver)

PBS Concession Card Holders who Order a prescription item will receive FREE Delivery (Delivery Waiver) regardless of Order value

Anticipated Delivery Times by location

Standard Parcel Delivery Times in business days

NEW SOUTH WALES / AUSTRALIAN CAPITAL TERRITORY

Sydney metropolitan 1 day

NSW country 1-2 days

Canberra Metro Areas 1-3 days

VICTORIA

Melbourne Metro areas 1 day

VIC country 2-3 days

QUEENSLAND

Brisbane Metro Areas 1-2 days

South East QLD 1-2 days

Central QLD 2-3 days

Far North QLD2-4 days 

Far North QLD (Remote Islands) 8-10 days

TASMANIA

Hobart/ Launceston Metro Areas 1-2 days

Regional Tasmania 3-4 days

SOUTH AUSTRALIA

Adelaide Metro Areas 1-2 days

SA country 3-4 days

NORTHERN TERRITORY

Darwin Metro Areas 3-4 days 

Alice Springs 4-5 days 

NT country 8-12 days

WESTERN AUSTRALIA

Perth metropolitan 1-2 days

 WA country 1-4 days

 

Postage and handling for international orders

We do not currently deliver outside of Australia 

Returns & exchanges

Returns Policy

The SUPERPHARMACY Returns Policy applies to all purchases of Products using the Site and forms part of the terms and conditions. If you wish to return a Product in accordance with our Returns Policy, then you must:

(a) Check your Goods as soon as they are delivered to you in order to ensure that: (i) they are what you ordered; and (ii) they are not damaged or faulty. If this is not the case you should contact Customer Service by telephone 13004MEDICINE to make arrangements to return that Product. The return of a Product must be authorised by the appointed SUPERPHARMACY

Customer Service officer prior to taking any action to return the Product. We will provide a

Return Authorisation Number which must be quoted when authorised to return a Product.

Damaged or Defective Goods

We will replace or refund (at our discretion) any items delivered to you that are damaged or defective at no charge.

A Product refund will be arranged as follows:

(1) You may return the Product to us at the time we deliver your next Order. Upon confirmation from the driver that the goods have been received in the condition supplied, we will refund your card of purchase with the funds being available within 3-5 business days.

(2) You may return the Product to a “Click & Collect” location as arranged with you, by our Customer Service Officer, for return back to SUPERPHARMACY, or

(3) By using a Free Post Postal Address provided by the Customer Service officer where there is no nearby “Click & Collect” location. The Product returned must include details of the Order and the Return Authorisation Number. Upon receipt of the returned Product we will refund your card of purchase with the funds being available within 3-5 business days.

A Product replacement will be arranged as follows:

(1) We may replace the Product at the time we are able to facilitate the next delivery. Upon confirmation from the driver that the goods have been received in the condition supplied, we will replace the Product.

(2) You may return the Product to a “Click & Collect” location as arranged with you by our Customer Service Officer for replacement by SUPERPHARMACY.

Incorrect Items Ordered

We will issue a full refund for items you ordered incorrectly if you notify us within 7 days of placing the order on the Site, this Product return refund is conditional on all item(s) being returned to SUPERPHARMACY unopened and in the original packaging. Postage costs will not be refunded. Please send the Product by registered mail as no item will be refunded until received by us. If we have sent you the incorrect product from what you ordered please contact our Customer Service on 13004MEDICINE.

When you return a Product please ensure it is packed to avoid damage in transit. We highly recommend you photograph the Product inside the packing prior to sending.

Prescription Returns

Due to NSW Health Regulations, prescription items cannot be returned for refund.

The SUPERPHARMACY Returns Policy applies in addition to any other rights to which you may be entitled under the consumer guarantees provisions of the Australian Consumer Law.