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Romiplostim (rbe) ro''-mi''p-lo''-sti''m
Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Nplate.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking Nplate against the benefits they expect it will have for you.
Keep this leaflet with the medicine.
You may need to read it again.

What Nplate is used for

Nplate is used to treat low blood platelet counts in people with immune (idiopathic) thrombocytopenic purpura (called ITP). ITP is a disease in which your immune system destroys your platelets.
Platelets are the cells in your blood that help seal cuts and form blood clots. If you have too few platelets you could bruise more easily than normal. You could also bleed for a long time after being injured. If your platelet count is very low, you may be at risk of serious, life-threatening bleeding.
This medicine works by increasing the number of platelets made by your body. Nplate makes your bone marrow produce more platelets. This helps to prevent bruising and bleeding.
Your doctor, however, may prescribe Nplate for another purpose.
This medicine is available only with a doctor's prescription.

Before you are given Nplate

When you must not be given it

Do not use Nplate if you have an allergy to:
any medicine containing romiplostim
any of the ingredients listed at the end of this leaflet.
any medicines that are produced using the bacteria E.coli.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
rash, itching or hives on the skin
add any other specific reactions listed in the PI.
Do not use it after the expiry date (EXP) date printed on the pack.
If you use it after the expiry date has passed, it may have no effect, or an unexpected effect.
Do not use it if the Nplate solution is cloudy or discoloured, or if it contains clumps or flakes.

Before you given it

Tell your doctor if:
you have allergies to:
any other medicines
any other substances such as foods, preservatives or dyes.
you are pregnant or intend to become pregnant
Nplate is not recommended to be used during pregnancy. Your doctor can discuss with you the risks and benefits involved.
you are breast-feeding or planning to breast-feed.
you have or have had any of the following medical conditions:
liver problems
kidney problems
blood clot
cancer or precancer of the blood
Tell your doctor if you stop taking Nplate.
Your blood platelet count may return to low levels and put you at risk of bleeding if you stop taking Nplate. Your doctor will discuss the risks with you.

Taking other medicines


How Nplate is given

Nplate is given as an injection under the skin. This is called a subcutaneous injection.
Nplate should be given to you under the guidance of an experienced doctor or nurse.
Self-administration is not recommended in children.
It is recommended that children receive their Nplate injection from an experienced doctor or nurse.
They may differ from the information contained in this leaflet.

How much is given

When you first start using Nplate your dose is 1 microgram per kilogram of your body weight, given once a week.
Your doctor will adjust your dose of Nplate depending on your blood platelet count.
Children (1 to 17 years)
Your doctor will adjust your dose of Nplate depending on your blood platelet count and any changes in your body weight.

When to use it

Nplate is injected once per week to keep your platelet counts in a safe range.

How long to use it


If you are given too much (overdose)

You may need urgent medical attention.

While you are using it

Things you must do

Telephone Amgen Medical Information Line on 1800 803 638 (free call within Australia) to enrol in Amgen's Pregnancy Surveillance Program if you become pregnant whilst using Nplate.
Your doctor may do some blood tests to check your platelet levels from time to time to make sure the medicine is working.
Children (1 to 17 years)
Your doctor will regularly check your body weight to ensure your dose of Nplate is right for you.

Things you must not do

Do not use Nplate to treat any other complaints unless your doctor tells you to.
Do not stop taking your medicine without checking with your doctor.
If you stop taking it you may return to a low blood platelet count. You will be at risk of bruising and bleeding.
If you are taking medicines which prevent blood clots (anticoagulants or -anti-platelet therapy) when you lower the dose or stop taking Nplate, you will have a greater risk of bleeding.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Nplate.
This medicine helps most people with low platelet counts, but may have unwanted side effects in some people.
Do not be alarmed by the lists of possible side effects. You may not experience any of them.
abdominal pain
joint or muscle pain, including shoulder pain
pain in your hands and feet
trouble or difficulty in sleeping
burning pain, redness and warmth in your hands and feet
redness, heat or pain of skin
allergic reaction.
hive-like swelling beneath the skin
Children (1 to 17 years)
upper respiratory tract infection including a cough, runny, or blocked nose
inflammation or pain of the nose, throat or mouth
upper abdominal pain
gastroenteritis or diarrhoea
itchy or non-itchy rash
inflammation of the eye (conjunctivitis)
ear infection
bleeding beneath the surface of the skin or bruising under the skin
swelling in the limbs/hands/feet.
Tell your doctor immediately if you notice any of the following:
tingling or numbness in your hands and feet.
If any of the following happens, stop using Nplate and tell your doctor immediately or seek medical attention:
swelling of the face, lips, mouth or throat which may cause difficultly in swallowing or breathing.
Some of these side effects, for example,
low blood platelet count after stopping Nplate,
very high platelet count,
increased bone marrow fibres
Children (1 to 17 years)
very high platelet count

After using Nplate


If you need to store Nplate:
Keep your medicine in the refrigerator, between 2°C and 8°C. Do not freeze.
Keep your medicine in the pack until it is time to use it. Protect it from light.
If you take the powder out of the pack it will not keep well.
Do not shake or vigorously agitate the vial.
After Nplate powder has been dissolved, use the solution as soon as possible.
If the dissolved Nplate solution will not be used immediately, store it in the refrigerator, between 2°C and 8°C.
It can only be stored this way for up to 24 hours.
Use only one dose per vial of dissolved Nplate; do not re-enter the vial. Discard unused portions. Do not save unused Nplate for later administration.
Do not freeze dissolved Nplate solution.
Do not place Nplate or dissolved Nplate solution in a freezer or in the freezer compartment of a refrigerator.
Keep it where children cannot reach it.


Return any unused or expired medicine to your pharmacist.

Product description

What it looks like

Your Nplate is supplied as white powder in a glass vial.
Nplate comes in two pack sizes:
- Nplate 250 µg/0.5 mL and
- Nplate 500 µg/1 mL
Each pack contains one vial.
It is prepared for use by dissolving the powder in sterile Water for Injections:
250µg/0.5mL vial containing 375µg romiplostim: powder dissolved in 0.72mL sterile Water for Injections
500µg/1mL vial containing 625µg romiplostim: powder dissolved in 1.2mL sterile Water for Injections.
The powder should dissolve in less than 2 minutes.


Active ingredient: romiplostim (rbe).
Inactive ingredients: mannitol, sucrose, histidine, diluted hydrochloric acid and polysorbate 20.

Manufacturer/ Supplier

Nplate is supplied in Australia by:
Amgen Australia Pty Ltd
(ABN 31 051 057 428)
Level 7, 123 Epping Road
Medical Information 1800 803 638
This leaflet was prepared in June 2019.
Australian Registration Numbers:
375 µg vial: 147187
625 µg vial: 147188
Nplate is a registered trademark of Amgen.