Nplate 500 micrograms powder and solvent for solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Nplate 250 micrograms powder and solvent for solution for injection

Nplate 500 micrograms powder and solvent for solution for injection

romiplostim

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any questions, ask your doctor, pharmacist or nurse.

• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.

• If you experience any side effects, talk to your doctor, pharmacist or nurse, including any possible side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Nplate is and what it is used for

2. What you need to know before using Nplate

3. How to use Nplate

4. Possible side effects

5. How to store Nplate

6. Contents of the pack and other information

7. Instructions for preparing and administering an injection of Nplate

1. What Nplate is and what it is used for

The active substance in Nplate is romiplostim, a protein used to treat low platelet counts in patients with primary immune thrombocytopenia (ITP). ITP is a condition in which your body's immune system destroys its own platelets. Platelets are blood cells that help heal wounds and form blood clots. Very low platelet counts can cause serious bruising and bleeding.

Nplate is used in adult patients (18 years of age or older) with ITP who may or may not have had their spleen removed and who have been previously treated with corticosteroids or immunoglobulins that were not effective.

Nplate works by stimulating the bone marrow (the part of the bone responsible for producing blood cells) to produce more platelets. This should help prevent bruising and bleeding associated with ITP.

2. What you need to know before using Nplate

Do not use Nplate

• if you are allergic to romiplostim or to any of the other ingredients of this medicine (listed in section 6).

• if you are allergic to other medicines produced using DNA technology that uses the microorganism Escherichia coli (E. coli).

Warnings and precautions

• If you stop taking Nplate, your platelet count is likely to become low again (thrombocytopenia). If you stop taking Nplate, your platelet count will need to be monitored, and your doctor will advise you on appropriate precautions.

• If you are at risk of developing blood clots or if blood clots run in your family. The risk of blood clots may also be increased if:

  • you have liver problems;
  • you are elderly (≥ 65 years);
  • you are bedridden;
  • you have cancer;
  • you are taking contraceptive pills or hormone replacement therapy;
  • you have recently undergone surgery or suffered an injury;
  • you are obese (overweight);
  • you are a smoker.

Consult your doctor, pharmacist, or nurse before starting to use Nplate.

If you develop a very high platelet count, your risk of blood clots may increase. Your doctor will adjust your dose of Nplate to ensure that your platelet count does not become too high.

Changes in the bone marrow (increased reticulin and possible bone marrow fibrosis)

Long-term use of Nplate may cause changes in your bone marrow. These changes may lead to abnormal blood cells or a reduced production of blood cells. A mild form of these bone marrow changes is called "increased reticulin," which has been observed in clinical trials of Nplate. It is unknown whether this may progress to a more serious condition called "fibrosis." Abnormal blood test results may indicate bone marrow changes. Your doctor will decide whether an abnormal blood test means that a bone marrow examination should be performed or whether treatment with Nplate should be discontinued.

Worsening of blood cancer

Your doctor may decide to perform a bone marrow biopsy if it is necessary to confirm that you have ITP and not another condition such as Myelodysplastic Syndrome (MDS). If you have MDS and receive Nplate, you may experience an increase in blast cell count and worsening of MDS, which may progress to acute myeloid leukemia, a type of blood cancer.

Loss of response to romiplostim

If you lose response to romiplostim or are unable to maintain a platelet response during treatment with romiplostim, your doctor will investigate the reasons, including whether you are developing increased bone marrow fibers (reticulin) or have developed antibodies that neutralize the activity of romiplostim.

Children and adolescents

The use of Nplate is not recommended in children under 18 years of age.

Other medicines and Nplate

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

If you are also taking other medicines that prevent blood clotting (anticoagulant or antiplatelet therapy), there is an increased risk of bleeding. Your doctor will discuss this with you.

If you are taking corticosteroids, danazol, and/or azathioprine, which you may be receiving to treat your ITP, their dosage may need to be reduced or discontinued when used in combination with Nplate.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Nplate is not recommended during pregnancy unless specifically indicated by your doctor.

It is unknown whether romiplostim is excreted in human milk. Nplate is not recommended during breastfeeding. The decision to discontinue breastfeeding or discontinue romiplostim therapy should be made after considering the benefits of breastfeeding for the infant and the benefits of romiplostim treatment for the mother.

Driving and using machines

Consult your doctor before driving or operating machinery, as some of the adverse effects (e.g., transient episodes of dizziness) may impair your ability to perform these activities safely.

3. How to use Nplate

Nplate must be administered under the direct supervision of a physician who carefully monitors the amount of Nplate given.

Nplate is administered once weekly by subcutaneous injection (under the skin).

The initial dose is 1 microgram of Nplate per kilogram of body weight, once per week. Your doctor will tell you how much Nplate you should use. Nplate should be injected once weekly to maintain platelet counts. Your doctor will take regular blood samples to assess how your platelets are responding and adjust the dose if necessary.

Once your platelet count is controlled, your doctor will continue to perform regular blood tests. Your dose may be adjusted later to maintain long-term control of your platelet count.

Always follow exactly the instructions for using Nplate provided by your doctor. If you are unsure, consult your doctor again on how to use Nplate.

Instructions for preparing and administering an injection of Nplate

After proper training, your doctor may allow you to self-inject Nplate. Please read the instructions at the end of this leaflet on how to inject Nplate, as discussed with your doctor. If your doctor has permitted you to self-inject, you must have monthly follow-ups with your doctor to determine whether Nplate is working or whether another treatment should be considered.

After the first month of self-injecting Nplate, you will need to demonstrate that you can still correctly prepare and inject Nplate.

If you use more Nplate than you should

Your doctor will ensure that you receive the correct amount of Nplate. If you have received more Nplate than you should have, you may not experience any physical symptoms, but your blood platelet levels may rise to very high levels, which could increase the risk of blood clots. Therefore, if your doctor suspects that you have received too much Nplate, it is recommended that you be monitored for any signs or symptoms of side effects and receive appropriate treatment immediately.

If your doctor has allowed you to self-inject and you use more Nplate than you should, inform your doctor immediately.

If you use less Nplate than you should

Your doctor will ensure that you receive the correct amount of Nplate. If you have received less Nplate than you should have, you may not experience any physical symptoms, but your blood platelet levels may drop to low levels, which could increase the risk of bleeding. Therefore, if your doctor suspects that you have received less Nplate than required, it is recommended that you be monitored for any signs or symptoms of side effects and receive appropriate treatment immediately.

If your doctor has allowed you to self-inject and you use less Nplate than you should, inform your doctor immediately.

If you forget to use Nplate

If you miss a dose of Nplate, your doctor will advise you when to receive your next dose.

If your doctor has allowed you to self-inject and you missed your injection, inform your doctor immediately.

If you stop using Nplate

If you stop using Nplate, you are likely to experience a return of low platelet counts (thrombocytopenia). Your doctor will decide whether you should stop taking Nplate.

Self-injecting Nplate

Your doctor may decide it is best for you to self-inject Nplate. Your doctor, nurse, or pharmacist will show you how to inject Nplate. Do not attempt to self-inject unless you have been properly trained. It is very important that you prepare Nplate correctly and take the correct dose (see section 7. Instructions for preparing and administering an injection of Nplate, at the end of this leaflet).

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Very common: may affect more than 1 in 10 people

• headache;
• allergic reaction;
• upper respiratory tract infection.

Common: may affect up to 1 in 10 people

• bone marrow disorder, including increase in bone marrow fibres (reticulin);
• difficulty in sleeping (insomnia);
• dizziness;
• tingling or numbness in the hands or feet (paraesthesia);
• migraine;
• skin redness (flushing);
• blood clot in an artery of the lung (pulmonary embolism);
• nausea;
• diarrhoea;
• abdominal pain;
• indigestion (dyspepsia);
• constipation;
• itching of the skin (pruritus);
• bleeding under the skin (ecchymosis);
• bruising (contusion);
• skin rash;
• joint pain (arthralgia);
• muscle pain or weakness (myalgia);
• pain in hands and feet;
• muscle spasm;
• back pain;
• bone pain;
• tiredness (fatigue);
• reaction at the injection site;
• swelling in the hands and feet (peripheral oedema);
• flu-like symptoms (influenza-like illness);
• pain;
• weakness (asthenia);
• fever (pyrexia);
• chills;
• contusion;
• swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema);
• gastroenteritis;
• palpitations;
• inflammation of the sinuses (sinusitis);
• inflammation of the airways leading to the lungs (bronchitis);
• blood clotting in veins (deep vein thrombosis).

Common: may affect up to 1 in 10 people (may be observed in blood or urine tests)

• low platelet count in blood (thrombocytopenia) and low platelet count in blood (thrombocytopenia) after stopping treatment with Nplate;
• platelet count higher than normal (thrombocytosis);
• anaemia.

Uncommon: may affect up to 1 in 100 people

• bone marrow disorder; bone marrow disorder causing scarring (myelofibrosis); enlargement of the spleen (splenomegaly); vaginal bleeding (vaginal haemorrhage); bleeding from the rectum (rectal haemorrhage); bleeding from the mouth (oral haemorrhage); bleeding at the injection site (injection site haemorrhage);
• heart attack (myocardial infarction); increased heart rate;
• dizziness or spinning sensation (vertigo);
• eye problems including: bleeding in the eyes (conjunctival haemorrhage); difficulty focusing or blurred vision (visual accommodation disorder, papilloedema or eye disorder); blindness; itching in the eyes (ocular pruritus); increased tears (increased lacrimation); or visual disturbances;
• digestive system problems including: vomiting; bad breath (halitosis); difficulty swallowing (dysphagia); indigestion or heartburn (gastro-oesophageal reflux disorder); blood in the stools (haematochezia); stomach discomfort; mouth ulcers or blisters in the mouth (stomatitis); discoloured teeth (dental discolouration);
• weight loss; weight gain; alcohol intolerance; loss of appetite (anorexia or decreased appetite); dehydration;
• general feeling of being unwell (malaise); chest pain; irritability; facial swelling (facial oedema); feeling of warmth; increased body temperature; nervous sensation;
• flu; localized infection; inflammation of the nasal passages and throat (nasopharyngitis);
• nose and throat problems including: cough; runny nose (rhinorrhoea); dry throat; shortness of breath or difficulty breathing (dyspnoea); nasal congestion; painful breathing (painful respiration);
• painful swollen joints caused by uric acid (a breakdown product of food) (gout);
• muscle stiffness; muscle weakness; shoulder pain; muscle contractions;
• nervous system problems including involuntary muscle contractions (clonus); distorted sense of taste (dysgeusia); reduced sense of taste (hypogeusia); sensation of reduced sensitivity, especially in the skin (hypoesthesia); nerve function disorders in arms and legs (peripheral neuropathy); blood clot in the transverse sinus (transverse sinus thrombosis);
• depression; abnormal dreams;
• hair loss (alopecia); sensitivity to light (photosensitivity reaction); acne; allergic skin reaction due to contact with allergens (contact dermatitis); skin manifestations with rash and blisters (eczema); dry skin; skin redness (erythema); severe peeling or scaly rash (exfoliative rash); abnormal hair growth; thickening and itching of the skin due to repeated scratching (prurigo); bleeding under the skin surface or bruising under the skin (purpura); itchy skin rash (papular rash); itchy skin rash (pruritic rash); generalized itchy rash (urticaria); skin lump (skin nodule); abnormal odour of the skin (abnormal skin odour);
• circulation problems including blood clots in the liver vein (portal vein thrombosis); low blood pressure (hypotension); increased blood pressure; blockage of a blood vessel (peripheral embolism); reduced blood flow in hands, ankles or feet (peripheral ischaemia); swelling and clotting in a vein, which may be extremely soft to touch (phlebitis or superficial thrombophlebitis); blood clotting (thrombosis);
• a rare condition characterised by episodes of burning pain, redness and warmth in the feet and hands (erythromelalgia).

Uncommon: may affect up to 1 in 100 people (may be observed in blood or urine tests)

• a rare type of anaemia in which red blood cells, white blood cells and platelets are reduced in number (aplastic anaemia);
• increased count of white blood cells in blood (leucocytosis);
• excessive platelet production (thrombocythaemia); increased platelet count; abnormal count of blood cells that prevent bleeding (abnormal platelet count);
• changes in certain blood tests (increased transaminases; increased blood lactate dehydrogenase);
• or cancer of the white blood cells (multiple myeloma);
• proteins in urine.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Nplate

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and label of the vial after EXP. The expiry date refers to the last day of the month indicated.

Store in a refrigerator (between 2°C and 8°C).

Do not freeze.

Keep in the original packaging to protect from light.

When stored in the original packaging, this medicine may be kept outside the refrigerator for a maximum period of 30 days at room temperature (up to 25**°**C).

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nplate

• The active substance is romiplostim.

Each vial of Nplate 250 micrograms powder for injectable solution contains a total of 375 micrograms of romiplostim. An additional volume has been added to each vial to ensure that 250 micrograms of romiplostim can be administered. After reconstitution, a final product volume of 0.5 ml of solution contains 250 micrograms of romiplostim (500 micrograms/ml).

Each vial of Nplate 500 micrograms powder for injectable solution contains a total of 625 micrograms of romiplostim. An additional volume has been added to each vial to ensure that 500 micrograms of romiplostim can be administered. After reconstitution, a final product volume of 1 ml of solution contains 500 micrograms of romiplostim (500 micrograms/ml).

• The other components are:

Powder: mannitol (E421), sucrose, L-histidine, hydrochloric acid (for pH adjustment) and polysorbate 20.

Solvent: water for injections.

Nature of the product and contents of the container

Nplate is a white powder for injectable solution supplied in a single-dose 5 ml glass vial.

Nplate is supplied in a pack or multiple pack containing 4 packs. Each pack contains:

1 vial of 250 micrograms or 500 micrograms of romiplostim.

1 pre-filled syringe containing 0.72 or 1.2 ml of water for injections for reconstitution.

1 plunger for the pre-filled syringe.

1 sterile vial adapter.

1 sterile 1 ml syringe with Luer lock.

1 sterile safety needle.

4 alcohol wipes.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

The Netherlands

Marketing Authorization Holder

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

The Netherlands

Manufacturer

Amgen Technology (Ireland) Unlimited Company

Pottery Road

Dun Laoghaire

Co Dublin

Ireland

Manufacturer

Amgen NV

Telecomlaan 5-7

1831 Diegem

Belgium

Further information about this medicinal product is available upon request from the local representative of the Marketing Authorization Holder.

Belgium/Belgium/Belgium s.a. Amgen n.v. Tel/Tel: +32 (0)2 7752711	Lithuania Amgen Switzerland AG Vilnius Branch Tel: +370 5 219 7474
Bulgaria Amgen Bulgaria EOOD Tel.: +359 (0)2 424 7440	Luxembourg/Luxembourg s.a. Amgen Belgium/Belgium Tel/Tel: +32 (0)2 7752711
Czech Republic Amgen s.r.o. Tel: +420 221 773 500	Hungary Amgen Kft. Tel.: +36 1 35 44 700
Denmark Amgen branch of Amgen AB, Sweden Tlf.: +45 39617500	Malta Amgen S.r.l. Italy Tel: +39 02 6241121
Germany Amgen GmbH Tel.: +49 89 1490960	Netherlands Amgen B.V. Tel: +31 (0)76 5732500
Estonia Amgen Switzerland AG Vilnius Branch Tel: +372 586 09553	Norway Amgen AB Tlf: +47 23308000
Greece Amgen Hellas Pharmaceutical E.P.E. Tel: +30 210 3447000	Austria Amgen GmbH Tel: +43 (0)1 50 217
Spain Amgen S.A. Tel: +34 93 600 18 60	Poland Amgen Biotechnologia Sp. z o.o. Tel.: +48 22 581 3000
France Amgen S.A.S. Tél: +33 (0)9 69 363 363	Portugal Amgen Biofarmacêutica, Lda. Tel: +351 21 4220606
Croatia Amgen d.o.o. Tel: +385 (0)1 562 57 20	Romania Amgen Romania SRL Tel: +4021 527 3000
Ireland Amgen Ireland Limited Tel: +353 1 8527400	Slovenia AMGEN zdravila d.o.o. Tel: +386 (0)1 585 1767
Iceland Vistor hf. Sími: +354 535 7000	Slovakia Amgen Slovakia s.r.o. Tel: +421 2 321 114 49
Italy Amgen S.r.l. Tel: +39 02 6241121	Finland/Suomi Amgen AB, branch in Finland/Amgen AB, filial i Finland Puh/Tel: +358 (0)9 54900500
Cyprus C.A. Papaellinas Ltd Tel: +357 22741 741	Sweden Amgen AB Tel: +46 (0)8 6951100
Latvia Amgen Switzerland AG Riga Branch Tel: +371 257 25888

Date of the most recent review of this leaflet in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu

1. Instructions for the preparation and administration of an injection of Nplate

This section contains information on how to self-inject Nplate. It is important that you do not attempt to self-administer the injection unless you have been trained by your doctor, nurse, or pharmacist. If you have any questions about how to give the injection, consult your doctor, nurse, or pharmacist. It is very important that the product is prepared correctly and that the correct dose is administered.

This section is divided into the following subsections:

Before starting

Step 1. Place the injection materials

Step 2. Prepare the vial for use, attach the vial adapter

Step 3. Prepare the sterile water syringe

Step 4. Reconstitute Nplate by injecting the water into the vial

Step 5. Prepare a new syringe for the injection

Step 6. Prepare the needle for the injection

Step 7. Choose and prepare the injection site

Step 8. Inject the Nplate solution

Step 9. Disposal of supplies

Before starting

Read all the instructions for use carefully. These instructions are intended for patients who have already been trained by their healthcare professional, such as their doctor, nurse, or pharmacist, in self-injection. If you have not been trained, please contact your healthcare professional.

The Nplate self-injection kit must be kept in its original packaging until use to protect the Nplate vial from light. Store the Nplate self-injection kit refrigerated between 2°C and 8°C.

Once Nplate has been reconstituted, inject immediately.

There may be leftover Nplate after administration of the prescribed dose. Do not reuse Nplate! Any reconstituted Nplate remaining after administration must be discarded immediately after completing the injection process. Leftover Nplate from the vial must NEVER be reused for another injection.

Step 1. Place the injection materials

Do the following:

• Select a flat, well-lit work surface, such as a table.

• Take the Nplate self-injection kit out of the refrigerator. Do not use if frozen. If you have any doubts about storage, contact your healthcare professional for further instructions.

• Check the expiry date printed on the self-injection kit. Do not use if the expiry date has passed. Do not proceed and inform your healthcare professional.

• Note: If your doctor has indicated that your Nplate dose requires more than one injection, you will need to use more than one self-injection kit. Follow the steps described in this leaflet and use as many self-injection kits as necessary to complete the prescribed dose of Nplate.

• Ensure you have the following components:

Alcohol swab pack x4

1 vial of 250 microgram powder or	13 mm vial adapter x1
500 microgram x1

Plunger for pre-filled syringe of sterile water x1 Pre-filled syringe of sterile water x1

1 ml syringe with Luer lock x1 Safety needle for injection x1

• Do not open components until instructed to do so in the instructions.

• Do not use components that have been altered or damaged.

• Do not reuse components.

Step 2. Prepare the vial for use, attach the vial adapter

Use: 2 alcohol wipes, 1 vial, and 1 vial adapter pack.

Do the following:

Wash your hands with soap and hot water. Clean the flat work surface with a new alcohol wipe. Remove the red plastic cap (250 micrograms) or blue (500 micrograms) from the vial.
Using a new alcohol wipe, clean the vial cap Do not touch the vial cap after cleaning it
Slowly peel back the paper from the vial adapter, keeping the vial adapter in the plastic packaging. Do not touch the vial cap or the tip of the vial adapter.
Keeping the vial on the table, and keeping the vial adapter in the plastic packaging, align the tip of the vial adapter with the center of the vial cap.
Push the vial adapter downward until it is firmly in place and cannot be pushed further down.
Remove the plastic packaging from the vial adapter, leaving the vial adapter on the vial. Do not touch the top of the vial adapter.

Step 3. Prepare the sterile water syringe

Use: The pre-filled sterile water syringe and plunger.

Before starting Step 3, please note the following:

• The transparent plastic plunger must ALWAYS be attached before breaking the white tip of the pre-filled sterile water syringe. Perform step 3a before step 3b.

Do the following:

Step 3a: Attach the clear plastic plunger to the prefilled sterile water syringe, by placing the threaded end of the plunger into the syringe and carefully turning the rod clockwise into the gray plunger syringe until you feel slight resistance. Do not overtighten.
Step 3b: Holding the syringe with one hand, bend the tip of the white plastic cover downward with the other hand. This will break the seal of the white plastic cap.
Once the seal is broken, remove the white plastic cover. You will see the gray rubber stopper in the cap.

Step 4. Reconstitute Nplate by injecting the water into the vial

Use: Prefilled syringe of sterile water and vial with vial adapter attached.

Before starting Step 4, please note the following:

• Reconstitute slowly and carefully. It is a protein and, as such, may be easily damaged by improper or excessive agitation.

Do the following:

Keeping the vial on the table, place the prefilled water syringe into the vial adapter, holding one side of the vial adapter with one hand and, with the other hand, turn the syringe tip clockwise into the adapter until you feel slight resistance.
Very slowly and gently, push the plunger down to inject all the water from the syringe into the vial. The water should flow slowly over the powder. Do not force the water into the vial. Note: After injecting the water into the vial, it is normal for the plunger to move back up. You do not need to maintain pressure on the plunger for the remainder of Step 4.	Press slowly and gently

Before continuing:

• Make sure that all the water is injected from the syringe into the vial before dissolving it.

Holding the area where the vial connects to its adapter between your fingers, gently remove the vial by rotating your wrist until all the powder has dissolved and the liquid in the vial is clear and colorless. Gently remove the vial.	Correct
Do not shake the vial Do not roll the vial between your palms Note: the powder may take up to 2 minutes to dissolve completely.	Incorrect

Before continuing:

• Visually inspect the dissolved liquid for particles and/or discoloration. It must be clear, colorless, and completely dissolved.

• Note: If there is any color or particles in the liquid, contact your healthcare professional.

• Ensure the liquid is completely dissolved before removing the syringe.

When Nplate is completely dissolved, remove the empty syringe from the vial adapter by turning it counterclockwise.

• Dispose of the empty syringe in a sharps or hazardous waste container. Keep the dissolved Nplate vial. Immediately prepare a new syringe for injection.

• Do not delay the Nplate injection.

Step 5. Prepare a new syringe for injection

Use: A new 1 ml syringe from the package and the vial with dissolved and clear Nplate.

Before continuing:

• Check your dose before starting this step.

• Note: Liquid Nplate is very potent, so accurate measurement of the dose is important.

• Make sure all air bubbles have been removed before injection.

Do the following:

Remove a 1 ml syringe from the package. Draw air into the syringe up to the 1 ml mark. Do not pull the plunger beyond the 1 ml mark.	Put air into the syringe up to the 1 ml mark
Attach the 1 ml syringe to the vial adapter of the reconstituted Nplate by turning the tip of the syringe clockwise onto the vial adapter until you feel slight resistance.
Inject air into the vial. Maintain pressure on the plunger. Turn the vial and syringe assembly upside down, so that the vial is directly above the syringe.	A.B.C. Turn downward
Withdraw all liquid contents into the syringe. The final volume is 0.5 ml for the 250 microgram vial and 1 ml for the 500 microgram vial. Do not pull the plunger beyond the end of the syringe.
Make sure the plunger remains in the syringe.	Correct
Check and remove all air bubbles from the syringe. Gently tap the syringe with your fingers to dislodge air bubbles from the liquid. Slowly push the plunger upward to force air bubbles out of the syringe.	Air bubbles: Correct Incorrect
Slowly push the plunger to leave only the amount prescribed by your healthcare provider. Ensure the tip of the plunger aligns with the syringe mark corresponding to your prescribed dose. If necessary, return liquid to the vial to achieve the desired dose.	Adjust amount to your prescribed dose

• Perform a final check to ensure the correct amount of liquid for your dose is in the syringe and that all air bubbles have been removed.

Before continuing:

• Make sure the correct amount of liquid for your dose remains in the syringe.

• Make sure all air bubbles are removed from the syringe.

Once all bubbles have been removed and the syringe is filled with the correct dose, remove the syringe from the vial adapter.
Keep the filled syringe in hand and do not touch the tip of the syringe. Do not turn the syringe upside down after removing it from the vial.

Step 6. Prepare the needle for injection

Use: The syringe filled with the measured dose of Nplate and the safety needle.

Do the following:

With the syringe in the palm of your hand and the tip pointing upwards, remove the safety needle from its packaging.
Attach the safety needle to the filled syringe. Firmly push the safety needle onto the syringe and turn clockwise to secure it to the Luer lock tip. The product is now ready for injection. IMMEDIATELY proceed to step 7.

Step 7. Choose and prepare the injection site

Use: New alcohol wipes.

Do the following:

Select the injection sites. Three areas are recommended for Nplate injection. Middle of the front of the thigh Abdomen, except for the area within 5 cm around the navel If someone else is administering the injection, the outer part of the upper arm may also be used Rotate different sites for each injection.
Do not inject into areas where the skin is soft, bruised, or hard. Do not inject into areas with scars or stretch marks. Clean the area where Nplate will be injected with an alcohol wipe, using a circular motion. Do not touch the area again before injecting.

Step 8. Inject the Nplate liquid

Use: Set with the filled syringe and needle.

Do the following:

Pull the pink safety cap (toward the syringe and away from the needle).
Remove the clear needle protector, holding the syringe in one hand and carefully pulling the protector straight off with the other hand. Remove the clear needle protector before injecting.
With one hand, gently pinch the clean area of skin and hold it firmly. With the other hand, hold the syringe (like a pencil) at a 45° angle to the skin. With a short, quick motion, insert the needle into the skin.
Inject the prescribed dose subcutaneously, as instructed by your doctor, nurse, or pharmacist. When the syringe is empty, remove the needle from the skin, carefully maintaining the same angle as during insertion. There may be slight bleeding at the injection site. You may press a cotton ball or gauze pad against the injection site for 10 seconds. Do not rub the injection site. If needed, you may cover the injection site with a small bandage.
After the injection, use your thumb (or fingertip) to activate the pink safety cap, pushing the cap forward with the same hand until you hear and/or feel a click and it closes securely over the needle.
Visually confirm that the needle tip is covered. Always cover the needle with the pink safety cap before disposing of it.

Step 9. Disposal of Supplies

Do the following:

• Immediately dispose of the syringe with the needle capped into a sharps disposal container.

• Immediately dispose of the used Nplate vial into an appropriate waste container.

• Ensure all remaining materials are discarded in the appropriate containers.

The injection device and Nplate vial MUST NEVER be reused.

• Dispose of the used needle and syringe in a puncture-resistant container.

Dispose of any remaining Nplate in an appropriate waste container. Any leftover from an Nplate vial MUST NEVER be reused for another injection.