RoActemra 162 mg solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

RoActemra 162 mg, solution for injection in pre-filled syringe

tocilizumab

Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

In addition to this leaflet, you will be given a patient alert card containing important safety information you should know before receiving RoActemra and during treatment with RoActemra.

Contents of this leaflet:

1. What RoActemra is and what it is used for
2. What you need to know before using RoActemra
3. How to use RoActemra
4. Possible side effects
5. How to store RoActemra
6. Contents of the pack and other information

1. What RoActemra is and what it is used for

RoActemra contains an active substance called tocilizumab, which is a protein derived from specific immune cells (monoclonal antibody) that blocks the action of a specific type of protein (cytokine) called interleukin-6. This protein is involved in inflammatory processes in the body, and by blocking it, inflammation can be reduced. RoActemra is indicated for the treatment of:

• Adults with moderate to severe active rheumatoid arthritis (RA), which is an autoimmune disease, when previous treatments have not worked well.

• Adults with severe, active and progressive rheumatoid arthritis (RA) who have not previously been treated with methotrexate.

RoActemra helps reduce the symptoms of RA such as pain and swelling in your joints and may also improve your ability to perform daily tasks. RoActemra has been shown to reduce the progression of joint cartilage and bone damage caused by the disease and to improve your ability to carry out daily activities.

RoActemra is usually used in combination with another RA medication called methotrexate. However, RoActemra may be given alone if your doctor determines that methotrexate is not suitable.

• Adults with a blood vessel disease called giant cell arteritis (GCA), caused by inflammation of the larger arteries in the body, especially those supplying blood to the head and neck. Symptoms may include headache, fatigue, and jaw pain. Complications may include strokes and blindness.

RoActemra can reduce pain and swelling in the arteries and veins of the head, neck, and arms.

GCA is often treated with medications called steroids. These are usually effective, but may cause side effects if used at high doses for long periods. Reducing the steroid dose may also lead to a flare-up of GCA. Adding RoActemra to treatment allows for a shorter duration of steroid use while still maintaining control of GCA.

• Children and adolescents aged 1 year and older with active systemic juvenile idiopathic arthritis (sJIA), an inflammatory disease causing pain and swelling in one or more joints, as well as fever and skin rash.

RoActemra is used to improve the symptoms of sJIA. It can be administered in combination with methotrexate or alone.

• Children and adolescents aged 2 years and older with active polyarticular juvenile idiopathic arthritis (pJIA). This is an inflammatory disease causing pain and swelling in one or more joints.

RoActemra is used to improve the symptoms of pJIA. It can be administered in combination with methotrexate or alone.

2. What you need to know before using RoActemra

Do not use RoActemra if

• You or a child (if the child is the patient you are caring for) are allergic to tocilizumab or to any of the other ingredients of this medicine (listed in section 6).
• You or a child (if the child is the patient you are caring for) have a serious active infection.

If any of these apply to you, consult your doctor. Do not use RoActemra.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting treatment with RoActemra.

• If you experience allergic reactions such as chest tightness, wheezing, dizziness, or severe lightheadedness, swelling of the lips, tongue, or face, or skin rash, hives, or itching during or after the injection, inform your doctor immediately.

• If you have experienced any symptoms of an allergic reaction after receiving RoActemra, do not take the next dose until you have informed your doctor and your doctor has instructed you to continue.

• If you have any type of infection, whether short- or long-term, or if you frequently get infections, inform your doctor immediately if you feel unwell. RoActemra may reduce your body's ability to respond to infections and may worsen an existing infection or increase the risk of acquiring a new infection.

• If you have had tuberculosis, inform your doctor. Your doctor will check for signs and symptoms of tuberculosis before starting treatment with RoActemra. Inform your doctor immediately if symptoms of tuberculosis (persistent cough, weight loss, general malaise, low-grade fever) or any other infection appear during or after treatment.

• If you have had intestinal ulcers or diverticulitis, inform your doctor. Symptoms may include abdominal pain and unexplained changes in bowel habits accompanied by fever.

• If you have liver disease, inform your doctor. Before using RoActemra, your doctor will perform a blood test to assess your liver function.

• If any patient has been recently vaccinated, or plans to be vaccinated, inform your doctor. All patients should be up to date with their vaccination schedule before starting treatment with RoActemra. Certain types of vaccines should not be administered while receiving RoActemra.

• If you have cancer, inform your doctor. Your doctor will need to decide whether you can continue treatment with RoActemra.

• If you have cardiovascular risk factors, such as high blood pressure or high cholesterol levels, inform your doctor. These factors need to be monitored and managed while receiving RoActemra.

• If you have moderate to severe kidney problems, your doctor will monitor you.

• If you have persistent headaches.

Your doctor will perform blood tests before you receive RoActemra to determine whether you have low white blood cell counts, low platelet counts, or elevated liver enzymes.

Children and adolescents

Subcutaneous injection of RoActemra is not recommended in children under 1 year of age.

RoActemra should not be administered to children with PJIA weighing less than 10 kg.

If a child has a history of macrophage activation syndrome (uncontrolled activation and proliferation of specific blood cells), inform your doctor. Your doctor will need to decide whether RoActemra can still be administered.

Other medicines and RoActemra

Inform your doctor if you are taking any other medicines or have recently taken any. This is because RoActemra may affect how some medicines work, and a dose adjustment may be needed. Inform your doctor if you have recently used medicines containing any of the following active substances:

• methylprednisolone, dexamethasone, used to reduce inflammation
• simvastatin or atorvastatin, used to reduce cholesterol levels
• calcium channel antagonists, such as amlodipine, used to treat high blood pressure
• theophylline, used in the treatment of asthma
• warfarin or fenprocoumon, used as anticoagulants
• phenytoin, used to treat seizures
• cyclosporine, used as an immunosuppressant in organ transplantation
• benzodiazepines, such as temazepam, used to treat anxiety.

Because there is no clinical experience, the use of RoActemra with other biological medicines used to treat RA, PJIA, sJIA, or GCA is not recommended.

Pregnancy, breastfeeding, and fertility

RoActemra should not be used during pregnancy unless clearly necessary. Talk to your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant.

Women of childbearing potential must use effective contraception during treatment and for at least 3 months after stopping treatment.

Interrupt breastfeeding if you start treatment with RoActemra and consult your doctor. Breastfeeding should not be resumed until at least 3 months after your last dose of RoActemra. It is unknown whether RoActemra passes into breast milk.

Driving and using machines

This medicine may cause dizziness. If you feel dizzy, do not drive or operate machinery.

RoActemra contains polysorbate 80 (E433)

This medicine contains 0.18 mg of polysorbate 80 in each 162 mg/0.9 ml pre-filled syringe, equivalent to 0.2 mg/ml. Polysorbates may cause allergic reactions. Inform your doctor if you or your child have any known allergies.

3. How to use RoActemra

Follow exactly the instructions for using this medicine as given by your doctor, pharmacist, or nurse. If you are unsure, please consult your doctor, pharmacist, or nurse again.

Treatment must be prescribed by a healthcare professional experienced in the diagnosis and treatment of RA, JIA, sJIA, or GCA.

Recommended dose

The dose for adults with RA or GCA is 162 mg (the content of one pre-filled syringe) administered once weekly.

Children and adolescents with JIA (from 1 year of age onwards)

The usual dose of RoActemra depends on the patient's body weight.

• If the patient weighs less than 30 kg: the dose is 162 mg (the content of one pre-filled syringe), once every 2 weeks
• If the patient weighs 30 kg or more: the dose is 162 mg (the content of one pre-filled syringe), once weekly.

Children and adolescents with sJIA (from 2 years of age onwards)

The usual dose of RoActemra depends on the patient's body weight.

• If the patient weighs less than 30 kg: the dose is 162 mg (the content of one pre-filled syringe), once every 3 weeks
• If the patient weighs 30 kg or more: the dose is 162 mg (the content of one pre-filled syringe), once every 2 weeks.

RoActemra is administered by injection under the skin (subcutaneously). Initially, your doctor or nurse may administer RoActemra to you. However, your doctor may decide that you can self-inject RoActemra. In this case, you will receive training on how to self-administer RoActemra by injection. Parents and caregivers will receive instructions on how to inject RoActemra to patients who cannot self-inject, such as children.

Talk to your doctor if you have any questions about how to self-administer an injection or how to administer it to the child you care for. Detailed “instructions for administration” can be found at the end of this leaflet.

If you are given more RoActemra than you should

Since RoActemra is administered in a pre-filled syringe, it is unlikely that you will be given too much. However, if you are concerned, speak with your doctor, pharmacist, or nurse.

If an adult with RA or GCA, or a child or adolescent with JIA, misses or forgets a dose

It is very important to use RoActemra exactly as prescribed by your doctor. Keep track of when your next dose is due.

• If you miss your weekly dose within 7 days, take your dose on the next scheduled day.
• If you miss your dose given once every 2 weeks within 7 days, inject a dose as soon as you remember, and administer your next dose according to your original schedule.
• If you miss your weekly or once-every-2-weeks dose for more than 7 days, or if you are unsure when to inject RoActemra, contact your doctor or pharmacist.

If a child or adolescent with sJIA misses or forgets a dose

It is very important to use RoActemra exactly as prescribed by the doctor. Keep track of the next dose.

• If you miss a dose within 7 days, inject a dose as soon as you remember, and administer the next dose according to your original schedule.
• If you miss a dose for more than 7 days, or if you are unsure when to inject RoActemra, contact your doctor or pharmacist.

If you stop treatment with RoActemra

You must not stop treatment with RoActemra without first consulting your doctor.

If you have any further questions about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

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

Adverse effects may occur up to at least 3 months after your last dose of RoActemra.

Possible serious adverse effects: consult your doctor immediately.

Consult your doctor immediately if you experience any of the following adverse effects:

These are common: may affect up to 1 in 10 patients

Allergic reactions during or after the injection:

• difficulty breathing, chest tightness, or dizziness
• skin rash, itching, hives, swelling of the lips, tongue, or face

Signs of serious infections:

• fever and chills
• blisters in the mouth or on the skin
• stomach pain

Signs and symptoms of liver toxicity

May affect up to 1 in 1,000 patients

• fatigue
• abdominal pain
• jaundice (yellowing of the skin or eyes)

List of other possible adverse effects

If you notice any of these symptoms, inform your doctor as soon as possible.

Very common adverse effects:

May affect more than 1 in 10 patients

• upper respiratory tract infections, with typical symptoms such as cough, nasal congestion, runny nose, sore throat, and headache
• high levels of fat in the blood (cholesterol)
• reactions at the injection site

Common adverse effects:

May affect up to 1 in 10 patients

• lung infection (pneumonia)
• herpes (herpes zoster)
• cold sores (oral herpes simplex), blisters
• skin infections (cellulitis), sometimes with fever and chills
• rash and itching, urticaria
• allergic reactions (hypersensitivity)
• eye infection (conjunctivitis)
• headache, dizziness, hypertension
• mouth ulcers, stomach pain
• fluid retention (edema) in the lower legs, weight gain
• cough, shortness of breath
• low white blood cell counts in blood tests (neutropenia, leucopenia)
• abnormal liver function tests (elevated transaminases)
• increased bilirubin measured by blood test
• low levels of fibrinogen in the blood (a protein involved in blood clotting)

Uncommon adverse effects:

May affect up to 1 in 100 patients

• diverticulitis (fever, nausea, diarrhea, constipation, stomach pain)
• red and swollen areas in the mouth
• elevated blood fats (triglycerides)
• stomach ulcers
• kidney stones
• hypothyroidism

Rare adverse effects:

May affect up to 1 in 1,000 patients

• Stevens-Johnson syndrome (skin rash, which may lead to blisters and severe skin peeling)
• life-threatening allergic reactions (anaphylaxis)
• inflammation of the liver (hepatitis), jaundice

Very rare adverse effects:

May affect up to 1 in 10,000 patients

• low counts of white blood cells, red blood cells, and platelets in blood tests
• liver failure

Adverse effects in children and adolescents with sJIA or pJIA

In children and adolescents with sJIA or pJIA, adverse effects are generally similar to those in adults. Some adverse effects occur more frequently in children and adolescents: inflammation of the nose and throat, headache, nausea, and decreased white blood cell count.

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 through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of RoActemra

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label of the pre-filled syringe and on the carton, following EXP. The expiry date refers to the last day of the month indicated.

Store in a refrigerator (between 2 °C – 8 °C). Do not freeze. When removed from the refrigerator, the pre-filled syringe may be stored for up to 2 weeks at a temperature not exceeding 30 °C.

Keep the pre-filled syringes in their outer packaging to protect them from light and moisture.

Do not use this medicine if it appears cloudy or contains particles, if it has a colour different from colourless to slightly yellowish, or if any part of the pre-filled syringe appears damaged.

Do not shake the syringe. After removing the needle cap, the injection should be administered within 5 minutes to prevent the medicine from drying and blocking the needle. If the pre-filled syringe is not used within 5 minutes after removing the needle cap, it must be disposed of in a sharps container and a new pre-filled syringe must be used.

If, after inserting the needle, the plunger of the syringe cannot be pushed, the pre-filled syringe must be disposed of in a sharps container and another new syringe must be used.

6. Contents of the container and other information

Composition of RoActemra

• The active substance is tocilizumab.

Each pre-filled syringe contains 162 mg of tocilizumab in 0.9 ml.

• The other components are L-Histidine, L-Histidine monohydrochloride monohydrate, L-Arginine/Hydrochloride of L-Arginine, L-Methionine, Polysorbate 80, Water for injections (see section 2 "RoActemra contains polysorbate 80 (E 433)").

Appearance of the product and contents of the container

RoActemra is an injection solution. The solution is colourless to slightly yellowish.

RoActemra is supplied in pre-filled syringes of 0.9 ml containing 162 mg of tocilizumab solution for injection.

Each pack contains 4 pre-filled syringes. The multiple pack contains 12 (3 packs of 4) pre-filled syringes. Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Roche Registration GmbH

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

Manufacturer

Roche Pharma AG Emil-Barell-Str. 1

79639 Grenzach-Wyhlen

Germany

More information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Belgium/Belgium/Belgium Luxembourg/Luxembourg N.V. Roche S.A. Belgium/Belgium/Belgium Tel/Tel: +32 (0) 2 525 82 11	Latvia Roche Latvija SIA Tel: +371 - 6 7039831
	Lithuania UAB “Roche Lietuva” Tel: +370 5 2546799
Czech Republic Roche s. r. o. Tel: +420 - 2 20382111	Hungary Roche (Hungary) Kft. Tel: +36 - 1 279 4500
Denmark Roche Pharmaceutical A/S Tlf: +45 - 36 39 99 99	Netherlands Roche Nederland B.V. Tel: +31 (0) 348 438050
Germany Roche Pharma AG Tel: +49 (0) 7624 140	Norway Roche Norge AS Tlf: +47 - 22 78 90 00
Estonia Roche Eesti OÜ Tel: +372 - 6 177 380	Austria Roche Austria GmbH Tel: +43 (0) 1 27739
Greece, Cyprus Roche (Hellas) A.E. Greece Tel: +30 210 61 66 100	Poland Roche Polska Sp. z o.o. Tel: +48 - 22 345 18 88
Spain Roche Farma S.A. Tel: +34 - 91 324 81 00	Portugal Roche Farmacêutica Química, Lda Tel: +351 - 21 425 70 00
France Roche Tél: +33 (0) 1 47 61 40 00	Romania Roche România S.R.L. Tel: +40 21 206 47 01
Croatia Roche d.o.o Tel: +385 1 47 22 333	Slovenia Roche farmacevtska družba d.o.o. Tel: +386 - 1 360 26 00
Ireland, Malta Roche Products (Ireland) Ltd. Ireland/Ireland Tel: +353 (0) 1 469 0700	Slovakia Roche Slovensko, s.r.o. Tel: +421 - 2 52638201
Iceland Roche Pharmaceutical A/S c/o Icepharma hf Sími: +354 540 8000	Finland/Finland Roche Oy Puh/Tel: +358 (0) 10 554 500
Italy Roche S.p.A. Tel: +39 - 039 2471	Sweden Roche AB Tel: +46 (0) 8 726 1200

Date of the most recent review of this leaflet

Other sources of information

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

What do I need to know to safely use my pre-filled RoActemra syringe?

It is important to read, understand, and follow these instructions so that you or your caregiver can correctly use the RoActemra syringe. These instructions do not replace the training your healthcare professional must provide. Your healthcare professional will show you how to properly prepare and inject the medication before you use the RoActemra syringe for the first time. Ask your healthcare professional any questions you may have. Do not attempt to administer an injection until you are certain you understand how to use the RoActemra syringe.

Please also read the patient leaflet included with the RoActemra syringe to obtain the most important information you need to know about this medicine. It is important that you remain under the care of your healthcare professional while being treated with RoActemra.

Important information:

• Do not use if the syringe appears damaged.
• Do not use if the medicine is cloudy, turbid, discolored, or contains particles.
• Do not attempt to disassemble the syringe at any time.
• Do not remove the needle cap until you are ready for injection.
• Do not inject through clothing covering your skin.
• Never reuse the same syringe.
• Do not touch the activation clips of the syringe shield, as this may damage the syringe.

Storage

Keep the RoActemra syringe and all medicines out of the sight and reach of children. Store the syringe in the refrigerator at a temperature of 2–8 °C. After removal from the refrigerator, the pre-filled syringe may be stored for up to a total of 2 weeks at a temperature not exceeding 30 °C, but without exceeding the original expiry date (EXP). Mark the corresponding date on the carton. The pre-filled syringe must always be stored in its original packaging. Protect the syringe from freezing and light. Keep syringes dry.

Parts of the pre-filled syringe

To administer your injection, you will need:

Included in the package:

• Pre-filled syringe.

Not included in the package:

• Alcohol wipe.
• Sterile cotton or gauze.
• Sharps container for safe disposal of the needle cap and used syringe.

A place to prepare your supplies:

• Find a clean, flat, well-lit surface such as a table.

Step 1. Visually inspect the syringe

• Take the carton containing the syringe from the refrigerator and open the carton. Do not touch the activation clips of the syringe shield, as this may damage the syringe.

• Remove the syringe from the carton and visually inspect both the syringe and the medication inside. This is important to ensure the syringe and medication can be safely used.

• Check the expiry date printed on the carton and on the syringe (see Fig. A) to ensure it has not passed. Do not use the syringe if the expiry date has passed. This is important to ensure the syringe and medication can be safely used.

Discard the syringe and do not use it if:

• The medicine is cloudy.
• The medicine contains particles.
• The medicine is any color other than colorless to pale yellow.
• Any part of the syringe appears damaged.

Step 2. Allow the syringe to reach room temperature

• Do not remove the needle cap from your syringe before Step 5. Doing so may cause the medication to dry and block the needle.

• Place the syringe on a clean, flat surface and allow it to reach room temperature (18 °C–28 °C) for 25–30 minutes to warm up. If you do not allow the syringe to reach room temperature, the injection may be uncomfortable and it may be difficult to push the plunger.

• Do not heat the syringe in any other way.

Step 3. Wash your hands

• Wash your hands with soap and water.

Step 4. Choose and prepare the injection site

• Recommended injection sites are the front and middle part of the thighs and the lower abdomen below the navel, except for the area within 5 cm immediately surrounding the navel (see Fig. B).

• If a caregiver is administering the injection, the outer surface of the upper arms may also be used (see Fig. B).

• You should use a different site each time you self-administer an injection, at least 3 cm away from the site used in your previous injection.

• Do not inject in areas where clothing such as a belt or waistband may press or rub. Do not inject into moles, scars, bruises, or areas where the skin is sensitive, red, hard, or not intact.

• Clean the chosen injection site using an alcohol wipe (see Fig. C) to reduce the risk of infection.

• Allow the skin to dry for about 10 seconds.
• Be sure not to touch the cleaned area before injection. Do not fan or blow on the cleaned area.

Step 5. Remove the needle cap

• Do not hold the syringe by the plunger while removing the needle cap.
• Firmly hold the syringe shield with one hand and remove the needle cap with the other hand (see Fig. D). If you are unable to remove the needle cap, you should ask your caregiver for help or contact your healthcare professional.

• Do not touch the needle or allow it to touch any surface.
• A small air bubble may be present in the RoActemra pre-filled syringe. It is not necessary to remove it.
• You may see a drop of liquid at the tip of the needle. This is normal.
• Dispose of the needle cap in the sharps container.

NOTE: Once the needle cap has been removed, the syringe must be used immediately.

• If the syringe is not used within 5 minutes after removing the needle cap, it must be discarded in the sharps container and a new syringe must be used. If the needle cap is removed and the syringe is not used within 5 minutes, the injection may be more difficult to administer, as the medication may dry and block the needle.

• Never reattach the needle cap after removing it.

Step 6. Administer the injection

• Hold the syringe comfortably in your hands.
• To ensure the needle can be properly inserted into your skin, pinch a fold of loose skin at the clean injection site with your free hand. Pinching the skin is important to ensure you inject under the skin (into the fatty tissue) and not deeper (into the muscle). Injecting into the muscle may result in an uncomfortable injection.
• Do not hold or push the plunger while inserting the needle into the skin.
• Insert the needle completely into the skin fold at an angle between 45° and 90° with a quick, firm motion (see Fig. E).

It is important to choose the correct angle to ensure the medication is released under the skin (into the fatty tissue); otherwise, the injection may be painful and the medication may not work properly.

• After insertion, keep the syringe in position and release the skin fold.
• Inject all the medication slowly by slowly pushing the plunger all the way down (see Fig. F). You must push the plunger all the way down to ensure the full dose of medication is administered and to ensure the activation clips on the syringe shield are fully pushed to the side. If the plunger is not fully depressed, the needle shield will not extend to cover the needle when it is withdrawn. If the needle is not covered, handle with care and place the syringe directly into the sharps container to avoid needle injury.

• Once the plunger is fully depressed, keep it pressed to ensure all medication is injected before removing the needle from the skin.
• Keep the plunger depressed while withdrawing the needle from the skin at the same angle as insertion (see Fig. G).

• If after inserting the needle you are unable to push the plunger, discard the pre-filled syringe into a sharps container and use a new pre-filled syringe (starting again from Step 2). If you continue to have difficulty, consult your healthcare professional.

• Once the needle is completely withdrawn from the skin, you may release the plunger, allowing the needle shield to cover the needle (see Fig. H).

• If you see drops of blood at the injection site, you may press the site with a sterile cotton ball or gauze for about 10 seconds.
• Do not rub the injection site.

Step 7. Disposal of the syringe

• Do not attempt to recap your syringe.

• Dispose of used syringes in a sharps container. Ask your doctor or pharmacist for information on where you can obtain a sharps container or what other puncture-resistant container you can use for safe disposal of your used syringes if you do not have one (see Fig. I).

Talk to your healthcare professional for instructions on the best way to dispose of used syringes. There may be national regulations regarding the disposal of used syringes.

Do not throw used syringes or the sharps container into your household trash, and do not recycle them.

• Dispose of a full container as instructed by your doctor or pharmacist.

• Always keep the sharps container out of sight and reach of children.

Patient advice regarding hypersensitivity reactions (also known as anaphylaxis, if severe)

If you develop symptoms such as, but not limited to, rash, itching, chills, swelling of the face, lips, tongue, or throat, chest pain, wheezing, difficulty breathing or swallowing, or a feeling of dizziness or fainting at any time outside the clinic, during or after injection with RoActemra, you must seek immediate emergency medical attention.

Patient advice regarding early recognition and treatment to limit the risk of serious infections

Be alert for early signs of infection such as:

• Body aches, fever, chills.
• Cough, discomfort/pressure in the chest, shortness of breath.
• Redness, warmth, unusual swelling of the skin or joints.
• Abdominal pain/tenderness and/or changes in bowel function.

Call your doctor and seek medical attention immediately if you think you may be developing an infection.

If you have any concerns or questions about your syringe, contact your doctor or pharmacist for assistance.