Cimzia 200 mg solution for injection in pre-filled pen

Patient Information Leaflet

Introduction

Patient Information Leaflet

Cimzia 200 mg solution for injection in cartridge for dosing dispenser

certolizumab pegol

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

• Keep this leaflet, as 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 you should not give it 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.

Contents of this leaflet

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

Your doctor will also provide you with a “Patient Information Card” containing important safety information you should know before receiving Cimzia and during treatment with this medicine. Keep this “Patient Information Card” with you.

1. What Cimzia is and what it is used for

Cimzia contains the active substance certolizumab pegol, a human antibody fragment. Antibodies are proteins that specifically recognize and bind to other proteins. Cimzia binds to a specific protein called tumour necrosis factor alpha (TNFα). By binding to it, Cimzia blocks TNFα, thereby reducing inflammation in conditions such as rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis, and psoriasis. Medicines that bind to TNFα are also known as TNF blockers.

Cimzia is used in adults for the treatment of the following inflammatory diseases:

• rheumatoid arthritis,
• axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis),
• psoriatic arthritis,
• plaque psoriasis.

Rheumatoid arthritis

Cimzia is used to treat rheumatoid arthritis. Rheumatoid arthritis is an inflammatory disease affecting the joints. If you have moderate to severe active rheumatoid arthritis, you may first be given other medicines, usually methotrexate. If you do not respond well enough to these medicines, you will be given Cimzia in combination with methotrexate to treat your rheumatoid arthritis. If your doctor determines that methotrexate is inappropriate, Cimzia may be given alone.

Cimzia in combination with methotrexate may also be used to treat severe, progressive, active rheumatoid arthritis without prior use of methotrexate or other disease-modifying treatments.

When administered in combination with methotrexate, Cimzia is used to:

• reduce the signs and symptoms of your disease,
• slow down joint damage to cartilage and bone caused by the disease,
• improve your physical function and ability to perform daily activities.

Ankylosing spondylitis and non-radiographic axial spondyloarthritis

Cimzia is used to treat ankylosing spondylitis and non-radiographic axial spondyloarthritis (sometimes referred to as non-radiographic axial spondyloarthritis). These diseases are inflammatory conditions of the spine. If you have ankylosing spondylitis or non-radiographic axial spondyloarthritis, you will first be treated with other medicines. If you do not respond well enough to these treatments, you will be given Cimzia to:

• reduce the signs and symptoms of your disease,
• improve your physical function and ability to perform daily activities.

Psoriatic arthritis

Cimzia is used to treat active psoriatic arthritis. Psoriatic arthritis is an inflammatory joint disease, usually accompanied by psoriasis. If you have active psoriatic arthritis, you will first be given other medicines, usually methotrexate. If you do not respond well enough to these medicines, you will be given Cimzia in combination with methotrexate to:

• reduce the signs and symptoms of your disease,
• improve your physical function and ability to perform daily activities.

If your doctor determines that methotrexate is not an appropriate treatment, Cimzia may be given alone.

Plaque psoriasis

Cimzia is used to treat moderate to severe plaque psoriasis. Plaque psoriasis is an inflammatory skin disease that may also affect the scalp and nails.

Cimzia is used to reduce skin inflammation and other signs and symptoms of the disease.

2. What you need to know before using Cimzia

DO NOT use Cimzia

• If you are ALLERGIC (hypersensitive) to certolizumab pegol or to any of the other components of this medicine (listed in section 6).
• If you have a serious infection, including active TUBERCULOSIS (TB).
• If you have moderate to severe HEART FAILURE. Inform your doctor if you have ever had or currently have serious heart problems.

Warnings and precautions

Before starting treatment with Cimzia, inform your doctor if:

Allergic reactions

• You experience ALLERGIC REACTIONS such as chest tightness, difficulty breathing, dizziness, swelling, or rash, stop using Cimzia and contact your doctor IMMEDIATELY. Some of these reactions may occur after the first dose of Cimzia.
• You have ever had an allergic reaction to latex.

Infections

• You have had RECURRENT OR OPPORTUNISTIC INFECTIONS or other conditions that increase your risk of infections (such as treatment with immunosuppressants, which are medicines that may reduce your ability to fight infections).
• You currently have any infection or develop symptoms such as fever, wounds, fatigue, or dental problems. While being treated with Cimzia, you may be more likely to get an infection, including serious infections, or in rare cases, life-threatening infections.
• Cases of TUBERCULOSIS (TB) have been reported in patients receiving Cimzia. Your doctor will examine you for signs or symptoms of tuberculosis before starting treatment with Cimzia. This will include a thorough medical history, chest X-ray, and tuberculin skin test. These test results must be recorded on your “Patient Information Card”. If you are diagnosed with latent (inactive) tuberculosis, you may need to receive appropriate anti-tuberculosis treatment before starting Cimzia. In rare cases, tuberculosis may develop during treatment, even if you have received preventive treatment for TB. It is very important that you inform your doctor if you have ever had tuberculosis or have been in contact with someone who has tuberculosis. If symptoms of tuberculosis (persistent cough, weight loss, general malaise, low-grade fever) or any other infection appear during or after treatment with Cimzia, contact your doctor immediately.
• You are at risk of infection with the HEPATITIS B VIRUS (HBV), if you are a carrier of HBV, or if you have an active HBV infection. Cimzia may increase the risk of HBV reactivation in carriers of this virus. If this occurs, you must stop using Cimzia. Your doctor should test you for HBV before starting treatment with Cimzia.

Heart failure

• If you have mild heart failure and are being treated with Cimzia, your doctor should closely monitor your heart condition. It is important to inform your doctor if you have had or currently have serious heart problems. If you develop new symptoms of heart failure or your current symptoms worsen (e.g., difficulty breathing or swelling in the feet), contact your doctor immediately. Your doctor will decide whether you should stop treatment with Cimzia.

Cancer

• Although uncommon, cases of certain types of CANCER have been observed in patients treated with Cimzia or other TNF-blocking agents. People with more severe rheumatoid arthritis and those who have had the disease for a long time may have a higher-than-average risk of developing lymphoma, a type of cancer affecting the lymphatic system. Treatment with Cimzia may increase the risk of developing lymphoma or other types of cancer. In addition, rare cases of non-melanoma skin cancer have been observed in patients using Cimzia. Inform your doctor if new skin lesions appear during or after treatment with Cimzia, or if existing lesions change in appearance. Cases of cancer, including rare types, have occurred in children and adolescents receiving TNF-blocking agents, some of which have been fatal (see below “Use in children and adolescents”).

Other diseases

• Patients with chronic obstructive pulmonary disease (COPD) or who are heavy smokers may have an increased risk of developing cancer with Cimzia treatment. If you have COPD or are a heavy smoker, discuss with your doctor whether treatment with a TNF-blocking medicine is appropriate for you.
• If you have a neurological disease such as multiple sclerosis, your doctor will decide whether you should use Cimzia.
• In some patients, the body may be unable to produce enough blood cells that help fight infections or those that help stop bleeding. If you have persistent fever, bruise easily, bleed excessively, or appear very pale, consult your doctor immediately. Your doctor may decide to discontinue treatment with Cimzia.
• Although rare, symptoms of a disease called lupus (e.g., persistent rash, fever, joint pain, and fatigue) may appear. Contact your doctor if you experience these symptoms. Your doctor may decide to stop treatment with Cimzia.

Vaccines

• Inform your doctor if you have received or are scheduled to receive any vaccine. Some vaccines (live vaccines) should not be given while you are being treated with Cimzia.
• Some vaccines may cause infections. If you received Cimzia during pregnancy, your baby may have an increased risk of such infections for up to approximately five months after your last dose during pregnancy. It is important to inform your baby’s doctors and other healthcare professionals about your Cimzia treatment so they can determine when your baby should be vaccinated.

Surgery or dental procedures

• Inform your doctor if you are scheduled for surgery or a dental procedure. Inform the surgeon or dentist that you are being treated with Cimzia by showing them your Patient Information Card.

Children and adolescents

The use of Cimzia is not recommended in patients under 18 years of age.

Using Cimzia with other medicines

DO NOT use Cimzia if you are taking the following medicines for rheumatoid arthritis:

• anakinra
• abatacept

If you have any doubts, consult your doctor.

Cimzia may be used together with:

• methotrexate,
• corticosteroids, or
• pain medicines, including non-steroidal anti-inflammatory drugs (also known as NSAIDs).

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Cimzia should only be used during pregnancy if clearly necessary. If you are a woman of childbearing potential, discuss with your doctor the use of appropriate contraceptive measures while using Cimzia. For women planning pregnancy, contraception may be considered for 5 months after the last dose of Cimzia.

If you received Cimzia during pregnancy, your baby may have an increased risk of infection. It is important to inform your baby’s doctors and other healthcare professionals about your Cimzia treatment before your baby receives any vaccinations (for more information, see the section on vaccines).

Cimzia may be used during breastfeeding.

Driving and using machines

The effect of Cimzia on the ability to drive and use machines is minor. Dizziness (including dizziness with a spinning sensation, blurred vision, and fatigue) may occur after using Cimzia.

Cimzia contains sodium acetate and sodium chloride

This medicine contains less than 23 mg (1 mmol) of sodium per 400 mg dose and is therefore considered essentially “sodium-free”.

3. How to use Cimzia

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Rheumatoid arthritis

• The starting dose for adults with rheumatoid arthritis is 400 mg administered at weeks 0, 2, and 4.
• This is followed by a maintenance dose of 200 mg every two weeks. If you respond to the medicine, your doctor may prescribe you an alternative maintenance dose of 400 mg every 4 weeks.
• Treatment with methotrexate is maintained during use of Cimzia. If your doctor determines that methotrexate is inappropriate, Cimzia may be given alone.

Axial spondyloarthritis

• The starting dose for adults with axial spondyloarthritis is 400 mg administered at weeks 0, 2, and 4.
• This is followed by a maintenance dose of 200 mg every two weeks (from week 6) or 400 mg every 4 weeks (from week 8), as directed by your doctor. If you have received Cimzia for at least 1 year and respond to the medicine, your doctor may prescribe you a reduced maintenance dose of 200 mg every 4 weeks.

Psoriatic arthritis

• The starting dose for adults with psoriatic arthritis is 400 mg administered at weeks 0, 2, and 4.
• This is followed by a maintenance dose of 200 mg every two weeks. If you respond to the medicine, your doctor may prescribe you an alternative maintenance dose of 400 mg every 4 weeks.
• Treatment with methotrexate is maintained during use of Cimzia. If your doctor determines that methotrexate is inappropriate, Cimzia may be given alone.

Plaque psoriasis

• The initial dose for adults with plaque psoriasis is 400 mg every 2 weeks administered at weeks 0, 2, and 4.
• This is followed by a maintenance dose of 200 mg every 2 weeks or 400 mg every 2 weeks, as directed by your doctor.

How to use Cimzia

Cimzia is normally administered by a specialist doctor or healthcare professional. Cimzia will be given as one injection (dose of 200 mg) or two injections (dose of 400 mg) under the skin (subcutaneously, abbreviated as: SC). It is usually injected into the thigh or abdomen. However, it must not be injected into areas where the skin is red, bruised, or hardened.

Instructions for self-injection of Cimzia

After appropriate training, your doctor may also allow you to self-inject Cimzia. Read the instructions on how to inject yourself with Cimzia at the end of this leaflet.

If your doctor has determined that you can self-inject this medicine, you must have follow-up visits with your doctor before continuing self-injection:

• after 12 weeks if you have rheumatoid arthritis, axial spondyloarthritis, or psoriatic arthritis; or
• after 16 weeks if you have plaque psoriasis.

This is so the doctor can determine whether Cimzia is working for you or whether another treatment should be considered.

If you use more Cimzia than you should

If your doctor has determined that you can self-inject this medicine and you accidentally inject Cimzia more frequently than prescribed, you must inform your doctor. Always carry your Patient Information Card and the medicine carton with you, even if it is empty.

If you forget to use Cimzia

If your doctor has determined that you can self-inject this medicine and you forget to administer an injection, you should inject the next dose of Cimzia as soon as you remember. Then, inject the following doses as previously instructed. Afterwards, speak with your doctor and administer subsequent doses according to the instructions given by your doctor.

If you stop using Cimzia

Do not stop treatment with Cimzia without first consulting your doctor.

If you have any further questions about the use of 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.

INFORM YOUR DOCTOR IMMEDIATELY if you notice any of the following adverse effects:

• severe rash, skin eruption or other signs of allergic reaction (urticaria)
• swelling of the face, hands, or feet (angioedema)
• breathing or swallowing difficulties (multiple possible causes for these symptoms)
• shortness of breath (dyspnea) on exertion or when lying down, or swelling of the feet (heart failure)
• symptoms of blood disorders such as persistent fever, bruising, bleeding, or paleness (pancytopenia, anemia, low platelet count, low white blood cell count)
• severe skin rashes. These may appear as red, target-shaped spots or circular patches, often with central blisters on the trunk, skin peeling, mouth ulcers, and sores in the throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).

INFORM YOUR DOCTOR AS SOON AS POSSIBLE if you notice any of the following adverse effects:

• signs of infection such as fever, malaise, wounds, dental problems, or burning sensation when urinating
• feeling weak or tired
• cough
• tingling
• numbness
• double vision
• weakness in arms or legs
• bruises or sores that do not heal

The symptoms described above may be due to some of the adverse effects listed below, which have been observed with Cimzia:

Frequent (may affect up to 1 in 10 patients):

• bacterial infections at any site (pus accumulation)
• viral infections (including cold sores, shingles, and influenza)
• fever
• high blood pressure
• rash or itching
• headaches (including migraine)
• sensory disturbances such as numbness, tingling, or burning sensations
• feeling weak and general malaise
• pain
• blood disorders
• liver problems
• injection site reactions
• nausea

Uncommon (may affect up to 1 in 100 patients):

• allergic diseases including rhinitis and allergic reactions to the medicine (including anaphylactic shock)
• antibodies directed against normal tissue
• cancers of the lymphatic system and blood such as lymphoma and leukemia
• solid tumors
• skin cancers, precancerous skin lesions
• benign (non-cancerous) tumors and cysts (including skin cysts)
• heart problems including weakened heart muscle, heart failure, myocardial infarction, chest discomfort or pressure, abnormal heart rhythm including irregular heartbeats
• edema (swelling of the face or legs)
• lupus-like symptoms (an immune disease affecting connective tissue): joint pain, skin rashes, photosensitivity, and fever
• inflammation of blood vessels
• sepsis (serious infection that may lead to organ failure, shock, or death)
• tuberculosis infection
• fungal infections (occur when the ability to fight infections is reduced)
• respiratory disorders and inflammation (including asthma, shortness of breath, cough, sinus blockage, pleuritis, or difficulty breathing)
• stomach problems including abdominal fluid accumulation, ulcers (including mouth ulcers), perforation, bloating, inflammation, burning, stomach discomfort, dry mouth
• bile-related problems
• muscle problems including increased muscle enzymes
• changes in blood levels of various salts
• changes in cholesterol and lipid blood levels
• blood clots in veins or lungs
• bleeding or bruising
• changes in blood cell counts, including low red blood cell count (anemia), low platelet count, increased platelet count
• swollen lymph nodes
• flu-like symptoms, chills, altered temperature perception, night sweats, flushing
• anxiety and mood disorders such as depression, appetite disturbances, weight changes
• dizziness
• ringing in the ears
• fainting, including loss of consciousness
• nerve disorders in the limbs including numbness, tingling, burning sensations, dizziness, tremor
• skin disorders such as new onset or worsening of psoriasis, skin inflammation (e.g., eczema), sweat gland disorders, ulcers, photosensitivity, acne, hair loss, skin color changes, nail separation, dry skin, and wounds
• healing problems
• urinary and kidney problems including impaired kidney function, blood in urine, and urinary abnormalities
• menstrual cycle disorders (monthly period) including absence of bleeding, excessive bleeding, or irregular bleeding
• breast disorders
• eye and eyelid inflammation, vision disturbances, tear problems
• increased levels of certain blood parameters (elevated blood alkaline phosphatase)
• prolonged clotting times

Rare (may affect up to 1 in 1,000 patients):

• gastrointestinal cancer, melanoma
• lung inflammation (interstitial lung disease, pulmonary inflammation)
• stroke, blood vessel blockage (arteriosclerosis), poor blood circulation causing numbness and paleness in fingers and toes (Raynaud's phenomenon), purple spots, skin discoloration, small veins near the skin surface becoming visible
• pericarditis (inflammation of the pericardium)
• cardiac arrhythmia
• spleen enlargement
• increased red blood cell mass
• abnormal white blood cell morphology
• gallstone formation
• kidney problems (including nephritis)
• immune disorders such as sarcoidosis (rash, joint pain, fever), serum sickness, inflammation of fatty tissue, angioneurotic edema (swelling of lips, face, throat)
• thyroid disorders (goiter, fatigue, weight loss)
• increased iron levels in the body
• increased blood levels of uric acid
• suicide attempt, mental disorder, delirium
• inflammation of the auditory nerve, vision problems, or facial nerves, coordination or balance disturbances
• increased gastrointestinal motility
• fistula (abnormal connection between organs) (in any area)
• mouth disorders including pain when swallowing
• skin peeling, vesicular disorders, changes in hair texture
• sexual dysfunction
• seizures
• worsening of a condition called dermatomyositis (characterized by muscle weakness accompanied by a skin rash)
• Stevens-Johnson syndrome (a serious skin disease where early symptoms include malaise, fever, headache, and rash)
• inflammatory skin rash (erythema multiforme)
• lichenoid reactions (itchy red-purple skin rash and/or thick white-gray lines on mucous membranes)

Not known (frequency cannot be estimated from available data):

• multiple sclerosis*
• Guillain-Barré syndrome*
• Merkel cell carcinoma (a type of skin cancer)*
• Kaposi's sarcoma (a rare cancer associated with human herpesvirus type 8 infection. Kaposi's sarcoma usually presents as purplish skin lesions).

*These events have been associated with this class of medicines, but their incidence with Cimzia is unknown.

Other adverse effects

When Cimzia has been used to treat other conditions, the following uncommon adverse effects have occurred:

• gastrointestinal stenosis (narrowing of part of the digestive tract)
• gastrointestinal obstruction (blockage of the digestive tract)
• general deterioration in physical health
• spontaneous abortion
• azoospermia (lack of sperm production)

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is an effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cimzia

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

Do not use this medicine after the expiry date stated on the pack after EXP and on the pen after EXP. The expiry date refers to the last day of the month indicated.

Store in a refrigerator (2 °C-8 °C).

Do not freeze.

Keep the pre-filled pen in the outer packaging to protect it from light.

Pre-filled pens may be stored at room temperature (not above 25 °C) for a single period not exceeding 10 days, protected from light. At the end of this period, pre-filled pens must be used or discarded.

Do not use this medicine if the solution is discoloured, cloudy, or if particles are visible.

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

6. Contents of the pack and other information

Composition of Cimzia

• The active substance is certolizumab pegol. Each pre-filled pen contains 200 mg of certolizumab pegol in one ml.
• The other components are: sodium acetate, sodium chloride, and water for injections (see “Cimzia contains sodium acetate and sodium chloride” in section 2).

Nature and contents of the container

Cimzia is supplied as a ready-to-use injectable solution in a pre-filled pen (Autoclicks). The solution is clear to opalescent and colourless to yellowish.

A Cimzia pack contains:

• two Autoclicks pre-filled pens containing the solution and
• two alcohol wipes (for cleaning the chosen injection sites).

Packs containing 2 pre-filled pens and 2 alcohol wipes, multiple packs containing 6 pre-filled pens (3 packs of 2) and 6 alcohol wipes (3 packs of 2), and multiple packs containing 10 pre-filled pens (5 packs of 2) and 10 alcohol wipes (5 packs of 2) are available.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

UCB Pharma SA
Allée de la Recherche 60
B-1070 Brussels
Belgium

Manufacturer

UCB Pharma S.A.
Chemin du Foriest
B-1420 Braine l'Alleud
Belgium

For more information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent revision of this leaflet: {MM/YYYY}.

Other sources of information

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

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INJECTION INSTRUCTIONS FOR CIMZIA USING A PRE-FILLED PEN

After appropriate training, you may self-inject or have someone else, such as a family member or friend, administer the injection. The following instructions explain how to use the pre-filled pen (AutoClicks) to inject Cimzia. Read them carefully and follow each step exactly. Your doctor or another healthcare professional will show you how to administer the injection yourself. Do not attempt to give the injection until you are confident that you fully understand how to prepare and administer it.

Below is a diagram of the AutoClicks pre-filled pen.

1: Orange band
2: Viewing window
3: Black grip
4: Transparent cap

1. Preparation

• Remove the Cimzia package from the refrigerator.

• If the seal(s) are missing or broken – do not use and contact your pharmacist.

  • Remove the following items from the Cimzia box and place them on a clean, flat surface:

• One or two AutoClicks pre-filled pens, depending on your prescribed dose

• One or two alcohol wipes

  • Check the expiration date on both the pre-filled pen and the box. Do not use Cimzia after the expiration date stated on the box after "EXP" and on the pre-filled pen after "EXP". The expiration date refers to the last day of the month indicated.
  • Allow the AutoClicks pre-filled pen to reach room temperature. This will take 30 to 45 minutes. This helps reduce discomfort during injection.

• Do not heat the pre-filled pen—allow it to warm up naturally.

• Do not remove the cap until you are ready to inject.

  • Wash your hands thoroughly.

2. Choosing and preparing the injection site

• Select an area on your thigh or abdomen.

• Each new injection should be administered in a different area from the site of the last injection.

• Never inject into an area where the skin is red, bruised, or hardened.

• Clean the injection site with the alcohol swab provided, using a circular motion from the center outward.

• Do not touch this area again before the injection.

3. Injection

• The pre-filled pen AutoClicks is designed to work precisely and safely. However, if any of the following steps go wrong and/or if you feel uncertain about the injection process, contact your doctor or pharmacist.
• Do not shake the pre-filled pen.

Check the medication through the viewing window.

• Do not use this medicine if the solution is discolored, cloudy, or if you see particles in it.
• You may see air bubbles – this is normal. Injecting a solution containing air bubbles subcutaneously is harmless.

• Hold the pre-filled pen firmly with one hand around the black grip.
• With the other hand, grasp the transparent cap and pull it straight off. Do not twist the cap when removing it, as this could jam the internal mechanism.

• Inject within 5 minutes after removing the cap. Do not replace the cap.
• Although out of sight, the needle is now exposed. Do not touch the needle, as this could activate the pre-filled pen. Hold the pen firmly against the previously cleaned skin (at a 90º angle) ("injection site").

• Press the pre-filled pen firmly against the skin. The injection begins when you hear the first "click" and the orange band disappears from the bottom of the pen.

• Continue holding the pre-filled pen firmly in place against the skin until you hear a second "click" and the viewing window turns orange. This may take up to 15 seconds. At this point, the injection is complete. If the viewing window turns orange and you hear the second click, this indicates that the injection has been completed. If you are uncertain about the injection process, contact your doctor or pharmacist. Do not attempt to repeat the injection process without first speaking to your doctor or pharmacist.

• The needle will automatically retract back into the empty pen. Do not touch the needle.

• You may now carefully and gently pull the pen straight out from the skin.

• Using a small piece of cotton, press gently on the injection site for a few seconds.

• Do not rub the injection site.

• If needed, you may cover the injection site with an adhesive bandage.

4. After use

• Do not reuse the pre-filled pen. There is no need to replace the cap.

• Immediately after the injection, dispose of the used pen(s) in a special container as instructed by your doctor, nurse, or pharmacist.

• Keep the container out of sight and out of reach of children.
• If your doctor has prescribed a second injection, repeat the injection process starting at step 2.