HUKYNDRA 40 mg SOLUTION FOR INJECTION IN PRE-FILLED PEN

Introduction

Package Leaflet: Information for the Patient

Hukyndra 40mg solution for injection in pre-filled pen

adalimumab

• This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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.
• Your doctor will give you a patient information card, which contains important safety information that you need to know before you start using and during treatment with Hukyndra. Keep this patient information card during your treatment and for 4 months after your last injection of Hukyndra.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Hukyndra and what is it used for

Hukyndra contains the active substance adalimumab

Hukyndra is used to treat:

• Rheumatoid arthritis
• Polyarticular juvenile idiopathic arthritis
• Enthesitis-related arthritis
• Ankylosing spondylitis
• Non-radiographic axial spondyloarthritis
• Psoriatic arthritis
• Plaque psoriasis
• Hidradenitis suppurativa
• Crohn's disease
• Ulcerative colitis
• Non-infectious uveitis

The active substance in Hukyndra, adalimumab, is a human monoclonal antibody. Monoclonal antibodies are proteins that target a specific target.

The target of adalimumab is a protein called tumour necrosis factor (TNFα), which is involved in the immune system (defence) and is found in high levels in the inflammatory diseases described above. By targeting TNFα, Hukyndra reduces the inflammatory process in these diseases.

Rheumatoid arthritis

Rheumatoid arthritis is an inflammatory disease of the joints.

Hukyndra is used to treat moderate to severe rheumatoid arthritis in adults. You may have been given other medicines that modify the disease, such as methotrexate, before. If you do not respond well enough to these medicines, you will be given Hukyndra.

Hukyndra may also be used to treat severe, active, and progressive rheumatoid arthritis without prior treatment with methotrexate.

Hukyndra can reduce the damage to the joints caused by the inflammatory disease and can help you move more freely.

Your doctor will decide if Hukyndra should be used with methotrexate or as monotherapy.

Polyarticular juvenile idiopathic arthritis

Polyarticular juvenile idiopathic arthritis is an inflammatory disease of the joints.

Hukyndra is used to treat polyarticular juvenile idiopathic arthritis in patients from 2 years of age. You may have been given other disease-modifying medicines, such as methotrexate, before. If you do not respond well enough to these medicines, you will be given Hukyndra.

Your doctor will decide if Hukyndra should be used with methotrexate or as monotherapy.

Enthesitis-related arthritis

Enthesitis-related arthritis is an inflammatory disease of the joints and the sites where tendons attach to the bone.

Hukyndra is used to treat enthesitis-related arthritis in patients from 6 years of age. You may have been given other disease-modifying medicines, such as methotrexate, before. If you do not respond well enough to these medicines, you will be given Hukyndra.

Ankylosing spondylitis and non-radiographic axial spondyloarthritis

Ankylosing spondylitis and non-radiographic axial spondyloarthritis are inflammatory diseases that affect the spine.

Hukyndra is used to treat severe ankylosing spondylitis and non-radiographic axial spondyloarthritis in adults. You may have been treated with other medicines before. If you do not respond well enough to these medicines, you will be given Hukyndra.

Psoriatic arthritis

Psoriatic arthritis is an inflammatory disease of the joints that is often associated with psoriasis.

Hukyndra is used to treat psoriatic arthritis in adults. Hukyndra can reduce the damage caused by the disease to the joints and can help you move more freely. You may have been treated with other medicines before. If you do not respond well enough to these medicines, you will be given Hukyndra.

Plaque psoriasis

Plaque psoriasis is a skin disease that causes red, scaly, crusty, and silvery-scaled patches. Plaque psoriasis can also affect the nails, causing them to deteriorate, thicken, and lift off the nail bed, which can be painful.

Hukyndra is used to treat

• chronic plaque psoriasis in adults and
• severe chronic plaque psoriasis in children and adolescents from 4 to 17 years of age who have not responded or are not suitable candidates for topical therapy and phototherapies.

Hidradenitis suppurativa

Hidradenitis suppurativa (also known as inverse acne) is a chronic and often painful inflammatory skin disease. Symptoms can include sensitive nodules (lumps) and abscesses (boils) that can ooze pus. It usually affects specific areas of the skin, such as under the breast, armpits, inner thighs, groin, and buttocks. There may also be scarring in the affected areas.

Hukyndra is used to treat

• moderate to severe hidradenitis suppurativa in adults and
• moderate to severe hidradenitis suppurativa in adolescents from 12 to 17 years.

Hukyndra can reduce the number of nodules and abscesses caused by the disease and the pain that is usually associated with this disease. You may have been treated with other medicines before. If you do not respond well enough to these medicines, you will be given Hukyndra.

Crohn's disease

Crohn's disease is an inflammatory disease of the digestive tract.

Hukyndra is used to treat

• moderate to severe Crohn's disease in adults and
• moderate to severe Crohn's disease in children and adolescents from 6 to 17 years.

You may have been given other medicines before. If you do not respond well enough to these medicines, you will be given Hukyndra.

Ulcerative colitis

Ulcerative colitis is an inflammatory disease of the large intestine.

Hukyndra is used to treat

• moderate to severe ulcerative colitis in adults
• moderate to severe ulcerative colitis in children and adolescents from 6 to 17 years

You may have been given other medicines before. If you do not respond well enough to these medicines, you will be given Hukyndra.

Non-infectious uveitis

Non-infectious uveitis is an inflammatory disease that affects certain parts of the eye.

Hukyndra is used to treat

• adults with non-infectious uveitis with inflammation that affects the back of the eye.
• children from 2 years of age with chronic non-infectious uveitis with inflammation that
• affects the front of the eye.

This inflammation can lead to a decrease in vision and/or the presence of floaters in the eye (black dots or thin lines that move across the field of vision). Hukyndra works by reducing this inflammation.

You may have been given other medicines before. If you do not respond well enough to these medicines, you will be given Hukyndra.

2. What you need to know before you start using Hukyndra

Do not use Hukyndra

• If you are allergic to adalimumab or to any of the other components of this medicine (listed in section 6).
• If you have active tuberculosis or other severe infections (see "Warnings and precautions"). If you have symptoms of any infection, such as fever, wounds, fatigue, dental problems, it is important that you inform your doctor.
• If you have moderate or severe heart failure. It is important that you tell your doctor if you have had or have any serious heart problems (see "Warnings and precautions").

Warnings and precautions

Consult your doctor or pharmacist before starting to use Hukyndra.

Allergic reactions

• If you have an allergic reaction with symptoms such as chest tightness, difficulty breathing, dizziness, swelling, or rash, stop administering Hukyndra and contact your doctor immediately, as these reactions can be life-threatening in rare cases.

Infections

• If you have any infection, including chronic infection or a localized infection in any part of the body (e.g., an ulcer on the leg), consult your doctor before starting treatment with Hukyndra. If you are unsure, contact your doctor.
• With Hukyndra treatment, you may be more likely to get infections. This risk may be higher if you have damaged lungs. These infections can be severe and include:
• • tuberculosis
  • infections caused by viruses, fungi, parasites, or bacteria
  • severe blood infection (sepsis)

In rare cases, these infections could be life-threatening. It is essential that if you have symptoms such as fever, wounds, fatigue, or dental problems, you tell your doctor. Your doctor may advise you to stop using Hukyndra for a while.

• Tell your doctor if you live or travel in areas where fungal infections (such as histoplasmosis, coccidioidomycosis, or blastomycosis) are common.
• Tell your doctor if you have had recurrent infections or other disorders that increase the risk of infections.
• If you are over 65 years old, you may be more susceptible to infections while being treated with Hukyndra. Both you and your doctor should pay special attention to the appearance of signs of infection while being treated with Hukyndra. It is crucial that you inform your doctor if you have symptoms of infections, such as fever, wounds, feeling of fatigue, or dental problems.

Tuberculosis

• • Since cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will examine you for signs or symptoms of tuberculosis before starting your treatment with Hukyndra. This will include a thorough medical examination, including your medical history and appropriate diagnostic tests (e.g., chest X-ray and tuberculin test). The performance and results of these tests should be recorded in your patient information card.
  • Tuberculosis can develop during treatment, even if you have received treatment to prevent tuberculosis.
  • If symptoms of tuberculosis (such as persistent cough, weight loss, lack of energy, low-grade fever) or any other infection appear during or after treatment, contact your doctor immediately.

Hepatitis B

• Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have had active HBV infections, or if you think you may be at risk of contracting HBV.
• • Your doctor should perform an HBV test. In people carrying HBV, adalimumab can cause the virus to become active again.
  • In rare cases, especially if you are taking other medications that suppress the immune system, HBV reactivation can be life-threatening.

Surgery or dental intervention

• If you are going to have surgery or dental intervention, tell your doctor that you are using Hukyndra. Your doctor may recommend that you temporarily stop treatment with Hukyndra.

Demyelinating disease

• If you have or develop a demyelinating disease (a disease that affects the insulation layer around nerves, such as multiple sclerosis), your doctor will decide whether you should be treated or continue treatment with Hukyndra. Inform your doctor immediately if you experience symptoms such as changes in vision, weakness in arms or legs, or numbness or tingling in any part of the body.

Vaccines

• Certain vaccines can cause infections and should not be administered if you are being treated with Hukyndra.
• • Consult your doctor before administering any type of vaccine.
  • If possible, it is recommended that children receive the scheduled vaccines for their age before starting treatment with Hukyndra.
  • If you received Hukyndra while pregnant, your baby may have a higher risk of contracting infections during the approximately five months following the last dose of Hukyndra you received during pregnancy. It is essential that you inform your baby's doctor and other healthcare professionals about the use of Hukyndra during pregnancy, so they can decide whether your baby should receive any vaccine.

Heart failure

• If you have mild heart failure and are being treated with Hukyndra, you may be closely monitored by your doctor. It is essential that you tell your doctor if you have had or have any serious heart problems. If you develop new symptoms or your symptoms worsen (e.g., difficulty breathing, or swelling of the feet), you should contact your doctor immediately. Your doctor will decide whether you should continue receiving Hukyndra.

Fever, bruising, bleeding, or pale appearance

• In some patients, the body may be unable to produce a sufficient number of the type of blood cells that help the body fight infections or contribute to stopping bleeding. Your doctor may decide to interrupt treatment. If you develop persistent fever, easy bruising, or bleeding, or are very pale, call your doctor immediately.

Cancer

• In very rare cases, certain types of cancer have been reported in children and adults treated with adalimumab or other TNF-blocking agents.
• • People with more severe rheumatoid arthritis and who have had the disease for a long time may have a higher-than-average risk of developing lymphoma (a cancer that affects the lymphatic system) and leukemia (a cancer that affects the blood and bone marrow).
  • If you are being treated with Hukyndra, the risk of developing lymphoma, leukemia, or other types of cancer may increase. A rare and severe type of lymphoma has been observed in patients treated with adalimumab. Some of these patients were also receiving treatment with azathioprine or 6-mercaptopurine.
  • Tell your doctor if you are taking azathioprine or 6-mercaptopurine with Hukyndra.
  • Cases of non-melanoma skin cancer have been observed in patients using adalimumab.
  • Tell your doctor if new skin lesions appear or if existing lesions change in appearance during or after treatment.
• Cancers other than lymphoma have been reported in patients with a certain lung disease, called Chronic Obstructive Pulmonary Disease (COPD), treated with another TNF-blocking agent. If you have COPD or are a heavy smoker, you should consult your doctor to determine if treatment with a TNF blocker is suitable for you.

Autoimmune disease

• In rare cases, treatment with Hukyndra may lead to a syndrome similar to lupus. Contact your doctor if you have symptoms such as unexplained persistent rash, fever, joint pain, or fatigue.

Children and adolescents

• Vaccines: if possible, your child should be up-to-date with all vaccines before using Hukyndra.

Other medicines and Hukyndra

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

Do not take Hukyndra with medicines that contain the following active substances due to an increased risk of severe infections:

• anakinra
• abatacept

Hukyndra can be taken with:

• methotrexate

• certain disease-modifying antirheumatic drugs (such as sulfasalazine, hydroxychloroquine, leflunomide, and injectable gold salts)

• steroids or pain medications, including non-steroidal anti-inflammatory drugs (NSAIDs).

If you have any doubts, consult your doctor.

Pregnancy and breastfeeding

• You should consider using adequate contraceptive methods to avoid becoming pregnant and continue using them for at least 5 months after the last treatment with Hukyndra.
• If you are pregnant, think you may be pregnant, or plan to have a baby, ask your doctor for advice on using this medicine.
• Hukyndra should be used during pregnancy only if necessary.
• According to a pregnancy study, there was no increased risk of congenital defects when the mother had received treatment with adalimumab during pregnancy compared to mothers with the same disease who did not receive treatment with adalimumab.
• Hukyndra can be used during breastfeeding.
• If you use Hukyndra while pregnant, your child may have a higher risk of contracting infections.

Driving and using machines

The influence of Hukyndra on the ability to drive, ride a bicycle, or use machines is small. You may experience dizziness and vision disturbances after using Hukyndra.

Hukyndra contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 0.4 ml; it is essentially "sodium-free".

3. How to use Hukyndra

Follow your doctor's or pharmacist's administration instructions for this medication exactly. If in doubt, consult your doctor or pharmacist again.

In the following table, the recommended doses of Hukyndra are indicated for each of its approved uses. Your doctor may prescribe a different dose of Hukyndra if you need a different dose.

• Hukyndra is only available in a 40 mg pre-filled syringe, 40 mg pre-filled pen, and 80 mg pre-filled syringe. Therefore, it is not possible to administer Hukyndra to patients who require less than a full 40 mg dose.

Form and route of administration

Hukyndra is injected under the skin (subcutaneously).

In section 7 "Instructions for use" detailed instructions are provided on how to inject Hukyndra.

If you use more Hukyndra than you should

If you accidentally inject Hukyndra more frequently than scheduled by your doctor or pharmacist, inform your doctor or pharmacist. Always carry the medicine box with you, even if it is empty.

If you forget to use Hukyndra

If you forget to administer an injection, you should inject the next dose of Hukyndra as soon as you remember. Then, the next dose will be administered as usual, as if you had not forgotten a dose.

If you stop treatment with Hukyndra

The decision to stop using Hukyndra should be discussed with your doctor. Your symptoms may return if you stop using Hukyndra.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate. However, some can be serious and require treatment. Side effects may appear up to at least 4 months after the last injection of Hukyndra.

Contact your doctor immediately if you notice any of the following effects

• severe rash, hives, or other signs of allergic reaction
• swelling of the face, hands, feet
• difficulty breathing, swallowing
• shortness of breath with physical activity or when lying down or swelling of feet.

Contact your doctor as soon as possible if you notice any of the following effects

• signs of infection such as fever, nausea, wounds, dental problems, burning sensation when urinating
• feeling of weakness or fatigue
• cough
• tingling
• numbness
• double vision
• weakness in arms or legs
• a lump or an open wound that does not heal
• signs and symptoms of blood disorders such as persistent fever, bruising, bleeding, and paleness

The symptoms described above may be signs of the following side effects, which have been observed with adalimumab.

Very common(may affect more than 1 in 10 people)

• reactions at the injection site (including pain, swelling, redness, or itching)
• lower respiratory tract infections (including colds, runny nose, sinusitis, pneumonia)
• headache
• abdominal pain
• nausea and vomiting
• rash
• muscle pain

Common(may affect up to 1 in 10 people)

• serious infections (including sepsis and flu)
• intestinal infections (including gastroenteritis)
• skin infections (including cellulitis and herpes)
• ear infection
• oral infections (including dental infection and cold sore)
• infections of the reproductive system
• urinary tract infections
• fungal infections
• joint infections
• benign tumors
• skin cancer
• allergic reactions (including seasonal allergy)
• dehydration
• mood changes (including depression)
• anxiety
• difficulty sleeping
• sensory disturbances such as tingling, prickling, or numbness
• migraine
• nerve root compression (including lower back pain and leg pain)
• visual disturbances
• eye inflammation
• eyelid inflammation and eye swelling
• dizziness (feeling of dizziness or spinning)
• sensation of rapid heartbeat
• high blood pressure
• flushing
• bruising (accumulation of blood outside blood vessels)
• cough
• asthma
• difficulty breathing
• gastrointestinal bleeding
• indigestion (indigestion, bloating, and heartburn)
• acid reflux
• dry eye syndrome (including dry eyes and mouth)
• itching
• itchy rash
• bruising
• skin inflammation (such as eczema)
• nail breakage on hands and feet
• increased sweating
• hair loss
• new or worsening psoriasis
• muscle spasms
• blood in urine
• kidney problems
• chest pain
• edema (swelling)
• fever
• decreased platelet count in blood, which increases the risk of bleeding or bruising
• wound healing problems

Uncommon(may affect up to 1 in 100 people)

• opportunistic infections (including tuberculosis and other infections that occur when disease resistance decreases)
• neurological infections (including viral meningitis)
• eye infections
• bacterial infections
• diverticulitis (inflammation and infection of the large intestine)
• cancer
• cancer affecting the lymphatic system
• melanoma
• immunological disorders that can affect the lungs, skin, and lymph nodes (the most common presentation is sarcoidosis)
• vasculitis (inflammation of blood vessels)
• tremor (feeling shaky)
• neuropathy (disorder of the nervous system)
• stroke
• hearing loss, tinnitus
• sensation of irregular heartbeat like skips
• heart problems that can cause difficulty breathing or swelling of ankles
• heart attack
• aneurysm of a major artery, inflammation, and clotting in a vein, blockage of a blood vessel
• lung diseases that can cause difficulty breathing (including inflammation)
• pulmonary embolism (blockage of a pulmonary artery)
• pleural effusion (abnormal fluid accumulation in the pleural space)
• pancreas inflammation that causes severe abdominal and back pain
• difficulty swallowing
• facial edema (swelling of the face)
• gallbladder inflammation; gallstones
• fatty liver
• night sweats
• scarring
• abnormal muscle crisis
• systemic lupus erythematosus (including skin inflammation, heart, lungs, joints, and other organs)
• sleep disturbances
• impotence
• inflammation

Rare(may affect up to 1 in 1000 people)

• leukemia (cancer that affects blood and bone marrow)
• severe allergic reaction with shock
• multiple sclerosis
• nervous system disorders (such as optic nerve inflammation and Guillain-Barré syndrome that can cause muscle weakness, abnormal sensations, tingling in arms and upper body)
• cardiac arrest
• pulmonary fibrosis (scarring in the lungs)
• intestinal perforation (hole in the intestine)
• hepatitis
• reactivation of hepatitis B virus
• autoimmune hepatitis (liver inflammation caused by the body's own immune system)
• cutaneous vasculitis (inflammation of blood vessels in the skin)
• Stevens-Johnson syndrome (early symptoms include discomfort, fever, headache, and rash)
• facial edema (swelling of the face) associated with allergic reactions
• erythema multiforme (inflammatory rash on the skin)
• lupus-like syndrome
• angioedema (localized skin inflammation)
• lichenoid skin reaction (purple-red rash with itching)

Frequency not known(cannot be estimated from the available data)

• hepatosplenic T-cell lymphoma (a rare and often fatal blood cancer)
• Merkel cell carcinoma (a type of skin cancer)
• Kaposi's sarcoma, a rare cancer related to human herpesvirus 8 infection. Kaposi's sarcoma usually occurs more frequently as purple skin lesions.
• liver failure
• worsening of a disease called dermatomyositis (seen as a skin rash accompanied by muscle weakness)
• weight gain (for most patients, weight gain was reduced)

Some side effects observed with adalimumab do not have symptoms and can only be identified through a blood test. These include:

Very common(may affect more than 1 in 10 people)

• low white blood cell count
• low red blood cell count
• increased lipids in blood
• increased liver enzymes

Common(may affect up to 1 in 10 people)

• high white blood cell count
• low platelet count
• increased uric acid in blood
• abnormal sodium levels in blood
• low calcium level in blood
• low phosphate level in blood
• high blood sugar
• high lactate dehydrogenase levels in blood
• presence of autoantibodies in blood
• low potassium level in blood

Uncommon(may affect up to 1 in 100 people)

• elevated bilirubin levels (liver function test)

Rare(may affect up to 1 in 1000 people)

• low counts in blood for white blood cells, red blood cells, and platelets

Reporting of side effects

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

5. Storage of Hukyndra

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

Do not use this medicine after the expiry date which is stated on the label and on the carton after “EXP”. The expiry date is the last day of the month shown.

Store in a refrigerator (between 2 °C and 8 °C). Do not freeze.

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

Alternative storage:

When necessary (e.g. when traveling), you may store a single Hukyndra pre-filled pen at 20 °C to 25 °C for a maximum period of up to 30 days - make sure to protect it from light. Once you have removed the pen from the refrigerator to store it at 20 °C to 25 °C, you must use it within the next 30 days or discard it, even if you put it back in the refrigerator.

You should note the date when you removed the pen from the refrigerator and the date after which you must discard the pen.

Do not use this medicine if the liquid is cloudy, discolored, or contains flakes or particles.

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

6. Package contents and further information

Composition of Hukyndra

The active substance is adalimumab.

The other ingredients are: sodium chloride, sucrose, polysorbate 80, water for injections, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment).

Appearance of Hukyndra and package contents

Hukyndra 40 mg solution for injection in pre-filled pen is supplied as 0.4 ml solution for injection in a pre-filled injection system (auto-injector) that contains a glass pre-filled syringe with a fixed needle and a plunger (bromobutyl rubber). The pen is a mechanical, hand-held, disposable, single-use injection device.

Each pack contains 1, 2 or 6 pre-filled pens packaged in a blister with 1, 2 or 6 alcohol swabs.

Not all pack sizes may be marketed.

Hukyndra may be available in a pre-filled syringe and/or pre-filled pen.

Marketing authorisation holder

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Manufacturers

Ivers-Lee CSM

Marie-Curie-Str.8

79539 Lörrach

Germany

Alvotech Hf

Sæmundargata 15-19

Reykjavik, 101

Iceland

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

You can obtain more information about this medicine from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet

Other sources of information

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

You can access detailed and up-to-date information about this medicine, including a video on how to use the pre-filled pen, by scanning the QR code included below or on the outer packaging with your smartphone. You can also access this information at the following internet address: hukyndrapatients.com

Include QR code

1. Instructions for use

INSTRUCTIONS FOR USE

Hukyndra (adalimumab) pre-filled pen

40 mg/0.4 ml solution for injection, for subcutaneous use

Read these instructions for use carefully before using the Hukyndra pre-filled pen for the first time

Before injecting

Your healthcare professional should show you how to use the Hukyndra pre-filled pen before you use it for the first time.

If you have previously used another adalimumab pen, this pen works differently from other pens on the market. Please read these instructions for use completely so that you understand how to correctly use the Hukyndra pre-filled pen before injecting yourself.

Important information

Do notuse the pen and call your healthcare professional or pharmacist if

• The liquid is cloudy, discolored, or has flakes or particles in it.
• The expiry date has passed.
• The pen has been left in direct sunlight.
• The pen has been dropped or crushed.

Keep the transparent cap on until just before injection. Keep the Hukyndra pre-filled pen out of the reach of children.

Read the instructions on all pages before using the Hukyndra pre-filled pen.

Consult the "Storage information" section at the end of these instructions on how to store the Hukyndra pre-filled pen.

Hukyndra pre-filled pen

How should I store the Hukyndra pre-filled pen?

Store the Hukyndra pre-filled pen in the original carton in the refrigerator between 2 °C and 8 °C. If necessary, for example when traveling, you can also store the Hukyndra pre-filled pen between 20 °C and 25 °C for a period of up to 30days.

Consult the "Storage information" section at the end of these instructions for more details.

STEP 1: Remove the Hukyndra pre-filled pen from the refrigerator and let it sit at room temperature (20°C to 25°C) for 15 to 30 minutes before injecting

Step 1a.Remove the Hukyndra pre-filled pen from the refrigerator (see Figure A).

Step 1b.Let the Hukyndra pre-filled pen sit at room temperature (20 °C to 25 °C) for 15 to 30 minutes before injecting (see Figure B).

• Do notremove the transparent cap while letting the Hukyndra pre-filled pen reach room temperature.
• Do notheat the Hukyndra pre-filled pen in any other way. For example, do notheat it in a microwave or with hot water.
• Do notuse the pre-filled pen if the liquid has been frozen (even if it has been thawed).

Figure A

Figure B

STEP 2: Check the expiry date, gather the devices, and wash your hands

Step 2a.Check the expiry date on the label of the Hukyndra pre-filled pen (see Figure C).

Do notuse the Hukyndra pre-filled pen if the expiry date has passed.

Figure C

Step 2b.Place the following on a clean, flat surface (see Figure D):

• 1 Hukyndra pre-filled pen and 1 alcohol swab.
• 1 cotton ball or gauze (not included).
• 1 puncture-resistant sharps container (not included). See Step 9 at the end of these instructions for use on how to dispose of your used Hukyndra pre-filled pen.

Step 2c.Wash and dry your hands (see Figure E).

Figure D

Figure E

STEP 3: Choose and clean the injection site

Step 3a.Choose an injection site (see Figure F):

• On the front of the thighs or,
• On the stomach (abdomen) at least 5 cm away from the navel.
• At least 3 cm away from your last injection site.

Step 3b.Clean the injection site with a circular motion using the alcohol swab (see Figure G).

Do notinject through clothing.

Do notinject into skin that is painful, bruised, red, hard, scarred, or has stretch marks or psoriasis plaques.

Figure F

Figure G

STEP 4: Check the medicine in the inspection window

Step 4a.Hold the Hukyndra pre-filled pen with the grey handle grip area facing upwards. Check the inspection window (see Figure H).

• It is normal to see 1 or more bubbles in the inspection window.
• Make sure the liquid is clear and colorless.

Do notuse the Hukyndra pre-filled pen if the liquid is cloudy or has particles.

Do notuse the Hukyndra pre-filled pen if it has been dropped or crushed.

Figure H

STEP 5: Remove the transparent cap

Step 5a.Pull off the transparent cap (see Figure I).

It is normal to see a few drops of liquid come out of the needle.

Step 5b.Discard the transparent cap.

Do notput the transparent cap back on the pen. This can damage the needle. The pen is ready to use after the transparent cap has been removed.

Step 5c.Turn the Hukyndra pre-filled pen so that the orange needle cover points towards the injection site.

Figure I

STEP 6: Pinch the skin and place the Hukyndra pre-filled pen on the injection site

Step 6a.Pinch the skin to make a raised area at the injection site and hold it firmly.

Step 6b.Place the orange needle cover straight (at a 90° angle) against the injection site (see Figure J).

Hold the pen so that you can see the inspection window.

Figure J

STEP 7: Administer the injection

Step 7a.Push and continue to push the pen down against the injection site (see Figure K).

• The first 'click' will mark the start of the injection (see Figure K). It may take up to 10 seconds to complete after the first 'click'.
• Continue to push the pen down against the injection site.
• The injection is complete when the orange indicator has stopped moving and you hear a second 'click' (see Figure L).

Do notlift or remove pressure from the injection site until you have confirmed that the injection is complete.

Figure K Figure L

STEP 8: Remove the Hukyndra pre-filled pen from the skin and skin care

Step 8a.When the injection is complete, slowly remove the Hukyndra pre-filled pen from the skin. The orange needle cover will cover the needle tip (see Figure M).

If there is more than a few drops of liquid at the injection site, contact your healthcare professional for assistance.

Step 8b.After completing the injection, place a cotton ball or gauze on the skin at the injection site.

Do notrub.

Mild bleeding at the injection site is normal.

Figure M

STEP 9: How should I dispose of the used Hukyndra pre-filled pen?

Step 9a.Put your used needles, pens, and sharps in a sharps disposal container immediately after use (see Figure N).

Do notthrow (dispose of) the pen in household waste.

Step 9b.The transparent cap, alcohol swab, cotton ball or gauze, and packaging can be thrown away in household waste.

If you do not have a sharps disposal container, you can use a household container that is:

• made of heavy-duty plastic,
• can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
• upright and stable during use,
• leak-resistant and
• properly labeled to warn of hazardous waste inside the container.

When your sharps disposal container is almost full, you should follow local guidelines for the proper disposal of your sharps disposal container.

Do notdispose of your used sharps disposal container in household waste.

Do notrecycle your used sharps disposal container.

Figure N