Hyrimoz® 40 mg/0.4 ml – patient leaflet, side effects, dosage

1What Hyrimoz is and what it is used for

Hyrimoz contains the active substance adalimumab, a medicine that acts on your body’s immune (defence) system.

Hidradenitis suppurativa in adults and adolescents

Hidradenitis suppurativa (sometimes called acne inversa) is a long-term and often painful inflammatory skin disease. Symptoms may include tender nodules (lumps) and abscesses (boils) that may leak pus. It most commonly affects specific areas of the skin, such as under the breasts, the armpits, inner thighs, groin and buttocks. Scarring may also occur in affected areas.

Hyrimoz is intended for the treatment of the following inflammatory diseases:

• rheumatoid arthritis,
• polyarticular juvenile idiopathic arthritis,
• enthesitis-related arthritis,
• ankylosing spondylitis,
• axial spondyloarthritis without radiographic evidence of ankylosing spondylitis,
• psoriatic arthritis,
• plaque psoriasis,
• hidradenitis suppurativa,
• Crohn’s disease,
• ulcerative colitis,
• non-infectious uveitis.

The active ingredient in Hyrimoz, adalimumab, is a monoclonal antibody. Monoclonal antibodies are proteins that attach to a specific target in the body.

The target of adalimumab is another protein called tumour necrosis factor (TNFα), which is present at increased levels in the inflammatory diseases listed above. By attaching to TNFα, Hyrimoz blocks its action and reduces the inflammation in these diseases.

Hyrimoz is used to treat

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

Hyrimoz can reduce the number of nodules and abscesses you have, and the pain that is often associated with the disease. You may first be given other medicines. If these medicines do not work well enough, you will be given Hyrimoz.

Crohn’s disease in adults and children

Crohn’s disease is an inflammatory disease of the gut.

Hyrimoz is used to treat

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

If you have Crohn’s disease you will first be given other medicines. If you do not respond well enough to these medicines, you will be given Hyrimoz to reduce the signs and symptoms of your Crohn’s disease.

Ulcerative colitis in adults and children

Ulcerative colitis is an inflammatory disease of large intestine.

Rheumatoid arthritis

Rheumatoid arthritis is an inflammatory disease of the joints.

Hyrimoz is used to treat rheumatoid arthritis in adults. If you have moderate to severe active rheumatoid arthritis, you may first be given other disease-modifying medicines, such as methotrexate. If these medicines do not work well enough, you will be given Hyrimoz to treat your rheumatoid arthritis. Hyrimoz can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.

Hyrimoz can slow down the damage to the cartilage and bone of the joints caused by the disease and improve physical function.

Usually, Hyrimoz is used with methotrexate. If your doctor considers that methotrexate is inappropriate, Hyrimoz can be given alone.

Hyrimoz is used to treat

• moderate to severe ulcerative colitis in adults and
• moderate to severe ulcerative colitis in children and adolescents aged 6 to 17 years. If you have ulcerative colitis you may first be given other medicines. If these medicines do not work well enough, you will be given Hyrimoz to reduce the signs and symptoms of your ulcerative colitis.

Non-infectious uveitis in adults and children

Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye. The inflammation leads to a decrease of vision and / or the presence of floaters in the eye (black dots or wispy lines that move across the field of vision). Hyrimoz works by reducing this inflammation.

Hyrimoz is used to treat

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

Polyarticular juvenile idiopathic arthritis

Polyarticular juvenile idiopathic arthritis is an inflammatory disease of the joints that usually first appear in childhood.

Hyrimoz is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years. Patients may first be given other disease-modifying medicines, such as methotrexate. If these medicines do not work well enough, patients will be given Hyrimoz.

Enthesitis-related arthritis

Enthesitis-related arthritis is an inflammatory disease of the joints and the places where tendons join the bone. Hyrimoz is used to treat enthesitis-related arthritis in patients from 6 years of age. Patients may first be given other disease-modifying medicines, such as methotrexate. If these medicines do not work well enough, patients will be given Hyrimoz.

Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis

You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Hyrimoz.

2What you need to know before you use Hyrimoz

Do not use Hyrimoz

• if you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
• if you have a severe infection, including tuberculosis, sepsis (blood poisoning) or other opportunistic infections (unusual infections associated with a weakened immune system). It is important that you tell your doctor if you have symptoms of infections, e.g. fever, wounds, feeling tired, dental problems (see “Warnings and precautions”).
• if you have moderate or severe heart failure. It is important to tell your doctor if you have had or have a serious heart condition (see “Warnings and precautions”).

Warnings and precautions

Talk to your doctor or pharmacist before using Hyrimoz.

Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, are inflammatory diseases of the spine.

Hyrimoz is used in adults to treat these conditions. If you have ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, you will first be given other medicines. If these medicines do not work well enough, you will be given Hyrimoz to reduce the signs and symptoms of your disease.

Allergic reaction

• If you have allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash, do not inject more Hyrimoz and contact your doctor immediately, since in rare cases, these reactions can be life- threatening.

  Infections

  • If you have an infection, including long-term or localised infection (for example leg ulcer), consult your doctor before starting Hyrimoz. If you are unsure, contact your doctor.
  • You might get infections more easily while you are receiving Hyrimoz treatment. This risk may increase if your lung function is reduced. These infections may be more serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other unusual infectious organisms and sepsis (blood poisoning).
  • In rare cases, these infections may be life-threatening. It is important to tell your doctor if you get symptoms such as fever, wounds, feeling tired or dental problems. Your doctor may recommend temporarily stopping Hyrimoz.

Tuberculosis (TB)

• As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will check you for signs and symptoms of tuberculosis before starting Hyrimoz. This will include a thorough medical evaluation including your medical history and screening tests (for example chest X-ray and a tuberculin test). The conduct and results of these tests should be recorded on your Patient Reminder Card. It is very important that you tell your doctor if you have ever had tuberculosis, or if you have been in close contact with someone who has had tuberculosis. Tuberculosis can develop during therapy even if you have had preventative treatment for tuberculosis. If symptoms of tuberculosis (persistent cough, weight loss, lack of energy, mild fever), or any other infection appear during or after therapy tell your doctor immediately.

Travel / recurrent infection

• Tell your doctor if you have lived or travelled in regions where fungal infections such as histoplasmosis, coccidioidomycosis or blastomycosis are very common.
• Tell your doctor if you have a history of recurrent infections or other conditions that increase the risk of infections.

Hepatitis B virus

• Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV infection or if you think you might be at risk of getting HBV. Your doctor should test you for HBV. Adalimumab can reactivate HBV infection in people who carry this virus. In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV infection can be life-threatening.

Age over 65 years

• If you are over 65 years you may be more susceptible to infections while taking Hyrimoz. You and your doctor should pay special attention to signs of infection while you are being treated with Hyrimoz. It is important to tell your doctor if you get symptoms of infections, such as fever, wounds, feeling tired or dental problems.

Surgery or dental procedures

• If you are about to have surgery or dental procedures tell your doctor that you are taking Hyrimoz. Your doctor may recommend temporarily stopping Hyrimoz.

Demyelinating disease

• If you have or develop demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if you should receive or continue to receive Hyrimoz. Tell your doctor immediately if you get symptoms like changes in your vision, weakness in your arms or legs or numbness or tingling in any part of your body.

Vaccine

• Certain vaccines contain living but weakened forms of disease-causing bacteria or viruses and should not be given during treatment with Hyrimoz in case they cause infections. Check with your doctor before you receive any vaccines. It is recommended that, if possible, children be given all the scheduled vaccinations for their age before they start treatment with Hyrimoz.

  If you receive Hyrimoz while you are pregnant, your baby may be at higher risk for getting an infection for up to about five months after the last dose you received during pregnancy. It is important that you tell your baby‘s doctors and other health care professionals about your Hyrimoz use during your pregnancy so they can decide when your baby should receive any vaccine.

Heart failure

• It is important to tell your doctor if you have had or have a serious heart condition. If you have mild heart failure and you are being treated with Hyrimoz, your heart failure status must be closely monitored by your doctor. If you develop new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor immediately.

Fever, bruising, bleeding or looking pale

• In some patients the body may fail to produce enough of the blood cells that fight off infections or help you to stop bleeding. If you develop a fever that does not go away, or you bruise or bleed very easily or look very pale, call your doctor right away. Your doctor may decide to stop treatment.

Cancer

• There have been very rare cases of certain kinds of cancer in children and adults taking adalimumab or other TNFα blockers. People with more serious rheumatoid arthritis who have had the disease for a long time may have a higher than average risk of getting lymphoma and leukaemia (cancers that affect blood cells and bone marrow). If you take Hyrimoz the risk of getting lymphoma, leukaemia, or other cancers may increase. On rare occasions, a specific and severe type of lymphoma has been observed in patients taking adalimumab. Some of those patients were also treated with the medicines azathioprine or mercaptopurine. Tell your doctor if you are taking azathioprine or mercaptopurine with Hyrimoz.
• In addition cases of non-melanoma skin cancer have been observed in patients taking adalimumab. If new areas of damaged skin appear during or after treatment or if existing marks or areas of damage change appearance, tell your doctor.
• There have been cases of cancers, other than lymphoma, in patients with a specific type of lung disease called chronic obstructive pulmonary disease (COPD) treated with another TNFα blocker. If you have COPD, or are a heavy smoker, you should discuss with your doctor whether treatment with a TNFα blocker is appropriate for you.

Autoimmune diseases

• On rare occasions, treatment with Hyrimoz could result in lupus-like syndrome. Contact your doctor, if symptoms such as persistent unexplained rash, fever, joint pain or tiredness occur.

Children and adolescents

• Do not give Hyrimoz to children with polyarticular juvenile idiopathic arthritis below the age of 2 years.
• Do not give Hyrimoz to children with paediatric plaque psoriasis or paediatric ulcerative colitis below the age of 4 years.
• Do not give Hyrimoz to children with paediatric Crohn’s disease below the age of 6 years.
• Do not use the 40 mg pre-filled pen if doses lower than 40 mg are recommended.

Other medicines and Hyrimoz

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

Hyrimoz can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), corticosteroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).

You should not take Hyrimoz with medicines containing the active substances anakinra or abatacept due to increased risk of serious infection. The combination of adalimumab as well as other TNF-antagonists and anakinra or abatacept is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions. If you have questions, please ask your doctor.

Pregnancy and breast-feeding

• You should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Hyrimoz treatment.
• If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
• Hyrimoz should only be used during a pregnancy if needed.
• According to a pregnancy study, there was no higher risk of birth defects when the mother had received adalimumab during pregnancy compared with mothers with the same disease who did not receive adalimumab.
• Hyrimoz can be used during breast-feeding.
• If you receive Hyrimoz during your pregnancy, your baby may have a higher risk for getting an infection.
• It is important that you tell your baby’s doctors and other health care professionals about your Hyrimoz use during your pregnancy before the baby receives any vaccine (for more information on vaccines see the “Warnings and precautions” section).

Driving and using machines

Hyrimoz may have a minor influence on your ability to drive, cycle or use machines. Room spinning sensation (vertigo) and vision disturbances may occur after taking Hyrimoz.

Hyrimoz contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 0.4 ml dose, that is to say essentially ‘sodium-free’.

3How to use Hyrimoz

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended doses for Hyrimoz in each of the approved uses are shown in the following table. Your doctor may prescribe another strength of Hyrimoz if you need a different dose.

Method and route of administration

Hyrimoz is administered by injection under the skin (by subcutaneous injection).

Detailed instructions on how to inject Hyrimoz are provided in section 7, “Instructions for use”. If you use more Hyrimoz than you should

If you accidentally inject Hyrimoz more frequently than you should, call your doctor or pharmacist and explain that you have taken more than required. Always take the outer carton of medicine with you, even if it is empty. If you forget to use Hyrimoz

If you forget to give yourself an injection, you should inject the next dose of Hyrimoz as soon as you remember. Then take your next dose as you would have on your originally scheduled day, had you not forgotten a dose.

If you stop using Hyrimoz

The decision to stop using Hyrimoz should be discussed with your doctor. Your symptoms may return upon stopping treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4Possible 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 may be serious and require treatment. Side effects may occur up to 4 months or more after the last Hyrimoz injection.

Seek medical attention urgently, if you notice any of the following signs of allergic reaction or heart failure:

• severe rash, hives;
• swollen face, hands, feet;
• trouble breathing, swallowing;
• shortness of breath with physical activity or upon lying down or swelling of the feet.

Tell your doctor as soon as possible, if you notice any of the following:

• signs and symptoms of infection such as fever, feeling sick, wounds, dental problems, burning on urination, feeling weak or tired or coughing;
• symptoms of nerve problems such as tingling, numbness, double vision or arm or leg weakness;
• signs of skin cancer such as a bump or open sore that doesn’t heal;
• signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding, paleness.

The following side effects have been observed with adalimumab:

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

• injection site reactions (including pain, swelling, redness or itching);
• respiratory tract infections (including cold, runny nose, sinus infection, pneumonia);
• headache;
• abdominal (belly) pain;
• nausea and vomiting;
• rash;
• pain in the muscles.

Common (may affect up to 1 in 10 people)

• serious infections (including blood poisoning and influenza);
• intestinal infections (including gastroenteritis);
• skin infections (including cellulitis and shingles);
• ear infections;

• mouth infections (including tooth infections and cold sores);

  • reproductive tract infections;

    Not known (frequency cannot be estimated from available data)

    1. 3. Removing the cap of your pen:

It is important that you:

• Only remove the cap when you are ready to use the pen.
• urinary tract infection;
• hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal);
• do not use the pen if either the seal on the outer carton or the safety seal on the pen is broken.
• Twist off the cap in the direction of the arrows (see Figure F).
• fungal infections;
• Merkel cell carcinoma (a type of skin cancer);
• keep your pen in the sealed outer carton until you are ready to use it.
• Once removed, throw away the cap. Do not try to re-attach the cap.
• joint infections;
• Kaposi’s sarcoma, a rare cancer related to infection with human herpes virus 8. Kaposi’s sarcoma most commonly appears as purple lesions on the skin;
• never leave the pen unattended where others might tamper with it.
• Use your pen within 5 minutes of removing the cap.
• benign tumours;
• do not use your pen, if you dropped it, it looks damaged, or if you dropped it with the cap removed.
• You may see a few drops of liquid come out of the needle. This is normal.
• skin cancer;• allergic reactions (including seasonal allergy);
• liver failure;
• inject Hyrimoz 15–30 minutes after taking it out of the refrigerator for a more comfortable injection.
• worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness).
• throw away the used pen right away after use. Do not re-use the pen. See “8. Disposing of used pens” at the end of this Instructions for Use.
• dehydration;
• weight gain (for most patients, the weight gain was small)

• mood swings (including depression);

  Some side effects observed with adalimumab may not have symptoms and may only be discovered through blood tests. These include:

How should you store your pen?

• anxiety;

  • Store your pen carton in a refrigerator, between 2°C to 8°C.

• difficulty sleeping;

  • When needed, for example when you are travelling, Hyrimoz may be stored at room temperature (up to 25°C) for a maximum period of 42 days. – be sure to protect it from light. Once removed from the refrigerator for room temperature storage, your pre-filled pen must be used within 42 days or discarded, even if it is later returned to the refrigerator.

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

• sensation disorders such as tingling, prickling or numbness;

  • low blood measurements for white blood cells;

• migraine;

  • low blood measurements for red blood cells;

• symptoms of nerve root compression (including low back pain and leg pain);

  • increased lipids in the blood;

• vision disturbances;

  Figure F: remove the cap

  • You should record the date when your pre-filled pen is first removed from the refrigerator, and the date after which it should be discarded.
  • raised liver enzymes.

• eye inflammation;

  1. 4. Holding the pen:

• inflammation of the eye lid and eye swelling;

  • Hold your pen at 90 degrees to the cleaned injection site (see Figure G).

Common (may affect up to 1 in 10 people)

• Keep your pen in the original carton until ready to use to protect from light.
• vertigo (sensation of room spinning);• sensation of heart beating rapidly;
• high blood measurements for white blood cells;
• Do not store your pen in extreme heat or cold.
• low blood measurements for platelets;
• Do not freeze your pen.
• high blood pressure;

• increased uric acid in the blood;

  Keep Hyrimoz and all medicines out of the reach of children.

• flushing;
• abnormal blood measurements for sodium;
• haematoma (a solid swelling with clotted blood);• cough;

• low blood measurements for calcium;

  What do you need for your injection?

• low blood measurements for phosphate;

  Place the following items on a clean, flat surface.

• asthma;

• high blood sugar;

  Included in your carton are:

• shortness of breath;
• high blood measurements for lactate dehydrogenase;
• Hyrimoz pre-filled pen/s (see Figure A). Each pen contains 40 mg/0.4 ml of adalimumab. Not included in your pen carton are (see Figure B):
• gastrointestinal bleeding;
• autoantibodies present in the blood;
• dyspepsia (indigestion, bloating, heart burn);
• low blood potassium.
• Alcohol wipe

• acid reflux disease;

  Figure G: hold your pen Correct Incorrect

  Uncommon (may affect up to 1 in 100 people)

• Cotton ball or gauze

• sicca syndrome (including dry eyes and dry mouth);

  Your injection

• Sharps disposal container See “8. Disposing of used pens” at the end of these Instructions for Use
• raised bilirubin measurement (liver blood test).
• itching;
• Adhesive bandage

• itchy rash;• bruising;

  Rare (may affect up to 1 in 1,000 people)

  You must read this before injecting

  During the injection you will hear 2 loud clicks:

• low blood measurements for white blood cells, red blood cells and platelet count.

• inflammation of the skin (such as eczema);

  o The first click indicates that the injection has started.

• breaking of finger nails and toe nails;

  Reporting of side effects

  o Several seconds later a second click will indicate that the injection is almost finished. You must keep holding your pen firmly against your skin until you see a green indicator fill the window and stop moving.

• increased sweating;

  If you or your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

• hair loss;

• new onset or worsening of psoriasis;

  Figure B: items not included in the carton

• muscle spasms;

  1. 5. Starting your injection:

• blood in urine;

  Before your injection

  • Press your pen firmly against the skin to start the injection (see Figure H).

5How to store Hyrimoz

• kidney problems;

  • The first click indicates the injection has started.

Preparing the pen

• chest pain;

  • Keep holding your pen firmly against your skin.

• oedema (a build-up of fluid in the body which causes the affected tissue to swell);

  • For a more comfortable injection, take your pen out of the

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

• The green indicator shows the progress of the injection.

• fever;• reduction in blood platelets which increases risk of bleeding or bruising;

  refrigerator 15 to 30 minutes before injecting Hyrimoz to allow it to reach room temperature.

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

• Look through the viewing window. The solution should be colourless or slightly yellowish as well as clear to slightly opalescent. Do not use if any particulates and / or discolorations are observed. You may see small air bubbles, which is normal. If you are concerned with the appearance of the solution, then contact your pharmacist for assistance.

• impaired healing.

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

  Keep the pre-filled pen in the outer carton in order to protect from light.

Uncommon (may affect up to 1 in 100 people)

• unusual infections (which include tuberculosis and other infections) that occur when resistance to disease is lowered;

  Alternative Storage:

  When needed (for example when you are travelling), Hyrimoz may be stored at room temperature (up to 25°C) for a maximum period of 42 days – be sure to protect it from light. Once removed from the refrigerator for room temper-ature storage, your pre-filled pen must be used within 42 days or discarded, even if it is later returned to the refrigerator. You should record the date when your pre-filled pen is first removed from the refrigerator, and the date after which it should be discarded.

• neurological infections (including viral meningitis);
• eye infections;
• bacterial infections;

• diverticulitis (inflammation and infection of the large intestine);

  Figure H: start your injection

• cancer, including cancer that affects the lymph system (lymphoma) and melanoma (a type of skin cancer);

  Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

  1. 6. Completing your injection:

• immune disorders that could affect the lungs, skin and lymph nodes (most commonly as a condition called sarcoidosis);

  • Listen for the second click. This indicates the injection is almost complete.
  • Check the green indicator fills the window and has stopped moving (see Figure I).

6Contents of the pack and other information

• vasculitis (inflammation of blood vessels);

  • The pen can now be removed.

figure C: Safety Checks before injection

• tremor (shaking);• neuropathy (nerve damage);

  • Look at the expiration date (EXP) on your pen (see Figure C). Do not use your pen if the expiration date has passed.

What Hyrimoz contains

• stroke;

  • Do not use if the safety seal has been broken.

• hearing loss, buzzing;

  • The active substance is adalimumab. Each pre-filled pen contains 40 mg of adalimumab in 0.4 ml of solution.

• sensation of heart beating irregularly such as skipped beats;

  • The other ingredients are adipic acid, mannitol (E 421) , polysorbate 80 (E 433), hydrochloric acid (E 507), sodium hydroxide (E 524) and water for injections.

    Contact your pharmacist if the pen fails any of the above mentioned checks.

• heart problems that can cause shortness of breath or ankle swelling;

  1. 1. Choosing your injection site:

• heart attack;

  • The recommended injection site is the front of your thighs. You may also use the lower abdomen, but not the area 5 cm around your navel (belly button) (see Figure D).

What Hyrimoz looks like and contents of the pack

• a sac in the wall of a major artery, inflammation and clot of a vein; blockage of a blood vessel;

• lung diseases causing shortness of breath (including inflammation);

  Hyrimoz 40 mg solution for injection (injection) in pre-filled pen is supplied as a 0.4 ml clear to slightly opalescent, colourless or slightly yellowish solution.

  • Choose a different site each time you give yourself an injection.

• pulmonary embolism (blockage in an artery of the lung);

  • Do not inject into areas where the skin is tender, bruised, red, scaly, or hard. Avoid areas with scars or stretch marks.

• pleural effusion (abnormal collection of fluid in the pleural space);

  Hyrimoz is supplied in a single-use pre-filled syringe assembled into a triangular-shaped pen with transparent window and label. The syringe inside the pen is made of type I glass with a stainless steel 29 gauge needle and an inner rubber needle cap (thermoplastic elastomer), containing 0.4 ml of solution.

  Figure I: complete your injection

• inflammation of the pancreas which causes severe pain in the abdomen and back;

  After your injection

  • If you have psoriasis, you should NOT inject directly into areas with psoriasis plaques.

• difficulty in swallowing;• facial oedema (swelling);

  1. 7. Check the green indicator fills the window (see Figure J):

Cartons contain 1, 2 and 4 pre-filled pens of Hyrimoz.

• This means the medicine has been delivered. Contact your doctor if the green indicator is not visible.

• gallbladder inflammation, gallbladder stones;

  Multipack cartons contain 6 (3 packs of 2) pre-filled pens of Hyrimoz.

• There may be a small amount of blood at the injection site. You can press a cotton ball or gauze over the injection site and hold it for 10 seconds. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if needed.

• fatty liver (build-up of fat in liver cells);

  Not all pack sizes may be marketed.

• night sweats;• scar;

  Hyrimoz is available as a pre-filled syringe and a pre-filled pen.

  Marketing Authorisation Holder

• abnormal muscle breakdown;

  Sandoz GmbH, Biochemiestr. 10, 6250 Kundl, Austria

• systemic lupus erythematosus (an immune disorder including inflammation of skin, heart, lung, joints and other organ systems);

  Manufacturer

  Sandoz GmbH Schaftenau, Biochemiestr. 10, 6336 Langkampfen, Austria

• sleep interruptions;

  Or Novartis Pharmaceutical Manufacturing GmbH, Biochemiestrasse 10, 6336 Langkampfen, Austria

• impotence;

  Figure D: choose your injection site

• inflammations.

  This leaflet was last revised in 04/2024

• Cleaning your injection site:

Rare (may affect up to 1 in 1,000 people)

Figure J: check the green indicator

• Wash your hands well with soap and water.

7Instructions for use

• leukaemia (cancer affecting the blood and bone marrow);

  1. 8. Disposing of used pens:
  • Using a circular motion, clean the injection site with an alcohol wipe. Let it dry before injecting (see Figure E).

• severe allergic reaction with shock;

  • Dispose of the used pens in a sharps container (closable, puncture-resistant container, see Figure K). For the safety and health of you and others, the pens must never be re-used.

• multiple sclerosis;

  To help avoid possible infections and to ensure that you use Hyrimoz correctly, it is important that you follow these instructions.

  • Do not touch the cleaned area again before injecting.

• nerve disorders (such as inflammation of the optic nerve to the eye, and Guillain-Barré syndrome, a condition that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body);

  • Do not throw away any medicines via wastewater or household waste. Ask your doctor or pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. Any unused product or waste material should be disposed of in accordance with local requirements.

Be sure that you read, understand, and follow these Instructions for use before injecting Hyrimoz. Your healthcare provider should show you how to prepare and inject Hyrimoz properly using the Hyrimoz single-dose pre-filled pen before you use it for the first time. Talk to your healthcare provider if you have any questions. Your Hyrimoz single-use pre-filled pen

• heart stops pumping;• pulmonary fibrosis (scarring of the lung);
• intestinal perforation (hole in the wall of the gut);
• hepatitis (liver inflammation);

• reactivation of hepatitis B infection;

  Needle

• autoimmune hepatitis (inflammation of the liver caused by the body’s own immune system);• cutaneous vasculitis (inflammation of blood vessels in the skin);• Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and blistering rash);• facial oedema (swelling) associated with allergic reactions;

  Needle guard

  Viewing window Internal needle cover Cap

  Figure E: clean your injection site

• erythema multiforme (inflammatory skin rash);

• lupus-like syndrome;

  Figure K: dispose of your used pen If you have any questions, please talk to a doctor, pharmacist or nurse who is familiar with Hyrimoz.

  Figure A: Hyrimoz pen parts

• angioedema (localised swelling of the skin);

• lichenoid skin reaction (itchy reddish-purple skin rash).

  In Figure A, the pen is shown with the cap removed. Do not remove the cap until you are ready to inject.

Signature Panel:

Signature Regulatory

Signature

Quality