Patient leaflet - Hyrimoz 80 mg/0.8 ml solution for injection in Pre-filled syringe
1. What 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.
Hyrimoz is intended for the treatment of the following inflammatory diseases:
- rheumatoid 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.
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.
Plaque psoriasis
Plaque psoriasis is an inflammatory skin condition that causes red, flaky, crusty patches of skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to crumble, become thickened and lift away from the nail bed which can be painful. Psoriasis is believed to be caused by a problem with the body’s immune system that leads to an increased production of skin cells.
Hyrimoz is used to treat moderate to severe plaque psoriasis in adults.
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 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 and
- 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 the large intestine.
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.
You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Hyrimoz.
2. What 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.
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 80 mg pre-filled syringe if doses other than 80 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 0.8 ml dose, that is to say essentially ‘sodium-free’.
3. How 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.
| Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis | ||
|---|---|---|
| Age orbody weight | How much and how often to take? | Notes |
| Adults | 40 mg every other week as a single dose | In rheumatoid arthritis, methotrexate is continued while using Hyrimoz. If your doctor determines that methotrexate is inappropriate, Hyrimoz can be given alone. If you have rheumatoid arthritis and you do not receive methotrexate with your Hyrimoz therapy, your doctor may decide to give 40 mg Hyrimoz every week or 80 mg every other week. |
| Plaque Psoriasis | ||
|---|---|---|
| Age or body weight | How much and how often to take? | Notes |
| Adults | First dose of 80 mg (one 80 mg injection), followed by 40 mg given every other week starting one week after the first dose. | You should continue to inject Hyrimoz for as long as your doctor has told you. If this dose does not work well enough, your doctor may increase the dosage to 40 mg every week or 80 mg every other week. |
| Hidradenitis suppurativa | ||
|---|---|---|
| Age or body weight | How much and how often to take? | Notes |
| Adults | First dose of 160 mg (two 80 mg injections in one day or one 80 mg injection per day for two consecutive days), followed by an 80 mg dose (one 80 mg injection) two weeks later. After two further weeks, continue with a dosage of 40 mg every week or 80 mg every other week, as prescribed by your doctor. | It is recommended that you use an antiseptic wash daily on the affected areas. |
| Adolescents from 12 to 17 years of age weighing 30 kg or more | First dose of 80 mg (one 80 mg injection), followed by 40 mg every other week starting one week later. | If this dose does not work well enough, your doctor may increase the dosage to 40 mg every week or 80 mg every other week. It is recommended that you use an antiseptic wash daily on the affected areas. |
| Crohn’s disease | ||
|---|---|---|
| Age or body weight | How much and how often to take? | Notes |
| Children, adolescents and adults weighing 40 kg or more | First dose of 80 mg (one 80 mg injections), followed by 40 mg every other week starting two weeks later. If a faster response is required your doctor may prescribe a first dose of 160 mg (two 80 mg injections in one day or one 80 mg injection per day for two consecutive days), followed by 80 mg (one 80 mg injection ) two weeks later. Thereafter the usual dose is 40 mg every other week. | If this dose does not work well enough, your doctor may increase the dosage to 40 mg every week or 80 mg every other week. |
| Paediatric Crohn’s disease | ||
|---|---|---|
| Age or body weight | How much and how often to take? | Notes |
| Children and adolescents from 6 to 17 years of age weighing less than 40 kg | First dose of 40 mg, followed by 20 mg every other week starting two weeks later. If a faster response is required, your doctor may prescribe a | If this dose does not work well enough, your child’s doctor may increase the dose frequency to 20 mg every week. |
first dose of 80 mg (one 80 mg injections), followed by 40 mg two weeks later. Thereafter the usual dose is 20 mg every other week. |
| Ulcerative colitis | ||
|---|---|---|
| Age or body weight | How much and how often to take? | Notes |
| Adults | First dose is 160 mg (two 80 mg injections in one day or as one 80 mg injection per day for two consecutive days), followed by 80 mg (one 80 mg injection) two weeks later. Thereafter, the usual dose is 40 mg every other week. | If this dose does not work well enough, your doctor may increase the dosage to 40 mg every week or 80 mg every other week. |
| Paediatric ulcerative colitis | ||
|---|---|---|
| Age and body weight | How much and how often to take? | Notes |
| Children and adolescents from 6 years of age weighing 40 kg or more | First dose is 160 mg (two 80 mg injections in one day or one 80 mg injection per day for two consecutive days) initially, followed by 80 mg (one 80 mg injection) two weeks later. Thereafter the usual dose is 80 mg every other week. | Patients who turn 18 years of age while on 80 mg every other week, should continue their prescribed dose |
| Children and adolescents from 6 years of age weighing less than 40 kg | First dose is 80 mg (one 80 mg injection) initially followed by 40 mg (as one 40 mg injection) two weeks later. Thereafter, the usual dose is 40 mg every other week. | Patients who turn 18 years of age while on 40 mg every other week, should continue their prescribed dose. |
| Non-infectious uveitis | ||
| Age or body weight | How much and how often to take? | Notes |
| Adults | First dose of 80 mg (one 80 mg injection), followed by 40 mg every other week starting one week after the first dose. | In non-infectious uveitis, corticosteroids or other medicines that influence the immune system may be continued while using Hyrimoz. Hyrimoz can also be given alone. You should continue to inject Hyrimoz for as long as your doctor has told you. |
| Children and adolescents from 2 | 40 mg every other week | Your doctor may also prescribe a first dose of 80 mg which |
| years of age weighing 30 kg or more | may be administered one week prior to the start of the usual dose of 40mg every other week. Hyrimoz is recommended for the use in combination with methotrexate. | |
|---|---|---|
| Children and adolescents from 2 years of age weighing less than 30 kg | 20 mg every other week | Your doctor may also prescribe a first dose of 40 mg which may be administered one week prior to the start of the usual dose of 20 mg every other week. Hyrimoz is recommended for the use in combination with methotrexate. |
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.
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 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;
- urinary tract infection;
- fungal infections;
- joint infections;
- benign tumours;
- skin cancer;
- allergic reactions (including seasonal allergy);
- dehydration;
- mood swings (including depression);
- anxiety;
- difficulty sleeping;
- sensation disorders such as tingling, prickling or numbness;
- migraine;
- symptoms of nerve root compression (including low back pain and leg pain);
- vision disturbances;
- eye inflammation;
- inflammation of the eye lid and eye swelling;
- vertigo (sensation of room spinning);
- sensation of heart beating rapidly;
- high blood pressure;
- flushing;
- haematoma (a solid swelling with clotted blood);
- cough;
- asthma;
- shortness of breath;
- gastrointestinal bleeding;
- dyspepsia (indigestion, bloating, heart burn);
- acid reflux disease;
- sicca syndrome (including dry eyes and dry mouth);
- itching;
- itchy rash;
- bruising;
- inflammation of the skin (such as eczema);
- breaking of finger nails and toe nails;
- increased sweating;
- hair loss;
- new onset or worsening of psoriasis;
- muscle spasms;
- blood in urine;
- kidney problems;
- chest pain;
- oedema (a build-up of fluid in the body which causes the affected tissue to swell);
- fever;
- reduction in blood platelets which increases risk of bleeding or bruising;
- impaired healing.
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;
- neurological infections (including viral meningitis);
- eye infections;
- bacterial infections;
- diverticulitis (inflammation and infection of the large intestine);
- cancer, including cancer that affects the lymph system (lymphoma) and melanoma (a type of skin cancer);
- immune disorders that could affect the lungs, skin and lymph nodes (most commonly as a condition called sarcoidosis);
- vasculitis (inflammation of blood vessels);
- tremor (shaking);
- neuropathy (nerve damage);
- stroke;
- hearing loss, buzzing;
- sensation of heart beating irregularly such as skipped beats;
- heart problems that can cause shortness of breath or ankle swelling;
- heart attack;
- 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);
- pulmonary embolism (blockage in an artery of the lung);
- pleural effusion (abnormal collection of fluid in the pleural space);
- inflammation of the pancreas which causes severe pain in the abdomen and back;
- difficulty in swallowing;
- facial oedema (swelling);
- gallbladder inflammation, gallbladder stones;
- fatty liver (build-up of fat in liver cells);
- night sweats;
- scar;
- abnormal muscle breakdown;
- systemic lupus erythematosus (an immune disorder including inflammation of skin, heart, lung, joints and other organ systems);
- sleep interruptions;
- impotence;
- inflammations.
Rare (may affect up to 1 in 1,000 people)
- leukaemia (cancer affecting the blood and bone marrow);
- severe allergic reaction with shock;
- multiple sclerosis;
- 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);
- 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;
- 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;
- erythema multiforme (inflammatory skin rash);
- lupus-like syndrome;
- angioedema (localised swelling of the skin);
- lichenoid skin reaction (itchy reddish-purple skin rash).
Not known (frequency cannot be estimated from available data)
- hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal);
- Merkel cell carcinoma (a type of skin cancer);
- 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;
- liver failure;
- worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness).
- weight gain (for most patients, the weight gain was small)
Some side effects observed with adalimumab may not have symptoms and may only be discovered through blood tests. These include:
Very common (may affect more than 1 in 10 people)
- low blood measurements for white blood cells;
- low blood measurements for red blood cells;
- increased lipids in the blood;
- raised liver enzymes.
Common (may affect up to 1 in 10 people)
- high blood measurements for white blood cells;
- low blood measurements for platelets;
- increased uric acid in the blood;
- abnormal blood measurements for sodium;
- low blood measurements for calcium;
- low blood measurements for phosphate;
- high blood sugar;
- high blood measurements for lactate dehydrogenase;
- autoantibodies present in the blood;
- low blood potassium.
Uncommon (may affect up to 1 in 100 people)
- raised bilirubin measurement (liver blood test).
Rare (may affect up to 1 in 1,000 people)
- low blood measurements for white blood cells, red blood cells and platelet count.
Reporting of side effects
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.
5. How to store Hyrimoz
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 / blister / carton after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C–8°C). Do not freeze.
Keep the pre-filled syringe in the outer carton in order to protect from light.
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 temperature storage, your pre-filled syringe 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 syringe is first removed from the refrigerator, and the date after which it should be discarded.
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.
6. Contents of the pack and other information
What Hyrimoz contains
- The active substance is adalimumab. Each pre-filled syringe contains 80 mg of adalimumab in 0.8 ml of solution.
- 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.
What Hyrimoz looks like and contents of the pack
Hyrimoz 80 mg solution for injection (injection) in pre-filled syringe is supplied as a 0.8 ml clear to slightly opalescent, colourless or slightly yellowish solution.
Hyrimoz is supplied in a single-use clear type I glass syringe with a stainless steel 29 gauge needle with a needle guard with finger flange, rubber needle cap (thermoplastic elastomer) and plastic plunger rod, containing 0.8 ml of solution.
Cartons contain 1 and 2 pre-filled syringes of Hyrimoz.
Multipack cartons contain 6 (3 packs of 2) pre-filled syringes of Hyrimoz.
Not all pack sizes may be marketed.
Hyrimoz is available as a pre-filled syringe and a pre-filled pen.
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestr. 10
6250 Kundl
Austria
Manufacturer
Sandoz GmbH Schaftenau
Biochemiestr. 10
6336 Langkampfen
Austria
Or
Novartis Pharmaceutical Manufacturing GmbH
Biochemiestrasse 10
6336 Langkampfen
Austria
This leaflet was last revised in 04/2024
- 7. Instructions for use
To help avoid possible infections and to ensure that you use the medicine correctly, it is important that you follow these instructions.
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 single-dose pre-filled syringe before you use it for the first time. Talk to your healthcare provider if you have any questions.
Your Hyrimoz single-use pre-filled syringe with needle guard and add-on finger flange
| Figure A: Hyrimoz pre-filled syringe with needle guard and finger flange |
|---|
| It is important that you: |
|---|
- do not use the pre-filled syringe if the seals of the blister are broken, as it may not be safe for you to use
- do not open the outer box until you are ready to use the pre-filled syringe.
- never leave the pre-filled syringe unattended where others might tamper with it.
- if you drop your syringe, do not use it if it looks damaged, or if you dropped it with the needle cap removed.
- do not remove the needle cap until just before you give the injection.
- be careful not to touch the needle guard wings before use. Touching them may cause the needle guard to be activated too early.
- do not remove the finger flange before the injection.
- inject Hyrimoz 15–30 minutes after taking it out of the refrigerator for a more comfortable injection.
- throw away the used syringe right away after use. Do not re-use a pre-filled syringe. See “4. Disposing of used pre-filled syringes” at the end of these Instructions for Use.
| How should you store Hyrimoz single-dose pre-filled syringe? |
|---|
- Store your outer carton of pre-filled syringes in a refrigerator, between 2°C to 8°C.
- 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 syringe 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 syringe is first removed from the refrigerator, and the date after which it should be discarded.
- Keep your pre-filled syringes in the original carton until ready to use to protect from light.
- Do not store the pre-filled syringes in extreme heat or cold.
- Do not freeze the pre-filled syringes.
| Keep Hyrimoz and all medicines out of the reach of children. |
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| What do you need for your injection? |
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Place the following items on a clean, flat surface. Included in your pre-filled syringe carton are: |
- Hyrimoz pre-filled syringe/s (see Figure A). Each pre-filled syringe contains 80 mg/0.8 ml of adalimumab.
| Not included in your HYRIMOZ pre-filled syringe carton are (see Figure B): |
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- Alcohol wipe
- Cotton ball or gauze
- Sharps disposal container. See “4. Disposing of used pre-filled syringes” at the end of this Instructions for Use.
- Adhesive bandage
 Figure B: items not included in the carton |
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| Before your injection | |
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 Figure C: needle guard is not activated – the single-dose pre-filled syringe is ready for use
|  Figure D: needle guard is activated – do not use
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| Preparing the syringe |
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| Contact your pharmacist if the syringe fails any of the above mentioned checks. |
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 Figure E: choose your injection site |
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 Figure F: clean your injection site |
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 Figure G: pull the needle cap off  Figure H: insert the needle |
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| Figure I: hold the syringe |
|  Figure J: lift the needle straight out  Figure K: slowly release the plunger |
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 Figure L: dispose of your used syringe |
If you have any questions, please talk to a doctor, pharmacist or nurse who is familiar with Hyrimoz
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