Patient leaflet - HUKYNDRA 40 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
1. What Hukyndra is and what it is used for
Hukyndra contains the active substance adalimumab.
Hukyndra is used to treat:
- 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 substance in Hukyndra, adalimumab, is a human monoclonal antibody. Monoclonal antibodies are proteins that attach to a specific target.
The target of adalimumab is a protein called tumour necrosis factor (TNFa), which is involved in the immune (defence) system and is present at increased levels in the inflammatory diseases listed above. By attaching to TNFa, Hukyndra decreases the process of inflammation 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 first be given other disease-modifying medicines, such as methotrexate. If you do not respond well enough to these medicines, you will be given Hukyndra.
Hukyndra can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.
Hukyndra can slow down the damage to the joints caused by the inflammatory disease and can help them move more freely.
Your doctor will decide if Hukyndra should be used with methotrexate or alone.
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 first be given other disease-modifying medicines, such as methotrexate. 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 alone.
Enthesitis-related arthritis
Enthesitis-related arthritis is an inflammatory disease of the joints and the places where tendons join the bone.
Hukyndra is used to treat enthesitis-related arthritis in patients from 6 years of age. You may first be given other disease-modifying medicines, such as methotrexate. If you do not respond well enough to these medicines, you will be given Hukyndra.
Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis are inflammatory diseases of the spine.
Hukyndra is used to treat severe ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults. You may first be given other medicines. 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 usually associated with psoriasis.
Hukyndra is used to treat psoriatic arthritis in adults. Hukyndra can slow down the damage to the joints caused by the disease and can help them move more freely.
You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Hukyndra.
Plaque psoriasis
Plaque psoriasis is a 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.
Hukyndra is used to treat
- moderate to severe chronic plaque psoriasis in adults and
- severe chronic plaque psoriasis in children and adolescents aged 4 to 17 years for whom topical therapy and phototherapies have either not worked very well or are not suitable.
Hidradenitis suppurativa
Hidradenitis suppurativa (sometimes called acne inversa) is a chronic 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.
Hukyndra is used to treat
- moderate to severe hidradenitis suppurativa in adults and
- moderate to severe hidradenitis suppurativa in adolescents aged 12 to 17 years
Hukyndra can reduce the number of nodules and abscesses caused by the disease and the pain that is often associated with the disease. You may first be given other medicines. 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 aged 6 to 17 years.
You may first be given other medicines. 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 and
- moderate to severe ulcerative colitis in children and adolescents aged 6 to 17 years
You may first be given other medicines. 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 affecting certain parts of the eye.
Hukyndra is used to treat
- adults with non-infectious uveitis with inflammation affecting the back of the eye
- children with chronic non-infectious uveitis from 2 years of age with inflammation affecting the front of the eye
This inflammation may lead 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). Hukyndra works by reducing this inflammation.
You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Hukyndra.
2. what you need to know before you use hukyndrado not use hukyndra if you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
- If you have active tuberculosis or other severe infections (see “Warnings and precautions”). It is important that you tell your doctor if you have symptoms of infections, for example, fever, wounds, feeling tired, dental problems.
- 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 Hukyndra.
Allergic reactions
- If you get allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash, do not inject more Hukyndra and contact your doctor immediately, since in rare cases, these reactions can be life-threatening.
Infections
- If you have an infection, including long-term infection or an infection in one part of the body (for example, leg ulcer) consult your doctor before starting Hukyndra. If you are unsure, contact your doctor.
- You might get infections more easily while you are receiving Hukyndra treatment. This risk may increase if you have problems with your lungs. These infections may be serious and include:
o tuberculosis
o infections caused by viruses, fungi, parasites or bacteria
o severe infection in the blood (sepsis)
In rare cases, these infections can 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 tell you to stop using Hukyndra for some time.
- Tell your doctor if you live or travel in regions where fungal infections (for example, histoplasmosis, coccidioidomycosis or blastomycosis) are very common.
- Tell your doctor if you have had infections which keep coming back or other conditions that increase the risk of infections.
- If you are over 65 years you may be more likely to get infections while taking Hukyndra. You and your doctor should pay special attention to signs of infection while you are being treated with Hukyndra. It is important to tell your doctor if you get symptoms of infections, such as fever, wounds, feeling tired or dental problems.
Tuberculosis
- 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. Ifyou have active tuberculosis, do not use Hukyndra.
o 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 Hukyndra. This will include a thorough medical evaluation including your medical history and appropriate 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.
o Tuberculosis can develop during therapy even if you have received treatment for the prevention of tuberculosis.
o If symptoms of tuberculosis (for example, cough that does not go away, weight loss, lack of energy, mild fever), or any other infection appear during or after therapy, tell your doctor immediately.
Hepatitis B
- Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV or if you think you might be at risk of getting HBV.
o Your doctor should test you for HBV. In people who carry HBV, adalimumab can cause the virus to become active again.
o In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV can be life-threatening.
Surgery or dental procedures
- If you are about to have surgery or dental procedures tell your doctor that you are taking Hukyndra. Your doctor may recommend temporary discontinuation of Hukyndra.
Demyelinating disease
- If you have or develop a 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 Hukyndra. Tell your doctor immediately if you experience symptoms like changes in your vision, weakness in your arms or legs or numbness or tingling in any part of your body.
Vaccinations
- Certain vaccines may cause infections and should not be given while receiving Hukyndra.
o Check with your doctor before you receive any vaccines.
o It is recommended that children, if possible, be given all the scheduled vaccinations for their age before they start treatment with Hukyndra.
o If you received Hukyndra while you were pregnant, your baby may be at higher risk for getting such an infection for up to approximately five months after the last Hukyndra dose you received during pregnancy. It is important that you tell your baby’s doctors and other health care professionals about your Hukyndra use during your pregnancy so they can decide when your baby should receive any vaccine.
Heart failure
- If you have mild heart failure and are being treated with Hukyndra, your heart failure status must be closely monitored by your doctor. It is important to tell your doctor if you have had or have a serious heart condition. 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. Your doctor will decide if you should receive Hukyndra.
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. Your doctor may decide to stop treatment. If you develop a fever that does not go away, develop light bruises or bleed very easily or look very pale, call your doctor right away.
Cancer
- There have been very rare cases of certain kinds of cancer in children and adult patients taking adalimumab or other TNF blockers.
o 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 (a cancer that affects the lymph system) and leukaemia (a cancer that affects the blood and bone marrow).
o If you take Hukyndra the risk of getting lymphoma, leukaemia, or other cancers may increase. On rare occasions, an uncommon and severe type of lymphoma has been seen in patients taking adalimumab. Some of those patients were also treated with azathioprine or 6-mercaptopurine.
o Tell your doctor if you are taking azathioprine or 6-mercaptopurine with Hukyndra.
o Cases of non-melanoma skin cancer have been observed in patients taking adalimumab.
o If new skin lesions appear during or after therapy or if existing lesions 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 TNF blocker. If you have COPD, or are a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for you.
Autoimmune disease
- On rare occasions, treatment with Hukyndra could result in lupus-like syndrome. Contact your doctor, if symptoms such as persistent unexplained rash, fever, joint pain or tiredness occur.
- Vaccinations: if possible, children should be up to date with all vaccinations 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.
You should not take Hukyndra with medicines containing the following active substances due to increased risk of serious infection:
- anakinra
- abatacept.
Hukyndra can be taken together with:
- methotrexate
- certain disease-modifying anti-rheumatic agents (for example, sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations)
- steroids or pain medicine including non-steroidal anti-inflammatory drugs (NSAIDs).
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 Hukyndra treatment.
- If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice about taking this medicine.
- Hukyndra 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.
- Hukyndra can be used during breast-feeding.
- If you receive Hukyndra 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 Hukyndra 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
Hukyndra may have a small effect on your ability to drive, cycle or use machines. Room spinning sensation and vision disturbances may occur after taking Hukyndra.
Hukyndra contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per 0.4 ml, that is to say essentially ‘sodium-free’.
3. how to use hukyndra
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 Hukyndra in each of the approved uses are shown in the following table. Your doctor may prescribe another strength of Hukyndra if you need a different dose.
| Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis | ||
| Age or body weight | How much and how often to take? | Notes |
| Adults | 40 mg every other week | In rheumatoid arthritis, methotrexate is continued while using Hukyndra. If your doctor decides that methotrexate is inappropriate, Hukyndra can be given alone. If you have rheumatoid arthritis and you do not receive methotrexate with your Hukyndra therapy, your doctor may decide to give Hukyndra 40 mg every week or 80 mg every other week. |
| Polyarticular juvenile idiopathic arthritis | ||
| Age or body weight | How much and how often to take? | Notes |
| Children, adolescents and adults from 2 years of age weighing 30 kg or more | 40 mg every other week | Not applicable |
| Enthesitis-related arthritis | ||
| Age or body weight | How much and how often to take? | Notes |
| Children, adolescents and adults from 6 years of age weighing 30 kg or more | 40 mg every other week | Not applicable |
| Plaque psoriasis | ||
| Age or body weight | How much and how often to take? | Notes |
| Adults | First dose of 80 mg (two 40 mg injections in one day), followed by 40 mg every other week starting one week after the first dose. | If you have an inadequate response, your doctor may increase the dose to 40 mg every week or 80 mg every other week. |
| Children and adolescents from 4 to 17 years of age weighing 30 kg or more | First dose of 40 mg, followed by 40 mg one week later. Thereafter, the usual dose is 40 mg every other week. | Not applicable |
| Hidradenitis suppurativa | ||
| Age or body weight | How much and how often to take? | Notes |
| Adults | First dose of 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by an 80 mg dose (two 40 mg injections in one day) two weeks later. After two further weeks, continue with a dose 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 (two 40 mg injections in one day), followed by 40 mg every other week starting one week later. | If you have an inadequate response to Hukyndra 40 mg every other week, your doctor may increase the dose 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 from 6 years of age weighing 40 kg or more | First dose of 80 mg (two 40 mg injections in one day), followed by 40 mg two weeks later. If a faster response is required, the doctor may prescribe a first dose of 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg (two 40 mg injections in one day) two weeks later. Thereafter, the usual dose is 40 mg every other week. | Your doctor may increase the dose to 40 mg every week or 80 mg every other week. |
| Children and adolescents from 6 to 17 years of age weighing less than 40 kg | First dose of 40 mg, followed by 20 mg two weeks later. If a faster response is required, the doctor may prescribe a first dose of 80 mg (two 40 mg injections in one day), followed by 40 mg two weeks later. Thereafter, the usual dose is 20 mg every other week. | Your doctor may increase the dose frequency to 20 mg every week. |
* Hukyndra is only available as 40 mg pre-filled syringe, 40 mg pre-filled pen and 80 mg pre-filled syringe. Thus, it is not possible to administer Hukyndra to patients that require less than a full 40 mg dose.
| Ulcerative colitis | ||
| Age or body weight | How much and how often to take? | Notes |
| Adults | First dose of 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg (two 40 mg injections in one day) two weeks later. Thereafter, the usual dose is 40 mg every other week. | Your doctor may increase the dose to 40 mg every week or 80 mg every other week. |
| Children and adolescents from 6 years of age weighing less than 40 kg | First dose of 80 mg (two 40 mg injections in one day), followed by 40 mg (one 40 mg injection) two weeks later. Thereafter, the usual dose is 40 mg every other week. | You should continue taking adalimumab at your usual dose, even after turning 18 years of age. |
| Children and adolescents from 6 years of age weighing 40 kg or more | First dose of 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg (two 40 mg injections in one day) two weeks later. Thereafter, the usual dose is 80 mg every other week. | You should continue taking adalimumab at your usual dose, even after turning 18 years of age. |
| Non-infectious uveitis | ||
| Age or body weight | How much and how often to take? | Notes |
| Adults | First dose of 80 mg (two 40 mg injections in one day), followed by 40 mg every other week starting one week after the first dose. | Corticosteroids or other medicines that influence the immune system may be continued while using Hukyndra. Hukyndra can also be given alone. |
| Children and adolescents from 2 years of age weighing at least 30 kg | 40 mg every other week | Your doctor may prescribe an initial dose of 80 mg to be administered one week prior to the start of the usual dose of 40 mg every other week. Hukyndra is recommended for use in combination with methotrexate. |
Method and route of administration
Hukyndra is administered by injection under the skin (by subcutaneous injection).
Detailed instructions on how to inject Hukyndra are provided in section 7, “Instructions for use”.
If you use more Hukyndra than you should
If you accidentally inject Hukyndra more frequently than told to by your doctor or pharmacist, call your doctor or pharmacist and tell them that you have taken more.
Always take the outer carton of the medicine with you, even if it is empty.
If you forget to use Hukyndra
If you forget to give yourself an injection, you should inject the next dose of Hukyndra 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 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 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 at least up to 4 months after the last Hukyndra injection.
Tell your doctor immediately if you notice any of the following
- severe rash, hives or other signs of allergic reaction
- swollen face, hands, feet
- trouble breathing, swallowing
- shortness of breath with physical activity or upon lying down or swelling of the feet
- signs of infection such as fever, feeling sick, wounds, dental problems, burning on urination
- feeling weak or tired
- coughing
- tingling
- numbness
- double vision
- arm or leg weakness
- a bump or open sore that doesn’t heal
- signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding, paleness
The symptoms described above can be signs of the below listed side effects, which 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 pain
- nausea and vomiting
- rash
- musculoskeletal pain
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
- oral 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
- nerve root compression (including low back pain and leg pain)
- vision disturbances
- eye inflammation
- inflammation of the eye lid and eye swelling
- vertigo (feeling of dizziness or spinning)
- sensation of heart beating rapidly
- high blood pressure
- flushing
- haematoma (collection of blood outside of blood vessels)
- 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
- hairloss
- new onset or worsening of psoriasis
- muscle spasms
- blood in urine
- kidney problems
- chest pain
- oedema (swelling)
- fever
- reduction in blood platelets which increases risk of bleeding or bruising
- impaired healing
- 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
- elevated 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)
- opportunistic 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
- cancer that affects the lymph system
- melanoma
- immune disorders that could affect the lungs, skin and lymph nodes (most commonly presenting as sarcoidosis)
- vasculitis (inflammation of blood vessels)
- tremor (shaking)
- neuropathy (disorder of the nerves)
- 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 of the face)
- gallbladder inflammation, gallbladder stones
- fatty liver
- night sweats
- scar
- abnormal muscle breakdown
- systemic lupus erythematosus (including inflammation of skin, heart, lung, joints and other organ systems)
- sleep interruptions
- impotence
- inflammations
Uncommon (may affect up to 1 in 100 people)
- elevated 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 get 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 at: 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 Hukyndra
Rare (may affect up to 1 in 1,000 people)
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), a single Hukyndra pre-filled syringe may be stored at 20 °C to 25 °C for a maximum period of up to 14 days – be sure to protect it from light. Once removed from the refrigerator for storage at 20 °C to 25 °C, the syringe must be used within the 14 days or discarded , even if it is returned to the refrigerator.
You should record the date when the syringe is first removed from refrigerator and the date after which it should be discarded.
Do not use this medicine if the liquid is cloudy, discoloured, or has flakes or particles in it.
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.
Detailed information on this medicine, including a video on how to use the pre-filled syringe, is available by scanning the QR code included below or the outer carton with a smartphone. The same information is also available on the following URL: hukyndrapatients.com
| STADA | 1 T |
| Product Title: Mpc-94258—01 | |
| Produkt/Product: HUKYNDRA 40MG INJ SYR 0.4ML TR GB:PIL | |
| STADA Mat.-Nr./Mat.-No.: 93026722108 GB | |
| STADA Art.-Nr./Art.-No.: 172442, 173063, 17244 | |
| Hersteller/Manufacturer: | |
| Art.Nr./Manufacturer Art.No.: n/a | |
| Format/Size: 420 × 891mm | |
| SchriftgroBe/Font-size: 10pt,10.5pt,11pt | |
| NTIN/GTIN: - | |
| PZN/EAN: - | |
| Pharma-Code: n/a | |
| Flattermarke/Collating mark: N/A | |
| 1. Colour: M Cyan | |
| 2. Colour: ■ Magenta | |
| 3. Colour: Yellow | |
| 4. Colour: ■ Black | |
| 5. Colour: M Keyline (Non-Printing) | |
| 6. Colour: M PANTONE 7636 C +20%+70% TIN | |
| 7. Colour ™ Technical Info (Non-Printing) | |
| 8. Colour: ■ | |
| 9. Colour: | |
| 10.Colour: | |
| II.Colour: | |
| 12.Colour: | |
| Version: 1 Datum/Date: 10.09.2021 |
- leukaemia (cancer affecting the blood and bone marrow)
- severe allergic reaction with shock
- multiple sclerosis
- nerve disorders (such as eye nerve inflammation and Guillain-Barre syndrome 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 intestine)
- hepatitis
- reactivation of hepatitis B
- 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 (early symptoms include malaise, fever, headache and rash)
- facial oedema (swelling of the face) 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 the 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
Hukyndra pre-filled syringe
◄ Finger Grip
Needle Cover
6. Contents of the pack and other information
What Hukyndra contains
– 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)
What Hukyndra looks like and contents of the pack
Hukyndra 40 mg solution for injection in pre-filled syringe with needle guard is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.4 ml preservative-free solution. The Hukyndra pre-filled syringe is a glass syringe containing a solution of adalimumab. Each pack contains 1, 2 or 6 pre-filled syringe(s) packed in a blister, with 1, 2 or 6 alcohol pad(s).
Not all pack sizes may be marketed.
Hukyndra may be available as a pre-filled syringe and/or a pre-filled pen.
Marketing Authorisation Holder
STADA, Linthwaite, Huddersfield, HD7 5QH, UK
Manufacturer
Ivers-Lee CSM, Marie-Curie-Str.8, 79539 Lorrach, Germany
This leaflet was last revised in September 2021
STADA
► STEP 1: Take syringe out of refrigerator and warm to 20 °C to 25 °C
7. Instructions for use
INSTRUCTIONS FOR USE
Hukyndra (adalimumab) pre-filled syringe
40 mg/0.4 ml solution for injection, for subcutaneous use
Read carefully these instructions for use before using the Hukyndra single-use pre-filled syringe
Important information you need to know before injecting Hukyndra single-use pre-filled syringe
= ◄ Plunger
for 15–30 minutes
1.1 Take Hukyndra out of the refrigerator (see Figure A).
1.2 Leave Hukyndra at 20 °C to 25 °C for 15 to 30 minutes before injecting (see Figure B).
- Do not remove the grey needle cover while allowing Hukyndra to reach 20 °C to 25 °C.
- Do not warm Hukyndra in any other way. For example, do not warm it in a microwave or in hot water.
- Do not use the pre-filled syringe if liquid has been frozen (even if thawed).
► STEP 4: Choose and clean injection site
4.1 Choose an injection site (see Figure F):
k STEP 7: Inject the medicine
- After the needle is in, let go of the skin.
Important information:
- For subcutaneous injection only
- Do not use the syringe and call your healthcare provider or pharmacist if:
- Liquid is cloudy, discoloured, or has flakes or particles in it
- Expiry date has passed
- Liquid has been frozen (even if thawed) or left in direct sunlight
- The pre-filled syringe has been dropped or crushed
- Keep the needle cover on until right before injection. Keep Hukyndra out of reach of children.
- See section 5 in the package leaflet for how to store Hukyndra single-use pre-filled syringe.
Before injecting:
Your healthcare provider should show you how to use Hukyndra single-use pre-filled syringe before you use it for the first time.
Current adalimumab syringe uses:
Even if you have used other adalimumab syringes on the market in the past, please read the instructions completely so that you understand how to properly use this device before attempting to inject.
Questions about using the Hukyndra pre-filled syringe?
Talk to your healthcare provider if you have any questions.
Preparing to inject Hukyndra pre-filled syringe
k STEP 2: Check expiry date and liquid medicine
- Do not use the pre-filled syringe if expiry (EXP) date has passed.
Check expiry date and liquid medicine
2.1 Check the expiry date on the pre-filled syringe label (see Figure C).
2.2 Check the liquid medicine in the syringe to ensure it is clear and colourless (Figure C).
- Do not use the syringe and call your healthcare provider
or pharmacist if liquid is cloudy, discoloured, or has flakes or particles in it.
EXP: MM/YYYY
Figure C
Injecting Hukyndra pre-filled syringe
k STEP 5: Remove needle cover
5.1 Hold the pre-filled syringe in one hand (see Figure H).
Figure G
7.1 Insert the needle into the pinched skin at about a 45-degree angle using a quick, dart-like motion (see Figure K).
7.2 Slowly push the plunger all the way in until all of the liquid is injected, and the pre-filled syringe is empty (see Figure L).
- On the front of your thighs or,
- Your abdomen (belly) at least 5 cm from your navel (belly button).
- Different from your last injection site (at least 3 cm from last injection site).
- Do not inject through clothes.
- Do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis.
45°
45°
Abdomen
Thigh
Figure L
Figure K
4.2 Wipe the injection site in a circular motion with the alcohol pad (see Figure G).
5.2 Gently pull the needle cover straight off with the other hand (see Figure H).
- Throw the needle cover away.
- Do not recap.
- Do not touch the needle with your fingers or let the needle touch anything.
- Hold the pre-filled syringe with the needle facing up. You may see air in the pre-filled syringe. Slowly push the plunger in to push the air out through the needle.
- You may see a drop of liquid at the end of the needle.
This is normal.
Figure H
k STEP 3: Gather supplies and wash hands
3.1 Place the following on a clean, flat surface (see Figure D):
- 1 single-use pre-filled syringe and alcohol pad.
- 1 cotton ball or gauze pad
Figure D
Figure E
k STEP 6: Grasp the syringe and pinch the skin
k STEP 9: Dispose used syringe into a sharps container
-
9.1 Put your used needles, syringes, and sharps in a sharps disposal container right away after use (see Figure N).
- Do not throw away (dispose of) loose needles and syringes in the household trash.
-
9.2 The needle cover, alcohol pad, cotton ball or gauze pad, and packaging may be placed in your household trash.
Figure J
Figure M
6.1 Hold the body of the pre-filled syringe in one hand between the thumb and index fingers, like a pencil (see Figure I). Do not pull back on the plunger at any time.
6.2 Gently squeeze (pinch) the area of cleaned skin at your injection site (abdomen or thigh) with your other hand (see Figure J). Hold the skin firmly.
FigureI
kSTEP 8: Allow pre-filled syringe to retract needle from skin
8.1 Slowly lift your finger from the plunger. The plunger will move up with your finger and retract the needle from the site, into the needle guard (see Figure M).
- The needle will not be retracted unless all the liquid is injected. Speak to your doctor, pharmacist or nurse if you think you have not given a full dose.
- It is normal to see a spring around the plunger rod after the needle is retracted.
-
8.2 After completing the injection, place the cotton ball or gauze pad on the skin over the injection site.
- Do not rub.
- Slight bleeding at the injection site is normal.
Disposing of Hukyndra pre-filled syringe
Figure N
Additional disposal information
- If you do not have a sharps disposal container, you may use a household container that is:
- made of a 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 labelled to warn of hazardous waste inside the container.
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