Hyrimoz - Adalimumab uses, dose and side effects

rheumatoid arthritis ,
polyarticular juvenile idiopathic arthritis ,
enthesitis-related arthritis ,
ankylosing spondylitis ,
axial spondylarthritis without radiographic evidence of ankylosing spondylitis ,
psoriatic arthritis,
psoriasis ,
hydradenitis suppurativa,
Crohn’s disease ,
ulcerative colitis and
uveit without infection .

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

The target of adalimumab is another protein called tumor necrosis factor (TNFα), which occurs in elevated levels in the inflammatory diseases listed above. By binding to TNFα, Hyrimoz can reduce 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 severely active rheumatoid arthritis, you will usually first receive other disease-modifying treatment, such as methotrexate. If these medicines do not have enough effect, your doctor may prescribe Hyrimoz to treat your rheumatoid arthritis.

Hyrimoz can also be used to treat severe, active, and progressive rheumatoid arthritis not previously treated with methotrexate.

Hyrimoz can slow down the destruction of cartilage and skeleton in the joints caused by the disease and thus increase your ability to perform daily activities.

Hyrimoz is commonly used with methotrexate. If your doctor considers methotrexate to be inappropriate, only Hyrimoz can be given.

Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis

Polyarticular juvenile idiopathic arthritis and encephalitis-related arthritis are inflammatory diseases of the joints that usually begin in childhood.

Hyrimoz is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents 2–17 years of age and encephalitis-related arthritis in children and adolescents 6–17 years of age. The patient may first be given other disease-modifying drugs, such as methotrexate. If these medicines do not have enough effect, the patient can get Hyrimoz as a treatment for polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.

Ankylosing spondylitis and axial spondylarthritis without radiographic evidence of ankylosing spondylitis

Ankylosing spondylitis and axial spondylarthritis without radiographic signs of ankylosing spondylitis are inflammatory diseases of the spine.

Hyrimoz is used to treat these diseases in adults. If you have ankylosing spondylitis or axial spondylarthritis without radiographic signs of ankylosing spondylitis, you will first be given other medicines. If these medicines do not have enough effect, you will be given Hyrimoz to reduce your symptoms.

Plaque psoriasis in adults and children

Plaque psoriasis is an inflammatory skin disease that causes red, flaky, and dry plaques on the skin covered by silvery scales. Plaque psoriasis can also involve the nails, which can then crumble, become thicker and lift from the nail bed, which can be painful. Psoriasis is believed to be caused by a disorder in the body’s immune system that leads to increased production of skin cells.

Hyrimoz is used to treat moderate to severe plaque psoriasis in adults. Hyrimoz is also used to treat severe plaque psoriasis in children and adolescents 4–17 years of age where topical skin treatment and UV light therapy have not had sufficient effect or are not appropriate.

Psoriatic arthritis

Psoriatic arthritis is an inflammatory disease of the joints caused by the disease psoriasis.

Hyrimoz is used to treat psoriatic arthritis in adults. Hyrimoz can slow down the damage to cartilage and bone in the joints caused by the disease, and improve physical function.

Hidradenitis suppurativa in adults and adolescents

Hidradenitis suppurativa (sometimes called acne inversa) is a long-lasting and often painful inflammatory skin disease. The symptoms can be sore nodules ( lumps ) and abscesses (boils) that can leak anywhere.

The disease usually affects specific areas of the skin, e.g. under the breasts, armpits, inside of the thighs, groin, and buttocks. Scarring can also occur in the affected areas.

Hyrimoz is used to treat hidradenitis suppurativa in adults and adolescents from 12 years of age. Hyrimoz can reduce the number of lumps and boils you have as well as the pain that is often linked to the disease. You may be given other medicines first. If these medicines do not have enough effect, you will be given Hyrimoz.

Crohn’s disease in adults and children

Crohn’s disease is an inflammatory bowel disease.

Hyrimoz is used to treat Crohn’s disease in adults and children 6-17 years of age. If you have Crohn’s disease, you will first be given other medicines. If these medicines do not help enough, you will be given Hyrimoz to reduce your symptoms of Crohn’s disease.

Ulcerative colitis

Ulcerative colitis is an inflammatory bowel disease.

Hyrimoz is used to treat ulcerative colitis in adults. If you have ulcerative colitis, you will first be given other medicines. If these medicines do not have enough effect, you will be given Hyrimoz to reduce your symptoms from the disease.

Uveitis without infection in adults and children

Uveitis is an inflammatory disease that affects certain parts of the eye. Inflammation can lead to impaired vision and/or the presence of floaters in the eye (black dots or thin lines moving across the field of view ). Hyrimoz works by reducing this inflammation.

Hyrimoz is used to treat

adults with uveitis without infection where inflammation affects the back of the eye
children from 2 years of age with chronic uveitis without infection where inflammation affects the front of the eye.

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 serious infection , including tuberculosis , sepsis ( sepsis ) or any other type of opportunistic infection (rare infection that can occur with a weakened immune system). It is important that you tell your doctor if you have symptoms of infection , e.g. fever, sores, tiredness or dental problems (see “Warnings and Precautions”).
if you have moderate or severe heart failure . It is important to tell your doctor if you have or have had a serious heart condition (see “Warnings and Precautions”)

Warnings and cautions

Talk to your doctor or pharmacist before using Hyrimoz.

Allergic reaction

If you get allergic reactions with symptoms such as tightness of the chest, wheezing, dizziness, swelling or rash, stop injecting Hyrimoz and contact your doctor immediately as these reactions can be life-threatening in rare cases.

Infection

If you have any infection , including long-term or local infections (eg leg ulcers), you must consult your doctor before starting Hyrimoz. If you are not sure, talk to your doctor.

You may be more likely to get an infection when you are treated with Hyrimoz. This risk may increase if you have impaired lung function. These infections can be serious and include tuberculosis , infection caused by viruses , fungi, parasites or bacteria or other rare infectious agents, or sepsis (blood poisoning).
In rare cases, these infections can become life-threatening. It is important to tell your doctor if you get symptoms such as fever, sores, tiredness or dental problems. Your doctor may advise you to temporarily stop using Hyrimoz.

Tuberculosis

As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will examine you for signs and symptoms of tuberculosis before starting treatment with Hyrimoz. It involves a thorough medical history and screening tests (eg lung X-ray and a tuberculin test). The performance and results of these tests should be indicated on your patient 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 treatment even if you have received preventive treatment. About symptoms of tuberculosis(persistent cough, weight loss, lethargy , mild fever), or if any other infection occurs during or after treatment, you must tell your doctor immediately.

Travel / recurrent infection s

Tell your doctor if you have lived or traveled in regions where fungal infections such as histoplasmosis , coccidioidomycosis or blastomycosis are common.
Tell your doctor if you have previously had problems with recurrent infections or other conditions that increase the risk of infection .

Hepatitis B virus

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

Age over 65 years

If you are over 65, you may be more susceptible to infection when using Hyrimoz. You and your doctor should pay special attention to signs of infection when you are being treated with Hyrimoz. It is important to tell your doctor if you get symptoms of infection , such as fever, sores, tiredness or dental problems.

Operations or dental procedures

If you are going to have an operation or a dental procedure soon, you should inform your doctor that you are taking Hyrimoz. Your doctor may advise you to temporarily stop using Hyrimoz.

Demyelinating disease

If you have or develop a demyelinating disease (a disease that affects the protective layer around the nerves) such as multiple sclerosis (MS), your doctor will make an assessment of whether you can or should continue to be treated with Hyrimoz. Tell your doctor immediately if you experience symptoms such as changes in vision, weakness in the arms or legs, or numbness or tingling anywhere on the body.

Vaccines

Some vaccines contain live but attenuated bacteria or viruses , and such vaccines should not be given during treatment with Hyrimoz as it may lead to infection . Check with your doctor before getting vaccinated. It is recommended that children, if possible, receive all vaccines that they should have according to the guidelines for their age before starting treatment. If you are treated with Hyrimoz during pregnancy, your newborn baby may have an increased risk of getting an infection for up to five months. after the last dose one you received during pregnancy. It is important that you tell your pediatrician and other healthcare professionals that you have used Hyrimoz during your pregnancy so that they can decide when your newborn baby should be vaccinated.

Heart failure

It is important to tell your doctor if you have or have had a serious heart condition. If you have mild heart failure and are being treated with Hyrimoz, your heart problems must be closely monitored by your doctor. If you develop new symptoms or if your symptoms of heart failure worsen (such as shortness of breath or swollen feet), you must contact your doctor immediately.

Fever, bruising, bleeding, or pallor

In some patients, the body is unable to produce enough of the blood cells that fight infection or stop bleeding. If you get a fever that does not go down, if you get bruises easily, bleed easily or look very pale, you should call your doctor immediately. Your doctor may then decide to stop treatment.

Cancer

Very rare cases of certain cancers have occurred in children and adults treated with adalimumab or other TNFα blockers. Patients with more severe rheumatoid arthritis who have had the disease for a long time may have an increased risk of developing lymphoma and leukemia (cancers that affect the blood cells and bone marrow ). If you are being treated with Hyrimoz, the risk of developing lymphoma , leukemia or any other type of cancer may increase . On rare occasions have a specific and severe type of lymphomaobserved in patients taking adalimumab. Some of these patients were also treated with the drugs azathioprine or mercaptopurine. Tell your doctor if you are taking azathioprine or mercaptopurine with Hyrimoz.
Cases of non- melanoma skin cancer have been reported in patients treated with adalimumab. If new areas of skin damage occur during or after treatment or if existing marks or damaged areas change appearance, tell your doctor.
Cancers other than lymphoma have in some cases been reported in patients with lung disease 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 it is appropriate to treat you with a TNFα. Blocker.

Autoimmune diseases

In rare cases, treatment with Hyrimoz may cause a lupus-like syndrome. Contact your doctor if symptoms such as persistent, unexplained rash, fever, joint pain or fatigue occur.

Children and young people

Do not give Hyrimoz to children who have polyarticular juvenile idiopathic arthritis and are under 2 years of age.
Do not give Hyrimoz to children who have plaque psoriasis or ulcerative colitis and are under 4 years of age.
Do not give Hyrimoz to children who have Crohn’s disease and are under 6 years of age.
Do not use the pre-filled pen of 40 mg for doses other than 40 mg.

Other medicines and Hyrimoz

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

Hyrimoz can be taken with methotrexate or certain disease-modifying anti-rheumatic drugs (sulfasalazine, hydroxychloroquine, leflunomide, and gold preparations for injection ), corticosteroids, or painkillers, including non-steroidal anti-inflammatory drugs ( NSAIDs ).

You should not use Hyrimoz with medicines containing the active substances anakinra or abatacept as it increases the risk of serious infection. The combination of adalimumab or other TNF – antagonists with anakinra or abatacept is not recommended as it may increase the risk of infection, including serious infections and other possible effects. If you have any further questions, ask your doctor.

Pregnancy and breastfeeding

You should consider using adequate contraception to prevent pregnancy while using Hyrimoz and continue to use it for at least 5 months after the last treatment with Hyrimoz.
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 pregnancy if needed.
According to a pregnancy study, there was no increased risk of birth defects when the mother had received adalimumab during pregnancy compared to mothers with the same disease who had not used adalimumab.
Hyrimoz can be used during breast-feeding.
If you get Hyrimoz during your pregnancy, your newborn baby may be at increased risk of getting an infection .
It is important that you tell your pediatrician and other healthcare professionals that you used Hyrimoz during your pregnancy before vaccinating your newborn baby. (For more information on vaccines, see the section “Warnings and Precautions”).

Driving and using machines

Hyrimoz may have a slight effect on your ability to drive, cycle or use machines. A feeling that the room is spinning (dizziness) and visual disturbances can occur when Hyrimoz is used.

Hyrimoz contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per 0,8 ml dose and is approximately’ sodium-free.

3. How to use Hyrimoz

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Hyrimoz is provided as a pen à 40 mg well as prefilled syringes each containing 20 mg and 40 mg so that patients can administer a full dose of 20 mg or 40 mg.

Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or axial spondylarthritis without radiographic evidence of ankylosing spondylitis
Age and body weight	How much and how often should the medicine be taken?	Remarks
Adults	40 mg every two weeks as a single dose	In rheumatoid arthritis, methotrexate is used with Hyrimoz. If methotrexate is not suitable for you, Hyrimoz can be used alone. If you have rheumatoid arthritis and do not receive methotrexate with Hyrimoz, the dose may be 40 mg adalimumab weekly or 80 mg every two weeks.

Polyarticular juvenile idiopathic arthritis
Age and body weight	How much and how often should the medicine be taken?	Remarks
Children (from 2 years of age), adolescents, and adults weighing 30 kg or more	40 mg every two weeks	Not current
Children (from 2 years of age), adolescents, and adults weighing from 10 kg to less than 30 kg	20 mg every two weeks	Not current

Enthesis-related arthritis
Age and body weight	How much and how often should the medicine be taken?	Remarks
Children, adolescents, and adults from 6 years of age weighing 30 kg or more	40 mg every two weeks	Not current
Children and adolescents from 6 years of age weighing from 15 kg to less than 30 kg	20 mg every two weeks	Not current

Psoriasis
Age and body weight	How much and how often should the medicine be taken?	Remarks
Adults	Starting dose of 80 mg (as two injections of 40 mg on the same day) followed by 40 mg given every two weeks, starting one week after the starting dose.	You should continue to use Hyrimoz for as long as your doctor prescribes it. If dose one does not have enough effect, your doctor may increase it to 40 mg every week or 80 mg every two weeks.

Plaque psoriasis in children and adolescents
Age and body weight	How much and how often should the medicine be taken?	Remarks
Children and adolescents 4–17 years old weighing 30 kg or more	Starting dose of 40 mg, followed by 40 mg one week later. Thereafter, the usual dose is 40 mg every two weeks.	Not current
Children and adolescents 4–17 years old weighing from 15 kg to less than 30 kg	Starting dose of 20 mg, followed by 20 mg one week later. Thereafter, the usual dose is 20 mg every two weeks.	Not current

Hidradenitis suppurativa
Age and body weight	How much and how often should the medicine be taken?	Remarks
Adults	Starting dose of 160 mg (as four injections of 40 mg on the same day or two injections of 40 mg per day for two consecutive days), followed by 80 mg (as two injections of 40 mg on the same day) two weeks later. After a further two weeks, continue treatment with 40 mg every week or 80 mg every other week, as prescribed by your doctor.	You should use a bactericidal solution daily on the affected areas.
Young people aged 12–17 who weigh 30 kg or more	Starting dose of 80 mg (as two injections of 40 mg on the same day), followed by 40 mg every two weeks starting one week later.	If dose one does not have enough effect, your doctor may increase the dose one to 40 mg every week or 80 mg every two weeks. You should use a bactericidal solution daily on the affected areas.

Crohn’s disease
Age and body weight	How much and how often should the medicine be taken?	Remarks
Adults	Starting dose of 80 mg (as two injections of 40 mg on the same day), followed by 40 mg every two weeks starting two weeks later. If the rapid response is required, you can get a starting dose of 160 mg (as four injections you’re a 40 mg on the same day or two injections à 40 mg per day for two consecutive days), followed by 80 mg (as two injection s à 40 mg on the same day) two weeks later. Thereafter, the usual dose is 40 mg every two weeks.	If dose one does not have enough effect, your doctor may increase your dose to 40 mg every week or 80 mg every two weeks.

Crohn’s disease in children and adolescents
Age and body weight	How much and how often should the medicine be taken?	Remarks
Children and adolescents aged 6–17 weighing 40 kg or more	Starting dose of 80 mg (as two injections of 40 mg on the same day), followed by 40 mg every two weeks starting two weeks later. If a faster response is needed, the physician may prescribe a starting dose of 160 mg (as four injections à 40 mg on the same day or as two injections s à 40 mg per day for two consecutive days), followed by 80 mg (as two injection s à 40 mg on the same day) two weeks later. Thereafter, the usual dose is 40 mg every two weeks.	If dose one does not have enough effect, your doctor may increase your dose to 40 mg every week or 80 mg every two weeks.
Children and adolescents aged 6–17 weighing less than 40 kg	Starting dose of 40 mg, followed by 20 mg every two weeks starting two weeks later. If a faster response is needed, your doctor may prescribe a starting dose of 80 mg (as two injections of 40 mg per day on the same day) followed by 40 mg two weeks later. Thereafter, the usual dose is 20 mg every two weeks.	If dose one does not have enough effect, your doctor may increase your dose to 20 mg weekly.

Ulcerative colitis
Age and body weight	How much and how often should the medicine be taken?	Remarks
Adults	Starting dose of 160 mg (as four injections of 40 mg on the same day or as two injections of 40 mg per day for two consecutive days) followed by 80 mg (as two injections of 40 mg on the same day) two weeks later. Thereafter, the usual dose is 40 mg every two weeks.	If dose one does not have enough effect, your doctor may increase your dose to 40 mg every week or 80 mg every two weeks.

Uveitis without infection
Age and body weight	How much and how often should the medicine be taken?	Remarks
Adults	Starting dose of 80 mg (as two injections of 40 mg), followed by 40 mg every two weeks starting one week after the starting dose.	In case of uveitis without infection, corticosteroids, or other drugs that affect the immune system, may continue to be taken during treatment with Hyrimoz. Hyrimoz can also be given alone. You should continue to use Hyrimoz for as long as your doctor prescribes it.
Children and adolescents from 2 years of age weighing 30 kg or more	40 mg every two weeks with methotrexate	Your doctor may also prescribe a starting dose of 80 mg given one week before starting the usual dose.
Children and adolescents from 2 years of age weighing less than 30 kg	20 mg every two weeks with methotrexate	Your doctor may also prescribe a starting dose of 40 mg given one week before starting the usual dose.

How Hyrimoz is given

Hyrimoz is given by injection under the skin ( subcutaneously ).

Detailed instructions on how to inject Hyrimoz can be found in section 7,

“User instructions”.

If you use more Hyrimoz than you should

If you happen to inject Hyrimoz more often than you have been prescribed, contact your doctor or pharmacist and tell them that you have taken too much of this medicine. Always take the outer carton with you, even if it is empty.

If you forget to use Hyrimoz

If you forget to give yourself an injection, take a dose of Hyrimoz as soon as you remember. Then take your next dose on a specific day that you would have done if you had not missed a dose.

If you stop using Hyrimoz

The decision to stop using Hyrimoz should be discussed with your doctor. Your symptoms may return when treatment is stopped.

If you have any further questions on the use of this product, 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 can occur up to at least 4 months, or even later, after the last Hyrimoz‑ injection.

Seek medical attention immediately if you experience any of the following signs of allergic reaction or heart failure:

severe rash, hives ;
swollen face, swollen hands, feet;
labored breathing, difficulty swallowing;
shortness of breath during exertion or in a supine position or if the feet swell.

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

signs and symptoms of infection such as fever, nausea, sores, dental problems, burning sensation when urinating, weakness‑ or tiredness or cough,
symptoms of nerve problems, such as tingling, loss of sensation, double vision or arm‑ or bone weakness,
signs of skin cancer, such as a bump or open wound that does not heal,
signs and symptoms of blood diseases such as prolonged fever, bruising, bleeding, pallor.

The following side effects have been observed with adalimumab:

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

injection site reactions (including pain, swelling, redness or itching );
respiratory tract infections (including colds, runny nose, sinusitis, pneumonia );
headache;
abdominal pain (stomach pain);
nausea and vomiting;
rash;
pain in the muscles.

Common (may affect up to 1 in 10 people)

serious infection (including sepsis and influenza );
infection is in the intestines (including gastroenteritis );
skin infections (including cellulite and shingles );
ear infections;
oral infections (including dental infections and cold sores);
infection is in the genitals;
urinary tract infections;
fungal infections;
joint infections;
benign tumors;
skin cancer;
allergic reactions (including seasonal allergy);
dehydration;
mood swings (including depression);
concern;
problems sleeping;
sensory disturbances such as tingling, ant crawling or numbness;
migraine;
symptoms of nerve root compression (with low back pain and leg pain);
visual disturbances;
eye inflammation;
inflammation of the eyelid and swelling of the eyes;
dizziness (feeling that the room is spinning);
feeling of heart beating fast;
Hypertension;
redness;
bleeding (bruising);
cough;
asthma;
shortness of breath;
bleeding in the gastrointestinal tract;
dyspepsia (indigestion, bloating, heartburn);
acid reflux;
dry eyes and dry mouth;
itching;
itchy rash;
bruises;
dermatitis (such as eczema );
fragile nails on fingers and toes;
increased sweating;
hair loss;
new onset or worsening of psoriasis;
muscle spasms;
blood in the urine;
kidney problems;
chest pain;
edema (accumulation of fluid in the body that causes the affected tissues to swell);
fever;
decreased platelet count ( platelets ) which increases the risk of bleeding or bruising;
impaired healing.

Uncommon (may affect up to 1 in 100 people)

unusual infections (such as tuberculosis and other infections ) that may occur when disease resistance is reduced;
neurological infections (including meningitis caused by viruses );
eye infections;
bacterial infections;
diverticulitis ( inflammation and infection of the colon);
cancers, including cancers affecting the lymphatic system ( lymphoma ) and melanoma (a type of skin cancer);
immune disorders that can affect the lungs, skin and lymph nodes (usually manifests as the disease sarcoidosis );
vasculitis ( inflammation of the blood vessels);
shaking;
neuropathy (nerve damage);
stroke ;
double vision;
hearing loss, ringing;
feeling of the heart beating irregularly like a missed heartbeat;
heart problems that can cause shortness of breath or swollen feet;
myocardial infarction;
a hernia in the great artery wall, inflammation and clot in a vein, blockage of a blood vessel;
lung disease causing shortness of breath (including pneumonia );
pulmonary embolism (blockage in a pulmonary artery);
pleural effusion (abnormal fluid accumulation between the lungs and chest);
inflammation of the pancreas that causes severe pain in the abdomen and back;
difficulty swallowing;
facial edema (swelling);
gallbladder inflammation, gallstones;
fatty liver (fat accumulation in the liver cells);
night sweats;
scar;
abnormal muscle breakdown;
SLE , systemic lupus erythomatosus (an immune disease that includes inflammation of the skin, heart, lungs, joints and other organ systems);
disturbed sleep;
impotence;
inflammation is.

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

leukemia (cancer that affects the blood and bone marrow );
severe allergic reaction with shock;
MS, multiple sclerosis;
nerve disorders (such as inflammation of the optic nerve to the eye and Guillain ‑ Barré syndrome, a condition that can cause muscle weakness, sensory disturbances, tingling in the arms and upper body);
cardiac arrest;
pulmonary fibrosis (scarring of the lung);
intestinal perforation (hole in the intestinal wall);
hepatitis (inflammation of the liver);
reactivation of hepatitis B infection;
autoimmune hepatitis (inflammation of the liver caused by the body’s own immune system);
cutaneous vasculitis ( inflammation of the blood vessels in the skin);
Stevens-Johnson syndrome (a life-threatening reaction with flu-like symptoms and skin rash with blisters);
facial edema (swelling) associated with allergic reactions;
erythema multiforme (inflammatory skin rash);
lupus ‑ similar syndrome;
angioedema (local swelling of the skin)
lichenoid skin reactions (itchy red-purple skin rash).

No known frequency (can not be calculated 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 associated with infection with human herpesvirus 8 Kaposi sarcoma occurs most often as purple spots on the skin;
liver failure;
aggravation of a condition called dermatomyositis (looks like a rash and is accompanied by muscle weakness);
weight gain (for most patients the weight gain was small).

Some side effects observed with adalimumab may not show symptoms and can only be detected by blood tests. These include:

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

low blood cell counts;
low blood cell counts;
elevated lipids in the blood;
elevated liver enzymes.

Common (may affect up to 1 in 10 people)

high blood cell counts;
low blood platelet counts;
elevated uric acid in the blood;
aberrant blood sodium levels;
low blood levels of calcium;
low blood levels of phosphate;
high blood sugar;
high blood levels of lactate dehydrogenase;
autoantibodies in the blood;
low blood levels of potassium .

Uncommon (may affect up to 1 in 100 people)

elevated levels of bilirubin (blood test for the liver).

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

low blood counts for white blood cells, red blood cells and platelets .

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

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 expiration date is the last day of the specified month.

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

Keep the pen in the outer carton. Sensitive to light.

Alternative storage:

If needed (for example if you are traveling), Hyrimoz can be stored at room temperature (up to 25 ° C) for a maximum of 21 days – make sure that the medicine is protected from light. When the pre-filled pen is taken out of the refrigerator to be stored at room temperature, it must be used within 21 days or discarded, even if the latter is put back in the refrigerator.

You must write down the date when the pre-filled syringe is taken out of the refrigerator for the first time, and the date when it must be discarded.

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

6. Contents of the packaging and other information

Content declaration

The active substance is adalimumab. Each pre-filled pen contains 40 mg of adalimumab in 0.8 ml solution.
The other ingredients are adipic acid, citric acid monohydrate, sodium chloride, mannitol, polysorbate 80, hydrochloric acid , sodium hydroxide and water for injections.

What the medicine looks like and contents of the pack

Hyrimoz 40 mg injection, solution for injection in a prefilled injection pen is in a sterile solution of 40 mg adalimumab dissolved in 0.8 ml of solution which is clear to slightly opalescent, colorless to pale yellow.

Hyrimoz in a prefilled syringe for single-use mounted in a triangular pen (SensoReady) with transparent windows and label. The syringe in the pen is made of type I glass, has a stainless steel needle and a rubber inner needle cover, and contains 0.8 ml of solution.

Each pack contains 1 or 2 pre-filled pens of Hyrimoz.

Each multi-pack contains 6 (3 × 2) pre-filled pens of Hyrimoz.

Not all pack sizes may be marketed.

Hyrimoz is available as a prefilled syringe as well as a pre-filled pen (SensoReady).

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Sandoz GmbH

Biochemiestr. 10

6250 Kundl

Austria

Manufacturer

Sandoz GmbH Schaftenau