40 mg / 0.8 ml injection solution
adalimumab

Read all of this leaflet carefully before your child starts taking this medicine. It contains information that is important for your child.

– Save this information, you may need to read it again.

– Your doctor will also give you a Patient Card, which contains important safety information that you must be aware of before giving Hulio to your child and during treatment with Hulio. Have the card with you / make sure your child has it with them at all times and for 4 months after your child’s last injection of Hulio.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for your child only. Do not give it to others. It can harm them, even if they show signs of illness similar to your child’s.

– If your child has any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about:
What Hulio is and what it is used for
2. What you need to know before giving Hulio to your child
3. How to use Hulio
4. Possible side effects
5. How to store Hulio
6. Contents of the packaging and other information

What Hulio is and what it is used for

Hulio contains the active substance adalimumab. Adalimumab is a drug that acts on the body’s immune system (defense).

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

  • children aged 2–17 years with polyarticular juvenile idiopathic arthritis
  • children aged 6–17 years with encephalitis-related arthritis
  • children aged 6–17 years with Crohn’s disease
  • children aged 4–17 years with plaque psoriasis
  • adolescents aged 12–17 years with hidradenitis suppurativa
  • children aged 2–17 years with chronic non- infectious uveitis affecting the front of the eye.

The active substance in Hulio, 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 tumor necrosis factor (TNFα), which is found in elevated levels in the inflammatory diseases listed above. By binding to TNFα, Hulio can reduce the inflammatory process in these diseases.

Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis

Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory diseases of the joints that often first occur in childhood.

Hulio is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2–17 years and encephalitis-related arthritis in children and adolescents aged 6–17 years. Your child may first be given other medicines for their illness, such as methotrexate. If these medicines do not help enough, your child will get Hulio to treat polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.

Children with Crohn’s disease

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

Hulio is used to treat Crohn’s disease in children aged 6-17 years. Your child will first be given other medicines. If these drugs do not help enough, your child will get Hulio to reduce the signs and symptoms of Crohn’s disease.

Children with plaque psoriasis

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.

Hulio is used to treat severe plaque psoriasis in children and adolescents 4–17 years of age where drugs applied to the skin and light therapy have not worked well enough or are not appropriate

Adolescents with hidradenitis suppurativa

Hidradenitis suppurativa (sometimes called acne inversa) is a chronic 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.

Hulio is used to treat hidradenitis suppurativa in adolescents from 12 years of age. Hulio can reduce the number of lumps and boils that the disease causes as well as the pain that is often associated with the disease. Patients may first receive other medicines. If these drugs do not help enough, patients will get Hulio

Chronic non-infectious uveitis affecting the front of the eye

Non- infectious uveitis is an inflammatory disease that affects certain parts of the eye. Inflammation leads to impaired vision and/or the presence of floaters in the eye (black dots or striped lines moving across the field of vision ). Hulio works by reducing this inflammation.

Hulio is used to treat children aged 2–17 years with chronic non-infectious uveitis where inflammation affects the front of the eye.

2. What you need to know before giving Hulio to your child

Do not give Hulio

  • If your child is allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6)
  • If your child has a severe infection , including tuberculosis (see “Warnings and Precautions”). It is important that you tell your doctor if your child has symptoms of infection , e.g. fever, sores, tiredness, dental problems.
  • If your child has moderate or severe heart failure . It is important to tell your doctor if your child has or has had a serious heart condition (see “Warnings and Precautions”).

Warnings and cautions

Talk to your child’s doctor or pharmacist before using Hulio.

Allergic reaction

If your child has allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling, or rash, stop injecting Hulio and contact a doctor immediately as these reactions can be life-threatening in rare cases.

Infection is

  • If your child has an infection , including chronic or local infections (eg leg ulcers), you must consult a doctor before starting Hulio. If you are not sure, talk to a doctor.
  • Your child may get infection more easily while he / she is receiving treatment with Hulio. This risk may increase if your child has impaired lung function. These infections can be serious and include tuberculosis , infections caused by viruses , fungi, parasites or bacteria, or other uncommon infectious organisms and sepsis (blood poisoning) which in rare cases can be life threatening. It is important to tell your doctor if your child develops symptoms such as fever, sores, tiredness or toothache. Your doctor may advise you to temporarily stop using Hulio.

Tuberculosis (TB)

  • As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will examine your child for signs and symptoms of tuberculosis before starting treatment with Hulio. This includes a comprehensive medical history and appropriate screening tests (eg, chest X-ray and a tuberculin test). The performance and results of these tests should be indicated on your child’s patient card. It is very important that you tell your doctor if your child has ever had tuberculosis , or if he / she has been in close contact with someone who has had tuberculosis . Tuberculosis can develop during treatment even if your child has received preventive treatment fortuberculosis . If 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 your child lives or travels in regions where fungal infections such as histoplasmosis , coccidioidomycosis or blastomycosis are common.
  • Tell your doctor if your child has previously had problems with recurrent infections or other ailments that increase the risk of infection .

Hepatitis B virus

  • Tell your doctor if your child is a carrier of the hepatitis B virus (HBV), if he / she has an active HBV infection or if you think he / she is at risk of getting HBV. Your doctor will test your child for hepatitis B. Hulio can cause reactivation of HBV in people who carry this virus . In some rare cases, especially if your child is taking other medicines that inhibit the immune system, reactivation of HBV can be life-threatening.

Surgery or dental surgery

  • If your child is about to have an operation or a dental procedure, inform the doctor that he / she is taking Hulio. Your doctor may advise you to temporarily stop using Hulio.

Demyelinating disease

  • If your child has or develops a demyelinating disease (a disease that affects the insulating layer around the nerves) such as multiple sclerosis (MS), your doctor will decide if he / she should get or continue to get Hulio. Tell your doctor immediately if your child develops symptoms such as changes in vision, weakness in the arms or legs, or numbness or tingling anywhere on the body.

Vaccine

  • Some vaccines that contain live but attenuated forms of bacteria or viruses can cause infection and should not be given during treatment with Hulio. Check with a doctor before your child is vaccinated. It is recommended that children, if possible, be vaccinated according to current guidelines for general vaccination before starting treatment with Hulio. If your baby has had Hulio during her pregnancy, your baby’s newborn baby may have an increased risk of getting such an infection for up to five months after the last dose she received during pregnancy. It is important that you tell your pediatrician and other healthcare professionals that your baby used Hulio during pregnancy so that they can decide when your baby’s newborn baby should be vaccinated.

Heart failure

  • It is important to tell your doctor if your child has or has had a serious heart condition. If your child has mild heart failure and is being treated with Hulio, his / her heart problems must be closely monitored by a doctor. If your child develops new symptoms or if symptoms of heart failure worsen (such as shortness of breath or swollen feet), you must contact a doctor immediately.

Fever, bruising, bleeding, or pallor

  • In some patients, the body is unable to produce enough blood cells to help fight infection or stop bleeding. If your child develops a fever that does not go down, bruises or bleeds easily or looks very pale, you should call a doctor immediately. The doctor can then decide that the treatment should be stopped.

Cancer

  • Very rare cases of certain cancers have occurred in children and adults taking 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 (cancer that affects the blood and bone marrow ). If your child is being treated with Hulio, the risk of developing lymphoma , leukemia or another type of cancer may increase . On rare occasions have a specific and severe type of lymphomaobserved in some patients taking adalimumab. Some of these patients were also treated with azathioprine or mercaptopurine. Tell your doctor if your child is taking azathioprine or mercaptopurine with Hulio.
  • Cases of non- melanoma skin cancer have also been reported in patients treated with adalimumab. If new skin ulcers occur during or after treatment or if existing birthmarks or skin ulcers change appearance, tell your doctor.
  • There have been cancers other than lymphoma , in patients with a specific lung disease called chronic obstructive pulmonary disease (COPD) and treated with other TNFα blockers. If your child has COPD, or is a heavy smoker, discuss with your doctor whether it is appropriate to treat your child with TNFα blockers.

Other drugs and Hulio

Tell your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines.

Hulio 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 ).

Your child should not use Hulio with medicines containing the active substances anakinra or abatacept. Concomitant use of Hulio and anakinra or abatacept is not recommended due to the possible increased risk of infections, including serious infections, and other possible drug interactions. If you have any further questions, ask your doctor.

Pregnancy and breastfeeding

• Your child should consider using adequate contraception to prevent becoming pregnant and continue to use it for at least 5 months after the last treatment with Hulio.

• If your child is pregnant thinks she may be pregnant or is planning to have a baby, consult her doctor before using this medicine.

Hulio should only be used during pregnancy if necessary.

• According to a pregnancy study, there was no increased risk of birth defects when the mother had received Hulio during pregnancy compared to mothers with the same disease who had not used Hulio.

• Hulio can be used during breastfeeding.

If your baby gets Hulio during her pregnancy, her newborn baby may be at increased risk of getting an infection.

• It is important that you tell your pediatrician and other healthcare professionals that she used Hulio during her pregnancy before vaccinating your newborn baby. For more information on vaccines, see the section “Warnings and precautions”.

Driving and using machines

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

Hulio contains sodium and sorbitol

Each vial of Hulio contains 38.2 mg of sorbitol. Sorbitol is a source of fructose. If your child has hereditary fructose intolerance, a rare, inherited disease, your child should not use this medicine. Patients with hereditary fructose intolerance cannot break down fructose, which can cause serious side effects. Contact a doctor before your child uses this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per vial, ie essentially ‘sodium-free.

3. How to use Hulio

Always use this medicine exactly as your doctor or pharmacist has told you. If you have any further questions on the use of this product, ask your doctor or pharmacist. Your doctor may prescribe a different strength of Hulio if your child needs a different dosage.

Children and adolescents with polyarticular juvenile idiopathic arthritis

Children and adolescents 2–17 years of age weighing from 10 kg to less than 30 kg:

The recommended dosage of Hulio is 20 mg every two weeks.

Children and adolescents 2–17 years of age weighing 30 kg or more :

The recommended dosage of Hulio is 40 mg every two weeks.

Children and adolescents with arthritis-related arthritis

Children and adolescents aged 6-17 weighing from 15 kg to less than 30 kg:

The recommended dosage of Hulio is 20 mg every two weeks.

Children and adolescents 6–17 years weighing 30 kg or more:

The recommended dosage of Hulio is 40 mg every two weeks.

Children and adolescents with Crohn’s disease

Children and adolescents 6–17 years weighing less than 40 kg:

The usual dose is 40 mg initially followed by 20 mg two weeks later. If a faster response is required, your child’s doctor may prescribe an initial dose of 80 mg (as two 40 mg injections on the same day) followed by 40 mg two weeks later.

Thereafter, the usual dose is 20 mg every two weeks. If this dose is not sufficient, your child’s doctor may increase the dose to one to 20 mg each week.

Children and adolescents 6–17 years weighing 40 kg or more:

The usual dose is 80 mg initially (as two 40 mg injections on the same day) followed by 40 mg two weeks later. If a faster response is required, your child’s doctor may prescribe a starting dose of 160 mg (as four 40 mg injections on the same day or as two 40 mg injections per day for two consecutive days) followed by 80 mg (as two 40 mg injection on the same day) two weeks later.

Thereafter, the usual dose is 40 mg every two weeks. If this dose is not sufficient, your child’s doctor may increase the dose to 40 mg every week or 80 mg every two weeks.

Children and adolescents with plaque psoriasis

Children and adolescents 4–17 years weighing from 15 kg to less than 30 kg:

The recommended dose of Hulio is a starting dose of 20 mg followed by 20 mg a week later. Thereafter, the usual dose is 20 mg every two weeks.

Children and adolescents 4–17 years weighing 30 kg or more:

The recommended dosage one of Hulio is a starting dose of 40 mg followed by 40 mg a week later. Thereafter, the usual dose is 40 mg every two weeks.

Adolescents with hidradenitis suppurativa (12–17 years old weighing at least 30 kg)

The recommended dosage one of Hulio is a starting dose of 80 mg (as two 40 mg injections on the same day) followed by 40 mg every other week starting one week later. If this dose is not sufficient, your child’s doctor may increase the dose to 40 mg every week or 80 mg every two weeks.

It is recommended that a bactericidal solution be used daily on the affected areas.

Children and adolescents with chronic non- infectious uveitis

Children and adolescents 2–17 years weighing less than 30 kg:

The usual dose of Hulio is 20 mg every two weeks with methotrexate.

Your child’s doctor may also prescribe a starting dose of 40 mg given one week before starting the usual dose.

arn and adolescents 2-17 years of age who weigh 30 kg or more:

The usual dose of Hulio is 40 mg every two weeks with methotrexate.

Your child’s doctor may also prescribe a starting dose of 80 mg given one week before the start of the usual dose.

For patients who have been prescribed a full 40 mg dose, Hulio is also available as a 40 mg pre-filled pen and 40 mg pre-filled syringe at the pharmacy.

How Hulio is given

Hulio is given by injection under the skin ( subcutaneous use).

Detailed instructions on how to inject Hulio can be found in section 7 – Instructions for use.

If you use more Hulio than you should

If you accidentally inject Hulio more often than your doctor advised, contact your doctor or pharmacist and tell them that your child has received too much. Always take the outer carton or medicine with you, even if it is empty.

If you forget to use Hulio

If you forget to give your child an injection, give a Huliodos as soon as you remember. Then give your child the next dose on a specific day that you would have done if you had not forgotten a dose.

If your child stops using Hulio

The decision to stop using Hulio should be discussed with your child’s doctor. Your child’s 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 urgent treatment.

Side effects can occur up to 4 months or longer after the last Hulio injection.

Seek medical attention immediately if your child develops any of the following signs of allergic reaction or heart failure:

  • severe rash, hives
  • swollen face, swollen hands or feet
  • difficult to breathe or swallow
  • pallor, dizziness, prolonged fever, bruising or bleeding easily.

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, 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 an 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 seen 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, throat infection , pneumonia )
  • abnormal blood test results
  • headache
  • abdominal pain
  • nausea and vomiting
  • musculoskeletal pain.

Common (may affect up to 1 in 10 people):

  • infection (including tuberculosis , sepsis, influenza , cellulite , shingles , ear infections, dental infections, cold sores, genital infections , urinary tract infections, fungal infections, joint infections)
  • benign tumor er
  • skin cancer
  • mild allergic reactions (including seasonal allergy)
  • dehydration
  • mood swings (including depression)
  • concern
  • trouble sleeping
  • sensory disturbances such as tingling, ant crawling or numbness
  • migraine
  • pain in the neck or back
  • visual disturbances
  • inflammation of the eye / eyelid or swelling of the eyes
  • dizziness (feeling that the room is spinning)
  • cough
  • feeling of heart beating fast
  • high blood pressure
  • reddening of the skin
  • blood clot
  • asthma
  • bleeding in the stomach
  • indigestion, bloating, heartburn
  • gastric acid reflux (acid reflux)
  • dry eyes and dry mouth
  • itching , dermatitis (including eczema )
  • increased sweating
  • hair loss
  • new onset or worsening of psoriasis (red flaky skin)
  • muscle spasms
  • blood in the urine
  • kidney problems
  • slow wound healing.

Uncommon (may affect up to 1 in 100 people):

  • cancer affecting the lymphatic system ( lymphoma )
  • immune disorders that can affect the lungs, skin and lymph nodes (usually as sarcoidosis )
  • inflammation of the blood vessels
  • shaking
  • nerve damage
  • stroke
  • double vision
  • hearing loss, ringing ears
  • irregular heartbeats
  • lung disease that causes shortness of breath (including inflammation )
  • blockage in a pulmonary artery
  • excessive fluid accumulation around the lungs
  • inflammation of the pancreas
  • difficulty swallowing
  • gallbladder inflammation, gallstones ar
  • fatty liver (fat accumulation in the liver cells)
  • night sweats
  • scar
  • abnormal muscle breakdown
  • systemic lupus erythomatosus (including inflammation of the skin, heart, lungs, joints and other organ systems)
  • excessive urination at night
  • impotence .

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

  • leukemia (cancer affecting blood and bone marrow )
  • multiple sclerosis
  • nerve disorders (such as ocular inflammation and Guillain-Barré syndrome which can cause muscle weakness, sensory disturbances, tingling in the arms and upper body)
  • heart attack
  • pulmonary fibrosis (scarring of the lung)
  • holes in the intestine
  • hepatitis
  • inflammation of the blood vessels in the skin
  • Stevens-Johnson syndrome
  • inflammatory skin rash
  • lupus-like syndrome
  • lichenoid skin reactions (itchy red-purple skin rash)

Has been reported (occurs in an unknown number of users):

  • hepatosplenic T-cell lymphoma (a rare blood cancer)
  • 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
  • aggravated skin rash accompanied by muscle weakness.

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 Hulio

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 / 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.

Store the vials in the outer carton. Sensitive to light.

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.
  • The other ingredients are monosodium glutamate, sorbitol, methionine, polysorbate 80, hydrochloric acid and water for injections.

What the medicine looks like and contents of the pack

Hulio 40 mg solution for injection ( injection ) in vials is provided in a sterile solution containing 40 mg adalimumab dissolved in 0.8 ml clear or slightly opalescent, colorless to slightly brownish yellow solution.

Hulio vial is made of glass and has a rubber stopper. Hulio is supplied in packs of 1 or 2 boxes. Each box contains 1 vial , 1 sterile syringe , 1 sterile needle, 1 sterile vial adapter and 2 alcohol swabs.

Hulio is also available in a pre-filled syringe or pre-filled pen .

Marketing Authorisation Holder

Mylan SAS

69800 Saint ‑ Priest

France

Manufacturer

AndersonBrecon (UK) Limited

Wye Valley Business Park

Brecon Road

Hay-on-Wye

Hereford

HR3 5PG

UK

McDermott Laboratories T / A Mylan Dublin Biologics

Newenham Court, Northern Cross, Malahide Road

Dublin 17

Ireland

Mylan Germany GmbH

Benzstraße 1

61352 Bad Homburg vd Höhe

Germany

Contact the representative of the marketing authorization holder to find out more about this medicine:

Muhammad Nadeem

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