Amsparity - Adalimumab uses, dose and side effects

Polyarticular juvenile idiopathic arthritis (rheumatoid arthritis)
Enthesitis-related arthritis (muscle, tendonitis, and joint inflammation) in children and adolescents
Plaque psoriasis in children and adolescents
Hidradenitis suppurativa ( inflammation of the skin) in adolescents
Crohn’s disease ( inflammation of the intestine) in children and adolescents
Uveitis ( inflammation of the eye) in children and adolescents

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

The target of adalimumab is a protein called tumor necrosis factor (TNFα), which is involved in the immune system and is found in elevated levels in the inflammatory diseases listed above. By binding to TNFα, Amsparity blocks its action and reduces inflammation in these diseases.

Polyarticular juvenile idiopathic arthritis

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

Amsparity is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents 2−17 years. Your child may first be given other disease-modifying medicines, such as methotrexate. If these medicines do not work enough, your child will be given Amsparity to treat polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.

Enthesitis-related arthritis in children and adolescents

Pediatric arthritis-related arthritis is an inflammatory disease of the joints and tendon attachments.

Amsparity is used to treat arthritis-related arthritis in children and adolescents 6−17 years of age. Your child may first be given other disease-modifying medicines, such as methotrexate. If these medicines do not work well enough, your child will be given Amsparity to treat arthritis-related arthritis.

Plaque psoriasis in children and adolescents

Plaque psoriasis is a 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 thought to be caused by a disorder in the body’s immune system that leads to increased production of skin cells.

Amsparity is used to treat severe plaque psoriasis in children and adolescents 4−17 years of age where local treatment and light therapy have not worked or are not appropriate.

Hidradenitis suppurativa in 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.

Amsparity is used to treat hidradenitis suppurativa in adolescents from 12 years of age. Amsparity can reduce the number of lumps and boils that your child has as well as the pain that is often associated with the disease. Your child may be given other medicines first. If these medicines do not have the desired effect, your child will receive Amsparity.

Crohn’s disease in children and adolescents

Crohn’s disease is an inflammatory bowel disease.

Amsparity is used to treat Crohn’s disease in children and adolescents aged 6−17 years.

If your child has Crohn’s disease, they will first be given other medicines. If these drugs do not help enough, your child will be given Amsparity to reduce the signs and symptoms of Crohn’s disease.

Uveitis in children and adolescents

Non- infectious uveitis (non-infectious 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 striped lines moving across the field of vision ). Amsparity works by reducing this inflammation.

Amsparity is used to treat children and adolescents from the age of 2 with chronic non- infectious uveitis where inflammation affects the front of the eye.

Your child may be given other medicines first. If these drugs do not work enough, your child will be given Amsparity to reduce the signs and symptoms of the disease.

2. What you need to know before your child uses Amsparity

Do not use Amsparity

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 serious infection, including active tuberculosis, sepsis ( sepsis ), or opportunistic infections (uncommon infections associated with a weakened immune system). It is important that you tell your child’s doctor if your child has symptoms of infection, e.g. fever, sores, tiredness, dental problems (see “Warnings and Precautions”).
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 Amsparity.

It is important that you and your child’s doctor document the name and batch number of your child’s medicine.

Allergic reactions

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

Infection is

If your child has an infection, including long-term infections or local infections(such as leg ulcers), you must consult a doctor before starting your child with Amsparity. If you are not sure, talk to your child’s doctor.
Your child may get an infection more easily while he/she is receiving treatment with Amsparity. This risk may increase if he/she has impaired lung function. These infections can be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other opportunistic infections (unusual infectious organisms ) and sepsis (blood poisoning). In rare cases, these can be infected is becoming life-threatening. It is important to tell your doctor if your child develops symptoms such as fever, sores, tiredness, or toothache. Your child’s doctor may recommend that Amsparity be discontinued temporarily.

Tuberculosis

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 Amsparity. This check includes a thorough review of the child’s medical history and appropriate examinations (eg chest X-ray and a tuberculin test). The implementation 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. If your child has active tuberculosis, do not use Amsparity.
Tuberculosis can develop during treatment even if your child has received preventive treatment for tuberculosis.
If symptoms of tuberculosis (for example, persistent cough, weight loss, lack of energy, mild fever), or if any other infection occurs during or after treatment, tell your child’s doctor immediately.

Infection during travel / recurrent infection

Tell your doctor if your child lives or travels in regions where fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic (constantly present).
Tell your doctor if your child has previously had problems with recurrent infections or other ailments that increase the risk of infection.
You and your child’s doctor should pay special attention to signs of infection while your child is being treated with Amsparity. It is important to tell your doctor if your child develops symptoms of infection, such as fever, sores, tiredness, or toothache.

Hepatitis B

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 should test your child for Hepatitis B. Adalimumab may reactivate HBV infection in people who carry the 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.

Operations and dental procedures

If your child is about to have an operation or a dental procedure, inform your doctor that he/she is taking Amsparity. Your child’s doctor may recommend that Amsparity be discontinued temporarily.

Demyelinating disease

If your child has or develops a demyelinating disease (a disease that affects the insulating layers around the nerves, such as multiple sclerosis (MS)), your doctor will assess whether he / she can or should continue to be treated with Amsparity. Tell your child’s 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.

Vaccination

Some vaccines contain live but attenuated forms of pathogenic bacteria or viruses that can cause infection and should not be given during treatment with Amsparity. Consult your child’s doctor before vaccinating your child. It is recommended that children, if possible, be vaccinated according to current general vaccination guidelines before starting treatment with Amsparity. If your baby has been given Amsparity while pregnant, her newborn baby may be at increased risk of getting an infection for up to about five months after the last dose. of Amsparity that she received during pregnancy. It is important that you tell your pediatrician and other healthcare professionals that she used Amsparity during her pregnancy so that they can decide when her 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 Amsparity, his / her heart problems must be closely monitored by the child’s doctor. If he/she develops new symptoms or if symptoms of heart failure worsen (eg 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 the body 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 child’s doctor can then decide that the treatment should be stopped.

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 (cancer that affects blood cells and bone marrow ). If your child is being treated with Amsparity, the risk of developing lymphoma, leukemia, or another type of cancer may increase. In rare cases have an unusual and severe type of lymphoma observed in patients taking adalimumab. Some of these patients were also treated with the drugs azathioprine or mercaptopurine. Tell your child’s doctor if your child is taking azathioprine or mercaptopurine with Amsparity.
Cases of non-melanoma skin cancer have also been reported in patients treated with adalimumab. If new skin ulcers appear during or after treatment, or if the appearance of existing marks or skin ulcers changes, tell your child’s doctor.
Cancers other than lymphoma have been reported in patients with chronic obstructive pulmonary disease (COPD) treated with other TNF- blockers. If your child has COPD or is a heavy smoker, discuss with your doctor whether it is appropriate for your child to be treated with a TNFα blocker.

Autoimmune diseases

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

Other medicines and Amsparity

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

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

Your child should not use Amsparity with medicines containing the active substances anakinra or abatacept due to the increased risk of serious infections. Co-administration of adalimumab, or other TNF – antagonists, with anakinra or abatacept, is not recommended based on the potential increased risk of infection, including serious infections and other potential pharmacological interactions. If you have any further questions, ask your child’s doctor.

Pregnancy, breastfeeding, and fertility

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 Amsparity.

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

Amsparity 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.

Amsparity can be used during breastfeeding.

If your baby gets Amsparity 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 Amsparity during her pregnancy before the newborn baby is vaccinated. For more information on vaccines, see the section “Warnings and precautions”.

Driving and using machines

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

Amsparity contains excipients

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

3. How your child uses Amsaprity

Always use this medicine exactly as your doctor, nurse or pharmacist has told you. If you are not sure, talk to your child’s doctor, nurse, or pharmacist. The child’s doctor may prescribe a different strength of Amsparity if the child needs a different dosage.

Amsparity is injected under the skin ( subcutaneous use).

Children and adolescents with polyarticular juvenile idiopathic arthritis

Children and adolescents from 2 years of age weighing from 10 kg up to 30 kg

The recommended dose of Amsparity is 20 mg every two weeks.

Children and adolescents from 2 years of age weighing 30 kg or more

The recommended dose of Amsparity is 40 mg every two weeks.

Children and adolescents with arthritis-related arthritis

Children and adolescents from 6 years of age weighing from 15 kg up to 30 kg

The recommended dose of Amsparity is 20 mg every two weeks.

Children and adolescents from 6 years of age weighing 30 kg or more

The recommended dose of Amsparity is 40 mg every two weeks.

Children and adolescents with psoriasis

Children and adolescents 4 −17 years weighing from 15 kg up to 30 kg

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

Adolescents with hidradenitis suppurativa 12−17 years who weigh 30 kg or more

The recommended dose of one of Amsparity 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 does not give the desired effect, your 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 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 does not give the desired effect, your child’s doctor may increase the dose by one to 20 mg every week.

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

The usual dose is 80 mg (as two 40 mg injections on the same day) initially 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 injections you on the same day) two weeks later.

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

Children and adolescents from 2 years of age with chronic non-infectious uveitis

Children and adolescents from 2 years of age weighing less than 30 kg

The usual dose of Amsparity 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.

Children and adolescents from 2 years of age weighing 30 kg or more

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

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

How Amsparity is given

Amsparity is given as an injection under the skin (via subcutaneous injection ).

Detailed instructions for injecting Amsparity can be found in the “Instructions for Use” section.

If you take more Amsparity than you should

If you accidentally inject your child with a larger amount of Amsparity solution or if you inject Amsparity more often than your doctor has prescribed, call your doctor or pharmacist and tell them that your child has been given too much of the medicine. Always carry the outer carton or vial with you, even if it is empty.

If you have given too little Amsparity

If you accidentally inject your child with a small amount of Amsparity solution or if you inject your child with Amsparity less often than your doctor has prescribed, call your doctor or pharmacist and tell them that your child has been given too little of the medicine. Always carry the outer carton or vial with you, even if it is empty.

If you have forgotten to give your child Amsparity

If you forget to give your child an injection of Amsparity, give the next dose of Amsparity as soon as you remember. Then give your child the next dose on the day you would have given it if you had not forgotten a dose.

If your child stops using Amsparity

The decision to stop using Amsparity 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 child’s 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 after the last Amsparity injection.

Seek medical attention immediately if any of the following symptoms occur:

severe rash, hives, or other signs of an allergic reaction
swollen face, swollen hands, feet
strained breathing, difficulty swallowing
shortness of breath during exertion or when lying down or if the feet swell.

Tell your child’s 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, coughing
symptoms of nerve problems such as tingling, numbness, double vision, or weakness in the arms or legs
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 signs and symptoms described above may represent the side effects described below, which have been observed with the use of 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
muscle and joint pain.

Common (may affect up to 1 in 10 people)

serious infection (including sepsis and flu )
infection is in the intestines (including gastroenteritis )
skin infections (including cellulite and shingles )
ear infections
oral infections (including dental infections and herpes on the lips)
infection is in the genitals
urinary tract infections
fungal infections
joint infections
benign tumor er
skin cancer
allergic reactions (including seasonal allergy)
dehydration
mood swings (including depression)
concern
trouble sleeping
sensory disturbances such as tingling, and crawling, or numbness
migraine
nerve root compression (including 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)
a feeling of the heart beating fast
high blood pressure
redness
hematoma (a solid swelling with coagulated blood)
cough
asthma
shortness of breath
bleeding in the gastrointestinal tract
dyspepsia (indigestion, gas in the stomach, heartburn)
reflux disease (acid reflux)
dry eyes and dry mouth
itching
itchy rash
bruises
dermatitis (such as eczema )
fragile fingernails and toenails
increased sweating
hair loss
new-onset or worsening psoriasis
muscle spasms
blood in the urine
kidney problems
chest pain
edema (an accumulation of fluid in the body that causes the affected tissue Roswell)
fever
decreased platelet count ( platelets ) which increases the risk of bleeding or bruising
impaired healing.

Uncommon (may affect up to 1 in 100 people)

opportunistic (unusual) infections (which include tuberculosis and other infections that may occur when resistance to the disease is reduced)
neurological infection (including meningitis caused by a virus )
eye infection er
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 as sarcoidosis )
vasculitis ( inflammation of the blood vessels)
shaking
neuropathy (nerve damage)
stroke (stroke)
double vision
hearing loss, earrings
the 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 a large artery wall, inflammation, and clot in a vein, blockage of a blood vessel
lung disease that causes shortness of breath (including pneumonia )
pulmonary embolism (blockage in a pulmonary artery)
pleural effusion (abnormal fluid accumulation between lungs and chest)
inflammation of the pancreas that causes severe pain in the abdomen and back
difficulty swallowing
facial edema (swelling of the face)
gallbladder inflammation, gallstones ar
fatty liver (fat accumulation in liver cells)
night sweats
scar
abnormal degradation of muscle tissue
the systemic lupus erythematosus (an immune disease that causes inflammation of the skin, heart, lungs, joints, and other organ systems)
sleep interruption
impotence
inflammation is.

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

leukemia (cancer affecting blood and bone marrow )
severe allergic reaction with shock
multiple sclerosis
nerve disorders (such as ocular inflammation and Guillain-Barré syndrome, a disease that can cause muscle weakness, sensory disturbances, tingling in the arms and upper body)
the heart stops pumping
pulmonary fibrosis (scarring of the lung)
intestinal perforation (hole in the intestine)
hepatitis (inflammation of the liver)
reactivation of hepatitis B infection
autoimmune hepatitis (hepatitis caused by the body’s own immune system)
cutaneous vasculitis ( inflammation of the blood vessels in the skin)
Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and rash with blisters)
facial edema (swelling of the face) associated with allergic reactions
erythema multiforme (inflammatory skin rash)
lupus-like syndrome (persistent, unexplained rash, fever, joint pain or fatigue)
angioedema (local swelling of the skin)
lichenoid skin reactions (itchy red-purple skin rash).

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

hepatosplenic T-cell lymphoma (a rare, often fatal blood cancer)
Merkel cell carcinoma (a type of skin cancer)
Kaposi’s sarcoma, 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 (manifested as a rash with accompanying muscle weakness).

Some side effects observed with Amsparity may not cause symptoms but may only be detected by blood tests. These include:

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

low blood cell counts
low blood counts for red blood cells
elevated levels of lipid in the blood
elevated liver enzymes.

Common (may affect up to 1 in 10 people)

high blood counts for white blood cells
low blood platelet counts
elevated levels of 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
presence of autoantibodies in the blood
low blood levels of potassium.

Uncommon (may affect up to 1 in 100 people)

elevated bilirubin levels (blood tests from 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 includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Amsparity

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.

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

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

Alternative storage:

If needed (for example when traveling), an Amsparity vial can be stored at room temperature (up to 30 ° C) for a maximum of 30 days – ensure that it is protected from light. When removed from the refrigerator for storage at room temperature, the vial must be used within 30 days or discarded, even if it is put back in the refrigerator.

You must write down the date when the vial is taken out of the refrigerator for the first time, and the date when it will be discarded.

Medicines should not be disposed of via wastewater or household waste. Ask your child’s doctor or 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 L-histidine, L-histidine hydrochloride monohydrate, sucrose, edetate disodium dihydrate, L-methionine, polysorbate 80, and water for injections.

What the medicine looks like and the contents of the pack

Amsparity 40 mg solution for injection in a vial is provided as a sterile solution containing 40 mg adalimumab dissolved in 0.8 ml solution.

Amsparity vial is a glass vial containing a clear, colorless to the very light brown solution of adalimumab. One pack contains 2 boxes, each containing 1 vial, 1 empty sterile syringe, 1 needle, 1 bottle adapter, and 2 alcohol swabs.

Amsparity may be available as a vial, pre-filled syringe and/or as a pre-filled pen.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Brussels

Belgium

Manufacturer

Pfizer Service Company BVBA

High Way 10

Zaventem 1930