100 mg powder for concentrate for infusion solution
Infliximab
1. What Inflectra is and what it is used for
Inflectra contains the active substance infliximab, which comes from humans and mice. Infliximab is a monoclonal antibody – a type of protein that binds to a specific target in the body called TNF alpha ( tumor necrosis factor-alpha).
Inflectra belongs to a group of medicines called “TNF inhibitors”. It is used in adults for the following inflammatory diseases:
- rheumatoid arthritis
- psoriatic arthritis
- ankylosing spondylitis (Bechterew’s disease)
- psoriasis .
Inflectra is also used in adults and children, 6 years and older in:
- Crohn’s disease
- ulcerative colitis .
Inflectra works by specifically binding to TNF alpha ( tumor necrosis factor-alpha) and blocking its function. TNF alpha is involved in inflammatory processes in the body, so by blocking them, inflammation in the body can be reduced.
Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory disease that affects the joints. If you have active rheumatoid arthritis, you will first be given other medicines. If these medicines do not work well enough, you will be given Inflectra to take in combination with another medicine called methotrexate to:
- reduce the signs and symptoms of the disease
- reduce the damage to the joints
- improve your physical function.
Psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints, usually associated with psoriasis. If you have active psoriatic arthritis, you will first be given other medicines. If these medicines do not work well enough, you will be given Inflectra to:
- reduce the signs and symptoms of the disease
- reduce the damage to the joints
- improve your physical function.
Ankylosing spondylitis (Bechterew’s disease)
Ankylosing spondylitis is an inflammatory disease of the spine. If you have ankylosing spondylitis, you will first be given other medicines. If these medicines do not work well enough, you will be given Inflectra to:
- reduce the signs and symptoms of the disease
- improve your physical function.
Psoriasis
Psoriasis is an inflammatory disease of the skin. If you have moderate or severe plaque psoriasis, you will first be given other medicines or treatments such as light therapy. If these medicines or treatments do not work well enough, you will receive Inflectra to reduce the signs and symptoms of the disease.
Ulcerative colitis
Ulcerative colitis is an inflammatory disease of the intestine. If you have ulcerative colitis, you will first be given other medicines. If these medicines do not work well enough, you will be given Inflectra to treat the disease.
Crohn’s disease
Crohn’s disease is an inflammatory disease of the intestine. If you have Crohn’s disease, you will first be given other medicines. If these medicines do not work well enough, you will be given Inflectra to:
- treat active Crohn’s disease
- reduce the number of abnormal passages ( fistulas ) through the skin from the intestine that have not been controlled with other drugs or surgery .
2. What you need to know before using Inflectra
You should not receive Inflectra if:
- You are allergic to infliximab or any of the other ingredients of this medicine (listed in section 6)
- You are allergic (hypersensitive) to protein that comes from mice
- You have tuberculosis ( TB ) or any other serious infection such as pneumonia or sepsis
- You have heart failure that is moderate or severe.
Do not use Inflectra if any of the above apply to you. If you are not sure, talk to your doctor before taking Inflectra.
Warnings and cautions
Talk to your doctor before or during treatment with Inflectra if you have:
Have been treated with any medicine containing infliximab before
- Tell your doctor if you have previously been treated with medicines containing infliximab and are now starting treatment with Inflectra again.
- If you have had a break in your infliximab treatment for more than 16 weeks, there is an increased risk of allergic reactions when you start treatment again.
Infections r
- Tell your doctor before receiving Inflectra if you have an infection, even if it is a very mild one.
- Tell your doctor before receiving Inflectra if you have ever lived in or traveled to areas where infection called histoplasmosis , coccidioidomycosis or blastomycosis is common. These infections are caused by a special type of fungus that can affect the lungs or other parts of the body.
- You can more easily get your infection when you are treated with Inflectra. If you are 65 years or older, the risk is higher.
- These infections can be serious and include tuberculosis , infections caused by viruses , fungi, bacteria or other organisms in the environment and blood poisoning that can be life-threatening.
- Tell your doctor immediately if you get any signs of infection during treatment with Inflectra. Such signs include fever, cough, flu-like signs, general malaise, red or hot skin, sores or dental problems. Your doctor may recommend that Inflectra treatment be temporarily stopped.
Tuberculosis (TBC)
- It is very important that you tell your doctor if you have ever had TB or if you have been in close contact with someone who has had or has TB.
- Your doctor will check if you have TB. Cases of TB have been reported in patients treated with infliximab, including in patients treated with anti-TB drugs. Your doctor will note the examinations on your Patient Card.
- If your doctor thinks you are at risk of getting TB, you can get anti-TB medication before you receive Inflectra.
- Tell your doctor immediately if you get any signs of TB during treatment with Inflectra. Such signs include persistent cough, weight loss, feeling tired, fever, night sweats.
Hepatitis B virus
- Tell your doctor before receiving Inflectra if you are a hepatitis B carrier or if you have ever had it.
- Tell your doctor if you think you are at risk of getting hepatitis B.
- Your doctor will test you for the hepatitis B virus .
- Treatment with TNF- antagonists such as Inflectra may reactivate the hepatitis B virus in patients carrying this virus , which in some cases may be life-threatening.
- If you experience hepatitis B reactivation, your doctor may need to stop treatment and prescribe drugs such as effective antiviral therapy with supportive care.
Heart problems
- Tell your doctor if you have heart problems such as mild heart failure .
- Your doctor will closely monitor your heart.
- Tell your doctor immediately if you get new or worsening signs of heart failure during treatment with Inflectra. Such signs include shortness of breath or swollen feet.
Cancer and lymphoma
- Tell your doctor before receiving Inflectra if you have or have ever had lymphoma (a type of blood cancer) or any other cancer.
- Patients with severe rheumatoid arthritis who have had the disease for a long time may have a higher risk of developing lymphoma .
- Children and adults treated with Inflectra may be at increased risk of developing lymphoma or any other cancer.
- Some patients who have received TNF- blockers including infliximab have developed a rare type of cancer called T-cell lymphoma of the liver and spleen . Of these patients, most were teenage boys or young men and most had either Crohn’s disease or ulcerative colitis . This type of cancer usually leads to death. Almost all patients had also received a drug containing azathioprine or mercaptopurine in addition to TNF inhibitors.
- Some patients treated with infliximab have developed certain types of skin cancer. Tell your doctor if there are any changes in the skin or growths on the skin during or after the treatment.
- Some women treated for rheumatoid arthritis with infliximab have developed cervical cancer. For women taking Inflectra, even those over 60 years of age: Your doctor may recommend regular examinations for cervical cancer.
Lung disease or heavy smoking
- Tell your doctor before receiving Inflectra if you have a lung disease called chronic obstructive pulmonary disease (COPD), or if you are a heavy smoker.
- Patients who have COPD or patients who are heavy smokers may have a higher risk of developing cancer during treatment with Inflectra.
Diseases of the nervous system
- Tell your doctor before receiving Inflectra if you have or have had problems affecting your nervous system. These include multiple sclerosis , Guillain ‑ Barré syndrome, if you have a seizure or have been diagnosed with “optic neuritis”.
- Tell your doctor immediately if you experience symptoms of nerve disease during treatment with Inflectra. Such signs include altered vision, weakness in the arms or legs, numbness or tingling in any part of the body.
Fistulas
- Tell your doctor if you have any abnormal skin opening ( fistula ) before receiving Inflectra.
Vaccinations
- Tell your doctor if you have recently had or are planning to get vaccinated.
- You should receive recommended vaccinations before starting treatment with Inflectra. You can get certain vaccines during treatment with Inflectra but you should not get live vaccines (vaccines that contain a live but attenuated infectious agent) during treatment with Inflectra as they may cause you infection .
- If you received Inflectra while you were pregnant, your baby may also be at a higher risk of getting a live vaccine infection for up to six months after birth. It is important that you tell your child’s doctor and other healthcare professionals if you have been treated with Inflectra. They can then decide when your child should receive a vaccine, including live vaccines such as BCG (used to prevent tuberculosis ). For more information, see the section on pregnancy and breastfeeding.
Antimicrobial agents
- Tell your doctor if you have recently received or are planning to receive treatment with an antimicrobial agent (such as BCG instillation which is used to treat cancer).
Operations or dental treatments
- Tell your doctor if you are going to have any surgery or dental treatment.
- Tell your doctor or dentist that you are being treated with Inflectra by showing your Patient Card.
Liver problem
- Some patients receiving infliximab have developed severe liver problems.
- Tell your doctor immediately if you experience symptoms of liver problems during treatment with Inflectra. Such signs include yellowing of the skin and eyes, dark brown urine, pain or swelling in the upper right side of the abdomen, joint pain, rash or fever.
Low blood levels
- In some patients receiving infliximab, the body may not be able to produce enough blood cells to help fight infection or to stop bleeding.
- Tell your doctor immediately if you experience symptoms of low blood pressure during treatment with Inflectra. Such signs include persistent fever, easy bleeding or bruising, small red or purple spots caused by bleeding under the skin or pallor.
Diseases of the immune system
- Some patients receiving infliximab have developed symptoms of an immune disorder called lupus.
- Tell your doctor immediately if you develop symptoms of lupus during treatment with Inflectra. Such signs include joint pain or rash on the cheeks or arms that are sensitive to the sun.
Children and young people
The above information also applies to children and young people. In addition:
- Some children and teens who have received TNF inhibitors, such as infliximab, have developed cancer, even rare types, which have sometimes led to death.
- More children taking Inflectra get an infection compared to adults.
- Children should receive recommended vaccinations before starting infliximab treatment. Children may receive certain vaccines during treatment with Inflectra but should not receive live vaccines while using Inflectra.
Inflectra should only be given to children being treated for Crohn’s disease or ulcerative colitis. These children must be 6 years or older.
If you are not sure if any of the above applies to you, talk to your doctor before receiving Inflectra.
Other medicines and Inflectra
Patients with inflammatory diseases are already taking medication to treat their problems. These drugs can cause side effects. Your doctor will tell you which other medicines you must continue to use when you receive Inflectra.
Tell your doctor if you are taking, have recently taken, or might take any other medicines, including medicines to treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis or psoriasis, or over-the-counter medicines such as vitamins and herbal remedies.
In particular, tell your doctor if you are taking any of the following medicines:
- Drugs that affect the immune system.
- Kineret (containing anakinra). Inflectra and Kineret should not be used together.
- Orencia (which contains abatacept). Inflectra and Orencia should not be used together.
You should not receive live vaccines when using Inflectra. If you have been pregnant and used Inflectra at the same time, talk to your child’s doctor and other healthcare professionals who have contact with your child. Inform about your treatment with Inflectra before the child receives any vaccine.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Inflectra.
Pregnancy, breastfeeding and fertility
- If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. Inflectra should only be used during pregnancy if your doctor thinks it is necessary.
- You should avoid becoming pregnant when you are treated with Inflectra and for 6 months after stopping treatment. Discuss the use of appropriate contraceptives during this time with your doctor.
- Do not breast-feed when you are being treated with Inflectra or for 6 months after stopping your Inflectra treatment.
- If you received Inflectra during your pregnancy, your baby may be at higher risk of getting an infection .
- It is important that you tell your child’s doctor and other healthcare professionals if you have been treated with Inflectra before your child receives any vaccine. If you received Inflectra during pregnancy and your baby receives BCG vaccine (used to prevent tuberculosis ) within 6 months after birth, it can lead to infection with serious complications, even fatal. Live vaccines such as BCG should not be given to your baby within 6 months of birth. For more information, see the section on vaccinations.
- Significantly decreased white blood cell counts have been reported in infants born to women treated with infliximab during pregnancy. If your child has a constant fever or infection , contact your child’s doctor immediately.
Driving and using machines
Inflectra is unlikely to affect your ability to drive or use tools or machines. If you feel tired, dizzy, or unwell after receiving Inflectra, do not drive or use any tools or machines.
Inflectra contains sodium
Inflectra contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free. However, before you can receive Inflectra, it must be mixed with a sodium-containing solution. Talk to your doctor if you have been prescribed a low-salt diet.
3. How Inflectra is given
Amount of Inflectra given
- Your doctor will decide on your dose and how often you should receive Inflectra. It depends on your illness, weight and how well you respond to Inflectra.
- The table below shows how you will most likely receive this medicine after your first dose .
| 2nd dos en | 2 weeks after 1st dose one |
| 3rd dos en | 6 weeks after 1st dose one |
| Additional dose er | Every 6 to 8 weeks depending on the disease |
Rheumatoid arthritis
The usual dose is 3 mg per kg body weight.
Psoriatic arthritis, ankylosing spondylitis (Bechterew’s disease), psoriasis, ulcerative colitis, and Crohn’s disease
The usual dose is 5 mg per kg body weight.
How Inflectra is given
- Inflectra will be given to you by a doctor or nurse at a hospital or clinic.
- Your doctor or nurse will prepare the medicine for infusion .
- The drug will be given as an infusion (drip) over 2 hours in a vein,usually in one arm. After the third treatment, your doctor may decide to give you your dose of Inflectra for 1 hour.
- You will be monitored while receiving Inflectra and also 1-2 hours afterwards.
Use for children and adolescents
For children (6 years or older) treated for Crohn’s disease or ulcerative colitis, the recommended dose is the same as for adults.
If you take more Inflectra than you should
Because this medicine is given by a doctor or nurse, it is unlikely that you will receive too much. There are no known side effects after taking too much Inflectra.
If you forget or miss your Inflectra infusion
If you have forgotten or missed a visit to get Inflectra, book a new visit as soon as possible.
If you have any further questions on the use of this product, ask your doctor.
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 patients may experience serious side effects that may require treatment. Side effects may also occur after stopping treatment with Inflectra.
Tell your doctor immediately if you notice any of the following:
- Signs of an allergic reaction such as swelling of the face, lips, mouth or throat, which can cause difficulty swallowing or breathing, skin rash, hives, swollen hands, feet or ankles. Some of these reactions can be serious or life-threatening. An allergic reaction can occur within 2 hours after injection one or later. Other signs of allergic side effects that can occur up to 12 days after injection include muscle aches, fever, joint or jaw pain, sore throat or headache.
- Signs of heart problems such as discomfort or pain in the chest, pain in the arm, abdominal pain, shortness of breath, anxiety, dizziness, dizziness, fainting, sweating, nausea, vomiting, fluttering or throbbing beats in the chest, fast or slow heartbeat and swollen feet.
- Signs of infection (includes TBC) such as fever, tiredness, cough which may be persistent, shortness of breath, flu-like symptoms , weight loss, night sweats, diarrhea, sores, accumulation of var in the intestine or around the anus (abscess), dental problems or burning sensation when urinating .
- Signs of lung problems such as cough, difficulty breathing or tightness in the chest.
- Possible signs of cancer , which include but are not limited to swollen lymph nodes , weight loss, fever, unusual lumps in the skin, changes in skin spots or skin color or unusual bleeding from the abdomen.
- Signs of nervous system problems (including eye problems) such as signs of stroke (sudden numbness or weakness in the face, arms or legs, especially on one side of the body; sudden confusion, difficulty speaking or understanding; difficulty seeing with one or both eyes , difficulty walking, dizziness, loss of balance or coordination, or severe headache), seizures, tingling / numbness in any part of the body, or weakness in the arms or legs, altered vision such as double vision or other eye problems.
- Signs of liver problems (including hepatitis B infection if you have had hepatitis B before ) such as yellowing of the skin or eyes, dark brown urine, pain or swelling in the upper right side of the abdomen, joint pain, rash or fever.
- Signs of an immune disease such as joint pain or rash on the cheeks or arms that are sensitive to the sun (lupus) or cough, shortness of breath, fever or rash ( sarcoidosis ).
- Signs of low blood levels such as persistent fever, easy bleeding or bruising, small red or purple spots caused by bleeding under the skin or pallor.
- Signs of severe skin problems such as reddish spots, or round spots often with blisters in the middle, localized on the upper body, large areas of scaly and tender skin (exfoliation), cold sores, sores in the throat, nose, genitals and eyes, or small lumps that are can spread throughout the body. These skin reactions may be accompanied by fever.
Tell your doctor immediately if you notice any of the above.
The following side effects have been observed with Inflectra:
Very common: may affect more than 1 in 10 people
- Abdominal pain, nausea
- Viral infections such as herpes or flu
- Upper respiratory tract infection such as sinusitis
- Headache
- Side effect is of an infusion
- Pain.
Common: may affect up to 1 in 10 people
- Changes in how the liver works, increase in liver enzyme values (shown by blood test)
- Infection is in the lungs or breasts such as bronchitis or pneumonia
- Severe or painful breathing, chest pain
- Bleeding in the stomach or intestines, diarrhea, indigestion, heartburn, constipation
- Hives ( urticaria ), itchy rash or dry skin
- Balance problems or dizziness
- Fever, increased sweating
- Circulatory problems such as low or high blood pressure
- Bruising, hot flashes or nosebleeds, hot, red skin ( redness )
- Feeling tired or weak
- Bacterial infections such as sepsis, abscess or skin infection ( cellulite )
- Fungal infection of the skin
- Blood problems such as anemia or low white blood cell count
- Swollen lymph nodes
- Depression, sleep problems
- Eye problems involving redness and infection s
- Rapid heartbeat ( tachycardia ) or palpitations
- Pain in joints, muscles or back
- Urinary tract infection
- Psoriasis , skin problems such as eczema and hair loss
- Injection site reactions such as pain, swelling, redness or itching
- Chills, accumulation of fluid under the skin that causes swelling
- Numbness or a stinging sensation.
Uncommon: may affect up to 1 in 100 people
- Poor blood supply, swelling in a blood vessel
- Accumulation of blood outside the blood vessels (hematoma) or bruising
- Skin problems such as blisters, warts, abnormal skin color or pigmentation or swollen lips, or thickening of the skin, or red, scaly and flaky skin
- Severe allergic reactions (eg anaphylaxis ), an immune disorder called lupus, allergic reactions to foreign protein s
- Impaired wound healing
- Swollen liver ( hepatitis ) or gallbladder, liver damage
- Feeling forgetful, annoyed, confused, nervous
- Eye problems that include blurred vision or impaired vision, swollen eyes or vagel
- New onset or worsening of existing heart failure , slow heartbeat
- Fainting
- Cramps, nerve problems
- Intestinal perforation or obstruction in the intestine, abdominal pain or cramps
- Swollen pancreas ( pancreatitis )
- Fungal infections such as yeast infection , or fungal infection of the nails
- Lung problems (such as edema )
- Fluid around the lungs (alveolar discharge)
- Narrowed airways in the lungs that cause difficulty breathing
- Inflammation of tissue around the lungs that causes sharp chest pain that worsens with breathing (pneumonia)
- Tuberculosis
- Kidney infections
- Low platelet count , too many white blood cells
- Infection is in the vagina
- Blood tests that show antibodies are against your own body.
Rare: may affect 1 in 1,000 people
- A type of blood cancer ( lymphoma )
- The blood does not supply enough oxygen to the body, circulatory problems such as narrowing of a blood vessel
- Meningitis ( meningitis )
- Infection is caused by a weakened immune system
- Hepatitis B infection if you have had hepatitis B before
- Inflammation of the liver caused by problems with the immune system ( autoimmune hepatitis )
- Liver problems that cause yellowing of the skin or eyes (jaundice)
- Abnormal swelling or growth of tissue
- Severe allergic reaction that may cause unconsciousness and may be life threatening (anaphylactic shock )
- Swelling of small blood vessels ( vasculitis )
- Immune disorders that may affect the lungs, skin and lymph nodes (such as sarcoidosis )
- Accumulation of immune cells derived from an inflammatory response (granulomatous lesions )
- Lack of interest or feelings
- Severe skin problems such as toxic epidermal necrolysis , Stevens-Johnson syndrome and acute generalized exanthematous pustulosis
- Other skin problems such as erythema multiforme, blisters and scaly skin, or boils ( furunculosis )
- Severe nervous system disorders such as transverse myelitis , multiple sclerosis- like disease, optic neuritis and Guillain ‑ Barré syndrome
- Inflammation of the eye that can cause changes in vision, including blindness
- Fluid around the pericardium (pouring into the pericardium)
- Severe lung problems (such as interstitial lung disease)
- Melanoma (a type of skin cancer)
- Cervical cancer
- Low blood levels, even greatly reduced white blood cell count
- Small red or purple spots caused by bleeding under the skin
- Lichenoid reactions (itchy red-purple rash and / or thread-like white-gray lines on mucous membranes)
- Abnormal levels of a protein in the blood called a “complement factor” that is part of the immune system.
Has been reported: occurs in an unknown number of users
- Cancer in children and adults
- An unusual blood cancer that mostly affects teenage boys or young men (T ‑ cell lymphoma in the liver and spleen )
- Liver failure
- 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.
- Exacerbation of a condition called dermatomyositis (seen as a skin rash with muscle weakness)
- Heart attack
- Stroke
- Temporary loss of vision during or within 2 hours after infusion
- Infection caused by a live vaccine due to a weakened immune system.
Additional side effects in children and adolescents
Children taking infliximab for Crohn’s disease had some differences in side effects compared to adults taking infliximab for Crohn’s disease. The side effects that occurred more frequently in children were: low red blood cell count ( anemia ), bloody stools, low total white blood cell count ( leukopenia ), red skin or redness (swelling), viral infections, low white blood cell count fighting infection ( neutropenia ), bone fractures, bacterial infection and allergic reactions in the respiratory tract.
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 Inflectra
Inflectra is usually stored by healthcare professionals at the hospital or clinic. The storage instructions are as follows if you need to know them:
- 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 and carton after “EXP”. The expiration date is the last day of the specified month.
- Store in a refrigerator (2 ° C-8 ° C).
- This medicine can also be stored in the original package outside the refrigerator at a maximum of 25 ° C for a single period of up to 6 months, but without exceeding the original expiry date. In such a situation, it should not be stored in the refrigerator again. Write the new expiration date on the box, with day / month / year. Discard the medicine if it is not used before the new expiry date or the expiration date printed on the carton, whichever comes first.
- When Inflectra is ready for infusion , it is recommended that it be used as soon as possible (within 3 hours). However, if the solution is prepared under germ-free conditions, it can be stored in a refrigerator at 2 ° C-8 ° C for up to 60 days and for a further 24 hours at 25 ° C after removal from the refrigerator.
- Do not use this medicine if it is discolored or contains particles.
6. Contents of the packaging and other information
Content declaration
- The active substance is infliximab. Each vial contains 100 mg infliximab. After reconstitution , each ml contains 10 mg infliximab
- The other ingredients are sucrose, polysorbate 80, sodium dihydrogen phosphate monohydrate and disodium phosphate dihydrate.
What the medicine looks like and contents of the pack
Inflectra is supplied in a glass vial containing a powder for concentrate for solution for infusion. The powder is white.
Inflectra is manufactured in packs of 1, 2, 3, 4, or 5 vials. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium
Manufacturer
Hospira Zagreb doo
Prudnička Cesta 60
10291 Prigorje Brdovečko
Croatia
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