Zessly – Infliximab uses, dose and side effects

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100 mg powder for concentrate for infusion liquid, solution
infliximab

What Zessly is and what it is used for

Zessly contains the active substance infliximab. 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).

Zessly 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.

Zessly is also used in adults and children, 6 years and older in:

  • Crohn’s disease
  • Ulcerative colitis.

Zessly works by specifically binding to TNF alpha and blocking its function. TNF alpha participates in inflammatory processes in the body and by blocking their inflammation in your body can be reduced.

Rheumatoid arthritis

Rheumatoid arthritis is an inflammatory disease that attacks 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 Zessly to be taken in combination with another medicine called methotrexate to:

  • Reduce 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 in association 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 Zessly to: •

  • Reduce 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 Zessly to:

  • Reduce 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 receive other medicines or treatments such as light therapy. If these medicines or treatments do not work well enough, you will be given Zessly 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 Zessly 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 Zessly to:

  • Treat active Crohn’s disease
  • Reduce the number of abnormal passages ( fistulas ) through the skin from the intestine that has not been controlled with other drugs or surgery.

What you need to know before using Zessly

You will not receive Zessly if:

  • You are allergic to infliximab or any of the other ingredients of this medicine (listed in section 6)
  • You are allergic (hypersensitive) to proteins that come from mice
  • You have tuberculosis (TB) or another serious infection such as pneumonia or blood poisoning
  • You have heart failure that is moderate or severe.

Do not use Zessly if any of the above applies to you. If you are not sure, talk to your doctor before receiving Zessly.

Warnings and precautions

Talk to your doctor before or during treatment with Zessly if you have:

Received treatment with any medicine containing infliximab before

  • Tell your doctor if you have previously received medicines containing infliximab and now start treatment with Zessly again.
  • If you have had a break in your treatment with infliximab for more than 16 weeks, there is an increased risk of allergic reactions when you start treatment again.

Infection you

  • Before receiving Zessly, tell your doctor if you have any infection, even if it is a very mild one.
  • Before receiving Zessly, tell your doctor if you have ever lived in or traveled to areas where infections called histoplasmosis, coccidioidomycosis, or blastomycosis are common. These infections are caused by a special type of fungus that can affect the lungs or other parts of the body.
  • You can get an infection more easily when you are treated with Zeiss. If you are 65 or older, the risk is higher.
  • These infections can be serious and include tuberculosis, an infection caused by viruses, fungi, bacteria, or other organisms in the environment, and blood poisoning which can be life-threatening.

Tell your doctor immediately if you develop any signs of infection during treatment with Zessly. Such signs include fever, cough, flu-like symptoms, general malaise, red or warm skin, sores, or toothache. Your doctor may recommend that Zessly’s treatment be temporarily stopped.

Tuberculosis (TB)

  • You must tell your doctor if you have ever had TB or if you have been in close contact with someone who has or has TB
  • Your doctor will check if you have TB. Cases of TB have been reported in patients treated with infliximab, even in patients already treated with anti-TB drugs. Your doctor will note the examinations on your Patient’s Card
  • If your doctor thinks you are at risk of TB, you may be given anti-TB medicines before you receive Zessly.

Tell your doctor immediately if you develop any signs of TB during treatment with Zessly. Such signs include persistent cough, weight loss, feeling tired, fever, and night sweats.

Hepatitis B virus

  • Before receiving Zessly, tell your doctor if you are a carrier of hepatitis B 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 inhibitors such as Zessly can cause the hepatitis B virus to reactivate in patients who carry this virus, which in some cases can be life-threatening.

Heart trouble

  • 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 develop new or worsening signs of heart failure during treatment with Zessly. Such signs include shortness of breath or swelling

feet.

Cancer and lymphoma

  • Before receiving Zessly, tell your doctor 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 Zessly may be at an increased risk of developing lymphoma or another cancer
  • Some patients who have received TNF inhibitors, 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 younger men, and most had either Crohn’s disease or ulcerative colitis. This type of cancer usually leads to death. In addition to TNF inhibitors, almost all patients had also received drugs containing azathioprine or 6-mercaptopurine.
  • Some patients treated with infliximab have developed certain types of skin cancer. Tell your doctor if there are any skin changes or growths on the skin during or after treatment.
  • Some women treated for rheumatoid arthritis with infliximab have developed cervical cancer. For women taking Zessly, even those over the age of 60: Your doctor may recommend regular screening for cervical cancer.

Lung disease or heavy smoking

  • Before receiving Zessly, tell your doctor 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 Zessly.

Diseases of the nervous system

  • Before receiving Zessly, tell your doctor if you have or have had problems affecting the nervous system. These include multiple sclerosis, Guillain-Barré syndrome if you have seizures or have been diagnosed with “optic neuritis”.

Tell your doctor immediately if you develop symptoms of nerve disease during treatment with Zessly. Such signs include changes in vision, weakness in the arms or legs, and numbness or tingling in any part of the body.

Fistulas

  • Tell your doctor if you have any abnormal skin opening ( fistula ) before receiving Zessly.

Vaccinations

  • Tell your doctor if you have recently received or plan to receive a vaccination
  • You should receive the recommended vaccinations before starting treatment with Zessly. You can receive certain vaccinations during treatment with Zessly, but you should not receive live vaccines (vaccines that contain a live but weakened infectious agent) because they can cause you to become infected.
  • If you received Zessly while you were pregnant, your baby may also be at a higher risk of getting an infection, as a result of having received a live vaccine in the first year of life. You must tell your child’s doctor and other healthcare professionals if you have been treated with Zeiss. They can then decide when your child should receive any vaccine, including live vaccines such as the BCG vaccine (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 plan to receive treatment with an antimicrobial agent (such as BCG instillation which is used to treat cancer).

Surgeries or dental treatments

  • Tell your doctor if you are going to have any surgery or dental treatment.
  • Tell the doctor or dentist that you are being treated with Zessly by showing your Patient Card.

Liver problems

  • Some patients receiving treatment with medicines containing infliximab have developed serious liver problems.

Tell your doctor immediately if you develop symptoms of liver problems during treatment with Zessly. 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 counts

  • In some patients receiving treatment with medicines containing infliximab, the body cannot produce enough blood cells to help fight infection or help stop bleeding.

Tell your doctor immediately if you develop symptoms of low blood levels during treatment with Zessly. Such signs include persistent fever, easy bleeding or bruising, small red or purple spots caused by bleeding under the skin, or paleness.

Problems with the immune system

  • Some patients receiving treatment with medicines containing infliximab have developed symptoms of an immune disease called lupus.

Tell your doctor immediately if you develop symptoms of lupus during treatment with Zessly. Such signs include joint pain or a 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 teenagers given TNF inhibitors, such as infliximab, have developed cancers, even rare types, that have sometimes led to the death
  • More children taking infliximab get infections compared to adults
  • Children should receive recommended vaccinations before starting treatment with Zessly. Children may receive certain vaccines during treatment with Zessly but should not receive live vaccines while using Zessly.

If you are not sure if any of the above apply to you, talk to your doctor before receiving Zessly.

Other medicines and Zessly

Patients who have inflammatory diseases are already taking drugs to treat their problems. These medicines can cause side effects. Your doctor will let you know which other medicines you must continue to use while receiving Zessly.

Tell your doctor if you are using, have recently used, or might use any other medicines, including other 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 medicines.

In particular, tell your doctor if you are taking any of the following medicines:

  • Medicines that affect the immune system
  • Kineret (anakinra). Zessly and Kineret should not be used together
  • Orencia (abatacept). Zessly and Orencia should not be used together.

You should not receive live vaccines while using Zessly. If you have been pregnant while using Zessly or if you receive Zessly while breastfeeding, talk to your child’s doctor and other healthcare professionals who have contact with your child. Inform about your treatment with Zessly before the child receives any vaccine.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before receiving Zessly.

Pregnancy, breastfeeding, and fertility

  • If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine. Zessly should only be used during pregnancy or breastfeeding if your doctor considers it necessary.
  • You must avoid becoming pregnant while you are being treated with Zessly and for 6 months after the end of treatment. Discuss the use of appropriate contraception during this time with your doctor.
  • If you received Zessly during your pregnancy, your baby may have a higher risk of getting an infection.
  • You must tell your child’s doctor and other healthcare professionals if you have been treated with Zessly before your child is given any vaccine. If you received Zessly during pregnancy and your baby is given the BCG vaccine (used to prevent tuberculosis ) within 12 months after birth, it can cause infection with serious complications, even death. Live vaccines such as the BCG vaccine should not be given to your baby within 12 months of birth unless your baby’s doctor recommends otherwise. For more information see the section on vaccinations.
  • If you are breastfeeding, you must tell your child’s doctor and other healthcare professionals that you are using Zessly before your child receives any vaccine. Live vaccines should not be given to your baby while you are breastfeeding unless your baby’s doctor recommends otherwise.
  • Severely decreased white blood cell counts have been reported in infants born to women treated with infliximab during pregnancy. If your child has persistent febrile illness or infection, contact your child’s doctor immediately.

Driving ability and use of machinery

Zessly is not likely to affect the ability to drive or use tools or machines. If you feel tired, dizzy, or sick after receiving Zessly, do not drive or use any tools or machinery.

Zessly contains sodium

Zessly contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is almost “sodium-free”. Zessly is prepared with a solution containing sodium before it is given to you. Talk to your doctor if you have been prescribed a low-salt (low-sodium) diet.

How Zessly is given

Rheumatoid arthritis

The usual dose is 3 mg per kg of body weight.

Psoriatic arthritis, Ankylosing spondylitis (Bechterew’s disease), psoriasis, Ulcerative colitis, and Crohn’s disease

The usual dose is 5 mg per kg of body weight.

How Zessly is given

  • Zeiss will be given to you by a doctor or nurse.
  • Your doctor or nurse will prepare the medicine for infusion.
  • The medicine will be given as an infusion (drip) (over 2 hours) into a vein, usually in your arm. After the third treatment, your doctor may decide to give you your dose of Zessly over 1 hour.
  • You will be monitored while you receive Zessly and also for 1-2 hours afterward.

Amount of Zessly given

  • Your doctor will decide your dose and how often you should receive Zessly. It depends on your illness, weight, and how well you respond to Zessly
  • The table below shows how you will usually receive this medicine after your first dose.
2nd dose one2 weeks after 1st dose one
3rd dose one6 weeks after 1st dose one
Additional dose youEvery 6 to 8 weeks depending on the disease

Use for children and adolescents

Zessly should only be given to children being treated for Crohn’s disease or ulcerative colitis. These children must be 6 years of age or older.

If you have been given too much Zessly

As this medicine is given by a doctor or nurse, you are unlikely to get too much. There are no known side effects after taking too much Zessly.

If you have forgotten or missed your Zessly infusion

If you have forgotten or missed a visit to receive Zessly, book a new visit as soon as possible.

If you have further questions about this medicine, contact your doctor.

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 can also occur after treatment with Zessly has ended.

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 may 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 of injection or later. Several signs of allergic side effects that can occur up to 12 days after injection include muscle pain, 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, pain in the abdomen, shortness of breath, anxiety, dizziness, lightheadedness, fainting, sweating, nausea, vomiting, fluttering or pounding beats in the chest, fast or slow heartbeat, and/or swelling feet.
  • Signs of infection (includes TB) such as fever, feeling tired, cough which may be persistent, shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhea, ulcers, accumulation of warts in the gut or around the anus (wound abscess), toothache or burning sensation when urinating.
  • Possible signs of cancer, include but are not limited to swollen lymph nodes, weight loss, fever, unusual skin lumps, changes in skin spots or skin color, or unusual vaginal bleeding.
  • Signs of lung problems such as coughing, difficulty breathing, or tightness in the chest.
  • Signs of nervous system problems (including eye problems) such as signs of stroke (sudden numbness or weakness of the face, arms, or legs, especially on one side of the body; sudden confusion, difficulty speaking or understanding; difficulty seeing in 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, changes in vision such as double vision or other eye problems.
  • Signs of liver problems (including hepatitis B infection if you have previously had hepatitis B) 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 a rash on cheeks or arms that are sensitive to the sun (lupus) or cough, shortness of breath, fever, or skin rash ( sarcoid ).
  • Signs of low blood levels such as persistent fever, easy bleeding or bruising, and small red or purple spots caused by bleeding under the skin, or paleness.
  • Signs of a serious skin problem such as reddish spots, or round spots often with blisters in the middle, located on the upper body, large areas of scaly and tender skin (exfoliation), mouth sores, sores on the throat, nose, genitals, and eyes, or small wart-filled bumps that can spread over the body. These skin reactions may be accompanied by fever.

Tell your doctor immediately if you observe any of the above.

The following side effects have been observed with medicines containing infliximab:

Very common: may affect more than 1 in 10 users

  • Abdominal pain, nausea
  • Viral infections such as herpes or influenza
  • An upper respiratory infections such as sinusitis
  • Headache
  • Side effects of an infusion
  • Pain.

Common: may affect up to 1 in 100 users

  • Changes in how the liver works, increase in liver enzyme levels (shown by blood tests)
  • Infection in your lung or chest such as bronchitis or pneumonia
  • Difficult 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
  • Circulation problems such as low or high blood pressure
  • Bruising, flushing or nosebleeds, warm, red skin ( flushing )
  • Feeling tired or weak
  • Bacterial infections such as blood poisoning, abscess, or skin infection ( cellulitis )
  • Fungal infection of the skin
  • Blood problems such as anemia or low white blood cell count
  • Swollen lymph nodes
  • Depression, sleep problems
  • Eye problems including red eyes and infection
  • Fast heartbeats ( tachycardia ) or palpitations
  • Pain in joints, muscles, or back
  • Urinary tract infection
  • Psoriasis, skin problems such as eczema and hair loss
  • Reactions at the injection site such as pain, swelling, redness, or itching
  • Chills, fluid accumulation under the skin causing swelling
  • Numbness or a tingling sensation.

Uncommon: may affect up to 1 in 100 users

  • Poor blood supply, swelling of 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, thickening of the skin, or red, scaly, and flaky skin
  • Severe allergic reaction (eg anaphylaxis ), an immune disease called lupus, allergic reactions to foreign proteins
  • Impaired wound healing
  • Swollen liver ( hepatitis ) or gallbladder, liver damage
  • Feeling forgetful, irritable, confused, nervous
  • Eye problems that include blurred or reduced vision, swollen eyes, or blurred vision
  • New onset or worsening of existing heart failure, slow heartbeats
  • Fainting
  • Cramps, nerve problems
  • Intestinal perforation or obstruction, abdominal pain or cramping
  • Swollen pancreas ( pancreatitis )
  • Fungal infections such as yeast infections or fungal nail infection
  • Lung problems (such as edema )
  • Fluid around the lungs (alveolar effusion)
  • Narrowing of the airways in the lungs causes difficulty breathing
  • Pleurisy, which causes sharp chest pain that worsens when breathing
  • Tuberculosis
  • Kidney infections
  • Low platelet count, too many white blood cells
  • Infection in the vagina
  • Blood tests that show antibodies against your own body
  • Changes in cholesterol and fat levels in the blood.

Rare: may affect up to 1 in 1,000 users

  • A type of blood cancer ( lymphoma )
  • The blood does not supply enough oxygen to the body, and circulation problems such as the narrowing of a blood vessel
  • Inflammation of the meninges ( meningitis )
  • Infection is caused by a weakened immune system
  • Hepatitis B infection if you have previously had hepatitis B
  • Inflammation of the liver caused by problems with the immune system ( autoimmune hepatitis )
  • Liver problems causing yellowing of the skin or eyes (jaundice)
  • Abnormal swelling or growth of tissue
  • The severe allergic reaction that can cause unconsciousness and can be life-threatening (anaphylactic shock )
  • Swelling of small blood vessels ( vasculitis )
  • Immune disorders that can affect the lungs, skin, and lymph nodes (such as sarcoidosis )
  • Accumulation of immune cells resulting from an inflammatory response (granulomatous changes)
  • Lack of interest or feelings
  • Serious skin problems such as toxic epidermal necrolysis, Stevens-Johnson syndrome, and acute generalized exanthematous pustulosis
  • Other skin problems such as erythema multiforme, lichenoid reactions (itchy red-purple skin rash and/or thread-like white-gray lines on mucous membranes), blisters and scaly skin, or boils ( furunculosis )
  • Serious disorders of the nervous system 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 (pericardial effusion)
  • Serious lung problems (such as interstitial lung disease)
  • Melanoma (a type of skin cancer)
  • Cervical cancer
  • Low blood values, also greatly reduced the number of white blood cells
  • Small red or purple spots caused by bleeding under the skin
  • Abnormal levels of a protein in the blood are called the ‘complement factor which is part of the immune system.

Has been reported: occurring 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 of the liver and spleen )
  • Liver failure
  • Merkel cell carcinoma (a type of skin cancer)
  • Kaposi’s sarcoma, is rare cancer associated with infection with human herpesvirus 8. Kaposi’s sarcoma most often appears as purple spots on the skin
  • Worsening of a condition called dermatomyositis (seen as skin rash with muscle weakness)
  • Heart attack
  • Stroke
  • Temporary loss of vision during or within 2 hours of infusion
  • Infection is caused by a live vaccine, because the immune system is weakened.

Additional side effects in children and adolescents

Children who took infliximab for Crohn’s disease had some differences in side effects compared to adults who took infliximab for Crohn’s disease. The side effects that occurred more often in children were: low number of red blood cells ( anemia ), bloody stools, low total levels of white blood cells ( leukopenia ), red skin or flushing (flushing), viral infections, low levels of white blood cells that fight infection ( neutropenia ), broken bones, bacterial infection and allergic reactions in the respiratory tract.

How to store Zessly

Zessly is usually stored by healthcare professionals. The storage instructions are as follows, in case you need to know them:

  • Keep this medicine out of the sight and reach of children.
  • Use before the expiry date 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 packaging outside the refrigerator at a maximum of 30°C for a single period of up to 6 months, but without passing the original expiry date. In such a situation, it should not be stored in the refrigerator again. Write the new expiry date on the carton, with day/month/year. Discard the medicine if it is not used before the new expiry date or the expiry date printed on the carton, whichever comes first.
  • When Zessly 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 sterile conditions, it can be stored in a refrigerator at 2°C – 8°C for 24 hours.
  • Do not use this medicine if it is discolored or contains particles.

Contents of the packaging and other information

Contents declaration

  • The active substance is infliximab. Each vial contains 100 mg of infliximab. After reconstitution, each ml contains 10 mg of infliximab
  • Other ingredients are disodium succinate hexahydrate, succinic acid, sucrose, and polysorbate 80.

Appearance and package sizes of the medicine

Zessly is supplied in a glass vial containing a powder for concentrate for solution for infusion (powder for concentrate). The powder is white.

Zessly is manufactured in packs of 1, 2, 3, 4, or 5 vials. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Holder

Sandoz GmbH

Biochemistry. 10

6250 Kundl

Austria

Manufacturer

Sandoz GmbH

Biochemistry. 10

6336 Langkampfen

Austria

Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:

Sandoz A/S

Phone: +45 63 95 10 00

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