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Avsola (Infliximab-axxq) (Generic Infliximab Injection)

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WARNING

The use of infliximab injection products may impair your ability to fight infection and raise your chance of developing serious infections, such as widespread severe viral, bacterial, or fungal infections. These infections may require medical treatment and may result in death. If you frequently experience any form of infection or believe you are experiencing one right now, let your doctor know. This includes transient infections (like cold sores), mild infections (such open cuts or sores), and persistent, chronic illnesses.Tell your doctor if you have diabetes, have an immune system disorder, or have ever lived in an area where severe fungal infections are more prevalent, such as the Ohio or Mississippi river valleys. If you are unsure whether infections are more prevalent in your location, ask your doctor. Additionally, let your doctor know if you’re using tocilizumab, dexamethasone, methylprednisolone (Medrol), prednisolone (Orapred ODT, Pediapred, Prelone), abatacept (Orencia), anakinra (Kineret), methotrexate (Otrexup, Rasuvo, Trexall), or any other immune system suppressing drugs (Actemra).

Throughout and soon after your treatment, your doctor will keep an eye out for any infections. Call your doctor right away if you suffer any of the following symptoms before your treatment starts, while it is being administered, or just afterward: a fever, intense exhaustion, flu-like symptoms, weakness, sweating, difficulty breathing, sore throat, coughing up bloody mucus, warm, red, or painful skin, diarrhoea, stomach discomfort, or other infection-related symptoms.

You might have hepatitis B (a virus that damages the liver) or tuberculosis (TB, a serious lung infection), yet show no signs of the illnesses. In this instance, infliximab injectable products may raise your risk of developing symptoms and a more serious infection. Your doctor may request a blood test to determine whether you have an inactive hepatitis B infection in addition to performing a skin test to determine whether you have a TB infection. Before you begin taking an infliximab injection product, your doctor may prescribe you medicine to treat this infection. Inform your doctor if you have or have ever had tuberculosis (TB), if you have lived in or travelled to an area where TB is prevalent, or if you have come into contact with someone who has TB. Call your doctor right away if you experience any of the following TB symptoms or if any of these symptoms appear while you are receiving treatment: cough, loss of muscular tone, weight loss, fever, or night sweats. Additionally, call your physician right away if you experience any of the following hepatitis B symptoms or if any of them appear during or after treatment: extreme fatigue, yellowing of the skin or eyes, appetite loss, nausea, or vomiting; muscle aches; dark urine; clay-colored bowel movements; fever; chills; stomach pain; or rash.

After receiving an infliximab injection product or comparable drugs, some kids, teens, and young adults developed severe or life-threatening malignancies, such as lymphoma (cancer that begins in the cells that fight infection). Hepatosplenic T-cell lymphoma (HSTCL), a highly deadly form of cancer that frequently results in death within a short period of time, was a side effect that occurred in certain male teenagers and young adults who used an infliximab product or comparable drugs. The majority of those who experienced HSTCL were receiving care for Crohn’s disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) or ulcerative colitis with an infliximab injection product or a comparable drug along with a different drug called azathioprine (Azasan, Imuran) or 6-mercaptopurine (a condition that causes swelling and ulcers in the lining of the colon [large intestine] and rectum) (Purinethol, Purixan). If your child has ever had cancer of any kind, let the doctor know. Call your child’s doctor right away if any of these symptoms appear while they are receiving therapy for your child: unexplained loss of weight, enlarged glands in the neck, underarms, or groyne, as well as simple bleeding or bruises. The hazards of giving your child an infliximab injection product should be discussed with your child’s doctor.

When you start therapy with an infliximab injection product and each time you get the drug, your doctor or pharmacist will provide you the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website.

The dangers of using an infliximab injection product should be discussed with your doctor.

Why is this medication prescribed?

Certain autoimmune illnesses (disorders in which the immune system assaults healthy portions of the body and results in pain, swelling, and destruction) can be treated with infliximab injection products, which include:

  • Methotrexate is also used to treat rheumatoid arthritis, a disorder in which the body attacks its own joints and results in pain, swelling, and loss of function (Rheumatrex, Trexall),
  • When other treatments have not alleviated the symptoms of Crohn’s disease (a disorder where the body attacks the lining of the digestive tract, resulting in discomfort, diarrhoea, weight loss, and fever) in adults and children older than 6 years,
  • Adults and kids aged 6 and older with ulcerative colitis, a disorder that results in swelling and ulcers in the lining of the large intestine, who have not improved despite taking various drugs,
  • Spondylitis with ankylosing (a condition in which the body attacks the joints of the spine and other areas causing pain and joint damage),
  • For patients with plaque psoriasis, a skin condition that causes red, scaly patches to appear on certain body parts, when existing therapies are insufficient,
  • Psoriatic arthritis is another (a condition that causes joint pain and swelling and scales on the skin).

Tumor necrosis factor-alpha (TNF-alpha) inhibitors are a class of drugs that includes Infliximab injectable preparations. They function by preventing the body’s production of TNF-alpha, a chemical that triggers inflammation.

How should this medicine be used?

A doctor or nurse must mix sterile water with the infliximab powder before injecting it intravenously (into a vein). It is typically administered at a doctor’s office once every 2 to 8 weeks, more frequently at the start of your treatment and less frequently as it progresses. You will receive your whole dose of an injection of infliximab in around 2 hours.

Serious adverse reactions to infliximab injectable products, including allergic responses both during and for two hours following an infusion, are possible. During this period, a doctor or nurse will keep an eye on you to make sure you are not having a severe reaction to the medication. To treat or stop adverse reactions to an infliximab injection product, your doctor may prescribe other medications. If you develop any of the following symptoms during or soon after your infusion, call your doctor or nurse right once. the following symptoms: hives, rash, itching, swelling of the hands, feet, ankles, or lower legs; face, eyes, mouth, throat, tongue, or lips; chest discomfort; flushing; dizziness; fainting; fever; chills; seizures; vision loss; and hives.

Although they may aid in symptom management, infliximab injectable products cannot treat your condition. Your doctor will closely monitor you to determine how effectively infliximab injectable products are working for you. If it is necessary, your doctor may increase the dosage of the medication you take if you have Crohn’s disease or rheumatoid arthritis. After 14 weeks of treatment for Crohn’s disease, if your condition has not improved, your doctor may decide to discontinue giving you infliximab injections. It is critical to communicate your feelings to your doctor during your therapy.

Other uses for this medicine

Behcet’s syndrome can occasionally be treated with infliximab injectable products (ulcers in the mouth and on the genitals and inflammation of various parts of the body). Discuss the potential dangers of using this medicine for your illness with your doctor.

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before using an infliximab injection product,

  • If you have any allergies to infliximab, infliximab-axxq, infliximab-dyyb, infliximab-abda, any drugs derived from murine (mouse) proteins, other drugs, or any of the chemicals in infliximab, infliximab-dyyb, or infliximab-abda injection, let your doctor and pharmacist know right away. If you are unsure whether a drug to which you are allergic is made from murine proteins, ask your doctor or pharmacist. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
  • Inform your doctor and pharmacist about all prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products that you are now taking or intend to use. Mention any of the following medications as well as any anticoagulants (blood thinners) including warfarin (Coumadin), cyclosporine (Gengraf, Neoral, Sandimmune), and theophylline (Elixophyllin, Theo-24, Theochron). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • If you have heart failure now or ever had it, let your doctor know (condition in which the heart cannot pump enough blood to other parts of the body). Your doctor might advise against using an infliximab injection.
  • Inform your physician if you have ever used phototherapy (a psoriasis treatment that involves exposing the skin to ultraviolet light) and if you currently have or have previously had a condition that affects your neurological system, such as multiple sclerosis (MS; loss of coordination, weakness, and numbness due to nerve damage), any type of cancer, Guillain-Barre syndrome (weakness, tingling, and potential paralysis brought on by sudden nerve damage), optic neuritis (inflammation of the nerve that transmits messages from the eye to the brain), seizures, numbness, burning, or tingling in any part of your body, bleeding issues or blood diseases, heart disease, or chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways).
  • If you are breastfeeding a child or intend to become pregnant, let your doctor know. Call your doctor if you become pregnant while using an infliximab injectable medication. The doctor of your newborn should be informed if you used an infliximab injection product during your pregnancy. Certain immunisations may need to be given to your baby later than usual.
  • Inform the surgeon or dentist that you are using an infliximab injection product if you are having surgery, including dental surgery.
  • If you have recently had a vaccination, let your doctor know. Additionally, ask your doctor whether you require any vaccines. Avoid getting any shots without first consulting your doctor. Before starting infliximab medication, it’s crucial that both adults and kids acquire all necessary vaccinations.
  • You should be informed that a delayed allergic reaction may occur 3 to 12 days after getting an infliximab injectable product. Let your doctor know immediately away if you experience any of the following symptoms a few days or longer after starting therapy: muscle or joint pain, a headache, a sore throat, a fever, a rash, hives, itching, and swelling of the hands, face, or lips are some of the symptoms.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What side effects can this medication cause?

Products for injecting infliximab may have negative effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Nausea
  • Heartburn
  • Headache
  • Clogged nose
  • Mouth with white spots
  • Itching, burning, and pain in the vagina, as well as other symptoms of a yeast infection
  • Flushing

Some adverse effects can be very harmful. While it’s unlikely that you will suffer any of the following symptoms, you should call your doctor right once if you do, as well as anyone indicated in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections:

  • Any kind of rash, such as one that worsens in the sun and appears on the arms or cheeks
  • Chest pain
  • Abnormal heartbeat
  • Arms, back, neck, or jaw pain
  • Abdominal pain
  • Swelling in the lower legs, stomach, ankles, or feet
  • Unexpected weight gain
  • Breathing difficulty
  • Eyesight alterations or fuzziness
  • Sudden weakness of the face, arm, or leg, particularly on one side of the body
  • Joint or muscle ache
  • Any area of the body experiencing numbness or tingling
  • Unexpected difficulty understanding, speaking, or concentrating
  • Sudden difficulty walking
  • Unsteadiness or weakness
  • Loss of coordination or balance
  • An unexpectedly bad headache
  • Seizures
  • The skin or eyes turning yellow
  • Urine with a dark colour
  • Reduced appetite
  • Upper right stomach region discomfort
  • Abnormal bleeding or bruising
  • Pale skin
  • Blood in the stool
  • Pus-filled lumps or red, scaly spots on the skin

 

Your risk of developing lymphoma (a cancer that starts in the cells that fight infection) and other malignancies may increase as a result of receiving an infliximab injection. The dangers of obtaining an infliximab injection product should be discussed with your doctor.

Other negative effects from infliximab injectable products are possible. If you experience any strange issues while taking this drug, call your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

The drug will be kept by your doctor in their office.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

What other information should I know?

Keep all of your appointments with your physician and the lab. To determine how well your body has responded to an infliximab injectable product, your doctor may request specific laboratory tests.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Avsola® (Infliximab-axxq)
  • Inflectra® (Infliximab-dyyb)
  • Remicade® (Infliximab)
  • Renflexis® (Infliximab-abda)
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