Ixifi Intravenous

In the U.S.

• Ixifi

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Immunological Agent

Pharmacologic Class: Infliximab

Infliximab-qbtx injection is used in adults to treat Crohn disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and chronic severe plaque psoriasis. It is also used in children to treat Crohn disease. Infliximab-qbtx injection is a monoclonal antibody that works to enhance and improve the immune system.

This medicine is available only with your doctor's prescription.

A doctor or other trained health professional will give you this medicine. It is given through a needle that is placed into one of your veins. It must be given slowly, so the needle will have to remain in place for at least 2 hours.

This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have questions.

You may also receive medicines (eg, allergy medicine, fever medicine, steroids) to help prevent possible unwanted effects during the injection.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Infliximab-qbtx may cause an infusion reaction while you are receiving it or right after the infusion ends. Check with your doctor or nurse right away if you have chest pain, fever, chills, itching, hives, rash, dizziness, fainting, lightheadedness, headache, joint pain, difficulty with swallowing, shortness of breath, trouble breathing, or swelling of the face, tongue, and throat.

Your body's ability to fight an infection may be reduced while you are using infliximab-qbtx. It is very important that you call your doctor at the first sign of any infection. Check with your doctor right away if you have a fever, chills, cough, flu-like symptoms, or unusual tiredness or weakness.

You will need to have a skin test for tuberculosis before you start receiving this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

A small number of people (including children and teenagers) who have used this medicine have developed certain types of cancer. This is more common in patients who have lung diseases (eg, emphysema, COPD) or are heavy smokers, and in psoriasis patients who have had phototherapy treatment for a long time. Phototherapy treatment is ultraviolet light or sunlight combined with oral medicine to make your skin sensitive to light. Some teenagers and young adults with Crohn disease or ulcerative colitis also developed a rare type of cancer called hepatosplenic T-cell lymphoma. Talk with your doctor if you have unusual bleeding, bruising, or weakness, swollen lymph nodes in the neck, underarms, or groin, unexplained weight loss, or red, scaly patches, or raised bumps with pus on the skin.

Receiving this medicine may increase your risk of getting skin cancer (eg, melanoma, Merkel cell carcinoma) or cervical cancer. If you have any changes or growths on your skin, abnormal vaginal bleeding or pelvic pain, check with your doctor right away.

It is important to have your heart checked closely if you receive infliximab-qbtx. Call your doctor right away if you have difficulty breathing, swelling in the ankles and feet, or a sudden weight gain.

Serious skin reactions can occur while you are receiving this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores, ulcers, or white spots in your mouth, or unusual tiredness or weakness.

This medicine may increase your chance of having a lupus-like syndrome or a liver disease called autoimmune hepatitis. Check with your doctor right away if you have dark brown-colored urine, fever or chills, a general feeling of discomfort, illness, or weakness, joint pain, light-colored stools, nausea and vomiting, a rash on the cheeks or arms that is worse in the sun, severe tiredness, upper right-sided stomach pain, or yellow eyes and skin.

While you are being treated with infliximab-qbtx, do not have any immunizations (vaccines) without your doctor's approval. Live virus vaccines should not be given with infliximab-qbtx. Your child's vaccinations must be current before receiving infliximab-qbtx. Talk to your child's doctor if you have any questions about this.

Women: If you have a baby while receiving infliximab-qbtx, make sure the baby's doctor knows that you were receiving this medicine. You will need to wait a few months before giving certain vaccines to your baby. Talk to the baby's doctor if you have questions.

Do not take other medicines unless they have been discussed with your doctor. This includes abatacept (Orencia®), anakinra (Kineret®), tocilizumab (Actemra®), or other medicines called biologics that are used to treat the same conditions as infliximab-qbtx. Using these medicines together with infliximab-qbtx may increase your chance of having serious unwanted effects.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Black, tarry stools
• bladder pain
• bloody or cloudy urine
• blurred vision
• body aches or pain
• chest pain
• chills
• cough
• cough producing mucus
• difficult, burning, or painful urination
• difficulty breathing
• dizziness
• dryness or soreness of the throat
• ear congestion
• fever
• frequent urge to urinate
• headache
• hoarseness
• itching, rash
• loss of voice
• lower back or side pain
• nasal congestion
• nervousness
• pain or swelling in the arms or legs
• pain or tenderness around the eyes and cheekbones
• painful or difficult urination
• pale skin
• pounding in the ears
• slow or fast heartbeat
• sneezing
• sores, ulcers, or white spots on the lips or in the mouth
• stuffy or runny nose
• swollen glands
• tender, swollen glands in the neck
• tightness in the chest
• trouble swallowing
• troubled breathing
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• voice changes

• Bleeding gums
• blood in the stool
• blue lips and fingernails
• blurred vision
• changes in skin color or tenderness of the foot or leg
• chest discomfort
• confusion
• coughing that sometimes produces a pink frothy sputum
• dark urine
• decreased urination
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• fast or noisy breathing
• feeling of discomfort
• general feeling of illness
• general tiredness and weakness
• high fever
• hives
• increase in heart rate
• increased sweating
• inflammation of the joints
• irregular heartbeat
• light-colored stools
• muscle aches
• nausea
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid, shallow breathing
• sunken eyes
• thirst
• upper right abdominal pain
• vomiting
• weight loss
• wrinkled skin
• yellow eyes and skin

• Back pain, sudden and severe
• blistering, peeling, loosening of the skin
• bloody nose
• burning, tingling, numbness or pain in the hands, arms, feet, or legs
• change in mental status
• clay-colored stools
• diarrhea
• difficulty speaking
• dilated neck veins
• double vision
• heavier menstrual periods
• inability to move arms, legs, or facial muscles
• inability to speak
• loss of appetite
• muscle weakness, sudden and progressing
• red, irritated eyes
• red skin lesions, often with a purple center
• seizures
• sensation of pins and needles
• slow or irregular breathing
• slow speech
• stabbing pain
• temporary vision loss
• vomiting of blood
• weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Belching
• diarrhea
• difficulty in moving
• feeling of warmth
• heartburn
• indigestion
• muscle stiffness
• redness of the face, neck, arms and occasionally, upper chest

• Constipation, severe

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.