Uses for AVSOLA

Infliximab-axxq injection is used to reduce the symptoms of moderate-to-severely active Crohn's disease and ulcerative colitis in adults and children who have been previously treated with other medicines but did not work well.

Infliximab-axxq injection is used alone or together with other medicines (eg, methotrexate) to reduce the symptoms and prevent the progression of moderate-to-severely active rheumatoid arthritis, psoriatic arthritis, and active ankylosing spondylitis.

Infliximab-axxq injection is also used to treat chronic severe (extensive or disabling) plaque psoriasis, which is a skin disease with red patches and white scales that do not go away. It is used in patients who cannot be treated with other medicines.

Infliximab-axxq is a monoclonal antibody that works to enhance and improve the immune system.

This medicine is to be given only by or under the direct supervision of your doctor.

Before using AVSOLA

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of infliximab-axxq injection for the treatment of Crohn's disease or ulcerative colitis in children 6 years of age and older. However, safety and efficacy have not been established in children younger than 6 years of age.

Appropriate studies performed to date have demonstrated that infliximab-axxq injection is not helpful in children with juvenile rheumatoid arthritis. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of infliximab-axxq injection in children with ankylosing spondylitis, plaque psoriasis, or psoriatic arthritis. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of infliximab-axxq injection in the elderly. However, elderly patients are more likely to have infections, which may require caution in patients receiving infliximab-axxq injection.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abatacept
• Adalimumab
• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Alefacept
• Anakinra
• Anifrolumab-fnia
• Bacillus of Calmette and Guerin Vaccine, Live
• Baricitinib
• Brodalumab
• Certolizumab Pegol
• Cyclosporine
• Dengue Tetravalent Vaccine, Live
• Etanercept
• Fosphenytoin
• Golimumab
• Guselkumab
• Influenza Virus Vaccine, Live
• Ixekizumab
• Measles Virus Vaccine, Live
• Methotrexate
• Mumps Virus Vaccine, Live
• Natalizumab
• Paclitaxel
• Phenytoin
• Poliovirus Vaccine, Live
• Quinidine
• Rilonacept
• Rituximab
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Sarilumab
• Sirolimus
• Smallpox Vaccine
• Tacrolimus
• Tocilizumab
• Tofacitinib
• Typhoid Vaccine, Live
• Ustekinumab
• Varicella Virus Vaccine, Live
• Vedolizumab
• Warfarin
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Aspergillosis (fungus infection), history of or
• Blastomycosis (fungus infection), history of or
• Blood or bone marrow problems (eg, pancytopenia), or history of or
• Candidiasis (fungus infection), history of or
• Coccidioidomycosis (fungus infection), history of or
• Diabetes or
• Guillain-Barré syndrome (nervous system disorder), history of or
• Hepatitis B, active or history of or
• Histoplasmosis (fungus infection), history of or
• Legionellosis (bacterial infection), history of or
• Leukopenia or neutropenia (low white blood cells) or
• Listeriosis (bacterial infection), history of or
• Liver disease or
• Multiple sclerosis, history of or
• Optic neuritis (eye problem) or
• Pneumocystosis (fungus infection), history of or
• Psoriasis (skin disease) or
• Seizures, history of or
• Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.

• Cancer, active or history of or
• Chronic obstructive pulmonary disease (COPD) or
• Heart or blood vessel disease—Use with caution. May increase risk for more side effects.

• Congestive heart failure, moderate to severe—Should not be given to patients with this condition.

• Tuberculosis, history of—Use with caution. Patients may need additional tuberculosis treatment.

Proper use of AVSOLA

A doctor or other trained health professional will give you or your child this medicine in a medical facility. 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.

Precautions while using AVSOLA

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

Infliximab-axxq may cause an infusion reaction, including a heart attack, stroke, changes in blood pressure, or heart rhythm problems (eg, arrhythmia), while you or your child 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, 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-axxq. 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, 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's 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-axxq. Call your doctor right away if you have difficulty breathing, swelling in the ankles and feet, or a sudden weight gain.

This medicine may increase your or your child's risk 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 stomach pain, or yellow eyes and skin.

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

Women: If you have a baby while receiving infliximab-axxq, 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.

Serious skin reactions can occur with 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.

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-axxq. Using these medicines together with infliximab-axxq may increase your chance of having serious unwanted effects.

Side Effects of AVSOLA

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:

More common

• Black, tarry stools
• bladder pain
• bloody or cloudy urine
• blurred vision
• body aches or pain
• chest pain or tightness
• 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 or rash
• loss of voice
• lower back or side pain
• 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
• trouble swallowing
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• voice changes

Rare

• 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 or stomach pain
• vomiting
• weight loss
• wrinkled skin
• yellow eyes and skin

Incidence not known

• 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 the 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:

More common

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

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.

Frequently asked questions

• What are the new drugs for the treatment of rheumatoid arthritis (RA)?
• What are biosimilar drugs?
• What causes Plaque Psoriasis?
• What are the new drugs for the treatment of plaque psoriasis?
• How many biosimilars have been approved in the United States?
• What is the mechanism of action of infliximab?
• What is the difference between Inflectra and Remicade?

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