Inflectra (Infliximab-dyyb Intravenous)

Generic name: Infliximab-dyyb
Drug class: TNF alfa inhibitors

Usage of Inflectra (Infliximab-dyyb Intravenous)

Infliximab-dyyb 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 and moderate to severely active ulcerative colitis. Infliximab-dyyb 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.

Inflectra (Infliximab-dyyb Intravenous) side 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:

More common

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 with exertion

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 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

Less common

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.

Before taking Inflectra (Infliximab-dyyb Intravenous)

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-dyyb injection for the treatment of Crohn 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-dyyb injection is not helpful in children with juvenile rheumatoid arthritis. Efficacy has not been established.

Geriatric

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

Levoketoconazole

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.

Relate drugs

How to use Inflectra (Infliximab-dyyb Intravenous)

A doctor or other trained health professional will give you 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.

Warnings

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 tests may be needed to check for unwanted effects.

Infliximab-dyyb 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-dyyb. 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 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-dyyb. 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 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 stomach pain, or yellow eyes and skin.

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

If you have a baby while receiving infliximab-dyyb, 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, red skin lesions, severe acne or a skin rash, sores or ulcers on the skin, or fever or chills with this medicine.

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

Disclaimer

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