infliximab-dyyb (Inflectra)

• Infliximab-dyyb is an antibody administered intravenously and is used for treating several chronic inflammatory diseases such as Crohn's disease, psoriatic arthritis, or rheumatoid arthritis. It is a biosimilar version of the biologic drug, infliximab (Remicade). Biologic drugs are drugs that are produced by natural, biologic processes, for example, within cells. A biosimilar version is a medication that works like the original biologic drug but is manufactured by a different company by a different process. Infliximab-dyyb works by blocking the effects of tumor necrosis factor alpha (TNF alpha), a substance made by cells of the body which has an important role in promoting inflammation. There are two other injectable drugs that block TNF alpha--adalimumab (Humira) and etanercept (Enbrel).
• Infliximab-dyyb reduces the signs and symptoms of inflammation by blocking the action of TNF-alpha. Infliximab-dyyb does not cure Crohn's disease, psoriatic arthritis, or rheumatoid arthritis. Infliximab-dyyb can retard the destruction of joints by rheumatoid arthritis.
• The FDA approved Infliximab-dyyb in April 2016.

What brand names are available for infliximab-dyyb?

Inflectra is the brand name available for infliximab-dyyb in the US.

Is infliximab-dyyb available as a generic drug?

No, this drug is not available in generic form.

Do I need a prescription for infliximab-dyyb?

Yes, a patient must obtain a prescription by a doctor or other health care professional to receive this medication.

Infliximab-dyyb is a medication that belongs to the class of drugs called biologics, and is approved for the treatment of the following health conditions.

• Crohn's and pediatric Crohn's disease: Reducing signs and symptoms and inducing and maintaining clinical remission in children and adult patients with moderate to severe disease who did not fully respond to conventional therapy. It also is used for the treatment of adult patients with fistulas due to Crohn's.
• Ulcerative Colitis: Reducing signs and symptoms and inducing and maintaining clinical remission and mucosal healing (healing of the lining of the colon), and eliminating corticosteroid use in adult patients with ulcerative colitis who did not fully respond to conventional therapy.
• Rheumatoid Arthritis: Infliximab-dyyb is used in combination with the medication methotrexate (Trexall, Rheumatrex) to reduce signs and symptoms, reduce structural damage, and slow the progression of rheumatoid arthritis.
• Ankylosing Spondylitis: Reducing signs and symptoms of ankylosing spondylitis (a type of arthritis).
• Psoriatic Arthritis: Reducing signs and symptoms, reducing structural damage, and slowing the progression of active psoriatic arthritis.
• Plaque Psoriasis: It is used for treatment of adult patients with chronic severe plaque psoriasis who need oral or injectable medications when other oral or injectable medications are medically less appropriate.

WARNING: Infliximab-dyyb is associated with increased risk of serious infections leading to hospitalization or death. These infections include:

• Tuberculosis (TB)
• Bacterial sepsis
• Invasive fungal infections (such as histoplasmosis)
• Infections due to other opportunistic pathogens. Infliximab-dyyb should be stopped if a serious infection develops.
• Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients received treatment with tumor necrosis factor (TNF) blockers, including infliximab products.
• Post marketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers, including infliximab products.

Common side effects of infliximab-dyyb include:

• Upper respiratory tract infections
• Urinary tract infections (UTIs)
• Cough
• Rash
• Back pain
• Nausea
• Vomiting
• Abdominal pain
• Headache
• Weakness
• Fever
• Low or high blood pressure
• Chest pain
• Difficulty breathing
• Rash
• Itching
• Fever
• Chills

Serious side effects of infliximab-dyyb include:

• Hepatosplenic T-cell lymphoma
• Tuberculosis
• Serious bacterial infections (sepsis)
• Serious fungal infections
• Cancer
• Liver toxicity
• Heart failure
• Leukemia
• Seizures
• Optic neuritis
• Severe allergic reactions (anaphylaxis)
• Sun sensitivity
• Pulmonary edema
• Severe infusion reactions
• Lupus erythematosus
• Interstitial lung disease
• Pneumonia
• Hepatitis B virus (HBV) reactivation
• Cytopenias
• Demyelinating disease

Infliximab-dyyb is administered intravenously (IV).

• Crohn's disease: The recommended dose is a 5 mg/kg at 0, 2, and 6 weeks and then 5 mg/kg every 8 weeks for Crohn's in adult or pediatric patients. Adults who initially responded but then relapsed may be treated with 10 mg/kg.
• Rheumatoid arthritis: The recommended dose for the treatment of rheumatoid arthritis is 3 mg/kg at 0, 2, and 6 weeks followed by 3 mg/kg every 8 weeks. Infliximab-dyyb should be combined with methotrexate. If response is incomplete, up to 10 mg/kg or treating every 4 weeks may be tried for this type of arthritis.
• Ulcerative colitis, psoriatic arthritis, and plaque psoriasis: are treated with a 5 mg/kg infusion at 0, 2, and 6 weeks and then 5 mg/kg every 8 weeks.
• Ankylosing spondylitis: treatment is with a 5 mg/kg infusion at 0, 2, and 6 weeks and then 5 mg/kg every 6 weeks.

• Because this medication may reduce the response of the immune system, it should not be administered with vaccines containing live bacteria or viruses.
• Combining this drug with anakinra (Kineret), abatacept (Orencia) or tocilizumab (Actemra), drugs that also reduce the response of the immune system, may increase the risk of serious infections.
• This drug may indirectly alter blood levels of warfarin (Coumadin, Jantoven), cyclosporine (Neoral), and other medications that are metabolized by liver enzymes called CYP450 because the formation of these liver enzymes is affected by the level of cytokines.

• Use of this drug in during pregnancy has not been adequately evaluated.
• It is not known if it is secreted in breast milk, and, therefore, if there are effects on the nursing infant.

What preparations of infliximab-dyyb are available?

• This medication is available in powder for infusion: 100 mg

How should I keep infliximab-dyyb stored?

• Infliximab-dyyb should be refrigerated at 2 C - 8 C (36 F - 46 F).
• This medication should not be used after the expiration date. It does not contain a preservative.