Infliximab-dyyb injection (Inflectra): IBD Drug Side Effects & Dosage

What is infliximab-dyyb, and how does it work?

• 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.

What are the uses for infliximab-dyyb?

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.

What are the side effects of infliximab-dyyb?

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

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What is the dosage for infliximab-dyyb?

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.

Which drugs or supplements interact with infliximab-dyyb?

• 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.

Ulcerative colitis affects the colon. The colon is also referred to as the…
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Is infliximab-dyyb safe to use during pregnancy or while breastfeeding?

• 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 else should I know about infliximab-dyyb?

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.