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:

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.

QUESTION

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.