List, Types, Side Effects, FDA Uses (Cancer)

What are human monoclonal antibodies?

An antibody is a protein produced by the body’s immune system in response to
antigens, which are harmful substances. Antigens include bacteria, fungi,
parasites, viruses, chemicals, and other substances the immune system identifies
as foreign. Sometimes the body mistakenly identifies normal tissues as foreign
and produces antibodies against the tissue. This is the underlying cause of
autoimmune conditions such as rheumatoid arthritis and multiple sclerosis
or MS.

Antibodies are naturally produced by the immune system. However, scientists
can produce antibodies in the lab that mimic the action of the immune system.
These man-made (synthetic) antibodies act against proteins that attack normal
tissues in people with autoimmune disorders. Man-made antibodies are produced by
introducing human genes that produce antibodies into mice or another suitable
mammal. The mice then are vaccinated with the antigen that scientists want to
produce antibodies against. This causes the immune cells of the mice to produce
the desired human antibody. The term monoclonal antibody means that the man-made
antibody is synthesized from cloned immune cells, and the identical monoclonal
antibody produced binds to one type of antigen. Polyclonal antibodies are
synthesized from different immune cells and the antibodies produced bind to
multiple antigens.

What are the uses for monoclonal antibodies?

The use of monoclonal antibodies to treat diseases is called
immunotherapy therapy because each type of monoclonal antibody will target a
specific targeted antigen in the body.

Uses for monoclonal antibodies include:

In these conditions the monoclonal antibody targets and interferes with the
action of a chemical or receptor that is involved in the development of the
condition that is being treated. For example, a monoclonal antibody used for
treating cancer may block a receptor that cancer cells use for preventing the
immune system from the destroying the cancer cell. Blocking this receptor allows
the immune system to recognize cancer cells and destroy them.

What are the side effects of monoclonal antibodies?

These side effects are compiled from side effects listed for several
monoclonal antibodies. Each type of monoclonal antibody has its own side effect
profile and may or may not cause some of the side effects listed here.

Common side effects of monoclonal antibodies include:

Other side effects of monoclonal antibodies include:

Serious side effects of monoclonal antibodies may include one or more of the
following:

What drugs or other compounds interact with monoclonal antibodies?

• Serious infections are more likely to occur when monoclonal antibodies are
  combined with other
  drugs that suppress the immune system (for example,
  steroids).
• Another example of drug interaction is that the drug
  methotrexate reduces the
  absorption of adalimumab (monoclonal antibody) by 29%-49%, but no adjustments to
  the dose of adalimumab need to be made when methotrexate is given concomitantly.
• Monoclonal antibodies may interfere with the effectiveness of vaccines. Live
  vaccines, including attenuated vaccines, should not be used while patients are
  being treated with monoclonal antibodies. Patients should complete all
  recommended immunizations prior to receiving monoclonal antibodies.

What formulations of monoclonal antibodies are available?

Monoclonal antibodies are designed to be administered by injection. They are
supplied as:

• Lyophilized powder for reconstitution
• Solution for injection

Is monoclonal antibody therapy safe during pregnancy or while breastfeeding?

• Monoclonal antibodies have not been adequately studied in
  pregnant women or
  women who are
  breastfeeding. Some monoclonal antibodies, for example, nivolumab
  (Opdivo) and pembrolizumab (Keytruda), may be harmful to the fetus because of
  their mechanism of action and from other results obtained from animal
  studies.
• It is not known whether monoclonal antibodies are present in breast milk. Mothers
  who are breastfeeding should decide whether to stop or discontinue the
  monoclonal antibody because many drugs, including large proteins like monoclonal
  antibodies, are excreted in breast milk and there is a risk of serious adverse
  effects in the infant.