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Guide Health: The cutting edge of biologicals

These newest types of drugs are manufactured by living organisms

Drugs are usually chemical molecules that block or enhance some activity within the body, and most drugs can easily be absorbed through your gastrointestinal tract in order to have their effect within the intended system.

However, the newest types of drugs are termed biologicals because they are manufactured by living organisms such as bacteria using techniques like recombinant DNA technology. Rather than tablets being produced in a pharmaceutical factory, large scale laboratories grow and harvest biologicals.

Biologicals are large complex molecules or mixtures of molecules. They are too large to be absorbed through the gastrointestinal tract, and thus need to be injected or infused.

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Temperature control is key to their stability, which means refrigeration is needed.

And, of course, they are also extremely expensive.

You can identify a biological because of the common suffix — mab. The “mab” refers to monoclonal antibodies which are part of the production process, for example adalimumab (Humira), infliximab (Remicade), rituximab (Rituxan), bevacizumab (Avastin), trastuzumab (Herceptin).

Their effectiveness arises from their ability to affect the body’s immune system.

Diseases like rheumatoid arthritis, psoriasis, multiple sclerosis, Crohn’s disease, and ulcerative colitis involve the immune system and are considered auto-immune diseases. Biologicals can target specific sites in the immune system to disrupt the disease process.

The immune system is also involved in cancers like leukemia, lymphoma, breast, colorectal, and kidney cancers, and biologicals also seem to have a place here.

Often, gene testing on the cancer is performed, and with the presence of a specific gene, it is known that a specific biological will be effective.

As with any parenteral drug, injection or infusion site reactions can occur, such as soreness, bruising and pain. And as with any drug, an allergy is always possible.

Because biologicals act on the immune system, they can also reduce resistance to infections.

Prior to starting treatment, you will be tested for tuberculosis because biologicals can activate this infection. Biologicals do not increase the risk for malignancies, but may unmask or accelerate them. And these drugs seem to cause elevations in liver enzymes.

Biologicals are intended for people who have moderate to severe diseases that involve the immune system and who have failed other “standard” therapy. Individuals who have other conditions such as diabetes, chronic obstructive pulmonary disease, or kidney disease can use biologicals, but need to have their underlying medical conditions well controlled in order to gain the most benefit without causing harmful complications.

Before a biological is started you should ensure that all your immunizations are up to date, and once you are using a biological, live vaccines are not recommended. If you need a live vaccine such as one for shingles prevention, you need to stop your biological following your physician’s recommendations.

With a biological, you do have an increased risk for infections, and need to be careful. Keep in mind that with biologicals, the positive effects are not usually immediate and you may still need to use your other therapies as well. They are definitely an advancement in therapy, but not a magic cure!

About the author


Marie Berry is a lawyer/pharmacist interested in health and education.



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