Biologics: Safety

Biologic therapies can be life-changing, but you must take them safely


Biologic therapies have proven to be very effective for people with inflammatory forms of arthritis like rheumatoid arthritis and psoriatic arthritis. They work by suppressing the immune system, which halts the inflammation process but leaves you at increased risk of infections.

Before Starting a Biologic

Before any biologic is prescribed, your doctor will ask you about the following:

  • Infections. If you have an infection, have had one recently, or have a history of chronic infection, your doctor will not begin treatment with a biologic. Signs of infection include fever, sweat, chills, muscle aches, cough, shortness of breath, painful sores on your body that do not improve, diarrhea or stomach pain, or excessive fatigue.
  • History of tuberculosis (TB). In many cases, biologics can cause reactivation of former bacterial or viral infections. You will have to have a skin or blood test for TB before starting any biologic.
  • History of hepatitis B or C. Hepatitis reactivation can occur with any biologic. This is a particular risk with rituximab and hepatitis B virus.
  • History of cancer, diabetes, a heart condition or a nervous disorder. Often, treatment for these conditions (current or past) puts you at an even greater increased risk for infection or adverse event.
  • Future vaccinations. Live vaccines are not recommended during treatment with any biologic drug. These include vaccines for the flu (nasal form only); shingles; measles, mumps and rubella (MMR); and others. If you need any live-virus vaccines, get them one to three months before starting immunosuppressant drugs. Discuss any vaccinations with your doctor first.
  • Future surgery. Treatment will either be postponed or suspended if you’re planning on having surgery. Different biologics will need to be stopped for different periods of time before surgery. You will not be able to start or restart the biologic until after your sutures or staples are removed and there is no sign of infection.
  • Pregnant, planning on becoming pregnant or breastfeeding. Long-term safety studies for fetuses and infants have not been determined for most biologics. Talk to your doctor if you are considering becoming pregnant.
  • Any allergies. If you are sensitive to latex or rubber, adalimumab is not recommended since the prefilled syringe contains these. Those allergic to E. coli proteins or currently taking etanercept should not take anakinra as these can cause adverse reactions in certain people.
  • If you live or have lived in certain areas such as the Ohio and Mississippi River valleys. Living in these areas can increase your risk for getting certain kinds of fungal infections.

Self-Injection Safety

All biologic drugs are administered as either an intravenous infusion or an injection, given in predetermined intervals depending on the specific drug. Only qualified health professionals should give infusions and initial injections. You can be taught to give yourself injections at home.

Basic safety instructions for self-injection include:

  • Store the medicine refrigerated and out of light. Most biologics should be brought to room temperature before injection. Ask your doctor how long your prescribed biologic can be left at room temperature.
  • Do not shake or freeze the drug or syringes.
  • Be sure to use sterile technique. Wear gloves, keep the area free of contaminants, clean the injection area with alcohol, and discard the syringe and needle safely.
  • Place the needle and syringe into an approved “sharps” container after use. Some pharmaceutical companies and infusion centers can provide these free of charge and dispose of them upon request.

Medication Interactions

Always tell your rheumatologist what medications and supplements you are taking. It’s also a good idea to fill all your prescriptions at the same pharmacy, so they can keep you informed about any possible drug interactions. Some common drug combinations that should be avoided include:

  • Rituximab should not be taken with cisplatin, a chemotherapy drug, because it can cause kidney damage.
  • Anakinra should not be taken with other TNF-inhibitors, specifically etanercept. You should also avoid anakinra if you are sensitive or allergic to E. coli proteins.
  • A combination of a biologic and immunosuppressant drugs used to treat cancer or transplant patients is not recommended. The risk of infection increases dramatically.

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