Orencia

Orencia is a prescription medication used to treat rheumatoid arthritis, juvenile idiopathic arthritis, and active psoriatic arthritis. 

Orencia belongs to a group of drugs called immunomodulators which work by blocking the activity of T-cells. A T-cell is a cell of the immune system that can cause swelling and joint damage in rheumatoid arthritis.

This medication comes in an injectable form that is usually given directly into a vein (IV) by a healthcare provider. Orencia may also be given as an injection just under the skin.

Common side effects of Orencia include headache, upper respiratory tract infection, sore throat, and nausea.

Orencia is a prescription medicine used alone or with other medications to reduce signs and symptoms in:

• adults with moderate to severe rheumatoid arthritis (RA), including those who have not been helped enough by other medicines for RA. In adults, Orencia may be used alone or with other RA treatments other than tumor necrosis factor (TNF) antagonists.
• children and adolescents 6 years of age and older with moderate to severe polyarticular juvenile idiopathic arthritis (JIA). Orencia may be used alone or with methotrexate.
• adults with active psoriatic arthritis (PsA).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Bristol-Myers Squibb Co.

• E.R. Squibb & Sons, L.L.C.

Orencia can cause serious side effects. See "Precautions" section.

Common side effects of Orencia include:

• headache
• upper respiratory tract infection
• sore throat
• nausea

In children and adolescents, other side effects may include:

• diarrhea
• cough
• fever
• stomach pain

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Orencia. For more information, ask your healthcare provider or pharmacist.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Orencia may affect the way other medicines work, and other medicines may affect the way Orencia works causing serious side effects.

Especially tell your healthcare provider if you take other biologic medicines that may affect your immune system, such as:

• Enbrel (etanercept)
• Humira (adalimumab)
• Remicade (infliximab)
• Kineret (anakinra)
• Rituxan (rituximab)
• Simponi (golimumab)
• Cimzia (certolizumab pegol)
• Actemra (tocilizumab)

You may have a higher chance of getting a serious infection if you take Orencia with other biologic medicines. 

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new prescription.

Orencia can cause serious side effects including:

• infections. Orencia can make you more likely to get infections or make the infection that you have get worse. Some patients have died from these infections. Call your healthcare provider right away if you have any symptoms of an infection. Symptoms of an infection may include:
  • fever
  • feel very tired
  • have a cough
  • have flu-like symptoms
  • warm, red, or painful skin
• allergic reactions. Allergic reactions can happen to people who use Orencia. Call your healthcare provider or go to the emergency room right away if you have any symptoms of an allergic reaction. Symptoms of an allergic reaction may include:
  • hives
  • swollen face, eyelids, lips, or tongue
  • trouble breathing
• hepatitis B infection in people who carry the virus in their blood. If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus can become active while you use Orencia. Your healthcare provider may do a blood test before you start treatment with Orencia.
• vaccinations. You should not receive Orencia with certain types of vaccines (live vaccines). Orencia may also cause some vaccinations to be less effective. Talk with your healthcare provider about your vaccination plans.
• breathing problems in patients with chronic obstructive pulmonary Disease (COPD). Some people may get certain respiratory problems more often if you receive Orencia and have COPD. Symptoms of respiratory problems include:
  • COPD that becomes worse
  • cough
  • trouble breathing
• cancer (malignancies). Certain kinds of cancer have been reported in people using Orencia. It is not known if Orencia increases your chance of getting certain kinds of cancer.

You should not receive Orencia if you are allergic to any of its ingredients.

You should not have any vaccinations while you are using Orencia or for 3 months after you stop using Orencia without talking to your doctor.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Orencia, there are no specific foods that you must exclude from your diet when receiving Orencia.

Before you use Orencia, tell your healthcare provider if you:

• are allergic to Orencia or to any of its ingredients
• have any kind of infection even if it is small (such as an open cut or sore), or an infection that is in your whole body (such as the flu). If you have an infection when taking Orencia, you may have a higher chance of getting serious side effects.
• have an infection that will not go away or an infection that keeps coming back.
• are allergic to Orencia or any of the ingredients in Orencia. 
• have or have had inflammation of your liver due to an infection (viral hepatitis). Before you use Orencia, your healthcare provider may examine you for hepatitis.
• have had a lung infection called tuberculosis (TB), a positive skin test for TB, or you recently have been in close contact with someone who has had TB. Before you use Orencia, your healthcare provider may examine you for TB or perform a skin test. Symptoms of TB may include:
  • a cough that does not go away
  • weight loss
  • fever
  • night sweats
• are scheduled to have surgery.
• recently received a vaccination or are scheduled for a vaccination. If you are receiving Orencia, and for 3 months after you stop receiving Orencia, you should not receive live vaccines.
• have a history of a breathing problem called chronic obstructive pulmonary disease (COPD).
• have diabetes and use a blood glucose monitor to check your blood sugar (blood glucose) levels. Orencia for intravenous infusion (given through a needle placed in a vein) contains maltose, a type of sugar that can give false high blood sugar readings with certain types of blood glucose monitors, on the day of Orencia infusion. Your doctor may tell you to use a different way to monitor your blood sugar levels.
• Orencia for subcutaneous injection (injected under the skin) does not contain maltose. You do not need to change your blood sugar monitoring if you are taking Orencia subcutaneously.
• have any other medical conditions.
• are pregnant or planning to become pregnant.
• are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Orencia falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Bristol-Myers Squibb Company has a registry for pregnant women exposed to Orencia. The purpose of this registry is to check the health of the pregnant mother and her child. Women are encouraged to call the registry themselves or ask their doctors to contact the registry for them by calling 1-877-311-8972.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if Orencia passes into your breast milk. You and your healthcare provider should decide if you will use Orencia or breastfeed. You should not do both.

• You may receive Orencia given by a healthcare provider through a vein in your arm (IV or intravenous infusion). It takes about 30 minutes to give you the full dose of medicine. You will then receive Orencia 2 weeks and 4 weeks after the first dose and then every 4 weeks.
• You may also receive Orencia as an injection under your skin (subcutaneous). If your healthcare provider decides that you or a caregiver can give your injections of Orencia at home, you or your caregiver should receive training on the right way to prepare and inject Orencia. Do not try to inject Orencia until you have been shown the right way to give the injections by your healthcare provider.
• Your healthcare provider will tell you how much Orencia to use and when to use it.

Your doctor will determine the best Orencia dosage for you based on your age and weight, your medical conditions, as well as other medications you take. Orencia is given by infusion into a vein (IV) at your doctor's office or another medical facility, or by subcutaneous injection (under the skin).

If you take too much Orencia, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Orencia is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if an overdose is suspected, seek emergency medical attention.

• Store Orencia in the refrigerator at 36°F to 46°F (2°C to 8°C).
• Keep Orencia in the original package and out of the light.
• Do not freeze this medication.
• Safely throw away medicine that is out of date or no longer needed.
• Keep Orencia and all medicines out of the reach of children.