In postmarketing experience, fatal anaphylaxis following the first infusion of ORENCIA and life-threatening cases of angioedema have been reported. A milliliter infusion bag or bottle of 0. Some of these infections have been fatal. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy which, in addition to their underlying disease, could further predispose them to infection. Caution should be exercised in patients with a history of infection or underlying conditions which may predispose them to infections.
Patients should be screened for tuberculosis and viral hepatitis in accordance with published guidelines, and if positive, treated according to standard medical practice prior to therapy with ORENCIA. Using only the silicone-free disposable syringe and an to gauge needle, withdraw 10 milliliters of Sterile Water for Injection, USP. Direct the stream of liquid to the side of the vial, injecting all 10 milliliters. Rotate the vial gently in a swirling motion until the contents are completely dissolved.
It's important not to shake the vial and avoid agitation. When the powder is completely dissolved, vent the vial with a needle to dissipate any foam that may have formed. The solution should be clear and colorless to pale yellow. Don't use the solution if there are opaque particles, discoloration, or other foreign particles visible. From a milliliter infusion bag or bottle, withdraw a volume of 0.
For 2 vials, remove 20 milliliters. For 3 vials, remove 30 milliliters. And for 4 vials, remove 40 milliliters. Gently mix the contents, making sure not to shake the bag or bottle, to complete the reconstitution. For first-time infusion patients, be sure to check the patient's full medical history and perform the appropriate tests prior to giving the infusion. For all patients, check their vital signs before infusion. Ask your patients if there have been any changes in the past month that would keep them from receiving an ORENCIA infusion such as a fever, cold, infection, or any other health issues.
Discard the solution if any particulate matter or discoloration is present. ORENCIA must be administered with an infusion set and a sterile, nonpyrogenic, low-protein-binding filter pore size of 0.
ORENCIA must be administered with an infusion set and a sterile, nonpyrogenic, low protein-binding filter with a pore size of 0. Be sure to check the patient's vital signs once again before the end of the infusion.
Before the patients leave, remind them to call the doctor immediately if they feel sick or experience any of the following signs of infection such as:. Remember, the most frequently reported acute infusion-related events occurring within one hour of infusion were dizziness, headache, and hypertension.
Patients with diabetes may get a false high blood sugar reading on test strips with glucose dehydrogenase pyrroloquinoline quinone GDH-PQQ. Therefore, you may want to recommend to these patients that they use a different testing monitor to avoid a possible false reading.
Generally speaking, be prepared to explain the infusion procedure, and tell patients specifically about what they can expect during an ORENCIA infusion. For all patients, be sure to ask how they're doing since the last infusion. You may want to ask if they've felt any difference in joint stiffness or pain. Altogether, patients will probably be at the infusion center for about an hour. Patients will be seated with their arm resting comfortably.
They will feel a small pinch when the needle is inserted into the arm at the beginning of the infusion process. If anything feels uncomfortable or unusual after that, or at any time during the infusion, they should notify a nurse immediately. What are some of the possible signs and symptoms of infusion reactions? Patients need to contact their healthcare provider immediately or get emergency medical help right away if they have hives, a swollen face, eyelids, lips, or tongue, or if they have trouble breathing.
If patients are new to biologic therapy, a response could be seen in as little as 15 days but may take up to 3 months. If patients have been previously treated with a biologic, a response could be seen within 4 to 6 weeks but may take up to 4 months. After patients receive their first infusion, they will have to get another one in 2 weeks, and then another 2 weeks after that. Please listen to the Important Safety Information, which follows. And finally, from all of us at Bristol-Myers Squibb, a special thank you for all that you do.
Blood Glucose Testing: ORENCIA for intravenous administration contains maltose, which may result in falsely elevated blood glucose readings on the day of infusion when using blood glucose monitors with test strips utilizing glucose dehydrogenase pyrroloquinoline quinone GDH-PQQ. Consider using monitors and advising patients to use monitors that do not react with maltose, such as those based on glucose dehydrogenase nicotine adenine dinucleotide GDH-NAD , glucose oxidase or glucose hexokinase test methods.
Healthcare professionals are encouraged to register patients by calling It is part of a class of drugs called biologics. Abatacept may be given as an injection under your skin that you administer yourself, similar to insulin injections. It may also be administered to you as an infusion intravenous medication. The abatacept subcutaneous injections shots are available as a mg prefilled syringe or auto-injector pen. It is given once a week. You will be instructed on how to give yourself injections.
If you have RA, your doctor may choose for you to have an intravenous IV loading dose before starting the abatacept injections. For these patients, the first subcutaneous injection is given within a day of the intravenous infusion. The intravenous IV infusion is given to you by a healthcare professional. This procedure usually takes about 30 minutes. After you receive your first dose you will get your second dose two weeks later and the third dose at four weeks from the first infusion.
After the third dose, you will then be given infusions every four weeks. If you are being switched to the subcutaneous injection from the intravenous infusion, the first injection should be given instead of the next scheduled intravenous infusion.
For patients who are using the subcutaneous injections, the medicine can cause slight irritation near the injection site. If this happens, the discomfort should be mild. If you have pain, swelling, warmth, or discoloration near the injection site, you should contact your healthcare provider.
Allergic reactions may happen. Call your healthcare provider or an emergency medical provider if you have any signs of an allergic reaction, such as rashes or hives; swollen face, eyelids, lips, or tongue; and difficulty breathing. The most common serious side effect is infection. Be sure to contact your physician if have any signs of infection, such as fever, fatigue, cough, or red or painful skin. You may have to stop abatacept while being treated for an infection.
You may also need to stop abatacept if you are planning a surgery.
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