Orencia

Generic name: abatacept
Brand name: Orencia, Orencia ClickJect, Orencia Prefilled Syringe
Dosage forms: intravenous powder for injection (250 mg); subcutaneous solution (125 mg/mL; 50 mg/0.4 mL; 87.5 mg/0.7 mL)
Drug class: Antirheumatics, Selective immunosuppressants

 

What is Orencia?

OrenciaOrencia is a medication used to treat the symptoms of Rheumatoid arthritis as well as to help prevent joint injuries that are caused by these diseases. Orencia is a prescription drug for children and adults who are at least 2 years old.

Orencia is also employed for treating active Psoriatic arthritis for adults.

Orencia does not provide an answer to any autoimmune disease and can only address the symptoms of the disease.

Orencia is also used for reasons not mentioned in this medication guide.

Warnings

An increased risk of infection when combined use of TNF Antagonists other Biologic RA/PsA Therapy or JAK Inhibitors

In controlled clinical trials conducted in patients suffering from adult RA in which patients received the concomitant intravenous treatment of Orencia with TNF antagonist therapy suffered more infections (63%against. 43%) and more serious infections (4.4 % against. 0.8 %) as compared to those treated only with antagonists of TNF. These studies failed to show an important increase in effectiveness when Orencia is administered concurrently together with TNF antagonists. Therefore the use of Orencia in conjunction with, as well as a TNF antagonist, would not be suggested. When transitioning between TNF antagonist treatment to the Orencia, patients must be monitored for any signs of infections. Also, concurrent use of Orenciaalongside other biologic RA/PsA therapies or JAK inhibitors is not advised.

Hypersensitivity

In clinical studies with 2688 healthy adult RA patients receiving Orencia intravenously, there were two instances (<0.1 %) of anaphylaxis-related reactions. Other reactions that could be related to hypersensitivity to medications, like hypertension, urticaria, and dyspnea, all were seen within less than 0.9 % of patients treated with Orencia. Of the 190 patients treated with Orenciain clinical trials conducted by pJIA there was one instance of hypersensitivity (0.5 %).

In postmarketing, fatal anaphylaxis has occurred following the initial infusion of Orencia as well as life-threatening instances of angioedema were reported. Angioedema can occur as early as the day following the initial dose of Orencia. However, it has also occurred following subsequent doses. Angioedema-related reactions have occurred within hours after administration, and in some instances, they had an extended time of onset (i.e. days).

The appropriate medical support measures to treat hypersensitivity reactions must be readily available to be used immediately should there be a reaction. If an anaphylactic, or other severe allergic reaction is observed the administration of Orencia intravenous or subcutaneously must be stopped immediately, with appropriate therapy being implemented, and treatment with Orencia must be stopped permanently.

 

Infections

Sepsis and other serious infections, such as sepsis and pneumonia were reported among patients who receive Orencia (serious infections were observed in 3 and 1.9 % of RA patients receiving Orencia or placebo intravenously and placebo, in turn). Certain of these infections are fatal. The majority of serious infections have been reported in patients receiving concomitant immunosuppressive treatments that, along with their existing disease, may increase their risk of contracting infections. A higher incidence of severe infections was reported among adult RA patients who are treated with concomitant anti-TNF antagonists as well as Orencia in comparison to those who are who were treated by Orencia by itself

Healthcare providers must be cautious when contemplating the treatment with Orencia for patients who have an underlying history of frequent infections, or underlying illnesses that can make them susceptible to infection, or chronic localized latent or chronic infections. Patients who contract a new infection during treatment with Orencia must be closely monitored. The use of Orencia should be stopped when a patient is diagnosed with an acute infection.

Before beginning Orencia the patient should be tested for the presence of latent tuberculosis (TB) infection by tuberculin skin tests. Orencia has not been evaluated for patients who have positive TB tests and the security of Orencia for patients with latent TB infections is unclear. Patients who test positive for TB in TB screening must be treated in accordance with the standard medical procedure prior to starting treatment with Orencia.

Antirheumatic treatments have been linked with hepatitis B activation. Thus, the screening of patients for viral liver disease needs to be conducted according to published guidelines before beginning treatment with Orencia. In clinical trials with Orencia patients who tested positive for hepatitis, were excluded from the study

Immunizations

Before initiating Orencia for adult and pediatric patients, it is commended to update vaccines according to current guidelines for vaccination. Orencia-treated patients can receive current non-live vaccines. Live vaccines shouldn’t be administered in conjunction with Orencia or for a period of three months following discontinuation. There is no information available regarding the possibility of transmission from people who receive live vaccines to patients taking Orencia. There are also medical reasons to administer live vaccines in infants exposed to Orencia in pregnancy. Based on the mechanism by which it exerts effect, Orencia may blunt the effectiveness of certain vaccinations.

 

Higher risk of adverse reactions when used in patients with chronic Obstructive Pulmonary Disease (COPD)

In the study, adult COPD patients receiving Orencia to treat RA had adverse events more often than patients who received a placebo treatment, including COPD exacerbations, coughs, and rhonchi, as well as dyspnea. The higher %age of patients who received Orencia had an adverse event that was serious when compared with patients who received placebo (27 % versus 6. The use of Orencia for patients suffering from COPD should be done with caution. Patients are monitored for the deterioration of their respiratory conditions.

 

Immunosuppression

There is a chance for drugs that block T cells’ activation, like Orencia, to alter host defenses against malignancies and infections because T cells are the primary source of immune cell responses. In clinical trials conducted on patients suffering from adult RA, a higher frequency of infections was observed in patients treated with Orencia in comparison to patients treated with placebo.  The effect of the treatment of Orencia on the development and progression of malignancies isn’t fully comprehended. There are reports of skin cancer, among patients who receive Orencia. A regular skin exam is advised for all patients receiving Orencia and those with high-risk factors for skin cancer.

 

Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV) Reactivation in aGVHD Prophylaxis following Hematopoietic Stem Transplantation (HSCT)

Post Transplant Lymphoproliferative Disorder (PTLD) was observed in patients who received Orencia as GVHD prophylaxis in HSCT that was not related. Of 116 patients treated with Orencia in 2004, 4 patients (3.4 %) were diagnosed with PTLD. All PTLD instances were linked to Epstein-Barr virus (EBV) infection. Three of the patients had EBV Serology-positive at baseline. One patient was negative at baseline EBV serology but the donor’s EBV serology was not known.

Three of the four patients stopped taking acyclovir on day 30 after the transplant. The time from the onset of the symptoms was between 49 and 89 days after transplantation. Check patients for EBV Reactivation as per the institutional guidelines. Prophylaxis is recommended against EBV infection for six months after transplantation to prevent EBV-associated TLD.

Cytomegalovirus (CMV) an invasive disease was observed among patients receiving Orencia as GVHD prophylaxis in HSCT that was not related to. Of the 116 patients treated with Orencia, 7% experienced CMV infected diseases until day 225 following transplant. All patients suffering from CMV infiltrating diseases have CMV seroconversion positive at the time of baseline. The median time between the onset of the disease was 91 days following transplantation. CMV-related diseases that were invasive mostly affected the digestive tract.

Monitor patients for CMV infection/reactivation for 6 months post-transplant regardless of the results of donor and recipient pre-transplant CMV serology. Consider prophylaxis for CMV infection/reactivation

 

Before you start taking this medicine, make sure to consult your doctor

It is best not to use Orencia in case you have an allergy to it.

Before you start Orencia, be sure to inform your doctor if previously suffered from tuberculosis or if someone within your family is suffering from tuberculosis, or has recently visited an area where tuberculosis can be found.

Inform your doctor if you have ever suffered from:

The use of Orencia could increase the risk of developing certain kinds of cancer, such as lymphoma (cancer of lymph nodes). This risk could be higher for older people. Discuss with your physician your risk.

Inform your doctor if are breastfeeding or pregnant.

If you’re pregnant and you are a registered mother, your name could be added to an ob-gyn registry to monitor the effects of Orencia on your baby.

The patients who are taking Orencia must be current on all vaccines for children prior to starting treatment.

How can I take Orencia?

Before you begin treatment with Orencia, your physician might run tests to be sure that you don’t have tuberculosis or any other infection.

Orencia can be injected under the skin or in the form of an injection into veins. The doctor will give your first dose and instruct you on how to make use of the drug on your own.

Orencia is injected beneath the skin when administered to a child aged between 2 and six years old.

Orencia is best administered slowly after injection into a vein. the IV infusion may be delayed for up to 30 minutes before it is completed.

Orencia is usually prescribed every one to four weeks. Follow the instructions of your physician.

Orencia needs to be mixed with a liquid (diluent) prior to using it. If you are using injections on your own ensure that you know how to blend and keep the medication.

Be sure to read and adhere to any instructions for use that come in your medication. Consult your physician or pharmacist for clarification if you aren’t sure about the instructions.

Make an injection only when you are prepared to administer it. Simply swirl, but do not shake the bottle. Don’t use the medicine if it appears like it is cloudy, has changed color, or has particles inside it. Consult your pharmacist about the new medication.

The contents of each bottle (bottle) or syringe that is prefilled is intended for use for one time only. It is best to dispose of it after one time, even if there’s still medicine within.

Make use of a needle and syringe just once, and then put them in a puncture-proof “sharps” container. Make sure you follow local or state laws regarding how to dispose of the container. Make sure it is out of range of pets and children.

If you require surgery, inform the surgeon in advance that you’re taking Orencia.

If you’ve had any experience with the virus hepatitis B using Orencia, the medication can make this virus active or worse. You could require a regular test of your liver’s function during the course of treatment and for a period of time following the discontinuation.

Orencia could cause false results in some blood sugar tests which can reveal high blood sugar levels. If you suffer from diabetes consult your physician about the best method to determine your blood sugar levels.

Autoimmune diseases are usually treated using a combination of several medications. Follow all medication as prescribed and carefully read the medical guides you are given. Don’t alter your dosage or schedule of dosing without your physician’s guidance.

Keep the Orencia in the original container in the refrigerator. Keep away from light and don’t freeze. Don’t use the medicine following when the deadline for expiration on the label is passed.

If you must transport your medication put the syringes inside an ice-filled cooler.

Orencia mixed with a diluting agent can be stored in an air-tight container as well as at ambient temperature and should be utilized at the earliest within 24 hours.

 

If I don’t take a dose?

Consult your physician for the appropriate treatment If you have missed the Orencia dosage.

If I consume too much?

Get medical attention immediately or contact for help at the Poison Help line at 1-800-222-1222.

What to avoid?

Don’t receive a “live” vaccine while using Orencia and for at least three months following the end of your treatment. The vaccine might not work at the same rate during this period and might not completely safeguard you against disease. Measles is a live virus that includes rubella, mumps (MMR) as well as rotavirus, yellow fever, typhoid varicella (chickenpox) Zoster ( shingles), and nasal influenza ( influenza) vaccine.

Beware of those with illnesses or suffering from infections. Contact your doctor right away in the event that you show symptoms of an infection.

Orencia side effects

Contact a medical professional immediately If you are experiencing symptoms that indicate an allergic reaction, such as symptoms of hives and breathing problems, and swelling of your lips, face, and tongue.

Certain side effects can occur when you receive the injection. Contact your physician immediately when you experience dizziness and lightheadedness, itchy, or suffer from an extreme headache or breathing difficulties within one hour of having received the injection.

You could contract infections more often, including severe or fatal illnesses. Call your doctor immediately if you notice symptoms of infection like:

Contact your doctor immediately in the event that you suffer from any of the following serious adverse symptoms:

Common side effects can be:

This isn’t a complete list of possible side effects, and others could happen. Contact your doctor to seek medical advice on the effects. You can report any adverse reactions to the FDA at 1-800-FDA-1088.

What other medications can interfere with Orencia?

Inform your doctor about any other medications you take including:

This list is not comprehensive. Other medications may interact with Orencia as well, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some interactions with drugs are not listed here. are listed here.

Additional details

Keep this medication and other medications away from the reach of children. Do not divulge your medications to others and only use the medication to treat the condition prescribed.

Always consult your physician to confirm that the information provided on this site is appropriate to your specific situation.

 

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