Orencia side effects

Generic name: abatacept
Brand name: Orencia
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.

 

Orencia side effects in adult patients With RA

Orencia side effects of Adult Patients With RA, treated with intravenous ORENCIA

 

 

 

 

Most Commonly Known Orencia side effects in Adult Patients with RA who are treated by Intravenous ORENCIA

Intravenous
ORENCIA
(n=1955)a
Placebo
(n=
Placebo
(n=989)b989)b
Headache 18% 13%
Nasopharyngitis 12% 9%
Dizziness 9% 7%
Cough 8% 7%
Back pain 7% 6%
Hypertension 7% 4%
Dyspepsia 6% 4%
Urinary tract infection 6% 5%
Rash 4% 3%
Pain in extremity 3% 2%

 


Diseases among Patients of Adult Age with RA Treatment by Intravenous ORENCIA

 

 

Malignancies among Patients of Adult Age with RA Treatable by Intravenous ORENCIA

 

 

 

Infusion-related reactions as well as Hypersensitivity Reactions 

 

 

Orencia side effects of Patients With COPD whose condition is treated for RA with intravenous ORENCIA

 

Orencia side effects of Adult Patients With RA treated with subcutaneous and Intravenous ORENCIA

 

Injection site reactions of Adult RA Patients Treatable by Subcutaneous ORENCIA

Orencia side effects of Adult Patients With PsA

 

 

Orencia side effects in patients With pJIA, treated by Intravenous ORENCIA

 

 

 

 

Orencia side effects in patients With pJIA treated with subcutaneous ORENCIA

 

 

Orencia side effects for patients who undergo unrelated donor Hematopoietic Stem Transfer

The data presented herein came from a single clinical study conducted by ORENCIA (GVHD-1) to treat aGVHD prophylaxis for patients 6 years old and older who have cancers of the hematologic type that were undergoing unrelated HSCT. All patients received methotrexate and calcineurin as the recommended treatment to treat aGVHD treatment. Two groups were assessed with a dose of 10 mg/kg (maximum dose of 1000 mg) by intravenous injection for an interval of 60 min on the day prior to transplantation (Day 1) Then, the infusion was administered on days 5 14, and 28 following transplantation

1):  A single-arm cohort of patients receiving ORENCIA treatment (n=43) that underwent 7 out of 8 Human leukocyte antigen (HLA)-matched HSCT from unrelated donors (7 of 8 cohorts) and

2.):  An uncontrolled cohort consisting of patients treated with ORENCIA (n=73) as well as placebo-treated patients (n=69) who received 8 of 8 HSCTs HLA-matched from non-related donors (8 of 8 patients in the cohort).

In the total of 116 people treated with ORENCIA of whom 27 (23 %) were between the ages of 6 and under 17 years old. aged.

The information on safety beginning with the initial dose of ORENCIA to Day 225 following transplantation in the study is presented below. The frequency of adverse reaction was calculated by pooling data from ORENCIA-treated patients in the two studies (n=116).

The most serious adverse reactions reported by more than 5 % of patients who took ORENCIA when combined with a calcineurin antagonist and methotrexate, included pyrexia (20 %) and pneumonia (8 8%)) an acute kidney injury (7 %), and diarrhea (6 %) as well as hypoxia (5 5 %) and nausea (5 5 %).

The permanent discontinuation of ORENCIA because of an adverse reaction was observed on two occasions (1.7 %) in one instance both of pneumonia and an allergic reaction.

The most frequently reported (>=10 %) adverse reactions among the ORENCIA patients were hypertension, anemia, CMV reactivation/CMV infection, epistaxis, pyrexia, pneumonia, and CD4 lymphocytes depleted. hypermagnesemia, as well as an acute injury to the kidney.

 

The table provides a summary of the incidence of adverse reactions within the investigation of ORENCIA in GVHD-1.

7 of 8 Cohort 8 of 8 Cohort
Adverse Reaction ORENCIA (+CNI and MTX)
(N=43)
ORENCIA (+CNI and MTX)
(N=73)
Placebo (+CNI and MTX)
(N=69)
All Grades

(%)

Grade 3 or 4

(%)

All Grades

(%)

Grade 3 or 4

(%)

All Grades

(%)

Grade 3 or 4

(%)

Blood and Lymphatic System Disorders
   Anemia 56 56 69 69 57 57
   CD4 lymphocytes decreased 14 14 14 14 9 9
Vascular Disorders
   Hypertension 49 49 43 43 38 38
General Disorders and Administrative Site Conditions
   Pyrexia 28 9 19 10 20 4
Infections and Infestations
   CMV Reactivation/CMV Infection 26 26 32 32 22 22
   Pneumonia 19 19 12 12 10 9
Respiratory and Mediastinal Disorders
   Epistaxis 12 12 16 16 10 10
Renal and Urinary Disorders
   Acute kidney injury 9 7 15 15 10 10
Metabolism and Nutrition Disorders
   Hypermagnesemia 5 5 18 18 10 10

 

Clinically relevant adverse reactions less than 10% of patients who took ORENCIA when combined with methotrexate and calcineurin inhibitor in Study GVHD-1. This included EBV Reactivation.

Immunogenicity

 

Impotency in Adults with RA who are treated by Intravenous ORENCIA

 

 

The Immunogenicity of Adult Patients with RA treated by subcutaneous and Intravenous ORENCIA

The Immunogenicity of Adult Patients with RA treated by ORENCIA 

 

The Immunogenicity of Adult Patients with RA Following Treatment withdrawal and Restarting ORENCIA 

Study SC-3 was carried out to study the effects of the immunogen of adult RA patients following treatment withdrawal (three months) and resumption in ORENCIA Subcutaneous therapy (patients were treated concurrently using methotrexate). A total of 157 patients participated during the initial 3-month treatment phase and the responders (n=120) were randomly assigned to either ORENCIA subcutaneously or placebo during the next three-month time period (withdrawal phase). Patients in this time period got open-label ORENCIA treatment for the last three-month study period (period 3.).

The study concluded that at the end of the period of withdrawal there were a number of patients who continued receiving subcutaneous ORENCIA developed antibodies against abatacept in comparison to 7/73 (10 %) in patients who received ORENCIA subcutaneously withdrawn in this time. Half of the patients who received a placebo subcutaneously during the period of withdrawal received one intravenous injection of ORENCIA at the beginning of period 3 and the other half received a placebo intravenously.

After the conclusion of period 3, in which all patients received subcutaneous ORENCIA infusions, the rate of immunogenicity was 1/38 (3 %) in the group that received subcutaneous ORENCIA all through the period, and 2/3 (3 %) for the group that received placebo throughout the withdrawal time.

When the therapy was reintroduced it was found that there were none of the injection reactions, and there was no difference in the response to therapy for patients who had been removed off subcutaneous treatments for three months or more compared to those who continued to receive Subcutaneous Therapy (these results were seen in those who did or didn’t received the intravenous load dose). The degree of safety demonstrated during this research was in line with what was observed in previous studies.

The Immunogenicity of Patients With pJIA treated by Intravenous ORENCIA

Antibodies that target the whole abatacept molecule, as well as the abatacept CTLA-4 portion, were determined by ELISA tests in patients suffering from pJIA after repeated treatment by intravenous ORENCIA throughout the open-label phase.

For patients who were removed from treatment for a period of up to six months within the period of double-blinding the frequency of formation of antibodies against the CTLA-4 component of the abatacept molecule was 41 % (22/54) and for those who continued to receive therapy, the %age was 13 % (7/54). Twenty of the patients had blood samples that could test for antibodies that had neutralizing activities. Of the 20 samples, 8 (40 %) patients were found to have neutralizing antibodies.

It was typically temporary and titers were not high. Antibodies were not linked to adverse incidents or changes in efficacy or a change in the abatacept concentrations in serum. In the case of patients who were removed from ORENCIA during the double-blind time period for up to six months, no significant incidents related to infusions were detected when re-initiating ORENCIA treatment.

Immunogenicity of patients being treated for the prevention of aGVHD by Intravenous RENCIA

The degree of immunogenicity was measured during HSCT procedures in patients. The overall incidence of immunogenicity, as well as related antibody titers, were not high from the intravenous 4-dose ORENCIA regimen utilized during this investigation. Of the 114 evaluated for immunogenicity individuals in those ORENCIA groups, no was positive in all of the ORENCIA therapy period (Day 1 to 28 days following the transplant).

The off-treatment period (Day 29 through Day 180 post-transplant) 6 out of 91 subjects that were evaluated for their immunogenicity (6.6 %) had positive results in the presence of CTLA4 or possibly Ig 4 of the 6 subjects who were positive were discovered to have at the very minimum one positive sample that showed neutralization activity. The study revealed that the immunogenicity positive subjects were able to identify ADA Positive samples by Day 180 (off-treatment period) which is why, because of the time-of-response and the timing of the response, the effect on PK or safety efficacy was not assessed.

 

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