Orencia (Bristol-Myers Squibb)
Orencia (Bristol-Myers Squibb) - General Information
Orencia (Bristol-Myers Squibb) is a soluble fusion protein, which links the extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) to the modified Fc (hinge, CH2, and CH3 domains) portion of human immunoglobulin G1 (IgG1). It is produced through recombinant DNA technology in mammalian cells. The drug has activity as a selective costimulation modulator with inhibitory activity on T lymphocytes. Although approved for the treatment of rheumatoid arthritis, Repligen has entered a slightly different formulation of CTLA4-Ig into clinical trials (RG2077).
Pharmacology of Orencia (Bristol-Myers Squibb)
Orencia (Bristol-Myers Squibb) is the first in a new class of drugs known as Selective Co-stimulation Modulators. Ordinarily, full T-cell activation requires binding of the T-cell receptor to an antigen-MHC complex on the antigen-presenting cell as well as a co-stimulatory signal provided by the binding of the CD28 protein on the surface of the T-cell with the CD80/86 proteins on the surface of the antigen-presenting cell. CTLA4 is a naturally occurring protein which is expressed on the surface of T-cells some hours or days after full T-cell activation and is capable of binding to CD80/86 on antigen-presenting cells with much greater affinity than CD28. Binding of CTLA4-Ig to CD80/86 provides a negative feedback mechanism which results in T-cell deactivation. Orencia (Bristol-Myers Squibb) was developed by Bristol-Myers-Squibb and is licensed in the US for the treatment of Rheumatoid Arthritis in the case of inadequate response to anti-TNF-alpha therapy.
Orencia (Bristol-Myers Squibb) for patients
This leaflet tells you about ORENCIA (pronounced oh-REN-see-ah). Please read this information before you start using ORENCIA and each time before you are scheduled to receive ORENCIA, in case something has changed. The information in this leaflet does not take the place of talking with your doctor before you start receiving this medicine and at check ups. Talk to your doctor if you have any questions about your treatment with ORENCIA.
What is ORENCIA?
ORENCIA is a medicine that is used to treat adults with moderate to severe rheumatoid arthritis (RA) who have not been helped by other medicines for RA. RA is a disease that causes pain and joint inflammation (tenderness and swelling). RA can also cause joint damage. Your doctor has decided to treat you with ORENCIA because your disease is still active even though you may have tried other treatments.
How does ORENCIA work?
ORENCIA is a medicine that keeps the immune system from attacking healthy tissues in the body. The immune system defends the body against infections caused by bacteria and viruses. A normal immune system leaves healthy body tissues alone. In people with RA, the immune system attacks normal body tissues causing damage and inflammation especially in the tissues of your joints. ORENCIA interferes with an important step in this attack. By decreasing the immune systems attack on normal tissues, ORENCIA can reduce pain and joint inflammation, and slow the damage to your bones and cartilage. However, ORENCIA can also lower your bodys ability to fight infection. ORENCIA treatment can make you more prone to getting infections or make any infection you have worse. It is important to tell your doctor if you think you have any infections.
Who should not receive ORENCIA?
You should not receive ORENCIA if you have ever had an allergic reaction to ORENCIA.
What should I tell my doctor before treatment with ORENCIA?
Before you receive treatment with ORENCIA you should tell your doctor if you:
· are taking a TNF blocker to treat RA. You may have a higher chance of getting a serious infection if you take ORENCIA with other biologic medications for RA.
· have any kind of infection including an infection that is in only one place in your body (such as an open cut or sore), or an infection that is in your whole body (such as the flu). Having an infection could put you at risk for serious side effects from ORENCIA. If you are unsure, please ask your doctor.
· have an infection that wont go away or a history of infections that keep coming back.
· have had tuberculosis (TB), a positive skin test for TB, or if you recently have been in close contact with someone who has had TB. If you develop any of the symptoms of TB (a dry cough that doesnt go away, weight loss, fever, night sweats) call your doctor right away. Before you start ORENCIA, your doctor may examine you for TB or perform a skin test.
· are scheduled to have surgery.
· recently received a vaccination or are scheduled for any vaccination.
· are pregnant or planning to become pregnant. It is not known if ORENCIA can harm your unborn baby.
· are breast-feeding. ORENCIA can pass into breast milk. You will need to decide to either breast-feed or receive treatment with ORENCIA, but not both.
If you are not sure or have any questions about any of this information, ask your doctor.
What important information do I need to know about side effects with ORENCIA?
Like all medicines that affect your immune system, ORENCIA can cause serious side effects. The possible serious side effects include:
· Serious infections. Patients taking ORENCIA are at increased risk for developing infections including pneumonia, and other infections caused by viruses, bacteria, or fungi. Call your doctor immediately if you feel sick or get any infection during treatment with ORENCIA.
· Allergic reactions. These reactions are usually mild or moderate and include hives, swollen face, eyelids, lips, tongue, throat, or trouble breathing.
· Malignancies. There have been rare cases of certain kinds of cancer in patients receiving ORENCIA. The role of ORENCIA in the development of cancer is not known.
What are the more common side effects with ORENCIA?
· The more common side effects with ORENCIA are headache, upper respiratory tract infection, sore throat, and nausea.
Can I receive ORENCIA if I am pregnant or breast-feeding?
ORENCIA has not been studied in pregnant women or nursing mothers, so we dont know what the effects are on pregnant women or nursing babies. You should tell your doctor if you are pregnant, become pregnant, or are thinking about becoming pregnant.
Can I receive ORENCIA if I am taking other medicines for my RA or other conditions?
Yes, you can take other medicines if your doctor has prescribed them or has told you it is okay to take them while you are receiving ORENCIA. It is important to tell your doctor if you are taking any other medicines including hormones, over the counter medicines, vitamins, supplements, or herbal products before you are treated with ORENCIA. If you start taking or plan to start taking any new medicine while you are receiving ORENCIA, tell your doctor. Taking ORENCIA with TNF blocker medications (Enbrel™, Humira ™, Remicade™) is not recommended.
How will ORENCIA be given to me?
ORENCIA will be given to you by a healthcare professional using an IV. This means the medicine will be given to you through a needle placed in a vein in your arm. It will take about 30 minutes to give you the full dose of medicine.
How often will I receive ORENCIA?
You will receive your first dose of ORENCIA followed by additional doses at 2 and 4 weeks after the first dose. You will then receive a dose every 4 weeks.
What should I do if I miss a dose of ORENCIA?
If you miss receiving ORENCIA when you are supposed to, ask your doctor when to schedule your next dose.
What if I still have questions?
If you have any questions or problems, always talk with your doctor. You can also call 1-800-ORENCIA toll-free or visit the ORENCIA internet site at www.ORENCIA.com or the company internet site at www.BMS.com.
Enbrel™, Humira ™, and Remicade™ are trademarks of their respective companies.
Orencia (Bristol-Myers Squibb) Interactions
Formal drug interaction studies have not been conducted with ORENCIA.
Population pharmacokinetic analyses revealed that MTX, NSAIDs, corticosteroids, and TNF blocking agents did not influence abatacept clearance. The majority of patients in RA clinical studies received one or more of the following concomitant medications with ORENCIA: MTX, NSAIDs, corticosteroids, TNF blocking agents, azathioprine, chloroquine, gold, hydroxychloroquine, leflunomide, sulfasalazine, and anakinra.
Concurrent administration of a TNF antagonist with ORENCIA has been associated with an increased risk of serious infections and no significant additional efficacy over use of the TNF antagonists alone. Concurrent therapy with ORENCIA and TNF antagonists is not recommended.
There is insufficient experience to assess the safety and efficacy of ORENCIA administered concurrently with anakinra, and therefore such use is not recommended.
Orencia (Bristol-Myers Squibb) Contraindications
ORENCIA should not be administered to patients with known hypersensitivity to ORENCIA or any of its components.
Additional information about Orencia (Bristol-Myers Squibb)
Orencia (Bristol-Myers Squibb) Indication: For the second line reduction of the signs and symptoms of moderate-to-severe active rheumatoid arthritis, inducing inducing major clinical response, slowing the progression of structural damage, and improving physical function in adult patients who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs), such as methotrexate or TNF antagonists. It is indicated both as a monotherapy and for use in combination with a continued regimen of DMARDs (not including TNF antagonists).
Mechanism Of Action: Orencia (Bristol-Myers Squibb) is a selective costimulation modulator, shown to inhibit Tcell (T lymphocyte) activation by binding to CD80 and CD86, thereby blocking interaction with CD28. Blockade of this interaction has been shown to inhibit the autoimmune T-Cell activation that has been implcated in the pathogenesis of rheumatoid arthritis.
Drug Interactions: Not Available
Food Interactions: Not Available
Generic Name: Abatacept
Synonyms: CTLA4-Ig; CTLA4-IgG4m; CTLA4Ig; CTLA4IgG4m; RG-1046; RG-2077; RG2077; RG1046
Drug Category: Antirheumatic Agents
Drug Type: Biotech; Approved; Investigational
Other Brand Names containing Abatacept: Orencia (Bristol-Myers Squibb);
Absorption: Not Available
Toxicity (Overdose): Doses up to 50 mg/kg have been administered without apparent toxic effect.
Protein Binding: Not Available
Biotransformation: Not Available
Half Life: 16.7 (12-23) days in healthy subjects, 13.1 (8-25) days in RA subjects.
Dosage Forms of Orencia (Bristol-Myers Squibb): Powder, for solution Intravenous
Chemical IUPAC Name: Not Available
Chemical Formula: Not Available
Abatacept on Wikipedia: https://en.wikipedia.org/wiki/Abatacept
Organisms Affected: Humans and other mammals