Abatacept-Orencia

U.S. BRAND NAMES — Orencia®
PHARMACOLOGIC CATEGORY Antirheumatic, Disease Modifying
DOSING: ADULTS — Rheumatoid arthritis: I.V.: Dosing is according to body weight. Repeat dose at 2 weeks and 4 weeks after initial dose, and every 4 weeks thereafter: <60>100 kg: 1000 mg
DOSING: ELDERLY — Refer to adult dosing. Due to potential for higher rates of infections and malignancies, use caution.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, powder for reconstitution [preservative free]: 250 mg
DOSAGE FORMS: CONCISE Injection, powder for reconstitution [preservative free]: Orencia®: 250 mg
GENERIC EQUIVALENT AVAILABLE — No
ADMINISTRATION — Infuse over 30 minutes. Administer through a 0.2-1.2 micron low protein-binding. filter
COMPATIBILITY — Stable in NS.
USE — Treatment of rheumatoid arthritis not responsive to other disease-modifying antirheumatic drugs (DMARD); may be used as monotherapy or in combination with other DMARDs (not in combination with TNF-blocking agents)
ADVERSE REACTIONS SIGNIFICANT — Note: Percentages not always reported; COPD patients experienced a higher frequency of COPD-related adverse reactions (COPD exacerbation, cough, dyspnea, pneumonia, rhonchi)
>10%: Central nervous system: Headache (18%) Gastrointestinal: Nausea Respiratory: Nasopharyngitis (12%), upper respiratory tract infection Miscellaneous: Infection
1% to 10%: Cardiovascular: Hypertension (7%) Central nervous system: Dizziness (9%) Dermatologic: Rash (4%) Gastrointestinal: Dyspepsia (6%) Genitourinary: Urinary tract infection (6%) Neuromuscular & skeletal: Back pain (7%), limb pain (3%) Respiratory: Cough (8%), bronchitis, pneumonia, rhinitis, sinusitis Miscellaneous: Infusion-related reactions (9%), herpes simplex, influenza
<1% (Limited to important or life-threatening): Anaphylaxis, anaphylactoid reactions, cellulitis, diverticulitis, dyspnea, flushing, hypersensitivity, hypotension, lung cancer, lymphoma, pruritus, pyelonephritis, urticaria, wheezing
CONTRAINDICATIONS — Hypersensitivity to abatacept or any component of the formulation; concurrent use with tumor necrosis factor (TNF) blocking agents (eg, adalimumab, etanercept, infliximab)
WARNINGS / PRECAUTIONS Concerns related to adverse effects: Anaphylaxis/hypersensitivity reactions: May cause hypersensitivity, anaphylaxis, or anaphylactoid reactions; medication for the treatment of hypersensitivity reactions should be available for immediate use. Infections: Caution should be exercised when considering the use in patients with a history of new/recurrent infections, with conditions that predispose them to infections, or with chronic, latent, or localized infections. Patients who develop a new infection while undergoing treatment should be monitored closely. If a patient develops a serious infection, therapy should be discontinued. Malignancy: Use may affect defenses against malignancies; impact on the development and course of malignancies is not fully defined. As compared to the general population, an increased risk of lymphoma has been noted in clinical trials; however, rheumatoid arthritis has been previously associated with an increased rate of lymphoma.
Disease-related concerns: COPD: Use caution with chronic obstructive pulmonary disease (COPD), higher incidences of adverse effects (COPD exacerbation, cough, rhonchi, dyspnea) have been observed; monitor closely.
Concurrent drug therapy issues: Anakinra: The manufacturer does not recommend concurrent use with anakinra. TNF-blocking agents: Patients receiving therapy in combination with TNF-blocking agents had higher rates of infections (including serious infections) than patients on TNF-blocking agents alone.
Special populations: Pediatrics: Safety and efficacy have not been established in children. Tuberculosis-positive patients: Safety has not been established in tuberculosis-positive patients; screen patients for latent tuberculosis infection prior to initiating therapy.
Other warnings/precautions: Immunizations: Patients should be brought up to date with all immunizations before initiating therapy. Live vaccines should not be given concurrently; there is no data available concerning secondary transmission of live vaccines in patients receiving therapy.
DRUG INTERACTIONS TNF-blocking agents: Concurrent use with abatacept may increase risk of infections; contraindicated.
Vaccines, live: Concomitant use has not be studied; currently recommended not to administer live vaccines during or for 3 months after the completion of abatacept treatment.
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — Teratogenic effects were not observed in animal studies. There are no adequate and well-controlled studies in pregnant women. Due to the potential risk for development of autoimmune disease in the fetus, use during pregnancy only if clearly needed.
LACTATION — Excretion in breast milk unknown/not recommended
BREAST-FEEDING CONSIDERATIONS — Due to the potential for adverse reactions and possible effects on the developing immune system, breast-feeding is not recommended.
PRICING — (data from drugstore.com)Injection (reconstituted) (Orencia) 250 mg (1): $498.99
MONITORING PARAMETERS — Signs and symptoms of infection
TOXICOLOGY / OVERDOSE COMPREHENSIVE — Doses up to 50 mg/kg have been tolerated. In the event of an overdose, monitor for signs and symptoms of adverse reactions; treatment should be symptom-directed and supportive.
MECHANISM OF ACTION — Selective costimulation modulator; inhibits T-cell (T-lymphocyte) activation by binding to CD80 and CD86 on antigen presenting cells (APC), thus blocking the required CD28 interaction between APCs and T cells. Activated T lymphocytes are found in the synovium of rheumatoid arthritis patients.
PHARMACODYNAMICS / KINETICS Distribution: Vss: 0.02-0.13 L/kg
Half-life elimination: 8-25 days
PATIENT INFORMATION — This drug can only be administered by infusion. Do not have any vaccinations while using this medication without consulting prescriber first. You will be more prone to infection. Avoid crowds and wash your hands frequently. Report infections (local or in your whole body) to prescriber immediately. You will need an overall health assessment prior to each treatment to ensure that you do not have an active infection. You may experience headache or dizziness (use caution when driving) or nausea (small frequent meals or sucking lozenges may help).