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Gdh21 Group 1..500 ABATACEPT Powder for injection may contain maltose, which may Abatacept (ab a TA sept) result in falsely-elevated serum glucose readings on the day of infusion. Higher incidences of infection and malig- Medication Safety Issues nancy were observed in the elderly; use with caution. Sound-alike/look-alike issues: Adverse Reactions (Reflective of adult population; Orencia may be confused with Oracea not specific for elderly) Note: Percentages not always Brand Names: US Orencia reported; COPD patients experienced a higher frequency Brand Names: Canada Orencia of COPD-related adverse reactions (COPD exacerbation, Index Terms BMS-188667; CTLA-4Ig cough, dyspnea, pneumonia, rhonchi) Generic Availability (US) No >10%: Pharmacologic Category Antirheumatic, Disease Mod- ≤ ifying; Selective T-Cell Costimulation Blocker Central nervous system: Headache ( 18%) Use Gastrointestinal: Nausea Respiratory: Nasopharyngitis (12%), upper respiratory Rheumatoid arthritis: Treatment of moderately to tract infection severely active adult rheumatoid arthritis (RA); may be Miscellaneous: Infection (adults 54%; children 36%), anti- used as monotherapy or in combination with other body development (2% to 41%) DMARDs 1% to 10%: Note: Abatacept should not be used in combination with Cardiovascular: Hypertension (7%) anakinra or TNF-blocking agents Central nervous system: Dizziness (9%) Contraindications There are no contraindications listed Dermatologic: Skin rash (4%) within the manufacturer's U.S. labeling. Gastrointestinal: Dyspepsia (6%), abdominal pain, Canadian labeling: Hypersensitivity to abatacept or any diarrhea component of the formulation; patients with, or at risk of Genitourinary: Urinary tract infection (6%) sepsis syndrome (eg, immunocompromised, HIV positive) Immunologic: Immunogenicity (1% to 2%) Warnings/Precautions Serious and potentially fatal infec- Infection: Herpes simplex infection, influenza tions (including tuberculosis and sepsis) have been Local: Injection site reaction (3%) reported, particularly in patients receiving concomitant Neuromuscular & skeletal: Back pain (7%), limb immunosuppressive therapy. RA patients receiving a con- pain (3%) comitant TNF antagonist experienced an even higher rate Respiratory: Cough (8%), bronchitis, pneumonia, rhinitis, of serious infection. Caution should be exercised when sinusitis considering the use of abatacept in any patient with a Miscellaneous: Infusion-related reaction (≤9%), fever history of recurrent infections, with conditions that predis- Drug Interactions pose them to infections, or with chronic, latent, or localized Metabolism/Transport Effects None known. infections. Patients who develop a new infection while Avoid Concomitant Use undergoing treatment should be monitored closely. If a Avoid concomitant use of Abatacept with any of the patient develops a serious infection, abatacept should be following: Anakinra; Anti-TNF Agents; BCG (Intravesical); discontinued. Screen patients for latent tuberculosis infec- Belimumab; Natalizumab; Pimecrolimus; RiTUXimab; tion prior to initiating abatacept; safety in tuberculosis- Tacrolimus (Topical); Tocilizumab; Tofacitinib; Vaccines positive patients has not been established. Treat patients (Live) testing positive according to standard therapy prior to Increased Effect/Toxicity initiating abatacept. Adult patients receiving abatacept in Abatacept may increase the levels/effects of: Belimumab; combination with TNF-blocking agents had higher rates of Leflunomide; Natalizumab; Tofacitinib; Vaccines (Live) infections (including serious infections) than patients on TNF-blocking agents alone. Potentially significant drug- The levels/effects of Abatacept may be increased by: drug interactions may exist, requiring dose or frequency Anakinra; Anti-TNF Agents; Denosumab; Pimecrolimus; adjustment, additional monitoring, and/or selection of alter- RiTUXimab; Roflumilast; Tacrolimus (Topical); Tocilizu- native therapy. The manufacturer does not recommend mab; Trastuzumab concurrent use with anakinra or TNF-blocking agents. Decreased Effect Monitor for signs and symptoms of infection when tran- Abatacept may decrease the levels/effects of: BCG sitioning from TNF-blocking agents to abatacept. Due to (Intravesical); Coccidioides immitis Skin Test; Sipuleu- the effect of T-cell inhibition on host defenses, abatacept cel-T; Vaccines (Inactivated); Vaccines (Live) may affect immune responses against infections and The levels/effects of Abatacept may be decreased by: malignancies; impact on the development and course of Echinacea malignancies is not fully defined. Preparation for Administration Use caution with chronic obstructive pulmonary disease IV: Reconstitute each vial with 10 mL SWFI using the (COPD), higher incidences of adverse effects (COPD provided silicone-free disposable syringe (discard solu- exacerbation, cough, rhonchi, dyspnea) have been tions accidentally reconstituted with siliconized syringe observed; monitor closely. Rare cases of hypersensitivity, as they may develop translucent particles). Inject SWFI anaphylaxis, or anaphylactoid reactions have been down the side of the vial to avoid foaming. The recon- reported with intravenous administration; may occur with stituted solution contains 25 mg/mL abatacept. Further first infusion. Some reactions (hypotension, urticaria, dysp- dilute (using a silicone-free syringe) in 100 mL NS to a nea) occurred within 24 hours of infusion. Discontinue final concentration of ≤10 mg/mL. Prior to adding abata- treatment if anaphylaxis or other serious allergic reaction cept to the 100 mL bag, the manufacturer recommends occurs; medications for the treatment of hypersensitivity withdrawing a volume of NS equal to the abatacept reactions should be available for immediate use. Patients volume required, resulting in a final volume of 100 mL. should be screened for viral hepatitis prior to use; anti- Mix gently; do not shake. rheumatic therapy may cause reactivation of hepatitis B. SubQ: Allow prefilled syringe to reach room temperature Patients should be brought up to date with all immuniza- prior to administration by removing from refrigerator tions before initiating therapy. Live vaccines should not be 30-60 minutes prior to administration. given concurrently or within 3 months of discontinuation of Storage/Stability therapy; there is no data available concerning secondary Prefilled syringe: Store at 2°C to 8°C (36°F to 46°F); do not transmission of live vaccines in patients receiving therapy. freeze. Protect from light. 18 ABIRATERONE ACETATE Powder for injection: Prior to reconstitution, store at 2°C to Dosage Forms Excipient information presented when 8°C (36°F to 46°F); do not freeze. Protect from light. After available (limited, particularly for generics); consult specific dilution, may be stored for up to 24 hours at room product labeling. temperature or refrigerated at 2°C to 8°C (36°F to Solution Prefilled Syringe, Subcutaneous [preservative 46°F). Must be used within 24 hours of reconstitution. free]: Mechanism of Action Selective costimulation modulator; Orencia: 125 mg/mL (1 mL) inhibits T-cell (T-lymphocyte) activation by binding to CD80 Solution Reconstituted, Intravenous [preservative free]: and CD86 on antigen presenting cells (APC), thus blocking Orencia: 250 mg (1 ea) the required CD28 interaction between APCs and T cells. ^ Activated T lymphocytes are found in the synovium of Abbott-43818 see Leuprolide on page 913 ^ rheumatoid arthritis patients. ABCD see Amphotericin B Cholesteryl Sulfate Complex Pharmacodynamics/Kinetics on page 94 Bioavailability: SubQ: 78.6% (relative to IV administration) ^ Abelcet see Amphotericin B (Lipid Complex) on page 98 Distribution: Vss: 0.02-0.13 L/kg ^ Abilify see ARIPiprazole on page 115 Half-life elimination: 8-25 days ^ Dosage Abilify Discmelt [DSC] see ARIPiprazole on page 115 Geriatric Refer to Dosage: Adult. Due to potential for ^ Abilify Maintena see ARIPiprazole on page 115 higher rates of infections and malignancies, use caution. ^ Abiraterone see Abiraterone Acetate on page 19 Adult Rheumatoid arthritis (RA): IV: Dosing is according to body weight. Following the Abiraterone Acetate (a bir A ter one AS e tate) initial IV infusion (using the weight-based dosing), Medication Safety Issues repeat IV infusion (using the same weight-based dos- Sound-alike/look-alike issues: ing) at 2 weeks and 4 weeks after the initial infusion, Zytiga may be confused with Jevtana, Xgeva, Xofigo, and every 4 weeks thereafter. Xtandi, Zometa, Zydelig <60 kg: 500 mg Brand Names: US Zytiga 60-100 kg: 750 mg Brand Names: Canada Zytiga >100 kg: 1000 mg Index Terms Abiraterone; CB7630 SubQ: 125 mg subcutaneously once weekly. Note: SubQ Generic Availability (US) No dosing may be initiated with or without an IV load- Pharmacologic Category Antiandrogen; Antineoplastic ing dose. Agent, Antiandrogen If initiating with an IV loading dose, administer the initial IV infusion (using the weight-based dosing), then Use Prostate cancer: Treatment of metastatic, castration- resistant prostate cancer (in combination with prednisone) administer 125 mg subcutaneously within 24 hours of the infusion, followed by 125 mg subcutaneously Contraindications once weekly thereafter. Canadian labeling: Additional contraindication (not in US If transitioning from IV therapy to SubQ therapy, admin- labeling): Hypersensitivity to abiraterone acetate or any ister the first SubQ dose instead of the next scheduled component of the formulation or container IV dose. Warnings/Precautions Hazardous agent
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