Names and pronunciation
(goal-lim′yu-mab) Simponi, Simponi Aria, Simponi IV
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Drug reference
(goal-lim′yu-mab) Simponi, Simponi Aria, Simponi IV
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Func. class.: Antirheumatic agent (disease modifying), immuno modulator
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Chem. class.: tumor necrosis factor modifier
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ACTION: Monoclonal antibody spe- cific for human tumor necrosis factor (TNF); elevated levels of TNF are found in patients with rheumatoid arthritis
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USES: Rheumatoid arthritis (RA), ankylosing spondylitis, psoriatic arthritis, ulcerative colitis
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CONTRAINDICATIONS: Hyper- sensitivity, active infections Precautions: Pregnancy, breastfeeding, children, geriatric patients, CNS demye- linating disease, Guillain-Barré syn- drome, HF, hepatitis B carriers, blood dyscrasias, surgery, MS, neurologic dis- ease, diabetes, immunosuppression
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Black Box Warning: TB; fungal, bacterial, viral infections, new primary malignancy Black Box Warning: TB: obtain TB skin test before starting treatment; treat latent TB before starting therapy; continue to monitor for TB even if TB test is negative • Blood dyscrasias: CBC, differential before and periodically during treatment Black Box Warning: Infection: fever, flulike symptoms, dyspnea, change in urination, redness/swelling around any wounds; stop treatment if present; some serious infections including sepsis may occur, may be fatal; patients with ac- tive infections should not be started on this product; obtain a chest x-ray, fun- gal serology, TB testing before starting treatment • HBV infection: test for HBV before starting treatment; HBV can be fatal in HBV carriers; monitor LFTs; hepatitis B serology, may reactivate HBV • HF: B/P, pulse, edema, SOB, may occur or worsen with treatment • Psoriasis: may occur or worsen Black Box Warning: Neoplastic dis- ease: may occur in those <18 yr; avoid use in those with known malignancies; monitor for secondary malignancies dur- ing treatment • Anaphylaxis: rash, dyspnea, wheez- ing, emergency equipment should be nearby, if present, discontinue product immediately • Pregnancy/breastfeeding: use only if benefits outweigh fetal risk; do not breastfeed, excretion unknown Black Box Warning: To report signs, symptoms of infection, allergic reaction, or lupuslike syndrome • To notify prescriber if pregnancy is planned or suspected; not to breastfeed
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SIDE EFFECTS CNS: Dizziness, paresthesia, CNS demy- G elinating disorder, weakness, Guillian- Barre syndrome, MS CV: Hypertension, HF GI: Hepatitis HEMA: Agranulocytosis, aplastic anemia, leukopenia, polycythemia, thrombocyto- penia, pancytopenia INTEG: Psoriasis MISC: Increased cancer risk; antibody development to this drug; risk for infec- tion (TB, invasive fungal infections, other opportunistic infections), may be fatal; inj-site reactions, anaphylaxis
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INTERACTIONS • Do not give concurrently with live vac- cines or within 3 mo; immunizations should be brought up to date before treatment • Dosage change may be needed: warfa- rin, cycloSPORINE, theophylline Increase: infection—abatacept, etaner- cept, rilonacept, riTUXimab, adalim- umab, anakinra, immunosuppressants, inFLIXimab; avoid concurrent use Drug/Lab Test Increase: LFTs Decrease: platelets, WBC, neutrophils Positive: ANA titer
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DOSAGE AND ROUTES Rheumatoid arthritis • Adult: SUBCUT 50 mg monthly; give with methotrexate; IV (Simponi Aria only) 2 mg/kg over 30 min, repeat 4 wk later, then q8wk give with methotrexate Ulcerative colitis: • Adult: SUBCUT 200 mg for 1 dose, then 100 mg in 2 wk, maintenance 100 mg q4wk starting at wk 6
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Available forms: Inj 50 mg/0.5 mL, 100 mg/mL prefilled syringe, SmartJect Auto Injector; inj 50 mg/4 mL single-use vial
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Administer: SUBCUT route • Refrigerate, do not freeze; allow to warm to room temperature before using • Visually inspect sol for particulate or discoloration; sol should be clear to slightly opalescent and colorless to slightly yellow; there may be tiny white particles; do not shake; rotate injection sites • Use multiple injection sites for multiple injections • Rotate injection sites, discard unused portions SmartJect Autoinjector • Allow the single-use prefilled autoin- jector to reach room temperature for at least 30 min • Immediately prior to use, remove cap. Inject within 5 min of cap removal. Do not put the cap back on • Place the open end of the autoinjector against the injection site at a 90-degree angle. Make sure the green safety sleeve is flat against the skin • Push the autoinjector firmly against the skin until the green safety sleeve slides fully into the clear cover, then press the button. Listen for a loud first click; do not pull the autoinjector away from the skin. Wait for the second click. This usually takes 3-6 sec but may take up to 15 sec. If the autoinjec- tor is pulled away from the skin before the injection is complete, the full dose may not be administered • Do not rub the injection site • If the viewing window is not yellow, call 800-526-7736; do not give a second dose without talking with the prescribing health care provider Prefilled syringe • Allow the single-use prefilled syringe to reach room temperature for at least 30 min prior to use • Immediately before use, remove the needle cover by pulling it straight off; do not twist off or recap. Inject within 5 min of needle cover removal • Hold the syringe in one hand like a pencil and use the other hand to gently pinch a fold of skin at the cleaned injec- tion site. Do not touch the plunger or the area above the finger flange prior to ad- ministration, as this may cause the nee- dle safety device to activate • Insert the needle at a 45-degree angle to the skin. Inject by pushing the plunger all the way down until it stops. Release pressure from the plunger. The safety guard will cover the needle and lock into place, removing the needle from the skin • Do not rub the injection site • Properly dispose of the used prefilled syringe IV route (Simponi Aria) • Calculate number of vials needed; do not shake; dilute total volume of product in NS to yield 100 mL for infusion; slowly add product, mix gently • Infuse over 30 min, use infusion set with in-line, low–protein-binding filter (0.22 mm pore size) • May store diluted solution for 4 hr
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Assess: • Pain, stiffness, ROM, swelling of joints during treatment • Inj-site pain, swelling; usually occur after 2 inj (4-5 days)
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Evaluate: • Therapeutic response: decreased in- flammation, pain in joints, decreased joint destruction
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • About self-administration if appropri- ate: inj should be made in thigh, abdo- men, upper arm; rotate sites at least 1 inch from old site; do not inject in areas that are bruised, red, hard • That, if medication not taken when due, to inject next dose as soon as remembered and then the following dose as scheduled • Not to receive any live virus vaccines during treatment
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PHARMACOKINETICS Half-life 2 wk, SUBCUT peak 2-7 days, IV peak 12 wk
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• Adult: SUBCUT 50 mg monthly; give with methotrexate; IV (Simponi Aria only) 2 mg/kg over 30 min, repeat 4 wk later, then q8wk give with methotrexate Ulcerative colitis:
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• Adult: SUBCUT 200 mg for 1 dose, then 100 mg in 2 wk, maintenance 100 mg q4wk starting at wk 6
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