Names and pronunciation
(na-ta-liz′u-mab) Tysabri
PDF page 938
Loading InternPractice…
Drug reference
(na-ta-liz′u-mab) Tysabri
PDF page 938
Func. class.: Biologic response modifier, immunoglobulins, monoclonal antibody
PDF page 938
ACTION: Biologic-response-modify- ing properties mediated through specific receptors on cells; may be secondary to blockade of the interaction of inflamma- tory cells with vascular endothelial cells
PDF page 938
USES: Ambulatory patients with relapsing/remitting MS who have not responded to other treatment; those with moderate to severe Crohn’s disease
PDF page 938
CONTRAINDICATIONS: Hypersen- sitivity, immunocompromised individuals (HIV, AIDS, leukemia, lymphoma, trans- plants), PML, murine (mouse) protein allergy
PDF page 938
Black Box Warning: Progressive multifo- cal leukoencephalopathy Precautions: Pregnancy, breastfeeding, geriatric patients, chronic progressive MS, depression, mental disorders, diabe- tes, TB, active infections, hepatotoxicity Black Box Warning: Progressive multi- focal leukoencephalopathy (weakness, paralysis, vision loss, impaired speech, cognitive deterioration; obtain gadolini- um-enhanced MRI scan of the brain, pos- sibly cerebrospinal fluid for JC viral DNA;) incidence of PML increases with number of doses, over 2 yr immunosuppressants and anti-JC virus antibody • Infection: report serious opportunistic infections to the manufacturer; those with Crohn’s disease and chronic oral cortico- steroids may be at greater risk of infection • Blood, renal, hepatic studies: CBC, dif- ferential, platelet counts, BUN, creati- nine, ALT, urinalysis, antibody testing • CNS symptoms: headache, fatigue, de- pression, rigors, tremors • GI status: abdominal discomfort, gastro- enteritis, severe hepatic injury, abnormal LFTs • Mental status: depression, deperson- alization, suicidal thoughts, insomnia • Anaphylaxis: SOB, hives; swelling, tightness in throat, chest pain; usually within 2 hr of infusion • Pregnancy/breastfeeding: use only if benefits outweigh fetal risk; avoid breast- feeding
PDF pages 938, 939
SIDE EFFECTS CNS: Headache, fatigue, rigors, syn- cope, tremors, depression, progressive multifocal leukoencephalopathy (PML), suicidal ideation, anxiety CV: Chest discomfort, hypo/hyperten- sion, tachycardia GI: Abdominal discomfort, abnormal LFT, gastroenteritis, severe hepatic injury GU: Amenorrhea, UTI, irregular menses, vaginitis, urinary frequency INTEG: Rash, dermatitis, pruritus, skin melanoma, infusion-related reactions MS: Arthralgia, myalgia RESP: Lower respiratory tract infec- tion, dyspnea SYST: Anaphylaxis, angioedema
PDF page 938
INTERACTIONS • Do not use with vaccines Increase: infection—immunosuppressants, antineoplastics, immunomodulators, tumor necrosis factors
PDF page 938
DOSAGE AND ROUTES • Adult: IV INFUSION 300 mg; give over 1 hr q4wk
PDF page 938
Available forms: Single-use vial, 300 mg/100 mL
PDF page 938
Administer: • Acetaminophen for fever, headache Intermittent IV INFUSION route • Use only clear, colorless solution, without particulates • Withdraw 15 mL from the vial inj con- centration into 100 mL 0.9% NaCl; do not use other diluents; mix completely; do not shake; infuse immediately or refrig- erate for ≤8 hr; flush with 0.9% NaCl before, after infusion; do not admix or use in same line with other agents • Withhold product at first sign of PML • Prescribers must be registered in the TOUCH Prescribing Program (1-800- 456-2255) • Store sol in refrigerator; do not freeze or shake; protect from light
PDF page 938
Assess: • MS symptoms; product should be used only by patients who have not responded to other treatments and for relapsing forms of MS and Crohn’s disease; restricted pre- scribing program; discuss risks, benefits
PDF page 938
Evaluate: • Therapeutic response: decreased symptoms of MS, Crohn’s disease
PDF page 939
CLINICAL CONSIDERATIONS
PDF page 938
Patient and caregiver information: • Purpose of medication, regimen • Provide patient or family member with written, detailed information about prod- uct (med guide) • That female patients may experience ir- regular menses, amenorrhea; may worsen over several days; to notify prescriber if pregnancy is suspected; to avoid breast- feeding while taking this product; if preg- nant, call the Tysabri Pregnancy Exposure Registry (1-800-456-2255) • To notify prescriber of possible in- fection: sore throat, cough, increased temperature, infusion-site reactions • That continuing follow-up will be needed at 3, 6 mo after first dose, then every 6 mo • To inform all prescribers of product use See Appendix B
PDF page 939
PHARMACOKINETICS Half-life approximately 11 days
PDF page 938
• Adult: IV INFUSION 300 mg; give over 1 hr q4wk
PDF page 938