Biologic Assignments Flashcards
what is the other name for omalizumab
xolair
what is omalizumab indicated for
xolair- 1) adults and adolescents 12 years and over with moderate-severe persistent asthma and whose symptoms are inadequately controlled with inhaled corticosteroids 2) adults and adolescents 12 and over with chronic idiopathic urticaria after antihistamine failure
how does omalizumab come
xolair-sterile powder for reconstitution and injection
efficacy of xolair
omalizumab-decrease in asthma related hospital admission, unscheduled dr visits and emergency room visits vs placebo
how does xolair work
omalizumab- targets receptor binding on IgE
special administration of omalizumab
xolair-SC-any dose above 150mg must be divided over more than one injection site- patient must be observed for minimum of two hours after each injection. Given q4weeks, or q2weeks if over 90kg
contraindications for xolair, and DI
omalizumab-rash, increased risk infection, heart attacks/failure/abnormal rhythms, fainting, mini stroke, blood clots, no DI
omalizumab pregnancy category
xolair- B
place in therapy for xolair
omalizumab- expensive, inconvenient, only for those 12 and over who are poorly controlled despite high dose steroid- is an appropriate add on with or without oral prednisone. Last line therapy
what is the other name for dinutuximab
unituxin
what is dinutuximab indicated for
unituxin- treatment of high risk neuroblastoma in combination with GM CSF, IL2 and isotretinoin in patients under 5 (peds) who show at minimum a partial response to other therapies
-is used as part of a multimodality regimen that includes surgery, chemo, and radiation
neuroblastoma-who affects and what is it-what drug is this relevant for
unituxin-dinutuximab-mostly children under 5 (suggests preconceptual and gestational link), may originate anywhere in SNS, most commonly presents as mass in abdomen, chest, neck and most commonly adrenal glands. Signs and sx vary with location of tumor. Prognosis often poor due to late detection. Treatment based on risk stratification
talk about risk categories for neuroblastoma- which drug is this relevant for
unituxin-dinutuximab- low to intermediate have good prognosis (treat with observation, surgery, and or chemo), high risk have poor prognosis and have aggressive treatment with chemo, surgery, myeloablative chemo, autologous stem cell rescue, transpolant, radiation, differentiation, and or immunotherapy
what is unituxin (how it works)
dinutuximab- glycosylated IgG mAb that targets the antigen GD2 which is on the surface of neuroblastoma cells and promotes cell growth- drug binds and induces cell lysis of GDs expressing cells
handling, storage and administration of unituxin
dinutuximab- fridge, no light, don’t shake, patient must be checked to ensure hematologic/resp/hepatic/renal adequacy first, added to NaCl. Store in fridge and use within 4 hours of prep. IV infusion over 10-20 hours for 4 consecutive days up to 5 cycles
adverse effects and DI of dinutuximab
unituxin- infusion reactions (prehydrate with NSS and diphenhydramine), neuropathic pain (morphine and or gabapentin or lidocaine), capillary leak syndrome, hypotension, sepsis, neurologic eye disorders, hypokalemia, embryo fetal tox (contraception advised), bone marrow suppression. No DI studies done
what is the brand name for palivizumab
synagis
what is synagis indicated for
palivizumab- prevention of serious lower respiratory tract diseases caused by RSV in children at high risk. Safety and efficacy has been established for children with premature history, infants with bronchopulmonary displasia, and children with congenital heart disease- only for prevention not treatment
what are risk factors for getting RSV, how to prevent it, and what drug is this relevant for
palivizumab-synagis- premature, congenital heart disease, airway abnormalities, down’s syndrome, cleft lip/palate- can assess these patients for prophylactic use of synagis. Can only prevent by washing hands, other than synagis
clinical presentation of RSV, why its worse in kids- what drug is this relevant for?
cold like symptoms that can progress to cough, fast breathing and wheezing in the acute phase (bronchiolitis). Can lead to death from lack of oxygenation or dehydration (more serious in young kids because smaller airways and immature immune system)
treatment for active RSV, what drug is this relevant for?
synagis aka palivizumab-no specific treatment besides supportive care, but trialed treatments include Antivirals (no effect), corticosteroids (small improvement if asthma), bronchodilators (not beta agonists, only continued in children with a reduction of wheezing shown), supportive care (hydration, humidifier, suction, may need supplemental oxygen or mechanical ventilation).
how palivizumab works
synagis-antibody to F glycoprotein of RSV (usually mediates fusion of virus to host cell membrane and to each other)- drug stops this and inhibits viral penetration into host cell as well
effectiveness of synagis
palivizumab- reduces RSV hospitalization for premature infants (80% in those without chronic lung disesase, 40% in those with, and 45% in congenital heart disease, but no effect for cystic fibrosis)
SE and CI (including preg) for palivizumab
synagis- AE fever, rash. CI in preg, patients with thrombocytopenia or any coagulation disorder
how to administer synagis, is it covered?
palivizumab- IM into anterolaterial thigh (not gluteal due to risk for siatic nerve damage), volumes greater than 1mL should be in divided doses. Give 15mg.kg.month for duration of RSV season. Covered in SK if child meets criteria
other name for inflectra
infliximab
what is infliximab
a disease modifying anti rheumatic drug (DMARD) for RA
treatment options for RA (include first line), what drug is this relevant for?
inflectra-infliximab- NSAIDs, glucocorticoids (prednisone), analgesics, DMARDs (methotrexate, leflunomide, hydroxychloroquine, cyclosporine, azathioprine), and biologics (abatacept, rituximab, certolizumab, etanercept, golimumab, tocilizumab, adilimumab) **Methotrexate is first line
how are inflectra and remicade related
both infliximab, but biosimilars. No significant differences in PK, efficacy, or time to onset
how does inflectra work
infliximab- binds to TNF alpha which impacts inflammatory processes (like cytokine production)
what is infliximab used for
inflectra- most commonly moderate to severe RA, but also ankylosing spondylitis, crohn’s, moderate to seere plaque psoriasis, psoriatic arthritis, and UC
how is inflectra administered
infliximab- IV at weeks 0.2.6 then q8w (3mg/kg for RA, 5mg/kg for others)
adverse reactions and CI for infliximab
inflectra AE- related to infusion process, infection, N/D, abdominal pain, increased liver enzymes (AE incidence similar with remicade), CI in severe heart failure or infections. DI= other biologics or live vaccines, and potentially cyp450 substrates
efficacy of infliximab, is it covered
inflectra- comparable or superior to other therapies for inflammatory conditions. Superior to othe DMARDs (like methotrexate). EDS coverage for remicade (if failed methotrexate and leflunomide), in 2014 inflectra recommended to be listed as well,
what is the other name for adalimumab
humira
administration of humira
adalimumab- SC
how does adalimumab work?
humira- for Crohn’s- IgG antibody that targets inflammatory mediators (especially TNF alpha- targets both soluble and transmembrane forms of it) to prevent binding will cell surface receptors
what is adalimumab indicated for
humira- treatment of RA, psoriatic arthritis, polyarticular juvenile idiopathic arthritis, plaque psoriasis, Crohn’s, UC, ankylosing spondylitis
-moderate to severe Crohns as second line if steroids did not induce remission or if intolerant to infliximab
efficacy of humira
adalimumab- superior to placebo in inducing remission for moderate to severe crohns disease who are naive to TNF antagonist therapy. Can induce and maintain remission and often used in combination with 6mercapto, azathiprine or methotrex. If ahve already tried infliximab efficacy may be reduced
how to administer humira
adalimumab- SC from prefiled syringe or pen-4 injections on day 1, 2 injections in two weeks, then maintenance of 1 injection (40mg) every two weeks after. Must be assessed after induction dose and ever 6 months by a specialist thereafter
AE of adalimumab and DI, pregnancy
Common SE, but CI if have active severe infection (sepsis, TB, etc) or heart failure, category B in pregnancy
coverage of Humira
adalimumab- EDS if refractory or other contraindications to several other medications
what is metastatic breast cancer often referred to as, what are risk factors, what drug is this relevant for?
advanced or stage 4, herceptin (trastuzumab); when cancer of the breasts spreads to distant sites, risks=over 40, nulliparity, early onset menses, late age menopause, OCP/hormone replacement, family hx (breast or ovarian)
symptoms of metastatic breast cancer, prognosis, what drug is this relevant for?
herceptin (trastuzumab)- depends on site of metastases, but common bone pain, trouble breathing, enlarged abdomen, jaundice, changes in mental status. All cases have neglected breast mass. Survival 23 months, bone only live longer. Untreated 9-12 months