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omalizumab

(oh mal iz' you mab)


Xolair

Pregnancy Category B

Drug classes
Monoclonal antibody
Antasthmatic

Therapeutic actions
Monoclonal antibody specific for IgE receptor sites on mast cells and basophils leading to a
decrease in the release of chemical mediators of allergic responses.

Indications
• To decrease the incidence of asthma exacerbations in adults and adolescents (> 12 yr)
with moderate to severe persistent asthma who have a positive skin test or reactivity to a
perennial aeroallergen and whose symptoms are not controlled with inhaled
corticosteroids

Contraindications and cautions


• Contraindicated with allergy to any component of the preparation.
• Use cautiously with pregnancy, lactation.

Available forms
Powder for reconstitutions injection—150 mg/5 mL vial

Dosages
ADULTS AND PATIENTS > 12 YR
150–375 mg by SC injection every 2–4 wk; dosage is based on pretreatment IgE levels and body
weight.
PEDIATRIC PATIENTS < 12 YR
Safety and efficacy not established.

Pharmacokinetics
Route Onset Peak
SC Slow 7–8 days
Metabolism: Liver and tissue; T1/2: 26 days
Distribution: May cross placenta; may enter breast milk
Excretion: Tissue

Adverse effects
• CNS: Headache, dizziness, earache
• Local: Injection site reactions
• Respiratory: URI, sinusitis, pharyngitis
• Skin: Pruritus, dermatitis
• Other: Malignancies, fatigue, pain, anaphylactic reactions
Nursing considerations
Assessment
• History: Allergy to any component of the preparation; pregnancy, lactation, positive
testing for aeroallergens
• Physical: Temperature; skin—color, lesions; orientation, reflexes; R, adventitious sounds

Interventions
• Arrange for pretreatment allergen testing.
• Ensure that patient has tried and failed control of symptoms using inhaled corticosteroids.
• Refrigerate vials; product contains no preservatives, do not use after expiration date on
the label. Protect from exposure to sunlight.
• Dissolve powder using solution provided; powder takes about 15–20 min to dissolve
completely; inject full 1.4 mL of fluid into vial, swirl, do not shake vial, for 5–10 sec
every 5 min until powder is completely dissolved. Remove full amount of solution from
the vial to ensure complete dosage. Solution must be used within 8 hr of reconstitution.
• Administer by SC injection only; keep a map of injection sites and rotate sites between
abdomen and upper thigh; do not use any area that is tender, bruised, red, or hard.
• Solution is viscous; the complete injection may take 5–10 sec.
• Continue the use of other antasthmatic drugs that have been used unless ordered to
discontinue by the health care provider. If inhaled corticosteroids have been used, dosage
should be gradually reduced under medical supervision.
• Discontinue drug and arrange for appropriate therapy at first sign of severe allergic
reaction.
• Suggest the use of barrier contraceptives to women of child-bearing age because the
effects of this drug on a fetus are not known.
• Suggest another method of feeding the baby if the drug is needed in a breastfeeding
woman.

Teaching points
• Take this drug exactly as prescribed. This drug helps to stop the chemical reactors in your
body that cause the signs and symptoms of your asthma. It is not useful for an acute
attack of asthma.
• You and a significant other should learn how to prepare the drug and administer it by
subcutaneous injection. The drug should be injected into the abdomen or upper thigh.
Prepare a chart of injection sites and rotate the sites—do not use a site that is tender,
bruised, red or hard.
• Keep a calendar to remind you to inject the drug every 2–4 wk as ordered.
• Refrigerate the drug; if you notice any particulate matter in the solution or if the solution
is discolored, do not use it. Discard that solution. Use an appropriate disposal unit for the
needles and syringes.
• This drug should not be taken during pregnancy or when nursing a baby unless it is
absolutely necessary; using barrier contraceptives is suggested because the effects of the
drug on the human fetus or nursing baby are not known.
• You are at a higher risk for developing cancer while you are taking this drug; keep regular
medical appointments for exam and screening.
• You will need periodic blood tests to evaluate the effect of this drug on your system.
• These side effects may occur: Headache (analgesics may help); respiratory infections
(you should avoid crowded areas and people with known infections and use strict hand-
washing techniques); redness and swelling at injection site (rotate sites; use warm soaks
if site is very uncomfortable; do not reinject into an irritated site).
• Report infection or swelling at injection sites, difficulty breathing, worsening of asthma
symptoms.

Adverse effects in Italic are most common; those in Bold are life-threatening.