XOLAIR *
Manufacturer Details
GENETECH INC
Compositions:
Omalizumab 150mg lyophilized powder for injection ,
Strength
|
Rate
|
Packing Style
|
150mg
|
0.00
|
in single-use vial
|
List of Related Indications:
List Of Drugs:
- Omalizumab - @ - Monoclonal Antibodies- Leukotriene Formation Inhibitors
Indication Type Description:
Indication:
Asthma
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Omalizumab Respiratory Roche/Genetech 03-02-2014
Adverse Reaction:
CNS- dizziness 3% fatigue 3%
Dermatogic - Dermatitis 2% Pruritus 2%
Musculoskeletal - arm pain 2% arthalgia 7% fracture 2% leg pain 3%
Miscellaneous- earache 2% pain 6%
Contra-Indications:
Severe hypersensitivity to omalizumab
Special Precautions-
Hypersensitivity - anaphylaxis has been reported to occur after administration of omalizumab.
Some of the reactions have been life threatening
Malignancy- malignant neoplasms were observed in omalizumab treated patients in clinical
stuudies of asthma and allergic disorders.
The impact of longer usage of omalizimab or use in patients at higher risks for malignancy
(eg, current smokers, elderly patients) is not known
Acute asthma exacerbation - do not use fot treatment of acute bronchspasm or status
asthmaticus
Corticosteroid reduction- do not abruptly discontinue systemic or inhaled corticosteroids upon
initiation of omalizumab therapy.
Perform decreases in corticosteroids under the direct supervision of a physician , however,
decreases may need to be performed gradually
Eosinophillic conditions- in rare case, patients with asthma on omalizumab therapy may present
serious systemic eosinophilla. These events have not always been associated with the reduction
of oral corticosteroids therapy. Be alert to eosinophilia, vasculitic rash, worsening of pumonary
symptoms.
Parasite ( helminth infection ) - monitor patients for point of geohelminth infection for such infection
while on omalizumab therapy. Insufficient data avialable to determine the length monitoring required
Pregnancy- use omalizumab during pregnancy only if required
Lactation- excercise caution when administering omalizumab to a breast feeding woman
Children- safety and efficacy in children younger than 12 years of age have not been established
Lab test abnormalities- serum total IgE levels increase following administration of omalizumab
because of formation of omalizumab IgE complexes noiticed. Elevated elevated IgE levels may
persist up to 1 year after discontinuation of omalizumab
Monitoring- closely monitor patients for anaphylaxis for an appriopiate time after administration
Closely monitor patients at high risk of geohelminth infection while they are on omalizumab
therapy
Dosages/ Overdosage Etc:
Indication-
Asthma
Dosage-
Adults and adlosnts 12 years of age-
Usual dosage - 150 to 375mg is administered simultaneously every 2 or 4 weeks.
Because the injection is viscous it may take 10 seconds to administer.
Patient Information:
1. Advice patients of the risk of life threatening anaphylaxis with omalizumab therapy
2. Inform patients that there have reports of anaphylaxis up to 4 days after administration of
omalizumab.
3. Omalizumab should be administered in a health care setting by a physician
4. Closely observe patients following administration.
5. Inform patients to report signs and symptoms of anaphylaxis
6. Tell patients receiving omalizumab not to decrease the dose or stop taking any other
asthma medications unlerss otherwise instructed by the Doctor
7. Tell patients that they may see immediate improvement in their asthma after begining
omalizumab therapy
Pregnancy and lactation:
Pregnancy-
Use omalizumab during pregnancy only if required
Lactation-
Excercise caution when administering omalizumab to a breast feeding woman
Children-
Safety and efficacy in children younger than 12 years of age have not been established