Efficacy and safety of omalizumab in nasal polyposis: two randomized phase III trials

Efficacy and safety of omalizumab in nasal polyposis: two randomized phase III trials:



Publication date: Available online 7 June 2020

Source: Journal of Allergy and Clinical Immunology

Author(s): Philippe Gevaert, Theodore A. Omachi, Jonathan Corren, Joaquim Mullol, Joseph Han, Stella E. Lee, Derrick Kaufman, Monica Ligueros-Saylan, Monet Howard, Rui Zhu, Ryan Owen, Kit Wong, Lutaf Islam, Claus Bachert







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Φάρμακο



Ενεργά συστατικά

1 Ομαλιζουμάμπη

2P471X1Z11 - OMALIZUMAB

Η ομαλιζουμάμπη (omalizumab) είναι εξανθρωποποιημένο μονοκλωνικό αντίσωμα που προκύπτει από ανασυνδυασμένο DNA, το οποίο δεσμεύει εκλεκτικά την ανθρώπινη ανοσοσφαιρίνη Ε (IgE). Η ομαλιζουμάμπη δεσμεύεται με την IgE και εμποδίζει τη σύνδεση της IgE με τον FcsRI (υποδοχέας IgE υψηλής συγγένειας) και κατά συνέπεια μειώνει την ποσότητα ελεύθερης IgE που είναι διαθέσιμη για να δώσει το έναυσμα για τον αλλεργικό καταρράκτη. Η αγωγή των ατοπικών ατόμων με ομαλιζουμάμπη είχε ως αποτέλεσμα μια σημαντική προς τα κάτω ρύθμιση των υποδοχέων FcsRI στα βασεόφιλα.



Ανατομική/θεραπευτική/χημική (ATC) ταξινόμηση

ΚωδικόςΤίτλοςΚατηγοριοποίηση

 R03DX05OmalizumabR Αναπνευστικό σύστημα → R03 Φάρμακα για τις αποφρακτικές παθήσεις των αεροφόρων οδών → R03D Άλλα φάρμακα για τις αποφρακτικές παθήσεις των αεροφόρων οδών, για συστηματική χορήγηση → R03DX Λοιπά φάρμακα για τις αποφρακτικές παθήσεις των αεροφόρων οδών, για συστηματική χορήγηση



Τρόποι και περιορισμοί διάθεσης

Προϊόν του οποίου η κυκλοφορία γίνεται με βάση τη νομοθεσία περί φαρμάκων που προορίζονται για ανθρώπινη χρήση.



 Κεντρική άδειαΆδεια κυκλοφορίας στην Ε.Ε. που χορηγείται από την Ευρωπαϊκή Επιτροπή μετά από αίτηση στον Ευρωπαϊκό Οργανισμό Φαρμάκων και αξιολόγηση από τους εμπειρογνώμονες και γνωμάτευση της θεσμοθετημένης επιτροπής φαρμακευτικών ιδιοσκευασμάτων.

 Πρωτότυπο φάρμακoΦάρμακο που χαρακτηρίστηκε πρωτότυπο από τον Ε.Ο.Φ. σύμφωνα με την 3η έκδοση του ενημερωτικού καταλόγου κυκλοφορούντων πρωτότυπων και αντιγράφων φαρμάκων.

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ΠΧΠ2019 SPC, Greece: XOLAIR 75 mg Ενέσιμο διάλυμα σε προγεμισμένη σύριγγαNovartis Europharm Ltd

ΠΧΠ2019 SPC: XOLAIR 150mg Solution for injection in pre-filled syringe

ΠΧΠ2019 SPC: XOLAIR 75mg Solution for injection in pre-filled syringe



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Πηγή: Γαληνός Οδηγός Φαρμάκων

Usual Adult Dose for Asthma - Maintenance

Injectable:
Dose preparation is based on weight and pre-treatment IgE levels:

30 to 60 kg:
-IgE 30 to 100 international units/mL: 150 mg subcutaneously every 4 weeks
-IgE 100 to 300 international units/mL: 300 mg subcutaneously every 4 weeks
-IgE 300 to 400 international units/mL: 225 mg subcutaneously every 2 weeks
-IgE 400 to 600 international units/mL: 300 mg subcutaneously every 2 weeks
-IgE 600 to 700 international units/mL: 375 mg subcutaneously every 2 weeks

60 to 70 kg:
-IgE 30 to 100 international units/mL: 150 mg subcutaneously every 4 weeks
-IgE 100 to 200 international units/mL: 300 mg subcutaneously every 4 weeks
-IgE 200 to 400 international units/mL: 225 mg subcutaneously every 2 weeks
-IgE 400 to 500 international units/mL: 300 mg subcutaneously every 2 weeks
-IgE 500 to 600 international units/mL: 375 mg subcutaneously every 2 weeks
-IgE greater than 600 international units/mL: Do not dose

70 to 90 kg:
-IgE 30 to 100 international units/mL: 150 mg subcutaneously every 4 weeks
-IgE 100 to 200 international units/mL: 300 mg subcutaneously every 4 weeks
-IgE 200 to 300 international units/mL: 225 mg subcutaneously every 2 weeks
-IgE 300 to 400 international units/mL: 300 mg subcutaneously every 2 weeks
-IgE 400 to 500 international units/mL: 375 mg subcutaneously every 2 weeks
-IgE greater than 500 international units/mL: Do not dose

90 to 150 kg:
-IgE 30 to 100 international units/mL: 300 mg subcutaneously every 4 weeks
-IgE 100 to 200 international units/mL: 225 mg subcutaneously every 2 weeks
-IgE 200 to 300 international units/mL: 300 mg subcutaneously every 2 weeks
-IgE greater than 300 international units/mL: Do not dose

Comments:
-Interruptions lasting less than 1 year: Dose based on serum IgE levels obtained at the initial dose determination.
-Interruptions lasting 1 year or more: Retest total serum IgE levels for dose determination.
-Periodically reassess the need for continued therapy based on the patient's disease severity and level of asthma control.

Use: Management of moderate to severe persistent asthma in patients inadequately controlled with inhaled corticosteroids and with a positive skin test or in vitro reactivity to a perennial aeroallergen

Usual Adult Dose for Urticaria

Injectable: 150 to 300 mg subcutaneously every 4 weeks

Comments:
-Dosing not dependent on IgE levels or body weight.
-Avoid administering more than 150 mg per injection site.

Use: Chronic idiopathic urticaria in patients remaining symptomatic after H1 antihistamine treatment

Usual Pediatric Dose for Asthma - Maintenance

Less than 12 years: Not recommended.
12 years and older:
Injectable: Dose preparation is based on weight and pre-treatment IgE levels:

30 to 60 kg:
-IgE 30 to 100 international units/mL: 150 mg subcutaneously every 4 weeks
-IgE 100 to 300 international units/mL: 300 mg subcutaneously every 4 weeks
-IgE 300 to 400 international units/mL: 225 mg subcutaneously every 2 weeks
-IgE 400 to 600 international units/mL: 300 mg subcutaneously every 2 weeks
-IgE 600 to 700 international units/mL: 375 mg subcutaneously every 2 weeks

60 to 70 kg:
-IgE 30 to 100 international units/mL: 150 mg subcutaneously every 4 weeks
-IgE 100 to 200 international units/mL: 300 mg subcutaneously every 4 weeks
-IgE 200 to 400 international units/mL: 225 mg subcutaneously every 2 weeks
-IgE 400 to 500 international units/mL: 300 mg subcutaneously every 2 weeks
-IgE 500 to 600 international units/mL: 375 mg subcutaneously every 2 weeks
-IgE greater than 600 international units/mL: Do not dose

70 to 90 kg:
-IgE 30 to 100 international units/mL: 150 mg subcutaneously every 4 weeks
-IgE 100 to 200 international units/mL: 300 mg subcutaneously every 4 weeks
-IgE 200 to 300 international units/mL: 225 mg subcutaneously every 2 weeks
-IgE 300 to 400 international units/mL: 300 mg subcutaneously every 2 weeks
-IgE 400 to 500 international units/mL: 375 mg subcutaneously every 2 weeks
-IgE greater than 500 international units/mL: Do not dose

90 to 150 kg:
-IgE 30 to 100 international units/mL: 300 mg subcutaneously every 4 weeks
-IgE 100 to 200 international units/mL: 225 mg subcutaneously every 2 weeks
-IgE 200 to 300 international units/mL: 300 mg subcutaneously every 2 weeks
-IgE greater than 300 international units/mL: Do not dose

Comments:
-Interruptions lasting less than 1 year: Dose based on serum IgE levels obtained at the initial dose determination.
-Interruptions lasting 1 year or more: Retest total serum IgE levels for dose determination.
-Periodically reassess the need for continued therapy based upon the patient's disease severity and level of asthma control.

Use: Management of moderate to severe persistent asthma in patients inadequately controlled with inhaled corticosteroids and with a positive skin test or in vitro reactivity to a perennial aeroallergen

Usual Pediatric Dose for Urticaria

Less than 12 years: Not recommended.
12 years and older:
Injectable: 150 to 300 mg subcutaneously every 4 weeks

Comments:
-Dosing not dependent on IgE levels or body weight.
-Avoid administering more than 150 mg per injection site.

Use: Chronic idiopathic urticaria in patients remaining symptomatic after H1 antihistamine treatment

Renal Dose Adjustments

Data not available; use with caution.

Liver Dose Adjustments

Data not available; use with caution.

Dose Adjustments

Dose adjustments may be required based on significant changes in weight. The manufacturer product information should be consulted.

Precautions

US BOXED WARNING:
-ANAPHYLAXIS: Bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat of tongue have been reported in patients administered this drug and may occur beyond 1 year after beginning treatment.
-Patients should be monitored after administration and anaphylaxis treatments should be available for use in the event of occurrence.
-Inform patients of signs/symptoms of anaphylaxis and advise them to seek immediate medical care in the event of a reaction.

Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
- Avoid administering more than 150 mg per injection site. Divide doses of greater than 150 mg among at least 2 injection sites.
-Adjust dosing if patient weight significantly changes.
-May take 5 to 10 seconds to inject.

Storage requirements:
-Refrigerate, protect from light.
-Once reconstituted, use within 8 hours (refrigerated) or 4 hours (room temperature).

Reconstitution/preparation techniques: The manufacturer product information should be consulted.

General:
-This drug is not indicated for the treatment of acute bronchospasm, status asthmaticus, other forms of urticaria, and other allergic conditions.
-This drug should be administered by a health care provider experienced in treating severe asthma or chronic spontaneous urticaria.

Monitoring:
-Retest serum IgE levels for dosing if this drug is interrupted for 1 year or longer
-Signs and symptoms of anaphylaxis or anaphylactoid reactions
-Assess asthma control or urticaria symptoms periodically

Patient advice:
-Do not discontinue current asthma or chronic urticaria therapy when beginning this drug.
-Instruct patients to notify their healthcare provider upon signs and symptoms of worsening asthma or allergic reaction.
-Advise patient to speak to healthcare provider if pregnant, intend to become pregnant, or are breastfeeding.