Version May 2024
Anaphylaxis has been reported after administration of ecallantide. Because of the risk of anaphylaxis, ecallantide should only be administered by a health care provider with appropriate medical support to manage anaphylaxis and hereditary angioedema. Health care providers should be aware of the similarity of symptoms between hypersensitivity reactions and hereditary angioedema, and patients should be monitored closely. Do not administer ecallantide to patients with known clinical hypersensitivity to ecallantide.
Hereditary angioedema attacks, treatment:
Note: Because of the risk of anaphylaxis, self-administration at home is not recommended; however, may be administered at home by a trained health care professional. Shortening the time between symptom onset and drug administration helps minimize morbidity and mortality (US HAEA [Busse 2021]).
SUBQ: 30 mg once, administered as three 10 mg (1 mL) injections into skin of the abdomen, upper arm, or thigh, ≥2 inches apart, and away from the location of angioedema; if attack persists after ≥1 hour, may repeat 1 additional 30 mg dose within 24 hours (Zuraw 2022; manufacturer's labeling).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Refer to adult dosing.
(For additional information see "Ecallantide: Pediatric drug information")
Hereditary angioedema (HAE), treatment:
Children 8 to <12 years of age: Limited data available (Frank 2016): SubQ: 30 mg (as three 10 mg [1 mL] injections); dosing based on data pooled from 4 clinical studies (n=29, ages 9 to 17 years including 25 who received at least 1 dose of ecallantide) (MacGinnitie 2013) and a single case report in an 8-year-old (Dy 2013); efficacy was observed with no adverse events reported.
Children ≥12 years and Adolescents: SubQ: 30 mg (as three 10 mg [1 mL] injections); if attack persists, may repeat an additional 30 mg within 24 hours.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Central nervous system: Headache (8% to 16%), fatigue (12%)
Gastrointestinal: Nausea (5% to 13%), diarrhea (4% to 11%)
Immunologic: Antibody development (IgE: 5% to 20%; neutralizing: 9%)
1% to 10%:
Dermatologic: Pruritus (5%), skin rash (3%), urticaria (2%)
Gastrointestinal: Vomiting (6%), upper abdominal pain (5%)
Hypersensitivity: Anaphylaxis (4%)
Local: Injection site reaction (3% to 7%; includes bruising, erythema, irritation, pain, pruritus, urticaria)
Respiratory: Upper respiratory tract infection (8%), nasopharyngitis (3% to 6%)
Miscellaneous: Fever (4% to 5%)
<1%, postmarketing, and/or case reports: Hypersensitivity reaction (chest discomfort, flushing, pharyngeal edema, rhinorrhea, sneezing, nasal congestion, throat irritation, wheezing, hypotension)
Hypersensitivity to ecallantide or any component of the formulation
Concerns related to adverse effects:
• Hypersensitivity reactions: Serious hypersensitivity reactions, including anaphylaxis have been reported. Reactions usually occur within 1 hour and may include chest discomfort, flushing, hypotension, nasal congestion, pharyngeal edema, pruritus, rash, rhinorrhea, sneezing, throat irritation, urticaria, and wheezing. Signs/symptoms of hypersensitivity reactions may be similar to those associated with hereditary angioedema attacks; therefore, consideration should be given to treatment methods; monitor patients closely.
• Immunogenicity: Some patients may develop antibodies to ecallantide during therapy; seroconversion may increase the risk of hypersensitivity reaction.
Other warnings/precautions:
• Appropriate use: The role of ecallantide in the management of patients with ACEI-induced angioedema is controversial (Bernstein 2015; Lewis 2015).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Subcutaneous [preservative free]:
Kalbitor: 10 mg/mL (1 mL)
No
Solution (Kalbitor Subcutaneous)
10 mg/mL (per mL): $6,648.44
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
SubQ: Administer as 3 (10 mg/mL each) injections subcutaneously into skin of abdomen, upper arm, or thigh (do not administer at site of attack). Recommended needle size is 27 gauge. Separate injections by 2 inches (5 cm). May inject all doses in same or different location; rotation of sites is not necessary. Monitor/observe for hypersensitivity. Should only be administered by a health care professional; not for self-administration.
Note: Administer only by a health care provider in presence of appropriate medical support to manage anaphylaxis and hereditary angioedema.
Parenteral: SubQ: Administer as 3 (10 mg/mL each) injections subcutaneously into skin of abdomen, upper arm, or thigh (do not administer at site of attack). Recommended needle size is 27 gauge. Separate injections by 2 inches (5 cm). May inject all doses in same or different location; rotation of sites is not necessary. Do not self-administer. Monitor/observe for hypersensitivity.
An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125277s081lbl.pdf#page=13, must be dispensed with this medication.
Hereditary angioedema attacks, treatment: Treatment of acute attacks of hereditary angioedema in patients 12 years of age and older.
None known.
There are no known significant interactions.
If treatment of acute attacks for hereditary angioedema (HAE) is needed during pregnancy, agents other than ecallantide are recommended. Patients with HAE should be monitored closely during pregnancy and for at least 72 hours after delivery (WAO/EAACI [Maurer 2022]).
It is not known if ecallantide is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Lactation may increase the frequency of hereditary angioedema (HAE) attacks; patients with HAE should be monitored closely. Agents other than ecallantide are recommended to treat acute attacks of hereditary angioedema in patients who are breastfeeding (WAO/EAACI [Maurer 2022]).
Monitor for hypersensitivity reaction
Ecallantide is a recombinant protein which inhibits the conversion of high molecular weight kininogen to bradykinin by selectively and reversibly inhibiting plasma kallikrein. Unregulated bradykinin production is thought to contribute to the increased vascular permeability and angioedema observed in HAE.
Onset: 30 minutes to 4 hours (Epstein 2008)
Distribution: Vd: 26.4 ± 7.8 L
Half-life elimination: 2 ± 0.5 hours
Time to peak: ~2 to 3 hours
Excretion: Primarily urine
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