Dosing & Uses
Dosage Forms & Strengths
injectable solution
- 10mg/mL (3mL, single-dose vial)
Hereditary Angioedema
Indicated for treatment of acute attacks of hereditary angioedema (HAE)
30 mg (3 mL) SC administered in 3 separate 10 mg (1 mL) injections
If attack persists, may administer an additional dose of 30 mg within 24 hr
Dosage Forms & Strengths
injectable solution
- 10mg/mL (3mL, single-dose vial)
Hereditary Angioedema
Indicated for treatment of acute attacks of hereditary angioedema (HAE) in adolescents aged ≥12 yr
<12 years: Safety and efficacy not established
≥12 years: As adults; 30 mg (3 mL) SC administered in 3 separate 10 mg (1 mL) injections
If attack persists, may administer additional 30 mg dose within 24 hr
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (6)
- axicabtagene ciloleucel
ecallantide, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- brexucabtagene autoleucel
ecallantide, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ciltacabtagene autoleucel
ecallantide, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- idecabtagene vicleucel
ecallantide, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- lisocabtagene maraleucel
ecallantide, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tisagenlecleucel
ecallantide, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
Monitor Closely (2)
- isavuconazonium sulfate
ecallantide and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.
- ublituximab
ublituximab and ecallantide both increase immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered
Minor (0)
Adverse Effects
>10%
Headache (16.1%)
Nausea (12.9%)
Fatigue (11.8%)
Diarrhea (10.6%)
1-10% (selected)
Upper respiratory tract infection (8.2%)
Nasopharyngitis (5.9%)
Vomiting (5.5%)
Pruritus (5.1%)
Upper abdominal pain (5.1%)
Pyrexia (4.7%)
Anaphylaxis (3.9%)
Injection site reactions
Rash
Urticaria
Warnings
Black Box Warnings
Anaphylaxis
- Anaphylaxis has been reported
- Administer by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema
- Be aware of similar symptoms between hypersensitivity reactions and hereditary angioedema and closely monitor
- Do not administer to patients with known clinical hypersensitivity to ecallantide
Contraindications
Hypersensitivity
Cautions
Risk of potentially serious hypersensitivity reactions, including anaphylaxis; observe patients for an appropriate period of time after administration; do not administer to patients with known hypersensitivity to ecallantide (see Contraindications and Black Box Warnings)
Pregnancy & Lactation
Pregnancy
Available data have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes
Animal data
- Increased early fetal deaths resulting in decreased live fetuses were observed in rats following treatment during organogenesis with IV dose ~1.6x the maximum recommended human dose (MRHD) in the presence of maternal toxicity
- No effects present on embryofetal survival or structural abnormalities in rats and rabbits following treatment during organogenesis with IV doses up to ~1.1 and 6x the MRHD, respectively, or rats treated with SC doses up to 2.4x the MRHD
Lactation
No data available on presence in human milk, effects on breastfed infants, effects on milk production
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Human plasma kallikrein inhibitor, thereby reducing conversion of kininogen to bradykinin; bradykinin production may contribute to increased vascular permeability and angioedema experienced in HAE
Absorption
Peak plasma concentration: 586 ng/mL
Peak plasma time: ~2-3 hr
AUC: 3,017 ng⋅hr/mL
Distribution
Vd: 26.4 L
Elimination
Clearance: 153 mL/min
Excretion: Urine (a small protein [7054 Da] and renal elimination demonstrated)
Administration
SC Preparation
Visually inspect for particulate matter and discoloration before administration; solution should appear clear and colorless; discard if there is particulate matter or discoloration
Withdraw 1 mL (10 mg) from vial using a large bore needle; change needle on syringe to a needle suitable for SC injection (ie, 27-gauge)
SC Administration
Should be administered by healthcare professional only with medical support
Inject SC in thigh, abdomen, or upper arm; no need for site rotation
Separate injection sites by at least 2 inches (5 cm) and away from anatomical site of attack
Storage
Unopened vials: Refrigerate at 2-8ºC (36-46ºF)
Vials removed from refrigeration: Store <30ºC (86ºF) and use within 14 days or return to refrigeration until use
Protect from light until use
Do not use beyond expiration date
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Kalbitor subcutaneous - | 10 mg/mL (1 mL) vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
ecallantide subcutaneous
ECALLANTIDE - INJECTION
(e-KAL-lan-tide)
COMMON BRAND NAME(S): Kalbitor
WARNING: Ecallantide may rarely cause serious (rarely fatal) allergic reactions. Patients who experience a severe allergic reaction with this drug must never use it again. Because the symptoms can be the same for an allergic reaction and the condition which this medication treats, you will be monitored closely by your healthcare providers as you receive this medication in a clinic or hospital. Immediate medical attention should be provided if you develop any signs of an allergic reaction such as rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, or chest pain.
USES: This medication is used to treat an acute attack of a certain immune disease passed down through families (hereditary angioedema-HAE). Ecallantide blocks a natural substance produced by the body (kallikrein) which acts to increase amounts of another natural substance (bradykinin) thought to cause the symptoms seen during an acute attack of HAE. This medication does not cure HAE. Ecallantide may lessen the symptoms during an acute attack of HAE such as rapid swelling and pain of the hands, feet, limbs, face, tongue, or throat. When attacks involve the intestines, symptoms may include abdominal pain/cramps, diarrhea or vomiting. Attacks of swelling may occur without reason. However, anxiety, stress, sickness, and surgery may trigger attacks in some people.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using ecallantide and each time you get a refill. If you have any questions, consult your doctor or pharmacist.Your healthcare provider will inject this medication under your skin either in the abdomen, thigh, or upper arms as directed by your doctor. You will receive three separate shots which should be separated by at least 2 inches (5 centimeters). An additional three shots may be given in a 24-hour period if the HAE attack continues.Do not receive an injection into skin that is tender, red, or hard.Dosage is based on your medical condition and response to treatment.Tell your doctor if your condition does not improve or if it worsens.
SIDE EFFECTS: See also Warning section.Bruising, itching, redness, swelling of the skin at the injection site may occur. Nausea, fever, or stuffy nose may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using ecallantide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Not applicable.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.
STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.
Information last revised May 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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Adding plans allows you to:
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