Kalbitor

>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

Pregnancy Category: C

Lactation: excretion in milk unknown; use with caution

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.

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

Pharmacokinetics

Half-life: 2 hr

Vd: 26.4 L

Peak plasma time: 2-3 hr  

Peak plasma concentration: 586 +/- 106 ng/mL

Clearance:  153 mL/min

Instructions

Because of risk for anaphylaxis, administered by healthcare professional only with medical support

Inject in thigh, abdomen, or upper arm

Since ecallantide is given by a healthcare professional, you are not likely to miss a dose.

Kalbitor is a prescription medication used to treat a genetic disease called hereditary angioedema.

Kalbitor belongs to a group of drugs called kallikrein inhibitors. These work by binding to a substance found in your body called kallikrein. This treats the symptoms the body experiences in an acute attack. 

This medication is available in an injectable form to be given directly under the skin (subcutaneously) by a healthcare professional. 

Common side effects of Kalbitor include headache, nausea, diarrhea, fever and pain or irritation at the injection site.

If Kalbitor is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Ecallantide is used to treat attacks of hereditary angioedema (an immune system disorder). This medication is used in people who are at least 16 years old.

Ecallantide is not a cure for hereditary angioedema.

Ecallantide may also be used for other purposes not listed in this medication guide.

Other drugs may interact with ecallantide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Hereditary Angioedema

Treatment of acute angioedema attacks in patients with hereditary angioedema (HAE).1 2 5 12 13

Designated an orphan drug by FDA for this use.7

A nurse or other trained health professional will give you or your child this medicine in a hospital or emergency clinic. This medicine is given as a shot under your skin (usually in the abdomen, thigh, or upper arm).

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad irritation where the shot was given.
• Trouble swallowing.
• Shortness of breath.
• Dizziness or passing out.
• A fast heartbeat.
• A heartbeat that does not feel normal.
• Feeling nervous and excitable.
• Flushing.
• Runny nose.
• Stuffy nose.
• Sneezing.
• Nose or throat irritation.

Recommended Dosing

The recommended dose of Kalbitor is 30 mg (3 mL), administered subcutaneously in three 10 mg (1 mL) injections. If the attack persists, an additional dose of 30 mg may be administered within a 24 hour period.

Administration Instructions

Kalbitor should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema.

Kalbitor should be refrigerated and protected from the light. Kalbitor is a clear, colorless liquid; visually inspect each vial for particulate matter and discoloration prior to administration. If there is particulate matter or discoloration, the vial should not be used.

Using aseptic technique, withdraw 1 mL (10 mg) of Kalbitor from the vial using a large bore needle. Change the needle on the syringe to a needle suitable for subcutaneous injection. The recommended needle size is 27 gauge. Inject Kalbitor into the skin of the abdomen, thigh, or upper arm. Repeat the procedure for each of the 3 vials comprising the Kalbitor dose. The injection site for each of the injections may be in the same or in different anatomic locations (abdomen, thigh, upper arm). There is no need for site rotation. Injection sites should be separated by at least 2 inches (5 cm) and away from the anatomical site of attack.

The same instructions apply to an additional dose administered within 24 hours. Different injection sites or the same anatomical location (as used for the first administration) may be used.

Hypersensitivity Reactions, Including Anaphylaxis

Potentially serious hypersensitivity reactions, including anaphylaxis, have occurred in patients treated with Kalbitor. In 255 HAE patients treated with intravenous or subcutaneous Kalbitor in clinical studies, 10 patients (4%) experienced anaphylaxis. For the subgroup of 187 patients treated with subcutaneous Kalbitor, 5 patients (3%) experienced anaphylaxis. Symptoms associated with these reactions have included chest discomfort, flushing, pharyngeal edema, pruritus, rhinorrhea, sneezing, nasal congestion, throat irritation, urticaria, wheezing, and hypotension. These reactions occurred within the first hour after dosing.

Other adverse reactions indicative of hypersensitivity reactions included the following: pruritus (5%), rash (3%), and urticaria (2%).

Patients should be observed for an appropriate period of time after administration of Kalbitor, taking into account the time to onset of anaphylaxis seen in clinical trials. Given the similarity in hypersensitivity symptoms and acute HAE symptoms, patients should be monitored closely in the event of a hypersensitivity reaction.

Kalbitor should not be administered to any patients with known clinical hypersensitivity to Kalbitor [see Contraindications (4)].

ATTENTION: Dispense the enclosed
Medication Guide to each patient.
NDC# 47783-101-01

Kalbitor®

ecallantide

10 mg/mL
Injection
For Subcutaneous Use Only
Single Use; Discard Unused Portion
Net Quantity: 3 Vials

Rx Only

You should not be treated with Kalbitor if you are allergic to ecallantide.

If possible before you receive Kalbitor, tell your doctor if you have a history of any type of allergy.

It is not known whether Kalbitor will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether ecallantide passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

In an emergency situation it may not be possible to tell your caregivers if you are pregnant or breast-feeding. Make sure any doctor caring for your pregnancy or your baby knows you have received this medicine.

Tell your caregivers right away if you have any of these signs of an allergic reaction to Kalbitor within 1 hour after receiving your injection:

• chest pain or tightness, fast or weak heartbeat;

• wheezing, cough, throat irritation, trouble breathing;

• hoarse voice, tight feeling in your throat, trouble swallowing;

• swelling of your lips, tongue, or throat;

• swelling or redness in your face;

• itching, rash, or hives;

• flushing (warmth, redness, or tingly feeling);

• sneezing, runny or stuffy nose; or

• dizziness, feeling like you might pass out.

An allergic reaction to ecallantide can cause symptoms that are similar to the signs of hereditary angioedema. Your caregivers will watch you closely to make sure you are not having an allergic reaction to ecallantide.

Common Kalbitor side effects may include:

• headache;

• nausea, diarrhea;

• fever;

• stuffy nose, sore throat; or

• skin reactions where the medicine was injected (redness, rash, itching, bruising, swelling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.