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Kalbitor

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Kalbitor

Kalbitor Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Kalbitor (ecallantide) Injection is a human plasma kallikrein inhibitor used to treat attacks of hereditary angioedema (an immune system disorder) in people who are at least 16 years old. It is not a cure for hereditary angioedema. Common side effects include bruising, itching, redness, swelling of the skin at the injection site. Nausea, fever, or stuffy nose may also occur.

The recommended dose of Kalbitor is 30 mg (3 mL), administered subcutaneously in three 10 mg (1 mL) injections. Kalbitor may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Kalbitor should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Kalbitor (ecallantide) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Kalbitor in Detail - Patient Information: Side Effects

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

  • chest pain or discomfort, fast or weak heartbeat;
  • flushing (warmth, redness, or tingly feeling);
  • feeling like you might pass out;
  • itching, rash, or hives;
  • runny nose, sneezing, stuffy nose;
  • wheezing, cough, throat irritation, trouble breathing; or
  • swelling of your face, lips, tongue, or throat.

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

Less serious side effects may include:

  • headache;
  • stomach pain, nausea, vomiting, diarrhea;
  • fever;
  • tired feeling;
  • sore throat; or
  • pain, bruising, itching, redness, rash, or irritation where the injection was given.

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.

Read the entire detailed patient monograph for Kalbitor (Ecallantide Injection) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Kalbitor Overview - Patient Information: Side Effects

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 persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Kalbitor (Ecallantide Injection)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Kalbitor FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Hypersensitivity reactions, including anaphylaxis, have occurred in patients treated with KALBITOR [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].

Clinical Trials Experience

Because clinical trials are conducted under varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety data described below reflect exposure to KALBITOR (ecallantide injection) in 255 patients with HAE treated with either intravenous or subcutaneous KALBITOR (ecallantide injection) . Of the 255 patients, 66% of patients were female and 86% were Caucasian. Patients treated with KALBITOR (ecallantide injection) were between the ages of 10 and 78 years.

Overall, the most common adverse reactions in 255 patients with HAE were headache (16.1%), nausea (12.9%), fatigue (11.8%), diarrhea (10.6%), upper respiratory tract infection (8.2%), injection site reactions (7.4%), nasopharyngitis (5.9%), vomiting (5.5%), pruritus (5.1%), upper abdominal pain (5.1%), and pyrexia (4.7%). Anaphylaxis was reported in 3.9% of patients with HAE. Injection site reactions were characterized by local pruritus, erythema, pain, irritation, urticaria, and/or bruising.

The incidence of adverse reactions below is based upon 2 placebo-controlled, clinical trials (EDEMA3® and EDEMA4®) in a total of 143 unique patients with HAE. Patients were treated with KALBITOR (ecallantide injection) 30 mg subcutaneous or placebo. Patients were permitted to participate sequentially in both placebo-controlled trials; safety data collected during exposure to KALBITOR (ecallantide injection) was attributed to treatment with KALBITOR (ecallantide injection) , and safety data collected during exposure to placebo was attributed to treatment with placebo. Table 1 shows adverse reactions occurring in > 3% of KALBITOR (ecallantide injection) -treated patients that also occurred at a higher rate than in the placebo-treated patients in the two controlled trials (EDEMA3 and EDEMA4) of the 30 mg subcutaneous dose.

Table 1: Adverse Reactions Occurring at ≥ 3% and Higher than Placebo in 2 Placebo Controlled Clinical Trials in Patients with HAE Treated with KALBITOR (ecallantide injection)

Adverse Reactions KALBITOR (ecallantide injection)
N=100
n (%)a
Placebo
N=81
n (%)a
Headache 8 (8%) 6 (7%)
Nausea 5 (5%) 1 (1%)
Diarrhea 4 (4%) 3 (4%)
Pyrexia 4 (4%) 0
Injection site reactions 3 (3%) 1 (1%)
Nasopharyngitis 3 (3%) 0
a Patient s experiencing more than 1 event with the same preferred term are counted only once for that preferred term.

Some patients in EDEMA3 and EDEMA4 received a second, open-label 30 mg subcutaneous dose of KALBITOR (ecallantide injection) within 24 hours following the initial dose. Adverse reactions reported by these patients who received the additional 30 mg subcutaneous dose of KALBITOR (ecallantide injection) were consistent with those reported in the patients receiving a single dose.

Immunogenicity

In the KALBITOR (ecallantide injection) HAE program, patients developed antibodies to KALBITOR (ecallantide injection) . Rates of seroconversion increased with exposure to KALBITOR (ecallantide injection) over time. Overall, 7.4% of patients seroconverted to anti-ecallantide antibodies. Neutralizing antibodies to ecallantide were determined in vitro to be present in 4.7% of patients.

Anti-ecallantide and anti-P. pastoris IgE antibodies were also detected. Patients who seroconvert may be at a higher risk of a hypersensitivity reaction. The long-term effects of antibodies to KALBITOR are not known.

The test results for the ecallantide program were determined using one of two assay formats: ELISA and bridging electrochemiluminescence (ECL). As with all therapeutic proteins, there is a potential for immunogenicity with the use of KALBITOR (ecallantide injection) . The incidence of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to KALBITOR (ecallantide injection) with the incidence of antibodies to other products may be misleading.

Read the entire FDA prescribing information for Kalbitor (Ecallantide Injection) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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