Question 1

What is kalbitor?

Accepted Answer

Kalbitor is a protein-based medication classified as a plasma kallikrein inhibitor. It is designed to address the underlying biological mechanisms that lead to episodes of severe swelling in hereditary angioedema. The medication works by binding to and blocking the activity of an enzyme called plasma kallikrein.

By inhibiting this enzyme, the medication helps to control the production of bradykinin, a substance that causes blood vessels to dilate and leak fluid into body tissues. This action helps to manage the physiological response that results in localized inflammation and swelling during an attack.

Question 2

What is kalbitor used for?

Accepted Answer

Kalbitor is used to treat acute attacks of hereditary angioedema in patients aged 12 years and older.

Question 3

How does kalbitor work?

Accepted Answer

Mechanism of Action

Hereditary angioedema (HAE) is a genetic condition that causes episodes of severe swelling. This swelling occurs because the body produces too much of a protein called bradykinin. Bradykinin causes blood vessels to widen and leak fluid into the surrounding tissues, leading to inflammation and pain.

Kalbitor contains the active ingredient ecallantide, which belongs to a class of drugs known as plasma kallikrein inhibitors. It works through the following process:

Targeting Kallikrein: The medication identifies and binds to an enzyme in the blood called plasma kallikrein.

Reducing Bradykinin: In people with HAE, plasma kallikrein is overactive and triggers the release of excessive bradykinin. By blocking this enzyme, Kalbitor stops the overproduction of bradykinin.

Controlling Swelling: Once the levels of bradykinin are lowered, the blood vessels stop leaking fluid, which helps to limit and resolve the swelling associated with an acute attack.

Because Kalbitor targets the specific pathway responsible for HAE symptoms, it is used to treat attacks after they have already started rather than to prevent them from occurring in the future.

Question 4

What are the active ingredients in kalbitor?

Accepted Answer

The active ingredient in kalbitor is ecallantide .

Question 5

What are the side effects of kalbitor?

Accepted Answer

Common side effects of kalbitor may include:

Headache

Nausea

Fatigue

Always consult with a healthcare professional about potential side effects.

Question 6

What drug class is kalbitor?

Accepted Answer

Kalbitor belongs to the kallikrein inhibitor drug class.

Question 7

What is the dosage of kalbitor and how do I take it?

Accepted Answer

Administration

Kalbitor is given as an injection under the skin (subcutaneously). Because of the risk of severe allergic reactions, it must only be administered by a healthcare professional in a medical setting where emergency treatment for anaphylaxis is available.

A single treatment typically consists of three separate injections. These injections are usually given in different areas, such as the abdomen, thigh, or upper arm.

Dosing Schedule

This medication is used as needed when symptoms of an acute hereditary angioedema attack occur. If the attack continues or symptoms return, a healthcare provider may administer a second dose within a 24-hour period.

Because this medication is administered by a healthcare professional during an acute medical event, there is no regular dosing schedule or risk of a missed dose in the traditional sense.

Question 8

Is kalbitor safe during pregnancy and breastfeeding?

Accepted Answer

Pregnancy

There is currently limited data on the use of Kalbitor in pregnant women. It is not known whether this medication can cause harm to an unborn baby or affect reproductive capacity, as adequate and well-controlled studies in humans have not been conducted. Additionally, animal reproduction studies have not been performed with this drug.

If you are pregnant or planning to become pregnant, you should discuss the potential benefits and risks of treatment with your healthcare provider. Kalbitor should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Breastfeeding

It is unknown if Kalbitor passes into human breast milk or if it could affect a nursing infant. Because many medications are excreted in human milk, caution is advised when Kalbitor is administered to someone who is breastfeeding. You should consult your healthcare provider to discuss the risks and benefits of breastfeeding while using this medication.

Question 9

What forms and strengths does kalbitor come in?

Accepted Answer

Available Forms

Kalbitor is supplied as a sterile, preservative-free, clear, and colorless liquid solution. It is intended for subcutaneous injection only.

Strengths and Packaging

This medication is available in the following format:

Single-use vial: Each vial contains the active ingredient, ecallantide, in a liquid solution.

Because of the risk of severe allergic reactions, Kalbitor must be administered by a healthcare professional in a clinical setting where medical support is available. A single dose often requires multiple injections from separate vials to reach the full amount needed for treatment.

Question 10

What is the FDA approval status of kalbitor?

Accepted Answer

FDA Approval and Indications

The U.S. Food and Drug Administration (FDA) approved Kalbitor in November 2009. It is specifically indicated for treating sudden attacks of hereditary angioedema (HAE) in adults and adolescents 12 years of age and older.

Boxed Warning

Kalbitor carries a boxed warning because it can cause anaphylaxis, a severe and potentially life-threatening allergic reaction. Clinical trials showed that some patients experienced these reactions within one hour of receiving the medication. Due to this risk, Kalbitor must only be administered by a healthcare professional who has access to the necessary medical support to manage anaphylaxis and HAE.

Regulatory Requirements

Because of the risk of anaphylaxis, the FDA implemented a Risk Evaluation and Mitigation Strategy (REMS). This program focuses on educating healthcare providers and patients about the risks associated with the drug and the requirement for professional administration in a clinical setting.

Question 11

What should I know about kalbitor and cost?

Accepted Answer

Factors Affecting Cost

Kalbitor is a specialty medication used to treat acute attacks of hereditary angioedema. Because it is not a drug you typically pick up at a retail pharmacy, several factors influence its total price:

Insurance Coverage: Most insurance plans cover Kalbitor, but your out-of-pocket costs will depend on your plan's specific deductible, copay, or coinsurance for specialty biologics.

Administration Setting: This medication must be administered by a healthcare professional in a medical setting, such as a doctor's office or clinic, to monitor for potential allergic reactions. You may be responsible for costs associated with the office visit and the clinical administration of the drug.

Dosage: A standard treatment consists of three injections. If the attack does not resolve, a second dose may be administered within 24 hours, which would increase the total cost for that treatment episode.

Financial Assistance and Support

Because Kalbitor is an expensive specialty drug, there are often resources available to help manage the cost:

Patient Assistance Programs: The manufacturer may offer programs for patients who are uninsured or meet certain income requirements to receive the medication at a reduced cost or for free.

Copay Assistance: Patients with commercial insurance may be eligible for copay cards or savings programs that lower the amount paid at the time of service.

Specialty Pharmacy Services: Specialty pharmacies often provide coordinators who can help navigate insurance approvals and identify potential funding sources or foundations that assist with high-cost medications.

To understand your specific costs, it is best to contact your insurance provider and the medical facility where you will receive treatment for a detailed estimate.

kalbitor

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How It Works

Side Effects

Warnings & Precautions

Dosage & How to Take

Pregnancy & Breastfeeding

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FDA / Regulatory Status

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