Ecallantide

What is Ecallantide?

• Ecallantide (KALBITOR) is a plasma kallikrein inhibitor used for the treatment of hereditary angioedema (HAE).

What are the uses of this medicine?

• Ecallantide (KALBITOR) is a prescription medicine used to treat sudden attacks of hereditary angioedema (HAE) in people 12 years of age and older.
• KALBITOR is not a cure for HAE.

How does this medicine work?

Hereditary angioedema:

• Hereditary angioedema (HAE) is a rare genetic disorder caused by mutations to C1-esterase-inhibitor (C1-INH) located on Chromosome 11q and inherited as an autosomal dominant trait.
• HAE is characterized by low levels of C1-INH activity and low levels of C4.
• C1-INH functions to regulate the activation of the complement and intrinsic coagulation (contact system pathway) and is a major endogenous inhibitor of plasma kallikrein.
• One critical aspect of this pathway is the conversion of High Molecular Weight (HMW) kininogen to bradykinin by the protease plasma kallikrein.
• In HAE, normal regulation of plasma kallikrein activity and the classical complement cascade is therefore not present.
• During attacks, unregulated activity of plasma kallikrein results in excessive bradykinin generation.
• Bradykinin is a vasodilator which is thought by some to be responsible for the characteristic HAE symptoms of localized swelling, inflammation, and pain.

• KALBITOR is a potent, selective, reversible inhibitor of plasma kallikrein.
• KALBITOR binds to plasma kallikrein and blocks its binding site, inhibiting the conversion of HMW kininogen to bradykinin.
• By directly inhibiting plasma kallikrein, KALBITOR reduces the conversion of HMW kininogen to bradykinin and thereby treats symptoms of the disease during acute episodic attacks of HAE.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to KALBITOR.

What drug interactions can this medicine cause?

• No formal drug interactions studies were performed.

Is this medicine FDA approved?

• On November 27, 2009, ecallantide was approved by the FDA for the treatment of acute attacks of hereditary angioedema for persons over 16 years of age.

How should this medicine be used?

Recommended dosage:

• 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:

• For each dose, you will receive 3 injections just under the skin (subcutaneous or SC injections) of your abdomen, thigh, or upper arm.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Single use glass vial containing 10 mg/mL of ecallantide as a solution for injection.

This medicine is available in fallowing brand namesː

• KALBITOR

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• nausea
• diarrhea
• fever
• injection site reactions, such as redness, rash, swelling, itching, or bruising
• stuffy nose

• Serious allergic reactions may happen in some people who receive KALBITOR

What special precautions should I follow?

• Potentially serious hypersensitivity reactions, including anaphylaxis, have occurred in patients treated with KALBITOR.
• Administer KALBITOR in a setting equipped to manage anaphylaxis and hereditary angioedema.
• Given the similarity in hypersensitivity symptoms and acute HAE symptoms, monitor patients closely for hypersensitivity reactions.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• There have been no reports of overdose with KALBITOR.

Management of overdosage:

• In cases of overdose, standard supportive measures should be adopted as required.

Can this medicine be used in pregnancy?

• The available data from the pharmacovigilance database for Kalbitor have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes
• It is not known if KALBITOR will harm your unborn baby.

Can this medicine be used in children?

• It is not known if KALBITOR is safe and effective in children under 12 years of age.

What are the active and inactive ingredients in this medicine?

• Active Ingredient: ecallantide
• Inactive ingredients: disodium hydrogen orthophosphate (dihydrate), monopotassium phosphate, potassium chloride, sodium chloride in water for injection.

Who manufactures and distributes this medicine?

Manufactured by:

• Takeda Pharmaceuticals U.S.A., Inc.
• Lexington, MA

• KALBITOR® is a registered trademark of Dyax Corp., a Takeda company.

What should I know about storage and disposal of this medication?

• KALBITOR should be kept refrigerated (2°C to 8°C/36°F to 46°F).
• Vials removed from refrigeration should be stored below 86°F/30°C and used within 14 days or returned to refrigeration until use.
• Protect vials from light until use.
• Do not use beyond the expiration date.

• Dailymed label info on Ecallantide
• FDA Ecallantide