Ecallantide

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

There may be other drugs that can interact with ecallantide. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Dosage Forms & Strengths

injectable solution

• 10mg/mL per single-use vial

Hereditary Angioedema (Acute Attacks)

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 per single-use vial

Hereditary Angioedema (Acute Attacks)

<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

Ecallantide may be found in some form under the following brand names:

• Kalbitor

Ecallantide is part of the drug class:

• Drugs used in hereditary angioedema

Serious side effects have been reported with ecallantide. See the "Drug Precautions" section.

Common side effects of ecallantide include the following:

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

This is not a complete list of ecallantide side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories-A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Ecallantide falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Selective, reversible plasma kallikrein inhibitor; biosynthetic (recombinant DNA origin) protein.1 2 3 4 5 6

General

• Administer only under supervision of qualified clinicians experienced in management of anaphylaxis and HAE and in a setting with appropriate and readily available medical support (e.g., antihistamines, epinephrine, corticosteroids) to manage such conditions.1 3 4 8 9 10 15

• Monitor for possible hypersensitivity reactions (e.g., anaphylaxis) for an appropriate period of time (i.e., at least 1 hour) after administration.1 9 10 15

• If persistent HAE attack symptoms are present, assess patient carefully prior to administration of second dose of ecallantide to determine whether symptoms represent HAE attack or hypersensitivity reaction.1 10 (See Sensitivity Reactions under Cautions.)

Administration

Sub-Q Administration

Administer by sub-Q injection.1 2 4 12 13

Vials are for single use only.1

To prepare a 30-mg dose: Withdraw 1 mL of ecallantide injection from a vial containing 10 mg/mL of the drug into an appropriately sized syringe using a large-bore needle.1 Perform procedure with each of 3 vials to prepare total dose (3 syringes each containing ecallantide 10 mg). 1

Prior to administration, replace large-bore needle on each syringe with a 27-gauge needle for sub-Q injection.1

Observe strict aseptic technique; drug vials contain no preservative.1

Inject sub-Q into abdomen, thigh, or upper arm.1 Use same anatomic site for all 3 injections or select different sites; separate injections administered at same site by 2 inches (5 cm) and inject away from site of HAE attack.1 Rotation of injection sites not necessary.1

If a second 30 mg-dose is required, may use same anatomic site as for initial dose or select different site.1

Dosage

Adults

Patients ≥16 years of age: 30 mg.1 May administer second 30-mg dose within 24 hours after initial dose for persistent HAE attack symptoms.1 10 15

Prescribing Limits

Adults

Patients ≥16 years of age: Maximum 60 mg (i.e., two 30-mg doses) in 24-hour period.1

Special Populations

Hepatic Impairment

No specific dosage recommendations.1

Renal Impairment

No specific dosage recommendations.1

Geriatric Patients

Select dosage with caution; usually initiate therapy at low end of dosage range.1 (See Geriatric Use under Cautions.)

• Importance of providing a medication guide to the patient each time the drug is administered.1 Importance of discussing potential risks and benefits of therapy with the patient; importance of the patient reading the medication guide prior to initiation of therapy and before subsequent treatment.1 11

• Importance of differentiating serious hypersensitivity reactions to ecallantide from symptoms of an HAE attack.1 9 10

• Risk of hypersensitivity reactions, including anaphylaxis.1 Importance of immediately informing clinician of possible hypersensitivity symptoms (e.g., shortness of breath, cough, chest tightness, trouble breathing, dizziness, fainting, irregular heartbeat, anxiety, reddening of the face, itching, hives, feeling of warmth, swelling of the throat or tongue, throat tightness, hoarse voice, trouble swallowing, runny nose, sneezing).1 10 Inform patients that most reactions occur within 1 hour following sub-Q injection of ecallantide.10 Importance of not administering ecallantide to patients with a history of hypersensitivity to the drug.1 9 10

• Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements.1

• Importance of informing patients of other important precautionary information.1 (See Cautions.)

Use ecallantide as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into the fatty part of the skin.

What do I do if I miss a dose?

• This medicine is given on an as needed basis.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time ecallantide is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take ecallantide or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to ecallantide. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

• DX-88

• Kalbitor

Hypersensitivity to ecallantide or any component of the formulation

Applies to ecallantide: subcutaneous solution

Along with its needed effects, ecallantide may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking ecallantide:

• Blurred vision
• chest discomfort
• confusion
• cough
• difficulty with breathing
• difficulty with swallowing
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast heartbeat
• feeling of warmth
• fever
• hives or welts, itching, or skin rash
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the face, neck, arms, and occasionally, upper chest
• redness of the skin
• runny nose
• sneezing
• stuffy nose
• sweating
• throat irritation
• tightness in the chest
• unusual tiredness or weakness

Some side effects of ecallantide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Headache

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• muscle aches
• nausea
• sore throat