Kalbitor (ecallantide) is a prescription biologic drug used to treat severe swelling caused by hereditary angioedema (HAE). Kalbitor can cause side effects that range from mild to serious. Examples include nausea, injection site reactions, and anaphylaxis.

Specifically, Kalbitor is a biologic drug* used to treat severe swelling caused by HAE in people ages 12 years and older.

The active ingredient in Kalbitor is ecallantide. (An active ingredient is what makes a drug work.) The drug comes as a liquid solution for injection under the skin. These injections are given by a healthcare professional in a hospital or clinic.

Keep reading to learn about common, mild, and serious side effects Kalbitor can cause. For a general overview of the drug, including details about its uses, see this article.

* A biologic drug is made from living cells, while other drugs are made from chemicals.

Some people may experience mild to serious side effects during Kalbitor treatment. Examples of the drug’s commonly reported side effects include:

* To learn more about this side effect, see the “Side effects explained” section below.

Mild side effects have been reported with Kalbitor. These include:

  • diarrhea
  • fever*
  • nausea
  • injection site reactions
  • runny or stuffy nose
  • mild allergic reaction*

In most cases, these side effects should be temporary. And some may be easily managed. But if you have symptoms that are ongoing or bothersome, talk with your doctor or pharmacist. And do not stop Kalbitor treatment unless your doctor recommends it.

Kalbitor may cause mild side effects other than those listed above. See the drug’s prescribing information for details.

* To learn more about this side effect, see the “Side effects explained” section below.

Severe allergic reactions, including anaphylaxis, have been reported with Kalbitor. In fact, Kalbitor has a boxed warning for anaphylaxis. To learn more about this side effect, see the “Side effects explained” section below.

If you develop serious side effects during Kalbitor treatment, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you’d like to notify the FDA about a side effect you’ve had with Kalbitor, visit MedWatch.

Learn more about some of the side effects Kalbitor may cause.

Severe allergic reactions

Although rare, anaphylaxis, a severe allergic reaction, is listed as a boxed warning for Kalbitor and was reported in the drug’s studies. A boxed warning is the most serious warning from the FDA.

You can suddenly develop anaphylaxis symptoms such as:

Kalbitor injections are given in a hospital or clinic by a trained healthcare professional. This is so that any HAE or allergic reaction symptoms (which are similar) can be closely monitored and managed. Most allergic reaction symptoms will occur within the first hour following the injection.

What might help

If you have mild symptoms of an allergic reaction, such as a mild skin rash or itchiness, between doses of Kalbitor, call your doctor right away. They may suggest a treatment to manage your symptoms. Examples include:

  • an oral antihistamine, such as diphenhydramine (Benadryl)
  • a product you apply to your skin, such as hydrocortisone cream

If your doctor confirms you’ve had a mild allergic reaction to Kalbitor, they’ll decide whether you should continue treatment.

If you have symptoms of a severe allergic reaction, such as swelling or difficulty breathing when not in a hospital or clinic, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care.

If your doctor confirms you’ve had a serious allergic reaction to Kalbitor, they may have you switch to a different treatment.

Fever

Fever was a common side effect reported in studies of Kalbitor. Fever may cause symptoms such as:

  • an increase in body temperature
  • sweating
  • chills (feeling cold without an apparent cause)
  • fatigue or low energy
  • decreased appetite

What might help

If you have fever symptoms during Kalbitor treatment, talk with your doctor. They’ll likely recommend the following:

  • drinking plenty of clear fluids such as water
  • taking a lukewarm bath or shower
  • taking acetaminophen (Tylenol) or ibuprofen (Advil)

If your temperature is 103°F (39.4°C) or higher, call your doctor right away.

If any of your side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Keeping track of side effects

During your Kalbitor treatment, consider taking notes on any side effects you’re having. You can then share this information with your doctor. This is especially helpful when you first start a new drug or combination of treatments.

Your side effect notes can include things such as:

  • what dose of the drug you were taking when you had the side effect
  • how soon you had the side effect after starting that dose
  • what your symptoms were
  • how your symptoms affected your daily activities
  • what other medications you were taking
  • any other information you feel is important

Taking notes and sharing them with your doctor will help them learn more about how Kalbitor affects you. They can then use this information to adjust your treatment plan if needed.

Below is important information you should consider before starting Kalbitor treatment.

Boxed warning: Risk of anaphylaxis

Kalbitor has a boxed warning for the risk of anaphylaxis. A boxed warning is the most serious warning from the FDA.

Although rare, Kalbitor can cause anaphylaxis and other serious allergic reactions. These allergic reactions can be life threatening and require hospital treatment.

To learn more, see the “Side effects explained” section above.

Other warnings

Kalbitor can sometimes cause harmful effects in people with certain conditions. This is known as a drug-condition interaction. Other factors may also affect whether Kalbitor is a good treatment option for you. Talk with your doctor about your health history before starting Kalbitor. Be sure to tell them if any of the following factors apply to you:

  • past allergic reaction to Kalbitor
  • pregnancy
  • breastfeeding

Alcohol and Kalbitor

There are no known interactions between alcohol and Kalbitor. If you have questions about consuming alcohol during Kalbitor treatment, talk with your doctor or pharmacist.

Pregnancy and breastfeeding with Kalbitor

There is limited information about the safety of Kalbitor use during pregnancy or while breastfeeding.

Pregnancy

Studies are not available on the use of Kalbitor during pregnancy, so it’s not known whether treatment is safe for pregnant people.

If you’re pregnant or planning to become pregnant, talk with your doctor before starting this medication.

Breastfeeding

It isn’t known whether Kalbitor is safe while breastfeeding. Studies are not available on the use of Kalbitor in people who are breastfeeding or the drug’s effects on a child who is breastfed.

If you’re breastfeeding or planning to do so, talk with your doctor before starting this medication.

Like most drugs, Kalbitor can cause a number of side effects that range from mild to serious. But most are temporary and go away after a few days to weeks. If you have questions about side effects this drug can cause, talk with your doctor. Examples of questions to help get you started include:

  • How soon after I receive Kalbitor might symptoms of anaphylaxis appear?
  • What medications could I take during Kalbitor treatment to decrease the risk of injection site reactions?
  • What signs and symptoms of fever should alert me to call my doctor or seek emergency care?

To learn more about Kalbitor, see these articles:

To get information on different conditions and tips for improving your health, subscribe to any of Healthline’s newsletters. You may also want to check out the online communities at Bezzy. It’s a place where people with certain conditions can find support and connect with others.

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.