Kalbitor

Kalbitor is a prescription medication used to treat a genetic disease called hereditary angioedema.

Kalbitor belongs to a group of drugs called kallikrein inhibitors. These work by binding to a substance found in your body called kallikrein. This treats the symptoms the body experiences in an acute attack. 

This medication is available in an injectable form to be given directly under the skin (subcutaneously) by a healthcare professional. 

Common side effects of Kalbitor include headache, nausea, diarrhea, fever and pain or irritation at the injection site.

Kalbitor is a prescription medication used to treat sudden attacks of hereditary angioedema (HAE) in people 12 and older. HAE is a rare genetic disorder that can cause swelling of the face and airways and stomach cramping.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Dyax Corp.

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

Common side effects of Kalbitor 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 Kalbitor 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.

No drug interactions have been studied by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Kalbitor including serious allergic reactions. These allergic reactions can be life-threatening and usually occur within 1 hour after receiving Kalbitor. Kalbitor should be given to you by a doctor or nurse in a healthcare setting where serious allergic reactions and hereditary angioedema (HAE) can be treated.

Symptoms of a serious allergic reaction to Kalbitor can be similar to the symptoms of HAE, the condition that you are being treated for. Your doctor or nurse should watch you for any signs of a serious allergic reaction after treatment with Kalbitor.

Tell your doctor or nurse right away if you have any of these symptoms of a serious allergic reaction during or after treatment with Kalbitor:

• wheezing, shortness of breath, cough, chest tightness, or trouble breathing
• dizziness, fainting, fast or weak heartbeat, or feeling nervous
• reddening of the face, itching, hives, or feeling warm
• swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing
• runny nose, nasal congestion, or sneezing

Do not take Kalbitor if you are allergic to Kalbitor or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Kalbitor, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Kalbitor, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Kalbitor or to any of its ingredients
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

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.

Kalbitor 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.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Kalbitor crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Kalbitor.

Take Kalbitor exactly as prescribed.

This medication is available in an injectable form to be given directly under the skin (subcutaneously) by a healthcare professional.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

For each dose, you will receive three 10 mg injections (total dose of 30 mg) given directly under the skin (subcutaneously) of your abdomen, thigh, or upper arm by a healthcare professional. If the attack persists, an additional dose of 30 mg may be given within a 24 hour period.

If Kalbitor is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

WARNING: ANAPHYLAXIS

Anaphylaxis has been reported after administration of KALBITOR. Because of the risk of anaphylaxis, KALBITOR should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema. Healthcare professionals should be aware of the similarity of symptoms between hypersensitivity reactions and hereditary angioedema and patients should be monitored closely. Do not administer KALBITOR to patients with known clinical hypersensitivity to KALBITOR.