C1 esterase inhibitor recombinant (Intravenous)

C1 esterase inhibitor recombinant is used to treat hereditary angioedema (HAE) in adults and teenagers. HAE is a rare condition that leads to swelling in the face, hands, feet, throat, stomach, bowels, or sexual organs. Individuals with HAE have low levels of C1 esterase inhibitor, and this medicine helps increase the levels of C1 esterase inhibitor in the body.

This medicine is available only with your doctor's prescription.

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it.

HAE attacks are life-threatening and require immediate medical attention. Check with your doctor right away, or go to an emergency room as soon as possible, even if you feel better after using this medicine.

This medicine may cause serious allergic reactions. These reactions can be life-threatening and require immediate medical attention. Call your doctor or nurse right away if you have a rash, itching, hives, hoarseness, chest tightness, lightheadedness, dizziness or fainting, shortness of breath, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive this medicine.

This medicine may increase your risk of developing blood clots. Check with your doctor right away if you have swelling and pain in your arms, legs, or stomach, chest pain, shortness of breath, loss of sensation, confusion, or problems with muscle control or speech.

In deciding to use a medicine, you and your doctor must consider the risks versus the benefits. For this medicine, please consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done on how C1 esterase inhibitor recombinant affects children 12 years of age and younger. Its safety and effectiveness have not been established.

Geriatric

Studies have not been done on how C1 esterase inhibitor recombinant affects older adults. Its safety and effectiveness have not been established.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together. In other cases, two different medicines may be used together, even if there is a chance of an interaction. In these situations, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Allergy to rabbits or rabbit-derived products—Should not be used in patients with this condition.

• Atherosclerosis or
• Blood clots, history of or
• Obesity or
• Prolonged immobilization—May increase risk for serious blood clots.

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

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

Less common

• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Incidence not known

• Cough
• difficulty swallowing
• dizziness
• fast heartbeat
• hives, itching, or skin rash
• pains in the chest, groin, or legs, especially calves of the legs
• severe headaches of sudden onset
• shortness of breath
• sudden loss of coordination
• sudden onset of shortness of breath for no apparent reason
• sudden onset of slurred speech
• sudden vision changes
• tightness in the chest
• unusual tiredness or weakness

Some side effects 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:

More common

• Headache

Less common

• Back pain
• burning sensation on the skin
• diarrhea
• feeling of constant movement of self or surroundings
• nausea
• sensation of spinning
• sneezing

Incidence not known

• Abdominal or stomach pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Ruconest

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Immune Modulator

Find detailed information on biosimilars for this medication.

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for 5 minutes.

This medicine may sometimes be given at home to patients who do not need to be in the hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use the medicine.

Make sure family members or other people you are with know how to inject the medicine in case you are unable to do it yourself during an HAE attack.

Use a new needle and syringe each time you inject your medicine.

Check the injection kits regularly to make sure that the powder or liquid has not changed its color. Do not use this medicine if the powder or liquid has changed its color, or if there are solids in the mixed liquid.

Carry this medicine with you at all times for emergency use in case you have an HAE attack.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:For hereditary angioedema: Adults and teenagers—Dose is based on body weight and must be determined by a doctor. The usual dose is 50 international units per kilogram (kg) of body weight injected into a vein. Your doctor may increase your dose as needed. However, the dose is usually not more than 4200 international units per day. Children 12 years of age and younger—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the powder vial in the refrigerator or at room temperature. Keep the medicine in the original carton until you are ready to use it. Do not freeze.

Use the mixed medicine immediately, or you may store in the refrigerator within 8 hours of mixing it.

Throw away the vial after you have used it, even if there is medicine left in it.