Rixubis (see Coagulation Factor IX Recombinant (Intravenous route))

Micromedex Detailed Drug Information for the Consumer [Internet]. Truven Health Analytics; 1974-2016.

Coagulation Factor IX Recombinant (Intravenous route)

koh-a-gyoo-LAY-shun FAK-tor NINE re-KOM-bin-ant

Brand Name(s)

In the US: Benefix, Ixinity, Rixubis

Dosage forms

Powder for Solution

Classifications

Therapeutic: Antihemophilic Agent

Uses of This Medicine

Coagulation factor IX, recombinant injection is used to control bleeding episodes and prevent bleeding during surgery in patients with hemophilia B (congenital Factor IX deficiency).

Factor IX is a protein that is produced naturally in the body. This medicine is a man-made protein produced to replicate the naturally occurring factor IX in the body. It is used to stop bleeding by helping the blood to clot in patients with hemophilia B.

This medicine is to be given only by or under the supervision of your doctor or other health care professional.

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Pregnancy

Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of This Medicine

A doctor or other trained health professional will give you or your child this medicine. You may also be trained to administer this medicine yourself. This medicine is given through a needle placed in one of your veins.

This medicine comes with a patient information leaflet. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Precautions While Using This Medicine

It is very important that your doctor check you closely while you or your child are receiving this medicine to make sure it is working properly. Blood and urine tests will be needed to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you or your child have a rash, itching skin, difficulty with swallowing, dizziness, a fast heartbeat, lightheadedness or fainting, restlessness, trouble breathing, swelling in your face, hands, tongue, or throat, or chest pain after you receive the medicine.

This medicine may increase your chance of having blood clotting problems. Tell your doctor right away if you or your child have a sudden or severe headache, problems with vision or speech, chest pain, shortness of breath, or numbness or weakness while you are receiving this medicine.

Call your doctor right away if you or your child start to have bleeding problems, especially if this medicine has worked well for you before.

Side Effects of This Medicine

Along with its needed effects, a medicine 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:

Incidence not known

Anxiety blurred vision burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings chest pain confusion cough difficult or labored breathing difficulty with swallowing dizziness or lightheadedness dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position fainting fast heartbeat hives, itching, or skin rash large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs nausea pains in the chest, groin, or legs, especially calves of the legs puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue restlessness severe headaches of sudden onset sudden loss of coordination sudden onset of shortness of breath for no apparent reason sudden onset of slurred speech sudden shortness of breath or troubled breathing sudden vision changes sweating tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area tightness in the chest unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness unusual tiredness or weakness vomiting

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:

Less common

Change in taste loss of taste headache pain in the arms or legs

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.