BeneFix, Coagulation Factor IX (Recombinant), is an injectable medicine that is used to help control and prevent bleeding in people with hemophilia B. Your doctor might also give you BeneFix before surgical procedures.

BeneFix is NOT used to treat hemophilia A.

Please see full Prescribing Information for BeneFix.

Patients should always ask their doctors for medical advice about adverse events.

You are encouraged to report adverse events related to Pfizer products by calling 1-800-438-1985 (U.S. only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. Visit https://www.fda.gov/MedWatch or call 1-800-FDA-1088.

--Brand Name--
US Brand Name:

• Benefix
• Ixinity
• Rixubis

--Description--
Coagulation factor IX, recombinant injection is used to treat, control, prevent, and decrease the frequency of bleeding episodes, and prevent bleeding during surgery in patients with hemophilia B (congenital Factor IX deficiency or Christmas disease).

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 and is available only with your doctor's prescription.

This product is available in the following dosage forms: Powder for Solution

--Before Using--
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:

Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of Ixinity® in children younger than 12 years of age. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of BeneFIX® to prevent or decrease the frequency of bleeding episodes in children 16 years of age and older, or to treat and control bleeding episodes or prevent bleeding during surgery in children younger than 12 years of age. However, because of BeneFIX®'s toxicity, it should be used with caution and an adjustment in the dose is needed. Children should be carefully monitored during treatment.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Rixubis™ in children.

Geriatric
Although appropriate studies on the relationship of age to the effects of coagulation factor IX, recombinant injection have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

Breastfeeding
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.

Drug Interactions
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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Concizumab-mtci
• Fitusiran

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.

Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to hamster protein—Should not be used in patients with this condition.
• Blood clots or a history of medical problems caused by blood clots or
• Liver disease—Use with caution. These conditions may increase the risk of developing blood clots.
• Disseminated intravascular coagulation (DIC) (blood clotting problem) or
• Fibrinolysis, signs of—Rixubis™ should not be used in patients with these conditions.
• Nephrotic syndrome (kidney problem)—Use with caution. May make this condition worse.
• Patients with factor IX inhibitors—May increase the risk of having an allergic reaction.

--Proper Use--
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. It is given through a needle placed into 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.

Missed Dose
Call your doctor or pharmacist for instructions.

--Precautions--
It is very important that your doctor check you or your child's closely and at regular visits to make sure this medicine is working properly. Blood and urine tests will be needed to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require 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.

Check with your doctor right away if you have a cloudy or bloody urine, dizziness, headache, numbness or tingling in the face, arms, or legs, swelling of the face, feet, or lower legs, or vision problems. These may be symptoms of a serious kidney problem called nephrotic syndrome.

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, trouble breathing, 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--
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:

More common

• Cough
• fever

Less common

• Back or side pain
• blurred vision
• chest tightness
• chills
• confusion
• difficult or labored breathing
• fast heartbeat
• hives
• itching, pain, redness, swelling, tenderness, blue discoloration, or warmth of the skin at the injection site
• nausea
• swelling of the foot or leg
• vomiting

Incidence not known

• Anxiety
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain
• cloudy or bloody urine
• difficulty with swallowing
• dizziness
• dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position
• headache
• itching, skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• pain, redness, or swelling in the arm or leg
• 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 slurred speech
• sudden vision changes
• sweating
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area
• trouble breathing
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• vision problems

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 or loss of taste
• drowsiness
• feeling of warmth
• pain in the arms or legs
• redness of the face, neck, arms, and occasionally, the upper chest
• shaking

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.