Profilnine SD

Factor IX is a prescription medication used for:

• control and prevention of bleeding episodes in adults with hemophilia B
• perioperative (before and after surgery) use in adults with hemophilia B
• Routine prophylaxis to prevent or reduce the frequency of bleeding episodes (long-acting factor IX)

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

Profilnine SD is part of the drug class:

• Blood coagulation factors

No Factor IX drug interactions have been reported, 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.

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

• have or have had any medical problems
• have any allergies, including allergies to hamsters
• are breastfeeding. It is not known if Factor IX passes into your milk and if it can harm your baby.
• are pregnant or breastfeeding

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

Take Factor IX exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Your healthcare provider will tell you how much Factor IX to use based on your weight, the severity of the factor IX deficiency, the location and extent of bleeding, your clinical condition, age and recovery of factor IX.

Routine prophylaxis with long-acting factor IX: 50 IU/kg once weekly or 100 IU/kg once every 10 days.

• Dose will be adjusted based on individual response.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Factor IX complex is injected into a vein through an IV. You may be shown how to use an IV at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.

Always check the strength of the medicine on the label to be sure you are using the correct potency.

Wash your hands before preparing and giving your injection.

Factor IX must be mixed with a liquid (diluent) before using it. Take the medicine and diluent out of the refrigerator and allow them to reach room temperature before mixing your dose. Do not heat the medicine or diluent. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

After mixing, gently swirl the mixture and allow the medicine to completely dissolve. Use the medicine as soon as possible after mixing.

You may store mixed medicine at room temperature but you must use it within 3 hours. Do not put mixed medicine into the refrigerator.

Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use the medication if it has changed colors or looks cloudy. Call your pharmacist for new medication.

A single dose of factor IX may be enough to control minor bleeding. If you need a second dose, wait at least 24 hours before using the medicine again.

Check your pulse before and during your injection. If your pulse rate changes, slow or stop the injection until your pulse rate returns to normal.

Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Wear a medical alert tag or carry an ID card stating that you have hemophilia. Any medical care provider who treats you should know that you have a bleeding or blood-clotting disorder.

If you need any type of surgery or dental work, tell the surgeon or dentist ahead of time that you have hemophilia.

Your body may develop antibodies or "inhibitors" to factor IX complex. When the body develops antibodies or "inhibitors" to the clotting factor, this treatment becomes less effective in preventing bleeding episodes.

Call your doctor if this medicine seems to be less effective in controlling your bleeding.

While using factor IX complex, you may need frequent blood tests.

Store Bebulin and its diluent in a refrigerator. Do not freeze.

Store Profilnine and its diluent at room temperature, away from moisture and heat.

Throw away any unused medicine or diluent after the expiration date on the label has passed.

Tell your doctor about all other medicines you use, especially:

• aminocaproic acid (Amicar); or

• tranexamic acid (Cyklokapron, Lysteda).

This list is not complete. Other drugs may interact with factor IX complex, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

In the U.S.

• Alphanine SD
• Alprolix
• Bebulin
• Bebulin VH
• Benefix
• Idelvion
• Ixinity
• Mononine
• Profilnine SD
• Proplex T
• Rebinyn
• Rixubis

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antihemophilic Agent

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

Blood clots may be especially likely to occur in premature and newborn babies, who are usually more sensitive than adults to the effects of injections of factor IX.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

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.

Studies in women suggest that this medication poses minimal risk to the infant when used during 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.

Interactions with Food/Tobacco/Alcohol

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:

• Blood clots or a history of medical problems caused by blood clots or
• Liver disease—Risk of bleeding or developing blood clots may be increased

• It is used to treat hemophilia.
• It is used to treat or prevent bleeding.

Use Profilnine SD as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a vein.

What do I do if I miss a dose?

• Call your doctor to find out what to do.