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Overview: Profilnine is used to prevent or treat certain types of bleeding in people with hemophilia B. It works by replacing a protein called factor IX, which temporarily helps your blood to clot properly. Common side effects include headache, fever, and chills. Serious side effects are rare but can include severe allergic reactions and blood clots.

Uses

What is Profilnine used for?

Profilnine (factor IX complex) is commonly used to prevent or treat certain types of bleeding in people with hemophilia B, which is a condition that causes your blood to not clot properly.

Profilnine may also be used for other conditions as determined by your health care provider.

How does Profilnine work (mechanism of action)?

Hemophilia B is caused when your body does not make enough of a protein called factor IX, which normally helps cause your blood to clot. Profilnine works by replacing factor IX, which temporarily helps your blood to clot properly.

How is Profilnine supplied (dosage forms)?

Brands and other names

  • Profilnine

Dosage forms and strengths

  • 500 IU single-dose vials
  • 1000 IU single-dose vials
  • 1500 IU single-dose vials

How should I store Profilnine?

Profilnine is usually given by a health care provider in a hospital or clinic. You will not store it at home.

Side Effects

What are the most common side effects of Profilnine?

The most common side effects of Profilnine are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Headache
  • Fever and chills
  • Flushing or hives
  • Nausea and vomiting
  • Tingling sensation
  • Lack of energy

There may be other side effects of Profilnine that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Profilnine?

While less common, the most serious side effects of Profilnine are described below, along with what to do if they happen.

Severe Allergic Reactions. Profilnine may cause allergic reactions, which can be serious. Get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Disseminated Intravascular Coagulation (DIC). Profilnine can cause a serious condition called disseminated intravascular coagulation (DIC), which causes blood clots in the blood vessels throughout your body. DIC can lead to serious and life-threatening bleeding. Call your health care provider right away if you have any of the following symptoms.

  • Bruises
  • Vomiting
  • Dizziness
  • Confusion
  • Low blood pressure
  • Pink, red, or brown urine (pee)
  • Vomit with blood that looks like coffee grounds
  • Red or black stools (looks like tar)
  • Coughing up blood or blood clots

Blood Clots. Profilnine may cause a blood clot in your arteries or veins and could cause a stroke, heart attack, or venous thromboembolism, including a blood clot in the lungs (pulmonary embolism) or deep vein thrombosis (DVT). Get emergency help if you have any of the following signs of blood clots. 

  • Chest pain or pressure
  • Fast or abnormal heartbeat
  • Trouble breathing
  • Pain in your back, jaw, throat, or arm
  • Sweating, upset stomach, vomiting, or dizziness
  • Sudden weakness on one side of your body
  • Sudden and severe headache
  • Slurred speech or trouble understanding speech
  • Pain, swelling, or tenderness in your arm or leg
  • Vision loss
  • Bulging eyes 
  • Double vision

Warnings & Precautions

Who should not use Profilnine?

Allergies to Ingredients. People who are allergic to any of the following should not use Profilnine.

  • Factor IX complex
  • Profilnine
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Profilnine.

What should I know about Profilnine before using it?

Do not use Profilnine unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Profilnine with other people, even if they have the same condition as you. It may harm them.

Profilnine is usually given by a health care provider in a hospital or clinic. 

Your health care provider should monitor your blood tests while you are being treated with Profilnine. Keep all appointments to have your blood checked.

Profilnine is made from human blood. There is a small risk that Profilnine may contain a virus or a substance called Creutzfeldt-Jakob disease agent, which can cause a rare brain disorder. Talk to your health care provider if you have concerns.

What should I tell my health care provider before using Profilnine?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Profilnine is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • History of blood clots
  • Liver problems
  • Latex sensitivity or allergy

Pregnancy. It is not known if or how Profilnine could affect pregnancy or harm a fetus. Tell your health care provider if you are pregnant or plan to become pregnant.

Breastfeeding. It is not known if Profilnine passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Profilnine?

For more information about Profilnine, you can call them at 888-474-3657.

Interactions

Does Profilnine interact with foods or drinks?

There are no known interactions between Profilnine and foods or drinks.

It is unknown if drinking alcohol will affect Profilnine.

Does Profilnine interact with other medicines (drug interactions)?

There are no known interactions between Profilnine and other medicines. Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Profilnine?

If you or someone else has used too much Profilnine, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Profilnine?

Profilnine is usually given by a health care provider in a hospital. Your health care provider will make sure you are receiving Profilnine as scheduled.

If you miss an appointment to get your Profilnine dose, call to make another appointment as soon as possible.