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Profilnine

Last reviewed on RxList: 2/29/2016
Profilnine Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 2/29/2016

Profilnine (factor IX complex) a mixture of the vitamin K-dependent clotting factors IX, II, X, and low levels of VII indicated for the prevention and control of bleeding in patients with factor IX deficiency (hemophilia B). Profilnine contains non-therapeutic levels of factor VII and is not indicated for use in the treatment of factor VII deficiency. Common side effects of Profilnine include headache, fever, chills, flushing, nausea, vomiting, tingling, lethargy, hives, and allergic reactions.

The dose of Profilnine is determined by the patient's bodyweight and the desired percent of Factor IX increase. Profilnine may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Profilnine should only be administered if needed. It is unknown if it would affect a fetus. Consult your doctor before breastfeeding.

Our Profilnine (factor IX complex) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Profilnine Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives or rash; fast heartbeats; chest tightness, wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

  • sweating and feeling short of breath;
  • a light-headed feeling, like you might pass out;
  • easy bruising, increased bleeding episodes;
  • bleeding from a wound or where the medicine was injected;
  • signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
  • signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.

Common side effects may include:

  • headache;
  • flushing (warmth, redness, or tingly feeling);
  • nausea, vomiting;
  • fever, chills; or
  • lack of energy.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Profilnine (Factor IX Complex Intravenous Administration)

QUESTION

What is hemophilia? See Answer
Profilnine Professional Information

SIDE EFFECTS

Adverse reactions with Profilnine may include headache, fever, chills, flushing, nausea, vomiting, tingling, lethargy, urticaria, and manifestations of allergic reactions.

The following adverse reactions have been identified during post-approval use of Profilnine: hypersensitivity reactions including shortness of breath, diaphoresis, and hypotension, as well as thrombosis including pulmonary embolism and deep vein thrombosis, disseminated intravascular coagulation, and inhibitor development. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

To report SUSPECTED ADVERSE REACTIONS, contact Grifols at 1-888-GRIFOLS (1-888-474- 3657) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Read the entire FDA prescribing information for Profilnine (Factor IX Complex Intravenous Administration)

Related Resources for Profilnine

© Profilnine Patient Information is supplied by Cerner Multum, Inc. and Profilnine Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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