Balfaxar

Balfaxar is used to reverse the effect of blood-thinning medicines like warfarin in adult patients who need urgent surgery or procedures to reduce the risk of bleeding. Balfaxar works to restore blood coagulation by increasing blood clotting factors that become low when taking warfarin tablets.

Balfaxar is a non-activated four factor prothrombin complex concentrate (4F-PCC). Balfaxar contains vitamin K-dependent factors Factor II (prothrombin), Factor VII, Factor IX and Factor X, as well as antithrombotic Proteins C and S.

The generic name for Balfaxar is prothrombin complex concentrate, human-lans.

Warfarin and other vitamin K antagonists are prescribed to prevent blood clots in patients who have had a heart attack, heart valve surgery, stroke, deep vein thrombosis/pulmonary embolism, or for certain types of irregular heartbeat (atrial fibrillation). Patients on warfarin or vitamin K antagonists have an increased risk of bleeding if they need to have urgent surgery or invasive procedures. Balfaxar (prothrombin complex concentrate, human-lans) is able to quickly restore coagulation, to reduce the risk of bleeding.

Balfaxar is given as an intravenous infusion by your healthcare provider before your procedure or surgery.

Balfaxar dosing is based on body weight.

Balfaxar powder should be reconstituted only directly before use.

The diluent for reconstitution of the lyophilized powder is sterile Water for Injection.

Administer Vitamin K concurrently to patients receiving Balfaxar. Vitamin K is administered to maintain Vitamin K-dependent clotting factor levels once the effects of Balfaxar have diminished.

Both fatal and non-fatal arterial and venous thromboembolic complications have been reported with this medicine in clinical trials and post-marketing surveillance. Tell your caregivers right away if you have signs of a blood clot, such as limb or abdomen swelling and/or pain, chest pain or pressure, shortness of breath, loss of sensation or motor power, altered consciousness, vision, or speech.

Restarting anticoagulation medicines should be carefully considered as soon as the risk of thromboembolic events outweighs the risk of acute bleeding.

This medicine may not be suitable for patients who have had thromboembolic events in the previous 3 months.

This medicine is made from human plasma; therefore, may carry the risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

You should not take this medicine if you are

• allergic to prothrombin complex concentrate, human-lans, or any of the components of the product.
• have a known allergy to heparin or a history of heparin-induced thrombocytopenia (HIT).
• IgA deficient patients with known antibodies against IgA.

Pregnancy

It is not known whether this medicine can harm an unborn baby. Tell your doctor if you are pregnant or planning a pregnancy.

Breastfeeding

It is not known if this medicine passes into breast milk or what effect it may have on milk production or on the breastfeeding infant.

Get emergency medical help if you have signs of an allergic reaction to Balfaxar: hives, rash; nausea, vomiting, feeling light-headed; fast heartbeats; chest tightness, wheezing, difficulty breathing; swelling of your face, lips, tongue, or throat.

Balfaxar side effects may include:

• low red blood cells (anemia) - pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet;
• stomach pain
• weakness or lack of energy
• infusion site reaction
• complications of stitches and wound healing
• pain during the procedure
• vomiting during procedure
• painful urination

Balfaxar dose is based on body weight and pre-treatment INR.

Usual Balfaxar Adult Dose for Reversal of Acquired Coagulation Factor Deficiency:

INR 2 to less than 4: 25 units of Factor IX/kg body weight given intravenously INR 4 to 6: 35 units of Factor IX/kg body weight given intravenously INR greater than 6: 50 units of Factor IX/kg body weight given intravenously Maximum dose: INR 2 to less than 4: 2500 units of Factor IX INR 4 to 6: 3500 units of Factor IX INR greater than 6: 5000 units of Factor IX

Duration of therapy:

Single dose. Repeat dosing is not supported by clinical data and is not recommended.

Comments:

Dosing is based on body weight up to but not exceeding 100 kg. For patients weighing more than 100 kg, the maximum dose should not be exceeded. The dose based on actual potency is stated on the vial, which will vary from 20-32 Factor IX units/mL after reconstitution.The actual potency for a 500 unit vial ranges from 400-640 units/vial. The actual potency for a 1000 unit vial ranges from 800-1280 units/vial.

Since this medicine is used when needed, it is usually given as a single dose.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may interact with the prothrombin complex, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Balfaxar vial for reconstitution

• Store at 2°C to 25°C (36°F to 77°F)
• Expiry is 36 months after manufacture.
• Store the vial in the original package to protect it from light.
• Do not freeze.

Reconstituted Balfaxar

• Reconstituted solution can be stored for up to 8 hours at room temperature (20°C to 25°C; 68°F to 77°F) if the sterility of the stored product is maintained.
• Discard partially used vials.

Active ingredient: Balfaxar is a human plasma-derived, purified, virus inactivated and nanofiltered non-activated Prothrombin Complex Concentrate (PCC) containing the coagulation factors II, VII, IX, and X and antithrombotic Proteins C and S.

Excipients: heparin and sodium citrate.

Balfaxar is sterile, endotoxin-free, and does not contain preservatives.

No albumin is added as a stabilizer.

The diluent for reconstitution of the lyophilized powder is sterile Water for Injection.

Manufactured by: Octapharma Pharmazeutika Produktionsges.m.b.H. Oberlaaer Strasse 235 1100 Vienna, Austria U.S. License No. 1646.

Distributed by: Octapharma USA Inc. 117 W Century Road Paramus, NJ 07652.