Proplex T

Proplex T,

trademark for human clotting factor IX.

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factor IX complex

Bebulin VH, Defix (UK), Hipfix (UK), Profilnine SD, Proplex T (heat-treated), Replenine (UK)

Pharmacologic class: Blood modifier

Therapeutic class: Antihemophilic

Pregnancy risk category C

Action

Converts fibrinogen to fibrin, increasing levels of clotting factors

Availability

Powder for injection: Various strengths; units specified on label

⊘Indications and dosages

➣ Factor IX deficiency (hemophilia B or Christmas disease); anticoagulant overdose

Adults and children: Dosage individualized; drug administered I.V. Use following equations to calculate approximate units needed:

Human product - 1 unit/kg times body weight (in kg) times desired increase in factor IX level, expressed as percentage of normal

Recombinant product - 1.2 units/kg times body weight (in kg) times desired increase in factor IX level, expressed as percentage of normal

Proplex T - 0.5 unit/kg times body weight (in kg) times desired increase in factor IX level, expressed as percentage of normal

Off-label uses

• Hepatic dysfunction
• Esophagitis
• Unspecified GI hemorrhage (human product)

Contraindications

• Hypersensitivity to mouse or hamster protein (with BeneFix)
• Fibrinolysis

Precautions

Use cautiously in:
• recent surgery
• pregnant patients
• children younger than age 6 (safety and efficacy not established).

Administration

☞ Give by slow I.V. infusion. Average infusion rate is 100 units (2 to 3 ml)/minute; don't exceed 10 ml/minute.
• If prescribed, administer hepatitis B vaccine before giving factor IX.
• Know that dosage is highly individualized according to degree of factor IX deficiency, patient's weight, and bleeding severity.
• Don't use glass syringe. Don't shake reconstituted solution or mix with other I.V. solutions.

Route	Onset	Peak	Duration
I.V.	Immediate	10-30 min	Unknown

Adverse reactions

CNS: light-headedness, paresthesia, headache

CV: blood pressure changes, thromboembolic reactions, myocardial infarction (MI)

EENT: allergic rhinitis

GI: nausea, vomiting

Hematologic: disseminated intravascular coagulation (DIC)

Respiratory: pulmonary embolism

Skin: rash, flushing, diaphoresis, pruritus, urticaria

Other: altered taste, fever, chills, burning sensation in jaw and skull, pain at I.V. injection site, hypersensitivity reactions including anaphylaxis

Interactions

Drug-drug. Aminocaproic acid: increased risk of thrombosis

Patient monitoring

• Be aware that factor IX complex may transmit hepatitis.
• Closely monitor vital signs during infusion.
☞ Observe for hemolytic reaction. If it occurs, stop infusion, flush line with saline solution, and notify prescriber immediately.
• Monitor I.V. injection site closely.
☞ Monitor coagulation studies closely. Know that drug may cause thromboembolic disorders, including MI and DIC.

Patient teaching

• Inform patient that drug may transmit diseases.
☞ Tell patient to immediately report signs and symptoms of hypersensitivity reaction, including rash, hives, tightness in chest, wheezing, shortness of breath, and swelling of throat or lips.
☞ Advise patient to immediately report unusual bleeding or bruising.
• Caution patient to avoid activities that can cause injury.
• Tell patient to wear medical identification stating that he has a blood-clotting disorder.
• Instruct patient to notify surgeon or dentist of his blood-clotting disorder before surgery or invasive dental procedures.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs mentioned above.