Replenine

factor IX complex

Bebulin VH, Defix (UK), Hipfix (UK), Octaplex (CA), 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.

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.

Replenine

A brand name for blood clotting FACTOR IX.