coagulation factor IX , Fc fusion protein
coagulation factor IX (Recombinant), Fc fusion protein
(ko-a-gyoo-lay-shun fac-tor nine eff-cee fyoo-zhun proh-teen),Alprolix
(trade name)Classification
Therapeutic: hemostatic agentsPharmacologic: clotting factor replacements
Indications
Action
Therapeutic effects
Pharmacokinetics
Time/action profile (decreased bleeding/risk of bleeding)
ROUTE | ONSET | PEAK | DURATION |
---|---|---|---|
IV | rapid | unknown | 6–48 hr † |
Contraindications/Precautions
Adverse Reactions/Side Effects
Central nervous system
- headache
Cardiovascular
- thrombembolism (↑risk with continuous infusion via central catheter) (life-threatening)
Gastrointestinal
- perioral paresthesia
Miscellaneous
- hypersensitivity reactions including anaphylaxis (life-threatening)
- production of neutralizing antibodies (inhibitors)
Interactions
Drug-Drug interaction
Bleeding risk may be ↑ by anticoagulants, antiplatelet agents, aspirin, fibrinolytics, NSAIDs, SSRIs andSNRIs.Route/Dosage
One unit/kg increases circulating Factor IX (FIX) level by 1%.
Availability
Nursing implications
Nursing assessment
- Assess for signs and symptoms of allergic reactions (angioedema, chest tightness, hypotension, rash, nausea, vomiting, paresthesia, restlessness, wheezing, dyspnea). If symptoms occur, discontinue therapy and treat symptomatically.
- Lab Test Considerations: If expected Factor IX activity levels are not attained or if bleeding is not controlled with recommended dose, perform a Bethesda assay to determine if inhibitors are present.
Potential Nursing Diagnoses
Ineffective tissue perfusion (Indications)Deficient knowledge, related to medication regimen (Patient/Family Teaching)
Implementation
Intravenous Administration
- Allow medication and diluent to come to room temperature before use. Follow manufacturer's guidelines for mixing. Final solution should be clear to slightly opalescent and colorless. Do not shake. Do not use solutions that are discolored or contain particulate matter. Use reconstituted solution within 3 hr. Do not refrigerate or freeze after reconstitution. Do not administer reconstituted solution in same tubing or container with other medications. Vials can be stored at room temperature for up to 6 mo and then should be discarded; do not return to refrigerator.
- Rate: Administer as a bolus infusion over several min. Determine rate based on patient's comfort; no >10 mL/min.
Patient/Family Teaching
- May be self-administered with proper training. Instruct patient to read Patient Information and Instructions for Use prior to starting therapy and with each refill in case of changes.
- Advise patient to notify health care professional immediately if signs and symptom of allergic reactions.
- Advise female patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
Evaluation/Desired Outcomes
- Control and prevention of bleeding in adults and children with Hemophilia B.