Factor IX (Recombinant), albumin fusion protein
Brand names: Idelvion
Drug class:
Antineoplastic Agents
Usage of Factor IX (Recombinant), albumin fusion protein
Hemophilia B
On-demand control and prevention of bleeding episodes in patients with hemophilia B (congenital Factor ix deficiency; Christmas Disease).
Maintenance of hemostasis in patients with hemophilia B undergoing surgery (i.e., perioperative management).
Designated an orphan drug by FDA for treatment of patients with hemophilia B.
Routine prophylaxis (i.e., administration at regular intervals) to prevent or reduce frequency of hemorrhagic events. Such prophylactic therapy considered the current standard of care for patients with hemophilia B. Decreases frequency of spontaneous musculoskeletal hemorrhage, preserves joint function, and improves quality of life.
Circulating half-life of factor IX (recombinant), albumin fusion protein longer than that of unmodified recombinant or plasma-derived factor IX preparations; may allow for less frequent dosing and improved patient compliance with prophylactic regimens.
Several factor IX concentrates are currently available in the US, including a variety of recombinant and plasma-derived preparations; the Medical and Scientific Advisory Council (MASAC) of the National Hemophilia Foundation recommends preferential use of recombinant factor IX preparations because of their potentially superior safety profile with respect to pathogen transmission. Other experts (e.g., World Federation of Hemophilia) state that choice of preparation should be determined by local criteria. When selecting an appropriate factor IX product, consider characteristics of each clotting factor concentrate, individual patient variables, patient/provider preference, and emerging data.
Manufacturer states that factor IX (recombinant), Fc fusion protein not indicated for induction of immune tolerance in patients with hemophilia B.
Relate drugs
- Abemaciclib (Systemic)
- Acyclovir (Systemic)
- Adenovirus Vaccine
- Aldomet
- Aluminum Acetate
- Aluminum Chloride (Topical)
- Ambien
- Ambien CR
- Aminosalicylic Acid
- Anacaulase
- Anacaulase
- Anifrolumab (Systemic)
- Antacids
- Anthrax Immune Globulin IV (Human)
- Antihemophilic Factor (Recombinant), Fc fusion protein (Systemic)
- Antihemophilic Factor (recombinant), Fc-VWF-XTEN Fusion Protein
- Antihemophilic Factor (recombinant), PEGylated
- Antithrombin alfa
- Antithrombin alfa
- Antithrombin III
- Antithrombin III
- Antithymocyte Globulin (Equine)
- Antivenin (Latrodectus mactans) (Equine)
- Apremilast (Systemic)
- Aprepitant/Fosaprepitant
- Articaine
- Asenapine
- Atracurium
- Atropine (EENT)
- Avacincaptad Pegol (EENT)
- Avacincaptad Pegol (EENT)
- Axicabtagene (Systemic)
- Clidinium
- Clindamycin (Systemic)
- Clonidine
- Clonidine (Epidural)
- Clonidine (Oral)
- Clonidine injection
- Clonidine transdermal
- Co-trimoxazole
- COVID-19 Vaccine (Janssen) (Systemic)
- COVID-19 Vaccine (Moderna)
- COVID-19 Vaccine (Pfizer-BioNTech)
- Crizanlizumab-tmca (Systemic)
- Cromolyn (EENT)
- Cromolyn (Systemic, Oral Inhalation)
- Crotalidae Polyvalent Immune Fab
- CycloSPORINE (EENT)
- CycloSPORINE (EENT)
- CycloSPORINE (Systemic)
- Cysteamine Bitartrate
- Cysteamine Hydrochloride
- Cysteamine Hydrochloride
- Cytomegalovirus Immune Globulin IV
- A1-Proteinase Inhibitor
- A1-Proteinase Inhibitor
- Bacitracin (EENT)
- Baloxavir
- Baloxavir
- Bazedoxifene
- Beclomethasone (EENT)
- Beclomethasone (Systemic, Oral Inhalation)
- Belladonna
- Belsomra
- Benralizumab (Systemic)
- Benzocaine (EENT)
- Bepotastine
- Betamethasone (Systemic)
- Betaxolol (EENT)
- Betaxolol (Systemic)
- Bexarotene (Systemic)
- Bismuth Salts
- Botulism Antitoxin (Equine)
- Brimonidine (EENT)
- Brivaracetam
- Brivaracetam
- Brolucizumab
- Brompheniramine
- Budesonide (EENT)
- Budesonide (Systemic, Oral Inhalation)
- Bulk-Forming Laxatives
- Bupivacaine (Local)
- BuPROPion (Systemic)
- Buspar
- Buspar Dividose
- Buspirone
- Butoconazole
- Cabotegravir (Systemic)
- Caffeine/Caffeine and Sodium Benzoate
- Calcitonin
- Calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate
- Calcium Salts
- Calcium, magnesium, potassium, and sodium oxybates
- Candida Albicans Skin Test Antigen
- Cantharidin (Topical)
- Capmatinib (Systemic)
- Carbachol
- Carbamide Peroxide
- Carbamide Peroxide
- Carmustine
- Castor Oil
- Catapres
- Catapres-TTS
- Catapres-TTS-1
- Catapres-TTS-2
- Catapres-TTS-3
- Ceftolozane/Tazobactam (Systemic)
- Cefuroxime
- Centruroides Immune F(ab′)2
- Cetirizine (EENT)
- Charcoal, Activated
- Chloramphenicol
- Chlorhexidine (EENT)
- Chlorhexidine (EENT)
- Cholera Vaccine Live Oral
- Choriogonadotropin Alfa
- Ciclesonide (EENT)
- Ciclesonide (Systemic, Oral Inhalation)
- Ciprofloxacin (EENT)
- Citrates
- Dacomitinib (Systemic)
- Dapsone (Systemic)
- Dapsone (Systemic)
- Daridorexant
- Darolutamide (Systemic)
- Dasatinib (Systemic)
- DAUNOrubicin and Cytarabine
- Dayvigo
- Dehydrated Alcohol
- Delafloxacin
- Delandistrogene Moxeparvovec (Systemic)
- Dengue Vaccine Live
- Dexamethasone (EENT)
- Dexamethasone (Systemic)
- Dexmedetomidine
- Dexmedetomidine
- Dexmedetomidine
- Dexmedetomidine (Intravenous)
- Dexmedetomidine (Oromucosal)
- Dexmedetomidine buccal/sublingual
- Dexmedetomidine injection
- Dextran 40
- Diclofenac (Systemic)
- Dihydroergotamine
- Dimethyl Fumarate (Systemic)
- Diphenoxylate
- Diphtheria and Tetanus Toxoids
- Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
- Diroximel Fumarate (Systemic)
- Docusate Salts
- Donislecel-jujn (Systemic)
- Doravirine, Lamivudine, and Tenofovir Disoproxil
- Doxepin (Systemic)
- Doxercalciferol
- Doxycycline (EENT)
- Doxycycline (Systemic)
- Doxycycline (Systemic)
- Doxylamine
- Duraclon
- Duraclon injection
- Dyclonine
- Edaravone
- Edluar
- Efgartigimod Alfa (Systemic)
- Eflornithine
- Eflornithine
- Elexacaftor, Tezacaftor, And Ivacaftor
- Elranatamab (Systemic)
- Elvitegravir, Cobicistat, Emtricitabine, and tenofovir Disoproxil Fumarate
- Emicizumab-kxwh (Systemic)
- Emtricitabine and Tenofovir Disoproxil Fumarate
- Entrectinib (Systemic)
- EPINEPHrine (EENT)
- EPINEPHrine (Systemic)
- Erythromycin (EENT)
- Erythromycin (Systemic)
- Estrogen-Progestin Combinations
- Estrogen-Progestin Combinations
- Estrogens, Conjugated
- Estropipate; Estrogens, Esterified
- Eszopiclone
- Ethchlorvynol
- Etranacogene Dezaparvovec
- Evinacumab (Systemic)
- Evinacumab (Systemic)
- Factor IX (Human), Factor IX Complex (Human)
- Factor IX (Recombinant)
- Factor IX (Recombinant), albumin fusion protein
- Factor IX (Recombinant), Fc fusion protein
- Factor VIIa (Recombinant)
- Factor Xa (recombinant), Inactivated-zhzo
- Factor Xa (recombinant), Inactivated-zhzo
- Factor XIII A-Subunit (Recombinant)
- Faricimab
- Fecal microbiota, live
- Fedratinib (Systemic)
- Fenofibric Acid/Fenofibrate
- Fibrinogen (Human)
- Flunisolide (EENT)
- Fluocinolone (EENT)
- Fluorides
- Fluorouracil (Systemic)
- Flurbiprofen (EENT)
- Flurbiprofen (EENT)
- Flurbiprofen (EENT)
- Flurbiprofen (EENT)
- Fluticasone (EENT)
- Fluticasone (Systemic, Oral Inhalation)
- Fluticasone and Vilanterol (Oral Inhalation)
- Ganciclovir Sodium
- Gatifloxacin (EENT)
- Gentamicin (EENT)
- Gentamicin (Systemic)
- Gilteritinib (Systemic)
- Glofitamab
- Glycopyrronium
- Glycopyrronium
- Gonadotropin, Chorionic
- Goserelin
- Guanabenz
- Guanadrel
- Guanethidine
- Guanfacine
- Haemophilus b Vaccine
- Hepatitis A Virus Vaccine Inactivated
- Hepatitis B Vaccine Recombinant
- Hetlioz
- Hetlioz LQ
- Homatropine
- Hydrocortisone (EENT)
- Hydrocortisone (Systemic)
- Hydroquinone
- Hylorel
- Hyperosmotic Laxatives
- Ibandronate
- Igalmi buccal/sublingual
- Imipenem, Cilastatin Sodium, and Relebactam
- Inclisiran (Systemic)
- Infliximab, Infliximab-dyyb
- Influenza Vaccine Live Intranasal
- Influenza Vaccine Recombinant
- Influenza Virus Vaccine Inactivated
- Inotuzumab
- Insulin Human
- Interferon Alfa
- Interferon Beta
- Interferon Gamma
- Intermezzo
- Intuniv
- Iodoquinol (Topical)
- Iodoquinol (Topical)
- Ipratropium (EENT)
- Ipratropium (EENT)
- Ipratropium (Systemic, Oral Inhalation)
- Ismelin
- Isoproterenol
- Ivermectin (Systemic)
- Ivermectin (Topical)
- Ixazomib Citrate (Systemic)
- Japanese Encephalitis Vaccine
- Kapvay
- Ketoconazole (Systemic)
- Ketorolac (EENT)
- Ketorolac (EENT)
- Ketorolac (EENT)
- Ketorolac (EENT)
- Ketorolac (Systemic)
- Ketotifen
- Lanthanum
- Lecanemab
- Lefamulin
- Lemborexant
- Lenacapavir (Systemic)
- Leniolisib
- Letermovir
- Letermovir
- Levodopa/Carbidopa
- LevoFLOXacin (EENT)
- LevoFLOXacin (Systemic)
- L-Glutamine
- Lidocaine (Local)
- Lidocaine (Systemic)
- Linezolid
- Lofexidine
- Loncastuximab
- Lotilaner (EENT)
- Lotilaner (EENT)
- Lucemyra
- Lumasiran Sodium
- Lumryz
- Lunesta
- Mannitol
- Mannitol
- Mb-Tab
- Measles, Mumps, and Rubella Vaccine
- Mecamylamine
- Mechlorethamine
- Mechlorethamine
- Melphalan (Systemic)
- Meningococcal Groups A, C, Y, and W-135 Vaccine
- Meprobamate
- Methoxy Polyethylene Glycol-epoetin Beta (Systemic)
- Methyldopa
- Methylergonovine, Ergonovine
- MetroNIDAZOLE (Systemic)
- MetroNIDAZOLE (Systemic)
- Miltown
- Minipress
- Minocycline (EENT)
- Minocycline (Systemic)
- Minoxidil (Systemic)
- Mometasone
- Mometasone (EENT)
- Moxifloxacin (EENT)
- Moxifloxacin (Systemic)
- Nalmefene
- Naloxone (Systemic)
- Natrol Melatonin + 5-HTP
- Nebivolol Hydrochloride
- Neomycin (EENT)
- Neomycin (Systemic)
- Netarsudil Mesylate
- Nexiclon XR
- Nicotine
- Nicotine
- Nicotine
- Nilotinib (Systemic)
- Nirmatrelvir
- Nirmatrelvir
- Nitroglycerin (Systemic)
- Ofloxacin (EENT)
- Ofloxacin (Systemic)
- Oliceridine Fumarate
- Olipudase Alfa-rpcp (Systemic)
- Olopatadine
- Omadacycline (Systemic)
- Osimertinib (Systemic)
- Oxacillin
- Oxymetazoline
- Pacritinib (Systemic)
- Palovarotene (Systemic)
- Paraldehyde
- Peginterferon Alfa
- Peginterferon Beta-1a (Systemic)
- Penicillin G
- Pentobarbital
- Pentosan
- Pilocarpine Hydrochloride
- Pilocarpine, Pilocarpine Hydrochloride, Pilocarpine Nitrate
- Placidyl
- Plasma Protein Fraction
- Plasminogen, Human-tmvh
- Pneumococcal Vaccine
- Polymyxin B (EENT)
- Polymyxin B (Systemic, Topical)
- PONATinib (Systemic)
- Poractant Alfa
- Posaconazole
- Potassium Supplements
- Pozelimab (Systemic)
- Pramoxine
- Prazosin
- Precedex
- Precedex injection
- PrednisoLONE (EENT)
- PrednisoLONE (Systemic)
- Progestins
- Propylhexedrine
- Protamine
- Protein C Concentrate
- Protein C Concentrate
- Prothrombin Complex Concentrate
- Pyrethrins with Piperonyl Butoxide
- Quviviq
- Ramelteon
- Relugolix, Estradiol, and Norethindrone Acetate
- Remdesivir (Systemic)
- Respiratory Syncytial Virus Vaccine, Adjuvanted (Systemic)
- RifAXIMin (Systemic)
- Roflumilast (Systemic)
- Roflumilast (Topical)
- Roflumilast (Topical)
- Rotavirus Vaccine Live Oral
- Rozanolixizumab (Systemic)
- Rozerem
- Ruxolitinib (Systemic)
- Saline Laxatives
- Selenious Acid
- Selexipag
- Selexipag
- Selpercatinib (Systemic)
- Sirolimus (Systemic)
- Sirolimus, albumin-bound
- Smallpox and Mpox Vaccine Live
- Smallpox Vaccine Live
- Sodium Chloride
- Sodium Ferric Gluconate
- Sodium Nitrite
- Sodium oxybate
- Sodium Phenylacetate and Sodium Benzoate
- Sodium Thiosulfate (Antidote) (Systemic)
- Sodium Thiosulfate (Protectant) (Systemic)
- Somatrogon (Systemic)
- Sonata
- Sotorasib (Systemic)
- Suvorexant
- Tacrolimus (Systemic)
- Tafenoquine (Arakoda)
- Tafenoquine (Krintafel)
- Talquetamab (Systemic)
- Tasimelteon
- Tedizolid
- Telotristat
- Tenex
- Terbinafine (Systemic)
- Tetrahydrozoline
- Tezacaftor and Ivacaftor
- Theophyllines
- Thrombin
- Thrombin Alfa (Recombinant) (Topical)
- Timolol (EENT)
- Timolol (Systemic)
- Tixagevimab and Cilgavimab
- Tobramycin (EENT)
- Tobramycin (Systemic)
- TraMADol (Systemic)
- Trametinib Dimethyl Sulfoxide
- Trancot
- Tremelimumab
- Tretinoin (Systemic)
- Triamcinolone (EENT)
- Triamcinolone (Systemic)
- Trimethobenzamide
- Tucatinib (Systemic)
- Unisom
- Vaccinia Immune Globulin IV
- Valoctocogene Roxaparvovec
- Valproate/Divalproex
- Valproate/Divalproex
- Vanspar
- Varenicline (Systemic)
- Varenicline (Systemic)
- Varenicline Tartrate (EENT)
- Vecamyl
- Vitamin B12
- Vonoprazan, Clarithromycin, and Amoxicillin
- Wytensin
- Xyrem
- Xywav
- Zaleplon
- Zirconium Cyclosilicate
- Zolpidem
- Zolpidem (Oral)
- Zolpidem (Oromucosal, Sublingual)
- ZolpiMist
- Zoster Vaccine Recombinant
- 5-hydroxytryptophan, melatonin, and pyridoxine
How to use Factor IX (Recombinant), albumin fusion protein
General
Administration
IV Administration
Administer by slow IV injection. (See Rate of Administration under Dosage and Administration.)
Reconstitution and AdministrationReconstitute with sterile water for injection (provided by manufacturer).
Allow drug vial and diluent to warm to room temperature prior to reconstitution. After addition of diluent, gently swirl vial until powder is completely dissolved; do not shake. Resultant solution should be clear or yellow to colorless; do not use if cloudy, discolored or if particulate matter observed.
If more than 1 vial is required to prepare dose, may pool reconstituted contents of multiple vials into a single syringe.
Administer using sterile infusion set and syringe.
Do not administer in the SAMe tubing or container with other drugs.
Administer immediately or within 4 hours after reconstitution.
Consult manufacturer’s labeling for specific instructions on reconstitution and preparation of factor IX (recombinant), albumin fusion protein.
Rate of AdministrationDetermine rate of administration by patient’s comfort level (not to exceed 10 mL/minute).
Dosage
Dosage (potency) expressed in terms of international units (IU, units) of factor IX activity. Potency is determined by an aPTT-based one-stage clotting assay calibrated against a WHO standard. Administration of 1 unit/kg factor IX (recombinant), albumin fusion protein increases circulating levels of factor IX by 1.3 units/dL in patients ≥12 years of age and by 1 unit/dL in patients <12 years of age.
Estimate dose required to achieve a particular percentage increase in plasma factor IX using the following formula:
Dose (units) = body weight (in kg) x desired factor IX increase (in % of normal or units/dL) × reciprocal of recovery (in units/kg per units/dL)
Determine desired factor IX level by the clinical situation and severity of bleeding. For recommendations on target factor IX levels for a given clinical situation, see the specific dosage sections for various uses below. These calculations and suggested dosage regimens are only approximations and should not preclude appropriate clinical monitoring and individualization of dosage based on the hemostatic requirements of patients. Measure factor IX activity after a dose is given to verify calculated dose.
If calculated dose is ineffective in achieving appropriate factor IX levels, consider possibility that Neutralizing antibodies (inhibitors) may have developed. (See Development of Inhibitors to Factor IX under Cautions.)
Pediatric Patients
Hemophilia BHigher doses or more frequent dosing may be required in pediatric patients because of increased clearance, shorter half-life, and lower recovery of factor IX.
On-Demand Control and Prevention of Bleeding IVMinor or moderate bleeding (e.g., uncomplicated hemarthroses, muscle bleeding [except iliopsoas], oral bleeding): Administer appropriate dose to achieve factor IX levels of 30–60% of normal. Repeat every 48–72 hours until bleeding resolves and healing achieved; single injection usually sufficient.
Major bleeding (e.g., limb- or life-threatening hemorrhage; deep muscle bleeding, including iliopsoas; intracranial; retropharyngeal): Administer appropriate dose to achieve factor IX levels of 60–100% of normal; repeat every 48–72 hours for 7–14 days until bleeding resolves and healing achieved. Administer maintenance dose weekly.
Perioperative Hemostasis IVMinor surgery (e.g., uncomplicated dental extraction): Administer appropriate dose to achieve a factor IX level of 50–80% of normal. Repeat every 48–72 hours until healing achieved; single injection usually sufficient.
Major surgery (e.g., intracranial, pharyngeal, retropharyngeal, retroperitoneal): Administer appropriate dose to achieve initial factor IX level of 60–100% of normal. Repeat every 48–72 hours for 7–14 days, or until bleeding resolves and healing achieved. Administer maintenance dose 1 or 2 times weekly.
Routine Prophylaxis IVPediatric patients <12 years of age: 40–55 units/kg every 7 days. Adjust dosage based on patient response.
Pediatric patients ≥12 years of age: Initially, 25–40 units/kg every 7 days. Patients well controlled on this regimen may be switched to 50–75 units/kg every 14 days. Adjust dosage based on patient response.
According to MASAC, institute prophylactic therapy at an early age (e.g., 1–2 years), prior to the onset of frequent bleeding; however, optimum duration of prophylaxis not known.
Individualize prophylactic dosage regimens; evaluate patients periodically to determine continued need for prophylaxis.
Adults
Hemophilia B On-Demand Control and Prevention of Bleeding IVMinor or moderate bleeding (e.g., uncomplicated hemarthroses, muscle bleeding [except iliopsoas], oral bleeding): Administer appropriate dose to achieve factor IX levels of 30–60% of normal. Repeat every 48–72 hours until bleeding resolves and healing achieved; single injection usually sufficient.
Major bleeding (e.g., limb- or life-threatening hemorrhage; deep muscle bleeding, including iliopsoas; intracranial; retropharyngeal): Administer appropriate dose to achieve factor IX levels of 60–100% of normal; repeat every 48–72 hours for 7–14 days until bleeding resolves and healing achieved. Administer maintenance dose weekly.
Perioperative Hemostasis IVMinor surgery (e.g., uncomplicated dental extraction): Administer appropriate dose to achieve a factor IX level of 50–80% of normal. Repeat dose every 48–72 hours until healing achieved; single injection usually sufficient.
Major surgery (e.g., intracranial, pharyngeal, retropharyngeal, retroperitoneal): Administer appropriate dose to achieve initial factor IX level of 60–100% of normal. Repeat every 48–72 hours for 7–14 days, or until bleeding resolves and healing achieved. Administer maintenance dose 1 or 2 times weekly.
Routine Prophylaxis IVInitially, 25–40 units/kg every 7 days. Patients well controlled on this regimen may be switched to 50–75 units/kg every 14 days. Adjust dosage based on patient response.
Individualize prophylactic dosage regimens; evaluate patients periodically to determine continued need for prophylaxis. Optimum duration of prophylaxis not known.
Warnings
Contraindications
Warnings/Precautions
Development of Inhibitors to Factor IX
Risk for development of inhibitors to factor IX following treatment with any factor IX preparation. Reported in <5% of patients with hemophilia B receiving factor IX concentrates.
Monitor patients regularly for development of inhibitors with appropriate clinical observation and laboratory tests. (See Laboratory Monitoring under Cautions.) Suspect presence of inhibitors if expected factor IX levels not achieved or bleeding not controlled with recommended dose, particularly in those who previously achieved a response.
Because of an association between inhibitor development and allergic Reactions, evaluate for presence of inhibitors in any patient experiencing hypersensitivity. (See Hypersensitivity under Cautions.) In patients with inhibitors, increased risk of anaphylaxis following re-exposure to factor IX (recombinant), albumin fusion protein.
Consultation with a hemophilia treatment center is strongly recommended for patients with inhibitors.
Thromboembolic Events
Risk of thromboembolic complications (e.g., pulmonary embolism, venous thromboembolism, arterial thrombosis).
Monitor for early manifestations of thromboembolism and consumptive coagulopathy in patients with hepatic disease, signs of fibrinolysis, or other risk factors for thromboembolism or disseminated intravascular coagulation (DIC).
Nephrotic Syndrome
Nephrotic syndrome reported following attempted immune tolerance induction in hemophilia B patients with factor IX inhibitors and history of allergic reactions. Safety and efficacy of factor IX (recombinant), albumin fusion protein for immune tolerance induction not established.
Laboratory Monitoring
Monitor factor IX levels (using aPTT-based one-stage clotting assay) to guide dosing and assess therapeutic response. Results can vary based on type of aPTT reagent; a Kaolin-based reagent is likely to result in an underestimation of factor IX activity.
Monitor for development of inhibitors. Perform appropriate laboratory test (i.e., Bethesda assay) to cOnfirm presence of an inhibitor. (See Development of Inhibitors to Factor IX under Cautions.)
Sensitivity Reactions
HypersensitivityRisk of hypersensitivity reactions, including anaphylaxis.
Closely observe patient for signs and symptoms of hypersensitivity (e.g., angioedema, chest tightness, hypotension, generalized urtIcaria, wheezing, dyspnea). If a hypersensitivity reaction occurs, immediately discontinue drug and initiate appropriate therapy.
Specific Populations
PregnancyNo adequate and well-controlled studies of factor IX (recombinant), albumin fusion protein in pregnant women. Animal reproductive and development studies lacking. Use during pregnancy only when clearly needed.
LactationNot known whether distributed into human milk; use with caution.
Pediatric UseSafety, efficacy, and pharmacokinetics of factor IX (recombinant), albumin fusion protein evaluated in 32 pediatric patients. Prophylactic administration of factor IX (recombinant), albumin fusion protein successful in preventing spontaneous bleeding episodes; no differences in safety profile in pediatric patients compared with adults.
Compared with adults, pediatric patients may have higher body weight-adjusted clearance, shorter half-life, and lower factor IX recovery; higher doses or more frequent dosing may be required. (See Dosage under Dosage and Administration.)
Geriatric UseInsufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger patients.
Common Adverse Effects
Headache.
Disclaimer
Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Popular Keywords
- metformin obat apa
- alahan panjang
- glimepiride obat apa
- takikardia adalah
- erau ernie
- pradiabetes
- besar88
- atrofi adalah
- kutu anjing
- trakeostomi
- mayzent pi
- enbrel auto injector not working
- enbrel interactions
- lenvima life expectancy
- leqvio pi
- what is lenvima
- lenvima pi
- empagliflozin-linagliptin
- encourage foundation for enbrel
- qulipta drug interactions