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Drug overview for ALPHANINE SD (factor ix):
Generic name: FACTOR IX (FACK-ter nine)
Drug class: Factor IX
Therapeutic class: Hematological Agents
Factor IX (human) is a preparation of blood coagulation factor IX prepared from pooled human plasma. Factor IX complex (human), also known as a 3-factor prothrombin complex concentrate (PCC), is a preparation of nonactivated blood coagulation factors II, VII, IX, and X derived from pooled human plasma.
No enhanced Uses information available for this drug.
Generic name: FACTOR IX (FACK-ter nine)
Drug class: Factor IX
Therapeutic class: Hematological Agents
Factor IX (human) is a preparation of blood coagulation factor IX prepared from pooled human plasma. Factor IX complex (human), also known as a 3-factor prothrombin complex concentrate (PCC), is a preparation of nonactivated blood coagulation factors II, VII, IX, and X derived from pooled human plasma.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for ALPHANINE SD (factor ix) have been approved by the FDA:
Indications:
Hemophilia B
Professional Synonyms:
Christmas disease
Factor IX deficiency
Factor IX dysfunction
Plasma thromboplastin component deficiency
PTC deficiency
Indications:
Hemophilia B
Professional Synonyms:
Christmas disease
Factor IX deficiency
Factor IX dysfunction
Plasma thromboplastin component deficiency
PTC deficiency
The following dosing information is available for ALPHANINE SD (factor ix):
Dose (potency) of factor IX (human) and factor IX complex (human) is expressed in terms of international units (IU, units) of factor IX activity. One unit is approximately equivalent to the amount of factor IX activity in 1 mL of pooled normal human plasma. The dosage of factor IX (human) or factor IX complex (human) required to establish hemostasis in patients with hemophilia B will vary with each patient and circumstance since there is considerable variability among patients and their clinical conditions.
Therefore, dosage should be carefully individualized and factor IX levels monitored frequently during therapy with the drugs. Close monitoring of factor IX levels is particularly important in cases of severe hemorrhage or major surgery. The dosing frequency for maintaining sufficiently increased levels of a deficient factor also is variable; although minor bleeding episodes may be controlled with a single dose, more severe bleeding may require administration of additional doses.
Therefore, dosage should be carefully individualized and factor IX levels monitored frequently during therapy with the drugs. Close monitoring of factor IX levels is particularly important in cases of severe hemorrhage or major surgery. The dosing frequency for maintaining sufficiently increased levels of a deficient factor also is variable; although minor bleeding episodes may be controlled with a single dose, more severe bleeding may require administration of additional doses.
No enhanced Administration information available for this drug.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for ALPHANINE SD (factor ix):
There are 1 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| Antifibrinolytics/Factor IX; Anti-Inhibitor Coagulant Conc SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Concurrent use may result in additive or synergistic effects on the coagulation pathways.(1-3) CLINICAL EFFECTS: Concurrent use may result in thrombosis.(1-3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of aminocaproic acid states that aminocaproic acid should not be administered concomitantly with Factor IX Complex concentrates or with Anti-inhibitor Coagulant concentrates.(1) The manufacturer of tranexamic acid states that tranexamic acid should not be administered concomitantly with Factor IX Complex concentrates or with Anti-inhibitor Coagulant concentrates.(2,3) Concurrent use may be warranted in select patients with hemophilia A or hemophilia B. Monitor patients closely for signs of thrombosis, disseminated intravascular coagulation, and hypercoagulability if concurrent use is deemed necessary.(4-6) DISCUSSION: Because of the increased risk of thrombosis, the manufacturer of aminocaproic acid states that aminocaproic acid should not be administered concomitantly with Factor IX Complex concentrates or with Anti-inhibitor Coagulant concentrates.(1) Because of the increased risk of thrombosis, the manufacturer of tranexamic acid states that tranexamic acid should not be administered concomitantly with Factor IX Complex concentrates or with Anti-inhibitor Coagulant concentrates.(2,3) In a study, eight hemophilia B patients undergoing dental extraction procedures received combination therapy with aminocaproic acid or tranexamic acid and monoclonal antibody purified factor IX for bleeding prophylaxis. All patients achieved hemostasis without clinical evidence of thrombosis as well as no changes were seen in hemoglobin, hematocrit, or in markers of hemostatic system activation.(4) In a study, seven hemophilia A patients with inhibitors and one with acquired hemophilia patient received activated prothrombin complex concentrate (APCC) and tranexamic acid for management of bleeding episodes and prevention of hemorrhage during surgery. Hemostatic outcomes were rated excellent or good in 10 out of 11 (91%) treatment episodes. No episodes of thrombosis or disseminated intravascular coagulation occurred during treatment.(5) A study in six hemophilia A patients and five healthy volunteers evaluated the use of tranexamic acid as an adjunct to APCC to control bleeding. Patients who received tranexamic acid had a significant increase in maximum clot firmness compared to healthy controls. No clinical or laboratory signs of thromboembolic events, disseminated intravascular coagulation, or hypercoagulability were observed.(6) |
AMICAR, AMINOCAPROIC ACID, CYKLOKAPRON, TRANEXAMIC ACID, TRANEXAMIC ACID-NACL |
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for ALPHANINE SD (factor ix):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 0 contraindications.
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Disseminated intravascular coagulation |
| Thromboembolic disorder |
There are 0 moderate contraindications.
The following adverse reaction information is available for ALPHANINE SD (factor ix):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 10 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acute myocardial infarction Disseminated intravascular coagulation Pulmonary thromboembolism Thromboembolic disorder Thrombotic disorder |
Anaphylaxis Urinary tract obstructive uropathy |
| Rare/Very Rare |
|---|
|
Hypersensitivity drug reaction Hypotension Renal colic |
There are 16 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Chills Injection site sequelae Nausea Oral paresthesia |
| Rare/Very Rare |
|---|
|
Anorexia Dizziness Dysgeusia Fatigue Fever Halitosis Headache disorder Hematuria Lethargy Palpitations Paresthesia Urticaria |
The following precautions are available for ALPHANINE SD (factor ix):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Animal reproduction studies have not been performed with factor IX (human) or factor IX complex (human). It is not known whether the preparations can cause fetal harm when administered to pregnant women or affect reproduction capacity. Factor IX (human) and factor IX complex (human) should be used during pregnancy only when clearly needed.
No enhanced Lactation information available for this drug.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for ALPHANINE SD (factor ix):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ALPHANINE SD (factor ix)'s list of indications:
| Hemophilia B | |
| D67 | Hereditary factor IX deficiency |
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