Innohep
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Questions & Answers
Side Effects & Adverse Reactions
INNOHEP® is not intended for intramuscular or intravenous administration.
INNOHEP® cannot be used interchangeably (unit for unit) with heparin or other low molecular weight heparins as they differ in manufacturing process, molecular weight distribution, anti-Xa and anti-IIa activities, units, and dosage. Each of these medications has its own instructions for use.
INNOHEP® should not be used in patients with a history of heparin-induced thrombocytopenia (see CONTRAINDICATIONS).
Hemorrhage: INNOHEP®, like other anticoagulants, should be used with extreme caution in conditions with increased risk of hemorrhage, such as bacterial endocarditis; severe uncontrolled hypertension; congenital or acquired bleeding disorders including hepatic failure and amyloidosis; active ulcerative and angiodysplastic gastrointestinal disease; hemorrhagic stroke; shortly after brain, spinal or ophthalmological surgery, or in patients treated concomitantly with platelet inhibitors. Bleeding can occur in any tissue or organ of the body during therapy with INNOHEP®. Hemorrhage in some cases has been reported to result in death or permanent disability. A hemorrhagic event should be seriously considered in the presence of an unexplained fall in hematocrit, hemoglobin, or blood pressure. If severe hemorrhage occurs, INNOHEP® should be discontinued.
Spinal or epidural hematomas can occur with the associated use of low molecular weight heparins or heparinoids and spinal/epidural anesthesia or spinal puncture which can result in long-term or permanent paralysis. The risk of these events is higher with the use of post-operative indwelling epidural catheters or with the concomitant use of additional drugs affecting hemostasis such as NSAIDs (see boxed WARNING and PRECAUTIONS, Drug Interactions).
Thrombocytopenia: Thrombocytopenia can occur with the administration of INNOHEP®.
In clinical studies, thrombocytopenia (platelet count <100,000/mm3 if baseline value ≥150,000/mm3, ≥50% decline if baseline <150,000/mm3) was identified in 1% of patients given INNOHEP®; severe thrombocytopenia (platelet count less than 50,000/mm3) occurred in 0.13%.
Thrombocytopenia of any degree should be monitored closely. If the platelet count falls below 100,000/mm3, INNOHEP® should be discontinued. Cases of thrombocytopenia with disseminated thrombosis also have been observed in clinical practice with heparins, and low molecular weight heparins, including tinzaparin sodium. Some of these cases were complicated by organ infarction with secondary organ dysfunction or limb ischemia, and have resulted in death.
Hypersensitivity: INNOHEP® contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown, but is probably low. Sulfite sensitivity is more frequent in asthmatic people than in non-asthmatic people.
Priapism: Priapism has been reported from post-marketing surveillance as a rare occurrence. In some cases surgical intervention was required.
Miscellaneous: INNOHEP® multiple dose vial contains benzyl alcohol as a preservative. The administration of medications containing benzyl alcohol as a preservative to premature neonates has been associated with a fatal “Gasping Syndrome." Because benzyl alcohol may cross the placenta, INNOHEP® preserved with benzyl alcohol should be used with caution in pregnant women only if clearly needed (see PRECAUTIONS, Pregnancy).
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
INNOHEP® is indicated for the treatment of acute symptomatic deep vein thrombosis with or without pulmonary embolism when administered in conjunction with warfarin sodium. The safety and effectiveness of INNOHEP® were established in hospitalized patients.
History
There is currently no drug history available for this drug.
Other Information
INNOHEP® is a sterile solution, containing tinzaparin sodium, a low molecular weight heparin. It is available in a multiple dose 2 mL vial.
Each 2 mL vial contains 20,000 anti-Factor Xa IU (anti-Xa) of tinzaparin sodium per mL, for a total of 40,000 IU, and 3.1 mg/mL sodium metabisulfite as a stabilizer. The vial contains 10 mg/mL benzyl alcohol as a preservative. Sodium hydroxide may be added to achieve a pH range of 5.0 to 7.5.
| Component |
Quantity per mL |
|---|---|
| 1 Corresponding to 3.4 mg/mL sodium bisulfite |
|
| Tinzaparin sodium | 20,000 anti-Xa IU |
| Benzyl alcohol, USP | 10 mg |
| Sodium metabisulfite, USP | 3.106 mg1 |
| Sodium hydroxide, USP | as necessary |
| Water for Injection, USP | q.s. to 1 mL |
Tinzaparin sodium is the sodium salt of a low molecular weight heparin obtained by controlled enzymatic depolymerization of heparin from porcine intestinal mucosa using heparinase from Flavobacterium heparinum. The majority of the components have a 2-O-sulpho-4-enepyranosuronic acid structure at the non-reducing end and a 2-N,6-O-disulpho-D-glucosamine structure at the reducing end of the chain.
Potency is determined by means of a biological assay and interpreted by the first International Low Molecular Weight Heparin Standard as units of anti-factor Xa (anti-Xa) activity per milligram. The mean tinzaparin sodium anti-factor Xa activity is approximately 100 IU per milligram. The average molecular weight ranges between 5,500 and 7,500 daltons. The molecular weight distribution is:
Structural Formula
Sources
Innohep Manufacturers
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Celgene Corporation
![Innohep (Tinzaparin Sodium) Injection [Celgene Corporation]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Innohep | Celgene Corporation
All patients should be evaluated for bleeding disorders before administration of INNOHEP®. Since coagulation parameters are unsuitable for monitoring INNOHEP® activity, routine monitoring of coagulation parameters is not required (see PRECAUTIONS, Laboratory Tests).
Adult DosageThe recommended dose of INNOHEP® for the treatment of DVT with or without PE is 175 anti-Xa IU/kg of body weight, administered SC once daily for at least 6 days and until the patient is adequately anticoagulated with warfarin (INR at least 2.0 for two consecutive days). Warfarin sodium therapy should be initiated when appropriate (usually within 1-3 days of INNOHEP® initiation). Pregnancy has little or no influence on the pharmacokinetics of INNOHEP® and no dosing adjustment is needed for pregnancy.
As INNOHEP® may theoretically affect the PT/INR, patients receiving both INNOHEP® and warfarin should have blood for PT/INR determination drawn just prior to the next scheduled dose of INNOHEP®.
Table 8 provides INNOHEP® doses for the treatment of DVT with or without PE. It is necessary to calculate the appropriate INNOHEP® dose for patient weights not displayed in Table 8.
An appropriately calibrated syringe should be used to assure withdrawal of the correct volume of drug from INNOHEP® vials.
Table 8 INNOHEP® Weight-based Dosing for Treatment of Deep Vein Thrombosis With or Without Symptomatic Pulmonary Embolism DVT Treatment Patient Body
Weight in
Pounds
175 IU/kg SC Once Daily
20,000 IU per mL
Patient Body
Weight in
Kilograms
Dose
(IU) Amount
(mL) 68-80 6,000 0.3 31-36 81-94 7,000 0.35 37-42 95-107 8,000 0.4 43-48 108-118 9,000 0.45 49-53 119-131 10,000 0.5 54-59 132-144 11,000 0.55 60-65 145-155 12,000 0.6 66-70 156-168 13,000 0.65 71-76 169-182 14,000 0.7 77-82 183-195 15,000 0.75 83-88 196-206 16,000 0.8 89-93 207-219 17,000 0.85 94-99 220-232 18,000 0.9 100-105 233-243 19,000 0.95 106-110 244-256 20,000 1 111-116 257-270 21,000 1.05 117-122 271-283 22,000 1.1 123-128 284-294 23,000 1.15 129-133 295-307 24,000 1.2 134-139 308-320 25,000 1.25 140-145 321-331 26,000 1.3 146-150 332-344 27,000 1.35 151-156 345-358 28,000 1.4 157-162To calculate the volume (mL) of an INNOHEP® 175 anti-Xa IU per kg SC dose for treatment of deep vein thrombosis:
Patient weight (kg) X 0.00875 mL/kg = volume to be administered (mL) subcutaneously AdministrationINNOHEP® is a clear, colorless to slightly yellow solution, and as with other parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
INNOHEP® is administered by SC injection. It must not be administered by intramuscular or intravenous injection.
Subcutaneous Injection Technique: Patients should be lying down (supine) or sitting and INNOHEP® administered by deep SC injection. Administration should be alternated between the left and right anterolateral and left and right posterolateral abdominal wall. The injection site should be varied daily. The whole length of the needle should be introduced into a skin fold held between the thumb and forefinger; the skin fold should be held throughout the injection. To minimize bruising, do not rub the injection site after completion of the injection.
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Leo Pharma Inc.
Innohep | Leo Pharma Inc.
All patients should be evaluated for bleeding disorders before administration of INNOHEP®. Since coagulation parameters are unsuitable for monitoring INNOHEP® activity, routine monitoring of coagulation parameters is not required (see PRECAUTIONS, Laboratory Tests).
Adult DosageThe recommended dose of INNOHEP® for the treatment of DVT with or without PE is 175 anti-Xa IU/kg of body weight, administered SC once daily for at least 6 days and until the patient is adequately anticoagulated with warfarin (INR at least 2.0 for two consecutive days). Warfarin sodium therapy should be initiated when appropriate (usually within 1-3 days of INNOHEP® initiation). Pregnancy has little or no influence on the pharmacokinetics of INNOHEP® and no dosing adjustment is needed for pregnancy.
As INNOHEP® may theoretically affect the PT/INR, patients receiving both INNOHEP® and warfarin should have blood for PT/INR determination drawn just prior to the next scheduled dose of INNOHEP®.
Table 8 provides INNOHEP® doses for the treatment of DVT with or without PE. It is necessary to calculate the appropriate INNOHEP® dose for patient weights not displayed in Table 8.
An appropriately calibrated syringe should be used to assure withdrawal of the correct volume of drug from INNOHEP® vials.
Table 8 INNOHEP® Weight-based Dosing for Treatment of Deep Vein Thrombosis With or Without Symptomatic Pulmonary Embolism DVT Treatment Patient Body
Weight in
Pounds
175 IU/kg SC Once Daily
20,000 IU per mL
Patient Body
Weight in
Kilograms
Dose
(IU) Amount
(mL) 68-80 6,000 0.3 31-36 81-94 7,000 0.35 37-42 95-107 8,000 0.4 43-48 108-118 9,000 0.45 49-53 119-131 10,000 0.5 54-59 132-144 11,000 0.55 60-65 145-155 12,000 0.6 66-70 156-168 13,000 0.65 71-76 169-182 14,000 0.7 77-82 183-195 15,000 0.75 83-88 196-206 16,000 0.8 89-93 207-219 17,000 0.85 94-99 220-232 18,000 0.9 100-105 233-243 19,000 0.95 106-110 244-256 20,000 1 111-116 257-270 21,000 1.05 117-122 271-283 22,000 1.1 123-128 284-294 23,000 1.15 129-133 295-307 24,000 1.2 134-139 308-320 25,000 1.25 140-145 321-331 26,000 1.3 146-150 332-344 27,000 1.35 151-156 345-358 28,000 1.4 157-162To calculate the volume (mL) of an INNOHEP® 175 anti-Xa IU per kg SC dose for treatment of deep vein thrombosis:
Patient weight (kg) X 0.00875 mL/kg = volume to be administered (mL) subcutaneously AdministrationINNOHEP® is a clear, colorless to slightly yellow solution, and as with other parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
INNOHEP® is administered by SC injection. It must not be administered by intramuscular or intravenous injection.
Subcutaneous Injection Technique: Patients should be lying down (supine) or sitting and INNOHEP® administered by deep SC injection. Administration should be alternated between the left and right anterolateral and left and right posterolateral abdominal wall. The injection site should be varied daily. The whole length of the needle should be introduced into a skin fold held between the thumb and forefinger; the skin fold should be held throughout the injection. To minimize bruising, do not rub the injection site after completion of the injection.
![Innohep (Tinzaparin Sodium) Injection, Solution [Leo Pharma Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1513b960-d9d1-11de-8a1e-0002a5d5c51b&name=innohep-05.jpg)
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