Adult Dosing

DVT with or without PE

• 175 anti-Xa IU/kg SC q24 hrs x 6 days and until the patient is adequately anticoagulated with warfarin (INR at least 2.0 for 2 consecutive days)
• Initiate warfarin therapy when appropriate (usually within 1-3 days of tinzaparin initiation)

• Evaluate all patients for bleeding disorders before administration of therapy
• Determine PT/INR just prior to the next scheduled dose of tinzaparin
• Administer by subcutaneous injection; do not administer by IM or IV injection
• Place the patient in supine or sitting position before administration
• Alternate injection site between the left and right anterolateral and left and right posterolateral abdominal wall
• Hold the skin fold between the thumb and forefinger, and introduce the whole length of the needle between it (the skin fold should be held throughout the injection)
• To minimize bruising, do not rub the injection site after completion of the injection

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of acute symptomatic deep vein thrombosis (DVT) with or without pulmonary embolism when administered with warfarin

• Hypersensitivity to any of the ingredients of the product
• Active major bleeding
• Patients with (or history of) heparin-induced thrombocytopenia
• Hypersensitivity to heparin, sulfites, benzyl alcohol, or pork products
• IM or IV administration
• Spinal or epidural anesthesia
• Thrombocytopenia
• Patients with recent lumbar puncture or indwelling epidural catheters

• Patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture are at risk of epidural or spinal hematomas, which may result in long-term or permanent paralysis. Consider these risks before scheduling patients for spinal procedures
• Factors which can increase the risk of hematomas (epidural/spinal) in such patients include: Use of indwelling epidural catheters, concomitant use of drugs that affect hemostasis (NSAIDs, platelet inhibitors, other anticoagulants), history of traumatic or repeated epidural or spinal punctures, or history of spinal deformity or spinal surgery
• Consider frequent monitoring of patients for signs and symptoms of neurological impairment; institute urgent treatment if neurological compromise is noted
• Evaluate benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis

Renal Dose Adjustment

• Severe renal impairment: Dose adjustments not defined; caution advised
• Consider alternative treatment in elderly patients with renal impairment

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Not indicated for intramuscular or intravenous administration
• Do not use interchangeably with heparin or other low molecular weight heparins
• Use in patients with a history of heparin-induced thrombocytopenia is contraindicated
• Consider alternative treatment in elderly patients with renal insufficiency, as tinzaparin increases the risk of death in these patients
• Tinzaparin may cause mild to fatal hemorrhage resulting in death or permanent disability. Hence, use cautiously in conditions with increased risk of hemorrhage. Consider a hemorrhagic event in the presence of an unexplained fall in hematocrit, hemoglobin, or blood pressure and immediately discontinue the drug if severe hemorrhage occurs
• Use of low molecular weight heparins or heparinoids and spinal/epidural anesthesia or spinal puncture may cause spinal or epidural hematomas, which can result in long-term or permanent paralysis. Use of post-operative indwelling epidural catheters or concomitant use of additional drugs affecting hemostasis such as NSAIDs can increase the risk of these events. Monitor such patients for signs and symptoms of neurological impairment and treat urgently if needed. Also, consider benefits and risks before neuraxial intervention in patients anticoagulated or planned to be anticoagulated for thromboprophylaxis [US Black Box Warning]
• The sulfite content of tinzaparin product may cause anaphylactic symptoms and life-threatening asthmatic episodes in certain susceptible people. Sulfite sensitivity is more frequent in asthmatic people than in non-asthmatics
• Thrombocytopenia have been reported with this therapy; it is advisable to discontinue the drug when the platelet count falls below 100,000/mm³
• Monitor periodic complete blood counts including platelet count and hematocrit or hemoglobin, and stool tests for occult blood during tinzaparin therapy
• Do not mix with other injections or infusions

Cautions: Use cautiously in

• Severe renal impairment
• Elderly patients with renal impairment
• Bleeding risk
• Recent major surgery
• History of GI bleeding
• History of recent trauma
• Bacterial endocarditis
• Uncontrolled HTN
• Hemorrhagic stroke
• Diabetic retinopathy
• Concurrent platelet inhibitors
• Congenital or acquired bleeding disorders
• Hepatic failure
• Amyloidosis
• Hemorrhagic stroke
• History of recent GI ulceration
• Active ulcerative and angiodysplastic GI disease

Pregnancy Category:B

Breastfeeding: Low molecular weight heparins are not excreted into breastmilk in significant amounts. Because no data are available on tinzaparin use during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 30 Aug 2011). As per manufacturer's data, it is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution is advised when administered to nursing women.

• CNS: Headahe, epidural/spinal hematoma, dizziness
• CV: Chest pain, arrhythmias, MI, thromboembolism, hypotension, hypertension, angina pectoris
• RESP: Pulmonary embolism, dyspnea
• HEMA: Hemorrhage, thrombocytopenia, anemia, granulocytopenia, thrombocythemia, pancytopenia, agranulocytosis
• EENT: Epistaxis
• GI: Nausea, constipation, vomiting, abdominal pain, diarrhea, dyspepsia, flatulence, melena, cholestatic hepatitis
• LAB TESTS: Increased AST, ALT
• LOCAL: Irritation, pain, hematoma, ecchymosis, cellulitis
• HYPERSENSITIVITY: Anaphylactic/anaphylactoid reactions, angioedema
• GU: UTI, hematuria, priapism
• REPRODUCTIVE: Congenital anomalies, fetal distress, fetal death
• DERM: Rash, skin necrosis, pruritus, bullous eruption
• MUSC: Back pain
• MISC: Fever, pain

• Anticoagulant; low molecular weight heparin with antithrombotic properties; binds to the plasma protein antithrombin III, forming a complex and accelerates the inhibition of several activated coagulation factors, especially Factors Xa and IIa (thrombin)
• Partially metabolized by desulphation and depolymerization
• Excretion: Primarily through renal route
• Half-life: 3-4 hrs

US Trade Name(s)

• Innohep (Discontinued)

US Availability

Innohep

• INJ: 20,000 IU/mL (2 mL vial)

Canadian Trade Name(s)

• Innohep

Canadian Availability

Innohep

• INJ: 10,000 IU/mL (0.25 mL prefilled syringes; 0.35 and 0.45 mL safety syringes; 2 mL vial)
• INJ: 20,000 IU/mL (0.5, 0.7, and 0.9 mL prefilled safety syringes; 2 mL vial)

UK Trade Name(s)

• Innohep

UK Availability

Innohep

• INJ: 10,000 IU/mL (2mL vial; 0.25, 0.35, 0.45 mL prefilled syringes)
• INJ: 20,000 IU/mL (2mL vial; 0.5, 0.7, 0.9 mL prefilled syringes)

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Hematology/Oncology

Anticoagulants

Heparins

Cardiovascular

Anticoagulants

Heparins