Tinzaparin

What is Tinzaparin?

• Tinzaparin (Innohep) is a low molecular weight heparin, used for the treatment and prophylaxis of deep vein thrombosis (DVT) and pulmonary embolism (PE).
• 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.

Tinzaparin

Tinzaparin sodium ball-and-stick

What are the uses of this medicine?

• Tinzaparin (Innohep) is used 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.

How does this medicine work?

• Tinzaparin sodium is a low molecular weight heparin with antithrombotic properties.
• Tinzaparin sodium inhibits reactions that lead to the clotting of blood including the formation of fibrin clots, both in vitro and in vivo. It acts as a potent co-inhibitor of several activated coagulation factors, especially Factors Xa and IIa (thrombin).
• The primary inhibitory activity is mediated through the plasma protease inhibitor, antithrombin.
• Neither unfractionated heparin nor tinzaparin sodium have intrinsic fibrinolytic activity; therefore, they do not lyse existing clots. Tinzaparin sodium induces release of tissue factor pathway inhibitor, which may contribute to the antithrombotic effect.
• Heparin is also known to have a variety of actions that are independent of its anticoagulant effects.
• These include interactions with endothelial cell growth factors, inhibition of smooth muscle cell proliferation, activation of lipoprotein lipase, suppression of aldosterone secretion, and induction of platelet aggregation.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with active major bleeding.
• with (or history of) heparin-induced thrombocytopenia.
• with hypersensitivity to tinzaparin sodium.
• aged 90 years or older with creatinine clearance ≤ 60 mL/min.
• with known hypersensitivity to heparin, sulfites, benzyl alcohol, or pork products.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• oral anticoagulants
• platelet inhibitors (e.g., salicylates, dipyridamole, sulfinpyrazone, dextran, NSAIDs including ketorolac tromethamine, ticlopidine, and clopidogrel)
• thrombolytics

Is this medicine FDA approved?

• It has been approved by the U.S. Food and Drug Administration (FDA) for once daily treatment and prophylaxis of deep vein thrombosis (DVT) and pulmonary embolism (PE).

How should this medicine be used?

Recommended dosage: Adult Dosage:

• The 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).

To 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

Administration:

• Innohep is administered by SC injection.
• It must not be administered by intramuscular or intravenous injection.
• Innohep® 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.
• 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a sterile solution, containing tinzaparin sodium, a low molecular weight heparin. It is available in a multiple dose 2 mL vial.

This medicine is available in fallowing brand namesː

• Innohep

What side effects can this medication cause?

The most common side effects of this medicine include:

• Bleeding
• Urinary Tract Infection
• Pulmonary Embolism
• Chest Pain
• Epistaxis
• Headache
• Nausea
• Hemorrhage NOS
• Back Pain
• Fever
• Pain
• Constipation
• Rash
• Dyspnea
• Vomiting
• Hematuria
• Abdominal Pain
• Diarrhea
• Anemia

Less common, but serious side effects may include:

• Fatal or nonfatal hemorrhage
• paralysis; paresthesia; headache, chest, abdomen, joint, muscle or other pain; dizziness; shortness of breath, difficult breathing or swallowing; swelling; weakness; hypotension, shock, or coma
• Thrombocytopenia
• Elevations of Serum Aminotransferases
• Local Reactions
• Hypersensitivity

What special precautions should I follow?

• Innohep® is not intended for intramuscular or [[]]intravenous administration.
• Innohep® should not be used in patients with a history of heparin-induced thrombocytopenia
• Innohep®, like other anticoagulants, should be used with extreme caution in conditions with increased risk of hemorrhage.
• 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.
• Thrombocytopenia can occur with the administration of Innohep. Thrombocytopenia of any degree should be monitored closely. If the platelet count falls below 100,000/mm3, Innohep® should be discontinued.
• Innohep® contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening asthmatic episodes in certain susceptible people.
• Priapism has been reported from post-marketing surveillance as a rare occurrence. In some cases surgical intervention was required.
• 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." Innohep® preserved with benzyl alcohol should be used with caution in pregnant women only if clearly needed.
• Innohep® should not be mixed with other injections or infusions.
• Innohep® should be used with care in patients with a bleeding diathesis, uncontrolled arterial hypertension, or a history of recent gastrointestinal ulceration, diabetic retinopathy, and hemorrhage.
• Patients aged 90 years or older with creatinine clearance ≤ 60 mL/min should not be treated with Innohep.
• It is not known whether tinzaparin sodium is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Innohep® is administered to nursing women.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• hemorrhagic complications
• Nosebleeds
• blood in urine or tarry stools may be noted as the first signs of bleeding.
• Easy bruising
• petechial hemorrhages
• hematoma

• Symptoms of acute toxicity included hematoma formation and bleeding at the injection site, anemia, decreased motor activity, unsteady gait, piloerection, and ptosis.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Most patients who have bleeding complications while receiving Innohep® can be controlled by discontinuing Innohep®, applying pressure to the site, if possible, and replacing volume and hemostatic blood elements (e.g., red blood cells, fresh frozen plasma, platelets) as required.
• In the event that this is ineffective, protamine sulfate can be administered.
• In cases of serious bleeding or large overdose, protamine sulfate (1% solution) can be given by slow IV infusion at a dose of 1 mg protamine for every 100 anti-Xa IU of Innohep® given.
• Protamine does not completely neutralize tinzaparin sodium anti-Xa activity (maximum about 60%).
• Particular care should be taken to avoid overdosage with protamine sulfate.
• Administration of protamine sulfate can cause severe hypotensive and anaphylactoid reactions.
• Because fatal reactions have been reported with protamine sulfate, it should be given only when resuscitation facilities are readily available.
• For additional information consult the labeling of Protamine Sulfate Injection, USP, products.

Can this medicine be used in pregnancy?

• Category B.
• Innohep® is not predicted to increase the risk of developmental abnormalities.
• Pregnant women receiving tinzaparin should be carefully monitored for evidence of bleeding or excessive anticoagulation.
• Hemorrhage can occur at any site and may lead to death of mother and/or fetus.
• Pregnant women should be apprised of the potential hazard to the fetus and the mother if tinzaparin is administered during pregnancy.

Can this medicine be used in children?

• Safety and effectiveness of tinzaparin sodium in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• tinzaparin sodium

Inactive ingredients:

• sodium metabisulfate
• benzyl alcohol
• sodium hydroxide
• water

Who manufactures and distributes this medicine?

MANUFACTURED FOR:

• Celgene Corporation
• Boulder, CO

MANUFACTURED BY:

• LEO Pharmaceutical Products
• Ballerup, Denmark

• Innohep® is a registered trademark of LEO Pharmaceutical Products.

What should I know about storage and disposal of this medication?

• Store at 25° C (77° F); excursions permitted to 15°-30° C (59°-86° F).

• Dailymed label info on Tinzaparin
• FDA Tinzaparin

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