Tinzaparin

Tinzaparin is used in the treatment of:

• Pulmonary Embolism
• Thromboembolism
• Venous Thrombosis

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Tinzaparin is usually given every day until your bleeding condition improves. Follow the directions on your prescription label.

Tinzaparin must not be used as a substitute for heparin. These two drugs are manufactured differently and have different dosages.

Tinzaparin is injected under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

You should be sitting or lying down during the injection. Do not inject tinzaparin into a muscle or a vein.

Use a different place on your stomach each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row.

Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use tinzaparin if it has changed colors or has particles in it. Call your pharmacist for new medication.

Use a disposable needle only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Tell any doctor who treats you that you are using tinzaparin. If you need surgery or dental work, tell the surgeon or dentist ahead of time that you are using this medication.

While using tinzaparin, your blood and your stool (bowel movement) may need to be tested often. Your nerve and muscle function may also need to be tested.

Store at room temperature away from moisture and heat.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Usual Adult Dose for Deep Vein Thrombosis:

175 anti-Xa intl units/kg subcutaneously once daily for at least 6 days and until the patient is adequately anticoagulated with warfarin.

All products:

• Tell all of your health care providers that you take tinzaparin. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• If you fall or hurt yourself, or if you hit your head, call your doctor right away. Talk with your doctor even if you feel fine.
• Use care if you weigh less than 100 pounds (45 kilograms).
• If you are 65 or older, use this medicine with care. You could have more side effects.
• This medicine is not approved for use in children. Talk with the doctor.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Multi-dose container:

• This medicine has benzyl alcohol in it. Benzyl alcohol may cause very bad and sometimes deadly side effects in newborns or infants. Talk with the doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking tinzaparin, call your doctor right away.

Prefilled syringes:

• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about tinzaparin, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about tinzaparin. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using tinzaparin.

Review Date: October 4, 2017

(tin ZA pa rin)

Tinzaparin is a low molecular weight heparin (average molecular weight ranges between 5,500 and 7,500 daltons, distributed as <2,000 daltons [<10%], 2,000 to 8,000 daltons [60% to 72%], and >8,000 daltons [22% to 36%]) that binds antithrombin III, enhancing the inhibition of several clotting factors, particularly factor Xa. Tinzaparin anti-Xa activity (70 to 120 units/mg) is greater than anti-IIa activity (~55 units/mg) and it has a higher ratio of antifactor Xa to antifactor IIa activity compared to unfractionated heparin. Low molecular weight heparins have a small effect on the activated partial thromboplastin time.

Absorption

Slow; absorption half-life ~3 hours after subcutaneous administration

Distribution

4 L

Metabolism

Does not undergo hepatic metabolism

Excretion

Urine

Time to Peak

4 to 6 hours

Hypersensitivity to tinzaparin sodium, heparin or other low molecular weight heparins (LMWH), or any component of the formulation; active bleeding from a local lesion such as an acute ulcer (eg, gastric, duodenal) or ulcerating carcinoma; history of confirmed or suspected immunologically-mediated heparin-induced thrombocytopenia (HIT) or positive in vitro platelet-aggregation test in the presence of tinzaparin; acute or subacute septic endocarditis; generalized hemorrhage tendency and other conditions involving increased risks of hemorrhage (eg, severe hepatic insufficiency, imminent abortion); hemophilia or major blood clotting disorders; acute cerebral insult or hemorrhagic cerebrovascular accidents without systemic emboli; uncontrolled severe hypertension; diabetic or hemorrhagic retinopathy; injury or surgery involving the brain, spinal cord, eyes or ears; spinal/epidural anesthesia in patients requiring treatment dosages of tinzaparin; use of multi-dose vials containing benzyl alcohol in children <3years of age, premature infants, and neonates

Note: Use of tinzaparin in patients with current HIT or HIT with thrombosis is not recommended and considered contraindicated due to high cross-reactivity to heparin-platelet factor-4 antibody (Guyatt [ACCP] 2012; Warkentin 1999).

As with all anticoagulants, bleeding is the major adverse effect of tinzaparin. Hemorrhage may occur at virtually any site. Risk is dependent on multiple variables.

>10%:

Hepatic: Increased serum ALT (≤13%)

Local: Hematoma at injection site

1% to 10%:

Cardiovascular: Chest pain (2%), angina pectoris (≥1%), cardiac arrhythmia (≥1%), coronary thrombosis (≥1%), myocardial infarction (≥1%), thromboembolism (≥1%)

Central nervous system: Headache (2%), pain (2%)

Dermatologic: Bullous rash (≥1%), erythematous rash (≥1%), maculopapular rash (≥1%), skin necrosis (≥1%)

Endrocrine & metabolic: Dependent edema (≥1%)

Gastrointestinal: Nausea (2%), abdominal pain (1%), constipation (1%), diarrhea (1%), vomiting (1%)

Genitourinary: Urinary tract infection (4%)

Hematologic & oncologic: Granulocytopenia (≥1%), hemorrhage (≥1%, including anorectal bleeding, gastrointestinal hemorrhage, hemarthrosis, hematemesis, hematuria, hemopericardium, injection site bleeding, melena, purpura, intra-abdominal bleeding, vaginal bleeding, wound hemorrhage; major: ≤3%, including intracranial, retroperitoneal, or bleeding into a major prosthetic joint), neoplasm (≥1%), thrombocytopenia (≥1%)

Hepatic: Increased serum AST (9%)

Hypersensitivity: Hypersensitivity reaction (≥1%)

Local: Cellulitis at injection site (≥1%)

Neuromuscular & skeletal: Back pain (2%)

Respiratory: Epistaxis (2%), dyspnea (1%)

Miscellaneous: Fever (2%)

<1% (Limited to important or life-threatening): Agranulocytosis, angioedema, anaphylactoid reaction, epidural hematoma (spinal), hemophthalmos, hemoptysis, hyperkalemia, increased gamma-glutamyl transferase, increased, lactate dehydrogenase, increased serum lipase, metabolic acidosis, osteoporosis, priapism, pruritus, skin rash, Stevens-Johnson syndrome, suppression of aldosterone synthesis, thrombocythemia, toxic epidermal necrolysis, urticaria

No specific renal dosing data are available; however, tinzaparin clearance is reduced in patients with renal dysfunction. Caution is advised when using tinzaparin in patients with severe renal dysfunction.