Drugs List

Therapeutic Indications

Uses

Deep vein thrombosis - treatment
Extended treatment of VTE in patients with active cancer
Pulmonary embolism - treatment

Unlicensed Uses

Treatment of VTE in pregnancy

Administration

For subcutaneous injection only.

Contraindications

Haemorrhage
Heparin treatment with concurrent locoregional anaesthesia
Neonates under 1 month
Recent trauma
Central nervous system trauma
Coagulopathy
Haemophilia
History of heparin-induced thrombocytopenia
Infective endocarditis
Ocular surgery
Ocular trauma
Peptic ulcer
Prosthetic heart valve with pregnancy
Recent central nervous system surgery
Recent cerebral haemorrhage
Severe hepatic impairment
Thrombocytopenia
Uncontrolled severe hypertension

Precautions and Warnings

Children 1 month to 18 years
Elderly
Predisposition to bleeding complications
Spinal/epidural anaesthesia
Breastfeeding
Chronic renal failure
Diabetes mellitus
Hyperkalaemia
Metabolic acidosis
Pregnancy
Prosthetic heart valve
Severe renal impairment

Not recommended for anticoagulation with prosthetic heart valves
Not all presentations are licensed for all indications
Contains sodium metabisulfite. Caution,may cause allergic reactions
Some presentations may contain benzyl alcohol
Avoid concurrent intramuscular injections - risk of haematoma
Do not use if any signs of precipitate or particulate matter apparent
Monitor platelets before starting and during treatment
Monitor for bleeding during treatment
Monitor patients undergoing spinal or epidural anaesthesia closely
Monitor plasma potassium in patients at risk of hyperkalaemia
Adrenal suppression may occur leading to hyperkalaemia
Discontinue if thrombocytopenia occurs
Spinal anaesthesia: tell patient-report symptoms of neurological impairment
Discontinue if severe skin reaction occurs
Not licensed for all indications in all age groups

Alternative treatment, such as surgery or thrombolysis, may be indicated in some patients with pulmonary embolism (e.g. those with severe haemodynamic instability).

In patients undergoing peridural or spinal anaesthesia or spinal puncture, the concurrent prophylactic use of heparin may be rarely associated with epidural or spinal haematoma resulting in prolonged or permanent paralysis. This risk is increased by the use of a peridural or spinal catheter for anaesthesia, by the concurrent use of drugs affecting haemostasis (such as NSAIDs, platelet inhibitors, or anticoagulants), and by traumatic or repeated puncture.

If neuraxial anaesthesia is anticipated, tinzaparin should be discontinued at least 24 hours prior to the procedure being performed. Tinzaparin may only be continued 4 to 6 hours after the use of spinal anaesthesia or after the catheter has been removed.

If anticoagulation therapy is administered with peridural or spinal anaesthesia, the patient should be closely monitored to detect any signs of neurological impairment, such as back pain, sensory and motor deficits, and bowel or bladder dysfunction. Patients should be advised to inform a nurse or physician immediately if signs of neurological impairment occur.

Pregnancy and Lactation

Pregnancy

Use tinzaparin with caution in pregnancy.

The manufacturer advises caution if tinzaparin is used during pregnancy. Tinzaparin does not cross the placenta and therefore cannot directly affect the embryo or foetus, through its effect on the mother. As such, available reports indicate no increased risk of teratogenic or developmental effects. Schaefer (2015) notes that low molecular weight heparins (LMWH) are preferred over unfractionated heparins in pregnant women due to their decreased risk of maternal osteoporosis, allergy, and heparin-induced thrombocytopenia.

Maternal death has been reported in pregnant women with prosthetic heart valves receiving full doses of tinzaparin and other LMWHs. Tinzaparin is therefore not recommended for use in pregnant women with prosthetic heart valves.

If spinal or epidural anaesthesia is anticipated, tinzaparin must be avoided. Epidural anaesthesia in pregnant women should always be delayed until at least 24 hours after administration of the last dose of tinzaparin. Prophylactic doses may be given with a minimum of 12 hours between the last administration of tinzaparin and the needle or catheter placement.

The multidose vial contains benzyl alcohol and therefore should not be used in pregnancy.

Lactation

Use tinzaparin with caution during breastfeeding.

The manufacturer advises caution during breastfeeding. The presence of tinzaparin in human breast milk is expected to be very low and therefore oral absorption of tinzaparin in the infant is very unlikely. Effects on exposed infants are unknown.

The multidose vial contains benzyl alcohol and therefore should not be used during breastfeeding.

Side Effects

Anaemia
Anaphylaxis
Angioedema
Bruising
Dermatitis
Ecchymosis
Elevated serum potassium
Haemorrhage
Headache
Hyperkalaemia
Hypersensitivity reactions
Hypoaldosteronism
Immunologically mediated thrombocytopenia
Increases in hepatic enzymes
Injection site reactions
Intraspinal haematoma
Osteoporosis
Priapism
Pruritus
Purpura
Rash
Skin necrosis
Stevens-Johnson syndrome
Thrombocytopenia
Thrombocytosis
Toxic skin reaction
Urticaria
Valve thrombosis in patients with prosthetic heart valves

Presentation

Injections of tinzaparin of high strength (20,000units/ml).

Drugs List

Therapeutic Indications

Uses

Deep vein thrombosis - treatment
Extended treatment of VTE in patients with active cancer
Pulmonary embolism - treatment

Unlicensed Uses

Treatment of VTE in pregnancy

Dosage

Adults

Children

Administration

For subcutaneous injection only.

Contraindications

Haemorrhage
Heparin treatment with concurrent locoregional anaesthesia
Neonates under 1 month
Recent trauma
Central nervous system trauma
Coagulopathy
Haemophilia
History of heparin-induced thrombocytopenia
Infective endocarditis
Ocular surgery
Ocular trauma
Peptic ulcer
Prosthetic heart valve with pregnancy
Recent central nervous system surgery
Recent cerebral haemorrhage
Severe hepatic impairment
Thrombocytopenia
Uncontrolled severe hypertension

Precautions and Warnings

Children 1 month to 18 years
Elderly
Predisposition to bleeding complications
Spinal/epidural anaesthesia
Breastfeeding
Chronic renal failure
Diabetes mellitus
Hyperkalaemia
Metabolic acidosis
Pregnancy
Prosthetic heart valve
Severe renal impairment

Not recommended for anticoagulation with prosthetic heart valves
Not all presentations are licensed for all indications
Contains sodium metabisulfite. Caution,may cause allergic reactions
Some presentations may contain benzyl alcohol
Avoid concurrent intramuscular injections - risk of haematoma
Do not use if any signs of precipitate or particulate matter apparent
Monitor platelets before starting and during treatment
Monitor for bleeding during treatment
Monitor patients undergoing spinal or epidural anaesthesia closely
Monitor plasma potassium in patients at risk of hyperkalaemia
Adrenal suppression may occur leading to hyperkalaemia
Discontinue if thrombocytopenia occurs
Spinal anaesthesia: tell patient-report symptoms of neurological impairment
Discontinue if severe skin reaction occurs
Not licensed for all indications in all age groups

Alternative treatment, such as surgery or thrombolysis, may be indicated in some patients with pulmonary embolism (e.g. those with severe haemodynamic instability).

In patients undergoing peridural or spinal anaesthesia or spinal puncture, the concurrent prophylactic use of heparin may be rarely associated with epidural or spinal haematoma resulting in prolonged or permanent paralysis. This risk is increased by the use of a peridural or spinal catheter for anaesthesia, by the concurrent use of drugs affecting haemostasis (such as NSAIDs, platelet inhibitors, or anticoagulants), and by traumatic or repeated puncture.

If neuraxial anaesthesia is anticipated, tinzaparin should be discontinued at least 24 hours prior to the procedure being performed. Tinzaparin may only be continued 4 to 6 hours after the use of spinal anaesthesia or after the catheter has been removed.

If anticoagulation therapy is administered with peridural or spinal anaesthesia, the patient should be closely monitored to detect any signs of neurological impairment, such as back pain, sensory and motor deficits, and bowel or bladder dysfunction. Patients should be advised to inform a nurse or physician immediately if signs of neurological impairment occur.

Pregnancy and Lactation

Pregnancy

Use tinzaparin with caution in pregnancy.

The manufacturer advises caution if tinzaparin is used during pregnancy. Tinzaparin does not cross the placenta and therefore cannot directly affect the embryo or foetus, through its effect on the mother. As such, available reports indicate no increased risk of teratogenic or developmental effects. Schaefer (2015) notes that low molecular weight heparins (LMWH) are preferred over unfractionated heparins in pregnant women due to their decreased risk of maternal osteoporosis, allergy, and heparin-induced thrombocytopenia.

Maternal death has been reported in pregnant women with prosthetic heart valves receiving full doses of tinzaparin and other LMWHs. Tinzaparin is therefore not recommended for use in pregnant women with prosthetic heart valves.

If spinal or epidural anaesthesia is anticipated, tinzaparin must be avoided. Epidural anaesthesia in pregnant women should always be delayed until at least 24 hours after administration of the last dose of tinzaparin. Prophylactic doses may be given with a minimum of 12 hours between the last administration of tinzaparin and the needle or catheter placement.

The multidose vial contains benzyl alcohol and therefore should not be used in pregnancy.

Lactation

Use tinzaparin with caution during breastfeeding.

The manufacturer advises caution during breastfeeding. The presence of tinzaparin in human breast milk is expected to be very low and therefore oral absorption of tinzaparin in the infant is very unlikely. Effects on exposed infants are unknown.

The multidose vial contains benzyl alcohol and therefore should not be used during breastfeeding.

Side Effects

Anaemia
Anaphylaxis
Angioedema
Bruising
Dermatitis
Ecchymosis
Elevated serum potassium
Haemorrhage
Headache
Hyperkalaemia
Hypersensitivity reactions
Hypoaldosteronism
Immunologically mediated thrombocytopenia
Increases in hepatic enzymes
Injection site reactions
Intraspinal haematoma
Osteoporosis
Priapism
Pruritus
Purpura
Rash
Skin necrosis
Stevens-Johnson syndrome
Thrombocytopenia
Thrombocytosis
Toxic skin reaction
Urticaria
Valve thrombosis in patients with prosthetic heart valves

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: January 2015

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Summary of Product Characteristics: Innohep 20,000 iu/ml. Leo Laboratories Ltd. Revised September 2017.
Summary of Product Characteristics: Innohep syringe 20,000 iu/ml. Leo Laboratories Ltd. Revised September 2017.
Summary of Product Characteristics: Tinzaparin sodium Syringe 20,000 IU/ml Solution for injection in pre-filled syringe. Revised January 2022.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 18 October 2017