Advanced Consumer Information

tinzaparin (Subcutaneous route)

tin-za-PAR-in

Subcutaneous routeSolution

Spinal/Epidural Hematomas
- When neuraxial anesthesia (epidural/spinal anesthesia) or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with low molecular weight heparins or heparinoids for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis.
- The risk of these events is increased by the use of indwelling epidural catheters for administration of analgesia or by the concomitant use of drugs affecting hemostasis such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, or other anticoagulants. The risk also appears to be increased by traumatic or repeated epidural or spinal puncture.
- Patients should be frequently monitored for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.
- The physician should consider the potential benefit versus risk before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis .

When neuraxial anesthesia (epidural/spinal anesthesia) or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with low molecular weight heparins or heparinoids are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis. The risk of these events is increased by the use of indwelling epidural catheters, by the concomitant use of drugs affecting hemostasis such as NSAIDs, platelet inhibitors, or other anticoagulants, or by traumatic or repeated epidural or spinal puncture. Patients should be frequently monitored for signs and symptoms of neurological impairment .

Commonly used brand name(s):

In the U.S.

Innohep

Available Dosage Forms:

Solution

Therapeutic Class: Anticoagulant

Pharmacologic Class: Low Molecular Weight Heparin

Uses For tinzaparin

Tinzaparin is used for the prevention and/or treatment of deep venous thrombosis, a condition in which harmful blood clots form in the blood vessels of the legs. These blood clots can travel to the lungs and can become lodged in the blood vessels of the lungs, causing a condition called pulmonary embolism. Tinzaparin is used for several days after surgery, while you are unable to walk. It is during this time that blood clots are most likely to form. Tinzaparin also may be used for other conditions as determined by your doctor.

tinzaparin is available only with your doctor's prescription.

Before Using tinzaparin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For tinzaparin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to tinzaparin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of tinzaparin in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tinzaparin in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment of dose in patients receiving tinzaparin.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using tinzaparin with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abciximab
Aceclofenac
Acemetacin
Acenocoumarol
Alclofenac
Alteplase, Recombinant
Ancrod
Anisindione
Anistreplase
Antithrombin, Recombinant
Antithrombin III Human
Apazone
Ardeparin
Argatroban
Benoxaprofen
Bivalirudin
Bromfenac
Bufexamac
Carprofen
Certoparin
Citalopram
Clometacin
Clonixin
Clopidogrel
Dalteparin
Danaparoid
Defibrotide
Dermatan Sulfate
Desirudin
Dexketoprofen
Dextran
Diclofenac
Dicumarol
Diflunisal
Dipyrone
Droxicam
Duloxetine
Enoxaparin
Eptifibatide
Escitalopram
Etodolac
Etofenamate
Felbinac
Fenbufen
Fenoprofen
Fentiazac
Floctafenine
Flufenamic Acid
Fluoxetine
Flurbiprofen
Fluvoxamine
Fondaparinux
Heparin
Ibuprofen
Indomethacin
Indoprofen
Isoxicam
Ketoprofen
Ketorolac
Lamifiban
Lornoxicam
Meclofenamate
Mefenamic Acid
Meloxicam
Nabumetone
Nadroparin
Naproxen
Niflumic Acid
Nimesulide
Oxaprozin
Oxyphenbutazone
Parnaparin
Paroxetine
Pentosan Polysulfate Sodium
Phenindione
Phenprocoumon
Phenylbutazone
Pirazolac
Piroxicam
Pirprofen
Propyphenazone
Proquazone
Reteplase, Recombinant
Reviparin
Sertraline
Sibrafiban
Streptokinase
Sulindac
Suprofen
Tenecteplase
Tenidap
Tenoxicam
Tiaprofenic Acid
Ticlopidine
Tinzaparin
Tirofiban
Tolmetin
Urokinase
Warfarin
Xemilofiban
Zomepirac

Using tinzaparin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Aspirin
Benorilate
Choline Salicylate
Magnesium Salicylate
Mesalamine
Olsalazine
Salicylamide
Salicylic Acid
Salsalate
Sodium Salicylate
Sodium Thiosalicylate
Trolamine Salicylate

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of tinzaparin

A nurse or other trained health professional will give you tinzaparin. tinzaparin is given as a shot under your skin.

If you are using tinzaparin at home, your doctor will teach you how to inject yourself with the medicine. Be sure to follow the directions carefully. Check with your doctor if you have any problems using the medicine.

Put used syringes in a puncture-resistant, disposable container, or dispose of them as directed by your doctor.

Dosing

The dose of tinzaparin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of tinzaparin. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For injection dosage form:
- For prevention of deep venous thrombosis (leg clots) due to surgery:
  - Adults
  - General surgery—3500 International Units (IU) 2 hours before surgery then 3500 IU once daily for seven to ten days.
  - Hip surgery—50 International Units (IU) per kilogram (kg) of body weight 2 hours before surgery then 50 IU per kg of body weight once daily for seven to ten days, or 75 IU per kg of body weight given after surgery once daily for seven to ten days.
  - Knee surgery—75 International Units (IU) per kilogram (kg) of body weight given after surgery once daily for seven to ten days.
  - Children—Use and dose must be determined by your doctor.
- For treatment of deep venous thrombosis (leg clots) with or without pulmonary embolism (lung clots):
  - Adults—Dose is based on body weight and must be determined by your doctor. The recommended dose is 175 International Units (IU) per kilogram (kg) of body weight injected under the skin once a day for six to seven days.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using tinzaparin

It is very important that your doctor check your progress at regular visits to make sure tinzaparin is working properly. Blood tests will be needed to check for unwanted effects. Be sure to keep all appointments.

tinzaparin may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble breathing; or chest pain after you receive tinzaparin.

Make sure your doctor knows if you have had an allergic reaction to heparin, sulfites, benzyl alcohol, or pork products.

Tinzaparin may cause bleeding problems. This risk is higher if you have a catheter in your back for administering pain medicine or anesthesia (sometimes called an "epidural") or if you have kidney problems. The risk of bleeding increases as the severity of your kidney problems increases. Discuss this with your doctor if you are concerned.

You may bleed and bruise more easily while you are using tinzaparin. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers. Avoid nose picking and forceful nose blowing.

Check with your doctor right away if you notice any unusual bleeding or bruising; black, tarry stools; bleeding gums; blood in the urine or stools; or pinpoint red spots on your skin.

Make sure any doctor or dentist who treats you knows that you are using tinzaparin. You may need to stop using tinzaparin several days before having surgery.

Do not take or discontinue other medicines unless they have been discussed with your doctor. This includes prescription medicines, nonprescription (over-the-counter [OTC]) medicines, and herbal or vitamin supplements.

tinzaparin may cause severe side effects in babies.

tinzaparin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Deep, dark purple bruise, pain, or swelling at the place of injection

Less common

Bladder pain
bleeding gums
blood in urine
bloody or cloudy urine
blurred vision
chest pain
chest tightness
chills
confusion
cough
coughing up blood
difficulty in breathing or swallowing
dizziness
faintness, or lightheadedness when getting up from a lying or sitting position suddenly
fast, slow, or irregular heartbeat
fever
frequent urge to urinate
headache
increased menstrual flow or vaginal bleeding
lower back or side pain
nosebleeds
pain or burning while urinating
painful or difficult urination
pale skin
palpitations
paralysis
pounding in the ears
prolonged bleeding from cuts
red or dark brown urine
red or black, tarry stools
severe or continuing dull nervousness
shortness of breath
skin rash
sore throat
sores, ulcers, or white spots on the lips or in the mouth
sweating
swollen glands
troubled breathing, exertional
unexplained pain, swelling, or discomfort, especially in the chest, abdomen, joints, or muscles
unusual bleeding or bruising
unusual tiredness or weakness
vomiting of blood or coffee ground-like material

Rare

Blue-green to black skin discoloration
bowel or bladder dysfunction
hives
itching
leg weakness
numbness
pain, redness, or sloughing of the skin at the place of injection
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
wheezing

Incidence not known

Abdominal or stomach pain
accumulation of pus
break in the skin, especially associated with blue-black discoloration, swelling, or drainage of fluid
change in vision
clay-colored stools
collection of blood under the skin
diarrhea
excessive thirst
hoarseness
large, flat, blue or purplish patches in the skin
large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
loss of appetite
malaise
muscle cramps
numbness and tingling of face, fingers, or toes
pain in the arms, legs, or lower back, especially pain in the calves and/or heels upon exertion
pain, redness, or swelling
painful knees and ankles
pale, bluish-colored, or cold hands or feet
problems with vision or hearing
raised, red swellings on the skin, buttocks, legs or ankles
redness, tenderness, burning, blistering, or peeling of skin (usually on the backs of arms and the fronts of legs, mouth, eyes, hands or feet)
red or irritated eyes
seeing floating spots before the eyes
swollen, red, tender area of infection
unpleasant breath odor
weak or absent pulses in the legs
yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common or rare

Constipation
nausea and vomiting
prolonged, painful, or inappropriate erection of the penis
trouble in sleeping

Incidence not known

Hives or welts
redness of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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