Innohep (Subcutaneous)

Tinzaparin is used to treat deep venous thrombosis, which is when harmful blood clots form in the blood vessels of the legs. These blood clots can travel to the lungs and get stuck in the blood vessels there, leading to a condition called pulmonary embolism. Tinzaparin is used for several days after surgery when you cannot walk, as this is when blood clots are most likely to form. Tinzaparin may also be used for other conditions as decided by your doctor.

This medicine is available only with your doctor's prescription.

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

This medicine may cause a serious 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 this medicine.

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

Tinzaparin may increase your chance of bleeding or bruising. This risk is higher if you have a catheter in your back for 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. 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.

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

Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.

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

This medicine contains benzyl alcohol which may cause serious reactions in newborn or premature infants. Discuss this with your doctor if you are concerned.

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

In deciding to use a medicine, you and your doctor need to consider the risks and benefits. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on how tinzaparin affects children. Its safety and effectiveness are not established in this age group.

Geriatric

Studies have not shown any specific problems in older adults that would limit the usefulness of tinzaparin. However, older patients are more likely to have kidney problems related to age, which may require a dose adjustment for those taking tinzaparin.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction could occur. In such cases, your doctor may need to adjust the dose or take other precautions. It is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are selected based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Defibrotide

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

• Abciximab
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Alipogene Tiparvovec
• Alteplase, Recombinant
• Amtolmetin Guacil
• Anagrelide
• Anistreplase
• Antithrombin, Recombinant
• Apixaban
• Argatroban
• Aspirin
• Bemiparin
• Betrixaban
• Bivalirudin
• Bromfenac
• Bufexamac
• Caplacizumab-yhdp
• Celecoxib
• Choline Salicylate
• Citalopram
• Clonixin
• Clopidogrel
• Collagenase, Clostridium histolyticum
• Curcumin
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Desvenlafaxine
• Dexibuprofen
• Dexketoprofen
• Dextran
• Diclofenac
• Diflunisal
• Dipyridamole
• Dipyrone
• Drotrecogin Alfa
• Droxicam
• Edoxaban
• Enoxaparin
• Eptifibatide
• Escitalopram
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Ibrutinib
• Ibuprofen
• Ibuprofen Lysine
• Iloprost
• Indomethacin
• Inotersen
• Ketoprofen
• Ketorolac
• Lepirudin
• Levomilnacipran
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Milnacipran
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nintedanib
• Omadacycline
• Orlistat
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Paroxetine
• Pentosan Polysulfate Sodium
• Phenindione
• Phenprocoumon
• Phenylbutazone
• Piketoprofen
• Piracetam
• Piroxicam
• Prasugrel
• Proglumetacin
• Propionic Acid
• Propyphenazone
• Proquazone
• Reteplase, Recombinant
• Rivaroxaban
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sarecycline
• Sertraline
• Sodium Salicylate
• Streptokinase
• Sulfinpyrazone
• Sulindac
• Tenecteplase
• Tenoxicam
• Tiaprofenic Acid
• Ticlopidine
• Tirofiban
• Tolfenamic Acid
• Tolmetin
• Trazodone
• Treprostinil
• Turmeric
• Urokinase
• Valdecoxib
• Venlafaxine
• Vilazodone
• Vorapaxar
• Vortioxetine
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or certain types of food, as interactions may happen. Using alcohol or tobacco with some medicines may also lead to interactions. The following interactions are based on their potential significance and are not necessarily all-inclusive.

Other Medical Problems

Other medical issues may affect the use of this medicine. Make sure to tell your doctor if you have any other medical problems, especially:

• Major bleeding, active or
• Thrombocytopenia, heparin-induced (or history of)—Should not be used in patients with these conditions.

• Blood disease or bleeding problems or
• Catheter insertion in your spine or
• Eye problems caused by diabetes or high blood pressure or
• Heart infection or
• Hypertension (high blood pressure), severe and uncontrolled or
• Liver disease or
• Stomach or intestinal ulcer, active or history of or
• Stroke, recent or
• Surgery (e.g., surgery of the eye, brain, or spine), recent or history of or
• Thrombocytopenia—Use with caution. The risk of bleeding may be increased.

• Kidney disease—Effects of tinzaparin may be increased due to slower removal of the medicine from the body.

• Prosthetic heart valve—Tinzaparin may not protect these patients from developing a blood clot.

Along with its necessary effects, a medicine can cause some unwanted effects. Although not all of these side effects may occur, if they do, 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 injection site

Less common

• Bladder pain
• bleeding gums
• blood in the urine
• bloody or cloudy urine
• blurred vision
• chest pain
• chest tightness
• chills
• confusion
• cough
• coughing up blood
• difficulty breathing or swallowing
• dizziness, faintness, or lightheadedness when standing up suddenly from a lying or sitting position
• 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
• ringing in the ears
• prolonged bleeding from cuts
• red or black, tarry stools
• red or dark brown urine
• 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
• trouble breathing during exertion
• unexplained pain, swelling, or discomfort, especially in the chest, abdomen or stomach, joints, or muscles
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting blood or material like coffee grounds

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Innohep

Pharmacologic Class: Low Molecular Weight Heparin

A nurse or other trained health professional will give you this medicine. This medicine is given as a shot under your skin, usually in the abdomen.

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.

You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections.

If the medicine in the vial (glass container) has changed color, or if you see particles in it, do not use it.

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

Dosing

The dose of this medicine 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 this medicine. 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) given 2 hours before surgery then 3500 IU once a day for 7 to 10 days. Hip surgery—50 International Units (IU) per kilogram (kg) of body weight given 2 hours before surgery then 50 IU per kg of body weight once a day for 7 to 10 days, or 75 IU per kg of body weight given after surgery once a day for 7 to 10 days. Knee surgery—75 International Units (IU) per kilogram (kg) of body weight given after surgery once a day for 7 to 10 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 dose is usually 175 International Units (IU) per kilogram (kg) of body weight injected under the skin once a day for 6 to 7 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.