What is Fragmin?

QUICK LINKS

• Blackbox Warning
• Overview
• Proper Use
• Dosing
• Missed Dose
• Use & Storage
• Before Using
• Allergies
• Pediatric
• Geriatric
• Breast Feeding
• Drug Interactions
• Other Interactions
• Other Medical Problems
• Precautions

Blackbox WarningTOP

OverviewTOP

Dalteparin is used to prevent 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. This medicine prevents blood clots from forming in blood vessels of patients with unstable angina or heart attack. Dalteparin is also used for several days after abdominal surgery, hip replacement surgery, or while you are unable to walk. It is during this time that blood clots are most likely to form. Dalteparin is also used for extended treatment of blood clots (eg, pulmonary embolism or deep vein thrombosis) in patients with cancer.

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

Proper UseTOP

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, buttocks, or thighs).

If you are using dalteparin 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) or prefilled syringe 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.

DosingTOP

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 blood clots after unstable angina (chest pain) or non–Q-wave myocardial infarction (a type of heart attack):
    • Adults—120 international units per kilogram (kg) of body weight injected under the skin (but not more than 10,000 international units) given every 12 hours for 5 to 8 days. Unless your doctor recommends otherwise, aspirin should be given 75 to 165 milligrams (mg) daily.
    • Children—Use and dose must be determined by your doctor.
  • For prevention of deep venous thrombosis after abdominal surgery:
    • Adults—2,500 or 5,000 international units injected under the skin once a day, or 2,500 international units injected under the skin followed by 2,500 international units injected under the skin given 12 hours later and then 5,000 international units injected under the skin once a day for 5 to 10 days.
    • Children—Use and dose must be determined by your doctor.
  • For prevention of deep venous thrombosis after hip replacement surgery:
    • Adults—
      • If started the evening before surgery: 5,000 international units injected under the skin followed by 5,000 international units injected under the skin 4 to 8 hours after surgery, or, .
      • If started on the day of surgery: 2,500 international units injected under the skin 2 hours before surgery followed by 2,500 international units injected under the skin 4 to 8 hours after surgery, then 5,000 in international units injected under the skin once a day, or,
      • If started after surgery: 2,500 international units injected under the skin given 4 to 8 hours after surgery, then 5,000 international units injected under the skin once a day. 5 to 10 days after surgery.
    • Children—Use and dose must be determined by your doctor.
  • For prevention of deep venous thrombosis in medical patients:
    • Adults—5,000 international units injected under the skin once a day for 12 to 14 days.
    • Children—Use and dose must be determined by your doctor.
  • For prevention of deep venous thrombosis and pulmonary embolism in patients with cancer:
    • Adults—On the first month, 200 international units per kilogram (kg) of total body weight injected under the skin (but not more than 18,000 international units) once a day. On months 2 to 6, 150 international units per kg of body weight injected under the skin once a day.
    • Children—Use and dose must be determined by your doctor.

Missed DoseTOP

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Use & StorageTOP

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.

If you were given a bottle of medicine to use with your syringes, you must use the medicine within 14 days after the first shot. Throw away the unused medicine in the bottle after 14 days.

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

Before UsingTOP

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 this medicine, the following should be considered:

AllergiesTOP

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

PediatricTOP

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

GeriatricTOP

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dalteparin in the elderly. However, elderly patients may require an adjustment in the dose, especially those who are at risk of bleeding or those who have kidney disease.

Breast FeedingTOP

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.

Drug InteractionsTOP

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of 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 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
• Alipogene Tiparvovec
• Alteplase, Recombinant
• Amtolmetin Guacil
• Anagrelide
• Anistreplase
• Antithrombin, Recombinant
• Apixaban
• Argatroban
• Bemiparin
• Betrixaban
• Bivalirudin
• Bromfenac
• Bufexamac
• Celecoxib
• Choline Salicylate
• Citalopram
• Clonixin
• Clopidogrel
• Collagenase, Clostridium histolyticum
• Dabigatran Etexilate
• Danaparoid
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyridamole
• Dipyrone
• Drotrecogin Alfa
• Droxicam
• Edoxaban
• Enoxaparin
• Eptifibatide
• Escitalopram
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenofibrate
• Fenofibric Acid
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Heparin
• Ibrutinib
• Ibuprofen
• Ibuprofen Lysine
• Iloprost
• Indomethacin
• Ketoprofen
• Ketorolac
• Lepirudin
• Levomilnacipran
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nintedanib
• 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
• Sertraline
• Sodium Salicylate
• Streptokinase
• Sulfinpyrazone
• Sulindac
• Tenecteplase
• Tenoxicam
• Tiaprofenic Acid
• Ticlopidine
• Tinzaparin
• Tirofiban
• Tolfenamic Acid
• Tolmetin
• Treprostinil
• Urokinase
• Valdecoxib
• Venlafaxine
• Vilazodone
• Vorapaxar
• Vortioxetine
• Warfarin

Other InteractionsTOP

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical ProblemsTOP

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

• Allergy to pork or heparin or
• Bleeding, active or
• Regional anesthesia or
• Thrombocytopenia (low platelet count in the blood), heparin-induced, or history of—Should not be used in patients with these conditions.

• 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
• Kidney disease or
• Liver disease or
• Stomach or intestinal ulcer or bleeding, active or recent or
• Stroke or
• Surgery (eg, surgery of the eye, brain, or spine), recent or history of or
• Thrombocytopenia—Use with caution. The risk of bleeding may be increased.

PrecautionsTOP

It is very important that your doctor check your progress at regular visits to see if the medicine is working properly. Blood tests may be needed to check for unwanted effects. Be sure to keep all appointments.

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

This medicine may increase your chance of bleeding or bruising. This risk is higher if you have poorly controlled high blood pressure, a heart infection, ulcers of the stomach, or other bleeding problems. Check with your doctor right away if you notice any unusual bleeding or bruising, black, tarry stools, blood. in the urine or stools, or pinpoint red spots on your skin. Avoid picking your nose. If you need to blow your nose, blow it gently.

This medicine may increase your chance of serious bleeding or nerve problems in your spine. This risk is higher if you have a catheter in your back for pain medicine or anesthetics, or have an injection into your spine (sometimes called an "epidural" or "spinal"). Other things that increase this risk are traumatic or repeated epidural or spinal punctures in the past, spinal deformity, previous spinal surgery, or use of other medications that increase the risk of bleeding. Check with your doctor right away if you develop weakness or numbness in your legs or feet, or incontinence of urine or stools.

Call your doctor right away if you start having pain in chest, groin, or legs, especially the calves, difficulty with breathing, severe, sudden headache, slurred speech, sudden, unexplained shortness of breath, sudden loss of coordination, sudden, severe weakness or numbness in the arm or leg, or vision changes. These may be symptoms of thromboembolism.

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.

Be careful not to cut yourself when you are using sharp objects, such as a safety razor or fingernail or toenail cutters. Avoid contact sports or other situations where bruising or injury could occur.

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

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