Danaparoid (Subcutaneous)

Danaparoid is used to prevent deep venous thrombosis, which is when harmful blood clots form in the blood vessels of the legs. These blood clots can move to the lungs and block blood vessels there, leading to a condition called pulmonary embolism. Danaparoid is used for several days after hip replacement surgery, while you are unable to walk. This is when blood clots are most likely to develop. Danaparoid may also be used for other conditions as determined by your doctor.

Danaparoid was available only with your doctor's prescription.

Organon, Inc. stopped making Orgaran® (danaparoid) on August 14, 2002.

Tell all your medical doctors and dentists that you are using this medicine.

Check with your doctor right away if you notice any of the following side effects:

• Bruising or bleeding, especially bleeding that is difficult to stop. Bleeding inside the body may sometimes show up as bloody or black, tarry stools, or feeling faint.
• Back pain; burning, pricking, tickling, or tingling feelings; leg weakness; numbness; paralysis; or issues with bowel or bladder function.

In deciding to use a medicine, it is important to consider the risks of taking the medicine versus the benefits it may provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever experienced any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know 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

Research on this medicine has only been conducted in adults, and there is no specific information comparing the use of danaparoid in children to other age groups.

Geriatric

Many medicines have not been specifically studied in older adults. Therefore, it may not be known whether they work exactly the same way as they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing the use of danaparoid in the elderly to other age groups.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to adjust the dose, or other precautions may be needed. When you are taking this medicine, it is particularly important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been 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 may change some of the other medicines you are taking.

• 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 together, your doctor may change the dose or how often you take one or both of the medicines.

• Abciximab
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Alipogene Tiparvovec
• Alteplase, Recombinant
• Amtolmetin Guacil
• Anagrelide
• Anistreplase
• Apixaban
• Argatroban
• Aspirin
• Bemiparin
• Betrixaban
• Bivalirudin
• Bromfenac
• Bufexamac
• Cangrelor
• Caplacizumab-yhdp
• Celecoxib
• Chamomile
• Choline Salicylate
• Cilostazol
• Citalopram
• Clonixin
• Clopidogrel
• Collagenase, Clostridium histolyticum
• Curcumin
• Dabigatran Etexilate
• Dalteparin
• Desvenlafaxine
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyridamole
• Dipyrone
• Drotrecogin Alfa
• Droxicam
• Edoxaban
• Enoxaparin
• Epoprostenol
• Eptifibatide
• Escitalopram
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Garlic
• Ginkgo
• Heparin
• 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
• Papaya
• 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
• Selexipag
• Sertraline
• Sodium Salicylate
• St John's Wort
• Streptokinase
• Sulfinpyrazone
• Sulindac
• Tan-Shen
• Tenecteplase
• Tenoxicam
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tinzaparin
• Tirofiban
• Tolfenamic Acid
• Tolmetin
• Trazodone
• Treprostinil
• Turmeric
• Urokinase
• Valdecoxib
• Venlafaxine
• Vilazodone
• Vorapaxar
• Vortioxetine
• Warfarin

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both medicines may be necessary for your treatment. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Chondroitin
• Coenzyme Q10
• Dong Quai
• Ginger
• Vitamin A

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used at or around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may increase the risk of certain side effects but may be necessary in some cases. If used together, your doctor may change the dose or how often you use this medicine or provide special instructions about the use of food, alcohol, or tobacco.

• Avocado

Other Medical Problems

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

• Bleeding problems or
• Heart infection or
• High blood pressure (hypertension) or
• Kidney disease or
• Active stomach or intestinal ulcer or
• Stroke—The risk of bleeding may be increased.

Also, inform your doctor if you have previously received danaparoid and had a reaction called thrombocytopenia (a low platelet count in the blood), or if new blood clots formed while you were receiving the medicine.

Additionally, tell your doctor if you have recently had surgery. This may increase the risk of serious bleeding while you are taking danaparoid.

Along with its intended effects, a medicine can also cause some unwanted effects. Not all of these side effects may happen, but if they do, you might need medical attention.

Stop taking this medicine and get emergency help right away if any of the following effects occur:

Less common

• Bleeding gums
• Coughing up blood
• Difficulty in breathing or swallowing
• Dizziness
• Headache
• Increased menstrual flow or vaginal bleeding
• Nosebleeds
• Paralysis
• Prolonged bleeding from cuts
• Red or black, tarry stools
• Red or dark brown urine
• Shortness of breath
• Unexplained pain, swelling, or discomfort, especially in the chest, abdomen, joints, or muscles
• Unusual bruising
• Vomiting of blood or coffee ground–like material; weakness

Rare

• Back pain
• Burning, pricking, tickling, or tingling sensation
• Leg weakness
• Numbness
• Problems with bowel or bladder function

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

• Fever

Rare

• Skin rash

Some side effects may happen that usually do not require medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may help you find 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:

More common

• Pain at injection site

Less common

• Constipation
• Nausea

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.

• Orgaran

Pharmacologic Class: Low Molecular Weight Heparin

If you are using danaparoid at home, your health care professional will teach you how to inject yourself with the medicine. Be sure to follow the directions carefully. Check with your health care professional 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 health care professional.

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) and pulmonary embolism (lung clots): Adults—750 anti-factor Xa units, injected under the skin, two times a day for up to fourteen days after surgery. Children—Use and dose must be determined by your doctor.

Missed Dose

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.

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.