Orgaran (Subcutaneous)

Danaparoid is used to prevent deep venous thrombosis, which is when harmful blood clots form in the blood vessels of the legs. These clots can move to the lungs and block blood vessels there, leading to a condition called pulmonary embolism. Danaparoid is given for several days after hip replacement surgery, while you are unable to walk. This is the time when blood clots are most likely to occur. Danaparoid may also be used for other conditions as decided 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. Internal bleeding may show up as bloody or black, tarry stools, or feelings of faintness.
• Back pain; burning, pricking, tickling, or tingling sensations; leg weakness; numbness; paralysis; or difficulties with bowel or bladder function.

In deciding to use a medicine, you and your doctor will weigh the risks of taking it against the benefits it may provide. Here are some important points to consider for this medicine:

Allergies

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

Pediatric

This medicine has only been studied in adults, and there is no specific information about how danaparoid works in children compared to other age groups.

Geriatric

Many medicines have not been specifically studied in older adults. Therefore, it may not be known if they work the same way as 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 with other age groups.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together, while others may be used together even if an interaction could happen. In these cases, your doctor may want to adjust the dose or take other precautions. It is especially important that your healthcare professional knows if you are taking any of the medicines listed below when you are using this medicine. The following interactions have been chosen based on their potential importance and are not necessarily all-inclusive.

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

• 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 raise the risk of certain side effects, but using both may be the best option for you. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both.

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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around mealtime or with certain foods due to possible interactions. Drinking alcohol or using tobacco with certain medicines may also lead to interactions. The following interactions have been highlighted based on their potential importance and are not necessarily all-inclusive.

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

• Avocado

Other Medical Problems

Other medical conditions may affect how this medicine is used. Be sure to inform your doctor if you have any other medical issues, 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, let your doctor know if you have recently had surgery, as this may increase the risk of serious bleeding while taking danaparoid.

Along with its intended effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

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

Less common

• Bleeding gums
• Coughing up blood
• Difficulty 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 blood or material that looks like coffee grounds; weakness

Rare

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

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

Less common

• Fever

Rare

• Skin rash

Some side effects may occur that usually do not require medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to suggest ways to prevent or lessen 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, consult 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.