Danaparoid - Injection

Pronunciation: dah-NAP-uh-roid

Common Brand Name(s): Orgaran

Important: How To Use This Information

This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Warning

Tell your doctor you are using this medication before undergoing any procedure involving spinal puncture/anesthesia. Using this medication before or after these procedures has caused major bruising or bleeding (epidural or spinal hematoma) inside the body. This effect may cause an inability to move (paralysis), which may be permanent. Get medical help right away if you have any of these serious side effects: tingling, weakness, numbness, pain, or loss of control of your bladder or bowels.

This risk is increased when this medication is used with other "blood thinning" medications (e.g., aspirin, clopidogrel, warfarin), NSAIDs (e.g., ibuprofen, naproxen), or certain medication delivery devices (indwelling epidural catheters). Tell your doctor if you are taking any of these medications. Do not stop using any prescribed medication or device without first talking to your doctor.

Your doctor will monitor you closely while you are using this medication.

Uses

Danaparoid is used to prevent harmful blood clots, especially in patients who have had or are having a certain bad reaction to heparin (Heparin-Induced Thrombocytopenia-HIT). Preventing harmful blood clots helps to reduce the risk of a stroke or heart attack. This medication helps keep your blood flowing smoothly by lowering the activity of certain substances in the blood that cause clotting. Danaparoid is an anticoagulant (commonly called a "blood thinner").

Conditions that increase your risk of developing blood clots include certain types of surgeries (e.g., hip replacement or abdominal surgery) and long periods of being in one position (immobile). For some medical conditions, danaparoid may be used with other "blood thinners."

How To Use

This medication is given by injection under the skin (subcutaneously) by a health care professional, usually twice daily following surgery. It is important to change the injection site often to limit irritation. For some conditions, this medication may be injected directly into a vein by a health care professional. This drug should not be injected into a muscle. This medication should not be mixed with or added to any other medication in the same syringe. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

Dosage is based on your medical condition, body weight, kidney function, and response to treatment. Therapy with this drug may be continued for up to 14 days or until the risk of harmful blood clot formation is reduced. Follow your doctor's directions carefully.

If you are giving yourself injections at home, make sure you learn how to prepare and inject this medication properly. Select a different site for each injection. Ask your doctor, pharmacist, or nurse any questions you may have about how to give yourself danaparoid. Learn how to properly dispose of used syringes, needles, and any unused medication. Never reuse needles or syringes.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same times each day.

Use this medication exactly as prescribed by your doctor. Do not skip any doses. It is very important to continue using this medication even if you feel well. Do not stop using danaparoid without first talking with your doctor.

Side Effects

See also Warning section.

Nausea, constipation, fever, headache, weakness, or pain/redness/irritation at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication can cause bleeding if its effect is too strong. Tell your doctor right away if any of these unlikely but serious signs of bleeding occur:

  • unusual pain/swelling/discomfort
  • unusual/prolonged bleeding
  • unusual/easy bruising

Tell your doctor right away if any of these rare but very serious signs of bleeding occur:

  • dark urine
  • black stools
  • severe headache
  • confusion
  • vision changes
  • unusual dizziness
  • fainting
  • seizures
  • weakness
  • numbness

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including:

  • rash
  • itching/swelling (especially of the face/tongue/throat)
  • severe dizziness
  • trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using danaparoid, tell your doctor or pharmacist if you are allergic to it; or to heparins or pork products; or if you have any other allergies. This product may contain inactive ingredients (such as sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

  • artificial heart valves
  • bleeding/blood problems
  • certain eye problems (hemorrhagic or diabetic retinopathy)
  • high blood pressure
  • infection of the heart
  • kidney disease
  • liver disease
  • certain stomach/intestinal problems (e.g., current or recent ulcers)
  • stroke
  • recent spinal procedures/puncture/surgery
  • recent eye/ear/brain surgery
  • asthma

Limit alcohol while taking this drug because it may increase the risk of stomach bleeding.

Before having surgery, tell your doctor or dentist that you are using danaparoid.

This medication can rarely cause heavy bleeding. Be very careful to avoid injuries (for example, due to contact sports). Use an electric razor when shaving and a soft toothbrush when brushing your teeth.

The elderly may be at greater risk for bleeding while using this drug.

During pregnancy, danaparoid should be used only when clearly needed. Discuss the risks and benefits with your doctor. Pregnant women with artificial heart valves need close monitoring (see Notes).

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medication because a very serious interaction may occur:

  • mifepristone

If you are currently using this medication, tell your doctor or pharmacist before starting danaparoid.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of:

  • sulfinpyrazone

This medication is sometimes used with other drugs that have "blood-thinning" or anti-platelet effects such as acenocoumarol, aspirin, clopidogrel, or warfarin. When these combinations are prescribed by your doctor, you will require closer monitoring to lessen your risk of bleeding. Keep all medical and laboratory appointments.

Check all prescription and nonprescription medicine labels carefully since many contain pain relievers/fever reducers (NSAIDs such as ibuprofen, naproxen, aspirin) that can increase the risk of bleeding/anti-platelet effect when used with danaparoid. Low-dose aspirin should be continued if prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention or to prevent clotting of artificial heart valves (usually at dosages of 81-325 milligrams per day). Consult your doctor or pharmacist for more details.

This medication may interfere with certain laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: unusual bleeding and bruising.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (e.g., blood counts including hemoglobin, hematocrit and platelets, checking stool for blood, blood pressure) should be performed periodically to monitor your progress or check for side effects. Additional lab tests (anti-factor Xa blood levels) should be performed in certain cases, especially if you have severe kidney disease, if you are pregnant and have an artificial heart valve, or if the danaparoid does not appear to be working properly. Consult your doctor for more details.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Storage

Store between 36-86 degrees F (2-30 degrees C) away from light and moisture. Do not freeze. Do not store in the bathroom. Keep all medicines away from children and pets.

If mixed in the correct IV fluid, this medication should be used within 48 hours if it has been stored at room temperature. Otherwise, discard any unused medication.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Medical Alert

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Is it an emergency?

If you or someone in your care has chest pains, difficulty breathing, or severe bleeding, it could be a life-threatening emergency. Call 9-1-1 or the local emergency number immediately.
If you are concerned about a possible poisoning or exposure to a toxic substance, call Poison Control now at 1-800-567-8911.

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