Prolastin-C intravenous

This medication is used to treat lung problems (emphysema) caused by a certain inherited disease (alpha-1-proteinase inhibitor deficiency). In people with this condition, lung damage is caused by elastase, a natural substance that the body needs to kill bacteria in the lungs. Normally, a protein (alpha-1-proteinase inhibitor) stops elastase from working when it is no longer needed. However, in people who do not make enough of this protein, elastase does not stop working and damages the lungs. This medication replaces the missing alpha-1-proteinase inhibitor and helps to prevent further lung damage.

How to use PROLASTIN C Vial

This medication is given by injection into a vein, usually once a week or as directed by your doctor.

If you are giving this medication at home, learn all preparation and usage instructions in the product package and from your health care professional. If any of the information is unclear, consult your doctor or pharmacist. If your brand of medication is stored in the refrigerator, allow the medication and mixing solution to warm to room temperature before mixing. Do not shake the mixed drug. Doing so may decrease the effectiveness of this medication.

Before using, check the product visually for particles or discoloration. Occasionally, a few small particles may remain in the vial. These particles will be removed by the filter provided with the medication. If the product is discolored, do not use the liquid.

Learn how to store and discard needles and medical supplies safely. Consult your pharmacist for details.

Dosage is based on your weight, medical condition and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, mark a reminder on a calendar and use it on the same day each week.

Tell your doctor if your condition worsens after several weeks.

Pain at the injection site, fever, dizziness, headache, drowsiness, numb/tingling skin, and muscle aches 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.

This medication is made from human blood. There is a very small chance that you may get infections from this medication (including viral infections such as hepatitis, parvovirus B19), even though careful screening of blood donors, special manufacturing processes, and many tests are all used to reduce this risk. Discuss the benefits and risks of treatment with your doctor. Tell your doctor right away if you develop any signs of hepatitis or other infection, including persistent fever, persistent sore throat, stuffy nose, unusual tiredness, unusual drowsiness, joint pain, persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin, dark urine.

A very serious allergic reaction to this drug is rare. However, stop receiving the drug and seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: hives, rash, itching/swelling (especially of the face/tongue/throat), chest tightness, 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.

Before using alpha-1-proteinase inhibitor, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, 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: selective IgA deficiency with antibodies to IgA, liver disease, heart problems (such as heart failure).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Since this medication is made from human blood, there is a very small chance that you may get infections from it (such as viral infections like hepatitis). It is recommended that you get the appropriate vaccinations (such as for hepatitis A and B) and that people giving this medication handle the medication with special caution to prevent virus infections. Consult your doctor for more details.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown whether this drug passes into breast milk. Consult your doctor before breast-feeding.

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor or pharmacist give you the best care, be sure to tell your doctor or pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Keep a list of all the products you use. Share the list with your doctor and pharmacist to reduce your risk for serious medication problems.

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.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as pulmonary function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule.

Storage

Different brands of this medication have differentstorage requirements. Ask your pharmacist how to store your brand. Do not freeze. After mixing this drug, do not refrigerate. Use the mixed drug within 3 hours. Discard any unused portion. Do not store in the bathroom. Keep all medicines away from children and pets.

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.Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.