Gammaked 10 gram/100 mL (10 %) injection solution

Generic name:
Immune globulin - intravenous/subcutaneous injection

Pronunciation
(i-MUNE GLOB-ue-lin)

Brand name(s)
Gammagard , Gamunex-C

This medication may cause serious (rarely fatal) kidney problems. This risk is higher if you have kidney problems, diabetes, a serious blood infection (sepsis), a certain blood problem (paraproteinemia), or a severe loss of body fluids (dehydration), as well as if you are older than 65 years or are using other drugs that may harm the kidneys (such as gentamicin).

This medication may also rarely cause serious problems from blood clots (such as heart attack, stroke, blood clots in the lungs or legs). You may be at increased risk for blood clots if you are an older adult, are severely dehydrated, have a catheter in a vein close to your heart for administering medications, or have a history of blood clots, heart/blood vessel disease, heart failure, stroke, or if you are immobile (such as very long plane flights or bedridden). If you use estrogen-containing products, these may also increase your risk.

Before using this medication, discuss the risks and benefits and if you have any of these conditions, report them to your doctor or pharmacist. The risk of kidney problems and blood clots may be decreased by infusing this medication more slowly or by using a less concentrated form of this medication if available. Being adequately hydrated before receiving this medication may also help reduce these risks.

Get medical help right away if any of these side effects occur: sudden weight gain, swelling of the hands/ankles/feet, a change in the amount of urine, shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, sudden dizziness/fainting, pain/swelling/warmth in the arm/leg, sudden/severe headache, trouble speaking, weakness on one side of the body, sudden vision changes, or confusion.

This medication is used in people with a certain type of weakened immune system (primary immune deficiency) to strengthen it and to lower the risk of infection. This medication is made from human blood that has a high level of antibodies which help fight infections.

This product is also used to increase the number of certain blood cells (platelets) in people with a certain blood disorder (idiopathic thrombocytopenic purpura-ITP). Platelets are needed to stop bleeding and to form normal blood clots.

In addition, this medication is used to treat a certain nerve disorder (chronic inflammatory demyelinating polyneuropathy-CIDP). This disorder causes weakness and numbness/tingling/pain in the arms and legs. This medication helps to improve these symptoms and prevents relapse.

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is usually given by slow injection (infusion) into a vein by a health care professional. The dosage is based on your medical condition, weight, and response to treatment.

If you have primary immune deficiency and respond well to this medication, your doctor may allow you to give this treatment at home. In this case, give this medication by infusion under the skin as directed by your doctor, usually once a week.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package. Let the medication vials come to room temperature before preparing the infusion. Do not shake the vials. Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site(s) each time to lessen injury under the skin. To lessen bruising, do not rub the injection site after each dose. Learn how to store and discard medical supplies safely.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

See also Warning section.

Headache, dizziness, fever, chills, back/joint pain, nausea, vomiting, cough, or pain/redness/swelling at the injection site may occur. If any of these effects last or get worse, tell your doctor or health care professional promptly.

Remember that this medication has been prescribed because your doctor 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.

Tell your doctor right away if you have any serious side effects, including:

• fast heartbeat
• unusual tiredness

Treatment with this medication may rarely cause a serious inflammation of the brain (aseptic meningitis syndrome) several hours to 2 days after your treatment. Get medical help right away if you develop severe headache, stiff neck, drowsiness, fever, sensitivity to light, eye pain, or nausea/vomiting.

Lung problems may rarely occur 1 to 6 hours after your treatment. Get medical help right away if you develop trouble breathing, chest pain, blue lips/skin, or fever.

A very serious allergic reaction to this drug is rare. However, get medical help right away 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.

See also Warning section.

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other immune globulin products; 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:

• blood clotting problems
• immunoglobulin A deficiency
• kidney disease

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor of any recent or planned immunizations/vaccinations. This medication may prevent a good response to certain live viral vaccines (such as measles, mumps, rubella, varicella). If you have recently received any of these vaccines, your doctor may have you tested for a response or have you vaccinated again later. If you plan on getting any of these vaccines, your doctor will instruct you about the best time to receive them so you get a good response. Also tell your doctor if you plan to travel to areas that have a measles outbreak or if you have been exposed to measles.

This medication is made from human blood. Even though the blood is carefully tested, and this medication goes through a special manufacturing process, there is an extremely small chance that you may get infections from the medication (for example, viruses such as hepatitis). Consult your doctor or pharmacist for more information.

Children may be more sensitive to the side effects of this medication, especially fever and vomiting.

Older adults may be more sensitive to the side effects of the drug, especially kidney problems.

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

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

See also Warning and Precautions sections.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medication may interfere with certain lab tests (such as blood type), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

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 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as complete blood counts, blood tests, immunoglobulin levels, kidney/liver function, urine volume) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Store in the refrigerator. Do not freeze. Refer to the manufacturer's instructions or your pharmacist for other storage details. Discard any unused portion of an opened vial. Keep all medications 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.

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.