Generic Name: immune globulin (human) (i-MUNE GLOB-ue-lin)
Brand Name: Flebogamma DIF
Flebogamma DIF may increase the risk of serious and sometimes fatal kidney problems. The risk may be greater if you already have kidney problems. The risk may also be greater if you have diabetes, dehydration or low blood volume, a blood infection, or abnormal proteins in the blood. You may also be at increased risk if you are older than 65 years or if you take another medicine that may harm your kidneys. Contact your doctor right away if you experience decreased urination, lower back or flank pain, swelling or bloating, sudden weight gain, shortness of breath, or weakness.
Flebogamma DIF may increase the risk of blood clots. The risk may be increased in older patients, if you will be confined to a bed or chair for a period of time, if you take estrogen products, or if you have certain catheters. The risk may also be increased if you have a condition that may increase your risk of blood clots, thick blood, heart problems, or a history of blood clots. Blood clots can occur if you do not have any of these conditions. Tell your doctor right away if you develop one-sided numbness or weakness; pain, redness, tenderness, warmth or swelling in the arms or legs; change in color of an arm or leg; chest pain or discomfort; shortness of breath; fast heartbeat; or coughing up blood. Discuss any questions or concerns with your doctor.
Flebogamma DIF is used for:
Providing antibodies to help prevent infection in certain patients who have a weakened immune system. It may also be used for other conditions as determined by your doctor.
Flebogamma DIF is an immune globulin. It works to prevent infection by providing antibodies that fight infection.
Do NOT use Flebogamma DIF if:
- you are allergic to any ingredient in Flebogamma DIF or to immune globulin (human)
- you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to blood or products that are produced from blood
- you have immunoglobulin A (IgA) deficiency, unless your doctor tells you otherwise
Contact your doctor or health care provider right away if any of these apply to you.
Before using Flebogamma DIF:
Some medical conditions may interact with Flebogamma DIF. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have high levels of proline in your blood (hyperprolinemia)
- if you have recently received any vaccinations or will be receiving a live vaccine (eg, measles, mumps)
- if you have heart problems, blood vessel problems (eg, narrowed arteries), bleeding or blood clotting problems, thick blood, or a history of a stroke, a heart attack, or blood clots
- if you will be confined to a bed or chair for a long period of time
- if you have kidney problems, diabetes, dehydration or low blood volume, a blood infection, a weakened immune system, abnormal proteins or high protein levels in the blood, or asthma
- if you have a history of migraine headaches
Some MEDICINES MAY INTERACT with Flebogamma DIF. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, cyclosporine, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], tacrolimus, vancomycin) because the risk of kidney side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the kidney
- Hydantoins (eg, phenytoin) because unexpected hypersensitivity reactions may occur
- Live vaccines (eg, measles, mumps, and rubella) because their effectiveness may be decreased by Flebogamma DIF
This may not be a complete list of all interactions that may occur. Ask your health care provider if Flebogamma DIF may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Flebogamma DIF:
Use Flebogamma DIF as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Flebogamma DIF is usually given as an injection at your doctor's office, hospital, or clinic.
- Do not use Flebogamma DIF if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- Do not use Flebogamma DIF if it has ever been frozen.
- Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- If you miss a dose of Flebogamma DIF, contact your doctor right away.
Ask your health care provider any questions you may have about how to use Flebogamma DIF.
Important safety information:
- Flebogamma DIF may cause dizziness or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Flebogamma DIF with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Patients who receive Flebogamma DIF for the first time, who switch from another brand of immune globulin, or who have not received immune globulin therapy within the past 8 weeks may have a risk of developing fever, chills, nausea, or vomiting. Tell your doctor right away if you experience any of these side effects.
- Aseptic meningitis syndrome (AMS) has been reported to occur rarely in association with the use of Flebogamma DIF. This usually begins within several hours to 2 days following treatment. Symptoms include severe headache, neck stiffness, unusual drowsiness, fever, painful eye movements, sensitivity to light, nausea, and vomiting.
- You may need to wait for a period of time after you use Flebogamma DIF before you receive a live vaccine (eg, measles, mumps). Talk with your doctor before you receive any vaccine.
- Flebogamma DIF is made from human plasma. There is an extremely low risk of developing a viral infection or Creutzfeldt-Jakob disease (CJD) after using Flebogamma DIF. Discuss any questions or concerns with your doctor.
- Flebogamma DIF may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Flebogamma DIF.
- Lab tests, including kidney function, blood thickness, and antibody levels, may be performed while you use Flebogamma DIF. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Flebogamma DIF with caution in the ELDERLY; they may be more sensitive to its effects, especially kidney problems and blood clots.
- Use Flebogamma DIF with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: It is not known if Flebogamma DIF can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Flebogamma DIF while you are pregnant. It is not known if Flebogamma DIF is found in breast milk. If you are or will be breast-feeding while you are using Flebogamma DIF, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Flebogamma DIF:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Back pain; chills; cough; diarrhea; dizziness; ear pain; fatigue; flushing; headache; muscle cramps; nausea; pain, swelling, muscle stiffness, or redness at the injection site; sore throat; stuffy nose; weakness.
Severe allergic reactions (rash; itching; hives; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, hands, face, lips, eyes, throat, or tongue; unusual hoarseness); blue lips, hands, or feet; calf or leg pain, tenderness, or swelling; chest pain or tightness; confusion; coughing up blood; eye pain or sensitivity to light; fainting; fast or irregular heartbeat; fever; increased or painful urination; numbness of an arm or a leg; one-sided weakness; red, swollen, blistered, or peeling skin; seizures; severe headache, dizziness, or stomach pain; shortness of breath or trouble breathing; speech problems; symptoms of kidney problems (eg, decreased urination, lower back or flank pain, swelling or bloating, sudden weight gain); symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, nausea, stomach pain, loss of appetite, unusual tiredness); unusual bruising or bleeding; vision problems; wheezing.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.Proper storage of Flebogamma DIF:
Flebogamma DIF is usually handled and stored by a health care provider. If you are using Flebogamma DIF at home, store Flebogamma DIF as directed by your pharmacist or health care provider. Keep Flebogamma DIF out of the reach of children and away from pets.
- If you have any questions about Flebogamma DIF, please talk with your doctor, pharmacist, or other health care provider.
- Flebogamma DIF is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Flebogamma DIF or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Flebogamma DIF. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Flebogamma DIF. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Flebogamma DIF.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.