Octagam

This medication is used to strengthen the body's natural defense system (immune system) to lower the risk of infection in persons with a weakened immune system. This medication is made from healthy human blood that has a high level of certain defensive substances (antibodies), which help fight infections. It is also used to increase the blood count (platelets) in persons with a certain blood disorder (idiopathic thrombocytopenia purpura-ITP). Platelets are needed to stop bleeding and form blood clots.

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule.

This medication is given by slow infusion into a vein by a health care professional. Your health care professional will start the medication slowly while monitoring you closely. If you have few or no side effects, the medication will be given faster. Tell your health care professional immediately if you experience any side effects such as flushing, chills, muscle cramps, back/joint pain, fever, nausea, vomiting, or shortness of breath. The infusion may need to be stopped or given more slowly. The dosage and frequency depends on your medical condition, weight, and response to treatment. For immune system problems, this medication is usually given once every 3 to 4 weeks. It may help to mark your calendar with a reminder. For blood problems (ITP), this medication may be given daily for 1 to 5 days the first time, with maintenance doses usually given one at a time based on your platelet count. Use this medication regularly in order to get the most benefit from it. Keep all your medical/lab appointments.

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. Some products that may interact with this drug include: drugs that may harm the kidneys (e.g., aminoglycosides such as gentamicin), "water pills" (diuretics such as furosemide). This medication may interfere with certain tests (including certain blood sugar tests, blood type), possibly causing false test results. This can lead to serious (possibly fatal) consequences. Tell all laboratory personnel and all your doctors and pharmacists that you use this medication, and which type of blood sugar testing strips you use.

Laboratory and/or medical tests (e.g., complete blood count, kidney/liver function tests, urine volume) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

Before using this medication, tell your doctor or pharmacist if you have had a bad or allergic reaction to it; or to other immunoglobulin products (e.g., CMV IgG); 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 flow problems (e.g., blood clots, coronary artery disease, heart attack, heart failure, stroke), certain immune system problems (immunoglobulin A deficiency, monoclonal gammopathies), diabetes, high blood pressure, high blood fats (triglycerides), migraines, current blood infection (sepsis), kidney disease, severe loss of body fluids (dehydration), long periods of bed rest or inability to move around. Some immune globulin products are made with maltose. This substance can cause false high blood sugar levels when your blood sugar is normal or even low. If you have diabetes, check with your pharmacist whether the product you are using contains maltose and whether your blood sugar testing supplies will work with this product. Rarely, serious problems have occurred when too much insulin was given because of false high sugar readings or when low blood sugar went untreated. Tell your doctor of any recent/planned vaccinations. This medication may prevent a good response to live viral vaccines (e.g., measles, mumps, German measles). If you are vaccinated less than 14 days before receiving this medication or during the 11 months after receiving this medication, you may need to be vaccinated again or tested to see whether the vaccine was effective. Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially the effects on the kidneys. 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.

Not applicable. This medication is given in a clinic and will not be stored at home.

Flushing, headache, dizziness, chills, muscle cramps, back/joint pain, fever, nausea, or vomiting may occur. Tell your doctor or other health care professional immediately if any of these effects occur, persist, or worsen. Pain, redness, and swelling at the injection site may also occur. If these effects continue or become bothersome, tell your doctor. 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. Tell your doctor right away if you have any serious side effects, including: easy bleeding/bruising, fainting, fast/irregular heartbeat, unusual tiredness. This medication may rarely cause serious problems from blood clots (e.g., pulmonary embolism, stroke, heart attack). Get medical help right away if any of these side effects occur: sudden shortness of breath, chest/jaw/left arm pain, confusion, coughing up blood, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, tingling/weakness/numbness in the arms/legs, sudden/severe headaches, slurred speech, weakness on one side of the body, vision problems/changes. Rarely, this product may contain substances that could cause infections because it is made from human blood. Though the risk is very low due to careful screening of blood donors, discuss the risks and benefits with your doctor. Tell your doctor immediately if you develop any signs of infection such as persistent sore throat/fever, yellowing eyes/skin, or dark urine. 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, high fever, sensitivity to light, eye pain, or severe nausea/vomiting. Lung problems may rarely occur 1 to 6 hours after your treatment. You will be monitored closely for any lung problems after your treatment. 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. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

This medication may cause serious (rarely fatal) kidney problems. The risk is higher in those who 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 in those who are older than 65 years or are taking other drugs that may harm the kidneys (e.g., gentamicin). Receiving this medication more slowly or using a less concentrated form of this drug may decrease the risk. Tell your doctor immediately if you notice shortness of breath, sudden weight gain, swelling of the hands/ankles/feet, a change in the amount/color of urine, or foamy/frothy urine.