OCTAGAM 10% is indicated for the treatment of chronic immune thrombocytopenic purpura (cITP) in adults and dermatomyositis (DM) in adults. For patients with cITP, it is used to rapidly increase the platelet count in the blood to help control or prevent bleeding. For patients with DM, it helps improve muscle function and skin rash.
OCTAGAM 10% is a liquid medication that contains Immunoglobulin G (IgG). OCTAGAM 10% is made from human plasma donated by healthy people. OCTAGAM 10% is given through the vein (intravenously) in a hospital, infusion center, or at home.
IMPORTANT SAFETY INFORMATION
Do not use OCTAGAM 10% if you have had a severe allergic reaction to IgG or other blood products or have deficiencies of immunoglobulin A (IgA) with antibodies to IgA.
OCTAGAM 10% can cause the following:
Blood clots in your heart, brain, lungs or other areas of your body
Kidney problems, or kidney failure
Tell your healthcare provider (HCP) if you have an allergy to corn. OCTAGAM 10% contains a type of sugar that is made from corn.
OCTAGAM 10% can cause the following serious side effects. Contact your HCP if you experience the following:
Swelling in your mouth or throat, hives/itching, breathing problems, wheezing, fainting, tightness in your chest, or dizziness. This could be a serious allergic reaction.
Decreased urination, swelling in your legs, sudden weight gain, or breathing problems, which could mean kidney failure
Pain and/or swelling of an arm or leg with warmth in the affected area, discoloration of an arm or leg, unexplained shortness of breath, chest pain or discomfort that worsens with deep breathing, unexplained rapid pulse, or numbness or weakness on one side of the body; these could be signs of a blood clot.
Yellow skin or eyes, dark-colored urine, fatigue, or increased heart rate, which could be signs of a blood problem.
Headache, stiff neck, drowsiness, fever, sensitivity to light, painful eye movements, or nausea and vomiting, which could mean an inflammation of the membranes covering your brain or spinal cord
Trouble breathing, chest pain, blue lips, arms or legs, and fever, which could be related to a lung problem. This typically occurs 1 to 6 hours following infusion.
Common side effects include headache, fever, nausea, vomiting, increased blood pressure, chills, musculoskeletal pain, dyspnea, infusion site reactions, and increased heart rate.
If you use a blood glucose monitor, check with your HCP to ensure that your monitor and test strips are acceptable to use while you are receiving OCTAGAM 10%.
These are not all of the possible side effects with OCTAGAM 10%. Tell your HCPs about any side effects that you have that cause concern or don't go away.
Please click here for full Prescribing Information, including complete BOXED WARNING.
Patients should always ask their doctors for medical advice about adverse events.
You may report an adverse event related to Pfizer products by calling 1-800-438-1985 (US only). If you prefer, you may contact the US Food and Drug Administration (FDA) directly. The FDA has established a reporting service known as MedWatch where healthcare professionals and consumers can report problems they suspect may be associated with the drugs and medical devices they prescribe, dispense, or use. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.
OCTAGAM® is a registered trademark of Octapharma AG.
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