About OCTAGAM 10% 

How will I receive
OCTAGAM 10%?

Efficacy

Safety

OCTAGAM 10% is a liquid medicine given through a needle inserted into a vein, known as an intravenous (IV) infusion

Patients in the clinical study received their infusion over 2 to 5 days. Your infusion may be given either at an infusion clinic or in your own home and will usually be given every 4 weeks.

Getting ready for your infusion

Make sure to drink a lot of water the day before and the  day of your IVIg therapy, and avoid caffeine and alcohol
Have an activity available to help pass the time (eg, reading a book)
Your IVIg therapy will be given through a needle inserted into your vein
Your blood pressure and temperature will be checked during treatment

During and after your infusion

Your infusion time will vary and could take several hours 
You can continue with the regular activities of your day, as tolerated
Call your doctor, nurse, or pharmacist with any questions, or if you have side effects

Efficacy

OCTAGAM 10% is the first and only FDA-approved IVIg treatment for DM in adults

In a clinical study, 95 adults with DM were given OCTAGAM 10% or placebo.

Patients in both treatment groups could continue taking their other medications while they were part of the study.

This study looked at patient improvements in muscle strength, amount of visible rash, activity level, quality of life, and protein levels in muscles. 
 

OCTAGAM 10% was shown to help improve symptoms of DM

How was improvement measured?

There were 3 different categories that defined how much symptoms improved: minimal, moderate, and major.

All 3 improvement categories were measured after 16 weeks.

Safety

Most common drug-related side effects

In a clinical study, the following side effects were reported by >5% of the patients:

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INDICATIONS AND USAGE

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.

This site is intended only for U.S. residents. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only and is not intended to replace discussions with a healthcare provider.

Pfizer
PO Box 29309
Mission, KS 66201

Manufactured by Octapharma Pharmazeutika Produktionsges m.b.H. Distributed by
Octapharma USA Inc.

PP-OTG-USA-0269-01 

© 2023 Pfizer Inc. 

All rights reserved. 

December 2023
PP-OTG-USA-0269-01© 2023 Pfizer Inc. All rights reserved. December 2023

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INDICATIONS AND USAGE

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.