Yimmugo

Pronunciation: Yim-mew-go
Generic name: immune globulin intravenous, human-dira
Dosage form: intravenous solution
Drug class: Immune globulins

Medically reviewed by Carmen Pope, BPharm. Last updated on Jun 19, 2024.

What is Yimmugo?

Yimmugo (immune globulin intravenous, human-dira) is an immune globulin 10% liquid given by intravenous (into a vein) infusion that may be used to treat primary humoral immunodeficiency (PI) in adults and children 2 years of age or older.

Yimmugo is a polyvalent immunoglobulin G preparation made from human blood that provides a broad range of immune globulin G (IgG) antibodies against a wide variety of pathogens and toxins, which can help a person with PI avoid recurrent, severe, infections. The exact way Yimmugo works is not fully understood but may include immunomodulatory effects. and may contain infectious agents such as viruses, the variant Creutzfeldt-Jakob disease [vCJD] agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Primary humoral immunodeficiency (PI) is a group of disorders characterized by an impaired ability to produce antibodies, which leads to an increased susceptibility to infection, especially bacterial infections affecting the respiratory and gastrointestinal tracts.

Yimmugo was FDA-approved on 13 June 2024.

Yimmugo side effects

The most common side effects of Yimmugo reported in 5% or more people in clinical trials include:

• headache
• upper respiratory tract infections
• fatigue
• nausea
• increased blood pressure.

Serious side effects

Yimmugo may cause serious side effects and comes with a Boxed Warning for thrombosis, renal dysfunction, and acute renal failure.

Thrombosis (blood clots) may occur following treatment with immune globulin intravenous (IGIV) products, including Yimmugo. The risk may be higher in seniors, with prolonged immobilization, with medical conditions that increase their risk of blood clots or a history of blood clots, using estrogens, indwelling catheters, hyperviscosity, and cardiovascular risk factors.

Kidney damage and toxicity which may be serious or rarely fatal have been reported with the administration of IGIV products in predisposed patients, those products that contain sucrose carry a higher risk. Yimmugo does not contain sucrose.

Your healthcare provider will assess your risk of thrombosis and kidney toxicity and if high, administer Yimmugo at the minimum dose and infusion rate practicable. You should be well-hydrated before administration. Call your healthcare provider immediately if you develop any signs or symptoms of thrombosis, such as shortness of breath, chest pain, a fast heartbeat, leg pain, or swelling. If you are at risk of developing kidney toxicity, your healthcare provider will monitor your kidney function, including blood urea nitrogen (BUN), serum creatinine, and urine output. Tell your healthcare provider right away if your urine output decreases, or you experience sudden weight gain, fluid retention/edema, and/or shortness of breath. Such symptoms may suggest kidney damage.

Also, tell your healthcare provider if you develop any of the following symptoms:

• a blood cell disorder--pale or yellowed skin, dark colored urine, fever, increased heart rate, confusion or weakness
• dehydration symptoms--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin
• kidney problems--little or no urination, swelling, rapid weight gain, feeling short of breath
• lung problems--chest pain, trouble breathing, blue-colored lips, fingers, or toes
• signs of a new infection--fever with a severe headache, neck stiffness, eye pain, and increased sensitivity to light
• signs of a blood clot--shortness of breath, chest pain with deep breathing, rapid heart rate, numbness or weakness on one side of the body, swelling, and warmth or discoloration in an arm or leg
• aseptic meningitis syndrome (AMS) which may include severe headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements, nausea, and vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to Grifols at 1-800-520-2807, the FDA at 1-800-FDA-1088, or www.fda.gov/medwatch.

Related/similar drugs

Hizentra, Gammagard Liquid, Privigen, immune globulin intravenous, Octagam, Cuvitru

Warnings

Should not be administered to people with a history of anaphylaxis or severe reactions to human immune globulin or IgA-deficient patients with antibodies to IgA and a history of hypersensitivity. Tell your healthcare provider at once if you develop hives, generalized urticaria, tightness of the chest, wheezing, or dizziness.

• Epinephrine should be available for immediate treatment of severe acute hypersensitivity reactions.

Hemolysis (the breakdown of red blood cells) can develop after Yimmugo infusions. People at higher risk include those receiving higher dosages of Yimmugo or of non-O blood group type. Your healthcare provider will monitor you for hemolysis.

Your healthcare provider will also monitor you for hyperproteinemia (high protein levels), increased serum viscosity, hyponatremia (low sodium levels) pseudo hyponatremia (false low sodium levels), aseptic meningitis syndrome (AMS), and pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]).

Yimmugo is made from donated human plasma and may contain infectious agents such as viruses, the variant Creutzfeldt-Jakob disease [vCJD] agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risks. 

Before taking

Tell your doctor about all your medical conditions and medications before taking Yimmugo. You may not be able to use this medicine if you:

• have had an allergic reaction to an immune globulin or blood product
• have immune globulin A (IgA) deficiency with antibody to IgA
• are pregnant or intending to become pregnant
• are breastfeeding.

Yimmugo can cause blood clots or kidney problems, especially in older adults or in people with certain conditions. Tell your doctor if you have ever had:

• heart problems, blood circulation problems, or "thick blood"
• a stroke or blood clot
• kidney disease
• diabetes
• an infection called sepsis
• or if you use estrogens (birth control pills or hormone replacement therapy); have been on long-term bedrest; or have a central intravenous (IV) catheter in place.

You may need a dose adjustment if you are exposed to measles, or if you travel to an area where this disease is common.

Pregnancy

No studies have been conducted regarding using Yimmugo in pregnant females. It is not known whether Yimmugo can harm an unborn baby or affect fertility. Talk to your healthcare provider about the risks versus benefits of using Yimmugo during pregnancy.

Breastfeeding

Immune globulins are excreted into human milk. Talk to your healthcare provider about the best way to feed your baby if you are receiving Yimmugo.

How is Yimmugo administered?

Yimmugo is given as an infusion into a vein, usually once every 3-4 weeks. A healthcare provider will give you this injection.

• Drink plenty of liquids while you are using immune globulin (intravenous) to help improve your blood flow and keep your kidneys working properly.
• You may need frequent blood or urine tests.
• This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Yimmugo.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Yimmugo injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Yimmugo?

Ask your doctor before receiving a "live" vaccine while using Yimmugo. The vaccine may not work as well and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

What other drugs will affect Yimmugo?

Yimmugo can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, bowel disorders, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).

• Loop diuretics, such as furosemide confound the results of serological testing.
• Yimmugo may interfere with the immune response to live vaccines (such as measles, mumps, rubella, and varicella). 
• Various passively transferred antibodies in immunoglobulin preparation may lead to misinterpretation of the results of serological testing.

Other drugs may affect Yimmugo, including hormones, prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Storage

Store Yimmugo refrigerated between 2°C to 8°C (36°F to 46°F) in its original carton to protect it from light.

May be kept out of the refrigerator for a single period at room temperature (more than 8°C and up to 25°C/more than 46°F and up to 77°F) for a single period not exceeding 6 months. Once the product has been taken out of the refrigerator, it must not be returned to the refrigerator. Please record the date of the beginning of storage at room temperature on the product carton.

Do not freeze. Do not use any solutions that have been frozen.

Do not use it after the expiration date.

Ingredients

Active ingredient: Human IgG (Immunoglobulin G) purified from human source plasma

Inactive ingredients: Water for injection, glycine (0.27 to 0.33 mmol/mL), polysorbate 80 (2 to 20 mcg/mL)

Yimmugo Screening Process:

Plasma Source: Pooled plasma from healthy volunteer donors collected at FDA-licensed facilities.

Plasma Testing: Each donation is tested negative for:

• Hepatitis B virus (HBV) surface antigen (HBsAg)
• Antibodies to human immunodeficiency virus (HIV) strains 1 and 2 (anti-HIV-1/2)
• Antibodies to the hepatitis C virus (anti-HCV)

Manufacturing Pool Testing: Additionally, samples from the manufacturing pool are tested for:

• HIV RNA, HCV RNA, HBV DNA, and Hepatitis A Virus (HAV) RNA (Nucleic Acid Amplification Testing, NAT) - Must be non-reactive
• Parvovirus B19 (B19V) DNA (NAT) - Must not exceed 104 IU/mL.

Additional Notes:

• Yimmugo contains not more than 300 mcg/mL of IgA and does not contain carbohydrate stabilizers (e.g., sucrose, maltose) or preservatives.
• The distribution of IgG subclasses is similar to that of normal plasma.
• Contains 100 ± 10 mg/mL protein, of which not less than 96% is IgG.
• The pH of Yimmugo ranges from 4.4 to 5.2 and osmolality ranges from 280 to 380 mOsmol/kg.

Yimmugo is supplied as a solution containing 10% IgG (100 mg/mL): 5 g in 50 mL, 10 g in 100 mL, 20 g in 200 mL. The components used in the Yimmugo packaging are not made with natural rubber latex.

Manufacturer

Biotest AG

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer