Gammagard

What is Gammagard?

Gammagard, a sterile solution made of human plasma, is available. It contains antibodies that help the body fight off infections from different diseases. Gammagard treats primary immune deficiency (PI) among adults and children aged two or more years. Gammagard can also be used to maintain muscle strength and improve disability in adults with multifocal neuropathy. MMN, a rare condition that causes progressive muscle weakness, is a disease with a high incidence. It is more common in the hands and lower arms than in the legs. There are several types of PIs. There are many types of PIs. Gammagard is a plasma product made from healthy human plasma. Gammagard contains antibodies that are collected from healthy donors and replace missing antibodies in patients with PI.

Warnings

Gammagard may cause blood clots. Blood clots are more likely to occur if there are risk factors, such as heart disease or blood circulation problems.

If you've ever:

• Signs that a blood clot is in the brain: sudden weakness or numbness (especially on one side), slurred or distorted speech, or problems with vision or equilibrium;
• Signs and symptoms of a blood clot in your heart or lung: chest discomfort, rapid heartbeat, sudden coughing, wheezing, or rapid breathing; or
• Signs of a Blood Clot in Your Leg: Pain, swelling, warmth, or redness on one or both legs

Immune globulin may also damage your kidneys. This is especially true if you have kidney disease and/or use other medications. Other drugs, including some over-the-counter medicines, can also harm the kidneys. If you notice any of the symptoms of a kidney disease, such as swelling, rapid growth in weight, or little or no urine, call your doctor immediately. Gammagard can help improve blood flow, which will keep your kidneys functioning properly.

Before you take this drug

Gammagard should not be used if you:

• You have experienced an allergic reaction to immune globulins or blood products.
• You have a deficiency of immune globulin A with antibodies to IgA.

Immune globulin may cause blood clots and kidney problems in certain people, particularly older adults or those with certain conditions.

Tell your doctor about any of the following to ensure that Gammagard will be safe for you:

• Heart problems, blood circulation issues or "thick blood";
• A stroke or blood clot
• Kidney disease
• Diabetes;
• Sepsis is an infection.
• If you are using estrogens (birth control pills and hormone replacement therapy),
• If you've been on bedrest for a long time,
• If you already have an intravenous central catheter (IV),

If you have been exposed to the measles or traveled to a region where it is prevalent, you may need to adjust your dose. Please inform your physician if you are expecting or breastfeeding. Gammagard, which is made of donated plasma from humans, may contain viruses and other infectious agents. Plasma is treated and tested to reduce the chance of contamination. However, there is still some risk. You should ask your doctor if there are any risks.

How to take Gammagard?

Gammagard can be injected through an IV or under the skin with an infusion pump. You may be taught how to inject at home. You should not inject this medicine yourself if you don't know how to properly give an injection. The condition you are treating will determine how you administer Gammagard and how often you receive the drug. Dosage instructions from your doctor are important. You should follow your doctor's instructions for how to mix and store your injections. Do not inject Gammagard in a vein if the doctor has instructed you to administer the medicine subcutaneously (under the skin). Gammagard comes complete with instructions to ensure safe and effective usage. Please follow the instructions carefully. If you have questions, ask your doctor or pharmacist. Gammagard should be administered slowly. You may have to use multiple catheters at once to inject the medicine into different areas of your body. Your healthcare provider will show you the best spots on your body for you to inject the medicine. Please follow your doctor's directions. Keep a journal of when and where you gave your injection.

Shaking the bottle can ruin the medicine. Do not prepare your dose until you are ready for an injection. Gammagard should not be mixed with any other medication in the same infusion. If the medication has become discolored or contains particles, do not use it. For new medicine, call your pharmacist. Before using, check the expiration dates on the container. Only use disposable injection items once (a needle or catheter). Ask your pharmacist how you can dispose of the puncture-proof container. Keep this container out of the reach of children and pets. While using Gammagard, you may need frequent blood tests. Gammagard can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Gammagard. Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Store Gammagard in the refrigerator or at room temperature. Do not freeze.

• if refrigerated: store at 2°C to 8°C [36°F to 46°F] for up to 36 months.
• if stored at room temperature: store at up to 25 °C [77 °F] for up to 24 months.

What happens if I miss the dose?

Call your doctor for instructions if you miss a dose.

What happens if I overdose?

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

What should be avoided?

Gammagard does not recommend receiving live vaccines such as measles, mumps and rubella (MMR), rotavirus, typhoid fever yellow fever varicella chickenpox zoster shingles vaccine as well as influenza vaccination (influenza vaccine).

Side effects of Gammagard

Be on the alert if you experience symptoms that suggest an adverse reaction from Gammagard: hives; wheezing; difficulty breathing; dizziness; feeling like passing out; swelling in your face, lips, tongue or throat. Seek medical assistance immediately in these instances. Some side effects may occur during the injection. Tell your caregiver if you feel light-headed, itchy, chilled, sweaty, or have chest discomfort, fast heartbeats, a severe headache, or pounding in your neck or ears.

Call your doctor at once if you have:

• A blood cell disorder: pale or yellowed skin, dark urine, fever, confusion, or weakness;
• Dehydration symptoms: feeling very thirsty or hot, being unable to urinate due to incontinence issues, excessive sweating or hot and dry skin conditions are just some of the indicators that you might be dehydrated;
• Kidney problems: short or no urination frequency, swelling, rapid weight gain and shortness of breath are symptoms.
• Lung problems: chest pain, wheezing, trouble breathing, blue-colored lips, fingers, or toes;
• Signs of new infection: fever with severe headache, neck stiffness, eye pain and increased light sensitivity;
• Signs of blood clot include shortness of breath, chest pain when deep breathing is conducted, rapid heart rate, numbness or weakness on one side of your body, swelling as well as warmth or discoloration in an arm or leg.

Gammagard can cause side effects that include runny or stuffy nose, sinus pain, cough and sore throat;

• Runny or stuffy nose, sinus pain, cough, sore throat;
• Fever, chills, weakness;
• Headache, back pain, muscle or joint pain;
• Dizziness, tiredness, and depressed mood;
• Swelling in your hands or feet;
• Skin rash, redness, or bruising;
• Do you suffer from blisters or ulcers in your mouth, red and swollen gums, difficulty swallowing;
• Nausea, diarrhea, stomach pain, upset stomach;
• Increased blood pressure;
• Redness, swelling or itching at the site where an injection was given are signs that treatment has taken effect.

These side effects may not be comprehensive; others may occur and should be reported immediately to a healthcare provider and FDA by calling 1-800-FDA-1088.

Interaction with other drug

Gammagard can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, bowel disorders, high blood pressure, Z pain, or arthritis (including Advil, Motrin, and Aleve).Other drugs, including prescription and over-the-counter medicines, vitamins, and herbal products may interact with immuno globulin; be sure to inform your healthcare provider of all medicines you're currently taking and any new ones you start or stop taking.